Sanofi SA · EURONEXT:SAN
Sanofi SA — Cowen & Co. Health Care Conference 2016
26 slides from Sanofi SA's conference presentation, Mar 8, 2016
Slide 1: Cowen & Co. Health Care Conference
Cowen & Co. Health Care Conference Dr. Elias Zerhouni, President – Global R&D Boston – March 8, 2016
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: Taking our Strategy Forward in 2016
Taking our Strategy Forward in 2016 Four Strategic Priorities 1 2 3 Deliver Sustain Reshape outstanding innovation the portfolio launches in R&D 4 Simplify the organization 3
Slide 4: Significant R&D Turnaround since 2012
Significant R&D Turnaround since 2012 2012 2015 Quality over Quantity(1) 79 projects 44 projects Prioritization Unprioritized Tiering system Biologics(2) 58% 85% External Innovation >65% >65% Early Development Fast to Market Fast to Proof of Concept Slower than industry Faster than industry Cycle Ti
Slide 5: Sustain Innovation in R&D
Sustain Innovation in R&D Deliver a Balanced Pipeline… … Focused on GBU Priorities Continue to strengthen R&D ● Sustain leadership: A Diabetes/CV, Vaccines, pipeline Rare Diseases B Implement the R&D 2.0 model ● Build competitive positions: Oncology, MS, Immunology Foster existing R&D C collaboratio
Slide 6: Global Roll-out Underway for Three Major Products
Global Roll-out Underway for Three Major Products ● Rapid market access ● Significant progress ● Priority introduction in obtained in the U.S.(1) achieved recently high endemic countries in U.S. Market Access ● Approvals recently ● Showing early promise ● >170m Commercial and granted in Mexico, the
Slide 7: Three Regulatory Filings for New Medicines Submitted
Three Regulatory Filings for New Medicines Submitted Type 2 Diabetes Type 2 Diabetes Rheumatoid Arthritis lixisenatide U.S. regulatory U.S. regulatory U.S. regulatory decision expected decision expected decision expected in July 2016(1) in August 2016(2) in Q4 2016(3) EU regulatory filing in
Slide 8: Positioning Sarilumab for Potential Success in the Rheumatoid Arthritis Biologic Market
Positioning Sarilumab for Potential Success in the Rheumatoid Arthritis Biologic Market(1) ● IL-6 plays key roles in the local joint symptoms and systemic manifestations of rheumatoid arthritis (RA) ● Entering an €18bn RA market where unmet need is still high ● IL-6 class >€1bn in sales and growing
Slide 9: MOBILITY: Sarilumab Inhibited Progression of Structural Damage
MOBILITY: Sarilumab Inhibited Progression of Structural Damage Change from Baseline in mTSS at Week 24 and Week 52 ● X-ray data(1) demonstrating 3 90% inhibition of progression of structural damage with 200 mg Q2W SC dosing 2 70% ● Safety profile consistent with 90% mechanism of action(2) 1 ● Most c
Slide 10: Dupilumab – A Pipeline in a Product with Multi-blockbuster Potential
Dupilumab – A Pipeline in a Product with Multi-blockbuster Potential(1) Fully Human IL-4Rα mAb Inhibiting Intracellular Signaling of Both IL-4 and IL-13 Atopic Dermatitis ● Received “Breakthrough Therapy” designation by FDA IL-4 IL-13 ● SOLO 1 and 2 Phase III top line results expected in Q1 2016 or
Slide 11: Atopic Dermatitis Is a Serious, Chronic, Inflammatory Skin Condition
Atopic Dermatitis Is a Serious, Chronic, Inflammatory Skin Condition ● Over 5 million people in the U.S. and EU(1) estimated to be affected by moderate-to-severe atopic dermatitis ● 40% of moderate-to-severe patients uncontrolled with topicals ● Characterized by eczematous dermatitis with intractabl
Slide 12: 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 Parameter Placebo 300mg q2w 300mg qw EASI Score(1) -18.1% -68.2% -73.7% 50/75/90 EASI 29.5%/11.5%/3.3% 78.1%/53.1%/29.7% 82.
Slide 13: Dupilumab Safety Findings in Moderate-to-Severe Atopic Dermatitis
Dupilumab Safety Findings in Moderate-to-Severe Atopic Dermatitis(1) Phase IIb Study Injection site Nasopharyngitis Headache reactions 32.3% 26.2% 25.0% 14.8% 9.5% 7.7% 3.3% 4.6% 3.3% Dupilumab Placebo Dupilumab Placebo Dupilumab Placebo ● Nasopharyngitis, the most common adverse event, balanced acr
Slide 14: Moderate-to-Severe Asthma Negatively Impacts the Lives of Patients
Moderate-to-Severe Asthma Negatively Impacts the Lives of Patients and Is Associated with High Burden to Society ● 235-300m people worldwide estimated to be affected by asthma(1) ● ~25m people in the U.S. alone ● 10 to 20% of patients uncontrolled despite existing therapies ● Chronic inflammatory di
Slide 15: Dupilumab Shows Improvement in Lung Function in Phase IIb Asthma
Dupilumab Shows Improvement in Lung Function in Phase IIb in Moderate-to-Severe Asthma Phase IIb - Mean Improvement in FEV1 at 24 Weeks (mL and % Change from Baseline) mL 22.9%(1) 400 24.9%(2) 16.6%(3) 300 17.3%(3) 13.4%(2) 12.8% 12.6%(2) 200 Placebo 200mg Q2W 7.0% 300mg Q2W 100 4.7% 0 High Eosinoph
Slide 16: 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 at 24 Weeks 1,0 1.0 0,8 0.8 -71%(1) 0,6 0.6 (2) -68%(2) -70%(3) -81% Placebo -60%(1) -70%(3) 200mg Q2W 0,4 0.4 300mg Q2W 0,2 0.2 0,0 0.0 High Eosino
Slide 17: Dupilumab Safety Profile in Moderate-to-Severe Asthma
Dupilumab Safety Profile in Moderate-to-Severe Asthma Phase IIb Study Injection site Infections Severe AEs reactions 59.2% 53.2% 52.0% 26.9% 13.3% 10.2% 5.7% 12.7% 4.0% Dupilumab Placebo Dupilumab Placebo Dupilumab Placebo ● Injection site reaction was the most common adverse event and was more freq
Slide 18: A Strong Profile Emerging from PoC Study Combining Lantus with Lixisenatide
A Strong Profile Emerging from PoC Study Combining Lantus® with Lixisenatide in Type 2 Diabetes(1) Fixed Ratio Combination Single Once Daily Injection = of Two Active Components Statistically significant A1c reduction More patients with A1c <7% FPG + PPG control Offsets weight gain versus insulin gl
Slide 19: Strengthening our R&D Portfolio in Diabetes with Two In-Licensing Agreements
Strengthening our R&D Portfolio in Diabetes with Two In-Licensing Agreements (2) Immunology Sotagliflozin - Phase II in T2 Diabetes Efpeglenatide – Phase II Phase III in T1 Diabetes ● Long acting GLP-1(3) ● Dual SGLT1 and SGLT2 inhibitor(1) ● Diabetes/Obesity ● Limiting meal time glucose absorption
Slide 20: Dual Agonists for GLP-1 and Glucagon/GIP Receptors
Dual Agonists for GLP-1 and Glucagon/GIP Receptors GLP-1/Glucagon Dual Agonist ● Novel synthetic peptidic molecules Glucose Control Similar to Liraglutide - Animal Data(1) developed in-house 10 8 ● Expected benefit is blood glucose HbA1c (%) control with superior weight loss over 6 Day -4 pure GLP-1
Slide 21: Olipudase alfa – An Investigational Treatment for ASMD
Olipudase alfa – An Investigational Treatment for ASMD with FDA Breakthrough Therapy Designation(1,2) ASMD Patient Diagnosis Therapeutic Approach ● Acid sphingomyelinase deficiency (ASMD), Target the underlying metabolic defect also known as Niemann-Pick Type B, is a by replacing the missing enzyme
Slide 22: Alnylam Collaboration Provides Access to Unique RNAi Opportunities
Alnylam Collaboration Provides Access to Unique RNAi Opportunities(1) patisiran Phase III ongoing RNAi therapeutic targeting in TTR Amyloidosis - transthyretin (TTR) Familial Amyloidotic ● Intravenous infusion Polyneuropathy ● World-class RNAi revusiran technology Phase III ongoing RNAi therapeutic
Slide 23: Rebuilding a Competitive Position in Oncology
Rebuilding a Competitive Position in Oncology Oncology Opportunity Largest therapeutic area ● 1 Maximize clinical assets, particularly isatuximab for pharmaceuticals (anti-CD38 mAb) and Antibody-Drug Conjugates ● 2 Recent collaborations to build a transformative pipeline Strong growth driven ● Regen
Slide 24: Isatuximab (anti-CD38 mAb): a Significant Opportunity in Multiple Myeloma
Isatuximab (anti-CD38 mAb): a Significant Opportunity to Potentially Address an Unmet Need in Multiple Myeloma ● Multiple Myeloma remains incurable ● 50,000 patients are diagnosed annually in the U.S. and Europe ● Encouraging efficacy in heavily pre-treated myeloma patients(1) ● Targets unique epito
Slide 25: New Strategic Alliance with Regeneron to Develop Cancer Treatments in IO
New Strategic Alliance with Regeneron to Develop Cancer Treatments in Emerging Field of IO Entering Immuno-Oncology Establish Sanofi’s presence in cancer immunotherapy, a rapidly growing and attractive segment of oncology 1 Significant unmet needs remain despite advances shown with checkpoint inhi
Slide 26: 2016 Will Be a Busy Year for R&D Pipeline News Flow
2016 Will Be a Busy Year for R&D Pipeline News Flow Expected Regulatory Decisions Q1 Q2 Q3 Q4 ● Dengvaxia® in endemic countries ● Lixisenatide in Diabetes (U.S.) ● LixiLan in Diabetes (U.S.) ● Sarilumab in Rheumatoid Arthritis (U.S.) Expected Regulatory Submissions Q1 Q2 Q3 Q4 ● LixiLan in Dia