Presentation

Transcription

Presentation

MEET SANOFI Management
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.
2
2015-2020 ROADMAP
Olivier Brandicourt
Chief Executive Officer
Agenda
Our vision for Sanofi
Sanofi’s path to success
Delivering performance
4
Many Elements Point towards a Favorable Outlook
for the Healthcare Industry despite Multiple Challenges
Opportunities
 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
Challenges
 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
5
Sanofi Has Important Strengths to Build On
in this Changing Environment
Leading
positions in
Diabetes, Vaccines,
Rare Diseases,
Emerging Markets
Record of
building leading
brands:
Lantus®, Fluzone®,
Cerezyme®
TA: Therapeutic Areas
Launching
a strong set
of products
across multiple TAs
Successful in
sourcing external
innovation:
Regeneron,
Alnylam, Voyager
Making credible
entry in new TAs
e.g. Multiple
Sclerosis
Strong skills
for managing
mature
businesses
6
Sanofi Also Has Challenges to Address
in Order to Succeed
1
Broad portfolio
2
Lantus® loss of exclusivity
3
4
5
Pressure on margins
Limited breadth of pipeline
Complexity
7
A New Strategic Direction for Sanofi Is Needed
to Change our Growth Trajectory
Sanofi is a global healthcare company focused
on disease prevention and treatment
Our Vision
for Sanofi
● 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
8
Agenda
9
We Have Four Strategic Priorities
1
2
Reshape
the portfolio
4
Deliver
outstanding
launches
3
Sustain
innovation
in R&D
Simplify the organization
10
1
Reshape the Portfolio
A
Sustain
leadership
B
Build competitive
positions
C
Explore strategic
options
● Diabetes/CV
● Multiple Sclerosis(1)
● Animal Health
● Vaccines
● Oncology(1)
● Rare Diseases(1)
● Immunology(1)
● Generics(2)
in Europe
● Emerging Markets(2)
● Consumer
Healthcare(2)
(1) Will be part of Specialty Care Global Business Unit
(2) Will be part of General Medicines and Emerging Markets Global Business Unit
11
A
Committed to Diabetes and Cardiovascular Diseases
1
Develop the insulin franchise
2
Strengthen the pipeline through external opportunities
and ambitious research
3
Lead the market shift to managing diabetes outcomes
4
Transform the management of hypercholesterolemia
Google
Life Sciences
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
12
Strengthening our R&D Portfolio in Diabetes
with Two In-Licensing Agreements
A
(2)
Immunology
Sotagliflozin - Phase II in T2 Diabetes
Phase III in T1 Diabetes
Efpeglenatide – Phase II
●
Long acting GLP-1(3)
●
Dual SGLT1 and SGLT2 inhibitor(1)
●
Diabetes/Obesity
●
Limiting meal time glucose absorption and
increasing renal glucose excretion
●
Weekly/monthly administration
●
Oral administration
●
Adjunct therapy
to insulin
in T1DM
●
Favorable
safety profile
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
T1DM: Diabetes mellitus type 1
(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
13
Growing Faster than Market in Vaccines
A
Projected Sanofi Pasteur Sales
1
2
Further develop strong vaccine brands
● Flu vaccines
● Pediatric combinations
● Adult boosters
High
single digit
sales CAGR
at CER
~€4.7bn
Successfully launch Dengvaxia®
~75%
of
sales
Dengue
€4.0bn
3
4
Flu
Expand our manufacturing
capacity
Pediatric
& boosters
Deliver novel high-value
vaccines e.g. C. diff vaccine
2014
2015e
2020e
14
A
Sustaining Leadership in Rare Diseases
Undiagnosed(1)
Undiagnosed(1)
Undiagnosed(1)
●
1 Sustain market share through patient-centered approach,
product differentiation and market access
●
2 Grow market through patient screening and manufacturing expansion
●
3 Advance internal and partnered novel pipeline
Sales CAGR for Rare Diseases expected at high single digit at CER over 2015-2020
(1) Genzyme internal analysis. Include China and India
15
A
Retaining #1 Position in Emerging Markets
through Greater Focus
Leader in Emerging Markets
EM sales ~€10.8bn in 2015e
~29% of Group sales(1)
A top 3 MNC player in BRIC-M
#3 in China
#1 in Brazil
●
1 Increase focus on priority countries/regions
●
Prioritize resource allocation
●
Adapt industrial footprint
●
Redefine scope to exclude Eastern Europe(1)
●
2 Win the emerging middle class
#2 in Russia
●
3 Innovate specifically for Emerging Markets
#4 in India
●
4 Optimize trade and channel management
#2 in Mexico
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
16
1
A
Sustain
leadership
B
Build competitive
positions
C
Explore strategic
options
● Diabetes/CV
● Animal Health
● Vaccines
● Oncology(1)
● Immunology(1)
● Generics(2)
in Europe
● Consumer
Healthcare(2)
17
B
Growing our Multiple Sclerosis Franchise
Multiple Sclerosis Franchise
Reported sales (€m)
€923m
Série2
Série1
●
1 Successfully complete global
launches of Aubagio® and Lemtrada®
●
2 Expand LCM activities to maximize
support to existing products
®
●
3 Reinforce presence in “high efficacy”
category
4 Enter the neuroprotection/
●
remyelination segment
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
2013 2013 2013 2013 2014 2014 2014 2014 2015 2015 2015
Ambition to double the size of the MS franchise from 2015 to 2020
LCM: Life Cycle Management
18
B
Rebuilding a Competitive Position in Oncology
Oncology Opportunity
Largest therapeutic area
for pharmaceuticals
Strong growth driven
by unmet need and
groundbreaking science
●
1 Maximize clinical assets, particularly isatuximab
(anti-CD38 mAb) and Antibody-Drug Conjugates
●
2 Build a transformative pipeline
●
Immuno-oncology collaboration with Regeneron
●
Collaboration with BioNTech on mRNA therapeutics
●
3 Rebuild critical mass
ADCs: Antibody-Drug Conjugates
19
B
Sarilumab and Dupilumab Represent Cornerstones
of a New Immunology Franchise
Immunology
● 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
● 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
● Recently submitted
to FDA
RA: Rheumatoid Arthritis
● Multi-disease, best in class drug
targeting Th2 pathway
TNF-IR: TNF inadequate responders
AD: Atopic Dermatitis
20
B
Build Scale in a Fragmented CHC Market
Ranked #5 in the
(1)
~€100bn OTC Market
Bayer
GSK
J&J
1
Maximize
Existing
Brands
Manage with speed,
agility and consumer
focus
2
Shape
New
Categories
Prepare the potential
Rx-to-OTC switch
of Cialis®
3
Build Scale
through Bolt-on
Acquisitions
Reach critical scale
in key countries and
priority categories
Pfizer
3.2%
Other
Reckitt Benckiser
P&G
Boehringer Ingelheim
Takeda
Taisho
(1) Nicholas Hall & Company, FY 2014
21
1
A
Sustain
leadership
B
Build competitive
positions
C
Explore strategic
options
● Diabetes/CV
● Animal Health
● Vaccines
● Oncology(1)
● Immunology(1)
● Generics(2)
in Europe
● Consumer
Healthcare(2)
22
C
Explore Strategic Options for Two Businesses
Merial
Generics in Europe
● 2015e sales >€2.4bn
● 2015e sales ~€1bn(1)
● Successful return to growth
(YTD +12.4% at CER)
● Above average profitability of
Generics businesses
● One of the most profitable AH
companies
● Ranked #5 in Europe,
few geographic synergies
(limited US presence)
● Ranks #1 in companion
animals and #4 overall
● But limited synergies
with other
businesses
in Sanofi
AH: Animal Health
(1) Western and Eastern Europe
● But consolidating market and
increased complexity
(biosimilars,
differentiated Gx)
23
2
Deliver Outstanding Launches
2014-2020: Up to 18 Launches Planned
Launched
Feb 2014 - Feb 2015
Focus on Six Launches
Other upcoming launches
patisiran
(U.S.)
(U.S.)
Shan5
PR5I
Vaccine
insulin
lispro
isatuximab
Rotavirus
Vaccine
Vaccine
24
Greater Focus on Six Major Launches
through GBU Structure
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
25
Sanofi Expects its Six Major Launches to Generate
Substantial Combined Sales
Sales Potential of Six Key Products
Expected
combined peak sales
of €12bn to €14bn(1)
(1) At CER, non-risk adjusted sales projections through 2025
26
Global Roll-out Underway and Showing Early
Promise in Key Markets
Weekly Sell Out Share (in Units/Packs)
within Basal Market(2)
Weekly NBRx Share
60%
Lantus®
50.9%
50%
8%
7.1%
7%
6%
40%
Levemir®
26.3%
30%
5%
Tresiba®
3.8%
4%
3%
20%
13.7%
10%
NPH
9.0%
0%
1
3
5
7
9 11 13 15 17 19 21 23 25 27 29
Weeks from Toujeo® Launch
2%
1%
0%
1
3
5
7
9
11 13 15 17 19 21 23 25
Weeks from Launch
Additional launches in Q3 in Japan, Canada, U.K. and other EU countries
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
27
Investing in a Broad LCM Program to Expand
the Evidence Base
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
●
Initial results expected in 2017,
extended follow-up findings in 2018
●
Higher single maximum daily
dose and greater capacity
28
Transforming the Management
of Hypercholesterolemia
2015
Launch Focus
Gradual Uptake Expected
2016 - 2017
Future Opportunity
Expansion and Acceleration
Building awareness &
education
● EU top 5 launches planned
in Q4 2015 and 2016
Executing centralized patient
initiation & distribution model
in the U.S.
● ODYSSEY OUTCOMES interim efficacy
analysis(1) expected in H2 2016
Gaining U.S. market access
Driving appropriate use &
adherence
● ODYSSEY OUTCOMES study
completion expected in late 2017
● Real world and life cycle studies
to support market access and
value for sub-populations
75 mg/1 mL pen
Praluent® is developed and commercialized in collaboration with Regeneron
(1) Second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred
150 mg/1 mL pen
29
The First Ever Dengue Vaccine(1)
Global Evidence Consensus
Risk & Burden of Dengue - 2010(5)
● 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)
Complete
absence
Complete
presence
Make dengue the next vaccine-preventable disease
(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
An Investigational Agent Combining Insulin
Glargine with Lixisenatide in a Daily Injection
Single Once Daily Injection
=
Fixed Ratio Combination
of Two Active Components
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
Expected key regulatory submissions: U.S. Q4 2015 & EU Q1 2016
PPG: Post-Prandial Glucose
FPG: Fasting Plasma Glucose
31
3
Sustain Innovation in R&D
Deliver a Balanced Pipeline…
Continue to strengthen R&D
A
pipeline
B
Implement the R&D 2.0 model
C
Foster existing R&D
collaborations (REGN, ALNY)
D
Increase capacity for external
innovation
… Focused on GBU Priorities
● Sustain leadership:
Diabetes/CV, Vaccines,
Rare Diseases
● Build competitive
positions: Oncology, MS,
Immunology
● Invest opportunistically:
Neurodegeneration/pain,
Infectious Diseases and
Ophthalmology
Increasing annual R&D investments up to €6bn
by 2020 while maintaining financial discipline
32
Further Expanding the R&D Pipeline Is a Key Objective
for the Next Phase
Phase II
Phase I
GZ402668
N
GLD52 (anti-CD52 mAb)
Relapsing multiple sclerosis
SAR113244
N
N
TRKA antagonist
Osteoarthritis
SAR425899
N
GLP-1R/GCGR dual agonist
Diabetes
SAR438335
N
N
N
Anti-CEACAM5 ADC
Solid tumors
SAR439684
PD-1 inhibitor
N
SAR439152
Anti-IL6R mAb
Uveitis
SAR422459
N
UshStat®
N
N
Antimalarial
isatuximab
SAR366234
SAR342434
N
Dengvaxia®
Mild-to-severe
dengue fever vaccine
Meningitis ACYW conj.
dupilumab
2nd generation meningococcal
conjugate infant vaccine
Anti-IL4Rα mAb
Atopic dermatitis, Asthma
Tuberculosis
Recombinant subunit vaccine
Fluzone® QIV HD
Quadrivalent inactivated
influenza vaccine - High dose
N
New Molecular Entity
N
sarilumab
Anti-IL6R mAb
Rheumatoid arthritis, U.S.
insulin lispro
Type 1+2 diabetes
sarilumab
N
patisiran (ALN-TTR02) N
siRNA inhibitor targeting TTR
Familial amyloidotic polyneuropathy
PR5I
DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine, U.S.,
EU
VaxiGrip® QIV IM
influenza vaccine (3 years+)
revusiran (ALN-TTRsc) N
Familial amyloidotic cardiomyopathy
Jevtana®
cabazitaxel
Metastatic prostate cancer (1L)
Diabetes
Streptococcus pneumonia
Herpes Simplex Virus Type 2
Cardiovascular Diseases
Vaccines
Rare Diseases
Oncology
Multiple Sclerosis
N
N
N
lixisenatide
GLP-1 agonist
Type 2 diabetes, U.S.
Anti-IL6R mAb
Rheumatoid arthritis, EU
N
N
N
Purified vero rabies vaccine
N
Anti-CD38 naked mAb
Multiple myeloma
LixiLan
lixisenatide + insulin glargine
Fixed-Ratio / Type 2 diabetes
Rabies VRVg
ferroquine / OZ439
N
olipudase alfa
sarilumab
Combination
N
rhASM
Niemann-Pick type B
Myosin 7A gene therapy
Usher syndrome 1B
HSV-2 vaccine
Cancer
Myosin inhibitor
Hypertrophic cardiomyopathy
SAR439774 (ALN-AT3) N
siRNA targeting Anti-Thrombin
Haemophilia
Meningitis & pneumonia vaccine
N
SAR156597
IL4/IL13 Bi-specific Ab
Idiopathic pulmonary fibrosis
EP2 receptor agonist
Elevated intraocular pressure
Cancer
SAR428926
LAMP-1 inhibitor
N
Anti-miR21 RNA
Alport syndrome
SAR228810
GZ402671
Oral GCS Inhibitor
Fabry Disease
Nasal polyposis;
Eosinophilic oesophagitis
ABCA4 gene therapy
Stargardt disease
Maytansin-loaded anti-CA6 mAb
Solid tumors
SAR408701
SAR339375
dupilumab
Anti-IL4Rα mAb
Anti-protofibrillar AB mAb
Alzheimer’s disease
GLP-1R/GIPR dual agonist
Diabetes
SAR566658
N
neo GAA
Pompe Disease
Anti-CXCR5 mAb
Systemic lupus erythematosus
GZ389988
GZ402666
Registration
Phase III
Immunology
Neurodegenerative Diseases
Clostridium difficile
Toxoid vaccine
Rotavirus
Live attenuated tetravalent
Rotavirus oral vaccine
VaxiGrip® QIV IM
influenza vaccine (3-36 months)
Infectious Diseases
Ophthalmology
33
4
Simplify the Organization
Move
to Global
Business
Unit
organization
Reshape
the plant
network
Create
one
Sanofi
culture
34
A New Organizational Model Is a Necessary Step to Drive
Focus and Simplification
Diabetes &
Cardiovascular
General
Medicines &
Emerging Markets
Sanofi
Genzyme
(Specialty Care)
Sanofi
Pasteur
(Vaccines)
Merial
(Animal Health)
P. Witz
P. Guenter
D. Meeker
O. Charmeil
C. Hellmann
 Diabetes
 CHC
 Rare diseases
 Cardiovascular
 Established
products
 Multiple
Sclerosis
 Generics
 Oncology
&
 Human
vaccines
 Animal Health
products
 Immunology
 Emerging
Markets(1)
 Similar to R&D and Industrial Affairs, all functions will be globalized(2)
New organization implemented beginning in January 2016(3)
(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
35
Reshaping Sanofi’s Plant Network
Industrial Footprint Evolution
# of sites
6
52
-26
102
● Continue to reshape plant network
1
to match business evolution
● Implement a more focused approach
in Emerging Markets
70
● Improve competitiveness
● Simplify product lines
2
● Invest in biologics in support
of launches and growth
2008
Merial
Acquisitions Investments/ Achieved
Transfers Restructuring
Genzyme
Sanofi Pasteur
2015
Pharmaceuticals
36
Targeting Cost Savings of €1.5bn by 2018
(1,2)
Largely Reinvested to Support Growth
● 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
Source of cost savings
● 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
(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
37
Agenda
38
The Roadmap for Sanofi
1
2015-17
2018-20
Reshape
Sanofi
Accelerate
growth
2
● 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
39
Objectives for the 2015-2020 Roadmap
Projected Evolution of Sanofi Sales over 2015-2020(1)
Diabetes &
Cardiovascular
General
Medicines &
Emerging Markets
Sanofi
Genzyme
(Specialty Care)
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
(1) Based on current group structure and at CER
40
Deploying Capital Effectively to Create Long Term Value
Balanced Capital Allocation Strategy to Support Growth and Returns
Priorities
for Free
Cash Flow
Use(1)
(1) After R&D investments
1
Organic investment
2
Acquisitions
3
Dividend
4
Stock repurchase
41
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
P&L RATIOS
& CAPITAL ALLOCATION
Jérôme Contamine
Executive Vice President, Chief Financial Officer
Agenda
P&L ratios
Capital allocation
44
Sanofi Is Investing in its Future
while Responding to Reduced Diabetes Expectations
2015-17
2018-20
Reshape
Sanofi
Accelerate
growth
● 2015-2020 sales CAGR of 3% to 4%(1)
● 2015-18 profitability impacted by:
1●
Investment in new product launches and R&D pipeline
2●
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
(1) Based on current group structure and at CER
45
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
Evolution of Gross Margin (%)
~69%
~69%
2015e
2015e
≥69%
67.7%
2013
Price & Mix
Industrial
performance
(1) At CER
FX
Price & Mix
Biologics
Industrial
Product
industrial performance
line
investment
optimization
2018e
46
Sanofi Has Increased R&D Productivity while Keeping
R&D Expenditures Relatively Stable over Last 5 Years
We have kept
R&D expenditures stable…
… and aligned
the R&D to sales ratio by activity
(2015e)
~€5.3bn
€4.8bn
€4.9bn
€4.8bn
€4.8bn
Animal Health
R&D
to sales 14.4%
ratio
~12%
Vaccines
7.7
2011
~15%
Pharmaceuticals
2012
2013
2014
14.1%
14.5%
14.3%
~7%
2015e
47
Increased R&D Investment to Fuel Long Term Growth
Going forward,
we expect a slight increase
in R&D to sales ratio
1
Invest in medical and LCM support for launches
● Toujeo® / Praluent® / Dengvaxia®
Range of
14% to 14.5%
Range of
15% to 15.5%
2
Advance late-stage pipeline development
● dupilumab / C. diff / isatuximab / sarilumab / LixiLan
3
Accelerate early-stage development
● New immuno-oncology collaboration with Regeneron
4
Expand open innovation model
● Finance development of future external projects
2012-2015e
2016e-2018e
(1) At CER and comparable structure
48
SG&A to Sales Ratio Expected to Remain Stable
over 2015-2018(1)
SG&A ratio is expected to remain stable
despite wave of new launches(1)
Sanofi has one of the lowest
SG&A ratios(2)
AstraZeneca
39%
Eli Lilly
33%
GSK
31%
Abbott
30%
Novo Nordisk
30%
BMS
30%
Novartis
30%
J&J
30%
Abbvie
29%
Pfizer
28%
Sanofi
27%
Merck
26%
Roche
Range of
27.5% to 28%
Similar
level
2015e
2016e-2018e
23%
(1) At CER and comparable structure
(2) Source: Published 2014 financial results - Sanofi analysis
49
Structuring a Global Cross Functional Organization
(Sanofi Business Services) and Globalizing the IT Function
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
One Global Information Solutions
Platform
● 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
50
Accelerated Growth over 2018-2020
2018-20
1
Accelerate
growth
2
● 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
51
Agenda
P&L ratios
Capital allocation
52
Deploying Capital Effectively to Create Long Term Value
Balanced Capital Allocation Strategy to Support Growth and Returns
Priorities
for Free
Cash Flow
Use(1)
(1) After R&D investments
1
Organic investment
2
Acquisitions
3
Dividend
4
Stock repurchase
53
1
Investing to Expand Biologic Manufacturing Capabilities
Keeping tight control on CapEx(1)…
~€1.5bn
€1.4bn
€1.2bn
€1.2bn
2013
2014
2012
2015e
…while investing in biologic capabilities
~€1.5bn
€1.4bn
2012
€1.2bn
€1.2bn
2013
2014
2015e
Pharma (w/o Genzyme)
Vaccines
Injectables + Biologics + Vaccines + Genzyme
Genzyme
Animal Health
Others
Investing between €1.8bn and 1.9bn annually in CapEx over 2016-2018
(1) CapEx w/o Product Acquisition
54
2
Strong Balance Sheet and Free Cash Flow
Free Cash Flow(1)
Net Debt
€8.5bn
to
€9.0bn
€10.9bn
€7.7bn
€8.4bn
€7.4bn
€6.5bn
€7.2bn
€7.2bn
~€6.5bn
€6.0bn
2011
2012
2013
2014
2015e
2011
2012
2013
2014
2015e
● 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 €
55
2
Sanofi Has Shown Financial Discipline in M&A Deals
Value
(€m)
EPS
accretion
Value
creation
Strong player in
Animal Health
$4.0bn
(1)
Strong CHC platform
to launch Rx-to-OTC
switches in the U.S.
$1.9bn
(1)
Leading biotech with
unique expertise in
Rare Diseases
$20.1bn
(1)
22.2% stake
valued at
(2)
Strategic antibody &
immuno-oncology
collaborations
Strategic alliance on
RNAi therapeutics
Build
critical mass
Strengthen
pipeline
€12.1bn(3)
11.9% stake
valued at
(2)
€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
56
2
Seek Opportunities to Enhance Growth Profile
through Targeted M&A
M&A Scope
● Business development
opportunities
boosting our growth
profile and offering
synergies
● Focus on transactions
driving value creation
IRR: Internal Rate of Return
CFROI: Cash Flow ROI
ROA: Return on Assets
Priority Areas
Financial Criteria
● Reinforcing priority
businesses
● Maintain rigorous
metrics
● Businesses with
portfolio or geographic
complementarities
● Key performance
indicators include:
● R&D collaborations
expanding our pipeline
● IRR
● CFROI
● ROA
● EPS accretion
57
3
Progressive Dividend Growth
Evolution of Dividend
● Consistent history of dividend
payment
● 21st consecutive year of dividend
increase in 2014
€2.65
€2.40
€2.77 €2.80
€2.85
2012
2014
(1)
€2.50
● Solid dividend yield
● Strong payout ratio
● Maintain progressive growth
of dividend
(1) 2014 dividend paid in 2015
2009
2010
2011
2013
58
4
Stock Repurchases Primarily to Absorb Dilution
Share Buyback (€bn)
2011
~€6.8bn
2012
€1.1bn
€0.8bn
over 5 years
2013
€1.6bn
2014
2015e
€1.8bn
~€1.5bn
Share buyback expected to be used to tackle dilution over time
59
Conclusion
1●
Balancing investment in Sanofi's future with response
to reduced diabetes expectations
2●
Simplification and savings to result in €1.5bn
of cost reduction by 2018, largely reinvested
3●
Profitability to reflect net investment phase 2016-2017
with margin expansion expected to begin in 2018
4●
Capital allocation optimized to support shareholder
returns (steady dividend growth) and to enhance
overall growth profile (disciplined M&A)
60
SUSTAINING INNOVATION IN R&D
Elias Zerhouni, MD
Christian Antoni
President, Global R&D
Vice President, Head Development
Immunology & Inflammation
Gary Nabel
Senior Vice President,
Chief Scientific Officer
Jorge Insuasty
Mike Panzara
Vice President, Multiple Sclerosis
and Neurology, Genzyme
Senior Vice President, Development
Seng Cheng
Philip Larsen
Vice President, Head of R&D
for Rare Diseases
Diabetes - Head of Research &
Early Development
Agenda
Executing a clear R&D strategy
Next wave of innovation
62
Significant R&D Turnaround since 2012
2012
2015
79 projects
44 projects
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
3 launches since 2008(3)
10 launches since 2012(4)
Quality over Quantity(1)
Prioritization
Launches
(1)
(2)
(3)
(4)
From first in human to approval
Peptide, protein, nucleic acid based molecular entities and vaccines
From beginning of 2008 to end of 2011: Pentacel® (2008), Multaq® (2009), Jevtana® (2010)
Toujeo®, Afrezza®, Cerdelga®, Lemtrada®, Aubagio®, Zaltrap®, Kynamro®, Hexaxim®, Fluzone® Quadrivalent, Praluent®
63
The Two Pillars of Our Research Strategy
Translational Medicine
Deep efforts in a
concentrated number
of projects
Open Innovation
Adapting technology
to the disease,
not the reverse
64
Sustain Innovation in R&D over 2015-2020
Deliver a Balanced Pipeline…
Continue to strengthen R&D
A
pipeline
B
Implement the R&D 2.0 model
C
Foster existing R&D
collaborations (REGN, ALNY)
D
Increase capacity for external
innovation
… Focused on GBU Priorities
● Sustain leadership:
Diabetes/CV, Vaccines,
Rare Diseases
● Build competitive
positions: Oncology, MS,
Immunology
● Invest opportunistically:
Neurodegeneration/pain,
Infectious Diseases and
Ophthalmology
65
Our Focus Today is on Building a Strong Follow-on
Portfolio to Mature in 2015-2020
ILLUSTRATIVE
Transformational
Enter novel and emerging
scientific opportunities with
breakthrough potential
Develop next generation
products for each GBU
INNOVATION
Expansion
20%
40%
Consolidation
Support actively our GBUs and
their competitive positioning
40%
TIME to Clinical Proof of Concept
0-2 years
3-5 years
5+ years
66
Further Expanding the R&D Pipeline Is a Key Objective
for the Next Phase
Phase II
Phase I
GZ402668
N
GLD52 (anti-CD52 mAb)
Relapsing multiple sclerosis
SAR113244
N
N
TRKA antagonist
Osteoarthritis
SAR425899
N
GLP-1R/GCGR dual agonist
Diabetes
SAR438335
N
N
N
Anti-CEACAM5 ADC
Solid tumors
SAR439684
PD-1 inhibitor
N
SAR439152
Anti-IL6R mAb
Uveitis
SAR422459
N
UshStat®
N
N
Antimalarial
isatuximab
SAR366234
SAR342434
N
Dengvaxia®
Mild-to-severe
dupilumab
Anti-IL4Rα mAb
Atopic dermatitis, Asthma
Tuberculosis
Fluzone® QIV HD
influenza vaccine - High dose
N
New Molecular Entity
N
sarilumab
Anti-IL6R mAb
Rheumatoid arthritis, U.S.
insulin lispro
Type 1+2 diabetes
sarilumab
N
patisiran (ALN-TTR02) N
PR5I
DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine, U.S.,
EU
VaxiGrip® QIV IM
revusiran (ALN-TTRsc) N
Jevtana®
cabazitaxel
Metastatic prostate cancer (1L)
Diabetes
Cardiovascular Diseases
Vaccines
Rare Diseases
Oncology
Multiple Sclerosis
N
N
N
lixisenatide
GLP-1 agonist
Type 2 diabetes, U.S.
Anti-IL6R mAb
Rheumatoid arthritis, EU
N
N
N
N
Anti-CD38 naked mAb
Multiple myeloma
LixiLan
lixisenatide + insulin glargine
Fixed-Ratio / Type 2 diabetes
Rabies VRVg
ferroquine / OZ439
N
olipudase alfa
sarilumab
Combination
N
rhASM
Niemann-Pick type B
Myosin 7A gene therapy
Usher syndrome 1B
HSV-2 vaccine
Cancer
Myosin inhibitor
Hypertrophic cardiomyopathy
SAR439774 (ALN-AT3) N
Haemophilia
N
SAR156597
IL4/IL13 Bi-specific Ab
Idiopathic pulmonary fibrosis
EP2 receptor agonist
Elevated intraocular pressure
Cancer
SAR428926
LAMP-1 inhibitor
N
Anti-miR21 RNA
Alport syndrome
SAR228810
GZ402671
Oral GCS Inhibitor
Fabry Disease
Nasal polyposis;
Eosinophilic oesophagitis
ABCA4 gene therapy
Stargardt disease
Maytansin-loaded anti-CA6 mAb
Solid tumors
SAR408701
SAR339375
dupilumab
Anti-IL4Rα mAb
Anti-protofibrillar AB mAb
Alzheimer’s disease
GLP-1R/GIPR dual agonist
Diabetes
SAR566658
N
neo GAA
Pompe Disease
Anti-CXCR5 mAb
Systemic lupus erythematosus
GZ389988
GZ402666
Registration
Phase III
Immunology
Neurodegenerative Diseases
Toxoid vaccine
Rotavirus
VaxiGrip® QIV IM
Infectious Diseases
Ophthalmology
67
Agenda
Executing a clear R&D strategy
Next wave of innovation
68
Potentially Transformative Drugs in Earlier Stages
of Development
Selected R&D Assets
1
Isatuximab - Multiple Myeloma
2
Immuno-oncology - Various oncology indications
Immunology
3
IL4/IL13 Bi-specific Ab - Idiopathic Pulmonary Fibrosis
Vaccines
4
C. difficile vaccine - Nosocomial infections
5
Olipudase alfa - Niemann-Pick type B
6
Patisiran(1) - Familial Amyloidotic Polyneuropathy
7
Revusiran(1) - Familial Amyloidotic Cardiomyopathy
8
ALN-AT3(1) - Haemophilia
9
Dual agonists - Type 2 Diabetes
Oncology
Rare Diseases
Diabetes
(1) Patisiran, revusiran and ALN-AT3 developed in collaboration with Alnylam
69
1
Anti-CD38 (isatuximab): a Significant Opportunity to
Potentially Address an Unmet Need in Multiple Myeloma
● 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
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
2
New Strategic Alliance with Regeneron to Develop
Cancer Treatments in Emerging Field of IO
Entering Immuno-Oncology
1
2
3
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
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
PD-1: Programmed death protein 1
LAG-3: Lymphocyte activation gene 3
(1) Including bi-specifics/multi-specifics antibodies
(2) REGN2810
IO: Immuno-Oncology
71
IL4/IL13 Bi-specific Antibody (Ab): Demonstrated
Biological Activity and Encouraging Safety Data
IL4/IL13 Bi-specific Ab: Sanofi
3
CH
2
CH
H1
CH
1
VH
er )
nk GS
) li G
(2 GG
4S S
G GG
G
(G
Ck
C
2
VL
2
VH
V
VL
VH
1
1
1
VL
2
H1
VL
VH
2
Fv An
po ti-IL
sit -1
io 3
Fv An
n
po ti-I
1
sit L-4
io
n
2
bo
nd
Ck
id
e
C
H1
Dis
ulf
C
H1
VH
1
VH
2
C
H2
1
2
2
VL
CH
1
VL
2
2
VL
VL
1
Ck
CH
3
ulf
Dis
e
id
nd
bo
IL13
Ck
C
H2
CH
3
● 5-year survival rate of 20%, comparable to
lung cancer
IL4
(G G4
G S(2
G
G ) li
SG n
G ker
G
G
S)
CH
3
is a severe & rare(1) chronic lung disease
with significant unmet need
VH
● Idiopathic Pulmonary Fibrosis (IPF)
3 1
L-1 n
ti-I itio
An pos
L-4 n 2
Fv
ti-I io
An osit
p
Fv
3
● 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)
BLOCK
BLOCK
BLOCK
● Administered subcutaneously
● Phase II PoC trial started in May 2015
Blocks IL4 and IL13 cytokines
Phase II study completion expected in H2 2017
(1) Estimated prevalence: ~115,000
(2) Phase I study in healthy subjects (n=36) and Idiopathic Pulmonary Fibrosis patients (n=18)
72
4
C. difficile Vaccine Targeting a High Risk Population
of 10 to 15 Million Elderly People in the U.S. Alone
Phase II successfully completed
●
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
Multinational Phase III ongoing
●
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
●
●
CDI case-driven study
Up to 15,000 adults to be enrolled –
1/3 already included
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
73
5
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)
Therapeutic Approach
Target the underlying metabolic defect
by replacing the missing enzyme
Sphingomyelin
Olipudase
alfa
Phosphorylcholine
Ceramide
●
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
Sphingosine
● FDA granted Breakthrough Therapy
Designation in May 2015
Intended result:
Reverse and prevent somatic disease
if treatment begins early
AcidCeramidase
(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.
74
Collaboration Provides Access to
Unique RNAi Opportunities
Transthyretin-Mediated Amyloidosis (ATTR) Program
Progressive,
debilitating
monogenic
disease
● ~50,000 patients worldwide
● FAP and FAC are the two predominant forms
● Liver transplantation is often required early and
TTR stabilizers provide modest benefit
Mutant
transthyretin (TTR)
is genetic cause
● Autosomal dominant with >100 defined mutations
● Misfolds and forms amyloid deposits in nerves, heart,
other tissues
RNAi
is a potentially
transformative
therapy
● Knockdown disease causing protein
● Aim to halt progression, possibly achieve regression
FAP: Familial amyloidotic polyneurapthy
FAC: Familial amyloidotic cardiomyopathy
75
6
Patisiran: an Investigational IV Administered RNAi
Therapeutic to Treat the FAP Form of ATTR
Patisiran: Familial Amyloidotic
Polyneuropathy
● Positive Phase II results in FA
Dose Response and Duration
of TTR Knockdown
% Mean Serum TTR Knockdown
Relative to Baseline (SEM) - n=29
● Statistically significant, dose dependent
TTR knockdown of up to 96%(1)
● Phase II Open-Label Extension (OLE)
ongoing
● APOLLO Phase III trial ongoing
●
Patisiran
Treatment Groups
FDA submission targeted for 2017
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)
Days Since First Visit
Cohorts 0.01-0.30 mg/kg q4w
Cohort 0.30 mg/kg q3w
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
76
7
Revusiran: an Investigational Subcutaneously Administered
RNAi Therapeutic to Treat the FAC Form of ATTR
Revusiran: Familial Amyloidotic
Cardiomyopathy
Rapid, Dose-dependent, Consistent, Durable
Knockdown of Serum TTR of Up to 95%
● Positive Phase II results in TTR
cardiac amyloidosis patients(1)
● Phase II Open Label Extension
(OLE) ongoing
Mean (SEM) % Serum TTR
Knockdown Relative to Baseline
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)
● Subcutaneous administration
● Phase III ENDEAVOUR trial
ongoing
ALN-TTRsc qd x5; qw x5
Study Day
Placebo(N=6)
Revusiran Dose Group
FAC: Familial amyloidotic cardiomyopathy
7.5 mg/kg MAD(N=6)
2.5 mg/kg MAD(N=3)
ATTR: Transthyretin (TTR)-mediated amyloidosis
10.0 mg/kg MAD(N=3)
5.0 mg/kg MAD(N=3)
(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
77
diffuse rash; no further discontinuations due to ISRs have occurred
8
ALN-AT3: an Investigational RNAi Therapeutic
Targeting Antithrombin
Coagulation Cascade
Intrinsic system
Extrinsic system
Hemophilia A
FVIII
● Antithrombin (AT) is a key endogenous
anticoagulant
FVIIa
FX
FVIIIa
● Inactivates Factor Xa and thrombin
FVII
● Expressed in liver; circulates in plasma
Hemophilia B
FIX
FIX
● Attenuates thrombin generation
● Human AT deficiency associated
with increased thrombin generation
FIXa
AT
AT
FXa
FVa
Prothrombin
Thrombin
Fibrinogen
Fibrin
Blood clot
FV
● Subcutaneous ALN-AT3 aimed at
correcting coagulation defects by
knockdown of AT
● Currently in Phase I in
moderate-to-severe
hemophilia
Phase III planned to start in mid-2016
78
9
Dual Agonists for GLP-1 and Glucagon/GIP Receptors
GLP-1/Glucagon Dual Agonist
● Novel synthetic peptidic molecules
developed in-house
8
HbA1c (%)
● Expected benefit is blood glucose
control with superior weight loss over
pure GLP-1 receptor agonists
Glucose Control Similar to Liraglutide - Animal Data(1)
10
● 60% of the T2D population
4
Day 28
0
Liraglutide
40 µg/kg
-1.2%
Sanofi dual
Placebo
Agonist 4 µg/kg
-1.4%
HbA1c vs. Placebo
GLP-1/Glucagon Dual Agonist
Body Weight Loss Superior to Liraglutide (~5%) - Animal Data(1)
% Body weight loss
(compared to day -5)
● Of particular interest in overweight to
obese people with T2D
Day ‐4
2
● 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
6
3
2
1
0
‐1
‐2
‐3
‐4
‐5
‐6
‐7
Placebo
Liraglutide
40 µg/kg
Sanofi dual
agonist 4 µg/kg
0
5
10
15
Study days
20
(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
25
30
79
Significant R&D Milestones Expected in the Next Year
Expected Regulatory Decisions
●
Dengvaxia® in Endemic Countries
●
Lixisenatide in Diabetes (U.S.)
Expected Regulatory Submissions
●
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
●
Dupilumab in Atopic Dermatitis
●
Insulin lispro in Diabetes
●
Sarilumab in Rheumatoid Arthritis (MONARCH)
Expected Phase III Starts
●
Meningitis ACYW conj. vaccine
Q4 2015
Q1 2016
Q2 2016
Q3 2016


Q4 2015
Q1 2016
Q2 2016
Q3 2016




Q4 2015
Q1 2016
Q2 2016
Q3 2016



Q4 2015
Q1 2016
Q2 2016
Q3 2016

80
Transforming the Lives of Patients
by Delivering Innovative Therapies
1 Significant pipeline turnaround since 2012
 Translational Medicine and Open Innovation
2 Increase R&D investments while maintaining financial discipline
 Consolidate / Expand / Transform
3 Implementation of the R&D 2.0 model and alignment with future GBUs
4 Wave of potentially transformative drugs in earlier stages of development
81
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
Agenda
Significant unmet medical needs
Sanofi’s global diabetes leadership
A broad and growing portfolio
83
Diabetes is a Huge and Growing Global Challenge(1)
Number of People Living with Diabetes Expected to Increase
by 53% between 2014 and 2035
46.3%
undiagnosed
North America
Americaand
Caribbean
30%
and
Caribbean
Europe
33%
Europe
WORLD
387m
Prevalence:
8.3%
Western Pacific
Western
Pacific 46%
South
South and
and
Central
CentralAmerica
America 55%
South East
EastAsia
Asia 64%
South
WORLD
592m
53%
Middle East
Middle
Eastand
and
North Africa
Africa 85%
Africa
Africa
93%
2014
(1) International Diabetes Federation Diabetes Atlas 6th Edition revision 2014
2035
84
Diabetes Costs to Society Are High and Escalating(1)
Diabetes Is a Human and Economic Burden
Every 7 seconds ● 4.9m deaths in 2014
1 person dies
from diabetes
77% of people
● 50% of deaths under 60 years of age
with diabetes live
in low- and middleincome countries
● Intersects with all dimensions of
development
1 healthcare $
in 9
● In 2014 diabetes expenditure
reached $612bn
is spent on diabetes
● 11% of worldwide healthcare expenditure
(1) International Diabetes Federation Diabetes Atlas 6th Edition revision 2014
85
Despite Treatment, Many Patients with Diabetes
Are Still not at A1c Goal(1)
Diabetes Patients in the U.S. (Random Sample)
T1D Patients
T2D Patients
53%
53%
Uncontrolled (A1c >7%)
Controlled (A1c ≤7%)
47%
47%
2013
(437)
2013
(2215)
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
86
Inappropriate Diabetes Management Leads to Costly
Consequences
Risk of Complications and A1c(1)
Microvascular
Complications
● Diabetic Retinopathy
Relative Risk in %
15
Retinopathy
13
Nephropathy
Neuropathy
11
Microalbuminuria
Macrovascular
Complications
● Stroke
9
● Diabetic Nephropathy
7
● Heart Disease
5
● Diabetic Neuropathy
● Peripheral Vascular
Disease
3
1
6
7
8
9
10
11
12
A1c (%)
25% to 45% of diabetes-attributed medical expenditures
spent treating complications of diabetes(2)
(1) Endocrinol Metab Clin 1996;25:243 - 254 (DCC Trial)
(2) Diabetes Care Publish Ahead of Print, published online March 6, 2013
87
Agenda
88
A Sizeable Presence in Diabetes Built on Lantus®,
our Insulin Flagship Brand
Sanofi Global Diabetes Sales
€7,273m
+12.1% at CER
-6% to -7%
at CER
2014
2015e
€6,568m
+18.7% at CER
€5,782m
+16.7% at CER
2012
2013
Global diabetes sales expected to decline at an average annualized
rate of between 4% and 8% at CER over the period of 2015-2018
89
Global Diabetes Sales Account for 20% of Group Sales
in the First 9 Months of 2015
YTD Sep 2015 Diabetes Sales by Geographies (in €m)
Sales Growth at CER
Total Group Sales
excluding Diabetes
€22,102 m
€3,260m
-14.2%
57%
+5.8%
€2,417m
+9.5%
79.6%
20.4%
43%
Diabetes
Sales
€5,677m
Regional Sales Growth at CER
Western Europe: +3.5%
-4.6%
Emerging Markets: +17.0%
RoW: +2.6%
U.S.
ex U.S.
90
Basal Insulins Constitute the Leading Insulin Segment
Across All Geographies
June MAT 2015 Insulin Market Breakdown by Insulin Type (Value)(1)
Market Share (%)
U.S.
Western Europe
9.5%
14.8%
36.5%
49.3%
54.0%
35.8%
Basal
SAI
Emerging Markets
Japan/Can/Aus/NZ
Premix
19.4%
38%
+ 10%
37.1%
19.3%
48.0%
43.5%
32.6%
(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
91
Sanofi Has Leading Positions in the Basal Market in All
Geographies
June MAT 2015 Basal Insulin Market Breakdown by Brand (Value)(1)
U.S.
Market Share (%)
Toujeo®
0.2%
Western Europe
11.4%
3.8%
3.9%
25.5%
23.3%
70.5%
61.4%
Lantus®
Levemir®
NPH
Emerging Markets
Japan/Can/Aus/NZ
Tresiba®
Toujeo®
12.9%
9.6%
28.3%
56.4%
1.4%
13.1%
64.4%
13.9%
(1) Market share data from Source IMS Health MIDAS MAT June 2015 – Copyright 2015 – All rights reserved
92
Basal Insulin Now the Gold Standard in Emerging Markets
and Sanofi Is Leading the Basal Segment
Insulin Market by Insulin Type (Value)
Emerging Market Share (%)
% of sales
50% 46%
Basal
Premix
SAI
43%
40%
37%
30%
31%
20%
23%
20%
10%
0%
2004
YTD June 2015
Focusing on expanding access to Lantus® in Emerging Markets
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
93
Agenda
94
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
3
Expand access to Lantus® in Emerging Markets
while managing Lantus® LoE(1) in mature markets
4
Lead market shift to data analytics and population
outcome care standards through Google collaboration
5
Strengthen pipeline through external opportunities
and ambitious research
(1) LoE: Loss of exclusivity
Google
Life Sciences
95
A Compelling Value Proposition
Introducing, from the Makers of Lantus®
Toujeo® – Designed and Developed to Be a New Basal Insulin Option(1)
1
Unmet
needs
2
Micro- Stable Activity Proven
precipitate
Profile
Efficacy
(1) Toujeo® Prescribing Information, February 2015
3
Predictable
Safety
Toujeo®
SoloStar®
Toujeo®
COACH
96
Encouraging U.S. Launch Metrics
Toujeo® TRx, NRx & NBRx Volume(1)
Basal Market NBRx Shares(2)
week of April 3 - week of Oct 23, 2015
week of April 3 - week of Oct 16, 2015
Share (%)
Rx (absolute)
16000
14000
12000
10000
8000
6000
Cumulative TRx
205,299
Cumulative NRx
134,476
Cumulative NBRx
91,838
15,511
TRx
60%
50%
9,037
NRx
40%
30%
5,717
NBRx
Lantus®
50.9%
Levemir®
26.3%
20%
4000
2000
0
10%
13.7%
NPH
9.0%
0%
Toujeo® uptake trending favorably compared to diabetes analogues(3)
(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
Rapid Market Access Obtained in the U.S.
Toujeo® Market Access
as of October 1, 2015
● Parity pricing with Lantus® helped
secure rapid and comparable
access
● Broad Medicare access achieved
ahead of standard timelines
● Focused pull-through
efforts in place
% Lives Covered
100%
86%
91%
80%
60%
Tier 2
69%
Tier 2
40%
20%
0%
Tier 3
17%
Commercial
Medicare
98
Germany Showing the Way for Other
EU Launches
Toujeo® Weekly Sell Out Data
within Basal Market(1,2)
Weekly Evolution of Sell Out Data
% Market Share in Units (Packs)
% Market Share Delta Development
vs. May 5, 2015 in Units (Packs)
8%
7.1%
7%
Win/Loss in
percentage
points
8%
6.0% 53.0%
6%
6%
% MS in
Basal
Market
4%
5%
Tresiba®
3.8%
4%
2%
0%
3%
-2%
2%
1%
-4%
0%
-6%
Toujeo®
Tresiba®
-4.0% 21.3%
Toujeo®
Launch on
May 5, 2015
Levemir® + Tresiba®
Lantus® + Toujeo®
Tresiba®
Ceased
Distribution
in Oct
2015(3)
(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
99
Global Launch Continues in EU, EM and RoW
H2 2015
UK
Czech Rep.
Norway
Austria
Finland
Ireland
Japan(1)
Canada
S. Korea
2016
Belgium
France
Greece
Sweden
Italy
Poland
Spain
Switzerland
Australia
Brazil
Mexico
Europe
EM and
Rest of
World
(1) The brandname of Toujeo® in Japan is Lantus® XR: launched in September 2015
100
Real-Life Study Program to Expand
the Evidence Base
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
● 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
A1c changes
● T2D patients uncontrolled
on basal insulin (EU)
● Target enrolment: 600
A1c changes
Initial results expected in 2017, extended follow-up findings in 2018
HEDIS – Healthcare Effectiveness Data and Information Set
101
An Investigational Agent Combining Insulin
Glargine with Lixisenatide in a Daily Injection
Single Once Daily Injection
=
Fixed Ratio Combination
of Two Active Components
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
Expected key regulatory submissions: U.S. Q4 2015 & EU Q1 2016
PPG: Post-Prandial Glucose
FPG: Fasting Plasma Glucose
102
Significant Opportunity in Type 2 Diabetes
Supported by Two Positive Phase III Studies
Two Well Defined U.S. T2D Patient
Populations for LixiLan
Positive Top-line Results in
Two Pivotal Phase III Studies
Met HbA1c primary endpoints compared to
insulin glargine and compared to lixisenatide
Patients
Not at Target
on OAD:
~5.5m
Patients
Uncontrolled
with Basal
Therapy:
1st injectable
drug
LixiLan-O study in patients
insufficiently controlled on OADs
Basal
intensification
LixiLan-L study in patients
not at goal on basal insulin
~4m
Regulatory submission expected in the U.S. in December 2015 and EU in Q1 2016
OAD: Oral anti-diabetic
103
Important Options for Prandial Diabetes Treatment
● 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
● 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
(1)
(2)
(3)
(4)
GLP-1 RA: glucagon-like peptide-1 receptor agonist
ELIXA evaluated CV outcomes in Type 2 Diabetes patients after Acute Coronary Syndrome during treatment with lixisenatide
PPG (post-prandial glucose) lowering effect evaluated after a test-meal - Meier JJ et al, 2014 ADA, Poster 1017-P
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
104
Continued Focus on Gaining Market Access,
Building Awareness and Appropriate Usage
Innovative Treatment
Option for Diabetes
A rapid-acting inhaled
insulin
Fast absorption rate
and short duration of
action(1)
An innovative device
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)
(2)
(3)
(4)
Despite the fast absorption of insulin (PK) from Afrezza®, the onset of activity (PD) was comparable to insulin lispro
Uncontrolled basal Insulin or Basal ± GLP1 ± OAD patients (A1c >7%)
Adelphi Real World: Diabetes DSP 9 (2012), Data on File. US Data
Excludes patients for whom Afrezza® is contraindicated
105
Diabetes Integrated Care: Significant Potential to Improve
Patients’ Lives
Leveraging Complementary Strengths
to Establish New Standards for Diabetes Care
● Leader in the technology space
Google
● Data analytics and integration of
information silos
Life Sciences
● Smart delivery and sensor devices
● Miniaturization
●
Leader in insulin management
●
Deep clinical and medical expertise
●
Regulatory and market access
●
Leading portfolio of pharmaceuticals
Improved
clinical
outcomes
Real-time
monitoring
& care
Significant
cost savings
Better
patient &
provider
engagement
106
A Broad and Growing Diabetes Portfolio
2000
basal insulin
2004
rapid-acting
injectable
insulin
2013
once-daily
GLP-1 RA(1)
2014
rapid-acting
inhaled
insulin
2015
new basal
insulin
2016+
basal insulin
and GLP-1 RA
combination(2)
®
(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
107
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
Agenda
Significant unmet need and cost burden
Strong and differentiated product profile
Initial uptake gradual as expected
Upcoming milestones and future opportunity
109
Cardiovascular Disease Is a Major Health and Economic
Burden with Uncontrolled LDL-C Being a Key Risk Factor
#1
24
million
Cause of death
worldwide(1)
claims more lives than all
forms of cancer combined
Patients at
high CV risk
fail to reach
LDL-C goals(4)
high cholesterol is a
key risk factor for
CV disease
$315
billion
$34,200
direct costs
(6)
€196
billion
€4,400€6,000(7)
Estimated cost
of CV disease
management(2,3)
includes health
expenditures and lost
productivity
Estimated cost of
an ACS event(5)
direct costs
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.
110
(7) Inflation adjusted to 2004; Smolderen KG, et al. Eur J Vasc Endovasc Surg 2012;43:198e207.
Agenda
111
Significant and Consistent LDL-C Reduction in
Five Double-Blind, Placebo-Controlled Trials(1)
75 mg Up-Titration Regimen(2)
Started and Maintained on 150 mg
COMBO I Study (n=316)(3)
LONG TERM Study (n=2,341)(3)
Majority Clinical ASCVD Patients
Majority Clinical ASCVD Patients(4)
Praluent®
75 mg/150 mg
Q2W + statin
+1%
0%
0%
-2%
-44%*
Praluent®
150 mg
Q2W + statin
Placebo + statin
Placebo + statin
-58%*
FH I & FHII Studies (n=735)(3)
High FH Study (n=107)(3)
Majority HeFH and/or Clinical ASCVD Patients
Majority HeFH and/or Clinical ASCVD Patients
+7%
0%
0%
Praluent®
75 mg/150 mg
Q2W + statin
Placebo + statin
-47%*
Praluent®
150 mg
Q2W + statin
-7%
-43%*
Placebo + statin
*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
112
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)
(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
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
(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
113
(4) Material developed according to European Medicines Agency Summary of Product Characteristics (SmPC)
Approved in the U.S. and EU in High CV Risk
Hypercholesterolemic Patients(1)
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)
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
(1) The effect of Praluent® on CV morbidity and mortality has not been determined
114
U.S. Label Criteria Represent 90% of Patients in
the ODYSSEY Clinical Trial Population(1)
90% of ODYSSEY population
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
36% with
Heterozygous Familial
Hypercholesterolemia (HeFH)
Diagnosed using Simon Broome or
Dutch Lipid Networking criteria including:
●
●
●
●
Cholesterol levels
Physical manifestations
Family history
Genetic testing
● Peripheral arterial disease presumed
to be of atherosclerotic origin
(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.
115
Eligible U.S. Hypercholesterolemic Patient
Population Comprised of Three Segments
ASCVD Patients
HeFH Patients
(~0.5m)
● Well defined population
● Diagnosed with HeFH
(~0.1m)
Underdiagnosed
population
Recent Event
(~1.3m)
● Event in last
12 months
High risk
Treatment engaged
population
Prior Event
(~9.2m)
● Event 13+ months
● CHD + ACS (6.9m)
● Stroke (1.4m)
● PAD (1.0m)
Heterogeneous
population
Addressable patient population could increase based on CV outcome data in late 2017
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)
116
Treatment Population in the U.S.
Influenced by Many Factors
Factors Influencing U.S. Praluent® Treatment Population
Patient, Physician,
Access Considerations
● Awareness
● Adoption
Utilization of
Existing Medicines
● Optimizing use of statin
and other lipid-lowering
therapies
● Willingness to inject
● Market access
gained
117
Agenda
118
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
● 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
QALY: Quality-Adjusted Life Years
WAC: Wholesaler Acquisition Cost
(1) Based on internal models
119
Comprehensive Support for U.S.
Patients and Prescribers
MyPraluent™ Assists with:
Coverage
● Benefits investigations
● Prior authorization assistance
● Appeals support
● Payer information
● Coverage exception support
Obtaining
Praluent® (alirocumab)
● Specialty pharmacy coordination
● Home delivery
● In-store pick up
Clinical Support
● On-call nurses
Cost(1)
● Patient self-injection training
● Copay support
(commercial)
● Patient Assistance
Program (uninsured)
● Copay foundation referrals
● Praluent® free of charge during
coverage appeals
● Adverse event reporting
● Product and disease information
● Information on diet and lifestyle
changes
Adherence
● Injection reminders
● Refill reminders
● Adherence education
(1) Subject to program requirements
120
U.S. Comprehensive Support Hub
Tracking Ahead of Expectations
Enrollments by Specialty (%)
● Majority of patients enrolled
by specialists
Specialists
● Around 5,000 prescribers
PCP/NP/
Other
● Benefits investigation requires at
least one month
● More time required for Medicare
Part D plans
73%
27%
● Efficient patient referral to specialty
pharmacy or patient assistance
programs
121
U.S. Launch Gradual as Market Access
and Awareness Accelerate
Praluent®
NRx Volume
week of Aug 7 - week of Oct 23, 2015
● Bolus of adjudicated patients awaiting
coverage decisions
NRx (absolute)
120
100
80
60
40
20
0
● Specialty pharmacy dispensing expected
to accelerate
Cumulative NRx
628
NRx
● 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
Source: IMS NPA Rapid Weekly
122
Agenda
123
ODYSSEY OUTCOMES Expected to Be Fully
Enrolled by Q4 2015
ODYSSEY OUTCOMES Clinical Trial Design(1)
Patients with
recent ACS
>40 years of
age
Double-blind treatment period (minimum of 2 years)
Praluent® 75mg SC Q2W
Run-in period
Randomization
4-52 weeks
after index event
Up-titration at Week 12 if needed
N=9,000
R
N=9,000
Screening visit:
Initiate high dose
statin therapy(2)
Continued
high dose statin
+ Diet (NCEP ATP III TLC
or equivalent diet)
Primary
Endpoint(4)
A composite
of major CV
endpoints
Placebo SC Q2W
Qualifying visit:
LDL-C must be
>70mg/dl(3)
(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
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
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
125
Global Launch Outside U.S. Ongoing
2016
H2 2015
Germany
UK
Italy
Spain
France
EU 5
Canada
Japan
Rest of
World
126
Leadership in the PCSK9 Market
2015
Launch Focus
Gradual Uptake Expected
2016-2017
Future Opportunity
Expansion and Acceleration
Building awareness &
education
● EU top 5 launches planned
in Q4 2015 and 2016
Executing centralized patient
initiation & distribution model
in the U.S.
● ODYSSEY OUTCOMES interim efficacy
analysis(1) expected in H2 2016
Gaining U.S. market access
Driving appropriate use &
adherence
● ODYSSEY OUTCOMES study
completion expected in late 2017
● Real world and life cycle studies
to support market access and
value for sub-populations
(1) Second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred
127
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
Agenda
Genzyme: a success story
Rare Diseases: an untapped opportunity
Multiple Sclerosis: a fast-growing player
129
Inspired by the Potential to Improve Patients' Lives
Milena , Argentina
Dean , Australia
Gaucher Disease
Multiple Sclerosis
130
2012-2015
Genzyme Has Delivered Strong Growth since 2012
Annual Sales
● Strong historic growth: >25%
per year over 2012-2015
~€3.5bn
● Leading position in Rare Diseases
€2,604m
● Growing presence in Multiple Sclerosis
~€1bn
Multiple
Sclerosis
~€2.5bn
Rare
Diseases
€2,142m
€1,785m
● 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
Growth
at CER
2012
2013
2014
2015e
+16.9%
+25.9%
+24.3%
>+25%
131
A Successful Model for Productive R&D Collaborations
Recent Collaborations(1,2)
● 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
(1) Expansion of the Alnylam collaboration was announced in Jan 2014
(2) Collaboration with Voyager was announced in Feb 2015
132
132
2015-2020
Rare Diseases and MS Will Remain Key Growth Drivers
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
Low
double digit
sales CAGR
at CER
>€6.0bn
>€2.0bn
~€3.5bn
● Growth driven mostly by increased
penetration of existing brands
Multiple
Sclerosis
~1/3
Rare
>€4.0bn Diseases
~2/3
● New launches expected to drive
growth beyond 2020
2015e
2020e
Significant improvement in BOI margin expected over 2015-2020
BOI: Business Operating Income
133
Agenda
134
Majority of Rare Disease Patients Are Still Undiagnosed(1)
>100,000
~50,000
Gaucher ~80%
10,000
Diagnosed
Fabry ~90%
7,000
5,000
10,000
Total
Treated
Genzyme
Treated
Diagnosed
6,000
Total
Treated
3,200
Genzyme
Treated
~50,000
20,000
Pompe ~95%
3,000
2,500
2,400
Diagnosed
Total
Treated
Genzyme
Treated
(1) Genzyme internal analysis - Includes China and India
Niemann-Pick (A&B)
~95%
1,300
Diagnosed
Total
Treated
Genzyme
Treated
135
Clear Strategies to Sustain Leadership in Rare Diseases
Gaucher
● Focus on hematologists
● Apply proven screening
protocols
● Facilitate access
● Optimize launch
of Cerdelga®
Fabry
● Focus primarily on
nephrologists
● Map family trees
● Develop oral GCS
Inhibitor
Pompe
● Focus on neurologists
and neuromuscular
specialists
● Perform testing
of high risk
patients
● Develop
neo-GAA(1)
Largest opportunity lies in undiagnosed and diagnosed/untreated
(1) Modified recombinant human GAA (acid alpha-glucosidase) harboring synthetic oligosaccharide ligands
136
Rare Diseases Franchise Sustained Leadership(1)
in YTD Sep 2015
Genzyme Rare Disease Sales (€m)
€630m
+13.0% at CER
€530m
€114m
Others
Others
€147m
Fabrazyme
Myozyme
&
€162m
Cerdelga
€189m
(2)
Cerezyme
Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015
€2,137m
€1,890m
(+11.2% at CER)
(+12.6% at CER)
(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
137
Genzyme Leading Innovation in Gaucher
Disease with Cerezyme® and Now Cerdelga®
● 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
Potential to grow Gaucher market and expand Genzyme Gaucher franchise to >€1bn
138
A Solid Rare Diseases R&D Pipeline
Phase I
Phase II
Phase III
GZ402666
Olipudase alfa
Patisiran(2) (ALN-TTR02)
Neo GAA
Pompe Disease
rhASM
Niemann-Pick type B
siRNA targeting TTR
SAR439774 (ALN-AT3)(1)
GZ402671
Revusiran(3) (ALN-TTRsc)
Haemophilia
Oral GCS Inhibitor
Fabry Disease
siRNA targeting TTR
Genzyme
Alnylam
(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
139
Addressing Niemann-Pick type B with Olipudase alfa(1),
an Enzyme Replacement Therapy Currently in Phase II
Niemann-Pick Patient Diagnosis
Therapeutic Approach
● Niemann-Pick is a serious lysosomal
storage disorder, characterized by fat
deposits in spleen and liver
Target the underlying metabolic defect
by replacing the missing enzyme
● Patient identification uses established
diagnosis algorithm for Gaucher
Olipudase
alfa
Sphingomyelin
Phosphorylcholine
Ceramide
AcidCeramidase
Sphingosine
Gaucher Hematology Campaign
● 3.8% of patients tested positive for
Niemann-Pick after testing negative
for Gaucher
Intended result:
Reverse and prevent somatic disease
if treatment begins early
FDA Breakthrough Therapy Designation granted in May 2015
(1) Recombinant form of human acid sphingomyelinase (ASM) developed as an enzyme replacement therapy
140
Hemophilia: a $10bn Market Set to Face Substantial
Changes
Hemophilia(1)
● 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
Unmet Medical Need(1)
● 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
Therapy with better benefit/risk profile is needed
(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)
141
ALN-AT3: an Investigational RNAi Therapeutic
Targeting Antithrombin
Coagulation Cascade
Intrinsic system
Extrinsic system
Hemophilia A
FVIII
● Antithrombin (AT) is a key endogenous
anticoagulant
FVIIa
FX
FVIIIa
● Inactivates Factor Xa and thrombin
FVII
● Expressed in liver; circulates in plasma
Hemophilia B
FIX
FIX
● Attenuates thrombin generation
● Human AT deficiency associated
with increased thrombin generation
FIXa
AT
AT
FXa
FVa
Prothrombin
Thrombin
Fibrinogen
Fibrin
Blood clot
FV
● Subcutaneous ALN-AT3 aimed at
correcting coagulation defects by
knockdown of AT
● Currently in Phase I in
moderate-to-severe
hemophilia
Phase III planned to start in mid-2016
142
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:
●1 Accelerate systematic patient identification initiatives
●2 Continue leadership in patient advocacy through genuine commitment
●3 Focus lifecycle and business development efforts in areas of expertise
and strengths to leverage synergies
●4 Advance internal and partnered novel pipeline
2020 Rare Diseases sales expected to exceed €4bn
143
Agenda
144
Despite Increased Treatment Options,
Significant Unmet Needs Remain in Multiple Sclerosis
Brain MRI Reveals Significant Progression
of Atrophy over 10 Years(1)
42 years-old
(1) Courtesy of Beth Fisher and Rick Rudick Cleveland Clinic
52 years-old
145
A Large and Growing Global MS Market
An Increasingly Competitive
Therapeutic Area
3 oral brands
Multiple Sclerosis Market
Global Sales(1)
~€22.6bn
€14.3bn
5 injectable interferon beta brands
~37%
~63%
2 injectable glatiramer acetate brands
including a generic
+8%
CAGR
~35%
~65%
2014
2020e
2 intravenous drugs
U.S.
ROW
(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
146
Multiple Sclerosis Franchise Sales Annualizing Over €1bn(1)
Genzyme Multiple Sclerosis Sales
€293m
€68m
Série2
Série1
®
€225m
Q1 2013
Q2 2013
Q3 2013
€168m
Q4 2013
Q1 2014
Q2 2014
Q3 2014
Q4 2014
€467m
(1) Multiplying Q3 2015 sales of €293m by four provides a hypothetical annual run rate of over €1bn sales
Q1 2015
Q2 2015
Q3 2015
€761m
147
Making Steady TRx Share Gains
Oral Therapies Have Gained
Significant Market Share(1)
Aubagio® Has Become the Fastest
Growing Oral MS Drug this Year(1)
25%
Injectable
Therapies
20%
U.S. Weekly TRx Share
Tecfidera®
21.1%
15%
62.5%
Oral
37.5% Therapies
10%
5%
Gilenya®
10.3%
6.2%
0%
(1) IMS U.S. - Week of October 23, 2015
148
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
149
Significantly Reduced Brain Volume Loss
in Relapsing Multiple Sclerosis(1)
Annualized Percentage Change
in Brain Volume(1)
Year 1
Relapse rate
Disability progression
MRI activity
Median % Change from Baseline
● An immunomodulatory
Disease Modifying
Treatment (DMT) with
demonstrated efficacy on:
N=276
Brain volume loss(1)
N=263
N=234
N=235
-0.39
-0.61
RR: 36.9%
p=0.0001
-0.9
-1.29
Placebo
Teriflunomide 14 mg
RR: Releapse Rate
(1) SIENA analysis of the TEMSO MRI dataset presented at ECTRIMS 2015
Year 2
RR: 30.6%
p=0.0001
150
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.
151
Durable Clinical Efficacy Through 5 Years
CARE-MS I Study Assessments
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
Annualized Relapse Rate (ARR)
(95% CI)
1,0
1.0
0,8
0.8
0,6
0.6
0,4
0.4
0,2
0.2
0.18
0.19
0.14
0.15
0.16
Year 4
Year 5
Year 3–5
(Month
24‒60)
0.0
0,0
Years 0–2 Year 3
Core Study
No. of
Patients
(1) Study in treatment-naive patients with active relapsing-remitting multiple sclerosis
376
Extension Study
349
342
340
349
152
Overcoming Barriers in the U.S. in Q4 2015
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
153
Our Strategy to Grow our Multiple Sclerosis Franchise
1● Successfully complete global launches of Aubagio® and Lemtrada®
2● Expand LCM activities to maximally support existing products
● Develop Lemtrada® for subcutaneous use
● Run a PoC study in Progressive MS with Lemtrada®
3● Reinforce presence in high efficacy segment
● Advance GLD52, a next generation anti-CD52 mAb,
through Phase I
4● Enter into the neuroprotection / remyelination segment
● Six programs currently in research
Ambition to double the size of the MS franchise sales from 2015 to 2020 to >€2bn
154
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
Agenda
The Vaccines market
Sanofi Pasteur growth perspectives
A balanced R&D pipeline
156
Immunization Is One of the Most Successful
and Cost-effective Health Interventions
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)
Vision:
~6m lives saved every year by vaccines
(= 10 lives per minute)(3)
“A world in which
no one suffers
A successful vaccination program adds more than
1% to a country GDP(4)
or dies from a
vaccine
preventable
€1bn saved annually from eradication of smallpox(5)
(1)
(2)
(3)
(4)
(5)
http://www.who.int/bulletin/volumes/86/2/07-040089/en/
Panhuis WG et al. N Engl J Med 2013; 369:2152-2158
Ehreth J. The global value of vaccination. Vaccine 2003; 21: 596-600
David E. Bloom DE. Valuing Vaccination. Presentation at Fondation Mérieux, Jan 19, 2015
http://www.who.int/mediacentre/news/notes/2010/smallpox_20100517/en/
disease”
157
A Concentrated Market with Sanofi Pasteur Ranking #1(1)
in Several Areas
2014 World Vaccine Market Sales(2)
~€21bn
CSL
Sanofi Pasteur Sales in 2014
€3,974m
1,178 #1
Flu
Others
Polio, Pertussis
& Hib
1,154
#2
GSK
19%
#3
Merck
Pfizer
Meningitis
430
#1
Adult boosters
398
#1
Travel and
Other Endemic
377
Others(3)
437
(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.
158
A Complex Industry Where We Have to Deliver
on Three Fronts
Complex Biological
Processes
Highly Regulated
Business
High CapEx
Requirements
● 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
● Continuously increasing GMP standards for batch release
by Health Authorities
● Market access often requires local manufacturing
● Much longer product life cycle than pharmaceuticals
● Incremental innovation provides high added-value
differentiation in the marketplace
GMP – Good manufacturing practices
159
Evolving Immunization Policies Are Creating Significant
Growth Opportunities
Projected Market Trends
% of Birth
Cohort
in 2020
% of Sales Sales Growth
in 2020
CAGR
2015-2020
9%
60%
3%
19%
23%
6%
72%
17%
10%
Status of Immunization Schedules
Market maturity
IPV
acP/Hib
Flu
Ped Flu
Rotavirus
Mature
Ongoing modernization
Under-developed
Level of coverage
IPV– Inactivated polio vaccine
acP – Acellular Pertussis
Hib – Haemophilus influenzae type b
Source: Sanofi Pasteur internal estimates based on various sources
Ped – Pediatric
160
2015-2020
Strong Visibility as Mid-Single Digit Growth Sustainable
Projected Market Growth(1)
~5%
CAGR
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
5
Growing middle class in
Emerging Markets
~€25bn
2015e
(1) Internal estimates
2020e
161
Agenda
The Vaccines market
162
2015-2020
Sanofi Pasteur Expected to Outperform Market Growth
1
2
Further develop strong vaccine brands
a in pediatric combinations
a)
b)
b in adult boosters
c)
c in flu vaccines
Projected Sanofi Pasteur Sales
High
single digit
sales CAGR
at CER
Successfully launch Dengvaxia®
~€4.7bn
3
Expand our manufacturing
capacity
4
Deliver novel high-value
vaccines e.g. C. diff vaccine
€3.7bn
~75%
of
sales
Dengue
€4.0bn
Flu
Pediatric
& boosters
2013
2014
2015e
2020e
163
1a
Modern Pediatric Combination Vaccines Will Fuel
Growth
Primary Vaccination Series(1) in Public
Markets Are Still wcP-based in Many
Countries(2)
Projected Drivers for Pediatric
Combination Vaccines
● Global polio eradication initiative
and IPV roll-out expected to
facilitate switch to acP combos
● Preference for IPV-containing acP
combination vaccines driven by their
convenience, immunogenicity and
safety profile
● acP expected to represent over 1/3
of all combos in revenues by 2020
Acellular Pertussis
acP users
Whole cell Pertussis
wcP users
● Expansion of penta- and hexavalent
combos
wcP GAVI
acP – Acellular Pertussis
wcP – Whole cell Pertussis
(1) Routine pediatric vaccination in infants and children
(2) World Market Analysis (Sanofi Pasteur), 2013
IPV– Inactivated polio vaccine
164
1a
Our Portfolio of Pediatric Combination Vaccines Well
Suited to Global Immunization Calendar Modernization
Primary Series - Infants and Children
aCel & aXim Product Families
(acP-based)
Mature Markets
U.S.
Western Europe
PR5I(1)
Middle Income &
Emerging Markets
China
Brazil
Mexico
RSA
etc.
Shan5™
(wcP-based)
UNICEF
GAVI
TM
Pediatric combination vaccines sales are expected
to grow double-digit CAGR over 2015-2020
(1) U.S. and EU regulatory review ongoing. Collaboration with Merck & Co
aXim products also distributed in Western Europe
165
1b
Boosters Demand Expected to Grow in Untapped
New Markets
Booster Markets in 2015(1)
Projected Drivers for Public
Booster Market
● Even where Tdap vaccines have
been introduced, coverage remains
relatively low
● Resurgence of pertussis calls for
more robust control measures
● Td Tdap replacement for routine
immunization
Tdap
Tetanus
Tetanus
Diphteria
Diphteria
acellular Pertussis
No Tdap
®
®
Launch of Adacel® and Adacel Polio® expected in 50 new markets over the next 5 years
Tdap: Tetanus, diphtheria and pertussis
(1) Sanofi estimates based on various sources
166
1c
Flu Vaccines: High Disease Burden and Low Vaccine
Coverage Generate Growth Opportunities
Estimated Vaccination Coverage Rates (VCR)
Still Below Target
Key selected
countries(1) VCR still below
WHO and EU targets of 75%
U.S. VCR still below
CDC target of 90%
100%
Immunization Rate (%)
90%
threshold
0%
75%
threshold
10m
100m
● 1 billion cases/year
Not Vaccinated
Vaccinated
30m
140m
320m
High Disease
Burden of Flu(2,3)
● 300,000-500,000
deaths/year
● €10-17bn/year in healthcare
cost in U.S. alone
Population aged
over 65 years
44m
(in million people)
(1) 17 key countries: Argentina, Australia, Brazil, Canada, Chile, China, France, Germany, Italy, Japan, Mexico, Russia, RSA, South Korea, Spain, UK, U.S
(2) WHO Fact sheet on influenza, N°211, March 2014
167
(3) Molinari N.-A.M. et al. Vaccine 25 (2007) 5086–5096
.
1c
Sanofi Pasteur Well Positioned with a Leading
Flu Vaccines Franchise
Sanofi Pasteur Flu Growth Drivers
Projected Flu Vaccines(3) Sales Mix Evolution
● Differentiation with Fluzone® HD
Fluzone® U.S.
● Superior efficacy(1) and significant
reduction in flu-related hospital
admissions(2) in people aged 65+
● U.S. introduction of Fluzone® HD QIV
expected by 2020
● Market expansion and conversion
to quadrivalent flu vaccines (QIV)
● U.S. switch to QIV almost complete
● Progressive switch in RoW expected
to start in 2017
● Global switch expected to be completed
by end of 2020
(1) DiazGranados CA et al. N Engl J Med 2014; 371:635-645
(2) Izurieta HS et al. Lancet Infect Dis 2015; 15: 293–300
(3) Intramuscular flu vaccines
2015
2020
Quadrivalent
Vaxigrip® RoW
2015
2020
168
2
The First Ever Dengue Vaccine(1)
● About half of the world’s population lives
in dengue endemic regions(2)
Global Evidence Consensus
Risk & Burden of Dengue - 2010(6)
● 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
● 70% to 90% of dengue cases are reported in
children aged 10+ in given endemic countries(4)
● Potential to reduce disease burden by
about 50% within 5 years if 20% of a country
population is vaccinated in endemic countries(5,6)
Complete
absence
Complete
presence
Make dengue the next vaccine-preventable disease
(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) Observed in Thailand, Indonesia and Colombia, Mexico, Brazil and Malaysia over the last 5 years - Jackson N. et al « Recent scientific and clinical
advances in Sanofi Pasteur’s Dengue Vaccine Program » ASTMH 64th Annual Meeting October 25-29, 2015. Philadelphia, USA
(5) Coudeville L et al. ASVAC 2015
(5) Coudeville L et al. SLIPE 2015
(6) Bhatt, 2013, Nature
169
Rapid Uptake to Generate Public Health
Impact and Return on Investment
2
Pre-launch
Launch
Implement catch-up
2015
2016
2017-20
● File submitted in 20 endemic
countries by year end
● Launch in 1st wave of
endemic countries
● Expand “catch-up” program
and reach peak sales
● First doses available for
delivery before of end 2015
● Start public vaccination
including catch up in high
endemic countries
● Prepare launch in 2nd &
3rd wave of countries
● Launch supported by current
production capacity
● Implementation of
post-licensure studies to
measure effectiveness and
impact of first programs
● Adapt production capacity
170
Policy Designed to Maximize Impact
in Public Markets
2
Broader Vaccination Program
Leads to Higher Impact on
Disease Burden(1,2)
% Reduction of disease
over 10 years at the population level
Setting a Pricing Policy
Linked to Impact
on Disease Outcomes
Average price per dose
0%
Variabilities
from one
country to
another
-70%
Number of age groups vaccinated
Number of age groups vaccinated
● Assessing vaccination impact at the
population level through modeling
● Program-based pricing policy
● Direct and indirect protection
● Equitable policy
● Maximize public health impact
● Vaccine efficacy and disease epidemiology
(1) Dengue Modeling Consortium ASTMH [2014]
(2) SP model ASVAC, SLIPE, ASTMH [2015]
171
3
Expand Vaccine Production Capacity to Ensure
Sustainability of Supply
Industrial Sites
Major Initiatives
1● Supply increase
Neuville
sur Saône
Toronto
● Invest in new capacity and
upgrade existing footprint
● Improve process robustness
Val-de-Reuil
Swiftwater
Canton
Marcy
l’Etoile
Shenzhen
Rockville
Ocoyoacac
Shantha
Hyderadad
2● Optimization
● Simplify product portfolio
● Harmonize antigens
3● Quality performance
Pilar
● Setting the new standard for
quality in vaccine industry
Projected cumulative CapEx of around €1bn over the next three years
172
Agenda
The Vaccines market
173
4
A Balanced Pipeline with New Targets and LCM
Projects
First in Class Novel
Vaccines
Strategic Life Cycle
Management
● Address unmet medical need
through innovative vaccine
development
● Enhance current vaccines to
improve efficacy
(e.g. dengue, tuberculosis)
● Develop new vaccine
segments
(e.g. nosocomial infections with
C. difficile vaccine)
(e.g. Flu QIV, Flu HD, PR5I)
● Defend key franchises from
competitor LCM activity
(e.g. 2nd generation meningitis
ACYW conj. vaccine)
● Advance internal R&D
programs
(e.g. Rotavirus)
● Establish collaborations on
external programs
(e.g. SK Chemical Co. for PCV
development)
● Access new markets
● Introduce new modalities
(e.g. HSV therapeutic vaccines)
Fill Portfolio Gap
(e.g. pediatric combos in Japan)
● Improve production processes
LCM – Life Cycle Management
PCV – Pneumococcal conjugate vaccine
HSV – Herpes simplex virus
174
4
Robust Sanofi Pasteur R&D Pipeline
Phase I
Registration
Phase III
Phase II
VaxiGrip® QIV IM
VaxiGrip® QIV IM
HSV-2 vaccine
Rabies VRVg
Toxoid vaccine
Fluzone® QIV HD
Rotavirus
Quadrivalent inactivated influenza
vaccine – High dose
Dengvaxia®
Mild-to-severe
PR5I
DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine, U.S., EU
Tuberculosis
New entities/modalities
Portfolio expansion
Strategic LCM
Several exciting targets in early stage development
New targets:
Respiratory syncytial virus (RSV), Cytomegalovirus (CMV),
Staph. Aureus, PCV
PCV – Pneumococcal conjugate vaccine
Universal flu and new
manufacturing
technologies
175
4
Rising Medical Need to Fight Clostridium difficile
Infection
High Disease
Burden of CDI(1)
● ~450,000 cases and 29,000 deaths
● Hospitalization rates more than
doubled in the U.S. between 2001
and 2010
● Increasingly reported in community
and nursing homes settings
● Sub-optimal current treatments and
high rates of recurrence
Potential target population
for first C. diff vaccine
Population at risk of CDI
~50 million adults (U.S.)(2)
● All adults aged 65+
● Some 64 and under with
chronic comorbidities requiring
frequent/prolonged antibiotic
use or hospitalization
~10-15 million adults
at high risk(3)
● Adults with elective surgeries
● Long-term care/nursing home
residents
● Healthcare costs of $5.9bn for
acute care facilities only
Objectives are to protect individuals from a potentially life threatening infection,
stop vicious cycle of recurrences and reduce transmission to other at-risk individuals
CDI: Clostidium difficile infection
(1) Sources: Lessa FC., N Engl J Med 2015;372:825-34, Kwon et al., Infect Dis Clin N Am 29 (2015) 123–134, and HCUP Projections Report # 2012-01
(2) CDI incidence >0.63%/ year
(3) CDI incidence >1.5%/year
176
4
C. difficile Candidate Vaccine to Address High Unmet
Medical Need
Phase II successfully completed
●
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
Multinational Phase III ongoing
●
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
●
●
CDI case-driven study
Up to 15,000 adults to be enrolled –
1/3 already included
Initiated in Q3 2013 and projected to take
4.5-5 years to complete
Fast Track Development Program designation granted by CBER
PCR – Polymerase chain reaction
CDI – Clostidium difficile infection
(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
177
Sanofi Pasteur Well Positioned for Sustainable and
Profitable Growth
● Sanofi Pasteur expects to grow faster than the vaccines market
with three main drivers
1 Widespread adoption of pediatric combination vaccines and adult boosters
●
2 Expansion of our differentiated offering for flu vaccines to new markets
●
3 Successfully launch the first ever dengue vaccine
●
● Operating margin expected to improve significantly over 2015-2020
● Product mix evolution
● Further improvement in industrial operations
178
EMERGING MARKETS
CONSUMER HEALTHCARE
ESTABLISHED PRODUCTS
Peter Guenter
Executive Vice President, Global Commercial Operations
Jean-Luc Lowinski
Senior Vice President, Asia region
Vincent Warnery
Senior Vice President, Global CHC Division
Agenda
Emerging Markets
Consumer Healthcare
Established Products
180
Sanofi Is the Healthcare Leader in Emerging Markets
Top 10 Players in Emerging Markets(3)
#1
Leader in Emerging Markets
4.1%
3.9%
€12bn
Sales of ~€12bn in 2015e(1)
3.6%
2.5%
32%
>1/3 of Group Sales generated
in Emerging Markets in 9M 2015(1)
2.4%
2.4%
160
Top
Commercial footprint in
~160 countries
Lantus® leads paradigm shift to
basal insulin in Emerging Markets(2)
2.3%
2.1%
1.6%
1.6%
(1) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium,
Luxembourg, Portugal, the Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark),
Japan, Australia, and New Zealand (excl. South Korea from Jan 1st 2015)
(2) Lantus® reached value market share of 56.4% in Emerging Markets, IMS MIDAS MAT June 2015
(3) Market share of total market without vaccines, IMS MIDAS MAT Q2 2015
181
Steady Growth Trajectory Despite Economic Slowdown
and Volatility in Emerging Markets
Quarterly Sales Growth in Emerging Markets(1)
+16.5%(2)
+11.4%
+9%
+10.4%
+9.9% +9.8%
at CER
+7.6% +7.9% +7.3% +7.5%
+6.8% +6.8% +6.5%
+5.5%
+5%
at CER
+2.8%
-2.3%
(3)
8.3%
% of Group sales
31.9%
(FY2012)
(1)
(2)
(3)
(4)
(5)
4.4%(4)
9.3%(5)
+8.7%
32.1%
(9M2015)
World excluding U.S., Canada, Western Europe, Japan, Australia, and New Zealand (excl. South Korea from Jan 1st 2015)
Including Brazil generics (excluding Brazil generics, Emerging Markets grew +8.6% in Q2 2014 at CER)
Including Brazil generics (excluding Brazil generics growth of Emerging Markets in Q2 2013 was +5.3%)
Including Brazil generics (excluding Brazil generics growth of Emerging Markets in FY 2013 was +7.1%)
Including Brazil generics (excluding Brazil generics, Emerging Markets grew +6.5% in FY 2014 at CER and +7.6% in Q4 2014 at CER)
182
Significant Contribution from All Regions Due to Well
Balanced Geographical Sales Mix in Emerging Markets
Stable Sales Mix Across Emerging Market(1) Regions
Sales growth
at CER
+8.3%
+4.4%(2)
+9.3%(3)
€3,435m
+11.3%
€3,013m
-1.5%(4)
€3,363m
+21.1%(5)
Latin America
€2,841m
+10.1%
€3,040m
+10.1%
€3,205m
+6.3%
Asia
€2,666m
+3.7%
€2,721m
+2.1%
€2,673m
+2.2%
€2,541m
+5.0%
Eastern Europe,
Russia & Turkey
€1,821m
+9.2%
€2,019m
+10.2%
€2,099m
+9.1%
€2,095m
+2.5%
Africa &
Middle East
2011
2012
2013
2014
€3,111m
+11.8%
€2,416m
+16.6%
(1)
(2)
(3)
(4)
(5)
+8.7%
World excluding U.S., Canada, Western Europe, Japan, Australia, and New Zealand (excl. South Korea from Q1 ‘15)
Including Brazil generics (excluding Brazil generics growth of Emerging Markets in FY2013 was +7.1% at CER)
Including Brazil generics (excluding Brazil generics, Emerging Markets grew +6.5% in FY 2014 at CER)
Including Brazil generics (excluding Generics in Brazil, LatAm grew 7.4% in FY 2013 at CER)
Including Brazil generics (excluding Generics in Brazil, LatAm grew +10.8% in FY 2014 at CER)
€2,525m
+7.1%
€2,747m
+12.1%
€1,789m
+5.8%
€1,694m
+7.7%
2015 YTD
183
Broad Presence Outside of BRIC-M(1) to Capture Growth
in Other Strategically Important Priority Countries
Growth in EM(2) not Dependent on Individual Country Performance
Sanofi Sales in Emerging Markets in 2014
€11,347m, +9.3%
A top 3 player among
MNC(4) peers in BRIC-M
markets(3)
BRIC-M(1)
countries,
€4,693m
41%
18
countries
with sales
of >€100m,
€3,990m
Others,
36%
€2,664m
23%
(1)
(2)
(3)
(4)
BRIC-M – Brazil, Russia, India, China, Mexico
Emerging Markets - World excluding U.S., Canada, Western Europe, Japan, Australia, and New Zealand
IMS MIDAS MAT Q2 2015 (Leading positions in 18 countries applies to total market in these countries)
MNC - Multinational Companies
184
Sanofi in China – A Strong and Growing Contributor
to EM Sales Despite Market Slowdown
China Is the Largest Contributor
to EM Sales, €1,603m in 2014,
4.7% of Total Group Sales
€11,347m
Sanofi China Has Outperformed
the Market and its MNC
Peers in Recent Quarters(1,2)
Sanofi Ranked #3 in China
among its MNC Peers(1,2)
Sales in China in RMB million
and growth in % (YTD Aug 2015)
Growth in %
+2.0%
+7.6%
+9.1%
+1.4%
+9.8%
Market
MNCs
11%
13%
14%
2012
2013
2014
Other Emerging Markets
China (as % of EM sales)
-1.1%
+8.7%
+0.9%
-6.7%
Total Pharmaceuticals Market
Growth +5.8%, YTD August 2015
-12.7%
Sales of Sanofi in China reached €1,614m, +16.7% for the first 9 months 2015
(1) IMS CHPA 2015 M8
(2) MNC - Multinational Companies
185
A Comprehensive Strategy for Sustainable Growth
in China
3 Growth Pillars for Sanofi in China
Enhance
core business
Diabetes
● Gain leadership through
treatment paradigm shift
towards basal insulin
● Lantus® is the leading
insulin brand in key cities(1)
Expand
geographically
Geographical expansion
into the County Market
● Expand patient reach
Plavix® & Low-cost model
Continue to drive
innovation
Innovation
● New product launches &
customize products for
China’s needs
● Support evolution to
volume
Enablers for
Sustainable Growth
Operating model
Compliance & Sustainability
People
Engagement & Development
Market access
Strengthen capability
Drive Efficiency & Productivity
Commercial excellence
(1) IMS CHPA July 2015
186
Superior Growth Contribution from Emerging Markets
Expected during 2014-2019…
Emerging Markets Expected to Grow
Faster than Mature Markets(1)
$1,330m
$993m
CAGR
+8%
Emerging
Markets
Mega Trends Remain
Compelling
>6bn people
Aging population
Rapidly emerging middle class
Middle and Affluent Consumers to
represent ~50% of EM population in
2025
Emerging
Markets
Improved access to medicines
Mature
Markets
2014
CAGR
+5%
Mature
Markets
Increasing healthcare spend as
% of GDP
2019e
(1) IMS Market Prognosis 2014-2019 (at constant exchange rates)
187
…but the Evolution of Emerging Markets Requires
an Adjustment of our Existing Business Model
Drivers of Historic Performance
Challenges to Business Model
in EM
● Strong heritage and broad product
portfolio of value brands
● Economic slowdown
● Bolt-on acquisitions and local
collaborations
● Increased competition from local
and regional players
● Industrial footprint
● Consolidation and
professionalization in the trade
channel
● ‘First-mover’ advantage
● Maintaining a commercial presence
during political instability
● Intensified pricing pressure
● New middle class demands
adaptation of product portfolio
188
Strategic Priorities to Address Changing Dynamics in
Emerging Markets
1
2
Build Priority Clusters
with Countries of
Strategic Importance…
Address unmet medical needs specific for EMs
Optimize Trade and Channel Management
●
5
Adapt portfolio and expand coverage
Innovate for Emerging Markets
●
4
…and Differentiate
Market Approach
by Country
‘Win’ Emerging Middle Class
●
3
~160
countries
Distribution, New Channels, Point of Sale
#1
in Emerging
Markets
Pursue External Growth Opportunities
●
M&A and collaborations
189
Key Success Factors to Reinforce Sanofi’s Leadership
in Emerging Markets 2015-2020
Priority
Countries
Maintain topline
growth rate in EM
by investing in
priority countries
Sustainable
Profitability
Sustain
operating margin
~37% in 2014(1)
#1
in Emerging
Markets
Market
Access
Growth driven
by volume
(1) Business Operating Margin in Emerging Markets excluding central administrative and R&D costs in 2014
190
Agenda
Emerging Markets
Consumer Healthcare
191
Sanofi Is a Leading Player in the Fragmented Global
OTC Market and Growing Faster than its Competitors
Sanofi Has Outgrown the Market
(1)
in Recent Years
Ranked #5 in the
(1)
~€100bn OTC Market
Bayer
Growth in %, 2010-2014 CAGR
GSK
7.4%
J&J
Reckitt Benckiser
Pfizer
Pfizer
3.2%
Other
6.2%
Reckitt Benckiser
P&G
Boehringer Ingelheim
Takeda
Taisho
4.5%
Takeda
4.0%
Boehringer
3.9%
Bayer
3.8%
P&G
3.1%
GSK 0.0%
-0.7% J&J
-2.1%
Taisho
OTC Market Growth: 4.1%
A top rank despite recent industry consolidation among peers
(1) Nicholas Hall & Company, FY2014, organic growth at CER
192
A Focus on Key Brands in Priority Categories
and a Strong Regional Presence
● Sales of €3,337m in 2014, +6.8% at CER(1)
● Leading positions in Priority Categories
● 8 brands with >€100m sales in 2014
● Top 10 Sanofi CHC countries generate >70% of sales
● Strong footprint in Emerging Markets
● ~50/50 sales split between Emerging and Mature Markets
● 21% of sales in the U.S. OTC market
(1) Several products previously recorded in prescription pharmaceuticals were transferred to Consumer Healthcare
products in 2013. Including the category changes (€273 million in 2013), CHC sales grew 16.5% in 2014
193
Priority Categories Drive Growth at Sanofi CHC
Sanofi CHC
Priority
Categories
Market
share in
category(1)
Global
rank in
category(1)
Growth of
category(1)
15.6%
#2
28.9%
Top 10 brands by sales in 2014(2)
generate >50% of CHC sales(5)
€350m, +37.1%(3)
12.6%
#1
€114m, n.m.
6.3%
€104m, +5.7%
4.0%
#3
6.1%
€235m, +27.1%(4)
2.3%
#3
€156m, +24.6%
€98m, +9.6%
7.1%
€88m, +17.9%
6.4%
#3
4.5%
€310m, +7.2%
(1)
(2)
(3)
(4)
(5)
Nicholas Hall & Company, FY2014
Growth in % at CER
Excluding the category change, -4.5% in 2014
Excluding the category change, +6.0% in 2014
Gold Bond® in the U.S. (not part of Global Categories) is 8th Sanofi CHC brand >€100m
€109m, +6.0%
€90m, +6.5%
194
3 Growth Axes For Continued Growth in CHC
1
2
3
Maximize Potential
of Existing Brands
Shape New
Categories
Gain Scale through
Bolt-on Acquisitions
●
●
●
●
●
●
●
Consumer-driven
innovations
Unique business model
Geographic expansion
CHC Vision
2020
Realize global & regional
switch opportunities
Leverage consumer
trends & preferences
Reach critical scale in
key countries
Optimize portfolio in
priority categories
195
1
Maximizing Brand Equity through Consumer-Driven
Innovations
● An iconic brand in France
● #1 most prescribed medicine(1)
● 93% brand awareness(2)
● >280m units sold(3)
● Adding a strong OTC range to Doliprane®’s
established Rx portfolio:
● Expanding the strong portfolio of OTC products
in acute pain; launched in France in November ‘15
● Preserving Doliprane® for HCPs as the preferred
prescription choice in chronic pain
(1)
(2)
(3)
(4)
(5)
Celtipharm, INN prescription tracking, 2015
Awareness Tracking Ipsos 2014 (October 2014)
Pharmatrend MAT Aug 2015
Nielsen xAOC; 52wk ending 08/29/15
TENS - Transcutaneous Electrical Nerve Stimulation
● A brand success story in pain relief
● >$100m retail sales in the U.S. after acquiring the
brand with $8m sales in 1991(4)
● From topical IcyHot® products to a
‘Smart Relief’ device technology
● Introducing IcyHot® Smart Relief TENS(5) therapy
● Launched in 2014, ‘Smart Relief’ sales have
been 100% incremental to IcyHot® brand
196
1
Maximizing Brand Equity through a Tailored
OTC Business Model Coupled with Medical Expertise
The Power of a Pharmaceutical Company’s Medical Expertise
Combined with a Consumer Culture
Consumer
Physician
Example of Allegra® promotion mix in 3 markets
Pharmacy
197
2
A Track Record of Commercial Success
with 2 of the Top-9 U.S. Switches since 2000
2014 Sales (€m) of Top Brands Switched
from Rx since 2000 in the U.S.(1)
● 2 Rx-to-OTC switches have
driven growth of Sanofi CHC in
the U.S.
483
● Allegra® and Nasacort® are now
leading brands in the CHC
Allergy category
● Sanofi positioned to be
a preferred switch partner
in the industry
Mucinex Zyrtec Claritin
Prilosec Miralax Nexium Plan B
24HR
OTC
Switch date: 2004 2002 2008 2011 2002 2007 2014 2006 2014
(1) N. Hall DB6
198
2
The Successes of Allegra® and Nasacort® Bode Well
for a Major Switch Opportunity in a New Category
Acquired
March
2010
Switch
date
2011
Switch
date
2014
● Licensing agreement with Lilly
signed in Q2 2014
● Opportunity to switch Cialis® in the
U.S., Europe, Canada and Australia(1)
● Ambition to transform how this
erectile dysfunction medicine is
offered to millions of men in the world
Developing additional consumer-centric offerings across new CHC categories
(1) Subject to Sanofi's receipt of all necessary regulatory approvals
199
199
3
Chattem Aquisition Was the Foundation
of Our Success in the U.S. CHC Market
5-year Retail Sales Growth Rate
CAGR (2011-2015)(1)
● Acquired in 2010 by Sanofi
● Tailored integration and preservation
of company values & capabilities
● In 2015, the fastest growing OTC
company by retail sales(1) in the U.S.
● >$1.3bn in retail sales in 2015
● 6 brands with sales >$100m
Chattem Reckitt Pfizer Church Bayer
& Dwight
J&J
P&G
Prestige
GSK
Reaching critical scale in key CHC countries is a #1 priority
200
(1) Nielsen xAOC; 52wk ending 08/29/15
200
Well Positioned for Continued
Above-Market Growth in CHC
EU
CEE
U.S.
Fostering continuous innovation to
address unmet consumer needs
Latin
America
Leveraging medical, scientific & quality
heritage
Asia &
Australia
Commitment to improve consumer
access to efficacious and safe
treatments via Rx-to-OTC switches
and other category shaping initiatives
Geographic build-up to attain critical
mass in key markets
Resource allocation to further improve
profitability
201
Agenda
Emerging Markets
Consumer Healthcare
202
Sales of Established Products Reached €11bn and
Represented 1/3 of Total Group Sales in 2014
2014 Sales by Business Segments(1)
€37,770m, +4.9%
Established
Products
Animal
Health
Vaccines
Pharmaceuticals
€27,720m, +4.4%
Pharmaceuticals
Other
(1) Growth at CER
●
2014 EP sales of €11,300m,
-6.7% at CER
●
41% of Pharmaceuticals
sales in 2014
●
Global presence
●
High volume portfolio
●
Size reflects strategic
importance for Sanofi
203
Future GBU Organization to Put Focus
on Established Products (EP)
Sales of Established Products
(in €m)
● EP portfolio includes
● Off-patent Rx brands
● Brands close to loss of exclusivity
● Select non-genericized brands
(e.g. Synvisc® in biosurgery)
● EP value proposition:
● Highly recognized medical value brands
€14,058m
€12,446m
€11,300m
~€11,700m
Mature Markets
● Well established experience among
physicians and patients
● Slower sales erosion in recent years
largely helped by Emerging Markets
Emerging Markets
204
Established Products Returned to Growth
in the First 9 Months 2015 Driven by Emerging Markets(1)
YTD 2015 Sales of Established Products by Geographies (in €m)
EP Sales in YTD 2015
€8,938m, +0.6% at CER
61%
Mature
Markets
€5,462m
-3.8% at CER
39%
EP Sales in Emerging Markets by Region
Emerging
Markets
€3,476m
+8.3% at CER
Eastern Europe,
Russia & Turkey
Growth at CER
+9.0%
+16.5%
+5.4%
+2.7%
Strong growth of Established Products in EM accelerated in Q3 2015 (+11%)
(1) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal,
the Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark), Japan, South Korea, Australia, and New Zealand
205
A Diverse Portfolio of Strong Medical Value Brands
in Large Therapeutic Classes
Sales by Therapeutic Class in 2014(1)
Sanofi’s historical flagship
products in large therapeutic
categories
25%
23%
2%
3%
6%
13%
9%
10%
Antibiotics
Antiarrhythmics
CNS
Hypertension
Antiplatelets
Business Characteristics of EP
9%
Urology
Renal
Anti-inflammatories
Anticoagulents
(1) Breakdown of first 66% of Established Products sales
● Cardiology, CNS, Anti-inflammatory
Addressing fundamental medical
needs with high quality medicines
● Targeted promotion
Strong influence of dispenser
(Physician, Pharmacist)
● Substitutability
206
Established Products Sales Concentrated
on Top 10 Brands
Top 10 Established
Products in 2014
Sales
Growth %
(at CER)
% of sales
in EM
€1,862m
+4.7%
46.2%
€1,699m
+2.1%
34.4%
Most of EP top 10 brands
exposed to generic competition
in 2014
● Plavix® in Japan and Renagel®
in EU in 2015
€727m
-16.6%
56.3%
€684m
-8.7%
10.1%
€395m
+0.5%
61.5%
€352m
-4.6%
11.1%
€306m
-18.4%
20.6%
€290m
+7.8%
3.1%
€281m
-5.9%
52.3%
€192m
-48.3%
2.6%
●
●
Top 10 products generated
60% of EP sales in 2014
● Significant differences in
regional sales profile between
Mature and Emerging Markets
●
Focus: New organizational
structure in Global Business
Unit to capture market
opportunities
207
Innovative and Focused Approach to Capture Market
Opportunities and Reinvigorate EP Growth
Emerging Markets
Mature Markets
● Building on brand equity and
established medical value
‒ e.g. Lovenox®, Synvisc®, Renvela®
‒ Expansion in segments where medical
value (e.g. Sevelamer)
● Portfolio reinforcement and
geographic expansion
Growth
Opportunities
for Established
Products
● Building on brand equity and
established medical value
‒ e.g. Plavix®, Aprovel®, CNS
‒ Access and medical education
● Innovation adapted to EM
and geographic expansion
‒ e.g. Aprovasc®
‒ e.g. L-Thyroxin expansion
● Multi-channel management
‒ Very selective, external partner if needed
Continuous Margin Improvement
Trade and channel management – (account management, point of sale, joint business planning)
208
APPENDIX
GBU Sales in 2014
FY 2014 net sales (€ million)
(1)
Total
Total Established Rx Products
Consumer Healthcare
Generics
Total Emerging Markets(9) Diabetes&Cardiovascular
Total Emerging Markets(9) Sanofi Genzyme
GBU General Medecines & Emerging Markets(9)
Total Oncology(2)
Total MS(3)
Total Rare Diseases(4)
GBU Sanofi Genzyme(10)
Total Diabetes(5)
Total Cardiovascular(6)
GBU Diabetes & Cardiovascular(10)
11,010
3,337
1,805
1,169
777
18,098
1,039
456
1,733
3,228
6,109
285
6,394
Total Pharmaceuticals
27,720
GBU Vaccines(7)
GBU Animal Health(8)
Total Group
3,974
2,076
33,770
(1)
Including Plavix, Lovenox, Renagel / Renvela, Aprovel, Allegra, Myslee / Ambien / Stilnox, Synvisc / Synvisc One, Depakine, Tritace, Lasix,
Targocid, Orudis, Cordarone, Xatral and Other Rx Drugs
(2) Including Taxotere, Jevtana, Eloxatine, Thymoglobulin, Mozobil, Zaltrap and Other Oncology
(3) Including Aubagio and Lemtrada
(4) Including Cerezyme, Cerdelga, Myozyme, Fabrazyme, Aldurazyme and Other Rare Diseases products
(5) Including Lantus, Apidra, Amaryl, Insuman, Lyxumia, Afrezza, Toujeo and Other Diabetes
(6) Including Praluent and Multaq
(7) Including Polio / Pertussis / Hib, Adult Booster Vaccines, Meningitis/Pneumonia, Influenza Vaccines, Travel & Other Endemics Vaccines and Other
Vaccines
(8) Including Fipronil products, Vaccines, Avermectin products and Others
(9) Emerging Markets is defined by world excluding U.S., Canada, Western & Eastern Europe (except Russia, Ukraine, Georgia, Belarus, Armenia and
Turkey), Japan, South Korea, Australia, New Zealand and Puerto Rico
(10) Excluding Emerging Markets
210

Presentation

Transcription

Similar documents

ASCO 2016 Multiples Myelom-Update

CIO Report