BofA MERRILL LYNCH HEALTHCARE CONFERENCEDr. Paul Chew,SVP, Chief Medical Officer / Head of Global Medical AffairsMay 14, 2...
2Forward Looking StatementsThis presentation contains forward-looking statements as defined in the Private Securities Liti...
33Building a Company with Sustainable Growth2009-2012Transforming whilemanaging the cliff• Investing in growth platforms• ...
Growth Platforms Grew by +8.6% in Q1 2013and Reached 71% of Sales4(1) Genzyme perimeter includes Rare Diseases and Multipl...
Q1 2013 Sales Were Affected by U.S. Loss of Exclusivityof Eloxatin® in August 2012 and by FX Fluctuations€9,040mQ4 2012€8,...
Q1 2013€1.22Q4 2012Q2 2012€1.17€1.46Q3 2012Q1 2012€1.67€1.83As Anticipated, Q1 2013 Business EPS Was Betterthan Q4 2012 Tr...
Executing a Successful StrategyDeliver sustainablelong-term growthand maximizeshareholder returnsSeize value-enhancing gro...
®Type 2 Diabetes EU roll-out started in late March 2013Recent Regulatory Approvals Have Resultedin Six New Product Launche...
Several Important Study Releases and RegulatoryMilestones Achieved in the Last 4 Months9Clinical Data Releases● Eliglustat...
Additional Phase III Trial Readouts and RegulatoryDecisions Expected Throughout 2013102013Expected Headline Phase III Data...
1111Focusing R&D on High-Value Projectsin Key Therapeutic Areas1 Diabetes2 Oncology3 Multiple Sclerosis and Rare Diseases4...
Broadening our Diabetes Platform with NewPatient-Focused Solutions12® ● Once-daily and pronounced PPG lowering effect● Use...
The proprietary name for lixisenatide in the U.S. is under consideration. Lixisenatide was in-licensed from Zealand Pharma...
Key Facts about MST2D Patients Treatedwith Basal Insulin(1) (worldwide)On basal insulinOn basal insulinwith controlledfast...
15Broad Phase III Program Evaluating Potential Clinical Benefitsof Improved PK/PD Profile of New Glargine FormulationEDITI...
16161 Diabetes2 Oncology3 Multiple Sclerosis and Rare Diseases4 Cardio-Metabolic Diseases5 Immunology6 VaccinesFocusing R&...
● Novel selective JAK2 inhibitor● Promising Phase II response rate inpatients with myelofibrosis (MF)● Phase III in MF (JA...
18181 Diabetes2 Oncology3 Multiple Sclerosis and Rare Diseases4 Cardio-Metabolic Diseases5 Immunology6 VaccinesFocusing R&...
Key Facts about MSMS TherapiesGlobal MS Market - Still Dominated by ABCRE Products19(1) ABCRE stands for Avonex®, Betasero...
2020(1) IMS Weekly Total Prescriptions(2) Based on data collected at Genzymes MS One to One™ Patient and Provider Support ...
2121®Reduction in Progression of DisabilityCARE-MS I CARE-MS IIAnnualized Relapse Rate● Significant efficacy results vs Re...
ENGAGE ENCOREPatients 40 160Study Duration 9 months 12 monthsPatientPopulationTreatmentnaïveStabilized onERT treatmentTrea...
23231 Diabetes2 Oncology3 Multiple Sclerosis and Rare Diseases4 Cardio-Metabolic Diseases5 Immunology6 VaccinesFocusing R&...
Alirocumab: First in Class and Targeting Unmet Needsin Hypercholesterolemia24LDL-C Change from baseline (Phase II)(2,4,5)S...
~21m patients globallyestimated not at goal for LDL-C(1)(mainly at high cardiovascular risk)Sanofi Commenced the First Pha...
Otamixaban: Providing Superior Outcomes WhileSimplifying Treatment During Interventional Procedures● Despite current thera...
27271 Diabetes2 Oncology3 Multiple Sclerosis and Rare Diseases4 Cardio-Metabolic Diseases5 Immunology6 VaccinesFocusing R&...
Sarilumab (Anti IL-6R mAb): Addressing an Unmet Needin Rheumatoid Arthritis● ~1/3 of RA patients treated withanti-TNFα do ...
● Fully human monoclonal antibodybinding to IL-4Rα● Targeting the common IL-4Rα subunit● Dual IL-4/IL-13 cytokine antagoni...
Launching the First and OnlyVoice-Guided Epinephrine Auto-Injector(1)(1) Sanofi U.S. licensed the North American commercia...
31311 Diabetes2 Oncology3 Multiple Sclerosis and Rare Diseases4 Cardio-Metabolic Diseases5 Immunology6 VaccinesFocusing R&...
32Dengue Vaccine: Addressing a Growing Global ThreatFirst Efficacy Results● Phase IIb results in ~4,000patients recently p...
FY 2008 FY 2009 FY 2010 FY 2011 FY 201214.1%Maintaining Rigorous Control of R&D Expenses WhileInvesting Significantly in P...
Ensuring R&D Contributes to Sanofi’s SuccessGlobalR&DGoalsCreate an efficient global R&D organizationMaximize synergies an...
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2013 - BofA Merrill Lynch Healthcare Conference

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2013 - BofA Merrill Lynch Healthcare Conference

  1. 1. BofA MERRILL LYNCH HEALTHCARE CONFERENCEDr. Paul Chew,SVP, Chief Medical Officer / Head of Global Medical AffairsMay 14, 2013
  2. 2. 2Forward 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 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,and statements regarding future performance. Forward-looking statements are generally identified by the words"expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofismanagement believes that the expectations reflected in such forward-looking statements are reasonable, investors arecautioned that forward-looking information and statements are subject to various risks and uncertainties, many of whichare difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments todiffer materially from those expressed in, or implied or projected by, the forward-looking information and statements.These risks and uncertainties include 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 theEMA, regarding whether and when to approve any drug, device or biological application that may be filed for any suchproduct candidates as well as their decisions regarding labeling and other matters that could affect the availability orcommercial potential of such product candidates, the absence of guarantee that the product candidates if approved willbe commercially successful, the future approval and commercial success of therapeutic alternatives, the Groups abilityto benefit from 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 as thosediscussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under"Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofis annual report on Form20-F for the year ended December 31, 2012. Other than as required by applicable law, Sanofi does not undertake anyobligation to update or revise any forward-looking information or statements.
  3. 3. 33Building a Company with Sustainable Growth2009-2012Transforming whilemanaging the cliff• Investing in growth platforms• Increasing diversification• Disciplined cost management2013+Generatingsustainable growth• Growing recurring sales• Launching innovative drugs• Optimizing capital allocation2005-2008Focusing onRx blockbusters• Blockbuster drugs• Patents challenged• R&D setbacks
  4. 4. Growth Platforms Grew by +8.6% in Q1 2013and Reached 71% of Sales4(1) Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises(2) Includes new product launches which do not belong to the other Growth Platforms listed above: Multaq®, Jevtana®, Mozobil®, Zaltrap® and Auvi-Q™+19.6%+3.1%+15.9%-3.1%+25.5%Other Innovative Products(2)€157m +13.7%+6.5%Consumer Healthcare €811mDiabetes Solutions €1,542mVaccines €697mAnimal Health €554mEmerging Markets €2,719mGenzyme(1)€493mQ1 2013 growth at CER
  5. 5. Q1 2013 Sales Were Affected by U.S. Loss of Exclusivityof Eloxatin® in August 2012 and by FX Fluctuations€9,040mQ4 2012€8,526mQ3 2012Q2 2012€8,870mQ1 2012€8,511mQ1 2013€8,059mSales5(1) Reported sales of Eloxatin® in the U.S. were €321m in Q1 2012 but only €8m in Q1 2013.(2) On a reported basis, sales in Q1 2013 were down -5.3%.The negative currency impact in Q1 2013 was €212m.-2.8%at CER(1)
  6. 6. Q1 2013€1.22Q4 2012Q2 2012€1.17€1.46Q3 2012Q1 2012€1.67€1.83As Anticipated, Q1 2013 Business EPS Was Betterthan Q4 2012 TroughBusiness EPS6-29.0%at CER(2)(1) With the retroactive application of IAS19R(2) On a reported basis, Q1 2013 EPS was down -33.3%Sanofi expects to resume Business EPS growth in H2 2013(1) (1) (1) (1)
  7. 7. Executing a Successful StrategyDeliver sustainablelong-term growthand maximizeshareholder returnsSeize value-enhancing growthopportunities317Adapt structure for futurechallenges and opportunities4Bring innovative products to market27Grow a global healthcare leaderwith synergistic platforms
  8. 8. ®Type 2 Diabetes EU roll-out started in late March 2013Recent Regulatory Approvals Have Resultedin Six New Product Launches8Zaltrap® is developed in collaboration with Regeneron, Kynamro™ with Isis Pharmaceuticals and Lyxumia® is in-licensedfrom Zealand Pharma. Sanofi U.S. licensed the North American commercialization rights to AUVI-Q™ from Intelliject Inc.Launch StatusProducts®MetastaticColorectal CancerIndicationsLaunched in the U.S. in August 2012EU roll-out started in late March 2013Relapsing Formsof Multiple Sclerosis®Launched in the U.S. in October 2012Launched in the U.S. in January 2013Life-Threatening AllergicReactionsPrevention of Poliomyelitis Launched in Japan in September 2012Homozygous FamilialHypercholesterolemiaLaunched in the U.S. in late March 2013
  9. 9. Several Important Study Releases and RegulatoryMilestones Achieved in the Last 4 Months9Clinical Data Releases● Eliglustat tartrate - Phase III inGaucher disease (ENCORE)● Dupilumab - PoC in Atopic Dermatitisand Severe Asthma● Lemtrada™ - Phase III in MS (1-yearExtension of CARE-MS Program)● Aubagio® - Phase III in ClinicallyIsolated Syndrome (TOPIC)Regulatory Milestones● Lemtrada™ FDA file acceptance in MS● Aubagio® positive CHMP opinion inMS and request for CHMP re-examination of NAS designation filed● Lyxumia®FDA file acceptance in type IIdiabetes● Hexyon®/Hexacima®EC approval(DTaP-IPV-Hib-HepB vaccine)● Quadrivalent Influenza Vaccineaccepted for review in EULemtrada™ is the registered trade name for alemtuzumab in MS submitted to health authorities.Lemtrada™ is developed in collaboration with Bayer HealthCare
  10. 10. Additional Phase III Trial Readouts and RegulatoryDecisions Expected Throughout 2013102013Expected Headline Phase III Data Releases Q2 Q3 Q4● New insulin glargine formulation in Diabetes (EDITION I & II) ● Otamixaban in Acute Coronary Syndrome (TAO) ● JAK2 inhibitor in Myelofibrosis (JAKARTA) ● Iniparib in Squamous Non Small Cell Lung Cancer ● Alirocumab (Anti-PCSK9) in Hypercholesterolemia (ODYSSEY Mono) Expected Regulatory Milestones Q2 Q3 Q4● Fluzone® Quadrivalent IM FDA decision in the U.S. ● Lemtrada™ CHMP opinion in Multiple Sclerosis in EU ● Lemtrada™ FDA decision in Multiple Sclerosis in the U.S.● Eliglustat regulatory submission in the U.S. and EU in Gaucher disease 
  11. 11. 1111Focusing R&D on High-Value Projectsin Key Therapeutic Areas1 Diabetes2 Oncology3 Multiple Sclerosis and Rare Diseases4 Cardio-Metabolic Diseases5 Immunology6 Vaccines
  12. 12. Broadening our Diabetes Platform with NewPatient-Focused Solutions12® ● Once-daily and pronounced PPG lowering effect● Use on top of basal insulin● ELIXA: CV outcome study ongoingLyxumia® is the proprietary name approved by the EMA for ixisenatide. The proprietary name for lixisenatidein the U.S. is under consideration. The U.S. FDA file acceptance occurred in February 2013. 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(1) EDITION I, II, III, IV, JPI, JPII - ClinicalTrials.gov Identifier: NCT 1499082, 01499095, 01676220 & 01683266, 01689129 & 01689142● Evaluating potential clinical benefits of improved PK/PDprofile and lower injection volume● EDITION program: six Phase III trials in T1D and T2D(1)● In order to complete its portfolio of insulin products,the Group initiated a biosimilar program● Two projects in Phase I clinical developmentNEWINSULIN GLARGINEFORMULATIONInsulinBiosimilarProgram
  13. 13. The proprietary name for lixisenatide in the U.S. is under consideration. Lixisenatide was in-licensed from Zealand Pharma A/S.A1C – HbA1c or Glycated hemoglobin(1) Adapted from IMS dataNow Approved in Europefor the Treatment of Type 2 Diabetes®13● ~4m patients worldwide on basal insulin with controlled fasting glucosebut with A1c >7%(1)● Pronounced post-prandial glucose lowering effect of Lyxumia®● Clinical development designed to support use on top of basal insulin● cardiovascular outcomes study ongoing● FDA file accepted in February 2013● Launched in Germany and the UKin March 2013First Once-a-Day Prandial GLP-1 Receptor Agonist
  14. 14. Key Facts about MST2D Patients Treatedwith Basal Insulin(1) (worldwide)On basal insulinOn basal insulinwith controlledfasting glucosebut A1c >7%4 millionon otherbasal insulins(2)4 millionon Lantus®4 millionLyxumia® is the proprietary name submitted to the EMA for the company’s investigational GLP-1 RA lixisenatide. The proprietary name for lixisenatidein the U.S. is under consideration.T2D – Type 2 Diabetes A1C – HbA1c or Glycated hemoglobin(1) Adapted from IMS data (2) Includes all types of basal insulinsClinical Development Designed to SupportUse in Combination with Basal Insulin®14MonoMono JapanMonotherapyPlacebo-controlledin OAD failureM (metformin)F1 (metformin)M Asia (metformin)S (sulfonylurea)P (pioglitazone)X vs. exenatideActive-controlledL AsiaLPlacebo-controlledon top ofbasal insulin Duo 1Phase III ProgramCurrently Developing a Combination of Lantus® and Lyxumia®
  15. 15. 15Broad Phase III Program Evaluating Potential Clinical Benefitsof Improved PK/PD Profile of New Glargine FormulationEDITION IT2D PatientsBasal BolusEDITION IIT2D PatientsBasal + OADPK/PD – Pharmacokinetic/Pharmacodynamic T1D and T2D: Type 1 and Type 2 diabetes OAD – Oral anti-diabetic drugs(1) EDITION I, II, III, IV, JPI, JPII - ClinicalTrials.gov Identifier: NCT 1499082, 01499095, 01676220 & 01683266, 01689129 & 01689142New Insulin Glargine FormulationDepot formation after subcutaneous injectionSchematic illustrationLantus® New GlargineFormulation15EDITION IIIT2D PatientsInsulin NaïveEDITION IVT1D PatientsBasal● Two Phase III trials in T2D high-doseinsulin users(1)● EDITION I results to be presented atthe ADA in June 2013● EDITION II headline results to becommunicated at the same time● Second set of four Phase III studiesstarted in H2 2012(1)● Two new studies also initiated in Japan(JPI and JPII)
  16. 16. 16161 Diabetes2 Oncology3 Multiple Sclerosis and Rare Diseases4 Cardio-Metabolic Diseases5 Immunology6 VaccinesFocusing R&D on High-Value Projectsin Key Therapeutic Areas
  17. 17. ● Novel selective JAK2 inhibitor● Promising Phase II response rate inpatients 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 previouslytreated with ruxolitinib% patients with ≥35% reductionin spleen volume from baselineJAK2 Inhibitor - Addressing Treatment Gaps for Patientswith Debilitating Hematologic MalignanciesSAR302503 - Phase II trial17
  18. 18. 18181 Diabetes2 Oncology3 Multiple Sclerosis and Rare Diseases4 Cardio-Metabolic Diseases5 Immunology6 VaccinesFocusing R&D on High-Value Projectsin Key Therapeutic Areas
  19. 19. Key Facts about MSMS TherapiesGlobal MS Market - Still Dominated by ABCRE Products19(1) ABCRE stands for Avonex®, Betaseron®/Betaferon®, Copaxone®, Rebif® and Extavia®(2) Reported sales of ABCRE products plus Tysabri®, and Gilenya® in 2012● A $13.8bn market in 2012 growingat a high single digit rate● “ABCRE” products(1) represented~80% of the global MS market invalue in 2012● Moderate efficacy and patientscontinue to relapse on therapy● Require frequent injections● Latest oral entrants represent newtreatment alternatives$3,996m29%$2,913m21%$1,569m11% $2,339m17%$1,630m12%2012 Sales andMarket Share in Value(2)$1,195m9%$159m1%All trademarks are the property of their respective owners
  20. 20. 2020(1) IMS Weekly Total Prescriptions(2) Based on data collected at Genzymes MS One to One™ Patient and Provider Support Center, Sep 2012-Jan 2013(3) NAS: New Active Substance(4) Clinical results for 14 mg dose; 7mg tablets are also available; CDMS = Clinically Definite Multiple Sclerosis®● Aubagio® Q1 2013 sales of €20m● Encouraging U.S. launch trends(1,2)● >83% of patients switched toAUBAGIO® were most recentlyon IFN-beta or Copaxone®● Positive CHMP opinion granted inMarch 2013● Request for CHMP re-examination ofNAS designation filed(3)● Ongoing regulatory review ofLemtrada™ in EU and the U.S.A Promising Entry in the Large MS MarketLemtrada™ is the registered trade name for alemtuzumab in MS submitted to health authoritiesLemtrada™ is developed in collaboration with Bayer HealthCareRELAPSE 31%DISABILITY 30%TEMSO(4)TOWER(4)TOPIC(4)RELAPSE 36%DISABILITY 31%REDUCTION IN RISK OFCONVERSION TO CDMS43%
  21. 21. 2121®Reduction in Progression of DisabilityCARE-MS I CARE-MS IIAnnualized Relapse Rate● Significant efficacy results vs Rebif®● Significantly reduced ARR in twostudies● Reduction of risk of six-monthsustained accumulation of disability● Safety profile generally managed withmonthly monitoring and conventionaltherapies● Infusion-associated reactions(2)● Infections more common in Lemtrada™patients(3)● Autoimmune events (thyroid disorders,ITP and neuropathies) detected viamonitoring and generally managedusing conventional therapies● Unique annual dosingSignificant Efficacy vs. Active Comparator(1)Lemtrada™ is not yet commercially marketedARR: Annualized Relapse Rate ITP: Idiopathic Thrombocytopenic PurpuraCARE-MS I and CARE-MS II were both head-to-head trials comparing Lemtrada™ versus Rebif®(1) Based on CARE-MS II study(2) Infusion-associated reactions were most common AE and were effectively managed with standard therapies(3) Risk of infections higher with Lemtrada™ and majority were mild to moderate
  22. 22. ENGAGE ENCOREPatients 40 160Study Duration 9 months 12 monthsPatientPopulationTreatmentnaïveStabilized onERT treatmentTreatmentArmseliglustatvs. placeboeliglustatvs. Cerezyme®Primary endpointmet  Secondary endpointsmet  22Phase IIIRegistration TrialsEliglustat(1)- A Novel Oral Therapy in Gaucher Disease● Innovative substrate inhibitor● Oral therapy● Eliminating challenges of infusions● Positive phase III results● ENGAGE(2): 30% absolute differencein spleen volume vs. placebo● ENCORE(3): non-inferiority efficacycriteria vs. Cerezyme met● No serious adverse events reportedin the primary analysis period(1) Eliglustat tartrate is an investigational drug and not yet approved(2) Primary endpoint was change in spleen volume. Secondary endpoints included improvements in hemoglobin levels, platelet levels andliver volume. Absolute difference in spleen volume p<0.0001.(3) Primary endpoint was stability of all composite endpoints for spleen volume, hemoglobin levels, platelet counts, and liver volumes.Secondary endpoints included stability criteria for the individual components of the composite endpoints including spleen volume,hemoglobin levels, platelet levels and liver volume
  23. 23. 23231 Diabetes2 Oncology3 Multiple Sclerosis and Rare Diseases4 Cardio-Metabolic Diseases5 Immunology6 VaccinesFocusing R&D on High-Value Projectsin Key Therapeutic Areas
  24. 24. Alirocumab: First in Class and Targeting Unmet Needsin Hypercholesterolemia24LDL-C Change from baseline (Phase II)(2,4,5)SAR236553 / REGN727 is developed in collaboration with RegeneronPCSK9: proprotein convertase subtilisin/kexin type 9, an enzyme that can contribute to elevated LDL-C levels through degradation of LDL-C receptorsCHD – Coronary Heart Disease LDL-C : Low Density Lipoprotein-Cholesterol TEAE : Treatment-Emergent Adverse Event(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 - p<0.0001 for % change SAR236553 vs. placebo● First-in-class fully-humanantibody targeting PCSK9● Landmark study demonstratedthat when PCSK9 is disabled,cholesterol and risk of CHDare greatly lowered(1)● Phase II data(2,3)● Significantly reduced meanLDL-C by 40% to 72% over8 to 12 weeks in patients withelevated LDL-C on stable doseof statins● Most common TEAE: mildinjection site reaction-80-70-60-50-40-30-20-100BASELINE WEEK 2 WEEK 4 WEEK 6 WEEK 8 WEEK 10 WEEK 12SAR236553 100 mg Q2W PlaceboSAR236553 50 mg Q2W SAR236553 150 mg Q2W∆ - 64.2%∆ - 5.1%∆ - 39.6%∆ - 72.4%Decrease in LDL-C shown is at week 12.
  25. 25. ~21m patients globallyestimated not at goal for LDL-C(1)(mainly at high cardiovascular risk)Sanofi Commenced the First Phase IIIProgram for an Anti-PCSK9 mAb25● ODYSSEY: a large global Phase IIIclinical program evaluating thesafety and efficacy of alirocumab● 22,000 patients, including those withelevated cardiovascular risk, intolerantto statins or patients with FH● Injected subcutaneously as one singleinjection every two weeks● Evaluating a 1mL auto-injector forboth Q2W doses, 75mg and 150mg● PCSK9 Development & Launch Unitcreated● Phase III ODYSSEY Mono dataexpected in Q3 2013(1) Adapted from Decision Resources 2008, Decision Resources 2010 and CVReg 2011(2) heFH: Heterozygous Familial HypercholesterolemiaTarget PopulationStatinIntolerantheFH(2)SecondaryPreventionPrimaryPreventionSAR236553 / REGN727 is developed in collaboration with Regeneron
  26. 26. Otamixaban: Providing Superior Outcomes WhileSimplifying Treatment During Interventional Procedures● Despite current therapies, death, MI,and readmission rates remain high● Otamixaban is the first IV direct andselective factor Xa inhibitor withquick onset/offset● 27% to 42% risk reduction in ACScomplications including death and MIin Phase Il(1)● Phase III TAO study ongoing withresults expected in Q2 2013(1) The Lancet, Volume 374, Issue 9692, Pages 762 - 764, 5 September 2009NSTE-ACS – Non-ST-Elevation Acute Coronary Syndrome MI – Myocardial Infarction UFH – Unfractionated HeparinTAO StudyModerate-to-high risk NSTE-ACS withplanned early invasive strategy (n=13,220)Primary endpoint:Death/Myocardial Infarction @ day 7OtamixabanRegimen 2(n=1,969)OtamixabanRegimen 1(n=1,969)UFH +Eptifibatide(n=1,969)R26Sponsor-blindedinterim analysis
  27. 27. 27271 Diabetes2 Oncology3 Multiple Sclerosis and Rare Diseases4 Cardio-Metabolic Diseases5 Immunology6 VaccinesFocusing R&D on High-Value Projectsin Key Therapeutic Areas
  28. 28. Sarilumab (Anti IL-6R mAb): Addressing an Unmet Needin Rheumatoid Arthritis● ~1/3 of RA patients treated withanti-TNFα do not respond totherapy● Sarilumab is a fully human, highaffinity, IL-6R mAb administeredsubcutaneously in combinationwith methotrexate● Positive Phase II with meaningfulimprovements in signs & symptomsof moderate-to-severe RA● 2 pivotal Phase III trials ongoing● SARIL-RA-MOBILITY fully enrolled● SARIL-RA-TARGET recruiting● New studies to start in Q2 2013MOBILITY Trial (Phase IIb Results)Sarilumab is developed in collaboration with RegeneronRA – Rheumatoid ArthritisIL-6R – Interleukin-6 receptorACR – American College of Rheumatology (ACR) Scoring System200 mg q2w17.3*40.4*65.4150 mg q2w11.835.366.7Placebo1.915.446.2ACR70ACR50ACR20* p<0.01 versus placebo (only unadjusted p-values <0.01 are considered statistically significant)ACR response at week 12 (%)A&R 2011; 63; suppl.10:404128
  29. 29. ● Fully human monoclonal antibodybinding to IL-4Rα● Targeting the common IL-4Rα subunit● Dual IL-4/IL-13 cytokine antagonismwith a single agent● Positive proof of concept datafor asthma and atopic dermatitisto be submitted for presentationat medical conferences in 2013● Phase IIb initiation in bothindications expected mid-yearAnti IL-4Rα mAb is developed in collaboration with RegeneronIL-4IL-4R cType IReceptorType IIReceptorIL-13IL-4R IL-13R1orIL-4 IL-13Dominant (some overlapping) functions in :• Initiated and drives TH2differentiation• Activation and growthof B cells• Class switching to IgEand IgG1a• Recruitment ofeosinophils• Airway hyperresponsiveness (AHR)• Goblet cell hyperplasia• Tissue remodeling• Fibrosis• Regulation ofgastrointestinal parasiteexpulsionAnti IL-4Rα mAb: Targeting Asthma and Atopic Dermatitis29
  30. 30. Launching the First and OnlyVoice-Guided Epinephrine Auto-Injector(1)(1) Sanofi U.S. licensed the North American commercialization rights to the epinephrine auto-injector from Intelliject, Inc.,(2) 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Practice Parameters(3) IMS MAT Data Dec 2012(4) Mylan Form 10-K for the period ending Dec 31, 2011 and Mylan Investor Day on Feb 21, 2012● Up to 6 million people in the U.S.may be at risk for anaphylaxis(2)● Epinephrine auto-injector marketestimated at $665m in 2012(3)● One main U.S. competitor with >95%market share(4): EpiPen® from Mylan● Auvi-Q™ offers a unique compactsize and shape● Audio and visual cues guide usersthrough the injection process● Retractable needle mechanism● Launched in the U.S. and Canadain Jan 201330
  31. 31. 31311 Diabetes2 Oncology3 Multiple Sclerosis and Rare Diseases4 Cardio-Metabolic Diseases5 Immunology6 VaccinesFocusing R&D on High-Value Projectsin Key Therapeutic Areas
  32. 32. 32Dengue Vaccine: Addressing a Growing Global ThreatFirst Efficacy Results● Phase IIb results in ~4,000patients recently publishedin the Lancet● Effective against DENV 1, 3and 4 (in the range of 60% to90%), with only DENV 2appearing to be resistant● Safe and well-toleratedSignificant DiseaseBurden● Estimated 220m dengueinfections worldwide per year● 2m cases of HemorrhagicFever● >500,000 hospitalizations and>20,000 deaths / year● Dengue: a public healthpriority in Asia and LatinAmerica32Ambitious Phase IIIProgram● Global Phase III programongoing● Large scale studies in LatAmand Asia● 31,000 children andadolescents● Results expected in 2014
  33. 33. FY 2008 FY 2009 FY 2010 FY 2011 FY 201214.1%Maintaining Rigorous Control of R&D Expenses WhileInvesting Significantly in Phase III Trials33● R&D expenses of €4,922m in 2012,down -1.0% at CER or -3.6% atCER with Genzyme pro formareflecting:● Good internal cost management● Ongoing transforming initiatives● Start of multiple Phase III trials (e.g.alirocumab, new insulin glargineformulation, sarilumab, JAK2)● R&D/Sales ratio down 0.3 pointsin 2012 vs. 201133R&D/Sales Ratio (%)14.4% 14.1%16.6%15.6%
  34. 34. Ensuring R&D Contributes to Sanofi’s SuccessGlobalR&DGoalsCreate an efficient global R&D organizationMaximize synergies and convergence around Hub modelLeverage economies of scaleImprove R&D cost structureFocus on high-value projectsExecute on late-stage projectsGuide early-stage portfolio prioritization utilizing medical value andtranslational medicineEstablish new models of external innovationEnhance the value of external opportunities and partnershipsAccelerate science by establishing creative and adapted modelswith partners across the healthcare ecosystem34

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