MEET SANOFI Management Forward Looking Statements
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MEET SANOFI Management 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. 2 2015-2020 ROADMAP Olivier Brandicourt Chief Executive Officer MEET SANOFI Management Agenda Our vision for Sanofi Sanofi’s path to success Delivering performance 4 Many Elements Point towards a Favorable Outlook for the Healthcare Industry despite Multiple Challenges Opportunities Challenges Growing and aging population Affordability is a key concern globally Unmet medical needs remain high Price pressure from payers in developed markets Improved R&D productivity across the industry Biosimilar threat and risk of interchangeability Exciting time scientifically Slowdown in economic growth Rising middle class in Emerging in Emerging Markets Markets More focused competitors building Empowered patients leadership positions 5 Sanofi Has Important Strengths to Build On in this Changing Environment Launching a strong set Leading of products Making credible positions in across multiple TAs entry in new TAs Diabetes, Vaccines, e.g. Multiple Rare Diseases, Sclerosis Emerging Markets Record of Strong skills building leading for managing brands: Successful in mature Lantus®, Fluzone®, sourcing external businesses Cerezyme® innovation: Regeneron, Alnylam, Voyager TA: Therapeutic Areas 6 Sanofi Also Has Challenges to Address in Order to Succeed 1 Broad portfolio 2 Lantus® loss of exclusivity 3 Pressure on margins 4 Limited breadth of pipeline 5 Complexity 7 A New Strategic Direction for Sanofi Is Needed to Change our Growth Trajectory Sanofi is a global healthcare company focused on disease prevention and treatment ● DIVERSIFIED in Pharmaceuticals, Vaccines and Consumer Healthcare Our Vision for Sanofi ● FOCUSED on 5 GBUs(1) ● INNOVATIVE to sustain long term growth ● SIMPLIFIED as an organization (1) Diabetes/Cardiovascular, General Medicines and Emerging Markets, Specialty Care, Vaccines, Animal Health 8 Agenda Our vision for Sanofi Sanofi’s path to success Delivering performance 9 We Have Four Strategic Priorities 1 2 3 Deliver Sustain Reshape outstanding innovation the portfolio launches in R&D 4 Simplify the organization 10 1 Reshape the Portfolio Sustain Build competitive Explore strategic A B C leadership positions options ● Diabetes/CV ● Multiple Sclerosis(1) ● Animal Health ● Vaccines ● Oncology(1) ● Generics(2) in Europe ● Rare Diseases(1) ● Immunology(1) ● Emerging Markets(2) ● Consumer Healthcare(2) (1) Will be part of Specialty Care Global Business Unit (2) Will be part of General Medicines and Emerging Markets Global Business Unit 11 A Committed to Diabetes and Cardiovascular Diseases 1 Develop the insulin franchise Strengthen the pipeline through external opportunities 2 and ambitious research 3 Lead the market shift to managing diabetes outcomes Google Life Sciences 4 Transform the management of hypercholesterolemia Ambition to grow Diabetes franchise beginning in 2019(1) Praluent® multi-blockbuster potential (1) Diabetes sales are expected to decline at an average annualized rate of -4% to -8% at CER over 2015-2018 Icons designed by Freepik 12 Strengthening our R&D Portfolio in Diabetes A with Two In-Licensing Agreements (2) Immunology Sotagliflozin - Phase II in T2 Diabetes Efpeglenatide – Phase II Phase III in T1 Diabetes ● Long acting GLP-1(3) (1) ● Dual SGLT1 and SGLT2 inhibitor ● Diabetes/Obesity ● Limiting meal time glucose absorption and ● Weekly/monthly administration increasing renal glucose excretion LAPS ● Oral administration Insulin 115 (HM12470) – Phase I ● Adjunct therapy ● Long acting insulin to insulin ● Less side-effects (hypoglycemia, obesity) in T1DM ● Weekly administration ● Favorable safety profile LAPS Insulin Combo – Pre-clinical ● Long acting insulin + efpeglenatide combination ● Weekly administration T1DM: Diabetes mellitus type 1 (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 13 (3) LAPS CA-Exendin-4 analog A Growing Faster than Market in Vaccines Projected Sanofi Pasteur Sales 1 Further develop strong vaccine brands High ● Flu vaccines single digit ● Pediatric combinations sales CAGR ● Adult boosters at CER ® ~75% 2 Successfully launch Dengvaxia ~€4.7bn Dengue of €4.0bn sales Flu 3 Expand our manufacturing capacity Pediatric & boosters 4 Deliver novel high-value vaccines e.g. C. diff vaccine 2014 2015e 2020e 14 A Sustaining Leadership in Rare Diseases Undiagnosed(1) Undiagnosed(1) Undiagnosed(1) ●1 Sustain market share through patient-centered approach, product differentiation and market access ●2 Grow market through patient screening and manufacturing expansion ●3 Advance internal and partnered novel pipeline Sales CAGR for Rare Diseases expected at high single digit at CER over 2015-2020 (1) Genzyme internal analysis. Include China and India 15 Retaining #1 Position in Emerging Markets A through Greater Focus Leader in Emerging Markets EM sales ~€10.8bn in 2015e ●1 Increase focus on priority countries/regions (1) ~29% of Group sales ● Prioritize resource allocation A top 3 MNC player in BRIC-M ● Adapt industrial footprint ● Redefine scope to exclude Eastern Europe(1) #3 in China ●2 Win the emerging middle class #1 in Brazil #2 in Russia ●3 Innovate specifically for Emerging Markets #4 in India ●4 Optimize trade and channel management #2 in Mexico 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 16 1 Reshape the Portfolio Sustain Build competitive Explore strategic A B C leadership positions options ● Diabetes/CV ● Multiple Sclerosis(1) ● Animal Health ● Vaccines ● Oncology(1) ● Generics(2) in Europe ● Rare Diseases(1) ● Immunology(1) ● Emerging Markets(2) ● Consumer Healthcare(2) (1) Will be part of Specialty Care Global Business Unit (2) Will be part of General Medicines and Emerging Markets Global Business Unit 17 B Growing our Multiple Sclerosis Franchise Multiple Sclerosis Franchise Reported sales (€m) €923m ●1 Successfully complete global launches of Aubagio® and Lemtrada® Série2 ●2 Expand LCM activities to maximize Série1 ® support to existing products ●3 Reinforce presence in “high efficacy” category ●4 Enter the neuroprotection/ remyelination segment Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2013 2013 2013 2013 2014 2014 2014 2014 2015 2015 2015 Ambition to double the size of the MS franchise from 2015 to 2020 LCM: Life Cycle Management 18 B Rebuilding a Competitive Position in Oncology Oncology Opportunity Largest therapeutic area for pharmaceuticals ●1 Maximize clinical assets, particularly isatuximab (anti-CD38 mAb) and Antibody-Drug Conjugates Strong growth driven by unmet need and ●2 Build a transformative pipeline groundbreaking science ● Immuno-oncology