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 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, 2014. 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
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 Powder
Toujeo® (insulin glargine) Injection 300 Units/mL
4. ELIXA: First CV Outcome Trial
with a GLP-1 Receptor Agonist
4
Matthew C. Riddle, Professor of Medicine
Oregon Health & Science University
5. 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
6. • 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
7. • 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
8. 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
9. 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
9
Unpublished data
15. 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
16. ELIXA Summary: CV Outcomes
• Placebo-controlled trial of lixisenatide in 6,068 patients
with 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
17. Lixisenatide: Standalone Use and
Combination with Basal Insulin
17
Riccardo Perfetti, M.D.
Senior Medical Officer, Diabetes
18. Easy-to-Use Once-Daily Prandial GLP-1
18
PPG – Post-Prandial Glucose OAD – Oral Anti-Diabetic drug OD – Once-daily SC – Subcutaneous
Lyxumia® 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
19. 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 documented
symptomatic 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%).
20. 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 LixiLan
in 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
21. Combining Insulin Glargine with Lixisenatide
in a Single Once Daily Injection
21
● Phase 3 program headline results
expected 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 Patients
for
Regulatory submission expected in the U.S. in Q4 2015 and EU in Q1 2016
22. 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 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
Glucose Control Similar to Liraglutide(1)
Body Weight Loss Superior to Liraglutide (~5%)(1)
Sanofi dual
agonist 4 µg/kg
Liraglutide
40 µg/kg
Placebo
%Bodyweightloss
(comparedtoday-5)HbA1c(%)
(1) 4 weeks study in obese, diabetic cynomolgus (m. fascicularis) 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
23. Afrezza® U.S. Update
23
Andrew Purcell
Vice President and Head, U.S. Diabetes
Business Unit
Afrezza® (insulin human) Inhalation Powder
24. Afrezza®: Targeted U.S. Launch
to 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)
25. 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
26. 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)
Unmet
needs
Micro-
precipitate
Stable Activity
Profile
Proven
Efficacy
Safety
Profile
Toujeo®
SoloStar®
Toujeo®
COACH
The Seven Story Topics
27. 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 3
Unrestricted
73%
52%
%
28. 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
29. 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
NRx
Share
TRx
Share
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 Weekly
Basal market includes Toujeo®, Lantus® family, Levemir® family (Levemir® is a Novo Nordisk brand), NPH 29
30. 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. Analogues
Toujeo® Source of Patients(2)
(PCP and ENDO)
% of Patients
30
Launch week
(1) IMS XPO Weekly WE 05/08/2015 (2) ImpactRx
ENDO – Endocrinologists PCP – Primary care physicians
®
®
®
®
®
% writers
31. ● Lantus® foothold provides a strong
foundation for Toujeo®
● EU label provides strong basis for
differentiation vs. Lantus®
● Including on pharmacodynamic properties
and 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%
NPH
12.2%
-5.4%
Launching of Toujeo® in Europe
31
2014 Basal Insulin Market
by 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
32. ● Positive opinion received for Lantus®XR
from 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 6
Months
-55%*
(0.21-0.96)
-36%*
(0.43-0.96)
Over 12
Months
-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)
33. 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)
34. 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 Care
July 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 Care
Sept. 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
35. 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
37. 2004-2014 Insulin Market
by Insulin Type (Value)
2014 Basal Insulin Market
by 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%
NPH
20.8%
+1.4%
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 Q4/2014 – Copyright 2015 – All rights reserved
SAI – Short acting insulin Levemir® and Tresiba® are Novo Nordisk brands
38. 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