2013 - ir - diabetes

IR THEMATIC CALL ON DIABETES

Chicago - June 24th, 2013

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 3

Agenda

Investigational New Insulin U300(1)

● Riccardo Perfetti, Senior Medical Officer, Diabetes

Lyxumia® (lixisenatide)(2)

● Hugo Fry, Global Project Leader Lixisenatide Family

Sanofi – A Long-Term Commitment to Fighting Diabetes

● Pierre Chancel, Senior Vice President, Diabetes

Q&A

(1) Investigational New Insulin U300 is in Phase III clinical development.

(2) Lyxumia® is the proprietary name approved by the EMA for lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration.

In the U.S.; lixisenatide is currently under review by the FDA. Lixisenatide was in-licensed from Zealand Pharma A/S.

Investigational New Insulin U300

Riccardo Perfetti

Senior Medical Officer, Diabetes - Sanofi

4

5

Investigational New Insulin U300: Building on the

Wealth of Evidence on Lantus®

● : Prescribers’ first choice for insulin therapy

● >10 years of broad clinical experience

● >7m Lantus® patients worldwide

● : A landmark seven-year cardiovascular (CV) outcomes trial(1)

● Over 12,500 participants at high CV risk with impaired fasting glucose,

impaired glucose tolerance or early type 2 diabetes

● ORIGIN results on Lantus® CV safety recently integrated into EU product label

● U.S. label expected to include CV safety findings from ORIGIN

Lantus®

The Gold Standard Basal Insulin

(1) Gerstein H at al, Am Heart J 2008; 155(1): 26-32

Investigational New Insulin U300: Striving to Further

Enhance the Value of Current Gold Standard Basal Insulin

6 PK: Pharmacokinetics PD: Pharmacodynamics

Targeted

Product

Profile

PK/PD

Profile

Clinical

Benefits

Product

Characteristics

2 3 1

U300 Provides Slower Insulin Glargine Release

After Subcutaneous Injection

7

More concentrated formulation (X3)

Reduced volume (1/3) and reduced surface area (1/2)

of insulin glargine subcutaneous depot

Slower release rate of insulin glargine

Schematic illustration

U300

Pharmacokinetic Profile Pharmacodynamic Profile

Serum Insulin Glargine Concentration Glucose Infusion Rate

Dahmen R et al, ADA 2013, abstract no. 113-OR. Euglycemic clamp study in T1D in steady state.

U300 Offers Even Flatter and More Prolonged PK/PD

Profile than Lantus®

U300 0.4U/Kg

Lantus® 0.4U/Kg

8

0 6 12 18 24 30 36

0

5

10

15

20

25

30

LLOQ 5.02 µU.mL-1

SC INJECTION

INS

UL

IN -

µU

.mL

-1

TIME - hour

U100 0.4 U.kg-1

U300 0.4 U.kg-1

LOESS 0.15

0 6 12 18 24 30 36

0

1

2

3

4

5DOSE 0.4 U.kg

-1

U300

U100

GIR

- m

g.k

g-1.m

in-1

TIME - hour

EDITION: A Comprehensive Phase III Program

Fully Recruited

9

Study Population Intervention # of patients

randomized

EDITION I Type 2 Basal + mealtime insulin 807

EDITION II Type 2 Basal + oral therapy 811

EDITION III Type 2 Insulin naïve 879

EDITION IV Type 1 Basal + mealtime insulin 550

EDITION JP I Type 1 Basal + bolus insulin 243

EDITION JP II Type 2 Basal + oral therapy 240

U300 vs.

EDITION I: First Phase III Study Completed

10

Baseline characteristics All patients

Age 60 years

Duration of diabetes 15.8 years

A1c 8.15%

BMI 36.6 kg/m2

Previous basal inulin All patients

Previous insulin Lantus 92%

NPH 8%

Duration of treatment 6.6 years

Previous dose 0.67 units/kg

Riddle MC et al, ADA 2013, Late Breaking Poster 43-LB

T2D: Type 2 Diabetes A1C: HbA1c or Glycated hemoglobin

n=403

Screening period Up to 2 weeks

Total daily dose Lantus® ≥42 U

(or equivalent dose of NPH)

Plus mealtime insulin

6-month efficacy and safety period

Qualifying visit:

7% ≤ A1c ≤10%

Mealtime insulin analogue (±metformin) R

T2D

patients U300

Lantus®

n=404

Endpoints

Fasting plasma glucose target: 80-100 mg/dL (4.4-5.6 mmol/L)

Basal insulin dose adjusted once weekly

n=807

Mean Change in A1c

-0.83%

EDITION I: U300 Showed Equivalent Glycemic Control

and Fewer Nocturnal Hypoglycemic Events vs. Lantus®

11

Similar Reduction in A1c(1)

in Both Groups

21% Reduction in Nocturnal Hypoglycemia

(Severe and/or Confirmed)

with U300 from Month 3 to 6(2)


(1) Primary endpoint: Change in A1c from baseline to Month 6

(2) First main secondary endpoint: Number (%) percentage of patients reporting at least one severe or confirmed (plasma glucose ≤70 mg/dL)

nocturnal [00:00 – 05:59 hrs] hypoglycemic event from month 3 to 6 (RR: Relative risk)

U300

Lantus®

Patients with at least one event

RR (95% CI): 0.79 (0.67-0.93)

p <0.0045

36.1%

46.0%

- 21%

8.4

8.2

8.0

7.8

7.6

7.4

7.2

7.0

Mean A1c (%) by visit

LOCF – Last value during main 6-month on-treatment

.

Mean A

1c (

%)

Baseline Week 12 Month 6 LOCF

Time

Not significant difference

between both groups

Lantus® U300

EDITION I: Lower Risk of Severe or Confirmed

Hypoglycemia Consistent Across Study Periods

12

Severe or Confirmed Hypoglycemia(1)

Nocturnal(2) Any Time of the Day (24-hour)

Baseline

to month 6

Baseline

to week 8

Week 9

to month 6(3)

Baseline

to month 6

Baseline

to week 8

Week 9

to month 6

Lantus® U300


(1) Number (%) percentage of patients reporting at least one severe or confirmed (plasma glucose ≤70 mg/dL) hypoglycemic event

(2) Defined as severe or confirmed by plasma glucose ≤70 mg/dL which occurred between 24:00 and 5:59 hours

(3) First main secondary endpoint

Patients with at least one event

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EDITION II: Topline Results Confirm Edition I Findings

Screening period Up to 2 weeks

Total daily dose Lantus® ≥42 U

(or equivalent dose of NPH)

Plus OADs

6-month efficacy and safety period

Qualifying visit:

7% ≤ HbA1c ≤10%

Oral antihyperglycemic drug(s)(1) R

T2D

patients U300

Lantus®

Endpoints

Fasting plasma glucose target: 80-100 mg/dL (4.4-5.6 mmol/L)

Basal insulin dose adjusted once weekly

n=811

(1) Except sulfonylureas which were prohibited within 2 months before the screening visit and during participation to the study

Similar glycemic control while fewer patients experienced nocturnal

hypoglycemic events compared with Lantus®

Reduction in severe or confirmed nocturnal hypoglycemic events from

month 3 to 6 were in the same range as that observed in EDITION I

Investigational New Insulin U300: Potential to Further

Enhance the Clinical Value of Basal Insulin

● Improved PK/PD profile

● Equivalent glycemic control with consistently fewer patients

with Type 2 diabetes experiencing hypoglycemic events as

compared to Lantus®

● Consistent results in EDITION I and II

● Next steps:

● Topline results of EDITION III & IV expected in H2 2013

● Expected regulatory submission in H1 2014 in U.S. and EU

14

U300

Lyxumia® (lixisenatide)

Hugo Fry

Global Project Leader Lixisenatide Family,

Sanofi

15

16

● Key benefits of Lyxumia®

complementing basal insulin

● Pronounced post-prandial glucose

(PPG) lowering effect

● Beneficial effect on body weight

● Minimal risk of hypoglycemia

● Indicated in EU for combination use

with OADs and basal insulin

● Attractive value proposition

A Positive Addition for Patients

on Basal Insulin

(1) Lyxumia® is the proprietary name approved by the EMA for lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration.

In the U.S.; lixisenatide is currently under review by the FDA. Lixisenatide was in-licensed from Zealand Pharma A/S.

®

Lyxumia®

Easy-to-Use Once-Daily Prandial GLP-1

First 2 weeks of therapy

Remainder of therapy

Lyxumia®

10 µg OD SC

Lyxumia®

20 µg OD SC

OD: Once-daily SC: Subcutaneous

0.0

-0.2

-0.4

-0.6

-0.8

-1.0

-25

-20

-15

-10

-5

0

A1c Control and Postprandial Hyperglycemia Reduction (PPHG)

with Lyxumia® as Add-on to Basal Insulin(1)

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Reduction in A1c From

Baseline to Week 24

LS mean difference -0.49

p <0.0001

LS

mean ±

SE

change

from

baselin

e

(%)

A1c Reduction Achieved

With Lixisenatide

as Add-on to Basal Insulin

MC Riddle, ADA 2013 (abstract 941-P) Pooled data were from three 24-week, randomized Phase III studies of lixisenatide

added to basal insulin ± oral agents compared with placebo (GetGoal-L, GetGoal-DUO-1 & GetGoal-L-Asia) (n=753)

AUC: Area under the curve LS: Least mean square SE: Standard error NS: Not significant 17

-15

-10

-5

0

Basal Postprandial

NS

LS mean difference –11.0

p<0.0001

Basal Hyperglycemic Exposure (AUCB) and

Postprandial Hyperglycemic Exposure (AUCP)

LS

mean ±

SE

change

from

baselin

e (

mm

ol/L·h

)

Decrease in PPHG Exposure

Achieved With Lixisenatide

as Add-on to Basal Insulin

Lixisenatide Placebo

0%

20%

40%

60%

80%

Byetta Victoza Bydureon Lyxumia

EU Rollout Will Continue Throughout 2013

18

Market Access

Activities on Track

● Already ~50% of key local formulary access

target

● Reached ~70% unaided awareness in

target stakeholders(1)

(1) Internal data (stakeholders: endocrinologists, diabetes specialist nurses, and payers)

GLP-1 Weekly Market Shares (in Volume)

Steady Market Penetration

® ® ® ®

®

Pre-licence 1 2 3 Wave 4

8.1%

– Broad Phase IIIb Program Ongoing

19

2012 2014 2013 2015

Prior to the Main Meal vs. Prior

to Breakfast Administration

PPG Effects when Added

to Lantus® (vs. Liraglutide)

Lixisenatide vs. Apidra® as an Add-on to

Lantus® (GetGoal Duo-2)

On Top of Basal Insulin and/or OADs in

elderly patients (GetGoal-O)

Specific Studies for Asian Market

ClinicalTrials.gov identifiers: NCT01147250, NCT01517412, NCT01596504, NCT 01768559, NCT01798706, and NCT01632163,,

®

CV outcomes study Enrolment will be completed in 2013

20

Combining Insulin Glargine with Lixisenatide

in One Single Daily Injection (LixiLan)

20

Potential to Be the First Combination

of Basal Insulin + GLP-1 in One Daily Injection in the U.S

+ ®

● Phase II Proof-of Concept study

completed

● Results support Go decision to Phase III

● Data guiding preparation for Phase III

program

● Full data to be submitted for publication

in a medical journal

● Phase III start expected in H1 2014

● Opportunities in patients not at target

on OADs and basal insulin

Lyxumia®: New Step to Expand Sanofi’s Position

in the Injectable Antidiabetic Drugs Market

● Encouraging launch progress in EU

● Regulatory decision in Japan expected mid-2013

● ELIXA CV outcome trial expected to complete enrolment

by end 2013

● FDA review ongoing including interim ELIXA data

● Start of Phase III program with LixiLan expected in H1 2014

21

Lyxumia®

Sanofi – A Long-Term Commitment

to Fighting Diabetes

22

Pierre Chancel

Senior Vice President, Diabetes, Sanofi

Sanofi Has a Well Established Global Presence

in Diabetes

Net sales growth is at constant exchange rate Market share: Source IMS Health MIDAS 2012 – Copyright 2012 – All rights reserved

W. Europe: France, Germany, UK, Italy, Spain, Greece, Belgium, Luxembourg, Portugal, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Denmark

Emerging Markets: World less North America (USA, Canada), Western Europe, Japan, Australia and New Zealand

RoW: Japan, Canada, Australia and New Zealand

Diabetes sales:

€3,167m, +21.5%

Diabetes market share:

21.1%

Diabetes sales:

€1,012m, +6.3%


18.1%

17.5%

Diabetes sales:

€459m, +0.2%


11.8%

7.9% Emerging

Markets 19.8%

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54.8% U.S.

Diabetes sales:

€1,144m, +22.5%


14.9%

Rest of

World

Western

Europe

FY 2012 Sales

€5,782m +16.7%

A Portfolio of Key Globally Marketed Brands

Supporting Sales Performance

Net Sales (€m)

Net Sales (€m)

Net Sales (€m)

Net Sales (€m)

24

Strong Sales Evolution Across All Geographies

U.S. Net Sales (€m)

Emerging Markets Net Sales (€m)

Western Europe Net Sales (€m)

Rest of the World Net Sales (€m)

25

Lantus®

Apidra®

Amaryl®

Insuman®

,

,

,

On Track to Deliver on our 5-year Goal for 2013(1)

x2

® ® ® ®

€bn

Global Diabetes Sales

26 (1) Objective communicated at the IR Thematic Seminar on Diabetes held on September 30, 2010

27

Sanofi is the Fastest Growing Insulin Player in the Fastest

Growing Segment

+17.6%

+13.1%

+ 4.4%

41.1%+12.4%

35.0%+18.9%

21.4%+7.8%

2.6% +8.9%

Breakdown By Insulin Player Market Share (%)

Growth vs. Prior Year (%)

Breakdown By Insulin Type Market Share (%)

Growth vs. prior year (%)

MAT Q1/2013 Worldwide Insulin Market Breakdown (Value)

Sanofi

Lilly

Others

Novo Basal

Premix

Short Acting

47.8%

18.3%

33.9%

Source: Market share data from IMS Health MIDAS Q1/2013 – Copyright 2013– All rights reserved

Sanofi Holds a Strong Position Among Insulin Players

28

MAT Q1/2013 Insulin Market Share by Insulin Player (Value) Market Share (%)

Growth vs. Prior Year (%)

Sanofi

45%

34%

16%5%

45%

26%

20%10%

51%

31%

19%

Lilly

Others

U.S. Western

Europe

Emerging Markets Japan/Can

Aus/NZ

+ 23% + 24%

+ 8%

- 1%

+ 21%

+ 3%

+ 1%

+ 4%

+ 4% + 0%

+ 7%

+ 16%

+ 14%

+ 15%

Novo

Source: Market share data from Source IMS Health MIDAS Q1/2013 – Copyright 2013 – All rights reserved

38% +24%

38% +23%

24% +8%

Basal Insulins Constitute the Leading and Fastest

Growing Insulin Segment Across All Geographies

29

Basal

Premix

Short Acting

MAT Q1/2013 Insulin Market Breakdown by Insulin Type (Value) Market Share (%)

Change vs. Prior Year (%) U.S. Western

Europe

Emerging Markets Japan/Can

Aus/NZ

17% - 5%

12% + 7%

25% - 5%

50% + 24%

47% + 5%

43% + 13%

42% + 12%

38% + 18%

19% + 10%

36% + 4%

33% + 6%

38% + 10%

Source: Market share data from Source IMS Health MIDAS Q1/2013 – Copyright 2013 – All rights reserved

State-of-the-Art, Easy-to-Use and Accurate Insulin Pens

to Match the Needs of People with Diabetes

30

Disposable pen Reusable pen Reusable pen

to expand offering

in Emerging Markets

Access and

Volume

Expansion

in Emerging

Markets

Multiple Growth Drivers to Sustain Sales Growth

of Lantus®

Development

of Integrated

Solutions Including Pens

& BGMs

Further

Increase in

Pen Usage

More Timely

Lantus®

Initiation

31

Shift from

Premix to

Basal

Combination

with

Lixisenatide

Leveraging

ORIGIN

CV Outcome

Study

Basal Use

CV Data

Market Access

Devices

New Products

Diabetes – A Key Growth Platform

● Lantus® well-established Gold Standard insulin

● First positive EDITION program results with Investigational

New Insulin U300

● Lyxumia® expected to expand our leading position

in injectable antidiabetic drugs market

● Start of Phase III program with LixiLan expected in H1 2014

● Strong confidence in ability to deliver high-single digit sales

CAGR over 2012-2015 for Diabetes

32

Sanofi

Diabetes

Q&A SESSION

33

2013 - ir - diabetes

Health & Medicine