Sanofi Sa · EURONEXT:SAN
Sanofi Sa — Berenberg European Conference 2015
30 slides from Sanofi Sa's conference presentation, May 19, 2015
Slide 1: Berenberg European Conference
Berenberg European Conference Dr. Elias Zerhouni, President – Global R&D Tarrytown, NY – May 19, 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: Q1 2015 - A Good Start to the Year
Q1 2015 - A Good Start to the Year ● Sales up +2.4% despite lower vaccines and U.S. Lantus® Delivering sales(1) 1 top line growth ● Solid performance of Genzyme and Merial Posting ● Higher OpEx driven by new launches 2 strong financial ● Business EPS up +2.6% at CER(2) results Bringing innovative ●
Slide 4: Sales Growth Driven by Genzyme and Merial in Q1 2015
Sales Growth Driven by Genzyme and Merial in Q1 2015(1) % of Sales Q1 2015 Sales by Business Areas Growth at CER 84.6% Pharmaceuticals €7,455m +2.2% 20.9% Diabetes €1,837m -3.2% 11.1% Consumer Healthcare €979m +5.3% 9.3% Genzyme €821m +30.9% 5.4% Generics €478m +10.2% 4.1% Oncology €357m -7.3% 33.8%
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 New once-daily long- U.S. (Feb 2015) 1 acting basal insulin EU (Apr 2015) Protection against four 2 U.S. (Dec 2014) strains of influenza virus Relapsing forms of 3 U.S. (Nov 2014) multiple sclerosis Oral Thera
Slide 7: Regulatory Filings for Three Major New Medicines or Vaccines
Regulatory Filings for Three Major New Medicines or Vaccines Submitted over the Last Year Key Regulatory Filings Hypercholesterolemia Pediatric hexavalent vaccine Dengue PR5i 6-in-1 Dengue vaccine U.S. U.S. Endemic markets(1) E.U. Praluent® (alirocumab) is developed in collaboration with Regeneron (
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 Shan5 ® Vaccine Vaccine (U.S.) insulin patisiran Anti-CD38 Rotavirus sarilumab Vaccine (U.S.) lispro mAb Vaccine Praluent® is the intended trade name for a
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 Basal Insulin with a Unique PK/PD Profile
New Basal Insulin with a Unique PK/PD Profile Reduction of Volume by 2/3 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 0 6 12 18
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) EDITION 1-2-3 pooled analysis published recently(2) 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 24 2
Slide 12: Global Launch of a New Basal Insulin Underway
Global Launch of a New Basal Insulin Underway ● Toujeo® was launched in the U.S. at the end of March ● Secured earlier and broader market access than expected ● Toujeo® COACH patient support program available at launch ● European Commission approved Toujeo® in April 2015 ● Launch in Germany and UK e
Slide 13: Additional Milestones Expected in 2015 to Further Expand our Diabetes Franchise
Additional Milestones Expected in 2015 to Further Expand our Diabetes Franchise Key Milestones for Lixisenatide in 2015 (1) (1,2) ELIXA study results support Completion of two Phase III U.S. regulatory submission trials expected in Q3 2015 expected in Q3 2015(3) LixiLan-O(4) LixiLan-L(4) U.S. regula
Slide 14: 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 15: 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 16: Dengue Vaccine: Efficacy Studies in Asia and LatAm Consistently Demonstrate a Reduction
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) 3.9 billion people(1) live in dengue-endemic countries Key Study Resul
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 endemic countries in Asia and Latin America ● First commercial batches produced and inventory build-up underway ● Up to 8
Slide 18: 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 19: 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 20: 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 21: Praluent Has the Potential to Transform Management of Hypercholesterolemic Patients
Praluent® Has the Potential to Transform Management of Hypercholesterolemic Patients with High CV Risk ● Regulatory reviews underway in the U.S. and Europe ● FDA decision expected in July 2015(1) ● EU decision expected in Q1 2016 ● 18-month results of ODYSSEY LONG TERM study were published in NEJM(2
Slide 22: Sarilumab: An Investigational IL-6R mAb for Rheumatoid Arthritis
Sarilumab: An Investigational IL-6R mAb for Rheumatoid Arthritis(1) ● Fully human, high affinity, IL-6R mAb ● 2 doses being evaluated: 150mg or 200mg ● Delivered subcutaneously every other week ● Evaluated for use with ergonomic pre-filled syringe or autoinjector sarilumab ● Three co-primary efficac
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 Total Sharp Score 2 70% 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 Th2-Mediated Allergic Diseases
Dupilumab Offers Potential to Change Management of Multiple Th2-Mediated Allergic Inflammatory Diseases(1) Dupilumab is a fully human mAb targeting IL-4Rα blocking intracellular signaling of both IL-4 and IL-13 Atopic Dermatitis ● Phase III ongoing IL-4 IL-13 ● Received “Breakthrough Therapy” design
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 Asthma
Dupilumab Shows Improvement in Lung Function in Phase IIb in Uncontrolled Moderate-to-Severe Asthma(1) Phase IIb - Mean Improvement in FEV1 (mL and % Change from Baseline) mL 500 25.9%(1) 400 25.8%(2) 18.0%(1) 300 17.7%(1) Placebo 200mg Q2W 200 10.4% 300mg Q2W 6.2% 100 0 (1) p<0.001 vs placebo High
Slide 27: Dupilumab Shows a 64-75% Reduction in Exacerbations in Phase IIb Asthma
Dupilumab Shows a 64-75% Reduction in Exacerbations in Phase IIb in Uncontrolled Moderate-to-Severe Asthma(1) 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) Placebo -67%(2) 0,4 0.4 -67%(3) 200mg Q2W -75%(1) 0.3 0,3 300mg Q2W 0.2 0,2 0,1 0.1 (
Slide 28: Patisiran and Revusiran Developed in Collaboration with Alnylam
Patisiran and Revusiran Developed in Collaboration with Alnylam(1) patisiran siRNA inhibitor targeting Phase III ongoing transthyretin (TTR) in Familial Amyloidotic ● Administered by Polyneuropathy ● World-class RNAi intravenous injection technology platform for rare genetic disease development ● Ma
Slide 29: A New Wave of Potentially Transformative Drugs
A New Wave of Potentially Transformative Drugs R&D Assets to Watch Phase II Phase I Vatelizumab(1) Olipudase alfa Multiple Sclerosis Niemann-Pick type B IL4/IL13 bi-specific mAb Neo GAA Idiopathic Pulmonary Fibrosis Pompe Disease Anti-GDF8 mAb C-MET kinase inhibitor Sarcopenia Solid Tumors Oral GCS
Slide 30: 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 Q1