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, 2011. Other than as required by applicable law,
Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
2
3. Results Reflect Generic Competition to Legacy Blockbusters (1)
and Loss of Exclusivity of Plavix® and Avapro® in the U.S. (2)
YTD Sales (€m) YTD Business EPS (€)
€26,421m
€24,881m €5.09 €5.01
+1.2% -8.4%
at CER(3) at CER(4)
YTD 2011 YTD 2012 YTD 2011 YTD 2012
(1) Eloxatin® and Aprovel® lost their exclusivity in the U.S. and EU, respectively, in August 2012
(2) Avapro® in March 2012 and Plavix ® in May 2012
(3) On a reported basis, YTD 2012 sales w ere up +6.2%
(4) On a reported basis, YTD 2012 Business EPS w as down -1.6% 3
4. In Q3 2012 Growth Platforms Represented Over 70% of Sales
(1)
Key Genericized Products Sales Growth Platforms Sales
(€m and % of Total Sales) (€m and % of Total Sales)
€6,412m
€5,753m
€5,381m
€3,339m 70.9%
of Total
€2,207m 4.4% Sales
of Total
Sales
€813m €752m
€399m
Q2 Q1 Q2 Q3 Q2 Q1 Q2 Q3
2009 2012 2009 2012
(1) Key genericized products include Lovenox ® U.S., Plavix ® Western EU, Taxotere® Western EU & U.S., Eloxatin® U.S., Ambien® family U.S., Allegra® U.S.,
Aprovel® Western EU, Xyzal® U.S., Xatral® U.S., Nasacort® U.S. and BMS Alliance (active ingredients of Plavix ® and Avapro® sold to BMS) 4
5. Growth Platforms Grew by +6.4% in Q3 2012
Growth at CER
Emerging Markets €2,821m +6.8%
Diabetes Solutions €1,486m +17.5%
Vaccines €1,481m +0.7%
Consumer Health Care €733m +5.9%
Animal Health €519m +3.8%
New Genzyme(1) €470m +22.5%
Innovative Products(2) €154m +7.6%
(1) New Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises
(2) Includes new product launches which do not belong to the Grow th Platforms listed above: Multaq®, Jevtana®, Mozobil® and Zaltrap® 5
6. Executing Successful Strategy to Reposition Sanofi
1 Increase innovation in R&D
Deliver
sustainable growth
Pursue external growth
2 opportunities
and generate
improved
shareholder returns
Adapt structure for future
3 challenges and opportunities
6
6
7. Several Regulatory Milestones Expected in Next 6 Months
Products Targeted Indications Expected Milestones
®
Metastatic
CHMP Opinion: Q4 2012
Colorectal Cancer
®
CHMP Opinion: Q4 2012
Type 2 Diabetes
FDA Submission: Dec 2012
TM
hoFH/severe heFH in EU CHMP Opinion: Q4 2012
and hoFH in the U.S PDUFA Date: Jan 29, 2013(1)
® Relapsing Forms of CHMP Opinion: Q1 2013
Multiple Sclerosis
Relapsing Forms of FDA Re-Submission on track(2)
Multiple Sclerosis CHMP Opinion: Q2 2013
New 6-in-1
DTP-HepB-Polio-Hib EU Licensure: Q2 2013
Paediatric Vaccine
(1) On October 18th 2012, an FDA AdCom recommended Kynamro™ for hoFH
(2) Sanofi w ill make an announcement w hen the FDA makes a decision concerning the acceptance of the file
Lyxumia® , Kynamro™ and Lemtrada™ are registered trade names submitted to health authorities for investigational agents
Zaltrap® is developed in collaboration w ith Regeneron, Kynamro™ w ith Isis Pharmaceuticals and Lyxumia® is in-licensed from Zealand Pharma
Genzyme is developing Lemtrada™ in MS in collaboration w ith Bayer HealthCare
hoFH: Homozygous Familial Hypercholesterolemia PDUFA: Prescription Drug User Fee Act
7
heFH: Heterozygous Familial Hypercholesterolemia CHMP: Committee for Medicinal Products for Human Use
8. Now Available in the U.S.
Key Facts about MS
Oncology
● A novel VEGF trap acting on
multiple angiogenic targets
● Indicated in combination with
FOLFIRI in mCRC patients
resistant to or progressing on
an oxaliplatin-containing regimen
● Significant improvement in
Overall Survival demonstrated
in the VELOUR study(1)
● Launch on-track with sales of
€7m in Q3 2012
(1) Van Cutsem, et al. Ann Oncol. 2011;22(suppl 5). Abstract O-0024 and presentation at: ESMO 13th WCGIC.
June 22-25, 2011; Barcelona, Spain. 8
9. An Exciting New Oral Treatment
Now Approved by FDA for Relapsing MS
● Aubagio® 14mg is the only oral MS drug to significantly delay disability progression in two
Phase III trials(5)
● Aubagio® 14mg provided statistically significant reduction in Annualized Relapse Rate
● Well-characterized safety profile across placebo-controlled trials (6)
● Convenient once-daily oral dosing
● Launched October 2012
TEMSO STUDY TOWER STUDY TEMSO STUDY TOWER STUDY
Annualized Relapse Rate(1) Annualized Relapse Rate(1) Reduction in Progression of Reduction in Progression of
Disability(2) Disability(2)
- 31.5% - 36.3% -29.8%(3)
p=0.0005 0.501 p=0.0001 p=0.0279(4)
0.539 0.273 -31.5%(3)
p=0.0442(4)
0.319 0.197
0.369 0.202
0.158
n=363 n=359 n=388 n=370 n=363 n=359 n=388 n=370
Placebo Aubagio® Placebo Aubagio® Placebo Aubagio® Placebo Aubagio®
14mg 14mg 14mg 14mg
(1) Adjusted f or Expanded Disability Status Scale score strata and region at baseline and takes duration of treatment into account
(2) At Week 108
(3) Deriv ed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as cov ariates
(4) Deriv ed f rom log-rank test with stratif ication of EDSS strata at baseline and region
(5) TEMSO and TOWER. Analy sis of the f ull TOWER data is ongoing and results will be presented at a f orthcoming scientif ic meeting; Aubagio® 7mg tablets are also av ailable in the U.S.
(6) The most f requent adv erse reactions f or AUBAGIO® in the placebo-controlled studies were ALT increased, alopecia, diarrhea, inf luenza, nausea, and paresthesia. 9
The AUBAGIO® label includes a boxed warning citing the risk of hepatotoxicity and teratogenicity (based on animal data).
13. Broadening our Diabetes Platform
with New Patient Focused Solutions
® ● Once-daily and pronounced PPG lowering effect
● Use on top of basal insulin
● ELIXA: CV outcome study ongoing
NEW ● Unique flat PK/PD profile and lower injection volume
INSULIN GLARGINE
FORMULATION ● EDITION program: six Phase III trials currently ongoing
in T1D and T2D(2)
● First state-of-the art re-usable insulin pen, manufactured
by a global company in India
● For use with Sanofi’s insulin portfolio in India and possibly
other Emerging Markets
Lyxumia® is the proprietary name submitted to the EMA for the company’s investigational GLP-1 RA lixisenatide. The proprietary name for lixisenatide in
the U.S. is under consideration. Lixisenatide is not currently approved or licensed anyw here in the w orld.
Lixisenatide w as in-licensed from Zealand Pharma A/S.
PPG: postprandial glucose PK/PD – Pharmacokinetic/Pharmacodynamic TD1 and TD2: Type 1 and Type 2 diabetes
(1) Except for the device intended for Japan (2 steps to maintenance dose w ith one pen)
(2) EDITION I, II, III, IV, JPI, JPII - ClinicalTrials.gov Identifier: NCT 1499082, 01499095, 01676220 & 01683266, 01689129 & 01689142 13
14. ® Clinical Development Designed to Support
Use in Combination with Basal Insulin
T2D Patients Treated
Phase III Program with Basal Insulin(1) (worldwide)
Mono
Monotherapy
Mono Japan On basal insulin On basal insulin
with controlled fasting
F1 (metformin)
glucose control
S (sulfonylurea)
Placebo-controlled but A1c >7%
M (metformin)
in OAD failure
P (pioglitazone)
M Asia (metformin)
4 million
on Lantus®
Active-controlled X vs. exenatide
4 million
4 million
Placebo-controlled L on other
on top of L Asia basal insulins(2)
basal insulin Duo 1
Lyxumia® is the proprietary name submitted to the EMA for the company’s investigational GLP-1 RA lixisenatide. The proprietary name for lixisenatide
in the U.S. is under consideration. Lixisenatide is not currently approved or licensed anyw here in the w orld.
T2D – Type 2 Diabetes A1C – HbA1c or Glycated hemoglobin
(1) Adapted from IMS data (2) Includes all types of basal insulins 14
15. Fix-Flex Device Has Been Developed for Joint
Administration of Lantus® and Lixisenatide
● Single injection per day coupled
with possibility to adjust Lantus®
dose
● Entering phases for
industrialization, validation,
usability and manufacturing +
● Device expected to be available
Lixisenatide
mid-2013 for Phase III initiation
Lyxumia® is the proprietary name submitted to the EMA for the company’s investigational GLP-1 RA lixisenatide. The proprietary name for lixisenatide
in the U.S. is under consideration. Lixisenatide is not currently approved or licensed anyw here in the w orld. 15
16. New Glargine Formulation
● Investigational glargine
formulation:
● Flat PK/PD profile New Insulin Glargine Formulation
● Lower injection volume Depot formation after subcutaneous injection
● Phase III trials ongoing in T2D
high-dose insulin users(1) Lantus® New Glargine
● Targeting ~1,600 patients Formulation
EDITION I EDITION II
T2D Patients T2D Patients
Basal Bolus Basal + OAD
● Second set of Phase III studies
recently started(2)
EDITION III EDITION IV Schematic illustration
T2D Patients T1D Patients
Insulin Naïve Basal
PK/PD – Pharmacokinetic/Pharmacodynamic OAD – Oral anti-diabetic drugs
(1) ClinicalTrials.gov Identifier: NCT1499082 & NCT01499095
(2) ClinicalTrials.gov Identifier: NCT01676220 & NCT01683266 16
17. Targeting Rare Familial Hypercholesterolemias
Understanding Rarity
● Four Phase III trials conducted
in severe FH forms ~40,000 patients(1)
● Significant reduction in LDL-C HoFH Severe FH
when added to a regimen of
maximally tolerated statin dose
and other lipid lowering therapies
● Sustained reduction in apo B
production decreased LDL
and Lp(a)
On statins:
● FDA Ad Com voted on October 60 million
18th recommending approval patients
HeFH:
1 million
patients
(1) Patients for hoFH and Severe FH in US and EU markets
hoFH – Homozygous Familial Hypercholesterolemia
Severe FH – Severe Familial Hypercholesterolemia = treated LDL-C CHD – Coronary Heart Disease
heFH – Heterozygous familial hypercholesterolemia 17
21. Otamixaban: Providing Superior Outcomes while
Simplifying Treatment during Interventional Procedures
TAO Study
● Despite current therapies, death, MI,
and readmission rates remain high Moderate-to-high risk NSTE-ACS with
planned early invasive strategy (n=13,220)
● Otamixaban is the first IV direct and
selective factor Xa inhibitor with R
quick onset/offset
● 27 to 42% risk reduction in ACS
complications including death and MI Otamixaban Otamixaban UFH +
Regimen 1 Regimen 2 Eptifibatide
in Phase Il(1) (n=1,969) (n=1,969) (n=1,969)
● Phase III TAO study ongoing with
Sponsor-blinded
results expected in Q2 2013 interim analysis
Primary endpoint:
Death/Myocardial Infarction @ day 7
(1) The Lancet, Volume 374, Issue 9692, Pages 762 - 764, 5 September 2009
NSTE-ACS – Non-ST-Elevation Acute Coronary Syndrome, MI – Myocardial Infarction, UFH – Unfractionated Heparin 21
22. Eliglustat(1) - A Novel Oral Therapy in Gaucher Disease
● Potent, novel substrate inhibitor Change in Spleen Volume
(% change at 9 months)
● Oral therapy
● Eliminating challenges of infusions +2%
Eliglustat
● Positive results from ENGAGE, Placebo
first Phase III study (vs. placebo)
● Primary endpoint and all secondary
30%
endpoints met
● Well tolerated with no serious
adverse events reported Absolute
● ENCORE Phase III results (vs. Difference
Cerezyme®) expected in early 2013
-28%
(1) Eliglustat tartrate is an investigational drug
(2) Secondary endpoints included improvements in hemoglobin levels and platelet levels, as w ell as liver volumes 22
23. Dengue Vaccine: Addressing a Growing Global Threat
Significant Disease Ambitious Phase III
First Efficacy Results
Burden Program
● Estimated 220m dengue ● Phase IIb results in ~4,000 ● Global Phase III program
infections worldwide per year patients recently published ongoing
in the Lancet
● 2m cases of Hemorrhagic ● Large scale studies in LatAm
Fever ● Effective against DENV 1, 3 and Asia
and 4 (in the range of 60% to
● >500,000 hospitalizations and 90%), with only DENV 2 ● 31,000 children and
>20,000 deaths / year appearing to be resistant adolescents
● Dengue: a public health ● Safe and well-tolerated ● Results expected in 2014
priority in Asia and Latin
America
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24. Ensuring R&D Contributes to Sanofi’s Success
An efficient global R&D organization
Maximize synergies and convergence around Hub model
Exploit economies of scale
Improve R&D cost structure
Focus on high-value projects
Global
Execute on late-stage projects
R&D Medical value and translational feasibility to guide early-stage
Goals portfolio prioritization
Establish new models of external innovation
Enhance the value of external opportunities and partnerships
Create open and creative models with partners across the
healthcare ecosystem
24