Sanofi Sa · EURONEXT:SAN
Sanofi Sa — JP Morgan Healthcare Conference 2015
33 slides from Sanofi Sa's conference presentation, Jan 12, 2015
Slide 1: JP Morgan Healthcare Conference
JP Morgan Healthcare Conference Dr. Elias Zerhouni, President – Global R&D San Francisco, January 12, 2015
Slide 2: Forward Looking Statements
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 under
Slide 3: Sanofi - Well Positioned For Future Success
Sanofi - Well Positioned For Future Success Solid financial ● Net sales up +5.0% at CER in 9M 2014(1) 1 performance ● Business EPS up +10.1% at CER in 9M 2014(1) Strong performance ● Growth Platforms up +10.8% at CER in 9M 2014 2 of Growth ● Now representing 76.1% of Group sales in 9M 2014 Platforms
Slide 4: Successful Growth Strategy Continues to Deliver Solid Top and Bottom Line Growth in 9M 2014
Successful Growth Strategy Continues to Deliver Solid Top and Bottom Line Growth in 9M 2014 Net Sales Business EPS -€0.24 +€1,225m -€1,021m +€0.37 €3.81 €24,698m €24,494m (2) €3.68 +5.0% +10.1% at CER(1) at CER(1) (2) 9M 2013 Incremental FX Impact 9M 2014 9M 2013 Incremental FX Impact 9M 2014 Sales
Slide 5: Consistent Strong Sales Performance of Growth Platforms
Consistent Strong Sales Performance of Growth Platforms Demonstrates the Sustainability of our Business Model Quarterly Sales Growth from Growth Platforms(1) +11.5% (2) 10.7% +10% +10.0% 10.0% at CER +8.6% +7.6% +7.9% +6.4% +6.2% (2) +5.7% +5.5% +5% at CER Q1 2012 Q2 2012 Q3 2012 Q4 2012 Q1 2013 Q2
Slide 6: Growth Platforms Grew +10.8% in 9M 2014 Representing 76.1% of Sales
Growth Platforms Grew +10.8%(1) in 9M 2014 Representing 76.1% of Sales 9M 2014 Sales & Growth at CER Emerging Markets(2) €8,221m +9.9% Diabetes Solutions €5,249m +12.5% Vaccines €2,797m +4.1% Consumer Healthcare(3) €2,520m -4.2% +17.3% Genzyme(4) €1,858m +25.1% Animal Health €1,569m +5.3% Other Inno
Slide 7: R&D Plays a Major Role in the Successful Execution of Sanofi's Strategy
R&D Plays a Major Role in the Successful Execution of Sanofi’s Strategy Grow a global healthcare leader 1 with synergistic platforms 2 Bring innovative products to market Deliver sustainable long-term growth by improving Seize value-enhancing growth 3 patients' lives opportunities Adapt structure fo
Slide 8: Sanofi Expects to Launch High Potential New Medicines and Vaccines at an Accelerated Pace
Sanofi Expects to Launch High Potential New Medicines and Vaccines at an Accelerated Pace ILLUSTRATIVE Up to 18 Launches 2014 - 2020 Dengue PR5i Praluent™ Shan5 alirocumab Vaccine Vaccine (U.S.) insulin patisiran Anti-CD38 Rotavirus sarilumab Vaccine lispro mAb Vaccine (U.S.) Praluent™ is the intend
Slide 9: The Only First-Line Oral Therapy for Adults with Gaucher Disease Type 1
The Only First-Line Oral Therapy for Adults with Gaucher Disease Type 1 ● Novel substrate inhibitor(1) ● Largest ever development program in Gaucher ● Almost 400 adults in 29 countries ● Efficacy demonstrated in untreated patients (ENGAGE) and in patients switching from ERT (ENCORE) ● Majority of ad
Slide 10: FDA Approval Is a Major Step Forward for People with Relapsing Forms of MS
FDA Approval Is a Major Step Forward for People with Relapsing Forms of MS ● Regulatory approvals granted in >40 countries(1) ● FDA approval received on Nov 14, 2014 ● Because of its safety profile, the use of Lemtrada® should generally be reserved for patients who have had an inadequate response to
Slide 11: Praluent: Significant Proportion of Hypercholesterolemic Patients Are at High CV Risk
Praluent™: Despite Current Therapy, a Significant Proportion of Hypercholesterolemic Patients Are at High CV Risk 2016 Estimates for U.S., EU Top 5 and Japan (in million patients)(1) Heterozygous Familial Hypercholesterolemia 1.2m Statin Intolerant 2.9m Primary Prevention 4.8m 24m Diabetes(2) 10.1m
Slide 12: Significant and Consistent LDL-C Reduction across All Reported Trials
Significant and Consistent LDL-C Reduction across All 10 Reported Trials Dosing Baseline LDL-C Change from Baseline at 24 Weeks Study q2w LDL-C (mg/dL) Alirocumab Comparator HIGH FH 150 mg 198 ↓ 46% ↓ 7% placebo HeFH FH I 75/150 mg(1) 145 ↓ 49% ↑ 9% placebo FH II 75/150 mg(1) 134 ↓ 49% ↑ 3% placebo
Slide 13: Post-hoc Adjudicated Major Adverse Cardiovascular Events
Post-hoc Adjudicated LONG TERM Major Adverse Cardiovascular Events(1) Kaplan-Meier Estimates for Time to First Adjudicated Major CV Event 0.06 Safety Analysis(2) Cox model analysis: Cumulative probability of event 0.05 HR=0.46 (95% CI: 0.26 to 0.82) Nominal p-value = <0.01 0.04 Placebo + max-tolerat
Slide 14: Praluent: Next Regulatory Milestones and Development Steps
Praluent™: Next Regulatory Milestones and Development Steps 1 Regulatory submissions in the U.S. and EU on track ● 6-month FDA priority review from filing date expected 2 Positive results from ODYSSEY CHOICE I & II and Open Label Extension (OLE) ongoing ● CHOICE I & II explore monthly dosing of alir
Slide 15: Hypoglycemia Contributes to Poor Compliance and Affects Treatment Efficacy
Hypoglycemia Contributes to Poor Compliance and Affects Treatment Efficacy(1) 50% of basal 30% to 60% insulin patients are experience not at A1c goal hypoglycemia 59% of new to Lantus® patients in the U.S. have significant compliance gaps The launch of Toujeo® will offer opportunities to address unm
Slide 16: A Smoother and Prolonged PK/PD Profile vs. Lantus
A Smoother and Prolonged PK/PD Profile vs. Lantus® Reduction of Volume by 2/3 More Constant PK/PD Profile(1) Median insulin concentration, µU/mL 20 Toujeo® 10 Lantus® 0 0 6 12 18 24 30 36 Lantus® Toujeo® Glucose infusion rate, mg/kg/min 3 Lantus® 2 Reduction of Depot Surface Area by 1/2 1 Toujeo® 0
Slide 17: The Next Generation of Basal Insulin with a Smoother PK/PD Profile than Lantus
The Next Generation of Basal Insulin with a Smoother PK/PD Profile than Lantus® TOUJEO • Smoother PK/PD profile than Lantus® • Full 24h coverage LANTUS • Less hypos than • Once daily Lantus • Less hypos • Improved patient than NPH experience • Treat to target NPH PK/PD Profile: Pharmacokinetic/Ph
Slide 18: Confirmed or Severe Hypoglycemia per Patient per Year Significantly Lower
Confirmed or Severe Hypoglycemia per Patient per Year Significantly Lower Cumulative Mean Number of Confirmed or Severe Hypoglycemia per Participant(1,3) Pooled analysis of EDITION 1-2-3 Lantus® Toujeo® Nocturnal(2) At any time(3) 3 10 -14% 8 2 6 -31% 4 1 2 p=0.0002 p=0.0116 0 0 0 4 8 12 16 20 24 28
Slide 19: A Unique Clinical Profile
A Unique Clinical Profile ● Easy insulin initiation Smoother glucose lowering and prolonged PK/PD profile Less hypoglycemia during the initiation period when titration occurs Less weight gain ● Long lasting benefit Sustained glucose control at 1 year Benefit in reduction of hypoglycemia maintained a
Slide 20: A Strong Drug Profile Emerging from PoC Study in Type 2 Diabetes
A Strong Drug Profile Emerging from PoC Study in Type 2 Diabetes Proof-of-Concept Study of Fixed-Ratio Once-Daily LixiLan in Type 2 DM on Metformin ● Robust A1c reduction from 84% of patients reached A1c 8.1% to 6.3%(1) goal <7% ● Reduced body weight (-1 kg) 68% reached this target with no ● Les
Slide 21: Combining Insulin Glargine with Lixisenatide in a Single Daily Injection
Combining Insulin Glargine with Lixisenatide in a Single Daily Injection U.S. Target Populations of T2D Patients for ● Phase III program initiated in Q1 2014 ● LixiLan-O study in patients insufficiently Patients controlled on OADs (1,125 patients) Not at Target 1st injectable ● LixiLan-L study in pa
Slide 22: Device is Unique and Innovative
Device is Unique and Innovative ● Small, discreet, easy-to-use inhaler ● No cleaning required ● No parts need to be replaced ● Breath powered ● Efficient delivery to the deep lung ● Minimal training needed ● Disposed after 15 days of use 22
Slide 23: Dengue Vaccine: Efficacy Studies in Asia and LatAm
Dengue Vaccine: Efficacy Studies in Asia and LatAm Consistently Demonstrate a Reduction in Dengue Disease Both Studies Met their Primary Efficacy Endpoints and Showed Consistent Safety Profile for the Observed Active Phase(2,3,7) 2.5 billion people(1) Key Study Results live in dengue-endemic countri
Slide 24: Dengue: An Unprecedented Industrial Commitment to Large Scale Vaccination Programs
Dengue: An Unprecedented Industrial Commitment to Ensure the Success of Large Scale Vaccination Programs Ready to Produce >1bn Doses over the Next 10 Years ● State-of-the-art facilities dedicated to the production of the dengue vaccine ● €300m investment ● Manufacturing capacity for 100m doses annua
Slide 25: Sarilumab: An Investigational IL-6R mAb for RA
Sarilumab: An Investigational IL-6R mAb for RA(1) ● Fully human, high affinity, IL-6R mAb ● 2 effective doses: 150mg or 200mg ● Delivered subcutaneously every other week ● Evaluated for use with ergonomic pre-filled syringe or autoinjector sarilumab ● Efficacy demonstrated across three co-primary en
Slide 26: Inhibiting Progression of Structural Damage in RA with Sarilumab
Inhibiting Progression of Structural Damage in RA with Sarilumab SARIL-RA-MOBILITY - Change from Baseline in mTSS 3 Placebo + MTX mTSS: 2.5 modified 2 70% Total Sharp Score 1.5 90% Sarilumab: van der Heijde 1 Sarilumab 150 mg + MTX* modified Total Sharp Score 0.5 (0-448) Sarilumab 200 mg + MTX* 0 We
Slide 27: Dupilumab Offers Potential to Change Management of Th2-Mediated Allergic Inflammatory Diseases
Dupilumab Offers Potential to Change Management of Multiple Th2-Mediated Allergic Inflammatory Diseases Dupilumab is a fully human monoclonal antibody targeting IL-4Rα blocking intracellular signaling of both IL-4 and IL-13 1 DERMATOLOGY IL‐4 IL‐13 Moderate-to-Severe Atopic Dermatitis or IL‐4R c I
Slide 28: Dupilumab Significantly Improved Signs and Symptoms in Moderate-to-Severe AD
Dupilumab Significantly Improved Signs and Symptoms in Moderate-to-Severe AD Patients Uncontrolled by Topicals Phase IIb Study in AD - Change in Efficacy Endpoints at 16 Weeks(1-6) Parameter Placebo 300mg q2w 300mg qw EASI Score 18% 68.2% 73.7% 50/75/90 EASI 29.5%/11.5%/3.3% 78.1%/53.1%/29.7% 82.5%/
Slide 29: Dupilumab Shows Improvement in Lung Function in Phase IIb Asthma
Dupilumab Shows Improvement in Lung Function in Phase IIb in Moderate-to-Severe Asthma(1) Phase IIb - Mean Improvement in FEV1 (mL and % Change from Baseline) mL 500 25.9%(1) (2) 400 25.8% (1) 18.0% (1) 300 17.7% Placebo 200mg Q2W 200 10.4% 300mg Q2W 6.2% 100 0 (1) p<0.001 vs placebo High Eosinophil
Slide 30: Dupilumab Shows a 64-75% Reduction in Exacerbations in Phase IIb Asthma
Dupilumab Shows a 64-75% Reduction in Exacerbations in Phase IIb in Moderate-to-Severe Asthma Phase IIb: Annualized Rate of Severe Exacerbation Events 0,9 0.9 0,8 0.8 0,7 0.7 0,6 0.6 0,5 0.5 -64% (1) (2) Placebo -67% 0,4 0.4 (1) -67% (3) 200mg Q2W -75% 0.3 0,3 300mg Q2W 0.2 0,2 0,1 0.1 (1) p<0.05 vs
Slide 31: Significantly Improving Returns from R&D
Significantly Improving Returns from R&D 2007 - 2013 Potential cumulative first 5 years sales 10 launches achieved ~€7.5bn(1,2) 2014 - 2020 Potential cumulative first 5 years sales Up to 18 launches expected >€30bn(1,2) (1) At CER, 5 years for each product from and including the first full year
Slide 32: Innovation Momentum Set to Continue in 2015
Innovation Momentum Set to Continue in 2015 2015 Expected Regulatory Decisions Q1 Q2 Q3 Q4 ● Cerdelga™ (eliglustat) in Gaucher disease (E.U.) ● Quadracel® pediatric vaccine (U.S.) ● Toujeo® in Diabetes (U.S.) ● Toujeo® in Diabetes (E.U.) ● PR5i 6-in-1 pediatric vaccine (U.S.) ● Praluent™ (
Slide 33: Strong Foundation for the Next Phase of Our Growth Strategy
Strong Foundation for the Next Phase of Our Growth Strategy Solid Sales and Business EPS growth in 9M 2014 Growth Platforms Continue to Deliver 6 Significant New Product Launches Expected During 2015(2) Long-term Value Creation through Innovation and Pipeline Execution (1) Q4 2013 financial results