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2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
2014/06 - IR - Diabetes
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2014/06 - IR - Diabetes

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  • 1. San Francisco – June 16th, 2014 IR Thematic Call on Diabetes
  • 2. 2 Sanofi 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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
  • 3. Introduction 3 Pascale Witz Executive Vice President, Global Divisions & Strategic Development
  • 4. 44 Agenda Unmet Needs with Diabetes Treatment ● Riccardo Perfetti, MD – Senior Medical Officer, Diabetes New Clinical Evidence on Toujeo® ● Matthew C. Riddle, Professor of Medicine – Oregon Health & Science University Sanofi Leading the Basal Insulin Market ● Pierre Chancel – Senior Vice President, Diabetes Sanofi Expanding its Diabetes Portfolio ● Pierre Chancel – Senior Vice President, Diabetes Moving Towards Integrated Care ● Pascale Witz – Executive Vice President, Global Divisions & Strategic Development Q&A Session Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL; “U300”) is new a basal insulin currently in development for the treatment of people with diabetes. Toujeo® is the intended trade name for U300. U300 is not currently approved or licensed anywhere in the world.
  • 5. Unmet Needs with Diabetes Treatment 5 Riccardo Perfetti, M.D. Senior Medical Officer, Diabetes
  • 6. Optimal dose often not reached during initiation or maintenance phase1–6 Fear of hypoglycemia & insulin- associated weight gain are barriers to effective insulin use7–13 High discontinuation of basal insulins during the first 6 months16 50% of patients on insulin are still not at target1–6 Significant burden of intra-patient glucose variability in patients15 Hypoglycemia is a major contributor to treatment discontinuation /transition14 Unmet Needs (1) Steinberg BA et al. Am Heart J 2008, (2) Chan JCN et al. Diabetes Care 2009, (3) Choi YJ et al. Diabetes Care 2009, (4) Banegas JR et al. Eur Heart J 2011, (5) Vouri SM et al. J Manag Care Pharm 2011, (6) Casagrande SS et al. Diabetes Care 2013, (7) Polonsky WH et al. Diabetes Care 2005, (8) Funnell MM et al. Clinical Diabetes 2007, (9) Karter AJ et al. Diabetes Care 2010, (10) Khunti K et al. Diabetes Care 2013, (11) Russell-Jones D et al. Diabetes Obes Metab 2007, (12) Pontiroli AE et al. Diabetes Obes Metab 2011, (13) DAWN2, Diabetes Attitudes, Wishes, and Needs Study, (14) Bron M et al. Postgrad Med 2012, (15) Skaff M et al. Health Psychol 2009, (16) Quantification of patient adherence to Lantus® treatment initiation, IMS (US, UK & Germany), 2013 [Market Research] Unmet Medical Needs Remain a Reality in the Insulin Space 6
  • 7. As for any Chronic Disease, People with Diabetes Struggle to Stay on Treatment Source: Quantification of Patient Adherence to Treatment Initiation (U.S., 2013), IMS 7 Proportion of Patients who Continue With Initially Prescribed Treatment % of Patients Continuing Treatment at Month 6 % of Patients Continuing Treatment at Month 12 0% 25% 50% 75% 100% 0% 25% 50% 75% 100%
  • 8. Patients Fear that Insulin Treatment May Be a Source of Hypoglycemia, Complexity and Weight Gain 0% 25% 50% 75% 100% Meant my disease was worsening Cause hypoglycemia Have to be on it forever once you start Represented failure to care of my health Difficult to integrate insulin injections into my daily routine Cause weight gain Injections would be painful Add restrictions to my eating/sleeping schedule My diabetes was NOT “severe enough” Would limit what I can eat Percent concerned (1) Source: Insulin glargine satisfaction study, Impact Rx, Dec 2012 (U.S., n=225) Top 10 Concerns With Insulin Initiation(1) 8
  • 9. Hypoglycemia is a Significant Contributor to Sub-Optimal Dosing and Discontinuation of Insulin Therapy 9 Patient reluctance to initiate or comply with insulin treatment Hard to maintain routine (treatment, eating habits); triggers hypoglycemia Reduced insulin dose Sub-optimal insulin dose lack of efficacy; not achieving A1c goals Treatment discontinuation or switch Eventual return to insulin treatment The drop-off cycle Source: Uncontrolled insulin drop-off patients and HCPs – insights regarding insulin drop-off Findings from previous S-A research – LOLA assessment of uncontrolled patients The drop-off cycle 4 5 6 2 3 1
  • 10. Emotional and Economic Burden Reported events associated with hypoglycemia in prior 12 months (%)(1) Substantial Cost Burden to the Healthcare System Associated with Hypoglycemia 10 3% 4% 55% 49% 10% Hospitalization ED visit Consulted HCP ≥1 Consulted HCP ≤5 Sick leave from work ED: Emergency department; HCP: Healthcare professional (1) Willis WD et al. Expert Rev Pharmacoecon Outcomes Res. 2013;13:123-130 and European online survey (n=1,848) (2) Ward A et al. J Med Econ, Vol. 17, No. 3, 2014, 176–183 Complication Estimated Costs Per Patient Hypoglycemia requiring hospitalization $16,478 Hypoglycemia requiring ED visit $1,331 Cost Impact of Hypoglycemia is High Estimated direct medical costs per patient per episode(2) ~1/3 of patients very worried about hypoglycemia
  • 11. Many People with Diabetes are Still Not at A1c Goal despite Treatment 11 47% 47% 53% 53% 2013 (437) 2013 (2215) Controlled (<=7%) Uncontrolled (>7%) All T1D Patients All T2D Diabetes Source: Adelphi Real World Diabetes Disease Specific Programme (DSP) X, 2013 Base: All US diabetic patients where doctor has stated most recent HbA1c (random sample). “All patients” are treated patients and must be on an OAD, GLP-1 or insulin
  • 12. Diabetes Is Associated with Micro and Macrovascular Complications 12 Microvascular Complications Macrovascular Complications Diabetic Retinopathy Leading cause of blindness in working-age adults Diabetic Nephropathy Leading cause of end-stage renal disease Heart Disease Leading cause of mortality in patients with Type 2 diabetes Peripheral Vascular Disease Leading cause of non-traumatic lower- extremity amputations Diabetic Neuropathy Leading cause of diabetic foot syndrome and non- traumatic lower-extremity amputations Stroke 25% of all ischemic strokes are due to diabetes alone or with hypertension (1) Endocrinol Metab Clin 1996;25:243 - 254 (DCC Trial) (2) Diabetes Care Publish Ahead of Print, published online March 6, 2013 Risk of complications and HbA1c(1) HbA1C(%) RelativeRiskin% 1 3 5 7 9 11 13 15 6 7 8 9 10 11 12 Retinopathy Nephropathy Microalbuminuria Neuropathy 25% to 45% of diabetes-attributed medical expenditures spent treating complications of diabetes(2)
  • 13. New Clinical Evidence on Toujeo® 13 Matthew C. Riddle, Professor of Medicine Oregon Health & Science University Toujeo® is the intended trade name for the investigational product insulin glargine 300 U/ml.
  • 14. Toujeo® Provides More Constant Absorption of Glargine after Subcutaneous Injection 14  Three-fold more concentrated formulation of glargine  Reduced volume (1/3) and reduced surface area (1/2) of subcutaneous depot  Slower and more constant rate of absorption Schematic illustration Toujeo®
  • 15. Toujeo® Has a Flatter and More Prolonged PK/PD Profile than Lantus® 15 Flatter PK Profile More Prolonged PD Profile Dahmen R et al, 2013 ADA, abstract 113-OR (euglycemic clamp study in T1D in steady state) PK/PD: Pharmacokinetic/Pharmacodynamic 0 6 12 18 24 30 36 0 1 2 3 4 5 DOSE 0.4 U.kg-1 U300 U100 GIR-mg.kg-1 .min-1 TIME - hour Glucose Infusion Rate 0 6 12 18 24 30 36 0 5 10 15 20 25 30 LLOQ 5.02 µU.mL-1 SC INJECTION INSULIN-µU.mL-1 TIME - hour U100 0.4 U.kg-1 U300 0.4 U.kg-1 LOESS 0.15 Toujeo® Lantus® Serum Insulin Glargine Concentration Toujeo® Lantus®
  • 16. EDITION: A Comprehensive Phase III Program Testing Toujeo® in Different Diabetes Populations 16 Study Population Intervention Data Released EDITION 1 Type 2 Basal + mealtime insulin √ EDITION 2 Type 2 Basal + oral therapy √ EDITION 3 Type 2 Insulin naïve √ EDITION 4 Type 1 Basal + mealtime insulin √ EDITION JP 1 Type 1 Basal + bolus insulin √ EDITION JP 2 Type 2 Basal + oral therapy √ Toujeo® vs. Today’s focus will be on Type 2 Diabetes
  • 17. Pooled Analysis of EDITION Phase III Trials in Type 2 Diabetes (T2D)(1) 17 Baseline characteristics Toujeo® Lantus® Age (years) 58.7 58.5 BMI (kg/m2) 34.7 34.8 Duration of diabetes (years) 12.7 12.6 A1c (%) 8.31 8.32 n=1,249 Screening period Up to 2 weeks Qualifying visit: 7% ≤ A1c ≤10% 7% ≤ A1c ≤10% 7% ≤ A1c ≤11% Concomitant glucose-lowering therapyR T2D patient (≥18 years old) Toujeo® Lantus® n=1,247 Evaluation of endpoints at 6 months FPG target: 80-100 mg/dL (4.4-5.6 mmol/L) Basal insulin dose adjusted once weekly Concomitant glucose-lowering therapy EDITION 1 + Mealtime insulin + Met EDITION 2 + Met + OADs(3) EDITION 3 + Met + OADs(4) Glucose-lowering therapy at screening: EDITION 1: Basal(2) + mealtime insulin + OADs 2: Basal(2) + OADs 3: Insulin naïve + OADs Met: metformin OAD: oral antihyperglycemic drug FPG: Fasting plasma glucose (1) Ritzel R et al, 2014 ADA, abstract 90-LB (2) Total daily dose Lantus® ≥42 U (or equivalent dose of NPH) (3) Use of sulfonylureas were prohibited within 2 months prior to screening and during the study (4) Except sulfonylureas, glinides and other OADs not approved for use with insulin Titration period Maintenance phase
  • 18. 7.00% 7.20% 7.40% 7.60% 7.80% 8.00% 8.20% 8.40% 0 1 2 3 4 5 6 7 8 8.4% 8.2% 8.0% 7.0% 7.2% 7.4% 7.6% 7.8% Baseline Week 12 Month 6 Toujeo® was as Effective as Lantus® in Improving Glycemic Control(1) 18 Mean A1c (%) from Baseline A1c(%)Mean±SE LS mean difference between groups (95% CI) 0.00 (-0.08 to 0.07) Lantus® Toujeo® (1) Pooled analysis of EDITION 1, 2 & 3 - Ritzel R et al, 2014 ADA, abstract 90-LB LS: Last square
  • 19. (1) Confirmed: ≤70 mg/dL (≤3.9 mmol/L) (2) Pooled analysis of EDITION 1, 2 & 3 - Ritzel R et al, 2014 ADA, abstract 90-LB With Toujeo® -- Lower Rates of Confirmed(1) or Severe Hypoglycemic Events(2) Event Rate Per Patient-Year Across The 6-Month Study Period Cumulative Mean Number of Events Per Patient Any Time (24 h) Nocturnal (00:00-05:59) 19 0 1 2 3 2 4 6 8 10 12 14 16 18 20 22 24 26 28 0 2 4 6 8 10 2 4 6 8 10 12 14 16 18 20 22 24 26 28 Week 15.22 3.06 17.73 2.10 = Statistically significant Week Lantus® Toujeo® Lantus® Toujeo® Lantus® Toujeo® -14% -31% RR: 0.69 (0.57 to 0.84) p=0.0002 RR: 0.86 ( 077 to 0.97) p=0.0116
  • 20. With Toujeo® -- Fewer Patients Experienced Confirmed or Severe Hypoglycemia across Study Periods(1) 20 0% 10% 20% 30% 40% 0% 10% 20% 30% 40% 50% 60% 70% 80% Nocturnal (00:00-05:59)Any Time of Day (24 h) Baseline to Week 8 Week 9 to Month 6 Baseline to Month 6 Baseline to Week 8 Week 9 to Month 6 Percentage of Patients Reporting ≥1 Event ≤ 70 mg/dL (3.9 mmol/L) Baseline to Month 6 RR: 0.91 (0.87 to 0.96) RR: 0.83 (0.77 to 0.89) RR: 0.75 (0.68 to 0.83) RR: 0.69 (0.58 to 0.81) RR: 0.92 (0.86 to 0.98) RR: 0.80 (0.71 to 0.91) Lantus® Toujeo® (1) Pooled analysis of EDITION 1, 2 & 3 - Ritzel R et al, 2014 ADA, abstract 90-LB -9% -25% = Statistically significant
  • 21. 21 0% 5% 10% 15% 20% 25% 0% 10% 20% 30% 40% 50% Baseline to Week 8 Week 9 to Month 6 Baseline to Month 6 Baseline to Week 8 Week 9 to Month 6 Baseline to Month 6 RR: 0.81 (0.72 to 0.90) RR: 0.78 (0.66 to 0.93) RR: 0.73 (0.59 to 0.81) RR: 0.73 (0.53 to 1.02) RR: 0.87 (0.76 to 1.01) RR: 0.76 (0.58 to 0.99) Lantus® Toujeo® Any Time of Day (24 h) Nocturnal (00:00-05:59) Percentage of Patients Reporting ≥1 Event ≤ 54 mg/dL (3.0 mmol/L) With Toujeo® -- Fewer Patients Experienced Confirmed or Severe Hypoglycemia across Study Periods(1) -19% -27% (1) Pooled analysis of EDITION 1, 2 & 3 - Ritzel R et al, 2014 ADA, abstract 90-LB = Statistically significant
  • 22. Less Weight Gain was Observed with Toujeo® than with Lantus®(1) 22 Mean Change From Baseline in Weight (kg) by Visit -0,50 0,00 0,50 1,001.0 0.5 0 -0,5 Mean difference between groups (95% CI) -0.28kg (−0.55 to 0.01) p=0.039 WeightChange(kg)Mean±SE Adverse Events Both treatments were generally well tolerated with similar rates of AEs Lantus® Toujeo® Mean dose 0.76 UI/kg/day Mean dose 0.85UI/kg/day (1) Pooled analysis of EDITION 1, 2 & 3 - Ritzel R et al, 2014 ADA, abstract 90-LB LOV: last on-treatment value defined as the last measurement made prior to or on the day of the last investigational product intake during the main 6-month on-treatment period. = Statistically significant
  • 23. 23 0 2 4 6 8 10 12 14 16 0 2 4 6 8 10 12 14 16 18 20 22 24 26 0 1 2 3 4 5 0 2 4 6 8 10 12 14 16 18 20 22 24 26 Cumulative Mean Number of Events Per Patient Any Time (24 h) Nocturnal (00:00-05:59) Week Week Lantus® Toujeo® Lantus® Toujeo® Event Rate Per Patient-Year Across The 6-Month Study Period 10.48 4.98 16.52 2.18 Lantus® Toujeo® -36% -55% RR: 0.45 (0.21 to 0.96) RR: 0.64 (0.43 to 0.96) (1) Confirmed: ≤70 mg/dL (≤3.9 mmol/L) (2) Terauchi Y et al. 2014 ADA, abstract 94-LB = Statistically significant EDITION JP 2 -- Lower Rates of Confirmed(1) or Severe Hypoglycemic Events(2)
  • 24. New Clinical Evidence on Toujeo® 24 ● A pooled analysis of 6-month data from EDITION 1, 2 and 3(1) demonstrated, compared with Lantus® ● Comparable glycemic control ● Less hypoglycemia, especially at night, and consistently in the first 8 weeks as well as from 8 weeks to 6 months ● Limited weight effect ● EDITION JP 2(2), in T2D Japanese patients uncontrolled on basal insulin, also showed significantly less hypoglycemia with Toujeo® ● Over one year of treatment in EDITION 1 (3) and 2 (4) , Toujeo® provided sustained glycemic control with a lower risk of hypoglycemia compared with Lantus® ● A sub-study (5) of EDITION 1 and 2 demonstrated no untoward effects of occasionally adapting dosing intervals by ±3 hours (1) Ritzel R et al, 2014 ADA, abstract 90-LB (2) Terauchi Y et al. 2014 ADA, abstract 94-LB (4) Yki-Järvinen H 2014 ADA, abstract 93-LB (3) Riddle MC et al 2014 ADA, abstract 81-LB (5) Riddle MC et al 2014 ADA, abstract 919-P Summary
  • 25. Conclusion 25 ● Toujeo® is as effective as Lantus® in controlling glucose in T2D ● Lower risk of hypoglycemia with Toujeo® was consistently found both early and late after intensification of treatment, in different populations, and when timing of injections was flexible ● These findings support the potential of Toujeo® to further enhance the clinical value of basal insulin Toujeo® in T2D
  • 26. Sanofi Leading the Basal Insulin Market 26 Pierre Chancel Senior Vice President, Diabetes, Sanofi
  • 27. 27 Global Treatment Paradigm Shift Towards Basal Insulin Breakdown By Insulin Type Market Share (%) 2003 - 2013 Worldwide Insulin Market Development (Value) 47.8% Source: Market share data from IMS Health MIDAS Q4/2013 – Copyright 2014 – All rights reserved 31.8% 48.9% 36.1% 17.1% 32.1% 34.0% 0% 10% 20% 30% 40% 50% 60% 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 % of Sales Basal Premix SAI
  • 28. Basal Insulin New Gold Standard in All Regions 28 2003 – 2013 Insulin Market by Insulin Type (Value) Market Share (%) + 23% + 24% + 8% - 1% + 3% + 1% + 4% + 0% + 7% + 14% + 15% 35.9% 51.3% 29.6% 11.3% 34.5% 37.4% 0% 10% 20% 30% 40% 50% 60% 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 % of Sales Basal Premix SAI 29.9% 47.7% 36.9% 16.3% 33.2% 36.0% 0% 10% 20% 30% 40% 50% 60% 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 % of Sales Basal Premix SAI 30.1% 42.7% 48.2% 37.8% 21.7% 19.5% 0% 10% 20% 30% 40% 50% 60% 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 % of Sales Basal Premix SAI 25.1% 44.2%45.1% 23.0% 29.8% 32.8% 0% 10% 20% 30% 40% 50% 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 % of Sales Basal Premix SAI Japan/Can/Aus/NZEmerging Markets(2) U.S. Western Europe(1) (1) France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark (2) World excluding the U.S. and Canada, Western Europe, Japan, Australia and New Zealand Source: Market share data from Source IMS Health MIDAS Q4/2013 – Copyright 2014 – All rights reserved
  • 29. 29 Sanofi has a Strong Position in the Basal Market, the Fastest Growing Insulin Segment Breakdown By Insulin Type Market Share (%) Growth vs. Prior Year (%) Basal Breakdown By Brand Market Share (%) Growth vs. Prior Year (%) 2013 Worldwide Insulin Market Breakdown (Value) 47.8% 18.3% SAI: Short-Acting Insulins NPH: Neutral Protamine Hagedorn Source: Market share data from IMS Health MIDAS Q4/2013 – Copyright 2014 – All rights reserved Basal 48.9% + 21.5 % SAI 34.0% +18.0 % Premix 17.1% + 7.3 % 69.3% + 22.9 % Levemir® 20.6% +27.4 % Tresiba® 0.2% NPH 9.9% +1.8% Lantus®
  • 30. Basal Insulins Constitute the Leading and Fastest Growing Insulin Segment Across All Geographies 30 2013 Insulin Market Breakdown by Insulin Type (Value) Market Share (%) Growth vs. Prior Year (%) U.S. Emerging Markets 17% - 5% 12% + 7% 50% + 24% 47% + 5% 42% + 12% 38% + 10% Source: Market share data from Source IMS Health MIDAS Q4/2013 – Copyright 2014 – All rights reserved 51.3% +28.8% 37.4% +24.1% 11.3% +12.0% 47.7% +5.0% 36.0% +3.7% 16.3% - 3.7% 42.7% +17.3% 19.5% +17.8% 37.8% +11.7% 44.2% +11.0% 32.8% +4.3% 23% -6.6% Western Europe Japan/Can/Aus/NZ Premix Basal SAI
  • 31. 60.8% +7.4% 24.8% +5.6% 14.1% - 5.9% 0.2% 69.0% +14.7% 17.6% + 2.4% 11.3% -11.0% 2.1% Lantus® as a Well-established Position on the Basal Market in all Geographies 31 2013 Basal Insulin Market Breakdown by Brand(Value) Market Share (%) Growth vs. Prior Year (%) 12% + 7% 50% + 24% Source: Market share data from Source IMS Health MIDAS Q4/2013 – Copyright 2014 – All rights reserved 74.4% +28.9% 20.8% +41.1% 4.9% -6.5% 56.3% +16.1% 16.3 % +17.1% 27.3 % +19.4% 0.1% U.S. Emerging Markets Western Europe Japan/Can/Aus/NZNPH Lantus® Levemir® Tresiba®
  • 32. Patients Initiating or Using Basal Insulin Therapy Represent a Large Pool of Diabetic Patients 32 Existing Basal Insulin users ~14m patients (80% T2D) >50% uncontrolled Insulin naïve patients starting Basal Insulin ~4m patients START WITH SWITCH TO STAY ON Patient numbers: Company estimates based on various sources – 11 main markets (U.S. Top 5 EU, Japan, and BRIC countries) Toujeo is the intended trade name for the investigational product insulin glargine U300/ml
  • 33. Toujeo®: New Generation Basal Insulin to Improve Patient Care 33 ● The basal insulin market is large and growing ● Patients initiating or using basal insulin therapy represent a broad pool of diabetics with unmet needs ● Toujeo® offers a competitive profile ● Sanofi uniquely positioned to sustain a strong foothold in diabetes with Toujeo® and other new product opportunities ● EMA evaluation of application recently started ● NDA submitted in the U.S. ● Submission in Japan planned in H2 2014 ● Phase IIIb/IV plan and patient support program Next Steps Conclusion
  • 34. Sanofi Expanding its Diabetes Portfolio 34 Pierre Chancel Senior Vice President, Diabetes, Sanofi
  • 35. ® New Data(1) Reinforces That Not All GLP-1 Receptor Agonists Are the Same 35 PPG Levels at Baseline and Week 8(1) ● More pronounced PPG-lowering effect of lixisenatide vs. liraglutide, as add-on to Lantus®(1) ● Lyxumia® launch status ● Commercially available in UK, Spain, Italy, Japan and Mexico ● ELIXA CV outcome trial on track ● Results expected in H1 2015 ● U.S. submission planned in summer 2015 *p<0.0001 for change vs. baseline †p<0.0001 for change with lixisenatide vs liraglutide (1) PPG (post-prandial glucose) lowering effect evaluated after a test-meal - Meier JJ et al, 2014 ADA, Poster 1017-P Treatment groups Day -1 / Before treatment (full lines) Week 8 (dotted lines)
  • 36. : Combining Insulin Glargine With Lixisenatide in a Single Daily Injection 36 ● Phase III program initiated in Q1 2014 ● LixiLan-O study in patients insufficiently controlled on OADs (1,125 patients) ● LixiLan-L study in patients not at goal on basal insulin (700 patients) ● >90% of study sites initiated ● Potential to be the first combination of [Basal Insulin + GLP-1] in a single daily injection marketed in the U.S. ● Targeted FDA submission could be as early as end of 2015 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
  • 37. New Insulin Lispro (SAR342434) Progressing to Phase III Development in H2 2014 37 ● Complementary to Sanofi Diabetes portfolio aiming at offering patients complete solutions for better outcomes ● Phase I completed ● Similar activity and exposure demonstrated to Humalog®(1) ● Phase III program to recruit ~1,000 patients ● Leading rapid-acting insulin among U.S. T1D pump users(2) Phase III study in T1D Patients vs. Humalog® Phase III study in T2D Patients vs. Humalog® Insulin lispro is marketed by Eli Lilly and Company as Humalog® (1) Using the euglycemic clamp technique in subjects with Type 1 Diabetes (data on file) (2) Sourced from www.insulin-pumpers.org (June 2, 2014) T1D: Type 1 Diabetes Insulin Lispro Structure LysB28 ProB29
  • 38. Moving Towards Integrated Care 38 Pascale Witz Executive Vice President, Global Divisions & Strategic Development
  • 39. No single product or service can satisfy the market demand for simple, complete solutions that provide better outcomes 39 Integrated Care: Tremendous Potential to Improve Patients’ Lives ● Increase adherence to products ● Better patient experience ● Improved outcome ● Cost control TOMORROWTODAY
  • 40. Working to Improve the Journey of People with Diabetes 40 ® Integrated Care BGM Drug Delivery Digital Heath Drugs Patient Support MyStar Care® LixiLan and Toujeo® are under development. These products are not approved or licensed anywhere in the world.
  • 41. Global Strategic Alliance between Sanofi and Medtronic Supports Broader Strategy(1) ● Leader in insulin pumps and continuous glucose monitoring ● Drug delivery technology ● Miniaturization ● Implantable devices ● Leader in insulin management ● Deep clinical and medical expertise ● Regulatory and market access ● Leading portfolio of pharmaceuticals Structured as open innovation model, leveraging complementary strengths of both companies Initial focus on novel drug-device combinations and care management services 41 (1) Sanofi and Medtronic announced on June 14, 2014 that they have signed a memorandum of understanding to enter into global strategic alliance in diabetes.
  • 42. 42 Taking Care of People with Diabetes
  • 43. Q&A 43

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