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IR Thematic Call on Diabetes Boston – June 9 th , 2015
39

Linea Sanofi en Diabetes ADA 2015

Feb 12, 2016

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Page 1: Linea Sanofi en Diabetes ADA 2015

IR Thematic Call on DiabetesBoston – June 9th, 2015

Page 2: Linea Sanofi en Diabetes ADA 2015

2

Forward Looking Statements

This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of1995, as amended. Forward-looking statements are statements that are not historical facts. These statements includeprojections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions andexpectations 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'smanagement believes that the expectations reflected in such forward-looking statements are reasonable, investors arecautioned that forward-looking information and statements are subject to various risks and uncertainties, many of whichare difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments todiffer 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 theEMA, regarding whether and when to approve any drug, device or biological application that may be filed for any suchproduct candidates as well as their decisions regarding labeling and other matters that could affect the availability orcommercial potential of such product candidates, the absence of guarantee that the product candidates if approved willbe commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's abilityto benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of costcontainment policies and subsequent changes thereto, the average number of shares outstanding as well as thosediscussed 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 Form20-F for the year ended December 31, 2014. Other than as required by applicable law, Sanofi does not undertake anyobligation to update or revise any forward-looking information or statements.

Page 3: Linea Sanofi en Diabetes ADA 2015

3

Agenda

3

ELIXA: First CV Outcome Trial with a GLP-1 Receptor Agonist

● Matthew C. Riddle, Professor of Medicine – Oregon Health & Science University

Lixisenatide: Standalone Use and Combination with Basal Insulin ● Riccardo Perfetti, MD – Senior Medical Officer, Diabetes

Afrezza® U.S. Update● Andrew Purcell – Vice President and Head, U.S. Diabetes Business Unit

Toujeo® Launch Progress● Andrew Purcell – Vice President and Head, U.S. Diabetes Business Unit● Raf Henein – Vice President, Global Brand Leader Toujeo®, Diabetes

Concluding Remarks

● Pierre Chancel – Senior Vice President, Diabetes

Q&A Session

Afrezza® (insulin human) Inhalation PowderToujeo® (insulin glargine) Injection 300 Units/mL

Page 4: Linea Sanofi en Diabetes ADA 2015

ELIXA: First CV Outcome Trial with a GLP-1 Receptor Agonist

4

Matthew C. Riddle, Professor of Medicine

Oregon Health & Science University

Page 5: Linea Sanofi en Diabetes ADA 2015

Evaluation of LIXisenatide in Acute Coronary Syndrome (ELIXA)

(Selected slides)

ADA June 8, 2015 Late Breaking Session

ClinTrials.gov NCT01147250

ELIXA Trial Executive Committee:Rafael Diaz, Kenneth Dickstein, Hertzel Gerstein, Lars Køber,

Eldrin Lewis, Aldo Maggioni, John McMurray, Marc Pfeffer, Jeffrey Probstfield, Matthew Riddle, Scott Solomon, Jean-Claude Tardif

on behalf of the ELIXA Investigators

5

Page 6: Linea Sanofi en Diabetes ADA 2015

• Randomized, double-blind, placebo-controlled event-driven trial• Patients with Type 2 DM within 180 days of ACS• Run-in period of 7 days; trained in self-administration of daily SC

volume-matched placebo• Lixisenatide or matching placebo (1:1)

Initial dose 10 µg/day Down- or up-titration permitted to maximum of 20 µg/day

• Glucose control managed by site investigators’ judgment

6(ELIXA Design/Baseline AHJ, 2015)

Design

Page 7: Linea Sanofi en Diabetes ADA 2015

• Primary (Composite) CV death, Non-fatal MI, Non-fatal stroke, Hospitalization

for unstable angina (UA)

• Secondary and Other Primary endpoint + hospitalization for HF Primary endpoint + hospitalization for HF + coronary

revascularization Percent change in urinary albumin/creatinine ratio from

baseline to 108 weeks All-cause death

7

Endpoints

Page 8: Linea Sanofi en Diabetes ADA 2015

Primary Outcome CV Death, MI, Stroke or UA

Lixisenatide: 406/3034 = 13.4%Placebo: 399/3034 = 13.2%

HR = 1.02 (0.89, 1.17)

8Unpublished data

Page 9: Linea Sanofi en Diabetes ADA 2015

Outcome

# and % of Subjects with Event, and Event Rate

Hazard Ratio(95% CI)

Placebo(N = 3034)

Lixisenatide(N = 3034)

CV Mortality 158 (5.2%)2.4/100pt-yr

156 (5.1%)2.3/100pt-yr 0.98 (0.78, 1.22)

MI (fatal / non-fatal) 261 (8.6%)4.1/100pt-yr

270 (8.9%)4.2/100pt-yr 1.03 (0.87, 1.22)

Stroke (fatal / non-fatal) 60 (2.0%)0.9/100pt-yr

67 (2.2%)1.0/100pt-yr 1.12 (0.79, 1.58)

Unstable Angina 10 (0.3%)0.1/100pt-yr

11 (0.4%)0.2/100pt-yr 1.11 (0.47, 2.62)

Individual Components of Primary

9Unpublished data

Page 10: Linea Sanofi en Diabetes ADA 2015

Outcome

# and % of Subjects with Event, and Event Rate

Hazard Ratio(95% CI)

Placebo(N = 3034)

Lixisenatide(N = 3034)

Primary + HF Hosp 469 (15.5%)7.6/100pt-yr

456 (15.0%)7.3/100pt-yr 0.97 (0.85, 1.10)

Primary + HF Hosp + Coronary Revasc

659 (21.7%)11.2/100pt-yr

661 (21.8%)11.1/100pt-yr 1.00 (0.90, 1.11)

HF Hosp 127 (4.2%)1.9/100pt-yr

122 (4.0%)1.8/100pt-yr 0.96 (0.75, 1.23)

CV Death + HF Hosp 253 (8.3%)3.9/100pt-yr

248 (8.2%)3.8/100pt-yr 0.97 (0.82, 1.16)

Secondary Outcomes

10Unpublished data

Page 11: Linea Sanofi en Diabetes ADA 2015

Lixisenatide: 66/682 = 9.7%Placebo: 69/676 = 10.2%

HR = 0.93 (0.66, 1.30)

Lixisenatide: 56/2352 = 2.4%Placebo: 58/2358 = 2.5%

HR = 0.97 (0.67, 1.40)

Hx HF

No Hx HF

Heart Failure Hospitalization(by History of HF)

11Unpublished data

Page 12: Linea Sanofi en Diabetes ADA 2015

Placebo

Lixisenatide

Mean post-baseline difference-0.27% (-0.32, -0.22)

8

7.5

6.5

Mea

n H

bA1c

(%)

7

0 12 24 36Months

12Unpublished data

HbA1c (mean, %)

Page 13: Linea Sanofi en Diabetes ADA 2015

Urine Albumin/Creatinine Ratio(median mg/g)

PlaceboN = 2830

LixisenatideN = 2803

Baseline 10.4 10.0

Month 6 11.5 10.2**

Month 18 12.5 11.1**

Month 24* 13.4 11.9**

Change: Baseline to M24 +34% +24%**

*pre-specified **p<0.01

Unpublished data13

Page 14: Linea Sanofi en Diabetes ADA 2015

Placebo

Lixisenatide

Mean post-baseline difference-0.7 kg (-0.9, -0.5)

0 12 24 360 12 24 36Months

2

1

0

-1

-2

kg

14

Unpublished data

Body Weight Change (kg)

Page 15: Linea Sanofi en Diabetes ADA 2015

1) Hypoglycemia levels similar despite lower HbA1c

2) Nausea and vomiting were ~3x more frequent with lixisenatide and led to discontinuation in 3.8%

3) Pancreatitis (5 vs. 8 events), pancreatic cancer (3 vs. 9), and other cancers were not increased with lixisenatide

4) Drug-related systemic allergy was not increased with lixisenatide (5 vs. 5)

15

Non-CV safety lixisenatide vs. placebo

Page 16: Linea Sanofi en Diabetes ADA 2015

ELIXA Summary: CV Outcomes

• Placebo-controlled trial of lixisenatide in 6,068 patientswith type 2 diabetes and ACS

• Demonstrates CV safety (as defined by FDA guidance), but not superiority in reducing CV events

• Additional analyses indicate safety with respect to heart failure events as well as death

16

Page 17: Linea Sanofi en Diabetes ADA 2015

Lixisenatide: Standalone Use and Combination with Basal Insulin

17

Riccardo Perfetti, M.D.

Senior Medical Officer, Diabetes

Page 18: Linea Sanofi en Diabetes ADA 2015

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

18

PPG – Post-Prandial Glucose OAD – Oral Anti-Diabetic drug OD – Once-daily SC – SubcutaneousLyxumia® is the proprietary name approved by the EMA for lixisenatide. Lixisenatide is an investigational new drug in the U.S. The proprietary name for lixisenatide in the U.S. is under consideration in the U.S.

First 2 weeks of therapy

Remainder of therapy

Lyxumia®

10 µg OD SC

Lyxumia®

20 µg OD SC

Lixisenatide: Moving Towards U.S. Regulatory Submission

U.S. regulatory submission expected late July 2015

● Phase 3 program evaluated efficacy and safety of lixisenatide on top of OADs or on top of basal insulin in adult patients

● makes lixisenatide the first GLP-1 with proven CV safety in CVOT

● Key benefits of lixisenatide:

● Pronounced PPG lowering effect

● Complementing basal insulin

● Demonstrated reduction in body weight

● Minimal risk of hypoglycemia

Page 19: Linea Sanofi en Diabetes ADA 2015

29.4%32.2%

22.2%24.2%

16.7%

9.2%

26.1%

17.6%

10.8%

Lixisenatide on top of glargine (n=297)Glulisine QD on top of glargine (n=298)Glulisine TID on top of glargine (n=295)

A1c <7% & no documentedsymptomatic hypoglycemia

A1c <7% & no weight gain

A1c <7% & no documented symptomatic hypoglycemia& no weight gain

GetGoal Duo- : Adding Lixisenatide to Insulin Glargine(1)

Has Advantages vs. Basal Bolus Regimen

No Unexpected Safety FindingAll Co-Primary Endpoints Met Non-inferiority of lixisenatide to both comparator

regimens on A1c reduction at 24 weeks(2)

Superiority of lixisenatide regimen to basal-bolus for body weight change(3)

Less documented hypoglycemia(4) and more GI events(5) with lixisenatide regimen

Patients Achieving Composite Endpoints

19

2 31

Source: Rosenstock et al. ADA 2015 (# 107-LB) and data on file. (1) 100 Units/mL (2) LS mean treatment diff. for lixisenatide (L) vs. Glulisine (G) QD: - 0.05% [95% CI: 0.170 to 0.064] and vs. G TID: 0.21% [95% CI: 0.095, 0.328] (3) LS mean treatment diff. : -1.99kg [95% CI: - 2.593 to 1.396], p<0.001 (4) Estimated rate ratio [95% CI]: 0.8 [0.5 to 1.1], p=0.123 vs G QD; 0.5 [0.3 to 0.7], p<0.0001 vs. G TID. (5) 25% of L-treated patients with ≥ 1 nausea vs. 2% or 1% with G QD or G TID. L-treated patients also reported vomiting (9%) and diarrhea (7%).

Page 20: Linea Sanofi en Diabetes ADA 2015

20

A Strong Drug Profile Emerging from PoC Study in Type 2 Diabetes

RA – Rapid-acting(1) Mean A1c change of 1.8% at Week 24 (n=161) (2) Mean change in body weight from baseline to Week 24 (n=161)(3) Documented symptomatic hypoglycemic events ≤70 mg/dL occurred in 21.7% of patients (n=161)Source: Rosenstock J et al. ADA 2014 (#332-OR) and ADA 2015 (# 169-OR)

Proof-of-Concept Study of Fixed-Ratio Once-Daily LixiLanin Type 2 DM on Metformin

84% of patients reached A1c goal <7%

68% reached this target with no documented hypoglycemia

56% reached it with no weight gain

46% with no weight gain and no documented hypoglycemia

● Robust A1c reduction from 8.1% to 6.3%(1)

● Reduced body weight (-1 kg)(2)

● Less frequent nausea and vomiting compared to what has been reported for the GLP-1 RA class

● Low incidence of symptomatic hypoglycemia(3), not impacted by the magnitude of A1c reduction

Building on the Wealth of Evidence on CV safety

Page 21: Linea Sanofi en Diabetes ADA 2015

Combining Insulin Glargine with Lixisenatide in a Single Once Daily Injection

21

● Phase 3 program headline resultsexpected in Q3 2015 ● LixiLan-O study in patients insufficiently

controlled on OADs

● LixiLan-L study in patients not at goal on basal insulin

● >1,900 adults patients enrolled

● Pre-filled SoloSTAR® pen platform● Flexibility allowing dosing adjustments to

cover wide insulin glargine needs (up to 60 IU) and clinically relevant lixisenatide dose (up to 20 µg)

Patients Uncontrolled

with basal therapy

~4m patients

Patients Not at Target

on OAD~5.5m

patients

Number of patients estimated for the U.S. (2017 projections based on internal model adapted from Adelphi)

1st injectable drug

Basal intensification

U.S. Target Populations of T2D Patientsfor

Regulatory submission expected in the U.S. in Q4 2015 and EU in Q1 2016

Page 22: Linea Sanofi en Diabetes ADA 2015

SAR425899: A Novel Dual Agonist for GLP-1 and Glucagon Receptors

22

● Novel synthetic peptidic molecule developed in-house

● Expected benefit is blood glucose control with superior weight loss over pure GLP-1 receptor agonists

● Currently in Phase 1 ● Single ascending dose trial successfully

completed in 2014

● Multiple ascending dose study in healthy volunteers (SC, once daily) initiated in April 2015

● 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 dualAgonist 4 µg/kg

Liraglutide40 µg/kg Placebo

‐7‐6‐5‐4‐3‐2‐10123

0 5 10 15 20 25 30Study days

Glucose Control Similar to Liraglutide(1)

Body Weight Loss Superior to Liraglutide (~5%)(1)

Sanofi dual agonist 4 µg/kg

Liraglutide40 µg/kg

Placebo%

Bod

y w

eigh

tlos

s(c

ompa

red

to d

ay-5

) H

bA1c

(%)

(1) 4 weeks study in obese, diabetic cynomolgus (m. fascicularis) comparing 4 µg/kg Sanofi dual agonist with 40 µg/kg liraglutideand vehicle (2-step uptitration to reach maintenance dose on day 6), data on file

Page 23: Linea Sanofi en Diabetes ADA 2015

Afrezza® U.S. Update

23

Andrew Purcell

Vice President and Head, U.S. Diabetes Business Unit

Afrezza® (insulin human) Inhalation Powder

Page 24: Linea Sanofi en Diabetes ADA 2015

Afrezza®: Targeted U.S. Launchto Build Awareness and Ensure Appropriate Usage

24

● U.S. launch of Afrezza® in Feb 2015● New option to initiate or intensify insulin

● Distinct PK/PD profile

● Ongoing efforts to improve market access

● Additional promotion in H2 2015● DTC promotion

● Afrezza® COACH Patient support program

● Peer-to-peer education

● 12-unit cartridge introduction

● New data from the AFFINITY 1 study● No increase in hypoglycemia risk resulting from a

supplemental dose of Afrezza® 90 min post-meal(1)

(1) Blonde et al, AACE 2015, Late breaking abstract(2) Baseline-corrected serum insulin concentration after administration of Afrezza® or subcutaneous insulin lispro in adults with T1D (n=12)

Distinct PK Profile(2)

Page 25: Linea Sanofi en Diabetes ADA 2015

Toujeo® Launch Progress

25

Andrew Purcell

Vice President and Head, U.S. Diabetes Business Unit

Raf Henein

Vice President, Global Brand Leader Toujeo®, Diabetes

Toujeo® (insulin glargine) Injection 300 Units/mL

Page 26: Linea Sanofi en Diabetes ADA 2015

Toujeo®: Compelling Promotion Message

26(1) Toujeo® Prescribing Information, February 2015.

Introducing, from the makers of Lantus®

Toujeo® – Designed and developed to be a new basal insulin option(1)

Unmetneeds

Micro-precipitate

Stable Activity Profile

ProvenEfficacy

SafetyProfile

Toujeo®

SoloStar®Toujeo®

COACH

The Seven Story Topics

Page 27: Linea Sanofi en Diabetes ADA 2015

Toujeo®: Early Success With U.S. Payer Access

● Price parity per unit vs. Lantus®

on a WAC basis

● Early and broad access secured● 73% unrestricted access in commercial

plans, including some early Tier 2 wins● 52% Medicare Part D lives already with

contracted formulary position

● Patient access supported by co-pay card; formulary negotiations in progress● Eligible patients will pay no more than $15

per Rx for the next 12 months ● Savings Card accepted in virtually all retail

pharmacies ● Use of RelayHealth e-VoucherRx provides

automated co-pay offset

27

Toujeo® Payer Access% Lives Covered, as of June 1st

WAC – Wholesaler Acquisition Cost

0

10

20

30

40

50

60

70

80

Commercial Medicare Part D

Tier 2

Tier 3Unrestricted

73%

52%

%

Page 28: Linea Sanofi en Diabetes ADA 2015

Toujeo® Patient Engagement Key to Optimal Use

28(1) CERTIFIED DIABETES EDUCATOR” and “CDE” are certification marks owned and registered by the National Certification Board for Diabetes Educators (NCBDE). NCBDE is not affiliated in any way with Sanofi US. NCBDE does not sponsor or endorse any diabetes-related products or services.

28

Live, one-on-one calls from a

dedicated COACH Guide

Product training & diabetes

education from CDEs(1)

Toujeo® Rx and COACH

enrollment through one of

multiple channels

Ongoing access to digital/mobile

resources

High-level Toujeo® COACH Program Overview

An Integrated, Tailored Support Program for all Toujeo® Patients

Page 29: Linea Sanofi en Diabetes ADA 2015

Toujeo® U.S. Launch at the End of March: Positive Early Signs

● Early Toujeo® NRx weekly trends encouraging

● Total Sanofi glargine maintains its share in basal market

0

500

1,000

1,500

2,000

2,500

3,000

Toujeo® NRx Volume

0.0

0.2

0.4

0.6

0.8

1.0

1.2

Toujeo® TRx & NRx Share

NRx NRxShare

TRxShare

Cumulative NRx>11,500

0

10

20

30

40

50

60

70

80

NRx Share

Total Glargine

Levemir®

NRx (absolute) Share (%)Share (%)

Source: IMS Rapid WeeklyBasal market includes Toujeo®, Lantus® family, Levemir® family (Levemir® is a Novo Nordisk brand), NPH 29

Page 30: Linea Sanofi en Diabetes ADA 2015

1,103

0

200

400

600

800

1,000

1,200

1 2 3 4 5 6 7 8

Toujeo

Trulicity

Tanzeum

Farxiga

Invokana

Toujeo®: U.S. Endocrinologists Driving Starts and Switches

● Endocrinologists continue to prescribe Toujeo® at higher rate than analogues

● Early adoption reflects confidence in glargine and low barriers to prescribe

● Physician willingness to prescribe across a broad patient base● ~75% from patients on existing basal insulins (mostly from Lantus®)

● ~ 25% from patients new to basal insulins

Lantus®

60%

Levemir®

13%

Other Insulins 2%

Insulin Naïve 24%

NPH 2%

Toujeo® New ENDO Prescribers(1)

vs. AnaloguesToujeo® Source of Patients(2)

(PCP and ENDO)% of Patients

30

Launch week

(1) IMS XPO Weekly WE 05/08/2015 (2) ImpactRxENDO – Endocrinologists PCP – Primary care physicians

®

®

®

®

®

% writers

Page 31: Linea Sanofi en Diabetes ADA 2015

● Lantus® foothold provides a strong foundation for Toujeo®

● EU label provides strong basis for differentiation vs. Lantus®

● Including on pharmacodynamic propertiesand lower risk of hypoglycemia

● EU launch roll-out recently initiated● First launch in Germany in May

• No IQWiG assessment required• Comprehensive sick fund coverage at launch

● NL and DK launches in June● Other EU countries expected to follow

in H2 2015 and 2016

● Launch of Toujeo® also planned in Canada in Q3 2015

Lantus®

62.1%+7.4%

Levemir®

24.0%+2.0%

Tresiba®

1.7%

NPH12.2%-5.4%

Launching of Toujeo® in Europe

31

2014 Basal Insulin Marketby Brand (Value)(1)

Western Europe Share (%)Growth vs. Prior Year (%)

IQWiG – Institute for Quality and Efficiency in Health Care Western Europe: France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark (1) Market share data from Source IMS Health MIDAS Q4/2014 – Copyright 2015 – All rights reserved

Page 32: Linea Sanofi en Diabetes ADA 2015

● Positive opinion received for Lantus®XRfrom BUKAI● 4-year reexamination period recommended

● Regulatory decision expected in mid 2015 and launch in Q3 2015

● 2-week prescription limitation applicable for one year post-launch

● Lantus® market share still represents ~57% of basal insulin market in Japan

● Strong reduction of hypoglycemia observed in T2D Japanese people

Lantus®XR Will Offer a Significant Upgrade to the Value Proposition to Japanese T2D Patients

32

EDITION JP-2(1)

T2D Patients on Basal Insulin + OAD

Nocturnal Hypoglycemia

Anytime Hypoglycemia

Over 6Months

-55%*(0.21-0.96)

-36%*(0.43-0.96)

Over 12Months

-59%*(0.18 to 0.92)

-36%*(0.44 to 0.94)

* Statistically significant reduction in the rate (95% confidence interval) of annualized confirmed (≤70 mg/dL[≤3.9 mmol/L]) of severe hypoglycemic events in favor of Lantus®XR vs. Lantus®

(1) Terauchi Y et al. 2014, ADA 2014 for 6-month results (#94-LB) and ADA 2015 for 12-month results (#98-OR)

Page 33: Linea Sanofi en Diabetes ADA 2015

Further Improving Toujeo® Delivery Device

33

● Same successful Solostar® platform as Lantus® with ergonomic design improvements● 5x lower dispense force● Shorter hold time● Smaller injection volume

● 50% more units per pen (450 IU)(1)

● No additional training needed for Lantus® users(1)

● Early feedback very positive on ease of use

● Committed to further develop the SoloSTAR® platform to address even broader needs

Toujeo® SoloStar® Pen

(1) Compared to Lantus® SoloStar® (300 IU)

Page 34: Linea Sanofi en Diabetes ADA 2015

34

"New Insulin Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 2 Diabetes Using Basal and Mealtime Insulin: Glucose Control and Hypoglycemia in a 6-Month Randomized Controlled Trial (EDITION 1)“ Riddle et al.

Diabetes CareJuly 2014

EDITION 1

"New Insulin Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 2 Diabetes Using Oral Agents and Basal Insulin: Glucose Control and Hypoglycemia in a 6-Month Randomized Controlled Trial (EDITION 2)“ Yki-Järvinen et al.

Diabetes CareSept. 2014

EDITION 2

"New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3)“ Bolli et al.

Diabetes, Obesity and Metabolism Feb. 2015

EDITION 3

Articles Published on EDITION Trials in T2D Center on Clinical Implications of the Lower Rate of Hypoglycemia

"Patient-level meta-analysis of EDITION 1,2 and 3: glycaemic control and hypoglycaemia with new insulin glargine 300 U/mL versus glargine 100 U/mL in people with T2DM" Ritzel et al.

Diabetes, Obesity and Metabolism April 2015

META-ANALYSIS

Page 35: Linea Sanofi en Diabetes ADA 2015

Toujeo® 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 35

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

Page 36: Linea Sanofi en Diabetes ADA 2015

Concluding Remarks

36

Pierre Chancel

Senior Vice President, Diabetes

Page 37: Linea Sanofi en Diabetes ADA 2015

2004-2014 Insulin Marketby Insulin Type (Value)

2014 Basal Insulin Marketby Brand (Value)

30.7%

42.0%

23.3%19.7%

46.0%

38.3%

0%

10%

20%

30%

40%

50%

2004 2014

% of Sales

Basal SAI premix

Basal Insulin Now the Gold Standard in Emerging Markets and Sanofi is Leading the Basal Segment

37

Emerging Market Share (%) Emerging Market Share (%)Growth vs. Prior Year (%)+ 8%

+ 7%

+ 14%

Lantus®

57.0% +20.1%Levemir®

16.6% +21.9%

Tresiba®

0.9%

Others 4.7%

+26.1%

NPH20.8% +1.4%

Emerging Markets: World excluding the U.S. and Canada, Western Europe, Japan, Korea, Australia and New ZealandSource: Market share data from Source IMS Health MIDAS Q4/2014 – Copyright 2015 – All rights reservedSAI – Short acting insulin Levemir® and Tresiba® are Novo Nordisk brands

Page 38: Linea Sanofi en Diabetes ADA 2015

Broadening our Portfolio to Sustain a Leadership Position in Diabetes

38

1 Establish next generation of basal insulins

2 Capture untapped patient needs by addressing their reluctance to start insulin

3 Innovate with a new combination of basal insulin and GLP-1

5 Drive better outcomes through integrated care solutions

4 Expand access to Lantus® in emerging countries while managing Lantus® LoE in mature markets

LoE – Loss of exclusivity

Page 39: Linea Sanofi en Diabetes ADA 2015

Q&A

39