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2016/01 - JP Morgan HC Conference

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2016/01 - JP Morgan HC Conference

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2016/01 - JP Morgan HC Conference

  1. 1. JP Morgan Healthcare Conference Olivier Brandicourt – Chief Executive Officer San Francisco - January 12, 2016
  2. 2. 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 initiatives 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, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
  3. 3. Key Accomplishments Since April 2015 On Our Way to Future Success 3 (1) LixiLan (U.S.), sarilumab (U.S.) and lixisenatide (U.S.) (2) BioNTech, Evotec, Google Life Sciences, Hanmi, Lexicon Pharmacuticals, Voyager Therapeutics and Regeneron (3) December 15, 2015 press release: Sanofi and Boehringer Ingelheim enter exclusive negotiations on business swap : Sanofi would become a global leader in Consumer Healthcare and Boehringer Ingelheim would become second largest Animal Health company Icons designed by Freepik 3 launches of major products – Toujeo®, Praluent® and Dengvaxia® 3 submissions for regulatory review(1) Accelerated BD(2) activities and strategic alliance in Immuno-oncology Key first transaction announced to reshape the portfolio(3) New organizational model to drive focus and simplification 2015-2020 strategic roadmap to create long term value
  4. 4. We Have Four Strategic Priorities 4 Reshape the portfolio Deliver outstanding launches Simplify the organization Sustain innovation in R&D 1 2 3 4
  5. 5. ● Multiple Sclerosis(1) ● Oncology(1) ● Immunology(1) ● Consumer Healthcare(2) ● Animal Health ● Generics(2) in Europe ● Diabetes/CV ● Vaccines ● Rare Diseases(1) ● Emerging Markets(2) Reshape the Portfolio 5 1 Explore strategic options CA Sustain leadership Build competitive positions B (1) Will be part of Specialty Care Global Business Unit (2) Will be part of General Medicines and Emerging Markets Global Business Unit
  6. 6. Sanofi and Boehringer Ingelheim Enter Exclusive Negotiations on Business Swap 6 Potential exchange of Sanofi Animal Health (Merial) and Boehringer Ingelheim (BI) CHC businesses ● Enterprise value: ● Merial: €11.4bn ● BI CHC: €6.7bn ● Gross cash payment from BI to Sanofi of €4.7bn (1) Following consultations with the relevant social bodies and subject to appropriate regulatory approvals (2) Taking into account the anticipated CHC results, share buybacks and potential synergies BI CHC: 7 core brands Expected CHC pro forma sales of ~€5.1bn in 2015e Sanofi would become a Leading player in CHC Goal is to close the potential transaction in Q4 2016(1) ● Sanofi intends to use a portion of the net proceeds of the transaction to repurchase shares ● The overall transaction is expected to be business EPS neutral in 2017 and accretive in subsequent years(2) >60% of sales
  7. 7. 7 4.6% 4.6% 4.4% 4.3% 3.4% 2.5% 2.1% 1.1% 1.0% 71.9% Other Global Categories(2) Segment Size in €bn Sanofi + BI CHC VMS(3) 27.6 #3 Cough & Cold Care 17.2 #6 Digestive health 14.4 #1 Pain Care 13.2 #2 Allergy Solutions 3.1 #3 Feminine Care 0.8 #1 Combined Worldwide CHC Market Share(1) Combined Worldwide CHC Sales - Priority Categories(4) (pro forma) Sanofi to Become a Global Leader in CHC (1) Nicholas Hall & Company, MAT Q3 2015 (2) As per Sanofi definition (3) Vitamins, Minerals and Supplements (4) Source: Nicholas Hall & Company, FY 2014 Taisho Reckitt Benckiser Pfizer J&J GSK Takeda P&G Bayer +
  8. 8. 8 Committed to Diabetes and Cardiovascular Diseases 1 Develop the insulin franchise 4 3 Lead the market shift to managing diabetes outcomes A Google Life Sciences 2 Strengthen the pipeline through external opportunities and ambitious research Transform the management of hypercholesterolemia Ambition to grow Diabetes franchise beginning in 2019(1) Praluent® multi-blockbuster potential(2) (1) Diabetes sales are expected to decline at an average annualized rate of -4% to -8% at CER over 2015-2018 (2) As of December 31, 2015, Sell-side analyst consensus for Praluent in 2020 per Vara is € 3,063m Icons designed by Freepik LixiLan filed in the U.S. with PRV Lexicon and Hanmi deals closed Significant U.S. market access achieved
  9. 9. 9 Strengthening our R&D Portfolio in Diabetes with Two In-Licensing Agreements A (1) SGLT2 (sodium-glucose cotransporter type 2) is a transporter responsible for most of the glucose reabsorption performed by the kidney SGLT1 (sodium-glucose cotransporter type 1) is a transporter responsible for glucose and galactose absorption in the gastrointestinal tract, and to a lesser extent than SGLT2, glucose reabsorption in the kidney (2) Subject to customary closing conditions (3) LAPS CA-Exendin-4 analog T1DM: Diabetes mellitus type 1 Sotagliflozin - Phase II in T2 Diabetes Phase III in T1 Diabetes ● Dual SGLT1 and SGLT2 inhibitor(1) ● Limiting meal time glucose absorption and increasing renal glucose excretion ● Oral administration ● Adjunct therapy to insulin in T1DM ● Favorable safety profile Immunology Efpeglenatide – Phase II ● Long acting GLP-1(3) ● Diabetes/Obesity ● Weekly/monthly administration LAPS Insulin 115 (HM12470) – Phase I ● Long acting insulin ● Less side-effects (hypoglycemia, obesity) ● Weekly administration LAPS Insulin Combo – Pre-clinical ● Long acting insulin + efpeglenatide combination ● Weekly administration (2)
  10. 10. Growing Faster than Market in Vaccines 10 A Further develop strong vaccine brands ● Flu vaccines ● Pediatric combinations ● Adult boosters Successfully launch Dengvaxia® Expand our manufacturing capacity Deliver novel high-value vaccines e.g. C. diff vaccine 2015e2014 €4.0bn 2020e Pediatric & boosters Flu Dengue ~75% of sales Projected Sanofi Pasteur Sales 1 2 3 4 High single digit sales CAGR at CER
  11. 11. Sustaining Leadership in Rare Diseases 11 A ● Sustain market share through patient-centered approach, product differentiation and market access ● Grow market through patient screening and manufacturing expansion ● Advance internal and partnered novel pipeline Sales CAGR for Rare Diseases expected at high single digit at CER over 2015-2020 1 2 3 Undiagnosed(1) Undiagnosed(1) Undiagnosed(1) (1) Genzyme internal analysis. Include China and India
  12. 12. Retaining #1 Position in Emerging Markets through Greater Focus 12 Leader in Emerging Markets(1) ● Increase focus on priority countries/regions ● Prioritize resource allocation ● Adapt industrial footprint ● Redefine scope to exclude Eastern Europe(1) ● Win the emerging middle class ● Innovate specifically for Emerging Markets ● Optimize trade and channel management #3 in China #1 in Brazil #2 in Russia #4 in India #2 in Mexico A A top 3 MNC player in BRIC-M 1 2 3 4 MNC: Multinational corporation (1) World excluding U.S., Canada, Western & Eastern Europe (except Russia, Ukraine, Georgia, Belarus and Armenia), Japan, South Korea, Australia, New Zealand and Puerto Rico
  13. 13. Growing our Multiple Sclerosis Franchise 13 ● Successfully complete global launches of Aubagio® and Lemtrada® ● Expand LCM activities to maximize support to existing products ● Reinforce presence in “high efficacy” category ● Enter the neuroprotection/ remyelination segment B Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Série2 Série1 Multiple Sclerosis Franchise Reported sales (€m) €923m ® 1 2 3 4 Ambition to double the size of the MS franchise from 2015 to 2020 LCM: Life Cycle Management
  14. 14. Rebuilding a Competitive Position in Oncology 14 ● Maximize clinical assets, particularly isatuximab (anti-CD38 mAb) and Antibody-Drug Conjugates ● Build a transformative pipeline ● Immuno-oncology collaboration with Regeneron ● Collaboration with BioNTech on mRNA therapeutics ● Rebuild critical mass Oncology Opportunity Largest therapeutic area for pharmaceuticals Strong growth driven by unmet need and groundbreaking science B 1 2 3 ADCs: Antibody-Drug Conjugates
  15. 15. Sarilumab and Dupilumab Represent Cornerstones of a New Immunology Franchise 15 ● Multi-disease, best in class drug targeting Th2 pathway ● Breakthrough treatment for atopic dermatitis ● Further opportunities in asthma and nasal polyposis ● Multi-blockbuster potential across key indications ● FDA submission in AD planned for Q3 2016 Immunology B ● Entering an €18bn RA market where unmet need is still high ● IL-6 class >€1bn in sales and growing >20% ● Aim to be preferred 2nd line for TNF-IR patients and preferred monotherapy ● Goal to differentiate through dosing, bone impact ● Filed with FDA in Q4 2015 RA: Rheumatoid Arthritis TNF-IR: TNF inadequate responders AD: Atopic Dermatitis
  16. 16. 16 Focus on 6 Products … … and Excel in Execution New GBU organization with clear accountability, P&L ownership and life cycle management to focus on: ● Delivering differentiated products rapidly ● Shaping the market ● Securing market access ● Driving uptake Deliver Outstanding Launches2 Expected combined peak sales of €12bn to €14bn(1) (1) At CER, non-risk adjusted sales projections through 2025
  17. 17. Global Roll-out Underway for Three Major Products ● Rapid market access obtained in the U.S.(1) ● Showing early promise in key markets ● U.S. uptake trending favorably compared to diabetes analogues(2) ● Launched globally in 20 countries ● Now accessible on formularies covering ~150m patients in the U.S. ● Only PCSK9 inhibitor preferred across UnitedHealth Group formularies ● ODYSSEY OUTCOMES interim efficacy analysis expected in H2 2016(3) ● First ever dengue vaccine ● Priority introduction in large endemic countries ● Approvals recently granted in Mexico, the Philippines and Brazil(4) ● Submitted in over 20 countries 17 Praluent® is developed and commercialized in collaboration with Regeneron (1) As of January 1, 2016, 86% of commercial and 91% of Medicare lives covered (2) Toujeo® analogues include: Bydureon® (AstraZeneca), Farxiga® (AstraZeneca), Invokana® (J&J), Levemir® (Novo Nordisk), Tanzeum® (GlaxoSmithKline), Tresiba® (Novo Nordisk) and Trulicity® (Eli Lilly) (3) Second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred (4) The Mexican Federal Commission for the Protection against Sanitary Risks, Philippines' Food and Drug Administration and Brazilian regulatory authorities ANVISA approved Dengvaxia®, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue virus serotypes in individuals from 9-45 years of age living in endemic areas.
  18. 18. 18 N New Molecular Entity Immunology Rare Diseases Oncology Diabetes Vaccines Infectious Diseases Cardiovascular Diseases Neurodegenerative Diseases Ophthalmology Multiple Sclerosis GZ402668 GLD52 (anti-CD52 mAb) Relapsing multiple sclerosis GZ402666 neo GAA Pompe Disease SAR113244 Anti-CXCR5 mAb Systemic lupus erythematosus SAR339375 Anti-miR21 RNA Alport syndrome GZ389988 TRKA antagonist Osteoarthritis SAR439774 (ALN-AT3) siRNA targeting Anti-Thrombin Haemophilia SAR425899 GLP-1R/GCGR dual agonist Diabetes SAR228810 Anti-protofibrillar AB mAb Alzheimer’s disease SAR438335 GLP-1R/GIPR dual agonist Diabetes SAR422459 ABCA4 gene therapy Stargardt disease SAR566658 Maytansin-loaded anti-CA6 mAb Solid tumors UshStat® Myosin 7A gene therapy Usher syndrome 1B SAR408701 Anti-CEACAM5 ADC Solid tumors SAR366234 EP2 receptor agonist Elevated intraocular pressure SAR439684 PD-1 inhibitor Cancer Streptococcus pneumonia Meningitis & pneumonia vaccine SAR428926 LAMP-1 inhibitor Cancer Herpes Simplex Virus Type 2 HSV-2 vaccine SAR439152 Myosin inhibitor Hypertrophic cardiomyopathy Phase I N N N N N N N N N N N N N N N N N dupilumab Anti-IL4Rα mAb Nasal polyposis; Eosinophilic oesophagitis GZ402671 Oral GCS Inhibitor Fabry Disease SAR156597 IL4/IL13 Bi-specific Ab Idiopathic pulmonary fibrosis olipudase alfa rhASM Niemann-Pick type B sarilumab Anti-IL6R mAb Uveitis Rabies VRVg Purified vero rabies vaccine Combination ferroquine / OZ439 Antimalarial Meningitis ACYW conj. 2nd generation meningococcal conjugate infant vaccine isatuximab Anti-CD38 naked mAb Multiple myeloma Tuberculosis Recombinant subunit vaccine Fluzone® QIV HD Quadrivalent inactivated influenza vaccine - High dose Phase II N N N N N LixiLan lixisenatide + insulin glargine Fixed-Ratio / Type 2 diabetes SAR342434 insulin lispro Type 1+2 diabetes sarilumab Anti-IL6R mAb Rheumatoid arthritis, EU dupilumab Anti-IL4Rα mAb Atopic dermatitis, Asthma patisiran (ALN-TTR02) siRNA inhibitor targeting TTR Familial amyloidotic polyneuropathy revusiran (ALN-TTRsc) siRNA inhibitor targeting TTR Familial amyloidotic cardiomyopathy Jevtana® cabazitaxel Metastatic prostate cancer (1L) Clostridium difficile Toxoid vaccine Rotavirus Live attenuated tetravalent Rotavirus oral vaccine VaxiGrip® QIV IM Quadrivalent inactivated influenza vaccine (3-36 months) Phase III N N N N N Registration lixisenatide GLP-1 agonist Type 2 diabetes, U.S. sarilumab Anti-IL6R mAb Rheumatoid arthritis, U.S. Dengvaxia® Mild-to-severe dengue fever vaccine PR5I DTP-HepB-Polio-Hib Pediatric hexavalent vaccine, U.S., EU VaxiGrip® QIV IM Quadrivalent inactivated influenza vaccine (3 years+) N N 3 Sustain Innovation in R&D(1) (1) Pipeline chart as of November 6, 2015
  19. 19. Diabetes Vaccines Rare Diseases 1 2 3 4 19 Isatuximab - Multiple Myeloma Immuno-oncology - Various oncology indications 5 6 7 (1) Patisiran, revusiran and ALN-AT3 developed in collaboration with Alnylam Potentially Transformative Drugs in Earlier Stages of Development Selected R&D Assets Oncology Immunology 8 Olipudase alfa - Niemann-Pick type B Patisiran(1) - Familial Amyloidotic Polyneuropathy Revusiran(1) - Familial Amyloidotic Cardiomyopathy Dual agonists - Type 2 Diabetes C. difficile vaccine - Nosocomial infections IL4/IL13 Bi-specific Ab - Idiopathic Pulmonary Fibrosis ALN-AT3(1) - Haemophilia NeoGAA - Pompe9 10
  20. 20. 20 Key R&D Milestones Expected in 2016 20 Expected Regulatory Decisions Q1 Q2 Q3 Q4 ● Lixisenatide in Diabetes (U.S.)  ● LixiLan in Diabetes (U.S.)  ● Sarilumab in Rheumatoid Arthritis (U.S.)  Expected Regulatory Submissions Q1 Q2 Q3 Q4 ● LixiLan in Diabetes (E.U.)  ● Dupilumab in Atopic Dermatitis (U.S.)  Expected Phase III / IIIb Data Q1 Q2 Q3 Q4 ● Dupilumab in Atopic Dermatitis  ● Insulin lispro in Diabetes (SORELLA )  ● Sarilumab in Rheumatoid Arthritis (MONARCH)  ● Praluent® ODYSSEY OUTCOMES interim analysis(1) Expected Phase III Starts Q1 Q2 Q3 Q4 ● Olipudase alfa in Niemann Pick type B(2)  ● NeoGAA in Pompe  ● Fitusiran in Hemophilia  ● Efpeglenatide in Diabetes  ● Sotagliflozin in Diabetes  ● Isatuximab in Multiple Myeloma  (1) Interim analysis for futility when ~50% of events have occurred; second interim analysis for futility and overwhelming efficacy when ~75% of events have occurred in H2 2016 (2) Pivotal phase II/III trial
  21. 21. Simplify the Organization 21 4 Create one Sanofi culture Reshape the plant network Move to Global Business Unit organization
  22. 22. The Roadmap for Sanofi 22 ● Invest for the future ● Refocus the portfolio ● Execute launches ● Reinforce pipeline through business development ● Simplify the organization ● Accelerate growth from priority launches ● Continue to build scale in priority businesses ● Capture margin improvement 1 2 2018-20 Accelerate growth 2015-17 Reshape Sanofi

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