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