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October 3rd, 2013
Teresa, Multiple Sclerosis, United States
IR Thematic Call on Multiple Sclerosis
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 policies 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, 2012. Other than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or statements.
3
Agenda
Key Highlights on Multiple Sclerosis Market
● Bill Sibold - Senior Vice President, Head of Multiple Sclerosis - Genzyme
Clinical Data Highlights
● Michael Panzara, MD, MPH - Therapeutic Area Head of MS & Neurology - Genzyme
Genzyme MS Global Launch Update
● Bill Sibold - Senior Vice President, Head of Multiple Sclerosis - Genzyme
Q&A Session
Multiple Sclerosis Market:
Key Highlights
Bill Sibold
SVP, Head of Multiple Sclerosis - Genzyme
4
5
Global MS Market - Significant and Growing Market
Key Facts about MS
● Serious disease with significant
unmet medical needs
● Symptoms include fatigue,
weakness, walking and balance
difficulties, vision problems
● A major impact on family, social
and professional life
● ~2.1m patients worldwide(1)
● ~410,000 patients in the U.S.(1)
● ~630,000 patients in EU(2)
Multiple Sclerosis
(1) National Multiple Sclerosis Society
(2) http://msj.sagepub.com/content/18/5/628.full.pdf
(3) Adapted from Evaluate Pharma July 2013; Reported sales of Copaxone®, Avonex®, Rebif®, Betaseron/Betaferon®, Extavia®,
Tysabri® and Gilenya® for 2012; 2007 sales converted using €/$ of 1.37, 2012 sales and 2017e sales converted using €/$ of 1.29
Multiple Sclerosis Market
Global Sales(3)
2012
2017e
U.S.
ROW
~€11bn
>€14bn
2007
~€5bn
~40% ~60%
2012-17 growth driven by new therapies, satisfying the unmet
needs of convenient administration and more efficacious therapy
~50% ~50%
MS Market in a State of Transition Presents Opportunities
6
Multiple Sclerosis Market Features
Today
● 7 Mechanisms of Action
● 10 Marketed Products
● 3 Modes of Administration
● Greater Treatment Urgency
In 2005
● 2 Mechanisms of Action
● 4 Marketed Products
● 1 Mode of Administration
● More Acceptance of Disease Activity
Increasing diversity of therapeutic options
allowing a more individualized treatment approach
7
MS Treatment Options Have Increased:
Oral and Intravenous Products Share Has Grown
Evolution of MS Market
(1) Company reported sales of Avonex®, Betaseron®/Betaferon®, Copaxone®, Rebif® and Tysabri ® converted using €/$ rate of 1.33
(2) Company reported sales of MS products in H1 2013. Aubagio®, Betaseron®, Copaxone®, Rebif® converted using €/$ rate of 1.31
(3) Injectable therapies include Avonex®, Betaseron®/Betaferon®, Copaxone®, Rebif®, Extavia®
(4) Intravenous therapies include Tysabri®
(5) Oral therapies include Aubagio®, Gilenya® and Tecfidera®
74%
15%
Total Half Year Sales
€5.9bn
H1 2007(1) H1 2013(2)
Total Half Year Sales
€2.4bn
Orals(5)
Intravenous Therapies(4)
Injectable Therapies(3)
11%
96%
4%
8
● Oral therapy(2) share projected to
increase four-fold to nearly 40% of
the MS market by 2017 driven by
new entrants
● Intravenous therapies(3) expected to
approach 20% of the market
● Injectable therapies(4) (ABCRE’s)
projected to decline by roughly half
of current usage by 2017
(1) Evaluate Pharma July 2013
(2) Oral category includes Aubagio®, Gilenya®, Tecfidera®, laquinimod, 2nd Gen S1Ps
(3) Intravenous category includes Tysabri®, Lemtrada®, ocrelizumab, daclizumab
(4) Injectable category includes Avonex®, Betaseron/Betaferon®, Copaxone®, Rebif®, Extavia®, Plegridy™
Transition to Oral and Intravenous Therapies
Expected to Continue
59%
0%
15%
30%
45%
60%
75%
90%
2012 2017e
MS Market Evolution(1,2,3,4)
(% market share)
Injectables
Intravenous
Orals
9
Michael Panzara, MD, MPH
Therapeutic Area Head of MS & Neurology - Genzyme
Clinical Data Highlights
Multiple Sclerosis Results in Significant Brain Injury with
Irreversible Consequences
42 years-old 52 years-old
Brain MRI Reveals Significant Progression of Atrophy Over 10 Years(1)
(1) Courtesy of Beth Fisher and Rick Rudick Cleveland Clinic 10
New Treatment Goals - Focus on Patient Outcomes
Unmet Needs New Goals
Symptom Alleviation Decrease MS activity and improve quality
of life
Halt or reverse damage
and disability
Promote repair, remyelination, durable
disability improvement
Improve disease control Freedom from disease activity
Convenient treatment regimens
to improve compliance
Dosing options, new routes of
administration, less frequent dosing
Maximize patient outcomes Superior effectiveness and favorable
benefit/risk vs. existing treatment
11
12
(1) O’Connor PW et al. N Engl J Med 2011;365:1293-1303
(2) Adjusted for Expanded Disability Status Scale score strata and region at baseline and takes duration of treatment
into account
(3) Kappos L et al. Mult Scler J 2012;18:(S4)9-53(153)
Once-Daily Oral Therapy with Robust Efficacy
TEMSO STUDY(1) TOWER STUDY(3)
Annualized Relapse Rate(2)
Placebo
- 36.3% p=0.0001
- 31.5% p=0.0005
Aubagio® 14mg
n=370
Placebo Aubagio® 14mg
0.539
0.319 0.369
0.501
n=363 n=358 n=388
Annualized Relapse Rate(2)
13
(1) O’Connor PW et al. N Engl J Med 2011;365:1293-1303
(2) At Week 108
(3) Derived using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates
(4) Derived from log-rank test with stratification of EDSS strata at baseline and region
(5) Kappos L et al. Mult Scler J 2012;18:(S4)9-53(153)
Only Oral Therapy to Show Significant Effect
on Disability in Two Phase III Trials
TEMSO STUDY(1) TOWER STUDY(5)
Reduction in Progression of
Disability(2)
Placebo
-29.8%(3) p=0.0279(4)
Aubagio® 14mg
Placebo Aubagio® 14mg
0.273
0.158
0.202 0.197
-31.5%(3)
p=0.0442(4)
Reduction in Progression of
Disability(2)
n=363 n=388 n=370 n=358
TEMSO(1) TEMSO Extension Study(2)
0.171 0.177
0.369
0.539
14mg/
14mg
Placebo/
14mg 14mg Placebo
Annualized Relapse Rate Annualized Relapse Rate
Long-term Efficacy and Safety Supported
by TEMSO Extension Trial
14
(1) Adjusted for Expanded Disability Status Scale score strata and region at baseline and takes duration of treatment
into account
(2) Freedman, M et al. Mult Scler J 2013; 19:(S1)74-558
● TEMSO extension trial included
patients receiving Aubagio® for
up to 9 years (up to 7 years
extension treatment)
● No new or unexpected safety
signals emerged during the study
● Measured clinical and MRI
disease activity remained low in
patients continuing on study
treatment
15
Similar Incidence of SAEs Among Aubagio®
and Placebo-treated Patients in Clinical Trials
● The Aubagio® label(1) includes:
● Risk of teratogenicity (based on animal data)
and hepatotoxicity
● ALT elevations
● Alopecia
● Diarrhea
● Influenza
● Nausea
● Paresthesia
SAE: Serious Adverse Event
(1) Adapted from U.S. Prescribing Information and European SmPC
Relative Proportion of T Cells
Increased with T-Reg Phenotype(2)
Months on Therapy
Potentially Rebalances the Immune System
● Selectively targets CD52
protein, depleting B and T cells
responsible for MS inflammatory
process
● A distinctive pattern of
lymphocyte repopulation occurs
over time(1)
● May reduce inflammatory
processes in MS and have
disease modifying effects
● Supported by durable efficacy
after two short treatment
courses
16
(1) Cox AL et al. Eur J Immunol 2005;35:3332-42., Hu Y et al. Immunology 2009;128:260-70, Havari E et al. ECTRIMS 2010, Jones JL et al. Brain 2010;133:2232-47
(2) Hartung HP et al. Mult Scler J 2012; 18:(S4)279-508
CD
4 T
reg
Cell C
ou
nts
(%
)
Lemtrada® 12 mg/day
Rebif®
Lemtrada® has been granted marketing authorization by the European Commission and is under review by the
regulatory authorities in the U.S. The mechanism by which it exerts therapeutic effect in multiple sclerosis is unknown.
Lemtrada® is developed in collaboration with Bayer HealthCare
17
CARE-MS I(1) CARE-MS II(2)
Randomized Patients 581 840
Study Duration 2 years 2 years
Patient
Population Treatment
naïve
Relapsed on
prior treatment
Treatment
Arms
Lemtrada®
vs. Rebif®
Lemtrada®
vs. Rebif®
Active Comparator Set High Bar for Success
(1) Coles AJ et al. Lancet. 2012;380(9856):1829-1839
(2) Cohen JA et al. Lancet. 2012;380(9856):1819-1828
18
Rebif®
- 55% p<0.0001
n=426
0.39
0.26
0.18
0.52
n=187 n=376 n=202
Lemtrada® Rebif®
- 49% p<0.0001
CARE-MS I(1) CARE-MS II(2)
Annualized Relapse Rate
Annualized Relapse Rate
Significant Comparative Efficacy Results
with Unique Annual Dosing Regimen
Lemtrada®
(1) Coles AJ et al. Lancet. 2012;380(9856):1829-1839
(2) Cohen JA et al. Lancet. 2012;380(9856):1819-1828
HR: Hazard Ratio
SAD: Sustained Accumulation of Disability
(1) CARE-MS I study in treatment-naïve patients did not show a significant reduction in sustained accumulation of disability
(2) Cohen J et al. AAN 2012:platform presentation of CARE-MS II.
Time to SAD(1,2)
CARE-MS II
19
21.1%
12.7%
Rebif®
Lemtrada®12 mg/day HR 0.58
Treatment effect: 42%
p=0.0084
Slowed Accumulation of Disability vs. Rebif®(1)
Pe
rce
nta
ge
of
Pa
tie
nts
wit
h S
AD
Improvement in Pre-Existing Disability:
6-Month Sustained Reduction in Disability
6-Month SRD
CARE-MS II(2)
Follow-up Month
0
3 15 18 21 24 12
Pe
rce
nta
ge o
f P
ati
en
ts w
ith
SR
D
10
40
6 9 0
30
20
HR: 2.57
p=0.0002
28.8%
12.9%
50 Rebif®
Lemtrada®12 mg
20
● Data suggests that improvement
in pre-existing disability was
more likely with Lemtrada® than
Rebif® regardless of which
functional system was impaired
by prior MS disease activity(1)
● All functional systems contributed
to EDSS improvement(1)
RRMS: Relapse Remitting Multiple Sclerosis
(1) Brinar, V ECTRIMS 2013 (P649)
(2) Cohen J AAN 2012:platform presentation of CARE-MS-II
Durable Effect on Sustained Reduction
in Disability Through Year 3
21 (1) Hartung HP ECTRIMS 2013(P592)
6-Month SRD(1)
CARE-MS II Extension Study ● More than 1/3 of Lemtrada®
treated patients in CARE-MS II
extension study attained
sustained disability improvement
by Year 3
● Approximately 80% of patients did
not receive re-treatment during
Year 3
● Fewer than 3% received another
disease modifying treatment in
Year 3
29%
35%
0 6 12 18 24 30 36 0
10
20
30
40
50
Follow-up Month
Pe
rce
nta
ge o
f P
ati
en
ts w
ith
SR
D
Safety Experience
from MS Development Program
● Infusion-associated reactions very common
● Premedication reduced/alleviated symptoms
● Infections common in both groups
● More common with Lemtrada®, low number of serious events
● Autoimmune events, some serious
● Detected via risk management plan allowing early diagnosis and treatment
22
23
Significant Global Regulatory Milestones Achieved
RRMS: Relapse Remitting Multiple Sclerosis
(1) Not indicated for treating non-active patients and those stable on therapy
● EU approved for adult patients with RRMS ● New Active Substance designated by
EMA providing 10 years of data exclusivity in the EU
● FDA approved for adult patients with relapsing forms of multiple sclerosis
● Also approved in Australia, Mexico, Argentina, Chile, South Korea
● EU approved for patients with RRMS with active disease as defined by clinical or imaging features(1)
● FDA decision expected in late
Q4 2013
● Regulatory reviews ongoing
in several other regions
Global Launch Update
Bill Sibold
SVP, Head of Multiple Sclerosis - Genzyme
24
Genzyme’s Critical Success Factors in MS
Products People Approach
● Lemtrada® and Aubagio®
are highly differentiated
novel products
● Fulfill unmet needs
● Well positioned for an
evolving market
● Accomplished team
● Leveraging experienced
Sanofi MS sales reps in
European countries
● Strong commitment and
relationships
● Science driven and
patient focused
● Long term partners
● Be leaders
25
Cumulative U.S. Weekly TRx(1)
Encouraging U.S. Launch Trends
(1) IMS Weekly Total Prescriptions
(2) Q3 2013 Aubagio® quarterly sales figure is an estimate to be validated when company earnings are released
on October 30, 2013
Aubagio®: Quarterly Sales
Week 48 Week 1
60,000 Tecfidera®
Gilenya®
Aubagio®
26
Q4 2012 Q2 2013 Q1 2013
€7m
€20m
€33m
Tecfidera® Launch
€44m(2)
Q3 2013e
40,000
20,000
Broad Based Patient Demand
DMT: Disease Modifying Therapy
(1) Based on data collected at Genzyme's MS One to One™ Patient and Provider Support Center, Sep 2012-Sep 2013
(2) BioTrends Research Group, LaunchTrends®: Aubagio® (teriflunomide) - Multiple Sclerosis (Wave 3) 2013
Aubagio® Prior Therapy(1) (Enrolled Patients)
27
● ~20% patients prescribed
Aubagio® were treatment-
naïve(2)
● >80% of patients switched to
Aubagio® were most recently
on ABCR’s
● Most frequently cited reasons
for initiating Aubagio®(2)
● Oral administration
● Once-daily dosing
● Needle Fatigue/Phobia
30.6%
22.0%
14.1%
3.9%
17.4%
8.5% 1.3%
Other
2.2%
28
Launching a Global MS Franchise(1)
(1) Timing of regulatory approvals and country reimbursement policies may impact projected launch timelines
2012 Selected Markets 2014
2012 Selected Markets 2014
29
Ready to Launch Our MS Franchise in the EU
Aubagio®
and Lemtrada®
approved
Field forces
hired and
trained
Patient support
infrastructure
and programs
in-place
First product
shipments
First EU sales
in October
2013
30
● Multiple Sclerosis market is significant and growing
● New therapies, satisfying the unmet needs of convenient
administration and increased efficacy, to drive growth
● Genzyme uniquely placed to seize opportunities in
Multiple Sclerosis
● Multiple Sclerosis team with proven track record
● Aubagio® and Lemtrada® are positioned for success
in an evolving market
Committed to Being Leaders in MS
Q&A SESSION
31