2012 - BofA Merill Lynch HC Conference


Published on

2012 - B of A Meryll Linch HC Conference

1 Like
  • Be the first to comment

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

2012 - BofA Merill Lynch HC Conference

  1. 1. BofA-Merrill Lynch Healthcare Conference Dr. Elias Zerhouni, President - Global R&D London, September 12th, 2012
  2. 2. Forward Looking StatementsThis presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Actof 1995, 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 ofSanofi, that could cause actual results and developments to differ materially from those expressed in, or impliedor projected by, the forward-looking information and statements. These risks and uncertainties include amongother things, the uncertainties inherent in research and development, future clinical data and analysis, includingpost marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and whento approve any drug, device or biological application that may be filed for any such product candidates as wellas their 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 thoselisted under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofisannual report on Form 20-F for the year ended December 31, 2011. 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. 3. Growth Platforms Accounted for 64.9% of Group Salesand Grew by +7.6% in Q2 2012 Growth at CER Emerging Markets €2,823m +9.8% Diabetes Solutions €1,436m +13.7% Vaccines €783m +3.0% Consumer Health Care €738m +11.3% Animal Health €576m +9.1% New Genzyme(1) €434m +9.1% Innovative Products(2) €152m +4.5% (1) New Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises (2) Multaq®, Jevtana® and Mozobil® 5
  4. 4. 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 6 6
  5. 5. Multiple Regulatory Milestones Expected in H2 2012 Products Targeted Indications Expected Milestones ® Metastatic FDA Approval on Aug 4th 2012 Colorectal Cancer CHMP Opinion: Q4 2012 ® Relapsing Forms of PDUFA Date: Sep 12th 2012 Multiple Sclerosis CHMP Opinion: Q1 2013 Relapsing Forms of FDA Re-Submission as soon as possible Multiple Sclerosis CHMP Opinion: Q2 2013 ® CHMP Opinion: Q4 2012 Type 2 Diabetes FDA Submission: Dec 2012 TM hoFH/severe heFH in EU CHMP Opinion: Q4 2012 and hoFH in the U.S PDUFA Date: Jan 29th 2013 Zaltrap®, Kynamro™, Aubagio®, Lyxumia® 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 hoFH: Homozygous Familial Hypercholesterolemia PDUFA: Prescription Drug User Fee Act heFH: Heterozygous Familial Hypercholesterolemia CHMP: Committee for Medicinal Products for Human Use 7
  6. 6. Now Available in the U.S. Key Facts about MS Oncology● 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) (1) Van Cutsem, et al. Ann Oncol. 2011;22(suppl 5). Abstract O-0024 and presentation at: ESMO 13th WCGIC. June 22-25, 2011; Barcelona, Spain. 8
  7. 7. Only Therapy(1) Slowing Accumulation of Disability Sustained for 6 months vs. Active Comparator For Illustrative Purposes Higher Hurdle (2) Active  ComparatorsTypical Threshold for Approval   Placebo Higher Hurdle 3 month EDSS 6 month (1) Investigational compound (2) Based on CARE-MS II 13
  8. 8. ® A GLP-1 Agonist for A1c Control with a Unique Biological ProfileA Unique Profile: Pronounced effect on postprandial glucose (PPG) levels Favorable safety profile with low risk of hypoglycemic events Once-daily injection, simple 1 step to maintenance dose, 1 pen per dose(1) Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is currently not approved or licensed anywhere in the world. Lixisenatide was in-licensed from Zealand Pharma A/S. (1) Except for the device intended for Japan (2 steps to maintenance dose with one pen) 16
  9. 9. ® Clinical Development Designed to Support Use in Combination with Basal Insulin T2D Patients Treated Phase III Program with Basal Insulin(1) (worldwide) Mono Monotherapy Mono Japan On basal insulin On basal insulin with controlled fasting F1 (metformin) glucose control S (sulfonylurea)Placebo-controlled but A1c >7% M (metformin) in OAD failure P (pioglitazone) M Asia (metformin) 4 million on Lantus® Active-controlled X vs. exenatide 4 million 4 millionPlacebo-controlled L on other on top of L Asia basal insulins(2) basal insulin Duo 1 T2D – Type 2 Diabetes A1C – HbA1c or Glycated hemoglobin (1) Adapted from IMS data (2) Includes all types of basal insulins 17
  10. 10. Fix-Flex Device Has Been Developed for JointAdministration of Lantus® and Lyxumia® ● Convenience of a single injection per day coupled with possibility to adjust Lantus® dose ● Entering phases for industrialization, validation, usability and manufacturing + ® ● Device expected to be available mid-2013 for Phase III initiation Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is currently not approved or licensed anywhere in the world. 18
  11. 11. New Glargine Formulation with Unique Pharmacokinetics ● New glargine formulation: New Insulin Glargine Formulation ● Unique flat PK/PD profile Depot formation after subcutaneous injection ● Lower injection volume ● Phase III trials ongoing in T2D Lantus® New Glargine high-dose insulin users(1) Formulation ● Targeting ~1,600 patients EDITION I EDITION II T2D Patients T2D Patients Basal Bolus Basal + OAD ● Second set of studies recently started Schematic illustration PK/PD – Pharmacokinetic/Pharmacodynamic OAD – Oral anti-diabetic drugs (1) ClinicalTrials.gov Identifier: NCT1499082 & NCT01499095 19
  12. 12. Otamixaban: Providing Superior Outcomes whileSimplifying Treatment during Interventional Procedures TAO Study ● Despite current therapies, death, MI, and readmission rates remain high Moderate-to-high risk NSTE-ACS with planned early invasive strategy (n=13,220) ● Otamixaban is the first IV direct and selective factor Xa inhibitor with R quick onset/offset ● 27 to 42% risk reduction in ACS complications including death and MI Otamixaban Otamixaban UFH + Regimen 1 Regimen 2 Eptifibatide in Phase Il(1) (n=1,969) (n=1,969) (n=1,969) ● Phase III TAO study ongoing with Sponsor-blinded results expected in Q2 2013 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
  13. 13. Eliglustat: 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 25 WORLD – World Organization of Research on Lysosomal Diseases
  14. 14. 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 26 26
  15. 15. Ensuring R&D Contributes to Sanofi’s Success 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 models with partners across the healthcare ecosystem 27
  16. 16. APPENDICESR&D Pipeline 28
  17. 17. Late Stage Pipeline – Pharma & Vaccines Phase III Registration eliglustat tartrate N otamixaban N Quadracel® Hexaxim®Glucosylceramide synthetase inhibitor Direct Xa inhibitor Diphtheria, tetanus, pertussis DTP-HepB-Polio-Hib vaccine Gaucher disease ACS & polio vaccine; 4-6 y of age iniparib N lixisenatide (AVE0010) Fluzone® QIV IM Plavix® (BSI-201) GLP-1 agonist Quadrivalent inactivated clopidogrel bisulfate squamous NSCLC (1L) Type 2 diabetes, U.S. influenza vaccines PAD, STEMI, Japan ombrabulin (AVE8062) N New formulation VaxiGrip® QIV IM teriflunomide N Vascular disrupting agent Insulin glargine Quadrivalent inactivated Relapsing forms of multiple sclerosis Soft tissue sarcoma (2L/3L) Type 1+2 diabetes influenza vaccines (RMS) – monotherapy, U.S. / EU SAR302503 (TG101348) N mipomersen alemtuzumab N JAK-2 inhibitor Apolipoprotein B-100 antisense Anti-CD52 mAb Myelofibrosis (1L) Severe HeFH, U.S. Multiple sclerosis, U.S. / EU Jevtana® SAR236553 N Allegra® Cabazitaxel Anti-PCSK-9 mAb fexofenadine Metastatic prostate cancer (1L) Hypercholesterolemia Dry syrup, Japan N mipomersen N SYNVISC-ONE™ sarilumab (SAR153191) Apolipoprotein B-100 antisense Medical device Anti-IL-6R mAb HoFH and severe HeFH in EU; Pain in hip OA RA HoFH in U.S. MACI® Dengue lixisenatide (AVE0010) N Cell-based treatment Mild-to-severe GLP-1 agonist Articular cartilage defects dengue fever vaccine Type 2 diabetes, EU / Japan teriflunomide aflibercept N DTP-HepB-Polio-Hib Multiple sclerosis VEGF-Trap Pediatric hexavalent vaccine (adjunct therapy & CIS) 2nd line mCRC, U.S. / EU N New Molecular Entity Oncology Thrombosis Vaccines Metabolic Disorders Central Nervous System Internal Medicine Ophthalmology Genetic diseases Biosurgery Aging Status as of July 26, 2012 29
  18. 18. Early Stage Pipeline – Pharma & Vaccines Phase II iniparib FOV1101 N SAR231893 N (BSI-201) FDC prednisolone/cyclosporine Anti-IL4 mAb Ovarian cancer (2L) Allergic conjunctivitis Asthma; Atopic dermatitis SAR3419 N N N safotibant (FOV2304) ferroquine Maytansin-loaded anti-CD19 mAb Bradykinin B1 antagonist Antimalarial B-cell malignancies refractory/relapsed Diabetic macular edema Malaria (DLBCL, 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 Endometrial cancer (1L) Osteoarthritis Malaria SAR245409 (XL765) N SAR292833 (GRC15300) N SAR279356 (F598) N Oral dual inhibitor of PI3K & mTOR TRPV3 antagonist Anti-PNAG mAb Breast cancer (1L) Neuropathic pain, osteoarthritic pain Serious infections ombrabulin (AVE8062) ACAM-Cdiff Vascular disrupting agent Clostridium difficile Ovarian cancer (2L) Toxoid vaccine SAR302503 (TG101348) JAK-2 inhibitor Rabies VRVg Polycythemia vera (2L) Purified vero rabies vaccine Incyte (ruxolitinib) resistant/intolerant MF Jevtana® Meninge ACYW conj. Cabazitaxel, Microtubule inhibitor 2nd generation meningococcal Small cell lung cancer (2L) Conjugate infant vaccine N New Molecular Entity Oncology Thrombosis Vaccines Metabolic Disorders Central Nervous System Internal Medicine Ophthalmology Genetic diseases Biosurgery Aging Status as of July 26, 2012 30
  19. 19. Early Stage Pipeline – Pharma & Vaccines Phase I SAR153192 N SAR405838 (MI-773) N SAR252067 N Rotavirus Anti-DLL4 mAb MDM2 / p53 antagonist Anti-LIGHT mAb Live Attenuated Tetravalent Solid tumors Solid tumors and hematological malignancies Crohn’s disease & Ulcerative colitis Rotavirus oral vaccine GZ402674 N SAR127963 N SAR339658 N Streptococcus pneumonia Non-camptothecin topo1 inhibitor P75 receptor antagonist VLA 2 antagonist Meningitis & pneumonia vaccine Solid tumors Trauma brain injury Inflammatory Bowel disease N GZ404477 N N SAR650984 SAR100842 Pseudomonas aeruginosa (AAV-hAADC) Anti-CD38 naked mAb LPA-1/LPA-3 Antibody fragment product Gene therapy Hematological malignancies Skin manifestation of scleroderma Prevention of ventilator-associated pneumonia Parkinsons disease SAR566658 N N SAR156597 N SAR391786 Tuberculosis Maytansin-loaded anti-DS6 mAb IL4/IL13 Bi-specific mAb Rehabilitation post orthopedic surgery Recombinant subunit vaccine DS6 positive solid tumors Idiopathic Pulmonary Fibrosis SAR307746 N SAR228810 N SAR407899 N RetinoStat® N Anti-Ang2 mAb Anti-protofibrillar AB mAb Rho kinase inhibitor Gene therapy Solid tumors Alzheimer’s disease Diabetic nephropathy Wet age-related macular degeneration (AMD) SAR125844 N SAR399063 N lixisenatide + Lantus® StarGen® N C-Met kinase inhibitor DHA-GLP + vit D GLP-1 agonist + insulin glargine Gene therapy Solid tumors Pre-sarcopenia Fix-Flex / Type 2 diabetes Stargardt disease Combinations N SAR164653 N GZ402663 (sFLT-01) N SAR404460 SAR245409 / MSC1936369B Cathepsin A inhibitor Gene therapy DHA-GPL + Vit D SAR245408/SAR256212 (MM121) CV-related complications & deaths in Age related Macular Degeneration Pre-sarcopenia Solid tumors diabetic patients (AMD) SAR393590 (Oral clofaribine) GZ402665 N SAR126119 N UshStat® N DNA synthesis inhibitor (rhASM) TAFIa inhibitor Gene therapy Hematological malignancies Niemann-Pick type B Acute ischemic stroke Usher syndrome 1B Jevtana® Cabazitaxel, Microtubule inhibitor Gastric cancer (2L) N New Molecular Entity Oncology Thrombosis Vaccines Status as of July 26, 2012 Metabolic Disorders Central Nervous System Internal Medicine 31 Ophthalmology Genetic diseases Biosurgery Aging
  20. 20. Expected R&D Milestones – Vaccines Product Event Timing Shan5® Start of Phase III study Q3 2012 Fluzone® QIV IM Submission of regulatory file in the U.S. Q3 2012 HexaximTM Submission of regulatory file in EU Q3 2012 Fluzone® QIV ID Start of Phase III study Q4 2012 Vaxigrip® QIV IM Submission of regulatory file in EU Q1 2013 Fluzone® QIV IM Expected licensure in the U.S. Q2 2013 HexaximTM Expected licensure in EU and international countries Q2 2013 34