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2013 - Jp Morgan HC 2013 - Jp Morgan HC Presentation Transcript

  • JP Morgan Healthcare ConferenceDr. Elias Zerhouni, President – Global R&D San Francisco, January 8, 2013
  • Forward Looking StatementsThis 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 includeprojections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions andexpectations with respect to future financial results, events, operations, services, product development and potential, andstatements regarding future performance. Forward-looking statements are generally identified by the words "expects","anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofis management believesthat the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict andgenerally beyond the control of Sanofi, that could cause actual results and developments to differ materially from thoseexpressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertaintiesinclude among other things, the uncertainties inherent in research and development, future clinical data and analysis,including post marketing, 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 as theirdecisions regarding labeling and other matters that could affect the availability or commercial potential of such productcandidates, the absence of guarantee that the product candidates if approved will be commercially successful, the futureapproval and commercial success of therapeutic alternatives, the Groups ability to benefit from external growthopportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies andsubsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in thepublic filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "CautionaryStatement Regarding Forward-Looking Statements" in Sanofis annual report on Form 20-F for the year ended December31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise anyforward-looking information or statements. 2
  • Repositioning Sanofi for Sustainable Growth 2005-2008 2009-2012 2013+ Focusing on Generating Transforming Rx Blockbusters Sustainable Growth • Blockbuster drugs • Investing in growth platforms • Growing recurring sales • Patents challenged • Increasing diversification • Improving risk profile • R&D setbacks • Managing patent cliff 3
  • Over 70% of Sales from Growth Platforms and Limited SalesExposure to Patent Cliff(1) as of Q3 2012 (1) (2) Key Genericized Products Sales Growth Platforms Sales (€m and % of Total Sales) (€m and % of Total Sales) €6,412m €5,753m €5,381m €3,339m 70.9% of Total €2,207m 4.4% Sales of Total Sales €813m €752m €399m Q2 Q1 Q2 Q3 Q2 Q1 Q2 Q3 2009 2012 2009 2012 (1) Key genericized products include Lovenox® U.S., Plavix® Western EU, Taxotere® Western EU & U.S., Eloxatin® U.S., Ambien® family U.S., Allegra® U.S., Aprovel® Western EU, Xyzal® U.S., Xatral® U.S., Nasacort® U.S. and BMS Alliance (active ingredients of Plavix® and Avapro® sold to BMS) (2) Growth Platforms include Emerging Markets, Diabetes Solutions, Vaccines, Consumer Health Care, Animal Health, New Genzyme (Rare Diseases and Multiple Sclerosis) and Innovative Products (new product launches which do not belong to the Growth Platforms listed above: Multaq®, Jevtana®, Mozobil® and Zaltrap®) 4
  • Executing Successful Strategy to Reposition Sanofi 1 Increase innovation in R&D Deliver sustainable growth Pursue external growth 2 opportunities and generate improved shareholder returns Adapt structure for future 3 challenges and opportunities 55
  • Multiple Regulatory Milestones Expected in Next Three Months Products Targeted Indications Expected Milestones ® Metastatic EC Decision: Q1 2013 Colorectal Cancer ® Relapsing Forms of CHMP Opinion: Q1 2013 Multiple Sclerosis Relapsing Forms of FDA Decision on File Acceptance: Q1 2013 Multiple Sclerosis CHMP Opinion: Q2 2013 ® EC Decision: Q1 2013 Type 2 Diabetes FDA Decision on File Acceptance: Q1 2013 TM hoFH in the U.S PDUFA Date: Jan 29, 2013(1) New 6-in-1 DTP-HepB-Polio-Hib CHMP Opinion: Q1 2013 Paediatric Vaccine (1) On October 18th 2012, an FDA AdCom recommended Kynamro™ for hoFH Lyxumia®, Kynamro™ and Lemtrada™ are registered trade names submitted to health authorities for investigational agents Zaltrap® is developed in collaboration with Regeneron, Kynamro™ with Isis Pharmaceuticals and Lyxumia® is in-licensed from Zealand Pharma Genzyme is developing Lemtrada™ in MS in collaboration with Bayer HealthCare hoFH: Homozygous Familial Hypercholesterolemia PDUFA: Prescription Drug User Fee Act EC: European Commission CHMP: Committee for Medicinal Products for Human Use 6 DTP-HepB-Polio-Hib: diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus type b
  • Focusing R&D on High-Value Projects in Key Therapeutic Areas 1 Diabetes 2 Oncology 3 Multiple Sclerosis and Rare Diseases 4 Cardio-Metabolic Diseases 5 Immunology 6 Vaccines 7
  • Broadening our Diabetes Platform with New Patient-FocusedSolutions ® ● Once-daily and pronounced PPG lowering effect ● Use on top of basal insulin ● ELIXA: CV outcome study ongoing NEW ● Unique flat PK/PD profile and lower injection volume INSULIN GLARGINE FORMULATION ● EDITION program: six Phase III trials currently ongoing in T1D and T2D(1) ● First state-of-the art reusable insulin pen, manufactured by a global company in India ● For use with Sanofi’s insulin portfolio in India and possibly other Emerging Markets Lyxumia® is the proprietary name submitted to the EMA for the company’s investigational GLP-1 RA lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration. Lixisenatide is not currently approved or licensed anywhere in the world. Lixisenatide was in-licensed from Zealand Pharma A/S. PPG: postprandial glucose PK/PD – Pharmacokinetic/Pharmacodynamic TD1 and TD2: Type 1 and Type 2 diabetes 8 (1) EDITION I, II, III, IV, JPI, JPII - ClinicalTrials.gov Identifier: NCT 1499082, 01499095, 01676220 & 01683266, 01689129 & 01689142
  • ® Clinical Development Designed to Support Use in Combination with Basal Insulin T2D Patients Treated Phase III Program Key Facts about MS with Basal Insulin (1) (worldwide) Mono Monotherapy On basal insulin Mono Japan On basal insulin with controlled F1 (metformin) fasting glucose S (sulfonylurea) but A1c >7%Placebo-controlled M (metformin) in OAD failure P (pioglitazone) 4 million M Asia (metformin) on Lantus® Active-controlled X vs. exenatide 4 million 4 million L on otherPlacebo-controlled basal insulins(2) on top of L Asia basal insulin Duo 1 Next step: to develop a combination of Lantus® and Lyxumia® Lyxumia® is the proprietary name submitted to the EMA for the company’s investigational GLP-1 RA lixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration. Lixisenatide is not currently approved or licensed anywhere in the world. T2D – Type 2 Diabetes A1C – HbA1c or Glycated hemoglobin 9 (1) Adapted from IMS data (2) Includes all types of basal insulins
  • Broad Phase III Program Evaluating Potential Clinical Benefitsof Improved PK/PD Profile of New Glargine Formulation New Insulin Glargine Formulation Depot formation after subcutaneous injection ● Two Phase III trials in T2D high-dose insulin users(1) New Glargine Lantus® ● 1,600 patients Formulation ● Headline results expected in Q2 2013 EDITION I EDITION II T2D Patients T2D Patients Basal Bolus Basal + OAD ● Second set of Phase III studies started in H2 2012(1) EDITION III EDITION IV T2D Patients T1D Patients Insulin Naïve Basal Schematic illustration ● Two new studies also initiated in Japan (JPI and JPII) OAD – Oral anti-diabetic drugs (1) EDITION I, II, III, IV, JPI, JPII - ClinicalTrials.gov Identifier: NCT 1499082, 01499095, 01676220 & 01683266, 01689129 & 01689142 10
  • Focusing R&D on High-Value Projects in Key Therapeutic Areas 1 Diabetes 2 Oncology 3 Multiple Sclerosis and Rare Diseases 4 Cardio-Metabolic Diseases 5 Immunology 6 Vaccines 11
  • U.S. Launch On Track and EU Roll Out Imminent● A novel VEGF trap acting on multiple angiogenic targets● Indicated in combination with FOLFIRI in mCRC patients resistant to or progressing on an oxaliplatin-containing regimen● Significant improvement in Overall Survival demonstrated in the VELOUR study(1)● European launch roll out expected to start as of Q1 2013 Zaltrap® is developed in collaboration with Regeneron (1) Van Cutsem, et al. JCO Oct 1, 2012:3499-3506; VEGF: Vascular endothelial growth factor FOLFIRI: FOL (folinic acid), F (fluorouracil) and IRI (irinotecan) 12 mCRC: Metastatic colorectal cancer
  • JAK2 inhibitor - Addressing Treatment Gaps for Patients withDebilitating Hematologic Malignancies % patients with ≥35% reduction ● Novel selective JAK2 inhibitor in spleen volume from baseline ● Promising Phase II response rate in SAR302503 - Phase II trial patients with myelofibrosis (MF) ● Phase III in MF (JAKARTA) ● Two doses (400 mg and 500 mg) selected ● Enrollment completed ● Headline results in Q2 2013 ● Two Phase II studies ongoing ● Polycythemia vera ● Myelofibrosis patients previously treated with ruxolitinib 13
  • Focusing R&D on High-Value Projects in Key Therapeutic Areas 1 Diabetes 2 Oncology 3 Multiple Sclerosis and Rare Diseases 4 Cardio-Metabolic Diseases 5 Immunology 6 Vaccines 14
  • Global MS Market - Significant and Expected to Grow Multiple Sclerosis Market Key FactsSclerosis Multiple about MS Global Sales(2,3) ● ~2.1m patients worldwide(1) CAGR ● Prevalent in young women >6% (~2:1 female/male ratio) $17.8bn ● Life expectancy 5-10 years lower than unaffected people $12.5bn 54% ● A major impact on family, social and professional life U.S. 56% ● Symptoms include fatigue, weakness, walking and balance 46% difficulties, vision problems ROW 44% 2011 2016e (1) National Multiple Sclerosis Society (2) 2011: Reported sales of Copaxone®, Avonex®, Rebif®, Betaseron/Betaferon®, Extavia®, Tysabri®, and Gilenya® (3) 2016e: Adapted from Evaluate Pharma report - December 2011 15
  • Global MS Market - Still Dominated by ABCRE Products 2011 Sales and Key Facts about MS MS Therapies Market Share in Value(2) ● “ABCRE” products(1) represented 84% of the global MS market in value in 2011 $3,884m 31% ● Moderate efficacy and patients continue to relapse on therapy $1,553m 12% $2,350m ● Require frequent injections 19% ● Latest entrants represent $2,686m treatment alternatives 21% $1,511m $154m ● Drives the benefit vs. risk 12% 1% discussion $494m 4% All trademarks are the property of their respective owners (1) ABCRE stands for Avonex®, Betaseron®/Betaferon®, Copaxone®, Rebif® and Extavia® (2) Reported sales of ABCRE products plus Tysabri®, and Gilenya® in 2011 16
  • ® An Exciting Oral Treatment for Relapsing MS● Aubagio® 14mg is the only oral MS drug to significantly delay disability progression in two Phase III trials(5)● Aubagio® 14mg provided statistically significant reduction in Annualized Relapse Rate● Convenience of OD oral administration to avoid the burden of regular injections● Encouraging Rx launch trends in the U.S. tracking ahead of fingolimod TEMSO STUDY TOWER STUDY TEMSO STUDY TOWER STUDY Annualized Relapse Rate(1) Annualized Relapse Rate(1) Reduction in Progression of Reduction in Progression of Disability(2) Disability(2) - 31.5% - 36.3% -29.8%(3) p=0.0005 0.501 p=0.0001 p=0.0279(4) 0.539 0.273 -31.5%(3) p=0.0442(4) 0.319 0.197 0.369 0.202 0.158 n=363 n=359 n=388 n=370 n=363 n=359 n=388 n=370 Placebo Aubagio® Placebo Aubagio® Placebo Aubagio® Placebo Aubagio® 14mg 14mg 14mg 14mg The most frequent adverse reactions for AUBAGIO® in the placebo-controlled studies were ALT increased, alopecia, diarrhea, influenza, nausea, and paresthesia. The AUBAGIO® label includes a boxed warning citing the risk of hepatotoxicity and teratogenicity (based on animal data). (1) Adjusted for Expanded Disability Status Scale score strata and region at baseline and takes duration of treatment into account (2) At Week 108 (3) Derived using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates (4) Derived from log-rank test with stratification of EDSS strata at baseline and region 17 (5) TEMSO and TOWER; Aubagio® 7mg tablets are also available in the U.S.
  • Only Therapy(1) Slowing Accumulation of Disability Sustained for 6 Months vs. Active Comparator For Illustrative Purposes Higher Hurdle (2) Active Comparators   Placebo Higher Hurdle 3 months EDSS 6 months EDSS: Expended Disability Status Scale (1) Investigational compound (2) Based on CARE-MS II 18
  • Significantly More Effective at Reducing ARR in Pivotal Trials(1) with Unique Dosing Regimen CARE-MS I CARE-MS II Annualized Relapse Rate Annualized Relapse Rate - 49% 0.52 p<0.0001 - 55% p<0.00010.39 0.26 0.18n=187 n=376 n=202 n=426Rebif® Lemtrada™ Rebif® Lemtrada™ ARR: Annualized Relapse Rate (1) CARE-MS I and CARE-MS II were both head-to-head trials comparing Lemtrada™ versus Rebif® 19
  • Eliglustat(1) - A Novel Oral Therapy in Gaucher Disease Change in Spleen Volume ● Potent, novel substrate inhibitor (% change at 9 months) ● Oral therapy +2% ● Eliminating challenges of infusions Eliglustat ● Positive results from ENGAGE, Placebo first Phase III study (vs. placebo) ● Primary endpoint and all secondary endpoints met(2) ● Well tolerated with no serious 30% adverse events reported in the Absolute  primary analysis period Difference ● ENCORE Phase III results (vs. Cerezyme®) expected in early 2013 -28% (1) Eliglustat tartrate is an investigational drug (2) Secondary endpoints included improvements in hemoglobin levels and platelet levels, as well as liver volumes 20
  • Focusing R&D on High-Value Projects in Key Therapeutic Areas 1 Diabetes 2 Oncology 3 Multiple Sclerosis and Rare Diseases 4 Cardio-Metabolic Diseases 5 Immunology 6 Vaccines 21
  • PCSK9 mAb: First in Class and Targeting Unmet Needsin Hypercholesterolemia ● First-in-class fully-human antibody LDL-C Change from baseline (Phase II)(2,4,5) targeting PCSK9 ● Landmark study demonstrated 0 BASELINE WEEK 2 WEEK 4 WEEK 6 WEEK 8 WEEK 10 WEEK 12 that when PCSK9 is disabled, -10 cholesterol and risk of CHD are ∆ - 5.1% -20 greatly lowered(1) -30 ∆ - 39.6% ● Phase II data(2,3) -40 ● Significantly reduced mean LDL-C -50 ∆ - 64.2% by 40% to 72% over 8 to 12 weeks -60 in patients with elevated LDL-C in -70 patients on stable dose of statins ∆ - 72.4% -80 ● Most common TEAE: mild injection SAR236553 100 mg Q2W Placebo SAR236553 50 mg Q2W SAR236553 150 mg Q2W site reaction Decrease in LDL-C shown is at week 12. SAR236553 / REGN727 is developed in collaboration with Regeneron PCSK9: proprotein convertase subtilisin/kexin type 9, an enzyme that can contribute to elevated LDL-C levels through degradation of LDL-C receptors 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 22 * P<0.0001 for % change SAR236553 vs. placebo
  • Sanofi Recently Started the First Ever Phase 3 Program for an Anti-PCSK9 mAb● ODYSSEY: a large global Phase 3 Target Population clinical program evaluating the safety and efficacy of SAR236553 ~21m patients globally estimated not at goal for LDL-C(1) ● 22,000 patients, including those with (mainly at high cardiovascular risk) elevated cardiovascular risk, intolerant to statins or patients with FH Primary ● Injected subcutaneously as one single Secondary Prevention injection every two weeks Prevention ● Evaluating a 1mL auto-injector for both Q2W doses, 75mg and 150mg● Creation of a PCSK9 Development heFH (2) & Launch Unit Statin  Intolerant SAR236553 / REGN727 is developed in collaboration with Regeneron (1) Adapted from Decision Resources 2008, Decision Resources 2010 and CVReg 2011 (2) heFH: Heterozygous Familial Hypercholesterolemia 23
  • Otamixaban: Providing Superior Outcomes while SimplifyingTreatment during Interventional Procedures ● Despite current therapies, death, MI, TAO Study and readmission rates remain high Moderate-to-high risk NSTE-ACS with ● Otamixaban is the first IV direct and planned early invasive strategy (n=13,220) selective factor Xa inhibitor with quick onset/offset R ● 27% to 42% risk reduction in ACS complications including death and MI Otamixaban Otamixaban UFH + in Phase Il(1) Regimen 1 Regimen 2 Eptifibatide (n=1,969) (n=1,969) (n=1,969) ● Phase III TAO study ongoing with results expected in Q2 2013 Sponsor-blinded interim analysis Primary endpoint: Death/Myocardial Infarction @ day 7 (1) The Lancet, Volume 374, Issue 9692, Pages 762 - 764, 5 September 2009 NSTE-ACS – Non-ST-Elevation Acute Coronary Syndrome, MI – Myocardial Infarction, UFH – Unfractionated Heparin 24
  • Focusing R&D on High-Value Projects in Key Therapeutic Areas 1 Diabetes 2 Oncology 3 Multiple Sclerosis and Rare Diseases 4 Cardio-Metabolic Diseases 5 Immunology 6 Vaccines 25
  • Sarilumab (Anti IL-6R mAb): Addressing an Unmet Needin Rheumatoid Arthritis ● ~1/3 of RA patients treated with MOBILITY Trial (Phase IIb Results) anti-TNFα do not respond to therapy ACR response at week 12 (%) ACR20 ● Sarilumab is a fully human, high 66.7 ACR50 65.4 affinity, IL-6R mAb administered ACR70 subcutaneously in combination with methotrexate 46.2 40.4* ● Positive Phase II with meaningful 35.3 improvements in signs & symptoms of moderate-to-severe RA 15.4 17.3* 11.8 ● 2 pivotal Phase III trials ongoing 1.9 ● SARIL-RA-MOBILITY fully enrolled Placebo 150 mg q2w 200 mg q2w ● SARIL-RA-TARGET recruiting * p<0.01 versus placebo (only unadjusted p-values <0.01 are considered statistically significant) ● New studies to start in H1 2013 A&R 2011; 63; suppl.10:4041 Sarilumab is developed in collaboration with Regeneron RA – Rheumatoid Arthritis IL-6R – Interleukin-6 receptor ACR – American College Of Rheumatology (ACR) Scoring System 26
  • Anti IL-4Rα mAb: Targeting Asthma and Atopic Dermatitis ● Fully human monoclonal antibody IL-4 IL-13 binding to IL-4Rα or ● Targeting the common IL-4Rα subunit ● Dual IL-4/IL-13 cytokine antagonism c IL-4R IL-4R IL-13R1 with a single agent ● Positive proof of concept data Type I Type II for asthma and atopic dermatitis Receptor Receptor to be submitted for presentation IL-4 IL-13 at medical conferences in 2013 Dominant (some overlapping) functions in : ● Phase 2b initiation in both • Initiated and drives TH2 • Airway hyper differentiation responsiveness (AHR) indications expected mid-year • Activation and growth • Goblet cell hyperplasia of B cells • Tissue remodeling • Class switching to IgE • Fibrosis and IgG1a • Regulation of • Recruitment of gastrointestinal parasite eosinophils expulsion Anti IL-4Rα mAb is developed in collaboration with Regeneron 27
  • An Innovative Product with a Breakthrough Design(1)● Nearly 6 million people in the U.S. may be at risk for anaphylaxis(2)● One main U.S. competitor with >95% market share(3): EpiPen® from Mylan ● Estimated U.S. sales of $570m(4)● Auvi-Q™ offers a unique compact size and shape ● Audio and visual cues guide users through the injection process ● Retractable needle mechanism● U.S. launch planned in Q1 2013 (1) Sanofi U.S. licensed the North American commercialization rights to the epinephrine auto-injector from Intelliject, Inc., (2) Source: 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Practice Parameters (3) Source: Mylan Form 10-K for the period ending Dec 31, 2011 and Mylan Investor Day on Feb 21, 2012 28 (4) IMS MAT sales through July 2012
  • Focusing R&D on High-Value Projects in Key Therapeutic Areas 1 Diabetes 2 Oncology 3 Multiple Sclerosis and Rare Diseases 4 Cardio-Metabolic Diseases 5 Immunology 6 Vaccines 29
  • Dengue Vaccine: Addressing a Growing Global Threat Significant Disease Ambitious Phase III First Efficacy Results Burden Program ● Estimated 220m dengue ● Phase IIb results in ~4,000 ● Global Phase III program infections worldwide per year patients recently published ongoing in the Lancet ● 2m cases of Hemorrhagic ● Large scale studies in LatAm Fever ● Effective against DENV 1, 3 and Asia and 4 (in the range of 60% to ● >500,000 hospitalizations and 90%), with only DENV 2 ● 31,000 children and >20,000 deaths / year appearing to be resistant adolescents ● Dengue: a public health ● Safe and well-tolerated ● Results expected in 2014 priority in Asia and Latin America 30 30
  • C. Diff Toxoid Vaccine: Preventing Primary SymptomaticClostridium Difficile Infections (CDI) ● Candidate vaccine shown to be safe CDI – A Growing Healthcare Problem and immunogenic in Phase I(1) and Phase II trials ● Most common cause of health care ● Broad functional antibody responses associated infections in developed to both toxins (A and B) countries(2) ● Multinational Phase III trial planned ● In the U.S. alone, a significant burden(3) to start in Q3 2013 ● ~28,000 deaths and up to 450,000 ● Case driven study hospital admissions ● Lot consistency trial to follow ● Associated cost of care: up to $3.4bn ● Fast Track Development Program ● Targeted patients at high risk of CDI: designation granted by CBER ● Elderly with antibiotic use, planned at-risk admissions to hospital and long-term care facilities residents CBER – Center for Biologics Evaluation and Research (1) Greenberg R, Vaccine, March 2012 (2) He M, Nature Genetics, December 2012, and Miller BA, Control Hosp Epidemiol, April 2011 (3) CDC Morbidity and Mortality Weekly Report, March 2012 31
  • Maintaining Rigorous Control of R&D Expenses ● R&D expenses of €4,811m in 2011 R&D/Sales Ratio (%) ● R&D spend of €3,564 million in 9M 16.6% 2012, down 6.0% at CER and with 15.6% 14.1% 14.4% Genzyme proforma reflecting: 13.5% ● Good internal cost management ● Ongoing transforming initiatives ● R&D/Sales ratio down 0.6 points in 9M 2012 vs. 9M 2011 (13.5% vs. 14.1%) FY 2008 FY 2009 FY 2010 FY 2011 9M 2012 32
  • Strengthening the R&D Leadership Team with New Talent Gary Nabel SVP, Chief Scientific Officer Chairman of the Strategic Development and Scientific Advisory Council Andrew Plump Jay Edelberg Deputy of President R&D Head of PCSK9 Launch Unit VP Research and Translational Medicine France NorthBoston hub Germany Tokyo America hub hub Beijing hub Asia Shanghai hub Eckhard Leifke Philippe Monteyne Diabetes - Head of VP Head of R&D France Development Victoria Richon Philip Just Larsen Oncology - Head of Research Diabetes - Head of Research & Early Development & Early Development Rodger Novak VP for Infectious diseases 33
  • Ensuring R&D Contributes to Sanofi’s Success Create an efficient global R&D organization Maximize synergies and convergence around Hub model Leverage economies of scale Improve R&D cost structure Focus on high-value projects Global Execute on late-stage projects R&D Guide early-stage portfolio prioritization utilizing medical value Goals and translational medicine Establish new models of external innovation Enhance the value of external opportunities and partnerships Accelerate science by establishing creative and adapted models with partners across the healthcare ecosystem 34
  • APPENDICESR&D Pipeline 35
  • Late Stage Pipeline – Pharma & Vaccines Phase III Registration eliglustat tartrate N otamixaban N Quadracel® Hexaxim™ / New hexavalent vaccineGlucosylceramide synthetase inhibitor Direct Xa inhibitor Diphtheria, tetanus, pertussis DTP-HepB-Polio-Hib vaccine Gaucher disease ACS & polio vaccine; 4-6 y of age N Insulin glargine VaxiGrip® QIV IM Fluzone® QIV IM iniparib (BSI-201) New formulation Quadrivalent inactivated Quadrivalent inactivated Squamous NSCLC (1L) influenza vaccine Type 1+2 diabetes influenza vaccine SAR302503 (TG101348) N mipomersen Dengue Aubagio® (teriflunomide) N JAK-2 inhibitor Apolipoprotein B-100 antisense Mild-to-severe Relapsing forms of Multiple sclerosis Myelofibrosis (1L) Severe HeFH, U.S. dengue fever vaccine (RMS) – Monotherapy, EU SAR236553 N alemtuzumab N Jevtana® (cabazitaxel) DTP-HepB-Polio-Hib Anti-PCSK-9 mAb Anti-CD52 mAb Metastatic prostate cancer (1L) Pediatric hexavalent vaccine Hypercholesterolemia Multiple sclerosis, EU, U.S. SYNVISC-ONE® sarilumab (SAR153191) N Fluzone® QIV ID Allegra® Medical device Anti-IL-6R mAb Quadrivalent inactivated fexofenadine Pain in hip OA Rheumatoid arthritis influenza vaccine Intradermal Dry syrup, Japan mipomersen N MACI® Apolipoprotein B-100 antisense Cell-based treatment HoFH and severe HeFH in EU; Articular cartilage defects HoFH in U.S. lixisenatide N GLP-1 agonist Type 2 diabetes, EU, Japan, U.S. Zaltrap® (aflibercept) VEGF-Trap 2nd line mCRC, EU N New Molecular Entity Oncology Thrombosis Vaccines Metabolic Disorders Central Nervous System Internal Medicine Ophthalmology Rare Diseases Biosurgery Aging 36
  • Early Stage Pipeline – Pharma & Vaccines Phase II FOV1101 N SAR231893 N iniparib (BSI-201) FDC prednisolone/cyclosporine Anti-IL4 mAb Platinum-resistant ovarian cancer (2L) Allergic conjunctivitis Asthma; Atopic dermatitis SAR3419 N N N SAR292833 (GRC15300) ferroquine Maytansin-loaded anti-CD19 mAb TRPV3 antagonist Antimalarial B-cell malignancies refractory/relapsed Neuropathic pain, osteoarthritic pain Malaria (NHL, ALL) SAR256212 (MM121) N SAR110894 N fresolimumab N anti-ErbB3 mAb H3 antagonist TGFβ antagonist Breast cancer (2L, 3L) Alzheimers disease Fibrosis SAR245408 (XL147) N SAR113945 N SAR97276 N Oral PI3K inhibitor IKK-β inhibitor Antimalarial Breast cancer Osteoarthritis Malaria SAR245409 (XL765) N Meninge ACYW conj. SAR279356 (F598) N Oral dual inhibitor of PI3K & mTOR 2nd generation meningococcal Anti-PNAG mAb Non-Hodgkin lymphoma Conjugate infant vaccine Serious infections SAR302503 (TG101348) ACAM-Cdiff SAR339658 N JAK-2 inhibitor Clostridium difficile VLA 2 antagonist Polycythemia vera (2L) Incyte (ruxolitinib) resistant/intolerant MF Toxoid vaccine Inflammatory bowel disease SAR156597 N Jevtana® (cabazitaxel) Rabies VRVg IL4/IL13 Bi-specific mAb Small cell lung cancer (2L) Purified vero rabies vaccine Idiopathic pulmonary fibrosis N New Molecular Entity Oncology Thrombosis Vaccines Metabolic Disorders Central Nervous System Internal Medicine Ophthalmology Rare Diseases Biosurgery Aging 37
  • Early Stage Pipeline – Pharma & Vaccines Phase I SAR153192 N SAR126119 N SAR252067 N Rotavirus Anti-DLL4 mAb TAFIa inhibitor Anti-LIGHT mAb Live Attenuated Tetravalent Solid tumors Acute ischemic stroke Crohn’s disease & Ulcerative colitis Rotavirus oral vaccine GZ402674 N SAR127963 N SAR100842 N Streptococcus pneumonia Non-camptothecin topo1 inhibitor P75 receptor antagonist LPA-1/LPA-3 Meningitis & pneumonia vaccine Solid tumors Trauma brain injury Skin manifestation of scleroderma N GZ404477 N N SAR650984 SAR113244 Pseudomonas aeruginosa (AAV-hAADC) Anti-CD38 naked mAb Anti-CXCRS mAb Antibody fragment product Gene therapy Hematological malignancies Systemic lupus erythematosus Prevention of ventilator-associated pneumonia Parkinsons disease SAR566658 N N SAR407899 N SAR391786 Tuberculosis Maytansin-loaded anti-DS6 mAb Rho kinase inhibitor Rehabilitation post orthopedic surgery Recombinant subunit vaccine DS6 positive solid tumors Diabetic nephropathy SAR307746 N SAR228810 N lixisenatide + Lantus® RetinoStat® N Anti-Ang2 mAb Anti-protofibrillar AB mAb GLP-1 agonist + insulin glargine Gene therapy Solid tumors Alzheimer’s disease Fix-Flex / Type 2 diabetes Wet age-related macular degeneration (AMD) SAR125844 N N SAR164653 N N SAR399063 StarGen® Cathepsin A inhibitor C-Met kinase inhibitor DHA-GLP + vit D CV-related complications & deaths in Gene therapy Solid tumors Pre-sarcopenia Stargardt disease diabetic patients Combinations N GZ402665 N GZ402663 (sFLT-01) N SAR404460 SAR245409 / MSC1936369B Gene therapy SAR245408/SAR256212 (MM121) DHA-GPL + Vit D (rhASM) Age-related macular degeneration Pre-sarcopenia Niemann-Pick type B Solid tumors (AMD) SAR405838 (MI-773) N GZ402671 N UshStat® N HDM2 / p53 antagonist GCS Inhibitor Gene therapy Solid tumors and hematological malignancies Fabry Disease Usher syndrome 1B SAR260301 N PI3K β selective PTEN – Deficient tumors N New Molecular Entity Oncology Thrombosis Vaccines Metabolic Disorders Central Nervous System Internal Medicine 38 Ophthalmology Rare Diseases Biosurgery Aging
  • R&D Pipeline Summary TableNew Molecular Entities (NMEs) and Vaccines Phase I Phase II Phase III Registration TOTALOncology 8 4 2 0 14Metabolic Disorders 2 0 1 2 5Thrombosis 1 0 1 0 2Central Nervous System 2 0 0 2 4 51Internal Medicine 3 7 1 0 11Ophthalmology 4 1 0 0 5Genetic Diseases 2 0 1 0 3Aging 4 3 0 0 7Vaccines 4 3 5 2 14TOTAL 30 18 11 6 65 48 17 NMEs & Vaccines 39
  • Expected R&D Milestones – Pharmaceuticals Product Event Timing Zaltrap® (aflibercept) Expected EC approval in 2nd line mCRC in EU Q1 2013 Lyxumia® (lixisenatide) Expected EC approval in type 2 diabetes in EU Q1 2013 Lyxumia® (lixisenatide) Expected FDA file acceptance in type 2 diabetes in U.S. Q1 2013 AubagioTM (teriflunomide) Expected CHMP decision in RMS in EU Q1 2013 Kynamro™ (mipomersen) Expected FDA decision in hoFH in the U.S. Q1 2013 eliglustat tartrate Phase III headline results in Gaucher disease (ENCORE) Q1 2013 Lemtrada™ (alemtuzumab) Expected CHMP decision in RMS in EU Q2 2013 iniparib Phase III headline results in 1st line squamous NSCLC Q2 2013 otamixaban Phase III headline results in ACS Q2 2013 JAK2 inhibitor Phase III headline results in myelofibrosis Q2 2013 Insulin glargine (new formulation) First Phase III headline results in diabetes Q2 2013 40
  • Expected R&D Milestones – Vaccines Product Event Timing Vaxigrip® QIV IM Expected submission of regulatory file in EU Q1 2013 6-in-1 paediatric vaccine Expected CHMP opinion in EU Q1 2013 Fluzone® QIV IM Expected FDA decision in the U.S. Q2 2013 C. Diff vaccine Expected start of Phase III study Q3 2013 41