2012 - BofA-Merrill Lynch HC Conference

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2012 - Merril Lynch HC Conference

2012 - Merril Lynch HC Conference

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  • 1. BofA MERRILL LYNCH HEALTHCARE CONFERENCE Dr. Paul Chew U.S. Chief Science Officer / Chief Medical Officer, SVP May 15, 2012
  • 2. Forward Looking StatementsThis presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of1995, as amended. Forward-looking statements are statements that are not historical facts. These statementsinclude projections and estimates and their underlying assumptions, statements regarding plans, objectives,intentions and expectations with respect to future financial results, events, operations, services, productdevelopment and potential, and statements regarding future performance. Forward-looking statements aregenerally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similarexpressions. Although Sanofis management believes that the expectations reflected in such forward-lookingstatements are reasonable, investors are cautioned that forward-looking information and statements are subjectto 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 orprojected by, the forward-looking information and statements. These risks and uncertainties include among otherthings, the uncertainties inherent in research and development, future clinical data and analysis, including postmarketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when toapprove any drug, device or biological application that may be filed for any such product candidates as well astheir decisions regarding labeling and other matters that could affect the availability or commercial potential ofsuch product candidates, the absence of guarantee that the product candidates if approved will be commerciallysuccessful, the future approval and commercial success of therapeutic alternatives, the Groups ability to benefitfrom external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of costcontainment policies and subsequent changes thereto, the average number of shares outstanding as well asthose discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listedunder "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofis annualreport on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofidoes not undertake any obligation to update or revise any forward-looking information or statements. 2
  • 3. 2012 - A Good Start to the Year Total Sales (€m) Business EPS (€) €8,511m €1.85 €7,779m €1.66 +7.0% +7.2% at CER at CER Q1 2011 Q1 2012 Q1 2011 Q1 2012 3
  • 4. Growth Platforms Accounted for 63.2% of Sales in Q1 2012 Growth at CER (1) Emerging Markets €2,624m +9.9% (1) Diabetes Solutions €1,311m +14.4% Consumer Health Care €805m +11.4% Vaccines €617m -0.2% Animal Health €578m -5.4% (3) New Genzyme(2) €400m +13.7% (3) (3) Innovative Products(4) €139m +6.3% (3) Growth is at CER (Constant Exchange Rates) (1) With Genzyme pro forma in Q1 2011, Emerging Market sales grew by 5.6%, and by 7.9% excluding vaccines (2) New Genzyme perimeter include Rare Diseases and Multiple Sclerosis franchises (3) Change on a constant structure basis and at constant exchange rates (4) Multaq®, Jevtana®, and Mozobil® 4
  • 5. Executing Successful Strategy to Reposition Sanofi 1 Increase innovation in R&D Deliver sustainable growth Pursue external growth 2 and generate opportunities improved shareholder returns Adapt structure for future 3 challenges and opportunities 5 5
  • 6. Executing our R&D Strategy An efficient global R&D organization Maximize synergies and convergence around Hub model Exploit economies of scale Improve R&D cost structure Focus on high-value projects Global Execute on late-stage projects R&D Medical value and translational feasibility to guide early-stage Goals portfolio prioritization Establish new models of external innovation Enhance the value of external opportunities and partnerships Create open and creative model of pharma-biotech partnership e.g. Warp Drive Bio 6
  • 7. Focusing on Delivering a Promising Development Portfolio Achieve Regulatory Milestones Submitted • Lemtrada™ Short-term • Aubagio™  EU/U.S. opportunities • Lyxumia® (1)  EU • Zaltrap™(2)  EU/U.S. • Semuloparin  EU/U.S. • Kynamro™ (3)  EU/U.S. Next Wave of Late-Stage Projects • New glargine formulation • Otamixaban Mid-term • Glargine-lixisenatide combo • Sarilumab opportunities • Dengue vaccine • JAK-2 inhibitor • Eliglustat • Iniparib • Anti-PCSK-9 mAb • Ombrabulin Lemtrada™, Aubagio™, Lyxumia®, Zaltrap™, and Kynamro™ are registered trade names submitted to health authorities for investigational agents (1) In-licensed from Zealand Pharma A/S (2) Partnership with Regeneron 7 (3) In-licensed from Isis Pharmaceuticals
  • 8. Genzyme - MSEmergence of a Franchise Addressing the Full Spectrumof Patient Needs in Multiple Sclerosis RRMS(2) and RMS(3) severe/ Early MS/CIS(1) early active MS highly active Convenience Convenience Efficacy with & safety & efficacy manageable safety Aubagio™ Aubagio® Rebif® Lemtrada™ Lemtrada™ CIS – Clinically Isolated Syndrome, TOPIC Phase III study presently ongoing RRMS – Relapse Remitting Multiple Sclerosis RMS – Relapsing Multiple Sclerosis 8 8
  • 9. CARE-MS I - Strong Effect on Relapse Proportion of Relapse-Free Patients at Year 2 HR 0.45 Lemtrada™ 12 mg/day P<0.001 Rebif® 78% 59% Coles A ECTRIMS 2011; platform presentation 9
  • 10. CARE-MS II - Reversing Disability in Some Patients Mean EDSS Change from Baseline Rebif® Lemtrada™ 12 mg/day 0.24 p=0.0064 p<0.0001 ‒0.17 p=0.0044 EDSS – Expanded Disability Status Score Cohen J AAN 2012; platform presentation 10
  • 11. Genzyme - MSAubagi A Once-Daily Oral Therapy with Comparable Efficacy to Injectable Interferon TEMSO: Reduction in Adjusted(1) ARR ● Efficacy demonstrated in TEMSO Placebo on both Relapse Rate and Disability Progression at 14mg T. 7 mg RRR: 31.2% p=0.0002 ● No superiority vs. Rebif® in RRR: 31.5% T. 14 mg TENERE but lower rate of TEAE- p=0.0005 related discontinuation 0 0,1 0,2 0,3 0,4 0,5 0,6 ● Manageable safety profile with up TEMSO: Reduction in Disability Progression (%) to 10 years of follow-up 30% Placebo T. 7 mg HRR: 23.7% T. 14 mg p=ns 20% HRR: 29.8% 10% p=0.0279 0% 0 12 24 36 48 60 72 84 96 108 Week (1) Adjusted for Expanded Disability Status Scale score strata at baseline and takes duration of treatment into account. TEAE – Treatment Emergent Adverse Events, ACTRIMS - Americas Committee for Treatment and Research in Multiple Sclerosis 11 ENS – European Neurological Society, ARR – Annualized Relapse Rate, RRR – Relative risk reduction, HRR – Hazard ratio reduction
  • 12. Diabetes ® A GLP-1 Agonist with Unique Post-Prandial Effect and One Step Titration Reported Lyxumia® Profile Mono  Drug naïve patients  Consistent GLP-1 class effects Mono Japan of A1c reduction and weight loss F1 (metformin)  S (sulfonylurea)   Pronounced effect on Placebo-controlled in OAD failure M (metformin)  post-prandial glucose P (pioglitazone)   Favorable safety profile with low M Asia (metformin) risk of hypoglycemic events Active-controlled X vs. exenatide   OD injection, simple 1 step L Asia Placebo-controlled on to maintenance dose, 1 pen top of basal insulin L  per dose Duo 1 (Lantus®)  Placebo-controlled Cardiovascular Ongoing Secondary prevention Outcomes Study Lixisenatide was in-licensed from Zealand Pharma A/S. Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is currently not approved or licensed anywhere in the world. 12
  • 13. Diabetes ® Optimal Complementary Pharmacological Profile with Basal Insulins T2D Patients Treated with Basal Insulin(1) (worldwide) ● 3 positive GetGoal trials with Lyxumia® on top of basal insulin On basal insulin On basal insulin with controlled fasting ● A1c target and PPG control glucose control achieved when used on top of but A1c >7% Lantus® in GetGoal-Duo 1(3) ● Development of injection device 4 million on Lantus® for variable Lantus® dose with fixed Lyxumia® dose on track 4 million for Phase III initiation early 4 million 2013 on other basal insulins(2) T2D – Type 2 Diabetes, A1C – Glycated hemoglobin, PPG – Post Prandial Glucose (1) Adapted from IMS data (2) Includes all types of basal insulins 13 (3) Top line results press release (6 Dec 2011) – Full results expected at a forthcoming scientific meeting
  • 14. DiabetesNew Glargine Formulation with Unique Pharmacokinetics ● New glargine formulation New Insulin Glargine Formulation Depot formation after subcutaneous injection provides ● Unique flat PK/PD profile Lantus® New Glargine ● Lower injection volume Formulation ● Phase III trials recently initiated in T2D high dose insulin users ● Targeting ~1,600 patients Schematic illustration PK/PD – Pharmacokinetic/pharmacodynamic T2D – Type 2 Diabetes 14
  • 15. OncologyStrengthening our Portfolio of Oncology Drugs ™ Zaltrap® aflibercept● A novel VEGF trap acting on ● Only ultra-LMWH effective in multiple angiogenic targets reducing VTE risk reduction in chemo-treated cancer patients● Previously treated metastatic colorectal cancer ● Without impact on major bleeding incidence ● VELOUR: Significant improvement in Overall Survival ● Treatment effect consistent across solid tumor types, stages ● Manageable safety profile and geographical regions consistent with previous studies Mulsevo™ is a registered trade name submitted to health authorities for an investigational agent NSCLC – Non Small Cell Lung Cancer 15 VTE – Venous Thrombo Embolism (includes Deep Venous Thrombosis and Pulmonary Embolism)
  • 16. Kynamro™: Targeting Rare Familial Hypercholesterolemias Understanding Rarity ● Four Phase III trials conducted in severe forms of ~40,000 patients(1) hypercholesterolemia HoFH Severe FH ● Sustained reduction in apo B production resulting in significant decreases in LDL-C and Lp(a) when added to a regimen of maximally tolerated statin dose and other lipid lowering therapies ● Adverse reactions include ISRs, On statins: FLS, and elevations in liver 60 million transaminases and fat patients ● Liver fat stabilized or decreased in HeFH: some patients with treatment 1 million beyond 12 months patients (1) Patients for HoFH and Severe FH in US and EU markets HoFH – Homozygous Familial Hypercholesterolemia Severe FH – Severe Familial Hypercholesterolemia = treated LDL-C CHD – Coronary Heart Disease HeFH – Heterozygous familial hypercholesterolemia ISR – Injection Site Reactions 16 FLS – Flu Like Symptoms
  • 17. Metabolic DisordersPCSK9 mAb: First in Class and Addressing Unmet Needsin Hypercholesterolemia LDL-C Change from baseline (Phase II)(2,4,5)● Landmark study demonstrated that when PCSK9 is disabled, cholesterol and risk of CHD are greatly lowered(1)● Phase II data(2)(3) ● Significantly reduced mean LDL-C by 40% to 72% over 8 to 12 weeks in patients with elevated LDL-C in patients on stable dose of statins ● Generally safe and well tolerated● Phase III targeted to start Q2 2012 CHD – Coronary Heart Disease (1) Cohen JC. N Engl J Med 2006;354(12):1264-72 (2) McKenney, et al JACC published online March 28 2012 (3) Roth et al JACC Volume 59, Issue 13, Supplement, 27 March 2012, E1620 (4) Patients with primary hypercholesterolemia receiving stable atorvastatin therapy; change from baseline to week 12 (5) LS mean (SE), using LOCF method 17 * P<0.0001 for % change SAR236553 vs. placebo
  • 18. Genzyme - Rare DiseasesEliglustat: a Novel Oral Therapy in Gaucher Disease(1) ● Potent, novel substrate inhibitor ● Convenience of oral therapy ● Eliminating challenges of infusing patients ● Clinical profile expected to be similar to Cerezyme® ● 4-year Phase II data at WORLD congress in February 2012 December 2006 December 2009 ● Phase III trials fully recruited pre-treatment (18 years) 3 years post treatment (21 years)(2) (1) Investigational drug (2) Patient from Phase II clinical trial WORLD – World Organization of Research on Lysosomal Diseases 18
  • 19. Eliglustat Clinical Data Comparable to Cerezyme® Eliglustat Phase 2 Trial Results: Mean Hb Change from Baseline Treatment Changes to 4 Years(1) % Change (g/dL) from Baseline Platelets +95% 4 100% 2 50% Hemoglobin +2.3 g/dL 0 0% Liver -28% -2 -50% Spleen -63% -4 -100% Baseline Year 1 Year 2 Year 3 Year 4 Cerezyme® Range (1) Cerezyme® Registry Data on File – Upper and Lower 95% Confidence Interval around Mean 19
  • 20. VaccinesDengue Vaccine: Addressing a Growing Global Threat Significant Disease Burden Ambitious R&D Program ● Estimated 220m dengue ● Global Phase III program infections worldwide per year (43,000 individuals) ● 2m cases of Hemorrhagic ● 1st efficacy results expected Fever by end of 2012 ● >500,000 hospitalizations and ● First submissions planned >20,000 deaths / year in 2013 ● Dengue: a public health priority in Asia and Latin America 20 20
  • 21. Eighteen Potential New Launches over 2012-2015 Cumulative Number of Projects Pharmaceuticals (excluding LCM) and Vaccines 18 14 8 Vaccines Rare Diseases & MS 5 Ophthalmology Diabetes Oncology Dengue vaccine Other Pharma Aubagio™ (teriflunomide) eliglustat Quadracel® Kynamro™ (mipomersen) SAR302503 DTP-HepB- Lemtrada™ (JAK-2 inhibitor) Lyxumia ® Polio-Hib (lixisenatide) (alemtuzumab) ombrabulin FOV1101 Zaltrap™ Fluzone® QIV IM (prednisporin) (aflibercept) iniparib semuloparin Hexaxim® otamixaban SAR236553 anti-PCSK-9 mAb 2012 2013 2014 2015 Note: Scope includes pharmaceuticals NMEs (excluding LCM – Life cycle management) and vaccines. Only first launches in a given market are mentioned. 21
  • 22. Key R&D Milestones for the Remainder of 2012 2012 Expected Regulatory Submissions Q2 Q3 Q4 ● Lemtrada™ (alemtuzumab) in RMS(1) in the U.S. and EU  ® ● Lyxumia (lixisenatide) in Type 2 diabetes in the U.S.(2)  Expected Headline Data Releases ® ● Lantus - ORIGIN study results  ® ● Lantus - Retrospective cohort studies results  ● Aubagio™ (teriflunomide) – TOWER headline Phase III results in RMS (3) ● Dengue vaccine - Phase IIb efficacy results  Expected Phase III Study Initiations ● Anti-PCSK-9 mAb - Phase III program in hypercholesterolemia  ● Sarilumab (Anti-IL-6R mAb) - Second Phase III trial  (1) RMS: Relapsing Forms of Multiple Sclerosis Lemtrada™, Aubagio™ and Lyxumia® are registered trade names submitted (2) Partnership with Zealand Pharma to health authorities for investigational agents (3) Mid year 2012 22
  • 23. Continued Execution of Strategy Expected to DeliverSustainable Growth 2012-2015 2012-2015 Sales CAGR At least 5% Diversified sources of growth  Scale in businesses with significant barriers to entry  Low small molecule patent exposure in mature markets(1) ~6% Large Emerging Markets presence(2) 38-40% Potential new product launches(3) 18 Operating margin evolution Rebounding 2012-2015 Business EPS CAGR > Sales CAGR Increased dividend payout ratio(4) 50% of 2013 results (1) 2012 sales from chemical products exposed to patent expiry in the U.S., Japan and Western Europe over 2012 -2015 (2) Based on 2015 internal estimates (3) Over 2012-2015 23 (4) Dividend paid in 2014