BofA MERRILL LYNCH HEALTHCARE CONFERENCE

Transcription

1 BofA MERRILL LYNCH HEALTHCARE CONFERENCE Dr. Paul Chew, SVP, Chief Medical Officer / Head of Global Medical Affairs May 14, 2013

2 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 underlying assumptions, statements regarding plans, objectives, intentions and expectations 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 Sanofi's management believes that 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 and generally beyond the control of Sanofi, that could cause actual results and developments to differ 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 the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed 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 Sanofi's annual report on Form 20-F for the year ended December 31, Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. 2

3 Building a Company with Sustainable Growth Focusing on Rx blockbusters Blockbuster drugs Patents challenged R&D setbacks Transforming while managing the cliff Investing in growth platforms Increasing diversification Disciplined cost management Generating sustainable growth Growing recurring sales Launching innovative drugs Optimizing capital allocation 3

4 Growth Platforms Grew by +8.6% in Q and Reached 71% of Sales Emerging Markets Diabetes Solutions 2,719m 1,542m Q growth at CER +6.5% +19.6% Consumer Healthcare 811m Vaccines 697m Animal Health 554m Genzyme (1) 493m +3.1% +15.9% -3.1% +25.5% Other Innovative Products (2) 157m +13.7% (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 4

5 Q Sales Were Affected by U.S. Loss of Exclusivity of Eloxatin in August 2012 and by FX Fluctuations Sales 8,511m 8,870m 9,040m 8,526m 8,059m -2.8% at CER (1) Q Q Q Q Q (1) Reported sales of Eloxatin in the U.S. were 321m in Q but only 8m in Q (2) On a reported basis, sales in Q were down -5.3%. The negative currency impact in Q was 212m. 5

6 As Anticipated, Q Business EPS Was Better than Q Trough Business EPS % at CER (2) Q (1) (1) (1) (1) Q Q Q Q Sanofi expects to resume Business EPS growth in H (1) With the retroactive application of IAS19R (2) On a reported basis, Q EPS was down -33.3% 6

7 Executing a Successful Strategy 1 Bring innovative products to market 2 3 Grow a global healthcare leader with synergistic platforms Seize value-enhancing growth opportunities Deliver sustainable long-term growth and maximize shareholder returns 4 Adapt structure for future challenges and opportunities 7

8 Recent Regulatory Approvals Have Resulted in Six New Product Launches Products Indications Launch Status Metastatic Colorectal Cancer Launched in the U.S. in August 2012 EU roll-out started in late March 2013 Prevention of Poliomyelitis Launched in Japan in September 2012 Relapsing Forms of Multiple Sclerosis Life-Threatening Allergic Reactions Launched in the U.S. in October 2012 Launched in the U.S. in January 2013 Type 2 Diabetes EU roll-out started in late March 2013 Homozygous Familial Hypercholesterolemia Launched in the U.S. in late March 2013 Zaltrap is developed in collaboration with Regeneron, Kynamro with Isis Pharmaceuticals and Lyxumia is in-licensed from Zealand Pharma. Sanofi U.S. licensed the North American commercialization rights to AUVI-Q from Intelliject Inc. 8

9 Several Important Study Releases and Regulatory Milestones Achieved in the Last 4 Months Clinical Data Releases Regulatory Milestones Eliglustat tartrate - Phase III in Gaucher disease (ENCORE) Dupilumab - PoC in Atopic Dermatitis and Severe Asthma Lemtrada - Phase III in MS (1-year Extension of CARE-MS Program) Aubagio - Phase III in Clinically Isolated Syndrome (TOPIC) Lemtrada FDA file acceptance in MS Aubagio positive CHMP opinion in MS and request for CHMP reexamination of NAS designation filed Lyxumia FDA file acceptance in type II diabetes Hexyon /Hexacima EC approval (DTaP-IPV-Hib-HepB vaccine) Quadrivalent Influenza Vaccine accepted 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 9

10 Additional Phase III Trial Readouts and Regulatory Decisions Expected Throughout Expected 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 10

11 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

12 Broadening our Diabetes Platform with New Patient-Focused Solutions Once-daily and pronounced PPG lowering effect Use on top of basal insulin ELIXA: CV outcome study ongoing NEW INSULIN GLARGINE FORMULATION Evaluating potential clinical benefits of improved PK/PD profile and lower injection volume EDITION program: six Phase III trials in T1D and T2D (1) Insulin Biosimilar Program In order to complete its portfolio of insulin products, the Group initiated a biosimilar program Two projects in Phase I clinical development Lyxumia is the proprietary name approved by the EMA for ixisenatide. The proprietary name for lixisenatide in the U.S. is under consideration. The U.S. FDA file acceptance occurred in February 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 , , & , &

13 Now Approved in Europe for the Treatment of Type 2 Diabetes First Once-a-Day Prandial GLP-1 Receptor Agonist ~4m patients worldwide on basal insulin with controlled fasting glucose but 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 UK in March 2013 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 data 13

14 Clinical Development Designed to Support Use in Combination with Basal Insulin Phase III Program T2D Patients Treated Key Facts about MS with Basal Insulin (1) (worldwide) Monotherapy Placebo-controlled in OAD failure Active-controlled Mono Mono Japan Placebo-controlled L on top of L Asia basal insulin Duo 1 F1 (metformin) S (sulfonylurea) M (metformin) P (pioglitazone) M Asia (metformin) X vs. exenatide On basal insulin 4 million on Lantus 4 million on other basal insulins (2) On basal insulin with controlled fasting glucose but A1c >7% 4 million Currently Developing 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. T2D Type 2 Diabetes A1C HbA1c or Glycated hemoglobin (1) Adapted from IMS data (2) Includes all types of basal insulins 14

15 Broad Phase III Program Evaluating Potential Clinical Benefits of Improved PK/PD Profile of New Glargine Formulation Two Phase III trials in T2D high-dose insulin users (1) EDITION I results to be presented at the ADA in June 2013 EDITION II headline results to be communicated at the same time New Insulin Glargine Formulation Depot formation after subcutaneous injection Lantus New Glargine Formulation EDITION I T2D Patients Basal Bolus EDITION II T2D Patients Basal + OAD Second set of four Phase III studies started in H (1) EDITION III T2D Patients Insulin Naïve EDITION IV T1D Patients Basal Schematic illustration Two new studies also initiated in Japan (JPI and JPII) PK/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 , , & , &

17 JAK2 Inhibitor - Addressing Treatment Gaps for Patients with Debilitating Hematologic Malignancies Novel selective JAK2 inhibitor Promising Phase II response rate in patients with myelofibrosis (MF) % patients with 35% reduction in spleen volume from baseline SAR Phase II trial Phase III in MF (JAKARTA) Two doses (400 mg and 500 mg) selected Enrollment completed Headline results in Q Two Phase II studies ongoing Polycythemia vera Myelofibrosis patients previously treated with ruxolitinib 17

19 Global MS Market - Still Dominated by ABCRE Products Key Facts about MS MS Therapies A $13.8bn market in 2012 growing at a high single digit rate ABCRE products (1) represented ~80% of the global MS market in value in 2012 Moderate efficacy and patients continue to relapse on therapy Require frequent injections Latest oral entrants represent new treatment alternatives 2012 Sales and Market Share in Value (2) $2,913m 21% $3,996m 29% $1,569m 11% $2,339m 17% $1,630m 12% $1,195m 9% $159m 1% 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

20 A Promising Entry in the Large MS Market Aubagio Q sales of 20m Encouraging U.S. launch trends (1,2) >83% of patients switched to AUBAGIO were most recently on IFN-beta or Copaxone Positive CHMP opinion granted in March 2013 Request for CHMP re-examination of NAS designation filed (3) Ongoing regulatory review of Lemtrada in EU and the U.S. TEMSO (4) RELAPSE 31% DISABILITY 30% TOWER (4) RELAPSE 36% DISABILITY 31% TOPIC (4) REDUCTION IN RISK OF CONVERSION TO CDMS 43% Lemtrada is the registered trade name for alemtuzumab in MS submitted to health authorities Lemtrada is developed in collaboration with Bayer HealthCare (1) IMS Weekly Total Prescriptions (2) Based on data collected at Genzyme's 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 20

21 Significant Efficacy vs. Active Comparator (1) Significant efficacy results vs Rebif Significantly reduced ARR in two studies Reduction of risk of six-month sustained accumulation of disability Safety profile generally managed with monthly monitoring and conventional therapies Infusion-associated reactions (2) Infections more common in Lemtrada patients (3) Autoimmune events (thyroid disorders, ITP and neuropathies) detected via monitoring and generally managed using conventional therapies Unique annual dosing CARE-MS I CARE-MS II Annualized Relapse Rate Reduction in Progression of Disability Lemtrada is not yet commercially marketed ARR: Annualized Relapse Rate ITP: Idiopathic Thrombocytopenic Purpura CARE-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 21

22 Eliglustat (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 difference in spleen volume vs. placebo ENCORE (3) : non-inferiority efficacy criteria vs. Cerezyme met No serious adverse events reported in the primary analysis period Phase III Registration Trials ENGAGE ENCORE Patients Study Duration 9 months 12 months Patient Population Treatment Arms Treatment naïve eliglustat vs. placebo Stabilized on ERT treatment eliglustat vs. Cerezyme Primary endpoint met Secondary endpoints met (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 and liver volume. Absolute difference in spleen volume p< (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 22

24 Alirocumab: First in Class and Targeting Unmet Needs in Hypercholesterolemia First-in-class fully-human antibody targeting PCSK9 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 on stable dose of statins Most common TEAE: mild injection site reaction LDL-C Change from baseline (Phase II) (2,4,5) BASELINE WEEK 2 WEEK 4 WEEK 6 WEEK 8 WEEK 10 WEEK % % % % SAR mg Q2W Placebo SAR mg Q2W SAR mg Q2W Decrease in LDL-C shown is at week 12. SAR / 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 LDL-C : Low Density Lipoprotein-Cholesterol TEAE : Treatment-Emergent Adverse Event (1) Cohen JC. N Engl J Med 2006;354(12): (2) McKenney, et al JACC published online March (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< for % change SAR vs. placebo 24

25 Sanofi Commenced the First Phase III Program for an Anti-PCSK9 mab ODYSSEY: a large global Phase III clinical program evaluating the safety and efficacy of alirocumab 22,000 patients, including those with elevated cardiovascular risk, intolerant to statins or patients with FH Target Population ~21m patients globally estimated not at goal for LDL-C (1) (mainly at high cardiovascular risk) Injected subcutaneously as one single injection every two weeks Evaluating a 1mL auto-injector for both Q2W doses, 75mg and 150mg PCSK9 Development & Launch Unit created Phase III ODYSSEY Mono data expected in Q Secondary Prevention Primary Prevention hefh (2) Statin Intolerant SAR / REGN727 is developed in collaboration with Regeneron (1) Adapted from Decision Resources 2008, Decision Resources 2010 and CVReg 2011 (2) hefh: Heterozygous Familial Hypercholesterolemia 25

26 Otamixaban: Providing Superior Outcomes While Simplifying Treatment During Interventional Procedures Despite current therapies, death, MI, and readmission rates remain high Otamixaban is the first IV direct and selective factor Xa inhibitor with quick onset/offset TAO Study Moderate-to-high risk NSTE-ACS with planned early invasive strategy (n=13,220) R 27% to 42% risk reduction in ACS complications including death and MI in Phase Il (1) Phase III TAO study ongoing with results expected in Q Otamixaban Regimen 1 (n=1,969) Sponsor-blinded interim analysis Otamixaban Regimen 2 (n=1,969) UFH + Eptifibatide (n=1,969) Primary endpoint: Death/Myocardial day 7 (1) The Lancet, Volume 374, Issue 9692, Pages , 5 September 2009 NSTE-ACS Non-ST-Elevation Acute Coronary Syndrome MI Myocardial Infarction UFH Unfractionated Heparin 26

28 Sarilumab (Anti IL-6R mab): Addressing an Unmet Need in Rheumatoid Arthritis ~1/3 of RA patients treated with anti-tnfα do not respond to therapy Sarilumab is a fully human, high affinity, IL-6R mab administered subcutaneously in combination with methotrexate Positive Phase II with meaningful improvements in signs & symptoms of moderate-to-severe RA 2 pivotal Phase III trials ongoing SARIL-RA-MOBILITY fully enrolled SARIL-RA-TARGET recruiting New studies to start in Q MOBILITY Trial (Phase IIb Results) ACR response at week 12 (%) * * Placebo 150 mg q2w 200 mg q2w * p<0.01 versus placebo (only unadjusted p-values <0.01 are considered statistically significant) A&R 2011; 63; suppl.10:4041 ACR20 ACR50 ACR70 Sarilumab is developed in collaboration with Regeneron RA Rheumatoid Arthritis IL-6R Interleukin-6 receptor ACR American College of Rheumatology (ACR) Scoring System 28

29 Anti IL-4Rα mab: Targeting Asthma and Atopic Dermatitis Fully human monoclonal antibody binding to IL-4Rα Targeting the common IL-4Rα subunit Dual IL-4/IL-13 cytokine antagonism with a single agent Positive proof of concept data for asthma and atopic dermatitis to be submitted for presentation at medical conferences in 2013 Phase IIb initiation in both indications expected mid-year IL-4R IL-4 Type I Receptor IL-4 c or IL-4R IL-13 Type II Receptor IL-13R 1 IL-13 Dominant (some overlapping) functions in : Initiated and drives T H 2 differentiation Activation and growth of B cells Class switching to IgE and IgG1a Recruitment of eosinophils Airway hyper responsiveness (AHR) Goblet cell hyperplasia Tissue remodeling Fibrosis Regulation of gastrointestinal parasite expulsion Anti IL-4Rα mab is developed in collaboration with Regeneron 29

30 Launching the First and Only Voice-Guided Epinephrine Auto-Injector (1) Up to 6 million people in the U.S. may be at risk for anaphylaxis (2) Epinephrine auto-injector market estimated at $665m in 2012 (3) One main U.S. competitor with >95% market share (4) : EpiPen from Mylan Auvi-Q offers a unique compact size and shape Audio and visual cues guide users through the injection process Retractable needle mechanism Launched in the U.S. and Canada in Jan 2013 (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,

32 Dengue Vaccine: Addressing a Growing Global Threat Significant Disease Burden First Efficacy Results Ambitious Phase III Program Estimated 220m dengue infections worldwide per year 2m cases of Hemorrhagic Fever >500,000 hospitalizations and >20,000 deaths / year Dengue: a public health priority in Asia and Latin America Phase IIb results in ~4,000 patients recently published in the Lancet Effective against DENV 1, 3 and 4 (in the range of 60% to 90%), with only DENV 2 appearing to be resistant Safe and well-tolerated Global Phase III program ongoing Large scale studies in LatAm and Asia 31,000 children and adolescents Results expected in

33 Maintaining Rigorous Control of R&D Expenses While Investing Significantly in Phase III Trials R&D expenses of 4,922m in 2012, down -1.0% at CER or -3.6% at CER with Genzyme pro forma reflecting: Good internal cost management Ongoing transforming initiatives Start of multiple Phase III trials (e.g. alirocumab, new insulin glargine formulation, sarilumab, JAK2) R&D/Sales ratio down 0.3 points in 2012 vs R&D/Sales Ratio (%) 16.6% 15.6% 14.1% 14.4% 14.1% FY 2008 FY 2009 FY 2010 FY 2011 FY

34 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 Global R&D Goals Focus on high-value projects Execute on late-stage projects Guide early-stage portfolio prioritization utilizing medical value 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