Sanofi Sa · EURONEXT:SAN
Sanofi Sa — Barclays Global Healthcare Conference 2015
30 slides from Sanofi Sa's conference presentation, Mar 10, 2015
Slide 1: Barclays Global Healthcare Conference
Barclays Global Healthcare Conference Dr. Paul Chew, Senior Vice President, Chief Medical Officer Miami, March 10, 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: In 2014, Sanofi Focused on Delivering Growth and Strengthening Innovation
In 2014, Sanofi Focused on Delivering Growth and Strengthening Innovation Returning ● Sales growth up 4.9% at CER 1 to top line ● Solid performance across Growth platforms(1) growth Delivering ● Business EPS up +7.3% at CER in line with expectations 2 strong financial ● Free Cash Flow up +12.3% resu
Slide 4: Growth Platforms Collectively Provide a Sustainable Base
Growth Platforms Collectively Provide a Sustainable Base Quarterly Sales Growth from Growth Platforms(1) +11.5% (2) 10.7% +10.0% 10.0% 10.3% +10% 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 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4
Slide 5: 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 6: Four New Products Granted Regulatory Approvals over the Last Year
Four New Products Granted Regulatory Approvals over the Last Year Key Regulatory Approvals U.S. (Feb 2015) New once-daily long- 1 acting basal insulin Positive CHMP Opinion (Feb 2015)(1) Protection against four 2 U.S. (Dec 2014) strains of influenza virus Relapsing forms of 3 U.S. (Nov 2014) multipl
Slide 7: Regulatory Filings for Three Major New Medicines or Vaccines Submitted over the Last Year
Regulatory Filings for Three Major New Medicines or Vaccines Submitted over the Last Year Key Regulatory Filings Hypercholesterolemia Pediatric hexavalent vaccine Dengue Praluent™ alirocumab PR5i 6-in-1 Dengue vaccine U.S. U.S. Endemic markets(1) E.U. Praluent™ (alirocumab) is developed in collabora
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: 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 (1) IMS Lifelink; U300 segmentation; Sanofi market research;
Slide 10: New Once-Daily Long-Acting Basal Insulin with a Unique PK/PD Profile
New Once-Daily Long-Acting Basal Insulin with a Unique PK/PD Profile 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 b
Slide 11: 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(1,4) Pooled analysis of EDITION 1-2-3(1,2) Lantus® Toujeo® Nocturnal(3) At any time(4) 3 10 -14% 8 2 6 -31% 4 1 2 p=0.0002 p=0.0116 0 0 0 4 8 12 16 20
Slide 12: Launching a New Once-Daily Long-Acting Basal Insulin
Launching a New Once-Daily Long-Acting Basal Insulin ● FDA approval granted on February 25, 2015 ● U.S. launch expected in early Q2 2015 ● Toujeo® COACH patient support program available at launch ● CHMP issued positive opinion recommending approval ● Launch in Germany and UK expected in Q2 2015 ● L
Slide 13: 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 14: 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 15: Device is Unique and Innovative
Device is Unique and Innovative ● Small inhaler ● No cleaning required ● No parts need to be replaced ● Breath powered ● Efficient delivery to the deep lung ● Minimal training ● Disposed after 15 days of use 15
Slide 16: Dengue Vaccine: Efficacy Studies in Asia and LatAm Consistently Demonstrate a Reduction in Dengue Disease
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 17: On Track to Make Dengue the Next Vaccine-Preventable Disease
On Track to Make Dengue the Next Vaccine-Preventable Disease A Breakthrough Innovation to Help Reduce the Burden of Dengue(1) ● Rolling submission for Dengue vaccine initiated in several endemic countries in Asia ● First completed submission expected in H1 2015 ● First commercial batches produced an
Slide 18: Praluent Has the Potential to Transform Management of Hypercholesterolemic Patients
Praluent™ Has the Potential to Transform Management of Hypercholesterolemic Patients with High CV Risk 1● Regulatory applications accepted in the U.S. and EU ● 6-month FDA priority review granted(1) 2● Positive results from ODYSSEY CHOICE I & II Praluent alirocumab ™ ● Evaluation of monthly dosing 3
Slide 19: Praluent: Despite Current Therapy, a Significant Proportion of 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 20: 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 21: Post-hoc Adjudicated LONG TERM 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 22: 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 23: 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 24: Dupilumab Offers Potential to Change Management of Multiple 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 25: Dupilumab Significantly Improved Signs and Symptoms in Moderate-to-Severe AD Patients
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 26: Dupilumab Shows Improvement in Lung Function in Phase IIb in Moderate-to-Severe 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 27: Dupilumab Shows a 64-75% Reduction in Exacerbations in Phase IIb in 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 0.8 0.7 0.6 0.5 -64% (1) (2) Placebo -67% 0.4 (1) -67% (3) 200mg Q2W -75% 0.3 300mg Q2W 0.2 0.1 (1) p<0.05 vs placebo 0 (2) p<0.01 vs placebo Hig
Slide 28: Sanofi Has Additional Potentially Transformative Drugs
Sanofi Has Additional Potentially Transformative Drugs R&D Assets to Watch(1) 1 Vatelizumab(2) 6 Neo GAA Multiple Sclerosis Pompe Disease 2 IL4/IL13 bi-specific mAb 7 C-MET kinase inhibitor Idiopathic Pulmonary Fibrosis Solid Tumors 3 Anti-GDF8 mAb 8 Anti-CXCR5 mAb Sarcopenia Systemic Lupus Erythema
Slide 29: Innovation Momentum Set to Continue in 2015
Innovation Momentum Set to Continue in 2015 2015 Expected Regulatory Decisions Q1 Q2 Q3 Q4 ● Toujeo® in Diabetes in U.S. & EU ● Praluent™ (alirocumab) in Hypercholesterolemia (U.S.) ● PR5i 6-in-1 pediatric vaccine (U.S.) ● Dengue vaccine in Endemic Countries Expected Regulatory Submissions Q
Slide 30: Our Focus Continues to Be on Excellence in Execution of Sanofi's Strategy
Our Focus Continues to Be on Excellence in Execution of Sanofi’s Strategy Strategy 2015 Focus Grow a global healthcare leader 1 with synergistic platforms Sustain leadership positions Bring innovative products 2 to market Ensure successful launches Adapt structure for future Focus company resources