Annual Review 2013 - Protecting life, giving hope - 4 SANOFI – ANNUAL REVIEW 2013 SANOFI – ANNUAL…

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  • ANNUAL REVIEW 2013

    PROTECTING LIFE, GIVING HOPE

  • 1SANOFI ANNUAL REVIEW 2013

    COMMITTED TO 7 BILLION PEOPLE

    Over the years, Sanofi has evolved to meet the new challenges of healthcare worldwide. Today, Sanofi is a global healthcare leader focused on one ultimate goal: to improve the lives of patients around the world. Patients are at the heart of our approach. We listen to their needs, support them in their disease and treat them. We have reinvented our research & development approach to accelerate both the pace of innovation and the development of breakthrough health solutions for patients. Through our diversified portfolio of medicines, vaccines and innovative therapeutic solutions, we strive to protect the health and meet the needs and hopes of the worlds 7 billion people.

    PROFILECONTENTS

    PREVENTING DISEASE AND SUPPORTING PATIENTS

    24

    IMPROVING ACCESS TO HEALTHCARE

    30

    EXPLORING THE BOUNDARIES OF MEDICAL INNOVATION

    162

    36GROWTH PLATFORMS

    Strategy12 38

    Executive Committee10

    Message from the Chairman, Serge Weinberg

    SANOFI RETURNS TO GROWTH

    4 6Interview ofChristopher Viehbacher

    ENTERING A NEW PHASE OF INNOVATION

    9 Board of Directors

    To keep in contact

    Performance, key figures 2013

    HIGHLIGHTS 2013

    7

  • 2 SANOFI ANNUAL REVIEW 2013 3SANOFI ANNUAL REVIEW 2013

    HIGHLIGHTS

    SANOFI PASTEUR AND THE BILL & MELINDA GATES FOUNDATION COLLABORATE TO ACCELERATE DISCOVERY OF NEW VACCINES

    The objective of this collaboration, announced in October2013, is to explore and develop new platforms and methods so as to accelerate R&D in vaccines. With this collaboration, both allies intend to accelerate the research and development of effective and affordable vaccines that will ultimately benefit the worlds poorest people. It will also allow the development and testing of new technologies that help advance other R&Dprograms.

    2013 was a solid year with new approvals, regulatory submissions and a robust R&D pipeline.

    2013: A YEAR OF ACHIEVEMENT

    Hypercholesterolemia Positive top-line results with alirocumab from first PhaseIII study

    Rheumatoid arthritis Positive PhaseIII results for sarilumab

    JANUARY FEBRUARY APR IL MAY JUNE AUGUSTJULY SEPTEMBER OCTOBER NOVEMBER DECEMBER

    AP

    PR

    OV

    ALS

    R&

    D

    DiabetesOnce-daily Lyxumia approval for treatment of type2 diabetes in Europe

    Gastro-intestinal (Consumer Healthcare) Rolaids re-introduced in the United States

    Allergies U.S. FDA approved Nasacort Allergy 24HR for over-the-counter use (nasal spray)

    Colorectal cancer Zaltrap approved in Europe (metastatic colorectal cancer)

    Multiple sclerosis Genzymes multiple sclerosis treatment LemtradaTM approved in Europe

    Animal HealthBroadlineTM (parasite treatment and prevention in cats) approved in Europe

    Gaucher diseaseU.S. FDA granted acceptance filed for Genzymes CerdelgaTM (eliglustat)

    Vaccines HexyonTM/Hexacima 6-in-1 pediatric vaccine approved in Europe

    Diabetes Lyxumia is the first diabetes therapy of its class approved in Japan for use in combination with basal insulin

    Animal Health U.S. FDA approved Merials NexGardTM (treatment and prevention of fleas and ticks in dogs)

    Multiple sclerosis Oral multiple sclerosis treatment Aubagio approved in Europe

    Homozygous familial hypercholesterolemia U.S. FDA approved of KynamroTM injection

    Clostridium difficile vaccine Initiated PhaseIII study

    Vaccines Fluzone HD vaccines topline result of a large-scale in preventing influenza in adults 65years of age and older.

    SANOFI AND REGENERONS LONG-TERM RELATIONSHIP ACHIEVE FURTHER PROGRESS

    Sanofis relationship with Regeneron, a major U.S. biopharmaceutical company, has grown steadily since 2003. Strong ties have been forged, leading to the development of potential new products in various therapeutic areas. In 2013, the partners have achieved great progress on the development of alirocumab, dupilumab and

    sarilumab, three key co-developed products. Dupilumab, which is in clinical development in PhaseII for the treatment of asthma and atopic dermatitis, is one of the most exciting emerging clinical candidates in the industry. Sanofi and Regeneron reported positive results for sarilumab in the first PhaseIII rheumatoid arthritis registration trial. Positive top-line results were also reported by Sanofi and Regeneron on alirocumab in the first PhaseIII study for patients with high cholesterol.

    MARCH

    AWARDS

    The new Lyxumia injection pen for patients with type2 diabetes, received the Good Design Award 2013 from the Japan Institute of Design Promotion. Itrecognizes Sanofis patient-centric approach.

    DiabetesPositive PhaseIII results for investigational new insulin U300

    Atopic dermatitis and asthma Positive PhaseIIa Results of dupilumab in moderate tosevere allergic asthma

    To learn more: www.sanofi.com See definitions, page 39.

  • 4 SANOFI ANNUAL REVIEW 2013 5SANOFI ANNUAL REVIEW 2013

    SANOFI RETURNS TO GROWTH

    2013 was pivotal for Sanofi, marked by the end of the impact of generification of some of our key products in the U.S., such as Plavix.

    The return to sales growth in September demonstrated the pertinence of the strategic choices implemented by the company since 2008.

    Our seven growth platformsEmerging Markets*, Vaccines, Diabetes Solutions, Consumer Healthcare, Genzyme (rare diseases and mutiple sclerosis), Animal Health and Other Innovative Products*represented 72.5% of total sales for the year. Genzymes strong growth in rare diseases and multiple sclerosis should be particularly noted. The occasional difficulties encountered in certain emerging markets have not altered our position: on the contrary, the lessons learned will enable us to advance to new levels on strengthened foundations. In this context, the Board spent several days

    in China in October to further explore strategic opportunities in the country.2013 also saw progress in the organisation of R&D and the evolution of several key projects: U300, alirocumab, sarilumab and Fluzone. Our late-stage product portfolio further progressed with nineprojects potentially being filed over the next four years. Further strengthening R&D remains a major priority as it is key to the Groups future.

    Although the years results were below our expectations, we recognize the considerable efforts made to adapt to markets and prepare Sanofi for its future.For this reason, the Board has decided topropose a dividend of 2.80 euros per share toshareholders, reflecting its confidence in Sanofis future.On behalf of the Board, I thank all of Sanofis employees for their commitment and the quality of their work.

    THE RETURN TO SALES GROWTH IN SEPTEMBER DEMONSTRATED THE PERTINENCE OF THE STRATEGIC CHOICES IMPLEMENTED BY THE COMPANY SINCE 2008

    AN EFFICIENT STRATEGY

    BUSINESS NET INCOME* (M)

    33 BN IN SALES

    PRESENT IN

    100COUNTRIES

    MORE THAN

    110,000EMPLOYEES

    MESSAGE

    8,101

    6,687

    8,748

    2012

    2011

    2013

    EVOLUTION OF DIVIDEND ()

    BUSINESS EARNINGS PER SHARE* ()

    2.772.80*

    2.65

    2012

    2011

    2013

    6.145.05

    6.62

    2011

    2012

    2013

    *Proposed for approval at the annual general meeting.

    *See definitions, page 39. *See definitions, page 39.

    SERGE WEINBERG, CHAIRMAN OF THE BOARD OF DIRECTORS

    *See definitions, page 39.*See definitions, page 39.

  • 6 SANOFI ANNUAL REVIEW 2013 7SANOFI ANNUAL REVIEW 2013

    INTERVIEW

    ENTERING A NEW PHASE OF INNOVATION

    CHRISTOPHER VIEHBACHER, CHIEF EXECUTIVE OFFICER SANOFI, CHAIRMAN GENZYME

    What are the major events of 2013 that marked the future for Sanofi? CHRISTOPHER VIEHBACHER: 2013 marked the inflection point for Sanofi. Throughout the year, we left the patent cliff further behind us and took decisive action to resolve temporary operational challenges in trade distribution channels in Brazil and production in the Toronto vaccines plant. We were able to return to sales growth in the second half of the year. Our growth platforms, which now represent 72.5% of sales, have been fuelling our growth for a number of years and enabled us to deliver the sustainable growth necessary to continue to invest in businesses, acquire, diversify and build anew Sanofi, ready for future success. These growth platformsDiabetes Solutions, Vaccines, Emerging Markets*, Consumer Healthcare, Genzyme (rare diseases and multiple sclerosis), Animal Health and Other Innovative Products*are less exposed overall topatent expiries and are now the predominant factor in our performance. In 2013, growth was led by diabetes. Genzyme had a very strong

    performance, driven primarily by the rare disease segment where we regained leadership in all products, but also the successful launch of multiple sclerosis treatment, Aubagio. When you look to the future, one of the most important elements is innovation, in particular, tohave new products to launch and a healthy pipeline. This is an area in which we made great progress. We had 7approvals throughout 2013 including in multiple sclerosis, diabetes, vaccines and cardiovascular. We now have a strong and credible late-stage development pipeline.

    What are the key assets that Sanofi has toensure success? C. V.: We are entering the second phase of renewal for Sanofi, that of Innovation. We have moved from being a traditional pharmaceutical company in 2008 to one of the worlds largest biopharmaceutical companies. 45% of our sales are from biologics and 80% of our development pipeline is now in biologics. This is up from 26% in 2008 and demons