SANOFI PRESENTATION Brussels March 27, 2018 Arnaud Delépine, Associate VP, Investor Relations

Transcription

1 SANOFI PRESENTATION Brussels March 27, 2018 Arnaud Delépine, Associate VP, Investor Relations 1

2 Forward-Looking Statements This press release 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 labelling 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, Sanofi s ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic conditions, 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, 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 Sanofi: a Diversified Healthcare Leader By activity By geographic region 2017 sales 35,055M Pharmacy 29,954M 85.4 % Vaccines 5,101M 14.6 % Europe 9,525M 27.2 % Emerging Markets 10,258M 29.3 % United States 11,855M 33.8 % Rest of the World 3,417M 9.7 % 3

4 Continued Progress on Sanofi s Strategic Transformation Reshape portfolio Execute launches Drive simplification Sustain innovation Acquisition of Bioverativ: strenghtens leadership in rare diseases Acquisition of Ablynx: expands rare blood disorder franchise (1) Divestiture of EU Generics expected in 2018 (2) Acquisition of Protein Sciences in Vaccines Dupixent : launch success Kevzara : steady share gains in the U.S. Praluent and Soliqua 100/33 /Suliqua TM : launches progressing slower than originally anticipated Fitusiran: global rights obtained in hemophilia (4) Focused organization delivered cost savings of 1.5bn since 2015, one year ahead of plan Cemiplimab et dupilumab (3) : Acceleration and expansion of their development Acquisition of Bioverativ: brings late-stage R&D pipeline Acquisition of Ablynx (1) : transformative Nanobody technology platform (1) Subject to the completion of the Ablynx acquisition announced on January 29, 2018 (2) Following completion of the dialogue with social partners (3) In collaboration with Regeneron (4) Alnylam will receive royalties based on net sales of fitusiran products 4

5 Financial Performance in 2017 R&D 5,472M Sales: 35,055M Gross Profit: 24,759M Selling & general expenses 10,058M Business operating income: 9,343M Tax 2,106M Financial expenses 273M Business net income: 6,964M Gross margin 70.6 % R&D / Sales ration 15.6 % Business operating margin 26.7 % Net margin 19.9 % 5

6 2017 EPS Broadly Stable In-Line with Expectations Company Sales Business EPS 33,821M 35,055M % at CER/CS -0.4% at CER CER= Constant Exchange Rates CS= Constant Structure, adjusted for BI CHC business, termination of SPMSD and others 6

7 2018 Financial Guidance FY 2018 Business EPS +2% to +5% at CER (1,2,3) FW impact on Business EPS -3% to -4% (4) based on December 2017 average exchange rates (1) Including the anticipated contribution from the recently announced acquisitions (2) Compared to FY2017 and barring major unforeseen adverse events (3) FY 2017 Business EPS of 5.54 (4) Difference between variation on a reported basis and variation at CER 7

8 An Organization Based on Five Global Business Units Consumer Healthcare Sanofi Pasteur Vaccines 5 GBUs Sanofi Genzyme Specialty Care General Medicines & Emerging Markets Diabetes & Cardiovascular 8

9 Sanofi Genzyme Speciality Care Success of the New Immunology Franchise Immunology Successful launch of Dupixent Kevzara launch progressing well Global Specialty Care Franchise Sales 6,678 M 19% of company sales Multiple Sclerosis Strong, growing franchise Rare Diseases Acquisitions strengthen leadership position Oncology Significant expansion of development pipeline % at CER Immunology Multiple Sclerosis Rare Diseases Oncology CER= Constant Exchange Rates 9

10 Dupixent : Global Roll-Out in Atopic Dermatitis in Launches and 2018 Expected Launches (2) IGA 4 IGA 1 H H H H Pictures of a patient before and after treatment with dupilumab (1) + 8 Emerging Market countries 2017 Sales: 219M (1) For illustration purposes only. Images are taken from one patient at baseline (left) and at 16 weeks (right). Results were not representative of all patients and individual results did vary (2) Launched in the U.S. in April 2017, Germany in December 2017, the Netherlands in January 2018 and Denmark in February

11 Dupixent : Global Launch Opportunities in Multiple Diseases Dupilumab expected to be a key growth driver with significant commercial potential in multiple diseases (1) FDA to review Dupixent (dupilumab) as potential treatment for moderate-to-severe asthma Growth Opportunities across Diseases, Geographies and Demographics (1) ILLUSTRATIVE COPD Allergies Eosinophilic Esophagitis Nasal Polyposis Pediatric AD Adult/adolescent Asthma Japan/RoW Adult/adolescent Asthma EU Adult/adolescent Asthma U.S. Adult AD in Japan and RoW Adult AD in EU Adult AD in U.S. (1) If approved in indications by applicable Health Authority COPD= Chronic Obstructive Pulmonary Disease AD= Atopic Dermatitis Time 11

12 Kevzara - A New Treatment for Patients with Moderately to Severely Active Rheumatoid Arthritis A major market with very important unmet needs 1.3 million people in the United States 2.9 million people in Europe Marketed in the U.S. since May 2017 and currently being launched in Europe Kevzara in collaboration with Regeneron 12

13 Strong Growth of the Multiple Sclerosis Franchise in 2017 Sales Evolution 2,041M 1,114M 1,720M M +20.8% at CER +13.6% at CER +23.2% at CER 467M CER= Constant Echange Rates 13

14 Sanofi Pasteur - Vaccines Leading vaccines in 5 areas: Influenza Pediatric Combinations Meningitis Adult Boosters Travelers and other vaccines for endemic countries A strenghtened pipeline with the acquisition of Protein Sciences Impact from the Dengvaxia label update 2017 Global Vaccines Franchise Sales 5,101M 14.6% of company sales +8.3% at CER/CS Pediatric Combinations Influenza Vaccines Meningitis/Pneumo Adult Boosters Travel/Endemic Other CER= Constant Exchange Rates CS= Constant Structure 14

15 Protein Sciences Broadens Our Leading Flu Vaccines Portfolio With Flublok (1) Growth driven by product differentiation following age 65y old Fluzone HD TIV Better efficacy Fluzone HD QIV 50y old Better efficacy Flublok -43% Cumulative confirmed Flu cases compared with Traditional QIV vaccines (2,3) 6m old Fluzone TIV VaxiGrip TIV Change standard of care Fluzone QIV VaxiGrip QIV HD= High-Dose (1) The Only FDA approved recombinant protein-based influenza vaccine approved for all adults 18 and older (2) Source: Full prescribing information (3) 15

16 Diabetes and Cardiovascular Diseases Global DCV Franchise Sales 6,905M 19.7% of company sales Diabetes Franchise Global sales down 11.1 % at CER in 2017 U.S. diabetes sales decline partially offset by strong performance in Emerging Markets +11.6% -0.6% +0.1% -20.2% United States Europe Emerging Markets Rest of the World 2017 All growth rates at Constant Exchange Rates (CER) 16

17 Odyssey Outcomes: Praluent Significantly Reduces Risk of Cardiovascular Events in High-Risk Patients Praluent reduced by 15% (1) the risk of major adverse cardiovascular events Approved in more than 60 countries Reduction of all cause mortality by 15% (2) A more pronounced effect observed in patients with baseline LDL-C levels 100 mg/dl Focus on patients with the greatest health risk Praluent (alirocumab) is developped in collaboration with Regeneron (1) HR=0.85, IC : , p= (2) HR=0.85; IC: , nominal p value = For more information: consult the press release from March 10,

18 Sanofi is One of the Top 3 Players in Consumer Healthcare Integration of the Boehringer Ingelheim CHC business being finalized Global CHC Franchise Sales 4,832M 13.8 % of company sales Allergies, Cough & Cold Pain +2.1% at CER/CS Digestive Nutritionals Allergies Pain Digestive Nutritionals Other 2017 CER= Constant Exchange Rates CS= Constant Structure 18

19 General Medicines & Emerging Markets: Leading Position in Emerging Countries Due to an Adapted Product Portfolio 2017 Global GEM Business Unit Sales 14,048M 40% of company sales Emerging Markets (1) Sanofi ranks #1 (2) Supported by strong growth of sales in China: 2.2Bn : +15.1% (3) Established Products Accounting for nearly one third of company sales (1) World excluding U.S., Canada, Europe, Japan, South Korea, Australia, New Zealand and Puerto Rico (2) Market share (without Vaccines), IMS MIDAS FY 2017 (3) At Constant Exchange Rates and Constant Structure 19

20 Sanofi is #1 in Emerging Markets More than 7 billion people Aging population Rapid emergence of a middle class Improving access to healthcare Growing GDP health expenses Emerging Markets up +6.0% in FY

21 Strategically and Financially Compelling M&A to Enhance Sanofi s Growth Profile and Create Value Value Value Creation (1) Build Leadership Position Strengthen Pipeline Immediate EPS Accretion (2) Transforming the lives of people with hemophilia, cold agglutinin disease and other rare blood disorders $11.6 bn Nanobody technology to develop therapeutics in areas of high unmet medical need 3.9 bn ~ (1) ROIC>WACC in 3 to 5 years (2) Business EPS is a non-gaap financial measure (see appendix to Sanofi quarterly financial release definitions) 21

22 Bioverativ: a Leading Hemophilia Portfolio, a New Platform in Other Rare Blood Disorders U.S. biotechnology company, ~450 employees 2017 Revenues: $1,168M +31.7% Leadership position in the large hemophilia market with two marketed products: (1) (2) R&D : pipeline includes candidates in cold agglutinin disease, hemophilia and other rare blood disorders Complementary fit with fitusiran; maximizes commercial potential of current and future products (1) Treatment in hemophilia A (2) Treatment in hemophilia B 22

23 Ablynx: Provides a Leading Platform Technology and Enhances our Late-Stage Pipeline 1 Innovative Nanobody platform strengthens Sanofi s multi-targeting R&D strategy 2 3 Caplacizumab expands rare blood disorders franchise following Bioverativ deal Complementary mid-stage and pre-clinical programs: hematology, inflammation, immuno-oncology, respiratory diseases 4 Expected to be neutral to Business EPS in 2018 and

24 Sanofi Research and Development 70 projects in development for NMEs or additional indications (1) 7 NME and Vaccine approvals since 2015 (2) 7 potential submissions in next 15 months >10 pivotal study starts in next 12 months (1) Includes 4 Phase 1 products and 1 Phase 2 product for which Sanofi has opt-in rights but has not exercised these rights (2) Adlyxin, Dengvaxia, Dupixent, Kevzara, Praluent, Soliqua /Suliqua 100/33, Toujeo 24

25 7 Potential Submissions (1) for New Products or Additional Indications Over Next 15 Months Planned Submissions Men Quad TT NDA, Type 1 Diabetes sbla, ODYSSEY CVOT sbla, AD, adolescents 12-<18y 2 nd generation meningococcal ACYW conjugate vaccine S S S cemiplimab BLA, metastatic CSCC isatuximab BLA, RRMM dupilumab sbla, Nasal Polyps (1) Number of submissions determined by first submission to a regulatory authority in a country; subsequent submissions to other global regulatory authorities are not included in the count of 7 potential submissions 25

26 New Wave of Pivotal Study Starts Expected in 2018 dupilumab (1) Anti-IL4Rα mab COPD Eosinophilic Esophagitis isatuximab Anti-CD38 mab 1L MM SCT eligible 1L MM SCT ineligible venglustat (2) Oral GCS inhibitor Autosomal dominant polycystic kidney disease (ADPKD) alemtuzumab Primary Progressive MS SAR GLP-1/GCR dual agonist Obesity cemiplimab (1) 1 st line NSCLC efpeglenatide (3) Once-weekly GLP-1RA Type 2 Diabetes mavacamten (4) Obstructive Hypertrophic Cardiomyopathy COPD= Chronic Obstructive Pulmonary Disease; NSCLC= Non-Small Cell Lung Cancer (1) Collaboration with Regeneron (2) Phase 2/3 registrational study (3) Collaboration with Hanmi (4) Collaboration with Myokardia. Sanofi will lead ex-u.s. regulatory and commercial activities to mavacamten program where it has ex-u.s. commercialization rights 26

27 Sanofi Share Performance vs. Pharma Company Peers since January 2018, in Euro Stock Performance since January 1 st, 2018 in CAC40: -1.4% Median -5.9% Average -4.1% 5.6% 13.8% -0.1% -2.0% -3.3% -4.8% -5.9% -8.1% -9.5% -9.3% -9.3% -9.0% -11.1% Source: Bloomberg 27

28 Sector Rotation from Defensive to More Cyclical Sectors Pharma 1.1% 3.6% 4.3% 9.5% 14.1% 14.8% -8.0% -5.8% -3.3% S&P Sectors since Sept 29, 2017 source Nasdaq as of March 1,

29 The Dividend is a Core Part of our Value Proposition to Shareholders Evolution of Dividend Proposed dividend of 3.03 per share for 2017 financial year (1) 24 th consecutive year of dividend increase (1) Submitted for approval by shareholders at the Annual General Meeting on May 2,

30 An Active Communication with our Individual Shareholders Your publications Shareholder Handbook Letter to Shareholders Fact Sheet SlideShare YouTube Online information Sanofi IR mobile app Social Media LinkedIn Twitter 30

31 Meetings with Shareholders Meetings planned in 2018 Shareholders Committee Paris Reims Bruxelles Nancy Nantes Lyon Nice Annual General Meeting 2018 May 2: Paris Salon Actionaria 2018 November 22-23: Paris 4 events planned in 2018 Visit of Marcy-l Etoile Sanofi Pasteur industrial site Meetings with management and the Chairman 31

32 Sanofi: Life is a Health Journey 32