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.
PREVENTING DISEASE AND SUPPORTING PATIENTS
IMPROVING ACCESS TO HEALTHCARE
EXPLORING THE BOUNDARIES OF MEDICAL INNOVATION
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
2 SANOFI ANNUAL REVIEW 2013 3SANOFI ANNUAL REVIEW 2013
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
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.
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
EVOLUTION OF DIVIDEND ()
BUSINESS EARNINGS PER SHARE* ()
*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
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