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MEET SANOFI Management
2
Forward Looking Statements
This presentation contains forward-looking statements as defined in the Private Securities Li...
MEET SANOFI Management
2015-2020 ROADMAP
Olivier Brandicourt
Chief Executive Officer
4
Agenda
Our vision for Sanofi
Sanofi’s path to success
Delivering performance
Many Elements Point towards a Favorable Outlook
for the Healthcare Industry despite Multiple Challenges
5
 Growing and ag...
6
Sanofi Has Important Strengths to Build On
in this Changing Environment
Launching
a strong set
of products
across multip...
7
Sanofi Also Has Challenges to Address
in Order to Succeed
Pressure on margins
Broad portfolio
Lantus® loss of exclusivit...
A New Strategic Direction for Sanofi Is Needed
to Change our Growth Trajectory
8
Sanofi is a global healthcare company foc...
9
Agenda
Sanofi’s path to success
Delivering performance
Our vision for Sanofi
We Have Four Strategic Priorities
10
Reshape
the portfolio
Deliver
outstanding
launches
Simplify the organization
Sustain
...
● Multiple Sclerosis(1)
● Oncology(1)
● Immunology(1)
● Consumer
Healthcare(2)
● Animal Health
● Generics(2)
in Europe
● D...
12
Committed to Diabetes and Cardiovascular Diseases
1 Develop the insulin franchise
4
3 Lead the market shift to managing...
13
Strengthening our R&D Portfolio in Diabetes
with Two In-Licensing Agreements
A
(1) SGLT2 (sodium-glucose cotransporter ...
Growing Faster than Market in Vaccines
14
A
Further develop strong vaccine brands
● Flu vaccines
● Pediatric combinations
...
Sustaining Leadership in Rare Diseases
15
A
● Sustain market share through patient-centered approach,
product differentiat...
Retaining #1 Position in Emerging Markets
through Greater Focus
16
Leader in Emerging Markets
● Increase focus on priority...
● Multiple Sclerosis(1)
● Oncology(1)
● Immunology(1)
● Consumer
Healthcare(2)
● Animal Health
● Generics(2)
in Europe
● D...
Growing our Multiple Sclerosis Franchise
18
● Successfully complete global
launches of Aubagio® and Lemtrada®
● Expand LCM...
Rebuilding a Competitive Position in Oncology
19
● Maximize clinical assets, particularly isatuximab
(anti-CD38 mAb) and A...
Sarilumab and Dupilumab Represent Cornerstones
of a New Immunology Franchise
20
● Multi-disease, best in class drug
target...
Shape
New
Categories
Prepare the potential
Rx-to-OTC switch
of Cialis®
Maximize
Existing
Brands
Manage with speed,
agility...
● Multiple Sclerosis(1)
● Oncology(1)
● Immunology(1)
● Consumer
Healthcare(2)
● Animal Health
● Generics(2)
in Europe
● D...
Explore Strategic Options for Two Businesses
23
C
● 2015e sales >€2.4bn
● Successful return to growth
(YTD +12.4% at CER)
...
24
2014-2020: Up to 18 Launches Planned
Deliver Outstanding Launches
(U.S.)
(U.S.)
patisiran
PR5I
Vaccine
VaccineShan5
ins...
Greater Focus on Six Major Launches
through GBU Structure
25
Focus on 6 Products … … and Excel in Execution
New GBU organi...
Sanofi Expects its Six Major Launches to Generate
Substantial Combined Sales
26
(1) At CER, non-risk adjusted sales projec...
0%
10%
20%
30%
40%
50%
60%
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29
Global Roll-out Underway and Showing Early
Promise in K...
Investing in a Broad LCM Program to Expand
the Evidence Base
28
Real Life Study Program
Establish the Value of Toujeo®
in ...
Transforming the Management
of Hypercholesterolemia
29
75 mg/1 mL pen 150 mg/1 mL pen
Building awareness &
education
Execu...
● About half of the world’s population lives
in dengue endemic regions(2)
● Recommended for the prevention of dengue
disea...
31
An Investigational Agent Combining Insulin
Glargine with Lixisenatide in a Daily Injection
FPG + PPG control
Statistica...
Sustain Innovation in R&D
32
● Sustain leadership:
Diabetes/CV, Vaccines,
Rare Diseases
● Build competitive
positions: Onc...
Further Expanding the R&D Pipeline Is a Key Objective
for the Next Phase
GZ402668
GLD52 (anti-CD52 mAb)
Relapsing multiple...
Simplify the Organization
34
4
Create
one
Sanofi
culture
Reshape
the plant
network
Move
to Global
Business
Unit
organizati...
 Diabetes
 Cardiovascular
Diabetes &
Cardiovascular
P. Witz
 Rare diseases
 Multiple
Sclerosis
 Oncology
 Immunology...
36
Reshaping Sanofi’s Plant Network
● Continue to reshape plant network
to match business evolution
● Implement a more foc...
Targeting Cost Savings of €1.5bn by 2018
Largely Reinvested to Support Growth
(1,2)
37
(1) The €1.5bn cost savings are at ...
38
Agenda
Sanofi’s path to success
Delivering performance
Our vision for Sanofi
The Roadmap for Sanofi
39
● Invest for the future
● Refocus the portfolio
● Execute launches
● Reinforce pipeline through
...
40
(1) Based on current group structure and at CER
Projected Evolution of Sanofi Sales over 2015-2020(1)
Diabetes &
Cardio...
41
Deploying Capital Effectively to Create Long Term Value
Balanced Capital Allocation Strategy to Support Growth and Retu...
By Delivering on Those Targets, We Will Create an Even
Stronger Company Positioned for Accelerated Growth
● Diversified, b...
MEET SANOFI Management
P&L RATIOS
& CAPITAL ALLOCATION
Jérôme Contamine
Executive Vice President, Chief Financial Officer
44
Agenda
P&L ratios
Capital allocation
Sanofi Is Investing in its Future
while Responding to Reduced Diabetes Expectations
● 2015-2020 sales CAGR of 3% to 4%(1)
...
46
(1) At CER
Gross Margin in 2018 Should Reach at Least 2015 Level(1)
despite Expected Headwinds
ILLUSTRATIVE
Manufacturi...
7.7
We have kept
R&D expenditures stable…
47
2011 2012 20142013
€4.8bn €4.9bn €4.8bn €4.8bn
14.4% 14.1% 14.5% 14.3%
R&D
to...
48
Range of
15% to 15.5%
Going forward,
we expect a slight increase
in R&D to sales ratio
2012-2015e 2016e-2018e
Range of
...
49
SG&A ratio is expected to remain stable
despite wave of new launches(1)
Similar
level
2015e 2016e-2018e
Range of
27.5% ...
Structuring a Global Cross Functional Organization
(Sanofi Business Services) and Globalizing the IT Function
50
One Sanof...
Accelerated Growth over 2018-2020
51
● Mid-single digit sales CAGR
● Growing sales contribution from launches
● Increased ...
52
Agenda
P&L ratios
Capital allocation
53
Deploying Capital Effectively to Create Long Term Value
Balanced Capital Allocation Strategy to Support Growth and Retu...
54
Investing to Expand Biologic Manufacturing Capabilities
Keeping tight control on CapEx(1)…
1
Investing between €1.8bn a...
55
€8.4bn
€7.4bn
€6.5bn
€7.2bn
~€6.5bn
2011 2012 2013 2014 2015e
Strong Balance Sheet and Free Cash Flow2
Net Debt
● Stron...
56
Sanofi Has Shown Financial Discipline in M&A Deals2
Value
(€m)
EPS
accretion
Value
creation
Build
critical mass
Strengt...
57
Seek Opportunities to Enhance Growth Profile
through Targeted M&A
2
M&A Scope
● Business development
opportunities
boos...
Evolution of Dividend
58
● Consistent history of dividend
payment
● 21st consecutive year of dividend
increase in 2014
● S...
59
Stock Repurchases Primarily to Absorb Dilution4
Share Buyback (€bn)
2015e
2014
~€1.5bn
€1.8bn
2013 €1.6bn
2012 €0.8bn
2...
Conclusion
● Balancing investment in Sanofi's future with response
to reduced diabetes expectations
● Simplification and s...
MEET SANOFI Management
SUSTAINING INNOVATION IN R&D
Elias Zerhouni, MD
President, Global R&D
Jorge Insuasty
Senior Vice Pr...
62
Agenda
Executing a clear R&D strategy
Next wave of innovation
Significant R&D Turnaround since 2012
(1) From first in human to approval
(2) Peptide, protein, nucleic acid based molecul...
The Two Pillars of Our Research Strategy
Translational Medicine
Open Innovation
Deep efforts in a
concentrated number
of p...
65
Continue to strengthen R&D
pipeline
A
C
D
B
Deliver a Balanced Pipeline… … Focused on GBU Priorities
Sustain Innovation...
0-2 years 5+ years3-5 years
TIME to Clinical Proof of Concept
Consolidation
Support actively our GBUs and
their competitiv...
Further Expanding the R&D Pipeline Is a Key Objective
for the Next Phase
67
N New Molecular Entity
Immunology
Rare Disease...
68
Agenda
Executing a clear R&D strategy
Next wave of innovation
Diabetes
Vaccines
Rare Diseases
1
2
3
4
69
Isatuximab - Multiple Myeloma
Immuno-oncology - Various oncology indications
5
...
MTD: Maximum Tolerated Dose
(1) Patients on monotherapy study had a median of 4 prior lines of treatment and all patients ...
71
New Strategic Alliance with Regeneron to Develop
Cancer Treatments in Emerging Field of IO
Establish Sanofi’s presence ...
IL4/IL13 Bi-specific Ab: Sanofi
IL4/IL13 Bi-specific Antibody (Ab): Demonstrated
Biological Activity and Encouraging Safet...
C. difficile Vaccine Targeting a High Risk Population
of 10 to 15 Million Elderly People in the U.S. Alone
● 660 volunteer...
Olipudase alfa – A Promising Investigational
Treatment for Niemann Pick type B
● Niemann Pick is a serious LSD(1)
characte...
Collaboration Provides Access to
Unique RNAi Opportunities
● ~50,000 patients worldwide
● FAP and FAC are the two predomin...
Patisiran: Familial Amyloidotic
Polyneuropathy
Patisiran: an Investigational IV Administered RNAi
Therapeutic to Treat the...
Revusiran: Familial Amyloidotic
Cardiomyopathy
● Positive Phase II results in TTR
cardiac amyloidosis patients(1)
● Phase ...
● Antithrombin (AT) is a key endogenous
anticoagulant
● Inactivates Factor Xa and thrombin
● Attenuates thrombin generatio...
Dual Agonists for GLP-1 and Glucagon/GIP Receptors
79
● Novel synthetic peptidic molecules
developed in-house
● Expected b...
80
Significant R&D Milestones Expected in the Next Year
80
Expected Regulatory Decisions Q4 2015 Q1 2016 Q2 2016 Q3 2016
●...
81
Transforming the Lives of Patients
by Delivering Innovative Therapies
Significant pipeline turnaround since 2012
 Tran...
MEET SANOFI Management
DIABETES
Pascale Witz
Executive Vice President, Diabetes & Cardiovascular
Pierre Chancel
Senior Vic...
83
Agenda
Sanofi’s global diabetes leadership
A broad and growing portfolio
Significant unmet medical needs
North America
and Caribbean
Europe
Western Pacific
South and
Central America
South East Asia
Middle East and
North Africa
...
1 healthcare $
in 9
is spent on diabetes
77% of people
with diabetes live
in low- and middle-
income countries
Every 7 sec...
Diabetes Patients in the U.S. (Random Sample)
Despite Treatment, Many Patients with Diabetes
Are Still not at A1c Goal(1)
...
Inappropriate Diabetes Management Leads to Costly
Consequences
87
Microvascular
Complications
● Diabetic Retinopathy
● Dia...
88
Agenda
Sanofi’s global diabetes leadership
A broad and growing portfolio
Significant unmet medical needs
A Sizeable Presence in Diabetes Built on Lantus®,
our Insulin Flagship Brand
Global diabetes sales expected to decline at ...
Global Diabetes Sales Account for 20% of Group Sales
in the First 9 Months of 2015
20.4%79.6%
57%
43%
U.S. ex U.S.
Diabete...
48.0%
32.6%
19.3%
Basal Insulins Constitute the Leading Insulin Segment
Across All Geographies
91
June MAT 2015 Insulin Ma...
64.4%13.1%
9.6%
12.9%
70.5%
25.5%
Toujeo®
0.2%
3.8%
56.4%
13.9%
1.4%
28.3%
61.4%23.3%
3.9%
11.4%
June MAT 2015 Basal Insul...
31%
43%
46%
37%
23%
20%
0%
10%
20%
30%
40%
50%
2004 YTD June 2015
% of sales Basal Premix SAI
Insulin Market by Insulin Ty...
94
Agenda
Sanofi’s global diabetes leadership
A broad and growing portfolio
Significant unmet medical needs
95
Broadening our Portfolio to Sustain a Leadership Position
in Diabetes
1 Establish next generation of basal insulins
2
I...
A Compelling Value Proposition
(1) Toujeo® Prescribing Information, February 2015
Introducing, from the Makers of Lantus®
...
0
2000
4000
6000
8000
10000
12000
14000
16000
0%
10%
20%
30%
40%
50%
60%
Basal Market NBRx Shares(2)
week of April 3 - wee...
Rapid Market Access Obtained in the U.S.
98
Toujeo® Market Access
as of October 1, 2015
% Lives Covered
17%
69%
0%
20%
40%...
0%
1%
2%
3%
4%
5%
6%
7%
8%
-6%
-4%
-2%
0%
2%
4%
6%
8%
Germany Showing the Way for Other
EU Launches
99
Levemir® and Tresib...
EM and
Rest of
World
Global Launch Continues in EU, EM and RoW
100
(1) The brandname of Toujeo® in Japan is Lantus® XR: la...
Real-Life Study Program to Expand
the Evidence Base
● Insulin-naïve T2D patients
(U.S.)
● Target enrolment: 3,270
● Primar...
102
An Investigational Agent Combining Insulin
Glargine with Lixisenatide in a Daily Injection
FPG + PPG control
Statistic...
Significant Opportunity in Type 2 Diabetes
Supported by Two Positive Phase III Studies
103
Patients
Uncontrolled
with Basa...
Important Options for Prandial Diabetes Treatment
104
● Once-daily prandial GLP-1 for Type 2 Diabetes(1)
● Positive ELIXA ...
Innovative Treatment
Option for Diabetes
Continued Focus on Gaining Market Access,
Building Awareness and Appropriate Usag...
Diabetes Integrated Care: Significant Potential to Improve
Patients’ Lives
● Leader in the technology space
● Data analyti...
107
2000
basal insulin
2004
rapid-acting
injectable
insulin
2014
rapid-acting
inhaled
insulin
®
2015
new basal
insulin
201...
MEET SANOFI Management
PRALUENT®
Pascale Witz
Executive Vice President, Diabetes & Cardiovascular
Ophra Rebière
Vice Presi...
109
Agenda
Significant unmet need and cost burden
Strong and differentiated product profile
Initial uptake gradual as expe...
Cardiovascular Disease Is a Major Health and Economic
Burden with Uncontrolled LDL-C Being a Key Risk Factor
110
ACS: Acut...
111
Agenda
Significant unmet need and cost burden
Strong and differentiated product profile
Initial uptake gradual as expe...
112
Significant and Consistent LDL-C Reduction in
Five Double-Blind, Placebo-Controlled Trials(1)
Praluent® is developed a...
113
Praluent® is developed and commercialized in collaboration with Regeneron
(1) In the pooled analysis of 6 studies with...
114
Approved in the U.S. and EU in High CV Risk
Hypercholesterolemic Patients(1)
Approved in EU on September 25, 2015
 In...
U.S. Label Criteria Represent 90% of Patients in
the ODYSSEY Clinical Trial Population(1)
115
Praluent® is developed and c...
HeFH Patients
(~0.5m)
● Well defined population
● Diagnosed with HeFH
(~0.1m)
Eligible U.S. Hypercholesterolemic Patient
P...
Treatment Population in the U.S.
Influenced by Many Factors
117
Praluent® is developed and commercialized in collaboration...
118
Agenda
Significant unmet need and cost burden
Strong and differentiated product profile
Initial uptake gradual as expe...
Early Success with U.S. Payer Access
● Praluent® offers significant medical
value to patients and payers
● Projected to be...
● Copay support
(commercial)
● Patient Assistance
Program (uninsured)
● Copay foundation referrals
● Praluent® free of cha...
121
U.S. Comprehensive Support Hub
Tracking Ahead of Expectations
● Majority of patients enrolled
by specialists
● Around ...
U.S. Launch Gradual as Market Access
and Awareness Accelerate
● Specialty pharmacy dispensing expected
to accelerate
● Bol...
123
Agenda
Significant unmet need and cost burden
Strong and differentiated product profile
Initial uptake gradual as expe...
ODYSSEY OUTCOMES Expected to Be Fully
Enrolled by Q4 2015
Praluent® is developed and commercialized in collaboration with ...
125
ODYSSEY OUTCOMES Second Interim Analysis
Expected in H2 2016
● ODYSSEY OUTCOMES trial design published in
Nov 2014(1,2...
Global Launch Outside U.S. Ongoing
126
H2 2015 2016
JapanCanada
Italy Spain France
EU 5
Rest of
World
Germany UK
Praluent®...
Leadership in the PCSK9 Market
127
2015
Launch Focus
Gradual Uptake Expected
2016-2017
Future Opportunity
Expansion and Ac...
MEET SANOFI Management
RARE DISEASES & MULTIPLE SCLEROSIS
David Meeker, MD
Executive Vice President, CEO Genzyme
Richard P...
129
Agenda
Genzyme: a success story
Rare Diseases: an untapped opportunity
Multiple Sclerosis: a fast-growing player
Inspired by the Potential to Improve Patients' Lives
130
Milena , Argentina
Gaucher Disease
Dean , Australia
Multiple Scle...
131
● Strong historic growth: >25%
per year over 2012-2015
● Leading position in Rare Diseases
● Growing presence in Multi...
132
A Successful Model for Productive R&D Collaborations
132
● World-class RNAi therapeutic technology
● Focus on genetic ...
133
2015-2020
Rare Diseases and MS Will Remain Key Growth Drivers
>€2.0bn
2020e
>€6.0bn
~€3.5bn
2015e
>€4.0bn
Multiple
Scl...
134
Agenda
Genzyme: a success story
Rare Diseases: an untapped opportunity
Multiple Sclerosis: a fast-growing player
Fabry ~90%
Diagnosed Total
Treated
Genzyme
Treated
3,2006,00010,000
Pompe ~95%
Diagnosed Total
Treated
Genzyme
Treated
2,4...
Clear Strategies to Sustain Leadership in Rare Diseases
● Focus on hematologists
● Apply proven screening
protocols
● Faci...
Rare Diseases Franchise Sustained Leadership(1)
in YTD Sep 2015
137
Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 201...
138
● Encouraging performance in first year after U.S. launch
● Almost 1/3 of Genzyme’s Gaucher portfolio in the U.S.
● U....
GZ402666
Neo GAA
Pompe Disease
Olipudase alfa
rhASM
Niemann-Pick type B
Patisiran(2) (ALN-TTR02)
siRNA targeting TTR
Famil...
● Niemann-Pick is a serious lysosomal
storage disorder, characterized by fat
deposits in spleen and liver
● Patient identi...
Hemophilia: a $10bn Market Set to Face Substantial
Changes
141
(1) World Federation of Hemophilia Annual Global Survey 201...
● Antithrombin (AT) is a key endogenous
anticoagulant
● Inactivates Factor Xa and thrombin
● Attenuates thrombin generatio...
143
Genzyme Is the Long-Established Leader and Innovator
in the Rare Diseases Area
Rare diseases sales have grown by +12% ...
144
Agenda
Genzyme: a success story
Rare Diseases: an untapped opportunity
Multiple Sclerosis: a fast-growing player
42 years-old 52 years-old
Brain MRI Reveals Significant Progression
of Atrophy over 10 Years(1)
145
(1) Courtesy of Beth F...
146
A Large and Growing Global MS Market
(1) Reported sales of Copaxone® (Teva), Avonex® (Biogen), Rebif® (Merck Serono), ...
Multiple Sclerosis Franchise Sales Annualizing Over €1bn(1)
147
Genzyme Multiple Sclerosis Sales
Q1 2013 Q2 2013 Q3 2013 Q...
148
37.5%62.5%
Oral
Therapies
Injectable
Therapies
Making Steady TRx Share Gains
Aubagio® Has Become the Fastest
Growing O...
149
A Successsful New Global Campaign
● Approved in more than 50 countries
● >40,000 people treated with Aubagio®
worldwid...
Significantly Reduced Brain Volume Loss
in Relapsing Multiple Sclerosis(1)
RR: Releapse Rate
(1) SIENA analysis of the TEM...
151
Potential to Transform MS Patients’ Lives
● Approved in more than 40 countries
● Extensive clinical development progra...
Core Study Extension Study
Durable Clinical Efficacy Through 5 Years
● 68% of patients did not receive additional
Lemtrada...
Key Drivers Q3 Q4
HCP Materials & Programs Package Insert
Incorporating Brand
Messaging
Consumer Materials X 
Patient Acq...
154
Our Strategy to Grow our Multiple Sclerosis Franchise
● Successfully complete global launches of Aubagio® and Lemtrada...
MEET SANOFI Management
VACCINES
Olivier Charmeil
Executive Vice President, Vaccines
Damian Braga
Senior Vice President, Co...
156
Agenda
The Vaccines market
Sanofi Pasteur growth perspectives
A balanced R&D pipeline
157
Immunization Is One of the Most Successful
and Cost-effective Health Interventions
A successful vaccination program ad...
A Concentrated Market with Sanofi Pasteur Ranking #1(1)
in Several Areas
Others
2014 World Vaccine Market Sales(2)
~€21bn
...
● Continuously increasing GMP standards for batch release
by Health Authorities
● Market access often requires local manuf...
160
Evolving Immunization Policies Are Creating Significant
Growth Opportunities
160
Level of coverage
Market maturity IPV...
161161
~5%
CAGR
2015e 2020e
Projected Market Growth(1) Projected Industry Growth Drivers
1
Launch of innovative vaccines t...
162
Agenda
The Vaccines market
Sanofi Pasteur growth perspectives
A balanced R&D pipeline
2015/11 - Meet Sanofi Management
2015/11 - Meet Sanofi Management
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2015/11 - Meet Sanofi Management
2015/11 - Meet Sanofi Management
2015/11 - Meet Sanofi Management
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2015/11 - Meet Sanofi Management
2015/11 - Meet Sanofi Management
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2015/11 - Meet Sanofi Management

  1. 1. MEET SANOFI Management
  2. 2. 2 Forward Looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
  3. 3. MEET SANOFI Management 2015-2020 ROADMAP Olivier Brandicourt Chief Executive Officer
  4. 4. 4 Agenda Our vision for Sanofi Sanofi’s path to success Delivering performance
  5. 5. Many Elements Point towards a Favorable Outlook for the Healthcare Industry despite Multiple Challenges 5  Growing and aging population  Unmet medical needs remain high  Improved R&D productivity across the industry  Exciting time scientifically  Rising middle class in Emerging Markets  Empowered patients  Affordability is a key concern globally  Price pressure from payers in developed markets  Biosimilar threat and risk of interchangeability  Slowdown in economic growth in Emerging Markets  More focused competitors building leadership positions ChallengesOpportunities
  6. 6. 6 Sanofi Has Important Strengths to Build On in this Changing Environment Launching a strong set of products across multiple TAs Leading positions in Diabetes, Vaccines, Rare Diseases, Emerging Markets Record of building leading brands: Lantus®, Fluzone®, Cerezyme® Successful in sourcing external innovation: Regeneron, Alnylam, Voyager Strong skills for managing mature businesses Making credible entry in new TAs e.g. Multiple Sclerosis TA: Therapeutic Areas
  7. 7. 7 Sanofi Also Has Challenges to Address in Order to Succeed Pressure on margins Broad portfolio Lantus® loss of exclusivity Limited breadth of pipeline Complexity 1 2 3 4 5
  8. 8. A New Strategic Direction for Sanofi Is Needed to Change our Growth Trajectory 8 Sanofi is a global healthcare company focused on disease prevention and treatment ● DIVERSIFIED in Pharmaceuticals, Vaccines and Consumer Healthcare ● FOCUSED on 5 GBUs(1) ● INNOVATIVE to sustain long term growth ● SIMPLIFIED as an organization (1) Diabetes/Cardiovascular, General Medicines and Emerging Markets, Specialty Care, Vaccines, Animal Health Our Vision for Sanofi
  9. 9. 9 Agenda Sanofi’s path to success Delivering performance Our vision for Sanofi
  10. 10. We Have Four Strategic Priorities 10 Reshape the portfolio Deliver outstanding launches Simplify the organization Sustain innovation in R&D 1 2 3 4
  11. 11. ● Multiple Sclerosis(1) ● Oncology(1) ● Immunology(1) ● Consumer Healthcare(2) ● Animal Health ● Generics(2) in Europe ● Diabetes/CV ● Vaccines ● Rare Diseases(1) ● Emerging Markets(2) Reshape the Portfolio 11 1 Explore strategic options CA Sustain leadership Build competitive positions B (1) Will be part of Specialty Care Global Business Unit (2) Will be part of General Medicines and Emerging Markets Global Business Unit
  12. 12. 12 Committed to Diabetes and Cardiovascular Diseases 1 Develop the insulin franchise 4 3 Lead the market shift to managing diabetes outcomes A Google Life Sciences 2 Strengthen the pipeline through external opportunities and ambitious research Transform the management of hypercholesterolemia Ambition to grow Diabetes franchise beginning in 2019(1) Praluent® multi-blockbuster potential (1) Diabetes sales are expected to decline at an average annualized rate of -4% to -8% at CER over 2015-2018 Icons designed by Freepik
  13. 13. 13 Strengthening our R&D Portfolio in Diabetes with Two In-Licensing Agreements A (1) SGLT2 (sodium-glucose cotransporter type 2) is a transporter responsible for most of the glucose reabsorption performed by the kidney SGLT1 (sodium-glucose cotransporter type 1) is a transporter responsible for glucose and galactose absorption in the gastrointestinal tract, and to a lesser extent than SGLT2, glucose reabsorption in the kidney (2) Subject to customary closing conditions (3) LAPS CA-Exendin-4 analog T1DM: Diabetes mellitus type 1 Sotagliflozin - Phase II in T2 Diabetes Phase III in T1 Diabetes ● Dual SGLT1 and SGLT2 inhibitor(1) ● Limiting meal time glucose absorption and increasing renal glucose excretion ● Oral administration ● Adjunct therapy to insulin in T1DM ● Favorable safety profile Immunology Efpeglenatide – Phase II ● Long acting GLP-1(3) ● Diabetes/Obesity ● Weekly/monthly administration LAPS Insulin 115 (HM12470) – Phase I ● Long acting insulin ● Less side-effects (hypoglycemia, obesity) ● Weekly administration LAPS Insulin Combo – Pre-clinical ● Long acting insulin + efpeglenatide combination ● Weekly administration (2)
  14. 14. Growing Faster than Market in Vaccines 14 A Further develop strong vaccine brands ● Flu vaccines ● Pediatric combinations ● Adult boosters Successfully launch Dengvaxia® Expand our manufacturing capacity Deliver novel high-value vaccines e.g. C. diff vaccine 2015e2014 €4.0bn 2020e Pediatric & boosters Flu Dengue ~75% of sales Projected Sanofi Pasteur Sales ~€4.7bn 1 2 3 4 High single digit sales CAGR at CER
  15. 15. Sustaining Leadership in Rare Diseases 15 A ● Sustain market share through patient-centered approach, product differentiation and market access ● Grow market through patient screening and manufacturing expansion ● Advance internal and partnered novel pipeline Sales CAGR for Rare Diseases expected at high single digit at CER over 2015-2020 1 2 3 Undiagnosed(1) Undiagnosed(1) Undiagnosed(1) (1) Genzyme internal analysis. Include China and India
  16. 16. Retaining #1 Position in Emerging Markets through Greater Focus 16 Leader in Emerging Markets ● Increase focus on priority countries/regions ● Prioritize resource allocation ● Adapt industrial footprint ● Redefine scope to exclude Eastern Europe(1) ● Win the emerging middle class ● Innovate specifically for Emerging Markets ● Optimize trade and channel management #3 in China #1 in Brazil #2 in Russia #4 in India #2 in Mexico A EM sales ~€10.8bn in 2015e ~29% of Group sales(1) A top 3 MNC player in BRIC-M 1 2 3 4 MNC: Multinational corporation (1) World excluding U.S., Canada, Western & Eastern Europe (except Russia, Ukraine, Georgia, Belarus and Armenia), Japan, South Korea, Australia, New Zealand and Puerto Rico
  17. 17. ● Multiple Sclerosis(1) ● Oncology(1) ● Immunology(1) ● Consumer Healthcare(2) ● Animal Health ● Generics(2) in Europe ● Diabetes/CV ● Vaccines ● Rare Diseases(1) ● Emerging Markets(2) Reshape the Portfolio 17 1 Explore strategic options CA Sustain leadership Build competitive positions B (1) Will be part of Specialty Care Global Business Unit (2) Will be part of General Medicines and Emerging Markets Global Business Unit
  18. 18. Growing our Multiple Sclerosis Franchise 18 ● Successfully complete global launches of Aubagio® and Lemtrada® ● Expand LCM activities to maximize support to existing products ● Reinforce presence in “high efficacy” category ● Enter the neuroprotection/ remyelination segment B Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Série2 Série1 Multiple Sclerosis Franchise Reported sales (€m) €923m ® 1 2 3 4 Ambition to double the size of the MS franchise from 2015 to 2020 LCM: Life Cycle Management
  19. 19. Rebuilding a Competitive Position in Oncology 19 ● Maximize clinical assets, particularly isatuximab (anti-CD38 mAb) and Antibody-Drug Conjugates ● Build a transformative pipeline ● Immuno-oncology collaboration with Regeneron ● Collaboration with BioNTech on mRNA therapeutics ● Rebuild critical mass Oncology Opportunity Largest therapeutic area for pharmaceuticals Strong growth driven by unmet need and groundbreaking science B 1 2 3 ADCs: Antibody-Drug Conjugates
  20. 20. Sarilumab and Dupilumab Represent Cornerstones of a New Immunology Franchise 20 ● Multi-disease, best in class drug targeting Th2 pathway ● Breakthrough treatment for atopic dermatitis ● Further opportunities in asthma and nasal polyposis ● Multi-blockbuster potential across key indications ● FDA submission in AD planned for Q3 2016 Immunology B ● Entering an €18bn RA market where unmet need is still high ● IL-6 class >€1bn in sales and growing >20% ● Aim to be preferred 2nd line for TNF-IR patients and preferred monotherapy ● Goal to differentiate through dosing, bone impact ● Recently submitted to FDA RA: Rheumatoid Arthritis TNF-IR: TNF inadequate responders AD: Atopic Dermatitis
  21. 21. Shape New Categories Prepare the potential Rx-to-OTC switch of Cialis® Maximize Existing Brands Manage with speed, agility and consumer focus 1 2 Build Scale in a Fragmented CHC Market 21 (1) Nicholas Hall & Company, FY 2014 B Ranked #5 in the ~€100bn OTC Market (1) 3.2% Taisho Reckitt Benckiser Pfizer J&J GSK Bayer Takeda Boehringer Ingelheim P&G Other Build Scale through Bolt-on Acquisitions Reach critical scale in key countries and priority categories 3
  22. 22. ● Multiple Sclerosis(1) ● Oncology(1) ● Immunology(1) ● Consumer Healthcare(2) ● Animal Health ● Generics(2) in Europe ● Diabetes/CV ● Vaccines ● Rare Diseases(1) ● Emerging Markets(2) Reshape the Portfolio 22 1 Explore strategic options CA Sustain leadership Build competitive positions B (1) Will be part of Specialty Care Global Business Unit (2) Will be part of General Medicines and Emerging Markets Global Business Unit
  23. 23. Explore Strategic Options for Two Businesses 23 C ● 2015e sales >€2.4bn ● Successful return to growth (YTD +12.4% at CER) ● One of the most profitable AH companies ● Ranks #1 in companion animals and #4 overall ● But limited synergies with other businesses in Sanofi Merial Generics in Europe ● 2015e sales ~€1bn(1) ● Above average profitability of Generics businesses ● Ranked #5 in Europe, few geographic synergies (limited US presence) ● But consolidating market and increased complexity (biosimilars, differentiated Gx) 23 AH: Animal Health (1) Western and Eastern Europe
  24. 24. 24 2014-2020: Up to 18 Launches Planned Deliver Outstanding Launches (U.S.) (U.S.) patisiran PR5I Vaccine VaccineShan5 insulin lispro Rotavirus Vaccine Launched Feb 2014 - Feb 2015 Other upcoming launchesFocus on Six Launches 2 isatuximab
  25. 25. Greater Focus on Six Major Launches through GBU Structure 25 Focus on 6 Products … … and Excel in Execution New GBU organization with clear accountability, P&L ownership and life cycle management to focus on: ● Delivering differentiated products rapidly ● Shaping the market ● Securing market access ● Driving uptake
  26. 26. Sanofi Expects its Six Major Launches to Generate Substantial Combined Sales 26 (1) At CER, non-risk adjusted sales projections through 2025 Expected combined peak sales of €12bn to €14bn(1) Sales Potential of Six Key Products
  27. 27. 0% 10% 20% 30% 40% 50% 60% 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 Global Roll-out Underway and Showing Early Promise in Key Markets 27 0% 1% 2% 3% 4% 5% 6% 7% 8% 1 3 5 7 9 11 13 15 17 19 21 23 25 Weekly NBRx Share within Basal Market(1) Lantus® 50.9% Levemir® 26.3% NPH 9.0% Weekly Sell Out Share (in Units/Packs) within Basal Market(2) 7.1% Levemir® and Tresiba® are Novo Nordisk brands (1) Basal market includes Toujeo®, Lantus®, Levemir® and NPH - Source: IMS Weekly - Data week of April 3 - week of Oct 16, 2015 (2) Insight Health Germany (Retail Apo-Weekly-Pharma) – All data including parallel trade; Toujeo® week of May 5 - Oct 27, 2015; Tresiba® week of April 29 - Oct 21, 2014 Weeks from Toujeo® Launch Weeks from Launch 3.8% Tresiba® Additional launches in Q3 in Japan, Canada, U.K. and other EU countries 13.7%
  28. 28. Investing in a Broad LCM Program to Expand the Evidence Base 28 Real Life Study Program Establish the Value of Toujeo® in Real World Clinical Practice Committed to a Phase IIIb/IV Program to Be Submitted to Health Authorities ● To enhance U.S. label ● To get deeper competitive data ● Start planned for 2016, data from 2017-to-2018 New Pen Device under Development ● Higher single maximum daily dose and greater capacity ● Initial results expected in 2017, extended follow-up findings in 2018 LCM: Life Cycle Management
  29. 29. Transforming the Management of Hypercholesterolemia 29 75 mg/1 mL pen 150 mg/1 mL pen Building awareness & education Executing centralized patient initiation & distribution model in the U.S. Gaining U.S. market access Driving appropriate use & adherence 2015 Launch Focus Gradual Uptake Expected ● EU top 5 launches planned in Q4 2015 and 2016 ● ODYSSEY OUTCOMES interim efficacy analysis(1) expected in H2 2016 ● ODYSSEY OUTCOMES study completion expected in late 2017 ● Real world and life cycle studies to support market access and value for sub-populations 2016 - 2017 Future Opportunity Expansion and Acceleration Praluent® is developed and commercialized in collaboration with Regeneron (1) Second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred
  30. 30. ● About half of the world’s population lives in dengue endemic regions(2) ● Recommended for the prevention of dengue disease in individuals 9 years and older living in endemic areas(3) ● Pooled efficacy data demonstrate(3) ● 65.5% protection against all 4 dengue serotypes ● 93.2% prevention against severe dengue ● 80.8% prevention of hospitalization due to dengue ● Potential to reduce disease burden by about 50% within 5 years if 20% of a country population is vaccinated in endemic countries(4,5) (1) Under regulatory review in major endemic countries in Asia and South America (2) WHO, 2015, Dengue Fact Sheet (3) Follow-up to 25 months post dose-1; Study population aged 9 to 16 years of age. Hadinegoro SR. et al. NEJM, 2015 Safety analyses showed similar reporting rates between the vaccine and control groups during clinical studies (4) Coudeville L et al. ASVAC 2015 (5) Coudeville L et al. SLIPE 2015 (6) Bhatt, 2013, Nature 30 The First Ever Dengue Vaccine(1) Make dengue the next vaccine-preventable disease Global Evidence Consensus Risk & Burden of Dengue - 2010(5) Complete absence Complete presence
  31. 31. 31 An Investigational Agent Combining Insulin Glargine with Lixisenatide in a Daily Injection FPG + PPG control Statistically significant A1c reduction versus components More patients with A1c <7% Weight neutral versus insulin glargine Reduced nausea versus lixisenatide alone No additional incidence of hypos vs. basal Fixed Ratio Combination of Two Active Components Single Once Daily Injection = Expected key regulatory submissions: U.S. Q4 2015 & EU Q1 2016 PPG: Post-Prandial Glucose FPG: Fasting Plasma Glucose
  32. 32. Sustain Innovation in R&D 32 ● Sustain leadership: Diabetes/CV, Vaccines, Rare Diseases ● Build competitive positions: Oncology, MS, Immunology ● Invest opportunistically: Neurodegeneration/pain, Infectious Diseases and Ophthalmology Continue to strengthen R&D pipeline A C D B Deliver a Balanced Pipeline… … Focused on GBU Priorities 3 Increasing annual R&D investments up to €6bn by 2020 while maintaining financial discipline Foster existing R&D collaborations (REGN, ALNY) Increase capacity for external innovation Implement the R&D 2.0 model
  33. 33. Further Expanding the R&D Pipeline Is a Key Objective for the Next Phase GZ402668 GLD52 (anti-CD52 mAb) Relapsing multiple sclerosis GZ402666 neo GAA Pompe Disease SAR113244 Anti-CXCR5 mAb Systemic lupus erythematosus SAR339375 Anti-miR21 RNA Alport syndrome GZ389988 TRKA antagonist Osteoarthritis SAR439774 (ALN-AT3) siRNA targeting Anti-Thrombin Haemophilia SAR425899 GLP-1R/GCGR dual agonist Diabetes SAR228810 Anti-protofibrillar AB mAb Alzheimer’s disease SAR438335 GLP-1R/GIPR dual agonist Diabetes SAR422459 ABCA4 gene therapy Stargardt disease SAR566658 Maytansin-loaded anti-CA6 mAb Solid tumors UshStat® Myosin 7A gene therapy Usher syndrome 1B SAR408701 Anti-CEACAM5 ADC Solid tumors SAR366234 EP2 receptor agonist Elevated intraocular pressure SAR439684 PD-1 inhibitor Cancer Streptococcus pneumonia Meningitis & pneumonia vaccine SAR428926 LAMP-1 inhibitor Cancer Herpes Simplex Virus Type 2 HSV-2 vaccine SAR439152 Myosin inhibitor Hypertrophic cardiomyopathy Phase I N N N 33 N N N N N N N N N N N N N N dupilumab Anti-IL4Rα mAb Nasal polyposis; Eosinophilic oesophagitis GZ402671 Oral GCS Inhibitor Fabry Disease SAR156597 IL4/IL13 Bi-specific Ab Idiopathic pulmonary fibrosis olipudase alfa rhASM Niemann-Pick type B sarilumab Anti-IL6R mAb Uveitis Rabies VRVg Purified vero rabies vaccine Combination ferroquine / OZ439 Antimalarial Meningitis ACYW conj. 2nd generation meningococcal conjugate infant vaccine isatuximab Anti-CD38 naked mAb Multiple myeloma Tuberculosis Recombinant subunit vaccine Fluzone® QIV HD Quadrivalent inactivated influenza vaccine - High dose Phase II N N N N N LixiLan lixisenatide + insulin glargine Fixed-Ratio / Type 2 diabetes SAR342434 insulin lispro Type 1+2 diabetes sarilumab Anti-IL6R mAb Rheumatoid arthritis, EU dupilumab Anti-IL4Rα mAb Atopic dermatitis, Asthma patisiran (ALN-TTR02) siRNA inhibitor targeting TTR Familial amyloidotic polyneuropathy revusiran (ALN-TTRsc) siRNA inhibitor targeting TTR Familial amyloidotic cardiomyopathy Jevtana® cabazitaxel Metastatic prostate cancer (1L) Clostridium difficile Toxoid vaccine Rotavirus Live attenuated tetravalent Rotavirus oral vaccine VaxiGrip® QIV IM Quadrivalent inactivated influenza vaccine (3-36 months) Phase III N N N N N Registration lixisenatide GLP-1 agonist Type 2 diabetes, U.S. sarilumab Anti-IL6R mAb Rheumatoid arthritis, U.S. Dengvaxia® Mild-to-severe dengue fever vaccine PR5I DTP-HepB-Polio-Hib Pediatric hexavalent vaccine, U.S., EU VaxiGrip® QIV IM Quadrivalent inactivated influenza vaccine (3 years+) N N New Molecular Entity Immunology Rare Diseases Oncology Diabetes Vaccines Infectious Diseases Cardiovascular Diseases Neurodegenerative Diseases Ophthalmology Multiple Sclerosis N
  34. 34. Simplify the Organization 34 4 Create one Sanofi culture Reshape the plant network Move to Global Business Unit organization
  35. 35.  Diabetes  Cardiovascular Diabetes & Cardiovascular P. Witz  Rare diseases  Multiple Sclerosis  Oncology  Immunology Sanofi Genzyme (Specialty Care) D. Meeker  CHC  Established products  Generics General Medicines & Emerging Markets P. Guenter Sanofi Pasteur (Vaccines) O. Charmeil Merial (Animal Health) C. Hellmann  Human vaccines  Animal Health products  Emerging Markets(1) & A New Organizational Model Is a Necessary Step to Drive Focus and Simplification 35 (1) All pharmaceutical businesses in Emerging Markets to report to General Medicine & Emerging Markets GBU (2) Global functions include Research & Development, Industrial Affairs, Finance, Human Resources, Business Development & Strategy, External Affairs, Information Systems, Medical, Legal, Compliance, Procurement (not an exhaustive list of functions) (3) The process of legal and social consultation will be followed as required  Similar to R&D and Industrial Affairs, all functions will be globalized(2) New organization implemented beginning in January 2016(3)
  36. 36. 36 Reshaping Sanofi’s Plant Network ● Continue to reshape plant network to match business evolution ● Implement a more focused approach in Emerging Markets ● Improve competitiveness ● Simplify product lines ● Invest in biologics in support of launches and growth 1 2 70 52 2008 2015Achieved Restructuring 102 Investments/ Transfers 6 -26 Acquisitions Merial PharmaceuticalsGenzyme Sanofi Pasteur Industrial Footprint Evolution # of sites
  37. 37. Targeting Cost Savings of €1.5bn by 2018 Largely Reinvested to Support Growth (1,2) 37 (1) The €1.5bn cost savings are at CER, before inflation and tax on a constant structure basis and by 2018. (2) The majority of these savings will be reinvested to launch biologics and to support growing businesses ● Significant investments required to launch biologics and to support growing businesses ● To balance the need for increased resources and to partly offset reduced diabetes sales expectations, Sanofi aims to generate cost savings of €1.5bn by 2018 ● 2/3 to come from simplification of the organization worldwide and from a more focused portfolio  50% of savings from Gross Margin  50% of savings from SG&A ● 1/3 to come from investment prioritization Source of cost savings
  38. 38. 38 Agenda Sanofi’s path to success Delivering performance Our vision for Sanofi
  39. 39. The Roadmap for Sanofi 39 ● Invest for the future ● Refocus the portfolio ● Execute launches ● Reinforce pipeline through business development ● Simplify the organization ● Accelerate growth from priority launches ● Continue to build scale in priority businesses ● Capture margin improvement 11 22 2018-20 Accelerate growth 2015-17 Reshape Sanofi
  40. 40. 40 (1) Based on current group structure and at CER Projected Evolution of Sanofi Sales over 2015-2020(1) Diabetes & Cardiovascular Sanofi Genzyme (Specialty Care) General Medicines & Emerging Markets Sanofi Pasteur (Vaccines) Merial (Animal Health) 2020 Sales broadly in line with 2015 Sales Low single digit Sales CAGR Double digit Sales CAGR High single digit Sales CAGR High single digit Sales CAGR Expected sales CAGR of +3% to +4% over 2015-2020 (1) Expected mid-single digit sales CAGR between 2018 and 2020 (1) Business EPS expected to grow faster than sales beginning in 2018 Objectives for the 2015-2020 Roadmap
  41. 41. 41 Deploying Capital Effectively to Create Long Term Value Balanced Capital Allocation Strategy to Support Growth and Returns (1) After R&D investments Priorities for Free Cash Flow Use(1) Dividend Organic investment Stock repurchase Acquisitions 1 2 3 4
  42. 42. By Delivering on Those Targets, We Will Create an Even Stronger Company Positioned for Accelerated Growth ● Diversified, but with a refocused portfolio ● Streamlined, accountable organization with high quality teams ● Innovation driven, to improve lives of millions of people ● Clear measures of success for launches ● Enhanced growth profile through disciplined M&A ● Sustainable growth and shareholder returns 42
  43. 43. MEET SANOFI Management P&L RATIOS & CAPITAL ALLOCATION Jérôme Contamine Executive Vice President, Chief Financial Officer
  44. 44. 44 Agenda P&L ratios Capital allocation
  45. 45. Sanofi Is Investing in its Future while Responding to Reduced Diabetes Expectations ● 2015-2020 sales CAGR of 3% to 4%(1) ● 2015-18 profitability impacted by: ● Investment in new product launches and R&D pipeline ● Reduced diabetes expectations (CAGR -4% to -8% over 2015-2018) ● Intensified cost savings (€1.5bn) by 2018 from business simplification and investment prioritization, largely reinvested to support future growth ● Beginning in 2018, Business EPS expected to grow faster than sales 45 1 2 (1) Based on current group structure and at CER 2018-20 Accelerate growth 2015-17 Reshape Sanofi
  46. 46. 46 (1) At CER Gross Margin in 2018 Should Reach at Least 2015 Level(1) despite Expected Headwinds ILLUSTRATIVE Manufacturing Performance Improved over 2013-2015e Savings Planned to Accelerate over 2015e-2018e FX 2015e ~69% Industrial performance 2013 Price & Mix 67.7% Product line optimization 2018eIndustrial performance Biologics industrial investment ~69% Price & Mix2015e Evolution of Gross Margin (%) ≥69%
  47. 47. 7.7 We have kept R&D expenditures stable… 47 2011 2012 20142013 €4.8bn €4.9bn €4.8bn €4.8bn 14.4% 14.1% 14.5% 14.3% R&D to sales ratio Sanofi Has Increased R&D Productivity while Keeping R&D Expenditures Relatively Stable over Last 5 Years … and aligned the R&D to sales ratio by activity (2015e) Animal Health Vaccines ~7% ~12% Pharmaceuticals ~15% 2015e ~€5.3bn
  48. 48. 48 Range of 15% to 15.5% Going forward, we expect a slight increase in R&D to sales ratio 2012-2015e 2016e-2018e Range of 14% to 14.5% Increased R&D Investment to Fuel Long Term Growth Invest in medical and LCM support for launches ● Toujeo® / Praluent® / Dengvaxia® Advance late-stage pipeline development ● dupilumab / C. diff / isatuximab / sarilumab / LixiLan Accelerate early-stage development ● New immuno-oncology collaboration with Regeneron Expand open innovation model ● Finance development of future external projects 1 2 3 4 LCM: Life Cycle Management (1) At CER and comparable structure Increasing annual R&D investments up to €6bn by 2020 while maintaining financial discipline
  49. 49. 49 SG&A ratio is expected to remain stable despite wave of new launches(1) Similar level 2015e 2016e-2018e Range of 27.5% to 28% Sanofi has one of the lowest SG&A ratios(2) Roche 23% Merck 26% Sanofi 27% Pfizer 28% Abbvie 29% J&J 30% Novartis 30% BMS 30% Novo Nordisk 30% Abbott 30% GSK 31% Eli Lilly 33% AstraZeneca 39% (1) At CER and comparable structure (2) Source: Published 2014 financial results - Sanofi analysis SG&A to Sales Ratio Expected to Remain Stable over 2015-2018(1)
  50. 50. Structuring a Global Cross Functional Organization (Sanofi Business Services) and Globalizing the IT Function 50 One Sanofi Business Services Organization (SBS) ● Consolidation of the core process delivery activities of: ● Some support functions (HR, Finance) ● Some expertise functions (Procurement, Real Estate, Facility Management) ● Provide best-in-class service delivery and customer partnering ● Standardization & consolidation leading to end-to-end process across Sanofi ● Globalization of the IT function to drive synergies ● Business applications simplification program ● Implementation of Service Management approach ● Aims to drive a competitive level of IT run cost ● Cutting-edge cloud strategy One Global Information Solutions Platform
  51. 51. Accelerated Growth over 2018-2020 51 ● Mid-single digit sales CAGR ● Growing sales contribution from launches ● Increased share of Specialty Care and Vaccines ● Rebalanced portfolio of General Medicines with lower exposure to EP in mature markets ● Business EPS growing faster than sales despite growing payouts to partners EP: Established Products 11 22 2018-20 Accelerate growth
  52. 52. 52 Agenda P&L ratios Capital allocation
  53. 53. 53 Deploying Capital Effectively to Create Long Term Value Balanced Capital Allocation Strategy to Support Growth and Returns (1) After R&D investments Priorities for Free Cash Flow Use(1) Dividend Organic investment Stock repurchase Acquisitions 1 2 3 4
  54. 54. 54 Investing to Expand Biologic Manufacturing Capabilities Keeping tight control on CapEx(1)… 1 Investing between €1.8bn and 1.9bn annually in CapEx over 2016-2018 …while investing in biologic capabilities 2015e ~€1.5bn 2014 €1.2bn 2013 €1.2bn 2012 €1.4bn Animal Health Vaccines Genzyme Pharma (w/o Genzyme) (1) CapEx w/o Product Acquisition ~€1.5bn 2014 €1.2bn 2013 €1.2bn 2012 €1.4bn 2015e Injectables + Biologics + Vaccines + Genzyme Others
  55. 55. 55 €8.4bn €7.4bn €6.5bn €7.2bn ~€6.5bn 2011 2012 2013 2014 2015e Strong Balance Sheet and Free Cash Flow2 Net Debt ● Strong long-term credit ratings (Moody’s A1; S&P AA) ● Current average cost of borrowings(2) : 1.6% (1) Free Cash Flow after change in working capital and before CapEx (2) Borrowing includes bonds denominated in € and U.S.$ and U.S. Commercial Paper drawings post swap into € Free Cash Flow(1) €10.9bn €7.7bn €6.0bn €7.2bn €8.5bn to €9.0bn 2011 2012 2013 2014 2015e
  56. 56. 56 Sanofi Has Shown Financial Discipline in M&A Deals2 Value (€m) EPS accretion Value creation Build critical mass Strengthen pipeline Strong player in Animal Health $4.0bn Strong CHC platform to launch Rx-to-OTC switches in the U.S. $1.9bn Leading biotech with unique expertise in Rare Diseases $20.1bn Strategic antibody & immuno-oncology collaborations 22.2% stake valued at €12.1bn(3) Strategic alliance on RNAi therapeutics 11.9% stake valued at €850m(3) (1) IRR (Internal Rate of Return) significantly exceeded WACC (2) Book value of €2,167m in Regeneron and Investments of €721m in Alnylam (3) Market value as of November 2, 2015 (1) (1) (1) (2) (2)
  57. 57. 57 Seek Opportunities to Enhance Growth Profile through Targeted M&A 2 M&A Scope ● Business development opportunities boosting our growth profile and offering synergies ● Focus on transactions driving value creation Financial Criteria ● Maintain rigorous metrics ● Key performance indicators include: ● IRR ● CFROI ● ROA ● EPS accretion Priority Areas ● Reinforcing priority businesses ● Businesses with portfolio or geographic complementarities ● R&D collaborations expanding our pipeline IRR: Internal Rate of Return CFROI: Cash Flow ROI ROA: Return on Assets
  58. 58. Evolution of Dividend 58 ● Consistent history of dividend payment ● 21st consecutive year of dividend increase in 2014 ● Solid dividend yield ● Strong payout ratio ● Maintain progressive growth of dividend Progressive Dividend Growth3 2011 €2.77 €2.40 €2.50 2012 2014 €2.65 2013 €2.80 2009 €2.85 2010 (1) 2014 dividend paid in 2015 (1)
  59. 59. 59 Stock Repurchases Primarily to Absorb Dilution4 Share Buyback (€bn) 2015e 2014 ~€1.5bn €1.8bn 2013 €1.6bn 2012 €0.8bn 2011 €1.1bn Share buyback expected to be used to tackle dilution over time ~€6.8bn over 5 years
  60. 60. Conclusion ● Balancing investment in Sanofi's future with response to reduced diabetes expectations ● Simplification and savings to result in €1.5bn of cost reduction by 2018, largely reinvested ● Profitability to reflect net investment phase 2016-2017 with margin expansion expected to begin in 2018 ● Capital allocation optimized to support shareholder returns (steady dividend growth) and to enhance overall growth profile (disciplined M&A) 60 11 22 33 44
  61. 61. MEET SANOFI Management SUSTAINING INNOVATION IN R&D Elias Zerhouni, MD President, Global R&D Jorge Insuasty Senior Vice President, Development Philip Larsen Diabetes - Head of Research & Early Development Mike Panzara Vice President, Multiple Sclerosis and Neurology, Genzyme Seng Cheng Vice President, Head of R&D for Rare Diseases Christian Antoni Vice President, Head Development Immunology & Inflammation Gary Nabel Senior Vice President, Chief Scientific Officer
  62. 62. 62 Agenda Executing a clear R&D strategy Next wave of innovation
  63. 63. Significant R&D Turnaround since 2012 (1) From first in human to approval (2) Peptide, protein, nucleic acid based molecular entities and vaccines (3) From beginning of 2008 to end of 2011: Pentacel® (2008), Multaq® (2009), Jevtana® (2010) (4) Toujeo®, Afrezza®, Cerdelga®, Lemtrada®, Aubagio®, Zaltrap®, Kynamro®, Hexaxim®, Fluzone® Quadrivalent, Praluent® 2012 2015 Quality over Quantity(1) 79 projects 44 projects Prioritization Unprioritized Tiering system Biologics(2) 58% 85% External Innovation >65% >65% Early Development Fast to Market Fast to Proof of Concept Cycle Times Slower than industry median Faster than industry median R&D Budget ~14% of sales ~14% of sales Launches 3 launches since 2008(3) 10 launches since 2012(4) 63
  64. 64. The Two Pillars of Our Research Strategy Translational Medicine Open Innovation Deep efforts in a concentrated number of projects Adapting technology to the disease, not the reverse 64
  65. 65. 65 Continue to strengthen R&D pipeline A C D B Deliver a Balanced Pipeline… … Focused on GBU Priorities Sustain Innovation in R&D over 2015-2020 Foster existing R&D collaborations (REGN, ALNY) Increase capacity for external innovation Implement the R&D 2.0 model Increasing annual R&D investments up to €6bn by 2020 while maintaining financial discipline ● Sustain leadership: Diabetes/CV, Vaccines, Rare Diseases ● Build competitive positions: Oncology, MS, Immunology ● Invest opportunistically: Neurodegeneration/pain, Infectious Diseases and Ophthalmology
  66. 66. 0-2 years 5+ years3-5 years TIME to Clinical Proof of Concept Consolidation Support actively our GBUs and their competitive positioning INNOVATION Transformational Enter novel and emerging scientific opportunities with breakthrough potential Expansion Develop next generation products for each GBU 40% 40% 20% Our Focus Today is on Building a Strong Follow-on Portfolio to Mature in 2015-2020 66 ILLUSTRATIVE
  67. 67. Further Expanding the R&D Pipeline Is a Key Objective for the Next Phase 67 N New Molecular Entity Immunology Rare Diseases Oncology Diabetes Vaccines Infectious Diseases Cardiovascular Diseases Neurodegenerative Diseases Ophthalmology Multiple Sclerosis GZ402668 GLD52 (anti-CD52 mAb) Relapsing multiple sclerosis GZ402666 neo GAA Pompe Disease SAR113244 Anti-CXCR5 mAb Systemic lupus erythematosus SAR339375 Anti-miR21 RNA Alport syndrome GZ389988 TRKA antagonist Osteoarthritis SAR439774 (ALN-AT3) siRNA targeting Anti-Thrombin Haemophilia SAR425899 GLP-1R/GCGR dual agonist Diabetes SAR228810 Anti-protofibrillar AB mAb Alzheimer’s disease SAR438335 GLP-1R/GIPR dual agonist Diabetes SAR422459 ABCA4 gene therapy Stargardt disease SAR566658 Maytansin-loaded anti-CA6 mAb Solid tumors UshStat® Myosin 7A gene therapy Usher syndrome 1B SAR408701 Anti-CEACAM5 ADC Solid tumors SAR366234 EP2 receptor agonist Elevated intraocular pressure SAR439684 PD-1 inhibitor Cancer Streptococcus pneumonia Meningitis & pneumonia vaccine SAR428926 LAMP-1 inhibitor Cancer Herpes Simplex Virus Type 2 HSV-2 vaccine SAR439152 Myosin inhibitor Hypertrophic cardiomyopathy Phase I N N N N N N N N N N N N N N N N N dupilumab Anti-IL4Rα mAb Nasal polyposis; Eosinophilic oesophagitis GZ402671 Oral GCS Inhibitor Fabry Disease SAR156597 IL4/IL13 Bi-specific Ab Idiopathic pulmonary fibrosis olipudase alfa rhASM Niemann-Pick type B sarilumab Anti-IL6R mAb Uveitis Rabies VRVg Purified vero rabies vaccine Combination ferroquine / OZ439 Antimalarial Meningitis ACYW conj. 2nd generation meningococcal conjugate infant vaccine isatuximab Anti-CD38 naked mAb Multiple myeloma Tuberculosis Recombinant subunit vaccine Fluzone® QIV HD Quadrivalent inactivated influenza vaccine - High dose Phase II N N N N N LixiLan lixisenatide + insulin glargine Fixed-Ratio / Type 2 diabetes SAR342434 insulin lispro Type 1+2 diabetes sarilumab Anti-IL6R mAb Rheumatoid arthritis, EU dupilumab Anti-IL4Rα mAb Atopic dermatitis, Asthma patisiran (ALN-TTR02) siRNA inhibitor targeting TTR Familial amyloidotic polyneuropathy revusiran (ALN-TTRsc) siRNA inhibitor targeting TTR Familial amyloidotic cardiomyopathy Jevtana® cabazitaxel Metastatic prostate cancer (1L) Clostridium difficile Toxoid vaccine Rotavirus Live attenuated tetravalent Rotavirus oral vaccine VaxiGrip® QIV IM Quadrivalent inactivated influenza vaccine (3-36 months) Phase III N N N N N Registration lixisenatide GLP-1 agonist Type 2 diabetes, U.S. sarilumab Anti-IL6R mAb Rheumatoid arthritis, U.S. Dengvaxia® Mild-to-severe dengue fever vaccine PR5I DTP-HepB-Polio-Hib Pediatric hexavalent vaccine, U.S., EU VaxiGrip® QIV IM Quadrivalent inactivated influenza vaccine (3 years+) N N
  68. 68. 68 Agenda Executing a clear R&D strategy Next wave of innovation
  69. 69. Diabetes Vaccines Rare Diseases 1 2 3 4 69 Isatuximab - Multiple Myeloma Immuno-oncology - Various oncology indications 5 6 7 9 (1) Patisiran, revusiran and ALN-AT3 developed in collaboration with Alnylam Potentially Transformative Drugs in Earlier Stages of Development Selected R&D Assets Oncology Immunology 8 Olipudase alfa - Niemann-Pick type B Patisiran(1) - Familial Amyloidotic Polyneuropathy Revusiran(1) - Familial Amyloidotic Cardiomyopathy Dual agonists - Type 2 Diabetes C. difficile vaccine - Nosocomial infections IL4/IL13 Bi-specific Ab - Idiopathic Pulmonary Fibrosis ALN-AT3(1) - Haemophilia
  70. 70. MTD: Maximum Tolerated Dose (1) Patients on monotherapy study had a median of 4 prior lines of treatment and all patients received IMiD and a proteasome inhibitor; Majority (66%) received pomalidomide or carfilzomib (2) Patients in combination study had median of 7 prior lines of treatment (74% refractory to prior Revlimid/dexamethasone and 81% refractory to IMiDs) HDeckert, et al. Clin Cancer Res 2014;20:4574–83. MOA: Mechanisms of action (3) 52% of the patients experienced IARs with 3% of patients with IARs of grade 3/ 4. Pre-treatment prophylaxis used for all patients. 70 ● Multiple Myeloma remains incurable ● 50,000 patients are diagnosed annually in the U.S. and Europe ● Encouraging efficacy in heavily pre-treated myeloma patients(1) ● Targets unique epitope possibly differentiating MoA(2) ● Manageable safety profile ● MTD not reached in single agent and combination ● Infusion reactions mainly cycles 1 & 2 and majority are Grade 1-2(3) ● No overlapping toxicity in combination with Revlimid® ● Monotherapy dose ranging study completed Anti-CD38 (isatuximab): a Significant Opportunity to Potentially Address an Unmet Need in Multiple Myeloma 1
  71. 71. 71 New Strategic Alliance with Regeneron to Develop Cancer Treatments in Emerging Field of IO Establish Sanofi’s presence in cancer immunotherapy, a rapidly growing and attractive segment of oncology  Significant unmet needs remain despite advances shown with checkpoint inhibitors PD-1: Programmed death protein 1 LAG-3: Lymphocyte activation gene 3 IO: Immuno-Oncology (1) Including bi-specifics/multi-specifics antibodies (2) REGN2810 2 Entering Immuno-Oncology 1 2 3 Expand oncology pipeline, developing potentially best-in-class new antibodies(1) and novel combination therapies  Alliance includes PD-1(2) in Phase I and a portfolio of antibodies, including GITR and LAG3, with the first of these entering Phase I in 2016 Enable development of multiple assets in a fast-evolving IO space with a scale and focus beyond our existing discovery agreement
  72. 72. IL4/IL13 Bi-specific Ab: Sanofi IL4/IL13 Bi-specific Antibody (Ab): Demonstrated Biological Activity and Encouraging Safety Data ● Idiopathic Pulmonary Fibrosis (IPF) is a severe & rare(1) chronic lung disease with significant unmet need ● 5-year survival rate of 20%, comparable to lung cancer ● Unlike dupilumab which blocks the IL4 receptor, the IL4/IL13 bispecific Ab binds to the IL4 and IL13 cytokines ● Dose-dependent decrease of TARC-CCL17 biomarker, confirming IL4/IL13 target engagement ● Safe and well tolerated in Phase I study(2) ● Administered subcutaneously ● Phase II PoC trial started in May 2015 72 Blocks IL4 and IL13 cytokines CH 3 CH 3 C H2 C H2 C H1 C H1 Ck Ck VH 2 VH2 VL2 VL2 VL1 VH1 VH1 VL1 Dis ulfid e bond G 4S(2 )linker (G G G G SG G G G S) Anti-IL-1 3 Fv positio n 1 A nti-IL-4 Fv positio n 2 CH 3 CH 3 C H2 C H2 C H1 C H1 Ck Ck VH 2 VH2 VL2 VL2 VL1 VH1 VH1 VL1 Dis ulfid e bond G 4S(2 )linker (G G G G SG G G G S) Anti-IL-1 3 Fv positio n 1 A nti-IL-4 Fv positio n 2 CH3 CH3CH2 CH2 CH1 CH1 Ck Ck VH2 VH2 VL2 VL2VL1 VH1 VH1 VL1 Dis ulfid e bond G 4S(2 )linker (G G G G SG G G G S) Anti-IL-1 3 Fv positio n 1 Anti-IL-4 Fv positio n 2 CH3 CH3CH2 CH2 CH1 CH1 Ck Ck VH2 VH2 VL2 VL2VL1 VH1 VH1 VL1 Dis ulfid e bond G 4S(2 )linker (G G G G SG G G G S) Anti-IL-1 3 Fv positio n 1 Anti-IL-4 Fv positio n 2 BLOCK BLOCK BLOCK IL4 IL13 (1) Estimated prevalence: ~115,000 (2) Phase I study in healthy subjects (n=36) and Idiopathic Pulmonary Fibrosis patients (n=18) 3 Phase II study completion expected in H2 2017
  73. 73. C. difficile Vaccine Targeting a High Risk Population of 10 to 15 Million Elderly People in the U.S. Alone ● 660 volunteers aged 40-75 years at risk of C. difficile infections were included in a 2-stage Phase II trial ● Stage 1: dose ranging(1) ● Stage 2: selection of vaccination schedule(2) ● Candidate vaccine generated an immune response against both C. diff toxins A and B ● Neutralizing antibodies were comparable across ages including elderly ● Adverse reactions were generally mild and of short duration ● Objective is to assess efficacy, safety and immunogenicity in preventing the onset of symptomatic PCR-confirmed primary CDI cases ● 3 injections at 0, 7, and 30 days ● Up to 15,000 adults to be enrolled – 1/3 already included ● CDI case-driven study ● Initiated in Q3 2013 and projected to take 4.5-5 years to complete Fast Track Development Program designation granted by CBER(3) PCR – Polymerase chain reaction (1) & (2) de Bruyn G et al. Poster presentations at 24th annual meeting of the European Congress of Clinical Microbiology and Infectious Disease (ECCMID), May 2014 (3) CBER: Center for Biologics Evaluation and Research Phase II successfully completed Multinational Phase III ongoing 73 4
  74. 74. Olipudase alfa – A Promising Investigational Treatment for Niemann Pick type B ● Niemann Pick is a serious LSD(1) characterized by fat deposits in spleen and liver and respiratory problems ● Estimated incidence for Niemann Pick is 0.4 to 0.6 in 100,000 newborns(2) ● Olipudase alfa is a recombinant form of human ASM(3) developed as an ERT(4) ● Positive efficacy response in Phase Ib on pulmonary function, liver volume and spleen volume(5) ● Pivotal Phase II/III trial expected to start by the end of 2015 ● FDA granted Breakthrough Therapy Designation in May 2015 74 5 Therapeutic Approach Phosphorylcholine Ceramide Sphingosine Acid- Ceramidase Intended result: Reverse and prevent somatic disease if treatment begins early Target the underlying metabolic defect by replacing the missing enzyme Olipudase alfa Olipudase alfa Sphingomyelin (1) LSD: lysosomal storage disorder (2) Meikle, P.J.,J.J. Hopwood, et al. (1999). “Prevalence of lysosomal storage disorders.” JAMA 281(3):249-254 ; Pinto, R., C. Caseiro, et al. (2004). “Prevalence of lysosomal storage diseases in Portugal.” Eur J Hum Genet 12(2):97-92; Poorthuis, B.J., R.A. Wevers, et al. (1999). “The frequency of lysosomal storage diseases in The Netherlands.” Hum Genet105(1-2):151-156; Poupetova, H.,J.Levinova, et al. (2010). “the birth prevalence of lysosomal storage disorders in the Czech Republic: comparison with data in different populations.” J Inherit Metab Dis. (3) ASM: acid sphingomyelinase (4) ERT: Enzyme Replacement Therapy (5) Study findings showed that the dose escalation regimen was well tolerated. No serious or severe adverse events or deaths were reported.
  75. 75. Collaboration Provides Access to Unique RNAi Opportunities ● ~50,000 patients worldwide ● FAP and FAC are the two predominant forms ● Liver transplantation is often required early and TTR stabilizers provide modest benefit ● Autosomal dominant with >100 defined mutations ● Misfolds and forms amyloid deposits in nerves, heart, other tissues Progressive, debilitating monogenic disease Mutant transthyretin (TTR) is genetic cause RNAi is a potentially transformative therapy ● Knockdown disease causing protein ● Aim to halt progression, possibly achieve regression Transthyretin-Mediated Amyloidosis (ATTR) Program FAP: Familial amyloidotic polyneurapthy FAC: Familial amyloidotic cardiomyopathy 75
  76. 76. Patisiran: Familial Amyloidotic Polyneuropathy Patisiran: an Investigational IV Administered RNAi Therapeutic to Treat the FAP Form of ATTR ● Positive Phase II results in FA ● Statistically significant, dose dependent TTR knockdown of up to 96%(1) ● Phase II Open-Label Extension (OLE) ongoing ● APOLLO Phase III trial ongoing ● FDA submission targeted for 2017 76 Dose Response and Duration of TTR Knockdown FAP: Familial amyloidotic polyneurapthy ATTR: Transthyretin (TTR)-mediated amyloidosis (1) Generally well tolerated in FAP patients out to nearly two years, with minimal drug-related adverse events reported. The most common drug-related or possibly drug-related adverse events were flushing (25.9%) and infusion-related reactions (18.5%), which were both mild in severity and did not result in any discontinuations. (2) Excludes post-day 28 data from one patient that experienced drug extravasation during second infusion % Mean Serum TTR Knockdown Relative to Baseline (SEM) - n=29 Days Since First Visit Cohort 0.30 mg/kg q3w Cohorts 0.01-0.30 mg/kg q4w 6 Patisiran Treatment Groups 0.01 mg/kg q4w (n=4) 0.05 mg/kg q4w (n=3) 0.15 mg/kg q4w (n=3) 0.30 mg/kg q4w (n=6)(2) 0.30 mg/kg q3w (n=12)
  77. 77. Revusiran: Familial Amyloidotic Cardiomyopathy ● Positive Phase II results in TTR cardiac amyloidosis patients(1) ● Phase II Open Label Extension (OLE) ongoing ● Subcutaneous administration ● Phase III ENDEAVOUR trial ongoing 77 Rapid, Dose-dependent, Consistent, Durable Knockdown of Serum TTR of Up to 95% Mean (SEM) % Serum TTR Knockdown Relative to Baseline Study Day Placebo(N=6) 2.5 mg/kg MAD(N=3) 5.0 mg/kg MAD(N=3) 7.5 mg/kg MAD(N=6) 10.0 mg/kg MAD(N=3) Revusiran Dose Group ALN-TTRsc qd x5; qw x5 Dose Level [mg/kg] Mean % kd (SD) 2.5 58.2 (11.1) 5 87.5 (7.2) 7.5 87.9 (1.2) 10 92.4 (1.5) 7 Revusiran: an Investigational Subcutaneously Administered RNAi Therapeutic to Treat the FAC Form of ATTR FAC: Familial amyloidotic cardiomyopathy ATTR: Transthyretin (TTR)-mediated amyloidosis (1) Generally well tolerated in the majority of ATTR cardiac amyloidosis patients. Serious adverse events (SAEs) were observed in 8 patients (32%), including one death due to infiltrative cardiomyopathy; none of the SAEs were deemed to be related to study drug. The majority of the adverse events (AEs) were mild or moderate in severity; injection site reactions (ISRs) were reported in 11 patients (44%). As previously reported, 3 patients discontinued due to recurrent localized reactions at the injection site or a diffuse rash; no further discontinuations due to ISRs have occurred
  78. 78. ● Antithrombin (AT) is a key endogenous anticoagulant ● Inactivates Factor Xa and thrombin ● Attenuates thrombin generation ● Expressed in liver; circulates in plasma ● Human AT deficiency associated with increased thrombin generation ● Subcutaneous ALN-AT3 aimed at correcting coagulation defects by knockdown of AT ● Currently in Phase I in moderate-to-severe hemophilia ALN-AT3: an Investigational RNAi Therapeutic Targeting Antithrombin AT FIX FVIII FIXa FVIIa FVII FVIIIa FVa FV FX FXa Fibrinogen Fibrin ThrombinProthrombin Blood clot Intrinsic system Extrinsic system Hemophilia B Hemophilia A FVIII FIX AT 78 Coagulation Cascade Phase III planned to start in mid-2016 8
  79. 79. Dual Agonists for GLP-1 and Glucagon/GIP Receptors 79 ● Novel synthetic peptidic molecules developed in-house ● Expected benefit is blood glucose control with superior weight loss over pure GLP-1 receptor agonists ● Phase I study of dual GLP-1/Glucagon agonist in healthy volunteers recently completed ● Phase I study of dual GLP-1/GIP agonist recently started ● Of particular interest in overweight to obese people with T2D ● 60% of the T2D population -1.4%-1.2% HbA1c vs. Placebo 0 2 4 6 8 10 Day ‐4 Day 28 Sanofi dual Agonist 4 µg/kg Liraglutide 40 µg/kg Placebo ‐7 ‐6 ‐5 ‐4 ‐3 ‐2 ‐1 0 1 2 3 0 5 10 15 20 25 30 Study days GLP-1/Glucagon Dual Agonist Glucose Control Similar to Liraglutide - Animal Data(1) GLP-1/Glucagon Dual Agonist Body Weight Loss Superior to Liraglutide (~5%) - Animal Data(1) Sanofi dual agonist 4 µg/kg Liraglutide 40 µg/kg Placebo %Bodyweightloss (comparedtoday-5)HbA1c(%) (1) 4 week study in obese, diabetic non-human primates comparing 4 µg/kg Sanofi dual agonist with 40 µg/kg liraglutide and vehicle (2-step uptitration to reach maintenance dose on day 6), data on file 9
  80. 80. 80 Significant R&D Milestones Expected in the Next Year 80 Expected Regulatory Decisions Q4 2015 Q1 2016 Q2 2016 Q3 2016 ● Dengvaxia® in Endemic Countries  ● Lixisenatide in Diabetes (U.S.)  Expected Regulatory Submissions Q4 2015 Q1 2016 Q2 2016 Q3 2016 ● Sarilumab in Rheumatoid Arthritis (U.S.) ● LixiLan in Diabetes (U.S.)  ● LixiLan in Diabetes (E.U.)  ● Rotavirus vaccine (India)  ● Dupilumab in Atopic Dermatitis (U.S.)  Expected Headline Phase III Data Releases Q4 2015 Q1 2016 Q2 2016 Q3 2016 ● Dupilumab in Atopic Dermatitis  ● Insulin lispro in Diabetes  ● Sarilumab in Rheumatoid Arthritis (MONARCH)  Expected Phase III Starts Q4 2015 Q1 2016 Q2 2016 Q3 2016 ● Meningitis ACYW conj. vaccine 
  81. 81. 81 Transforming the Lives of Patients by Delivering Innovative Therapies Significant pipeline turnaround since 2012  Translational Medicine and Open Innovation Increase R&D investments while maintaining financial discipline  Consolidate / Expand / Transform Implementation of the R&D 2.0 model and alignment with future GBUs Wave of potentially transformative drugs in earlier stages of development 1 2 3 4
  82. 82. MEET SANOFI Management DIABETES Pascale Witz Executive Vice President, Diabetes & Cardiovascular Pierre Chancel Senior Vice President, Diabetes Andrew Purcell Vice President and Head, U.S. Diabetes Business Unit Riccardo Perfetti, MD Senior Medical Officer, Diabetes
  83. 83. 83 Agenda Sanofi’s global diabetes leadership A broad and growing portfolio Significant unmet medical needs
  84. 84. North America and Caribbean Europe Western Pacific South and Central America South East Asia Middle East and North Africa Africa 2014 Diabetes is a Huge and Growing Global Challenge(1) 84 (1) International Diabetes Federation Diabetes Atlas 6th Edition revision 2014 2035 WORLD 387m Prevalence: 8.3% Number of People Living with Diabetes Expected to Increase by 53% between 2014 and 2035 46.3% undiagnosed WORLD 592m 53% North America and Caribbean 30% Europe 33% Western Pacific 46% South and Central America 55% South East Asia 64% Middle East and North Africa 85% Africa 93%
  85. 85. 1 healthcare $ in 9 is spent on diabetes 77% of people with diabetes live in low- and middle- income countries Every 7 seconds 1 person dies from diabetes ● 4.9m deaths in 2014 ● 50% of deaths under 60 years of age ● Intersects with all dimensions of development ● In 2014 diabetes expenditure reached $612bn ● 11% of worldwide healthcare expenditure Diabetes Is a Human and Economic Burden Diabetes Costs to Society Are High and Escalating(1) 85 (1) International Diabetes Federation Diabetes Atlas 6th Edition revision 2014 Icons designed by Freepik
  86. 86. Diabetes Patients in the U.S. (Random Sample) Despite Treatment, Many Patients with Diabetes Are Still not at A1c Goal(1) 86 47% 47% 53% 53% 2013 (437) 2013 (2215) T1D Patients T2D Patients A1c: glycated haemoglobin (1) Adelphi Real World Diabetes Disease Specific Program (DSP) X, 2013 Base: U.S. diabetic patients where doctor has stated most recent A1c (random sample) All patients are treated patients and must be on an OAD, GLP-1 or insulin Uncontrolled (A1c >7%) Controlled (A1c ≤7%)
  87. 87. Inappropriate Diabetes Management Leads to Costly Consequences 87 Microvascular Complications ● Diabetic Retinopathy ● Diabetic Nephropathy ● Diabetic Neuropathy (1) Endocrinol Metab Clin 1996;25:243 - 254 (DCC Trial) (2) Diabetes Care Publish Ahead of Print, published online March 6, 2013 Risk of Complications and A1c(1) 25% to 45% of diabetes-attributed medical expenditures spent treating complications of diabetes(2) A1c (%) Relative Risk in % 1 3 5 7 9 11 13 15 6 7 8 9 10 11 12 Retinopathy Nephropathy Microalbuminuria Neuropathy Macrovascular Complications ● Stroke ● Heart Disease ● Peripheral Vascular Disease
  88. 88. 88 Agenda Sanofi’s global diabetes leadership A broad and growing portfolio Significant unmet medical needs
  89. 89. A Sizeable Presence in Diabetes Built on Lantus®, our Insulin Flagship Brand Global diabetes sales expected to decline at an average annualized rate of between 4% and 8% at CER over the period of 2015-2018 Sanofi Global Diabetes Sales 89 2012 2013 2014 2015e €5,782m +16.7% at CER €6,568m +18.7% at CER €7,273m +12.1% at CER -6% to -7% at CER
  90. 90. Global Diabetes Sales Account for 20% of Group Sales in the First 9 Months of 2015 20.4%79.6% 57% 43% U.S. ex U.S. Diabetes Sales €5,677m -4.6% Total Group Sales excluding Diabetes €22,102 m +5.8% YTD Sep 2015 Diabetes Sales by Geographies (in €m) €2,417m +9.5% €3,260m -14.2% Western Europe: +3.5% Emerging Markets: +17.0% RoW: +2.6% Sales Growth at CER Regional Sales Growth at CER 90
  91. 91. 48.0% 32.6% 19.3% Basal Insulins Constitute the Leading Insulin Segment Across All Geographies 91 June MAT 2015 Insulin Market Breakdown by Insulin Type (Value)(1) Market Share (%) U.S. Emerging Markets 38% + 10% (1) Market share data from Source IMS Health MIDAS MAT June 2015 – Copyright 2015 – All rights reserved Note: IMS data is based on list prices and does not take account of privately-negotiated discounts and rebates Western Europe Japan/Can/Aus/NZ Premix Basal SAI 49.3% 35.8% 14.8% 43.5% 37.1% 19.4% 54.0%36.5% 9.5%
  92. 92. 64.4%13.1% 9.6% 12.9% 70.5% 25.5% Toujeo® 0.2% 3.8% 56.4% 13.9% 1.4% 28.3% 61.4%23.3% 3.9% 11.4% June MAT 2015 Basal Insulin Market Breakdown by Brand (Value)(1) Market Share (%) Sanofi Has Leading Positions in the Basal Market in All Geographies 92 Levemir® and Tresiba® are Novo Nordisk brands (1) Market share data from Source IMS Health MIDAS MAT June 2015 – Copyright 2015 – All rights reserved U.S. Emerging Markets Western Europe Japan/Can/Aus/NZ NPH Lantus® Levemir® Tresiba® Toujeo®
  93. 93. 31% 43% 46% 37% 23% 20% 0% 10% 20% 30% 40% 50% 2004 YTD June 2015 % of sales Basal Premix SAI Insulin Market by Insulin Type (Value) Basal Insulin Now the Gold Standard in Emerging Markets and Sanofi Is Leading the Basal Segment 93 Emerging Market Share (%) Emerging Markets: World excluding the U.S. and Canada, Western Europe, Japan, Korea, Australia and New Zealand Source: Market share data from Source IMS Health MIDAS Q2/2015 – Copyright 2015 – All rights reserved SAI – Short acting insulin Focusing on expanding access to Lantus® in Emerging Markets
  94. 94. 94 Agenda Sanofi’s global diabetes leadership A broad and growing portfolio Significant unmet medical needs
  95. 95. 95 Broadening our Portfolio to Sustain a Leadership Position in Diabetes 1 Establish next generation of basal insulins 2 Innovate with a new combination of basal insulin and GLP-1 4 Lead market shift to data analytics and population outcome care standards through Google collaboration 3 Expand access to Lantus® in Emerging Markets while managing Lantus® LoE(1) in mature markets 5 Strengthen pipeline through external opportunities and ambitious research (1) LoE: Loss of exclusivity Google Life Sciences
  96. 96. A Compelling Value Proposition (1) Toujeo® Prescribing Information, February 2015 Introducing, from the Makers of Lantus® Toujeo® – Designed and Developed to Be a New Basal Insulin Option(1) Unmet needs Micro- precipitate Stable Activity Profile Proven Efficacy Predictable Safety Toujeo® SoloStar® Toujeo® COACH 1 2 3 96
  97. 97. 0 2000 4000 6000 8000 10000 12000 14000 16000 0% 10% 20% 30% 40% 50% 60% Basal Market NBRx Shares(2) week of April 3 - week of Oct 16, 2015 Lantus® 50.9% Share (%) Encouraging U.S. Launch Metrics (1) IMS Weekly Data (2) Basal market includes Toujeo®, Lantus®, Levemir® (Novo Nordisk) and NPH - Source: IMS Weekly Data (3) Toujeo® analogues include: Bydureon® (AstraZeneca), Invokana® (J&J), Farxiga® (AstraZeneca), Trulicity® (Eli Lilly), Tanzeum® (GlaxoSmithKline) and Levemir® (Novo Nordisk) 97 Toujeo® TRx, NRx & NBRx Volume(1) week of April 3 - week of Oct 23, 2015 9,037 NRx Rx (absolute) Cumulative TRx 205,299 15,511 TRx 13.7% Levemir® 26.3% 5,717 NBRx Cumulative NBRx 91,838 NPH 9.0% Toujeo® uptake trending favorably compared to diabetes analogues(3) Cumulative NRx 134,476
  98. 98. Rapid Market Access Obtained in the U.S. 98 Toujeo® Market Access as of October 1, 2015 % Lives Covered 17% 69% 0% 20% 40% 60% 80% 100% Commercial Medicare Tier 2 Tier 2 Tier 3 91% 86% ● Parity pricing with Lantus® helped secure rapid and comparable access ● Broad Medicare access achieved ahead of standard timelines ● Focused pull-through efforts in place
  99. 99. 0% 1% 2% 3% 4% 5% 6% 7% 8% -6% -4% -2% 0% 2% 4% 6% 8% Germany Showing the Way for Other EU Launches 99 Levemir® and Tresiba® are Novo Nordisk brands (1) Insight Health Germany (Retail Apo-Weekly-Pharma) – All data including parallel trade (2) Toujeo® week of May 5 - Oct 27, 2015; Tresiba® week of April 29 - Oct 21, 2014 (3) In July 2015 Novo Nordisk announced that the company decided to cease distribution of Tresiba® in Germany at the end of September 2015 following a negative outcome of price negotiations with the GKV-Spitzenverband, the German national association of statutory health insurance funds Weekly Evolution of Sell Out Data within Basal Market(1) % Market Share Delta Development vs. May 5, 2015 in Units (Packs) Toujeo® Weekly Sell Out Data within Basal Market(1,2) % Market Share in Units (Packs) 21.3% 53.0% % MS in Basal Market Win/Loss in percentage points 6.0% -4.0% Toujeo® Launch on May 5, 2015 Levemir® + Tresiba® Lantus® + Toujeo® 7.1% Tresiba® 3.8% Tresiba® Ceased Distribution in Oct 2015(3) Tresiba®Toujeo®
  100. 100. EM and Rest of World Global Launch Continues in EU, EM and RoW 100 (1) The brandname of Toujeo® in Japan is Lantus® XR: launched in September 2015 H2 2015 2016 Europe Italy France Spain UK Czech Rep. Finland Australia BrazilS. Korea MexicoCanada SwitzerlandJapan(1) Belgium GreeceNorway IrelandAustria Sweden Poland
  101. 101. Real-Life Study Program to Expand the Evidence Base ● Insulin-naïve T2D patients (U.S.) ● Target enrolment: 3,270 ● Primary endpoint: composite endpoint (A1c+hypo) according to the HEDIS criteria ● Insulin-naïve T2D patients (EU) ● Target enrolment: 800 ● Primary endpoint: A1c changes ● T2D patients uncontrolled on basal insulin (EU) ● Target enrolment: 600 ● Primary endpoint: A1c changes HEDIS – Healthcare Effectiveness Data and Information Set 101 Initial results expected in 2017, extended follow-up findings in 2018 Study Program to Investigate Patient Experience, Clinical Effectiveness and Health Resource Utilization in People with Type 2 Diabetes >4,500 adults with T2D from the U.S. and Europe
  102. 102. 102 An Investigational Agent Combining Insulin Glargine with Lixisenatide in a Daily Injection FPG + PPG control Statistically significant A1c reduction versus components More patients with A1c <7% Weight neutral versus insulin glargine Reduced nausea versus lixisenatide alone No additional incidence of hypos vs. basal Fixed Ratio Combination of Two Active Components Single Once Daily Injection = Expected key regulatory submissions: U.S. Q4 2015 & EU Q1 2016 PPG: Post-Prandial Glucose FPG: Fasting Plasma Glucose
  103. 103. Significant Opportunity in Type 2 Diabetes Supported by Two Positive Phase III Studies 103 Patients Uncontrolled with Basal Therapy: ~4m Patients Not at Target on OAD: ~5.5m 1st injectable drug Basal intensification Two Well Defined U.S. T2D Patient Populations for LixiLan Positive Top-line Results in Two Pivotal Phase III Studies OAD: Oral anti-diabetic Met HbA1c primary endpoints compared to insulin glargine and compared to lixisenatide Regulatory submission expected in the U.S. in December 2015 and EU in Q1 2016 LixiLan-O study in patients insufficiently controlled on OADs LixiLan-L study in patients not at goal on basal insulin
  104. 104. Important Options for Prandial Diabetes Treatment 104 ● Once-daily prandial GLP-1 for Type 2 Diabetes(1) ● Positive ELIXA study results demonstrated CV safety(2) ● More pronounced PPG-lowering compared to liraglutide(3) ● U.S. regulatory decision expected in Q3 2016 ● Approved in over 50 countries worldwide (1) GLP-1 RA: glucagon-like peptide-1 receptor agonist (2) ELIXA evaluated CV outcomes in Type 2 Diabetes patients after Acute Coronary Syndrome during treatment with lixisenatide (3) PPG (post-prandial glucose) lowering effect evaluated after a test-meal - Meier JJ et al, 2014 ADA, Poster 1017-P (4) Apidra® is for adults with type 2 diabetes or adults and children (4 years and older) with type 1 diabetes to improve blood sugar control ● A rapid acting, mealtime, injectable insulin for Type 1 and Type 2 Diabetes(4) ● Available in SoloSTAR® pen ● Strong double-digit YTD Sep 2015 growth in Emerging Markets ● U.S. performance in YTD Sep 2015 was driven by lower demand that was partially offset by price increases ®
  105. 105. Innovative Treatment Option for Diabetes Continued Focus on Gaining Market Access, Building Awareness and Appropriate Usage A rapid-acting inhaled insulin Fast absorption rate and short duration of action(1) An innovative device 105 U.S. Launch in Feb 2015 ● Time needed for Afrezza® to demonstrate its potential ● Gradual market access ● FDA requirements for starting patients on Afrezza® ● Novel mode of administration and innovative nature of the product ● DTC advertising campaign and expanded number of physician targets for sales force ● Commercial focus on ~1.1m uncontrolled basal insulin intensification patients(2,3,4) (1) Despite the fast absorption of insulin (PK) from Afrezza®, the onset of activity (PD) was comparable to insulin lispro (2) Uncontrolled basal Insulin or Basal ± GLP1 ± OAD patients (A1c >7%) (3) Adelphi Real World: Diabetes DSP 9 (2012), Data on File. US Data (4) Excludes patients for whom Afrezza® is contraindicated
  106. 106. Diabetes Integrated Care: Significant Potential to Improve Patients’ Lives ● Leader in the technology space ● Data analytics and integration of information silos ● Smart delivery and sensor devices ● Miniaturization ● Leader in insulin management ● Deep clinical and medical expertise ● Regulatory and market access ● Leading portfolio of pharmaceuticals Significant cost savings Better patient & provider engage- ment Leveraging Complementary Strengths to Establish New Standards for Diabetes Care 106 Improved clinical outcomes Real-time monitoring & care Google Life Sciences
  107. 107. 107 2000 basal insulin 2004 rapid-acting injectable insulin 2014 rapid-acting inhaled insulin ® 2015 new basal insulin 2016+ basal insulin and GLP-1 RA combination(2) 2013 once-daily GLP-1 RA(1) (1) Lyxumia® approved for treatment of Type 2 Diabetes in Europe in February 2013; U.S. regulatory decision expected in Q3 2016 (2) LixiLan regulatory submission expected in the U.S. in December 2015 and EU in Q1 2016 A Broad and Growing Diabetes Portfolio
  108. 108. MEET SANOFI Management PRALUENT® Pascale Witz Executive Vice President, Diabetes & Cardiovascular Ophra Rebière Vice President, General Manager, Brand Team Leader Praluent® Victoria Carey Vice President, Head of U.S. Alirocumab Commercial Praluent® is developed and commercialized in collaboration with Regeneron
  109. 109. 109 Agenda Significant unmet need and cost burden Strong and differentiated product profile Initial uptake gradual as expected Upcoming milestones and future opportunity
  110. 110. Cardiovascular Disease Is a Major Health and Economic Burden with Uncontrolled LDL-C Being a Key Risk Factor 110 ACS: Acute Coronary Syndrome (1) CDC and Prevention. Heart Disease Facts. Available from http://www.cdc.gov/heartdisease/facts.htm. Last accessed 29 April 2015 (2) Go AS, Mozaffarian D, Roger VL, et al. Circulation. 2014;129(3): e28-e292 (3) Zhao Z, Winget M. Economic burden of illness of acute coronary syndromes: medical and productivity costs. BMC Health Serv Res. 2011;11:35 (4) 2016 estimates for U.S., EU Top 5 and Japan; U.S. NHANES, Market Scan, IMS and Sanofi estimates; includes HeFH and primary and secondary prevention (5) Costs based insurance claims data; Long term care (e.g. rehab, nursing home) and indirect costs (e.g. lost productivity) are not included; the estimated one-year cost of an ACS among working-age Americans (direct and indirect) $50,000 - $119,000 (6) Inflation adjusted to 2007; OSullivan AK. Pharmacoeconomics. 2011;29(8):693-704. (7) Inflation adjusted to 2004; Smolderen KG, et al. Eur J Vasc Endovasc Surg 2012;43:198e207. #1 Cause of death worldwide(1) claims more lives than all forms of cancer combined Estimated cost of CV disease management(2,3) includes health expenditures and lost productivity Estimated cost of an ACS event(5) Patients at high CV risk fail to reach LDL-C goals(4) high cholesterol is a key risk factor for CV disease 24 million $315 billion $34,200(6) direct costs €196 billion €4,400- €6,000(7) direct costs
  111. 111. 111 Agenda Significant unmet need and cost burden Strong and differentiated product profile Initial uptake gradual as expected Upcoming milestones and future opportunity
  112. 112. 112 Significant and Consistent LDL-C Reduction in Five Double-Blind, Placebo-Controlled Trials(1) Praluent® is developed and commercialized in collaboration with Regeneron *p<0.0001; ASCVD: Clinical Atherosclerotic Cardiovascular Disease; HeFH: Heterozygous Familial Hypercholesterolemia (1) Praluent® data from U.S. FDA Prescribing Information (2) Criteria-based up-titration to 150 mg Q2W at week 12 for patients who did not achieve their pre-specified target LDL-C at week 8 (3) LDL-C mean % change from baseline; 24 week (primary endpoint) (4) In the LONG TERM study, 18% of patients had HeFH -44%* -2% COMBO I Study (n=316)(3) Majority Clinical ASCVD Patients Praluent® 75 mg/150 mg Q2W + statin Placebo + statin 0% -58%* +1% LONG TERM Study (n=2,341)(3) Majority Clinical ASCVD Patients(4) Praluent® 150 mg Q2W + statin Placebo + statin 0% +7% -47%* FH I & FHII Studies (n=735)(3) Majority HeFH and/or Clinical ASCVD Patients Praluent® 75 mg/150 mg Q2W + statin Placebo + statin 0% -43%* -7% High FH Study (n=107)(3) Majority HeFH and/or Clinical ASCVD Patients Praluent® 150 mg Q2W + statin Placebo + statin 0% 75 mg Up-Titration Regimen(2) Started and Maintained on 150 mg
  113. 113. 113 Praluent® is developed and commercialized in collaboration with Regeneron (1) In the pooled analysis of 6 studies with alirocumab 75mg Q2W on background statin (FH1, FH2, Combo 1, Combo 2, Option 1 and Option 2), 73.7% of patients achieved LDL-C<70 or <100 mg/dL (depending on CV risk) at Week 8, and did not require up-titration (2) IMS NPA Rapid Weekly (3) ODYSSEY clinical trials using the auto-injector included: High FH, Mono and Alternative, FH1, FH2, Combo 1, Combo 2, Option 1 and Option 2 (4) Material developed according to European Medicines Agency Summary of Product Characteristics (SmPC) Effective LDL-C Reduction on Lower Dose with Auto-Injector Available for Both Doses at Launch Over 70% of Patients Using Lower 75mg Dose Reached LDL-C Goal in ODYSSEY Clinical Trials(1) ● 95% of dispensed prescriptions in the U.S. for lower 75mg dose(2) 75 mg/1 mL pen 150 mg/1 mL pen Both doses available in a single-dose, 1-mL, auto-injector pen and prefilled syringe (4) High Injection Acceptance by Patients Supported by Auto-Injector in ODYSSEY Clinical Trials(3) ● Single 1mL dosage forms for subcutaneous self-injection at home
  114. 114. 114 Approved in the U.S. and EU in High CV Risk Hypercholesterolemic Patients(1) Approved in EU on September 25, 2015  Indicated in adults with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidaemia, as an adjunct to diet in patients unable to reach their LDL-C goals with a maximally-tolerated statin and patients who are statin intolerant, or for whom a statin is contraindicated FDA approval granted on July 24, 2015  Indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL cholesterol (LDL-C) Praluent® is developed and commercialized in collaboration with Regeneron (1) The effect of Praluent® on CV morbidity and mortality has not been determined
  115. 115. U.S. Label Criteria Represent 90% of Patients in the ODYSSEY Clinical Trial Population(1) 115 Praluent® is developed and commercialized in collaboration with Regeneron (1) Based on five double-blind, placebo-controlled studies that are included in the label (2) Non-heterozygous FH based on AHA/ACC Guidelines, Stone et al. 54% with Clinical Atherosclerotic Cardiovascular Disease (ASCVD)(2) Defined as any of the following diagnoses: ● Acute coronary syndromes ● History including ● Myocardial infarction ● Stable or unstable angina ● Coronary or other arterial revascularization ● Stroke/transient ischemic stroke ● Peripheral arterial disease presumed to be of atherosclerotic origin Diagnosed using Simon Broome or Dutch Lipid Networking criteria including: ● Cholesterol levels ● Physical manifestations ● Family history ● Genetic testing 36% with Heterozygous Familial Hypercholesterolemia (HeFH) 90% of ODYSSEY population
  116. 116. HeFH Patients (~0.5m) ● Well defined population ● Diagnosed with HeFH (~0.1m) Eligible U.S. Hypercholesterolemic Patient Population Comprised of Three Segments 116 Praluent® is developed and commercialized in collaboration with Regeneron ASCVD: Clinical Atherosclerotic Cardiovascular Disease; HeFH: Heterozygous Familial Hypercholesterolemia CHD: Coronary Heart Disease; ACS: Acute Coronary Syndrome; PAD: Peripheral Artery Disease Source: US NHANES, Market Scan – US inputs (estimated 2016 population) Icons designed by Freepik Addressable patient population could increase based on CV outcome data in late 2017 ASCVD Patients Recent Event (~1.3m) ● Event in last 12 months Prior Event (~9.2m) ● Event 13+ months ● CHD + ACS (6.9m) ● Stroke (1.4m) ● PAD (1.0m) Heterogeneous population High risk Treatment engaged populationUnderdiagnosed population
  117. 117. Treatment Population in the U.S. Influenced by Many Factors 117 Praluent® is developed and commercialized in collaboration with Regeneron Factors Influencing U.S. Praluent® Treatment Population Utilization of Existing Medicines ● Optimizing use of statin and other lipid-lowering therapies Patient, Physician, Access Considerations ● Awareness ● Adoption ● Willingness to inject ● Market access gained
  118. 118. 118 Agenda Significant unmet need and cost burden Strong and differentiated product profile Initial uptake gradual as expected Upcoming milestones and future opportunity
  119. 119. Early Success with U.S. Payer Access ● Praluent® offers significant medical value to patients and payers ● Projected to be cost-effective based on standard QALY model analyses(1) ● Average WAC for Praluent® is $40 per day or $14,600 per year ● Actual patient and payer cost is lower ● Patient assistance and bridge reimbursement programs ● Commercial plan rebates ● Mandated government payer rebates 119 Praluent® is developed and commercialized in collaboration with Regeneron QALY: Quality-Adjusted Life Years WAC: Wholesaler Acquisition Cost (1) Based on internal models ● Preferred Tier 2 formulary position granted by ESI ● Parity access for both PCSK9 brands ● 30m commercial formulary lives directly managed by ESI ● Additional 50m lives utilize ESI to model and support customer formulary ● Formulary status at CVS and UnitedHealthcare pending
  120. 120. ● Copay support (commercial) ● Patient Assistance Program (uninsured) ● Copay foundation referrals ● Praluent® free of charge during coverage appeals ● Benefits investigations ● Prior authorization assistance ● Appeals support ● Payer information ● Coverage exception support 120 Comprehensive Support for U.S. Patients and Prescribers MyPraluent™ Assists with: Coverage Cost(1) Obtaining Praluent® (alirocumab) Clinical Support Adherence ● Specialty pharmacy coordination ● Home delivery ● In-store pick up ● On-call nurses ● Patient self-injection training ● Adverse event reporting ● Product and disease information ● Information on diet and lifestyle changes ● Injection reminders ● Refill reminders ● Adherence education Praluent® is developed and commercialized in collaboration with Regeneron (1) Subject to program requirements
  121. 121. 121 U.S. Comprehensive Support Hub Tracking Ahead of Expectations ● Majority of patients enrolled by specialists ● Around 5,000 prescribers ● Benefits investigation requires at least one month ● More time required for Medicare Part D plans ● Efficient patient referral to specialty pharmacy or patient assistance programs Enrollments by Specialty (%) PCP/NP/ Other Specialists 73% 27% Praluent® is developed and commercialized in collaboration with Regeneron
  122. 122. U.S. Launch Gradual as Market Access and Awareness Accelerate ● Specialty pharmacy dispensing expected to accelerate ● Bolus of adjudicated patients awaiting coverage decisions ● Weekly IMS NPA prescription data under-reports underlying demand ● Product samples and reimbursement bridge program not captured ● Express Scripts specialty pharmacy (Accredo) blocked Praluent® prescription data prior to October 9, 2015 ● Does not capture non-retail prescriptions 0 20 40 60 80 100 120 Praluent® NRx Volume week of Aug 7 - week of Oct 23, 2015 NRx Cumulative NRx 628 NRx (absolute) Praluent® is developed and commercialized in collaboration with Regeneron Source: IMS NPA Rapid Weekly 122
  123. 123. 123 Agenda Significant unmet need and cost burden Strong and differentiated product profile Initial uptake gradual as expected Upcoming milestones and future opportunity
  124. 124. ODYSSEY OUTCOMES Expected to Be Fully Enrolled by Q4 2015 Praluent® is developed and commercialized in collaboration with Regeneron (1) Rationale and design in Schwartz GG et al. Am Heart J 2014;0:1-8.e1. (2) High intensity statin therapy include atorvastatin 40/80mg or rosuvastatin 20/40mg (3) Patients can also qualify with apoB>80mg/dL or non-HDL-C > 100 mg/dL (4) The effect of Praluent® on morbidity and mortality has not yet been determined. Primary endpoint is a composite endpoint of coronary heart disease death, non-fatal myocardial infarction, fatal and non-fatal ischemic stroke, and unstable angina requiring hospitalization 124 N=9,000 Run-in period Randomization 4-52 weeks after index event Screening visit: Initiate high dose statin therapy(2) Double-blind treatment period (minimum of 2 years) Qualifying visit: LDL-C must be >70mg/dl(3) R Patients with recent ACS >40 years of age Praluent® 75mg SC Q2W Up-titration at Week 12 if needed Placebo SC Q2W N=9,000 + Diet (NCEP ATP III TLC or equivalent diet) Continued high dose statin Primary Endpoint(4) A composite of major CV endpoints ODYSSEY OUTCOMES Clinical Trial Design(1)
  125. 125. 125 ODYSSEY OUTCOMES Second Interim Analysis Expected in H2 2016 ● ODYSSEY OUTCOMES trial design published in Nov 2014(1,2) ● Two interim analyses planned prior to study completion in late 2017 ● 90% power to detect an expected 15% hazard reduction in the primary endpoint ● DSMB will conduct two interim analyses to assess safety and efficacy ● Interim analysis for futility when ~50% of events have occurred ● Second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred in H2 2016 Praluent® is developed and commercialized in collaboration with Regeneron DSMB: Data Safety Monitoring Board (1) Rationale and design in Schwartz GG et al. Am Heart J 2014;0:1-8.e1. (2) Assumptions include the incidence of a primary endpoint event in the placebo group, 1% of patients lost to follow-up through 24 months, a median LDL-C at baseline of 90 mg/dL, and a 50% reduction of LDL-C from baseline with Praluent® treatment
  126. 126. Global Launch Outside U.S. Ongoing 126 H2 2015 2016 JapanCanada Italy Spain France EU 5 Rest of World Germany UK Praluent® is developed and commercialized in collaboration with Regeneron
  127. 127. Leadership in the PCSK9 Market 127 2015 Launch Focus Gradual Uptake Expected 2016-2017 Future Opportunity Expansion and Acceleration Praluent® is developed and commercialized in collaboration with Regeneron (1) Second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred Building awareness & education Executing centralized patient initiation & distribution model in the U.S. Gaining U.S. market access Driving appropriate use & adherence ● EU top 5 launches planned in Q4 2015 and 2016 ● ODYSSEY OUTCOMES interim efficacy analysis(1) expected in H2 2016 ● ODYSSEY OUTCOMES study completion expected in late 2017 ● Real world and life cycle studies to support market access and value for sub-populations
  128. 128. MEET SANOFI Management RARE DISEASES & MULTIPLE SCLEROSIS David Meeker, MD Executive Vice President, CEO Genzyme Richard Peters Senior Vice President, Head of Rare Diseases Bill Sibold Senior Vice President, Head of Multiple Sclerosis
  129. 129. 129 Agenda Genzyme: a success story Rare Diseases: an untapped opportunity Multiple Sclerosis: a fast-growing player
  130. 130. Inspired by the Potential to Improve Patients' Lives 130 Milena , Argentina Gaucher Disease Dean , Australia Multiple Sclerosis
  131. 131. 131 ● Strong historic growth: >25% per year over 2012-2015 ● Leading position in Rare Diseases ● Growing presence in Multiple Sclerosis ● Around 10% of Sanofi sales(1) ● Proven ability to execute in specialized disease areas ● Historic supply chain issues successfully addressed (1) Calculated using YTD Q3 2015 sales 2012-2015 Genzyme Has Delivered Strong Growth since 2012 ~€1bn ~€3.5bn 2015e €1,785m ~€2.5bn 2014 €2,604m 2013 €2,142m 2012 Multiple Sclerosis Rare Diseases +24.3%Growth at CER +25.9%+16.9% Annual Sales >+25%
  132. 132. 132 A Successful Model for Productive R&D Collaborations 132 ● World-class RNAi therapeutic technology ● Focus on genetic diseases with a clear translational model for RNA interference ● $875m invested in equity, upfront and milestone payments and R&D costs ● Opt-in rights exercised for two Phase III candidates (patisiran, revusiran) and one Phase I program (ALN-AT3) ● Novel adeno-associated virus (AAV) gene therapy platform ● Targeting rare CNS disorders ● e.g.: Huntington’s and Parkinson’s disease, Friedreich’s ataxia ● $100m upfront commitment and up to $745m in milestones Recent Collaborations(1,2) (1) Expansion of the Alnylam collaboration was announced in Jan 2014 (2) Collaboration with Voyager was announced in Feb 2015
  133. 133. 133 2015-2020 Rare Diseases and MS Will Remain Key Growth Drivers >€2.0bn 2020e >€6.0bn ~€3.5bn 2015e >€4.0bn Multiple Sclerosis ~1/3 Rare Diseases ~2/3 Annual Sales (€m) ● Solid growth expected from 2015 to 2020 despite increasing competition and pricing pressure ● Rare diseases and MS each expected to contribute strongly ● Growth driven mostly by increased penetration of existing brands ● New launches expected to drive growth beyond 2020 Significant improvement in BOI margin expected over 2015-2020 Low double digit sales CAGR at CER BOI: Business Operating Income
  134. 134. 134 Agenda Genzyme: a success story Rare Diseases: an untapped opportunity Multiple Sclerosis: a fast-growing player
  135. 135. Fabry ~90% Diagnosed Total Treated Genzyme Treated 3,2006,00010,000 Pompe ~95% Diagnosed Total Treated Genzyme Treated 2,4002,5003,000 Gaucher ~80% Diagnosed Total Treated Genzyme Treated 5,0007,000 10,000 Niemann-Pick (A&B) ~95% Diagnosed Total Treated Genzyme Treated 1,300 Majority of Rare Disease Patients Are Still Undiagnosed(1) ~50,000 >100,000 (1) Genzyme internal analysis - Includes China and India ~50,000 20,000 135
  136. 136. Clear Strategies to Sustain Leadership in Rare Diseases ● Focus on hematologists ● Apply proven screening protocols ● Facilitate access ● Optimize launch of Cerdelga® ● Focus primarily on nephrologists ● Map family trees ● Develop oral GCS Inhibitor ● Focus on neurologists and neuromuscular specialists ● Perform testing of high risk patients ● Develop neo-GAA(1) Gaucher Fabry Pompe Largest opportunity lies in undiagnosed and diagnosed/untreated 136 (1) Modified recombinant human GAA (acid alpha-glucosidase) harboring synthetic oligosaccharide ligands
  137. 137. Rare Diseases Franchise Sustained Leadership(1) in YTD Sep 2015 137 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Others Fabrazyme Myozyme Cerdelga Cerezyme Genzyme Rare Disease Sales (€m) €630m +13.0% at CER €530m €147m €189m €114m €162m (1) Cerezyme® + Cerdelga® value share is 74% and Fabrazyme® value share is 59% based on Q3 2015 reported sales by Sanofi and Shire (2) Cerdelga® sales were €18m in Q3 2015 (2) & Others €2,137m (+11.2% at CER) €1,890m (+12.6% at CER)
  138. 138. 138 ● Encouraging performance in first year after U.S. launch ● Almost 1/3 of Genzyme’s Gaucher portfolio in the U.S. ● U.S. Gaucher market share of 17% ● 60% of patients new to Genzyme ● Genzyme Gaucher patient share estimated at 60% in the U.S. versus 52% a year prior ● Available in 8 countries by end of 2015 ● 2015 sales expected to exceed €60m ● 14 additional countries expected in 2016 Genzyme Leading Innovation in Gaucher Disease with Cerezyme® and Now Cerdelga® Potential to grow Gaucher market and expand Genzyme Gaucher franchise to >€1bn
  139. 139. GZ402666 Neo GAA Pompe Disease Olipudase alfa rhASM Niemann-Pick type B Patisiran(2) (ALN-TTR02) siRNA targeting TTR Familial amyloidotic polyneuropathy SAR439774 (ALN-AT3)(1) siRNA targeting Anti-Thrombin Haemophilia GZ402671 Oral GCS Inhibitor Fabry Disease Revusiran(3) (ALN-TTRsc) siRNA targeting TTR Familial amyloidotic cardiomyopathy Phase I 139139 Phase II Phase III Genzyme Alnylam A Solid Rare Diseases R&D Pipeline (1) Genzyme recently opted into ALN-AT3 in territories outside of North America and Western Europe, retaining its opt-in right to North America and Western Europe. Specifically, Genzyme has the right to either co-develop and co-promote ALN-AT3 in Alnylam's territory or to maintain its ROW rights for ALN-AT3 and obtain a global license to ALN-AS1 in acute hepatic porphyrias. Genzyme will exercise this selection right upon completion of PoC for ALN-AS1, which is expected to occur in 2016 (2) Genzyme territories include Japan, APAC, Latam and Eastern Europe (3) Genzyme territories include Japan, APAC, Latam and Eastern Europe with co-develop/co-promotion right in U.S. and Western Europe
  140. 140. ● Niemann-Pick is a serious lysosomal storage disorder, characterized by fat deposits in spleen and liver ● Patient identification uses established diagnosis algorithm for Gaucher ● 3.8% of patients tested positive for Niemann-Pick after testing negative for Gaucher Gaucher Hematology Campaign Niemann-Pick Patient Diagnosis Addressing Niemann-Pick type B with Olipudase alfa(1) , an Enzyme Replacement Therapy Currently in Phase II Therapeutic Approach Phosphorylcholine Ceramide Sphingosine Acid- Ceramidase Intended result: Reverse and prevent somatic disease if treatment begins early Target the underlying metabolic defect by replacing the missing enzyme Olipudase alfa Olipudase alfa 140 Sphingomyelin (1) Recombinant form of human acid sphingomyelinase (ASM) developed as an enzyme replacement therapy FDA Breakthrough Therapy Designation granted in May 2015
  141. 141. Hemophilia: a $10bn Market Set to Face Substantial Changes 141 (1) World Federation of Hemophilia Annual Global Survey 2014 (2) World Federation of Hemophilia Guidelines for the management of hemophilia. (http://www1.wfh.org/publications/files/pdf-1472.pdf) ● Inhibitors ● Overcome anti-factor antibodies ● 15-25 bleeds/year; >5 in-hospital days/year ● ~ 3,500 patients ● Prophylaxis ● Goal of therapy for all patients(2) ● Only 42-48% of patients receive prophylactic therapy ● Recessive X-linked monogenic disease ● Hemophilia A: loss of function in Factor VIII ● ~140,000 patients ● Hemophilia B: loss of function in Factor IX ● ~28,000 patients Hemophilia(1) Unmet Medical Need(1) Therapy with better benefit/risk profile is needed
  142. 142. ● Antithrombin (AT) is a key endogenous anticoagulant ● Inactivates Factor Xa and thrombin ● Attenuates thrombin generation ● Expressed in liver; circulates in plasma ● Human AT deficiency associated with increased thrombin generation ● Subcutaneous ALN-AT3 aimed at correcting coagulation defects by knockdown of AT ● Currently in Phase I in moderate-to-severe hemophilia ALN-AT3: an Investigational RNAi Therapeutic Targeting Antithrombin AT FIX FVIII FIXa FVIIa FVII FVIIIa FVa FV FX FXa Fibrinogen Fibrin ThrombinProthrombin Blood clot Intrinsic system Extrinsic system Hemophilia B Hemophilia A FVIII FIX AT 142 Coagulation Cascade Phase III planned to start in mid-2016
  143. 143. 143 Genzyme Is the Long-Established Leader and Innovator in the Rare Diseases Area Rare diseases sales have grown by +12% CAGR since 2012. Drivers to sustain growth in this category are: ● Accelerate systematic patient identification initiatives ● Continue leadership in patient advocacy through genuine commitment ● Focus lifecycle and business development efforts in areas of expertise and strengths to leverage synergies ● Advance internal and partnered novel pipeline 1 2 3 4 2020 Rare Diseases sales expected to exceed €4bn
  144. 144. 144 Agenda Genzyme: a success story Rare Diseases: an untapped opportunity Multiple Sclerosis: a fast-growing player
  145. 145. 42 years-old 52 years-old Brain MRI Reveals Significant Progression of Atrophy over 10 Years(1) 145 (1) Courtesy of Beth Fisher and Rick Rudick Cleveland Clinic Despite Increased Treatment Options, Significant Unmet Needs Remain in Multiple Sclerosis
  146. 146. 146 A Large and Growing Global MS Market (1) Reported sales of Copaxone® (Teva), Avonex® (Biogen), Rebif® (Merck Serono), Betaseron/Betaferon® (Bayer), Extavia® (Novartis), Tysabri® (Biogen) and Gilenya® (Novartis) for 2014 sales converted using €/$ of 1.3 and 2020e Genzyme estimates Multiple Sclerosis Market Global Sales(1) 2020e ROW €14.3bn ~€22.6bn ~35% ~65% 3 oral brands 5 injectable interferon beta brands 2 injectable glatiramer acetate brands including a generic 2 intravenous drugs +8% CAGR An Increasingly Competitive Therapeutic Area 2014 U.S. ~37% ~63%
  147. 147. Multiple Sclerosis Franchise Sales Annualizing Over €1bn(1) 147 Genzyme Multiple Sclerosis Sales Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Série2 Série1 €293m €68m €225m (1) Multiplying Q3 2015 sales of €293m by four provides a hypothetical annual run rate of over €1bn sales ® €168m €467m €761m
  148. 148. 148 37.5%62.5% Oral Therapies Injectable Therapies Making Steady TRx Share Gains Aubagio® Has Become the Fastest Growing Oral MS Drug this Year(1) Oral Therapies Have Gained Significant Market Share(1) (1) IMS U.S. - Week of October 23, 2015 Tecfidera® 21.1% 0% 5% 10% 15% 20% 25% Gilenya® 10.3% 6.2% U.S. Weekly TRx Share
  149. 149. 149 A Successsful New Global Campaign ● Approved in more than 50 countries ● >40,000 people treated with Aubagio® worldwide ● Only oral MS treatment to significantly reduce the risk of SAD in 2 Phase III studies in RMS(1) (TEMSO and TOWER) ● Positive data in early MS(2) (TOPIC) ● New analysis of MRI data showing significant reductions in brain volume loss ● Favorable tolerability, once daily dosing SAD: sustained accumulation of disability (1) AUBAGIO® (teriflunomide) is effective across key measures of disease activity: sustained disability progression (14 mg only), annualized relapse rate, and MRI activity. Common side effects with AUBAGIO led to treatment discontinuation rates ≤3.3% in clinical trials. (2) Patients with a first clinical event consistent with MS
  150. 150. Significantly Reduced Brain Volume Loss in Relapsing Multiple Sclerosis(1) RR: Releapse Rate (1) SIENA analysis of the TEMSO MRI dataset presented at ECTRIMS 2015 -0.61 -1.29 -0.39 -0.9 Year 1 Year 2 Median%ChangefromBaseline Placebo Teriflunomide 14 mg RR: 36.9% p=0.0001 N=276 N=263 RR: 30.6% p=0.0001 N=234 N=235 Annualized Percentage Change in Brain Volume(1) ● An immunomodulatory Disease Modifying Treatment (DMT) with demonstrated efficacy on: Relapse rate Disability progression MRI activity Brain volume loss(1) 150
  151. 151. 151 Potential to Transform MS Patients’ Lives ● Approved in more than 40 countries ● Extensive clinical development program with 5,400 patient-years of follow-up ● Durable improvements in relapse, disability, and MRI outcomes over 5 years in active RRMS demonstrated in CARE-MS I and II extension studies  No retreatment with Lemtrada® after the initial 2 courses in the core studies for most patients through Year 5 (1) The most common side effects of Lemtrada® are rash, headache, thyroid disorder, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, fungal infection, arthralgia, pain in extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and vomiting. Other serious side effects associated with Lemtrada® include autoimmune thyroid disease, autoimmune cytopenias, infections and pneumonitis. (2) Label includes a boxed warning noting a risk of serious, sometimes fatal autoimmune conditions, serious and lifethreatening infusion reactions and noting Lemtrada® may cause an increased risk of malignancies including thyroid cancer, melanoma and lymphoproliferative disorders. Lemtrada® is contraindicated in patients with HlV infection.
  152. 152. Core Study Extension Study Durable Clinical Efficacy Through 5 Years ● 68% of patients did not receive additional Lemtrada® treatment during the four years following the initial two courses of treatment (Months 0 and 12) ● 80% of patients were free from 6-month disability progression through Year 5 ● The median yearly brain volume loss was -0.20% or less in Year 3, 4 and 5 of the extension study, lower than what was observed during the two-year pivotal study No. of Patients 376 349 342 340 349 (Month 24‒60) Annualized Relapse Rate (ARR) (95% CI) CARE-MS I Study Assessments Through 5 Years (1) Study in treatment-naive patients with active relapsing-remitting multiple sclerosis 152 0.18 0.19 0.14 0.15 0.16 0,0 0,2 0,4 0,6 0,8 1,0 Years 0–2 Year 3 Year 4 Year 5 Year 3–5 1.0 0.8 0.6 0.4 0.2 0.0
  153. 153. Key Drivers Q3 Q4 HCP Materials & Programs Package Insert Incorporating Brand Messaging Consumer Materials X  Patient Acquisition/Digital/ REMS Monitoring Website X Full Site w/Videos Reimbursement Misc. J Q-Code Overcoming Barriers in the U.S. in Q4 2015 153
  154. 154. 154 Our Strategy to Grow our Multiple Sclerosis Franchise ● Successfully complete global launches of Aubagio® and Lemtrada® ● Expand LCM activities to maximally support existing products ● Develop Lemtrada® for subcutaneous use ● Run a PoC study in Progressive MS with Lemtrada® ● Reinforce presence in high efficacy segment ● Advance GLD52, a next generation anti-CD52 mAb, through Phase I ● Enter into the neuroprotection / remyelination segment ● Six programs currently in research 1 2 3 4 Ambition to double the size of the MS franchise sales from 2015 to 2020 to >€2bn
  155. 155. MEET SANOFI Management VACCINES Olivier Charmeil Executive Vice President, Vaccines Damian Braga Senior Vice President, Commercial Operations Guillaume Leroy Vice President, Dengue Company John Shiver Senior Vice President, R&D
  156. 156. 156 Agenda The Vaccines market Sanofi Pasteur growth perspectives A balanced R&D pipeline
  157. 157. 157 Immunization Is One of the Most Successful and Cost-effective Health Interventions A successful vaccination program adds more than 1% to a country GDP(4) Vaccination is rivalled only by clean water for reducing mortality rates and improving lives(1) Childhood vaccination in U.S. has prevented more than 100m serious cases of infectious disease since 1924(2) ~6m lives saved every year by vaccines (= 10 lives per minute)(3) €1bn saved annually from eradication of smallpox(5) (1) http://www.who.int/bulletin/volumes/86/2/07-040089/en/ (2) Panhuis WG et al. N Engl J Med 2013; 369:2152-2158 (3) Ehreth J. The global value of vaccination. Vaccine 2003; 21: 596-600 (4) David E. Bloom DE. Valuing Vaccination. Presentation at Fondation Mérieux, Jan 19, 2015 (5) http://www.who.int/mediacentre/news/notes/2010/smallpox_20100517/en/ Vision: “A world in which no one suffers or dies from a vaccine preventable disease”
  158. 158. A Concentrated Market with Sanofi Pasteur Ranking #1(1) in Several Areas Others 2014 World Vaccine Market Sales(2) ~€21bn 19% GSK Merck Pfizer 158 (1) Sanofi Pasteur internal analysis (2) Sanofi Pasteur sales includes 50% of Sanofi Pasteur MSD JV sales (excludes supply sales from Sanofi Pasteur to JV); 50% of JV sales added to Merck sales. GSK = GSK + Novartis (excluding Flu vaccines); CSL = CSL + Novartis Flu (market view pro forma) (3) Include VaxServe sales (€314m in 2014). VaxServe is a Sanofi Pasteur company that supplies vaccines in the U.S. Sanofi Pasteur Sales in 2014 €3,974m Travel and Other Endemic Others(3) 437 377 Adult boosters 398 Meningitis 430 Polio, Pertussis & Hib 1,154 Flu 1,178 #1 #2 #1 #3 CSL #1
  159. 159. ● Continuously increasing GMP standards for batch release by Health Authorities ● Market access often requires local manufacturing ● Very high level of expertise required in industrial processes which often cannot be automated ● Need to continually adapt production process to satisfy evolving regulatory demand ● Much longer product life cycle than pharmaceuticals ● Incremental innovation provides high added-value differentiation in the marketplace A Complex Industry Where We Have to Deliver on Three Fronts Complex Biological Processes Highly Regulated Business High CapEx Requirements 159 GMP – Good manufacturing practices
  160. 160. 160 Evolving Immunization Policies Are Creating Significant Growth Opportunities 160 Level of coverage Market maturity IPV acP/Hib Flu Ped Flu Rotavirus Mature Ongoing modernization Under-developed Status of Immunization Schedules IPV– Inactivated polio vaccine acP – Acellular Pertussis Hib – Haemophilus influenzae type b Ped – Pediatric Projected Market Trends % of Birth Cohort in 2020 9% 19% 72% Sales Growth CAGR 2015-2020 3% 6% 10% % of Sales in 2020 60% 23% 17% Source: Sanofi Pasteur internal estimates based on various sources
  161. 161. 161161 ~5% CAGR 2015e 2020e Projected Market Growth(1) Projected Industry Growth Drivers 1 Launch of innovative vaccines to prevent diseases with unmet need 2 Reach target immunization coverage rates in mature markets 3 Pricing improvement driven by more innovative vaccines 4 Modernization of immunization schedule in middle income countries 2015-2020 Strong Visibility as Mid-Single Digit Growth Sustainable (1) Internal estimates ~€25bn 5 Growing middle class in Emerging Markets
  162. 162. 162 Agenda The Vaccines market Sanofi Pasteur growth perspectives A balanced R&D pipeline

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