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IR Thematic Call on Diabetes
Boston – June 9th, 2015
2
Forward Looking Statements
This presentation contains forward-looking statements as defined in the Private Securities Li...
3
Agenda
3
ELIXA: First CV Outcome Trial with a GLP-1 Receptor Agonist
● Matthew C. Riddle, Professor of Medicine – Oregon...
ELIXA: First CV Outcome Trial
with a GLP-1 Receptor Agonist
4
Matthew C. Riddle, Professor of Medicine
Oregon Health & Sci...
Evaluation of LIXisenatide in
Acute Coronary Syndrome (ELIXA)
(Selected slides)
ADA June 8, 2015
Late Breaking Session
Cli...
• Randomized, double-blind, placebo-controlled event-driven trial
• Patients with Type 2 DM within 180 days of ACS
• Run-i...
• Primary (Composite)
 CV death, Non-fatal MI, Non-fatal stroke, Hospitalization
for unstable angina (UA)
• Secondary and...
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)...
Outcome
# and % of Subjects with Event,
and Event Rate
Hazard Ratio
(95% CI)
Placebo
(N = 3034)
Lixisenatide
(N = 3034)
CV...
Outcome
# and % of Subjects with Event,
and Event Rate
Hazard Ratio
(95% CI)
Placebo
(N = 3034)
Lixisenatide
(N = 3034)
Pr...
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 =...
Placebo
Lixisenatide
Mean post-baseline difference
-0.27% (-0.32, -0.22)
8
7.5
6.5
MeanHbA1c(%)
7
0 12 24 36
Months
12Unpu...
Urine Albumin/Creatinine Ratio
(median mg/g)
Placebo
N = 2830
Lixisenatide
N = 2803
Baseline 10.4 10.0
Month 6 11.5 10.2**...
Placebo
Lixisenatide
Mean post-baseline difference
-0.7 kg (-0.9, -0.5)
0 12 24 36
0 12 24 36
Months
2
1
0
-1
-2
kg
14
Unp...
1) Hypoglycemia levels similar despite lower HbA1c
2) Nausea and vomiting were ~3x more frequent with
lixisenatide and led...
ELIXA Summary: CV Outcomes
• Placebo-controlled trial of lixisenatide in 6,068 patients
with type 2 diabetes and ACS
• Dem...
Lixisenatide: Standalone Use and
Combination with Basal Insulin
17
Riccardo Perfetti, M.D.
Senior Medical Officer, Diabetes
Easy-to-Use Once-Daily Prandial GLP-1
18
PPG – Post-Prandial Glucose OAD – Oral Anti-Diabetic drug OD – Once-daily SC – Su...
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 glargi...
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 ...
Combining Insulin Glargine with Lixisenatide
in a Single Once Daily Injection
21
● Phase 3 program headline results
expect...
SAR425899: A Novel Dual Agonist
for GLP-1 and Glucagon Receptors
22
● Novel synthetic peptidic molecule
developed in-house...
Afrezza® U.S. Update
23
Andrew Purcell
Vice President and Head, U.S. Diabetes
Business Unit
Afrezza® (insulin human) Inhal...
Afrezza®: Targeted U.S. Launch
to Build Awareness and Ensure Appropriate Usage
24
● U.S. launch of Afrezza® in Feb 2015
● ...
Toujeo® Launch Progress
25
Andrew Purcell
Vice President and
Head, U.S. Diabetes
Business Unit
Raf Henein
Vice President,
...
Toujeo®: Compelling Promotion Message
26
(1) Toujeo® Prescribing Information, February 2015.
Introducing, from the makers ...
Toujeo®: Early Success With U.S. Payer Access
● Price parity per unit vs. Lantus®
on a WAC basis
● Early and broad access ...
Toujeo® Patient Engagement Key to Optimal Use
28
(1) CERTIFIED DIABETES EDUCATOR” and “CDE” are certification marks owned ...
Toujeo® U.S. Launch at the End of March:
Positive Early Signs
● Early Toujeo® NRx weekly trends encouraging
● Total Sanofi...
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. Endocrinologis...
● Lantus® foothold provides a strong
foundation for Toujeo®
● EU label provides strong basis for
differentiation vs. Lantu...
● Positive opinion received for Lantus®XR
from BUKAI
● 4-year reexamination period recommended
● Regulatory decision expec...
Further Improving Toujeo® Delivery Device
33
● Same successful Solostar® platform as Lantus® with ergonomic design improve...
34
"New Insulin Glargine 300 Units/mL
Versus Glargine 100 Units/mL in
People With Type 2 Diabetes Using
Basal and Mealtime...
Toujeo® Real-Life Study Program to Expand
the Evidence Base
● Insulin-naïve T2D patients
(U.S.)
● Target enrolment: 3,270
...
Concluding Remarks
36
Pierre Chancel
Senior Vice President, Diabetes
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%
...
Broadening our Portfolio to Sustain a Leadership Position
in Diabetes
38
1 Establish next generation of basal insulins
2
C...
Q&A
39
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2015/03 - IR - Diabetes

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2015/03 - IR - Diabetes

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2015/03 - IR - Diabetes

  1. 1. IR Thematic Call on Diabetes Boston – June 9th, 2015
  2. 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. 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. 4. ELIXA: First CV Outcome Trial with a GLP-1 Receptor Agonist 4 Matthew C. Riddle, Professor of Medicine Oregon Health & Science University
  5. 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. 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. 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. 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. 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
  10. 10. 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 10 Unpublished data
  11. 11. 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) 11 Unpublished data
  12. 12. Placebo Lixisenatide Mean post-baseline difference -0.27% (-0.32, -0.22) 8 7.5 6.5 MeanHbA1c(%) 7 0 12 24 36 Months 12Unpublished data HbA1c (mean, %)
  13. 13. Urine Albumin/Creatinine Ratio (median mg/g) Placebo N = 2830 Lixisenatide N = 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 data 13
  14. 14. Placebo Lixisenatide Mean post-baseline difference -0.7 kg (-0.9, -0.5) 0 12 24 36 0 12 24 36 Months 2 1 0 -1 -2 kg 14 Unpublished data Body Weight Change (kg)
  15. 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. 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. 17. Lixisenatide: Standalone Use and Combination with Basal Insulin 17 Riccardo Perfetti, M.D. Senior Medical Officer, Diabetes
  18. 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. 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. 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. 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. 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. 23. Afrezza® U.S. Update 23 Andrew Purcell Vice President and Head, U.S. Diabetes Business Unit Afrezza® (insulin human) Inhalation Powder
  24. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
  36. 36. Concluding Remarks 36 Pierre Chancel Senior Vice President, Diabetes
  37. 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. 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
  39. 39. Q&A 39

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