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ANNUAL REVIEW 2013 PROTECTING LIFE, GIVING HOPE CONTENTS 2 16 4 6 Message from the Chairman, Serge Weinberg Interview of Christopher Viehbacher SANOFI RETURNS TO GROWTH EXPLORING THE BOUNDARIES OF MEDICAL INNOVATION 2013 HIGHLIGHTS 24 PREVENTING DISEASE AND SUPPORTING PATIENTS ENTERING A NEW PHASE OF INNOVATION 30 9 Board of Directors 10 Executive Committee 12 Strategy IMPROVING ACCESS TO HEALTHCARE 36 7 GROWTH PLATFORMS Performance, key figures 2013 38 To keep in contact… PROFILE 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 world’s 7 billion people. SANOFI – ANNUAL REVIEW 2013 1 HIGHLIGHTS 2013: A YEAR OF ACHIEVEMENT 2013 was a solid year with new approvals, regulatory submissions and a robust R&D pipeline. Diabetes Once-daily Lyxumia® approval for treatment of type 2 diabetes in Europe Vaccines Multiple sclerosis HexyonTM/Hexacima® 6-in-1 pediatric vaccine approved in Europe Oral multiple sclerosis treatment Aubagio® approved in Europe APPROVALS Diabetes Homozygous familial hypercholesterolemia U.S. FDA approved of KynamroTM injection Zaltrap® approved in Europe (metastatic colorectal cancer) F E B R UA R Y MARCH APRIL M AY JUNE R&D JA N UA R Y Lyxumia® is the first diabetes therapy of its class approved in Japan for use in combination with basal insulin Colorectal cancer SANOFI AND REGENERON’S LONG-TERM RELATIONSHIP ACHIEVE FURTHER PROGRESS Sanofi’s 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 2 SANOFI – ANNUAL REVIEW 2013 Atopic dermatitis and asthma Diabetes Positive Phase IIa Results of dupilumab in moderate to severe allergic asthma Positive Phase III results for investigational new insulin U300 sarilumab, three key co-developed products. Dupilumab, which is in clinical development in Phase II 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 Phase III rheumatoid arthritis registration trial. Positive top-line results were also reported by Sanofi and Regeneron on alirocumab in the first Phase III study for patients with high cholesterol. J U LY AWARDS The new Lyxumia® injection pen for patients with type 2 diabetes, received the Good Design Award 2013 from the Japan Institute of Design Promotion. It recognizes Sanofi’s patient-centric approach. Multiple sclerosis Gaucher disease Allergies Genzyme’s multiple sclerosis treatment LemtradaTM approved in Europe Gastro-intestinal (Consumer Healthcare) Rolaids® re-introduced in the United States AU G U S T U.S. FDA granted acceptance filed for Genzyme’s CerdelgaTM (eliglustat) U.S. FDA approved Nasacort® Allergy 24HR for over-thecounter use (nasal spray) Animal Health Animal Health U.S. FDA approved Merial’s NexGardTM (treatment and prevention of fleas and ticks in dogs) SEPTEMBER BroadlineTM (parasite treatment and prevention in cats) approved in Europe O CTO B E R N OV E M B E R DECEMBER Vaccines Hypercholesterolemia Rheumatoid arthritis Fluzone® HD vaccines topline result of a large-scale in preventing influenza in adults 65 years of age and older. Positive top-line results with alirocumab from first Phase III study Positive Phase III results for sarilumab Clostridium difficile vaccine Initiated Phase III study SANOFI PASTEUR AND THE BILL & MELINDA GATES FOUNDATION COLLABORATE TO ACCELERATE DISCOVERY OF NEW VACCINES The objective of this collaboration, announced in October 2013, 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 world’s poorest people. It will also allow the development and testing of new technologies that help advance other R&D programs. To learn more: www.sanofi.com See definitions, page 39. SANOFI – ANNUAL REVIEW 2013 3 MESSAGE SANOFI RETURNS TO GROWTH 2 013 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 platforms—Emerging 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. Genzyme’s 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 SERGE WEINBERG, CHAIRMAN OF THE BOARD OF DIRECTORS *See definitions, page 39. AN EFFICIENT STRATEGY MORE THAN 110,000 EMPLOYEES 4 SANOFI – ANNUAL REVIEW 2013 PRESENT IN 100 COUNTRIES €33 IN SALES BN Although the year’s 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 to propose a dividend of 2.80 euros per share to shareholders, reflecting its confidence in Sanofi’s future. On behalf of the Board, I thank all of Sanofi’s 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” 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 nine projects potentially being filed over the next four years. Further strengthening R&D remains a major priority as it is key to the Group’s future. *See definitions, page 39. 2.80* 2.65 2013 2012 5.05 2011 2013 2012 2011 6,687 *See definitions, page 39. 2.77 6.14 2012 6.62 8,101 EVOLUTION OF DIVIDEND (€) 2011 8,748 BUSINESS EARNINGS PER SHARE* (€) 2013 BUSINESS NET INCOME* (M€) *Proposed for approval at the annual general meeting. SANOFI – ANNUAL REVIEW 2013 5 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 a “new” Sanofi, ready for future success. These growth platforms—Diabetes Solutions, Vaccines, Emerging Markets*, Consumer Healthcare, Genzyme (rare diseases and multiple sclerosis), Animal Health and Other Innovative Products*—are less exposed overall to patent expiries and are now the predominant factor in our performance. In 2013, growth was led by diabetes. Genzyme had a very strong *See definitions, page 39. A SOLID R&D PIPELINE 9 7 *As of February 6, 2014. *To learn more: Form 20-F 2013. late-stage projects* are expected to be filed for approval over the next 4 years 6 SANOFI – ANNUAL REVIEW 2013 approvals throughout 2013* 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, to have new products to launch and a healthy pipeline. This is an area in which we made great progress. We had 7 approvals 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 to ensure 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 world’s 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 demonstrates the significant change in our approach. We now have one of the strongest development portfolios in our industry with the possibility of 9 launches over the next 4 years. These new investigational products are exciting and would respond to unmet needs of millions of patients. “WE HAVE MOVED FROM BEING A TRADITIONAL PHARMACEUTICAL COMPANY TO ONE OF THE WORLD’S LARGEST BIOPHARMACEUTICAL COMPANIES.” Can you bring us through some of the key products in late-stage development pipeline? C. V.: Alirocumab, a PCSK9 inhibitor developed with our partner Regeneron, shows encouraging first Phase III results in hypercholesterolemia. SALES AND GROWTH AT CONSTANT EXCHANGE RATES (M€) GROWTH PLATFORMS NOW ACCOUNT FOR 72.5% OF SALES Emerging Markets 10,957 Diabetes Solutions 6,568 Vaccines 3,716 Consumer Healthcare 3,004 Genzyme 2,142 Animal Health 1,985 Other Innovative Products 705 +4.4% +18.7% - 0.1% +5.2% +25.9% - 5.3% +18.8% SANOFI – ANNUAL REVIEW 2013 7 Bill Gates, Dr Margaret Chan, Director General, WHO, and Christopher Viehbacher for the “United to Combat Neglected Tropical Diseases” event—April 2014. We have 2 monoclonal antibodies in clinical development. One, the IL-4, with really interesting first results in both severe asthma and atopic dermatitis. In fact, once you have a drug like this, in 2 auto-immune diseases, it could often work in other diseases. We have a list of multiple potential indications that we are investigating for this product. We also are developing an IL-6 for rheumatoid arthritis. This is a $21 billion worldwide biologics market and the IL-6 part of that market is rapidly growing, so the future outlook is promising. We have our potential dengue vaccine coming down the line. Dengue affects half the world’s population right across Africa, Asia and Latin America. We have been working on it for 20 years and I believe it is going to be an important contribution to public health. Another important vaccine will be for Clostridium difficile. This vaccine in development would be used to fight antibiotic resistant infections acquired in hospitals, which is becoming increasingly challenging. I am also looking forward to seeing the approval of PR5i vaccine, the first 6-in-1 vaccine to be made available in the U.S., protecting children from diphtheria, tetanus, pertussis, polio, Hib and hepatitis B. 8 SANOFI – ANNUAL REVIEW 2013 In diabetes, we continue to endeavor to bring innovative products to the market to provide better management of this worldwide epidemic. Lyxumia®, our GLP-1, is already launched in Europe and Japan and we intend to submit to the FDA upon completion of the ELIXA trial in 2015. We have a new investigational insulin, U300, which has demonstrated strong results in trials to date and we also have LixiLan, which is a combined insulin and GLP-1. If approved, all of these will continue to reinforce our leadership in diabetes. It is also important to mention our strong commitment to rare diseases through our Genzyme division. While each disease impacts a small “I BELIEVE OUR DENGUE VACCINE IS GOING TO BE AN IMPORTANT CONTRIBUTION TO PUBLIC HEALTH.” number of individuals, there are nearly 7,000 rare diseases that affect an estimated 350 million people worldwide. We have a rich development portfolio in this area and we are currently working on a new potential oral therapy for Gaucher’s disease, CerdelgaTM. This would be an important product in development for patients’ quality of life, as they currently have to spend hours getting an infusion every 2 weeks. In Animal Health we have 2 new products launching to protect our pets. One is NexGardTM for dogs and the other is BroadlineTM for cats. In the Consumer Healthcare division, we have launched Nasacort® without prescription in the U.S. which will complement Allegra® to help people fight the effects of allergies. All in all, I am proud of the progress achieved over the last 5 years which ensure we succeed in our mission, to bring innovative solutions to those in need. GOVERNANCE THE BOARD OF DIRECTORS T he Company’s corporate governance agenda is founded on the Afep-Medef code, available on the Medef (www.medef.fr) and Sanofi (www.sanofi.com) websites. Sanofi is administered by a Board of Directors currently comprising 16 members, including 4 women; 11 members are considered independent. Each year, the Board of Directors conducts a review to ensure that there is an appropriate balance in its composition and the composition of its Committees. In particular, the Board seeks to ensure a balanced representation of men and women with diverse backgrounds and countries of origin, to reflect the diversified and global nature of the Group’s business. AS OF DECEMBER 31, 2013, THE BOARD OF DIRECTORS IS COMPOSED OF THE 16 FOLLOWING MEMBERS. *Independent Director. Subject to the authority expressly reserved by law to the shareholders’ meetings and within the scope of the corporate purpose, the Board of Directors deals with and decides upon all issues relating to the proper management of the Company and other matters concerning the Board. It determines the general direction of the Company’s activities and ensures that they are implemented. Recently, the Board of Directors proposed the appointment of a new independent Director at the General Meeting of Shareholders to be held on May 5, 2014: Patrick Kron. He would replace Lord Douro, who has served on the Board for 12 years and will not seek another term. Serge Weinberg*, Chairman of the Board of Directors Christopher Viehbacher, Chief Executive Officer Jean-René Fourtou* Claudie Haigneré* Igor Landau Fabienne Lecorvaisier* Laurent Attal Suet-Fern Lee* Uwe Bicker* Christian Mulliez Robert Castaigne* Carole Piwnica* Thierry Desmarest Klaus Pohle* Lord Douro* Gérard Van Kemmel* To learn more: Form 20-F www.sanofi.com SANOFI – ANNUAL REVIEW 2013 9 GOVERNANCE EXECUTIVE COMMITTEE Jérôme Contamine, Executive Vice President, Chief Financial Officer Carsten Hellmann, Executive Vice President, Merial David P. Meeker, Executive Vice President & Chief Executive Officer Genzyme Pascale Witz, Executive Vice President, Global Divisions & Strategic Development 10 SANOFI – ANNUAL REVIEW 2013 Elias Zerhouni, President, Global R&D Karen Linehan, Executive Vice President, Legal Affairs and General Counsel Philippe Luscan, Executive Vice President, Global Industrial Affairs David-Alexandre Gros, Executive Vice President, Chief Strategy Officer I am proud of the progress achieved over the last 5 years which ensure we succeed in our mission, to bring innovative solutions to those in need. Christopher Viehbacher, Chief Executive Officer Sanofi, Chairman Genzyme Olivier Charmeil, Executive Vice President, Vaccines Roberto Pucci, Executive Vice President, Human Resources Peter Guenter, Executive Vice President, Global Commercial Operations SANOFI – ANNUAL REVIEW 2013 11 EME MA STRATEGY Emerging market growth for the healt leader in these fast gr well positioned to ca Sanofi can rely on seve historical presence, a to local needs, its loca and its commercia numbe 80% live in em * 7 GROWTH PLATFORMS OTHER INNOVATIVE PRODUCTS(1) Sanofi has reinvented its R&D approach. We now have a more open R&D model with increased external collaborations. We put patients at the core of our approach and focus on the development of biologic medicines. This transformation has led to significant improvement in our capacity to accelerate the pace of research and to develop more effective health solutions for patients in various therapeutic areas. our development 80% ofprojects are biologics (2) (1) See definitions, page 39. (2) 39 new molecular entities and vaccines of a total of 49. Source: Sanofi annual results 2013. VACC Sanofi Pasteur respo primary objective improving health As one of the world Sanofi plays an active of epidemics around people with one of of vaccines, covering for children +1billio dose yearl ERGING ARKETS ts are the main driver of th industry. As an historical rowing economies, Sanofi is apture their future growth. eral assets: its balanced and a product portfolio adapted ally based industrial network l presence across a large er of countries. of the world’s* population erging markets DIABETES SOLUTIONS To respond to the increasing number of people with diabetes around the world, Sanofi offers integrated and personalized solutions, based on innovation and proximity to patients. Our solutions aim to simplify their lives. We constantly innovate to offer patients new treatments and advanced medical devices that facilitate the management of diabetes. With innovation at its foundation, Sanofi has shaped the future of diabetes care for 90 years. people 382 million with diabetes *Source: IMF 2010. Source: IDF Atlas Sixth Edition, International Diabetes Federation 2013. CONSUMER HEALTHCARE GENZYME, RARE DISEASES AND MULTIPLE SCLEROSIS Through Genzyme, Sanofi provides hope to patients affected by rare diseases and multiple sclerosis around the world. Over the past three years, Genzyme has strengthened its leadership thanks to the development of new targeted therapeutic solutions for rare diseases and global approvals of Aubagio® and LemtradaTM(1) for multiple sclerosis. CINES onds to the Group’s e: promoting and around the world. leaders in vaccines, e role in the prevention the world. We provide f the largest ranges 20 infectious diseases and adults. n vaccine es produced ly ±7,000 identified rare (2) Thanks to consumer insight-driven innovation, Sanofi CHC provides people around the world with solutions such as Allegra®, Lactacyd®/Dermacyd®, No-Spa®, Enterogermina®, SuperVita 21 to name a few to help them manage their health and well-being in their daily life. Being directly in touch with consumers allows us to better capture their thoughts to better address their needs, research the trends and target the most relevant product categories for us to invest in. rd largest 3 consumer healthcare player in the world* *Source: IMS MAT Dec. 2013, Nicholas Hall & Company. diseases (1) See definitions, page 39. (2) Source: Global Genes Project. ANIMAL HEALTH Through Merial, Sanofi is a world leader in animal health. Merial is increasing its presence in emerging markets and launching innovative products for pets and production animals. The launch of the next generation of flea and tick control for pets is expected to significantly strengthen its position. significant 10 expected new products to be launched over the next 3 years SANOFI, A GLOBAL HEALTHCARE LEADER OUR COMMITMENTS 16 EXPLORING THE BOUNDARIES OF MEDICAL INNOVATION Sanofi has created an open innovation model, based on solid collaborations with its partners and the scientific community. With this new R&D approach, Sanofi can meet its main challenges: accelerating the transformation of scientific innovation into targeted therapeutic solutions for patients and developing new biologic entities. 24 PREVENTING DISEASE AND SUPPORTING PATIENTS By preventing disease, we protect health. By supporting patients, we can help to improve their quality of life. Sanofi is committed to supporting patients at every stage of their life. We offer a complete range of integrated and personalized health solutions that give patients hope of a better life. 30 IMPROVING ACCESS TO HEALTHCARE The global spread of chronic diseases and greater access to healthcare in developing countries creates new challenges. As a world leader in healthcare, Sanofi is convinced that it is its responsibility to provide improved access to healthcare in the more than 100 developed and emerging markets in which it operates. Dean, aged 45, married with two daughters, lives in Queensland, Australia. Account manager in an advertising agency, Dean wakes up every day at 6.00 a.m. for his morning jog before going to work. In 2007, he discovered that he was suffering from multiple sclerosis, but thanks to his treatment, he continues to lead the life that he chose and to pursue his passions. EXPLORING THE BOUNDARIES OF MEDICAL INNOVATION MORE THAN 2 MILLION PEOPLE 350 2.5 Source: World Health Organization. Source: Global Genes Project. Source: World Health Organization. AROUND THE WORLD SUFFER FROM MULTIPLE SCLEROSIS 16 SANOFI – ANNUAL REVIEW 2013 million people worldwide suffer from rare diseases billion people worldwide are at risk of developing dengue fever Meet Dean on sanofi.com and share his hope. €4.8bn of investment in R&D in 2013 OUR MAIN AREAS OF RESEARCH 9 late-stage projects* • • • • Multiple Sclerosis Diabetes Oncology Rare Diseases • Cardiometabolic Diseases • Immunology • Vaccines *As of February 6, 2014. SANOFI – ANNUAL REVIEW 2013 17 A REINVENTED R&D MODEL FOR SUSTAINABLE GROWTH 2013 was a milestone year for Research & Development. It marked the positive result of its transformation into a more open and productive model, centered on patients and focused on biotechnologies. Sanofi’s growing portfolio of high potential products in late-stage development demonstrates the success of its new R&D approach. Building a new R&D model Over the past years, Sanofi has taken significant steps to build a new R&D founded on two pillars: translational medicine and open innovation based on outstanding science. The translational medicine approach puts a focus on patients earlier in the disease discovery phase. Through the insights of patients, scientists can better understand the disease and its molecular system. They can thus accelerate the pace of research and the development of medicines that better fit the needs “9 LATE-STAGE PROJECTS ARE EXPECTED TO BE FILED FOR APPROVAL OVER THE NEXT 4 YEARS.” of patients. To complement its internal resources and access the best science, Sanofi has developed an open innovation approach. It has 18 SANOFI – ANNUAL REVIEW 2013 created hubs in each of its main locations to provide the assets for its researchers and scientists to interact together and to work in networks with the scientific and medical community. Sanofi has also built solid relationships with biotechnology companies, research institutes, universities, hospitals and patients, across many geographic regions. Accelerating our move towards becoming a biopharmaceutical company Sanofi has also accelerated its transition from a chemical into a biologic company. This growing footprint in biopharmaceutical is a very promising move, as biologic products offer higher chances of success than traditional chemical molecules. In 2013, the Group achieved tremendous progress: 80% of its overall development pipeline products are biologics. These successes illustrate the Group’s collaboration strategy with key players, such as Regeneron, a leading U.S. biotechnology company. Their long-term collaboration has led innovative investigational products, such as alirocumab for cholesterol related diseases, sarilumab for rheumatoid arthritis and dupilumab for atopic dermatitis or severe allergic asthma. Developing first-in-class products in key therapeutic areas In 2013, Sanofi has demonstrated its capacity to innovate, with the building of a robust and innovative Phase III pipeline. Nine late-stage projects are expected to be filed for approval over the next four years. Addressing patients’ A STRONG PORTFOLIO, INCLUDING ADVANCES IN BIOTECHNOLOGY(1) PHASE I 23 molecules being tested on a limited number of healthy subjects 49 pharmaceutical and vaccine solutions currently at the research stage APPROVALS AND LAUNCHES 2014-2018 9 potential filings: U300, LixiLan, Lixisenatide (U.S.), dengue vaccine, C. diff vaccine, sarilumab, alirocumab, dupilumab, 6-in-1 vaccine (U.S.) 2013 7 approvals and launches: Aubagio ® (EU), LemtradaTM(2) (EU), Lyxumia ®(2) (EU and Japan), Zaltrap ®(2) (EU), Kynamro ®(2) (U.S.), Fluzone ® QIV (U.S.), HexyonTM/ Hexacima ® (EU) PHASE II 14 products in clinic trials with patients REGISTRATION PHASE III 11 biological molecules 1 solution has been submitted to health authorities for approval: Cerdelga ® (EU and U.S.) (1) Information provided as of February 6, 2014. (2) See deinitions, page 39. need, these potential future launches reflect the efficiency of a more productive R&D, which allocates its resources dynamically across the Group. Sanofi is working to improve its range of therapeutic solutions with U300, a new investigational basal insulin, with the goal of enabling people to take control of their diabetes with less low blood sugar events and well-tolerated titration-to-target. 80% OF BIOLOGIC MOLECULES The LixiLan Phase III development program has been initiated for the fixed-ratio combination of Lantus® (insulin glargin) with Lyxumia® (lixisenatide) in a single daily injection. If approved, the fixed-ratio combination of Lantus® and Lyxumia® could be a fixed-ratio product combining basal insulin with a GLP-1 receptor agonist to control both fasting hyperglycemia and meal related hyperglycemia. Sanofi Pasteur has initiated Phase III trials in three vaccines. The first one is a potential first-in-class dengue vaccine, which is a major health issue affecting almost 2.5 billion people at risk worldwide. The Clostridium difficile vaccine, in development, prevents nosocomial diseases. The third, hexavalent, is the only fully liquid, ready-to-use, 6-in-1 pediatric vaccine* in development, highly improving comfort for infants. Other key strategic products in clinical development include sarilumab, in rheumatoid arthritis and alirocumab, the PCSK9 antibody tested in patients with high cholesterol levels and at high cardiovascular. Finally, dupilumab, an investigational antibody for atopic dermatitis and severe asthma, was named “Clinical Advance of the Year” by Scrip Intelligence at the 9th annual Scrip Awards. *Diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis and invasive infections caused by Haemophilus inluenzae type b. Elias Zerhouni, President of Global Research & Development “We have great teams and scientific expertise at Sanofi. However, the complexity of human disease is such that no single institution, company or country has all the internal resources to solve global health issues by itself. I believe that good research is done in an ecosystem of intellectual ventures, composed of associations, hospitals, patients, biotech companies, research institutes, and many others. With our open innovation approach, our researchers and scientists have the ability to interact together and with their environment to facilitate and accelerate the discovery and development of new treatments. With such good foundations in place, I am confident in our ability to better execute our core mission: improving the lives of patients and inspiring hope around the world.” SANOFI – ANNUAL REVIEW 2013 19 LOWERING CHOLESTEROL: FROM PATIENT BEDSIDE TO LAB BENCH Marc, France, with familial hypercholesterolemia. C ontrol of cholesterol levels is a key issue in the prevention of heart disease and many patients are unable to achieve their desired LDL-C (low-density lipoproteincholesterol, or “bad” cholesterol) levels despite treatment with standard of care (lipid-lowering agents) and appropriate diet and physical exercice. The discovery of PCSK9 (proprotein convertase subtilisin/kexin type 9) involvement in hypercholesterolemia illustrates the transfer of knowledge from patient bedside to lab bench, leading to the development of a potential treatment. Texas, a genetic study of 300 patients with very low serum cholesterol levels demonstrated a PCSK9 protein deficiency. The role of this protein in hypercholesterolemia was thus evidenced. DNA talks Genetics researchers took DNA samples from patients with low cholesterol levels and found that subjects bearing a PCSK9 mutation had lower LDL-C (“bad” cholesterol) levels. It also corresponded to a significant drop in coronary disease for this population over a 15 years period. Getting to know PCSK9 2003 Patients A patient consulted at Necker in Paris, France, for severe hypercholesterolemia: a genetic study revealed a hyperactive PCSK9 gene. The same year, in Dallas, 20 SANOFI – ANNUAL REVIEW 2013 PCSK9 plays an important role in the LDL-C metabolism. It regulates the LDL receptors density at the surface of the liver cells by promoting their degradation. Inhibition of PCSK9 increases availability of LDL receptors and represents a potentially novel mechanism for lowering LDL-C. A potential future therapy Working with our collaborator Regeneron we have since developed a potential PCSK9 inhibitor, alirocumab. The first Phase III results are encouraging. Results of Phase III clinical trials of alirocumab with statins and different background therapies, in a variety of patient populations, are expected in 2014. 2015 Expected submission of alirocumab The ODYSSEY program, involving 23,000 patients, is running to schedule, with expected regulatory submissions for alirocumab in early 2015 outside the U.S. and in 2015 in the U.S. Any information provided on cited products is in no way intended to encourage their use. MULTIPLE SCLEROSIS: AUBAGIO® AND LEMTRADA , NEW HOPE FOR PATIENTS TM David P. Meeker, Executive Vice President & Chief Executive Officer Genzyme “ Shani, Australia, with multiple sclerosis. T wo new treatments for multiple sclerosis were approved by the European Commission during the second half of 2013. Aubagio® (teriflunomide) and Lemtrada™(1) (alemtuzumab) provide new options for meeting the diverse needs of patients. Both address relapsing remitting multiple sclerosis in adults, and demonstrated positive effects in Phase III clinical trials. The EU approval of Aubagio® was based on two trials that showed the treatment significantly reduced annualized relapse rates and time to disability progression at two years versus a placebo. As a once-daily oral therapy, Aubagio® also offers patients an attractive alternative to traditional injectable treatments. Lemtrada™ has a novel dosing and administration schedule, with the first treatment course administered via intravenous infusion on five consecutive days. The second course is administered on three consecutive days, 12 months later. Two clinical trials in patients who were either new to treatment or had relapsed on a previous therapy, showed that Lemtrada™ was significantly more effective at reducing annualized relapse rates than interferon beta-1a. Lemtrada™(2) and Aubagio® are currently approved in more than 30 countries. (1) See definitions, page 39. (2) Genzyme to resubmit LemtradaTM application for FDA review, March 2014. The approvals of Lemtrada™ and Aubagio® in the European Union represent an important milestone for Genzyme and demonstrate our focus on scientific innovation and commitment to multiple sclerosis patients. “ LEMTRADA™ AND AUBAGIO® ARE CURRENTLY APPROVED IN MORE THAN 30 COUNTRIES IN JANUARY 2014, GENZYME AND ALNYLAM, a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi, expanded their strategic agreement to develop and commercialize treatments for rare genetic diseases. SANOFI – ANNUAL REVIEW 2013 21 ASTHMA AND ATOPIC DERMATITIS: RELIEF FROM DUPILUMAB* U p to 300 million people around the world are estimated to suffer from asthma, and its debilitating effects account for between 1% and 2% of healthcare spending in developed countries. Between 10% and 20% of these patients are unable to properly control the disease with the treatments currently available. Sanofi and Regeneron are now testing a new monoclonal antibody, dupilumab. Asthma: a clinical advance In a Phase IIa, a study of 104 patients with moderateto-severe allergic asthma investigational product dupilumab achieved an 87% reduction in the incidence of asthma exacerbation after withdrawal of background medication, compared to patients given a placebo. Improvements in lung function, clinical symptoms of asthma and other parameters were also noted during the trial, whose results were published in the New England Journal of Medicine in May 2013. Dupilumab was subsequently voted “Clinical Advance of the Year” by the industry publication Scrip Intelligence. Atopic dermatitis Along with asthma investigational product, dupilumab is currently in Phase IIb trials for the treatment for atopic dermatitis, an inflammatory skin condition that can affect the overall quality of patients’ lives. Sanofi and Regeneron aim to satisfy an unmet medical need; there is currently no well-tolerated, long-term treatment for moderate to severe cases of patients with atopic dermatitis uncontrolled with topical treatments. ALLERGIES AUVI-QTM*—A POTENTIAL LIFE-SAVER Distribution has begun in the United States of Auvi-QTM, a breakthrough device for self-injecting epinephrine to treat life-threatening allergic reactions. The size and shape of a credit card, with the thickness of a smartphone, the Auvi-QTM is unique in that it talks patients and care-givers through the injection process, and also provides visual cues. Up to six million Americans could be at risk of anaphylaxis, typically from food allergies, and surveys indicate that half of allergy sufferers worry that their existing auto-injector may not be used correctly. Sanofi has licensed the commercialization rights for North America from Intelliject, Inc. Auvi-QTM was created by teams of scientists led by twin brothers who were born with potentially life-threatening allergies. POLIO VACCINES TO THE POLIO ERADICATION Sanofi Pasteur is committed to provide the majority of the injectable inactived polio vaccines, in response to a Unicef tender, to achieve polio eradication by 2018. *Investigational product. Zsombor, Hungary, with asthma. CLOSTRIDIUM DIFFICILE VACCINE IN DEVELOPMENT REACHES PHASE III An investigational vaccine to prevent Clostridium difficile (C. diff), a major cause of life-threatening infections in hospitals and nursing homes, moved into Phase III trial stage during the summer of 2013. C. diff is a spore-forming bacterium that causes intestinal disease. The toxins lead to death in 8 to 15% of those infected. The vaccine is designed to produce an immune response that targets these toxins. Entitled Cdiffense, the Phase III study will eventually involve 15,000 adults at 200 sites across 17 countries and is excepted to be completed by end of 2017. *See definitions, page 39. 22 SANOFI – ANNUAL REVIEW 2013 Any information provided on cited products is in no way intended to encourage their use. DENGUE FEVER: A VACCINE ON THE HORIZON Immunization session for the clinical trial Phase IIb with our dengue vaccine in Thailand. Olivier Charmeil, Executive Vice President, Vaccines “ Dengue represents an increased public health problem… and we are in a very good position to provide a solution where none currently exists. “ S anofi is hopeful to become the first company to offer a vaccine against dengue fever, a potentially fatal disease that infects 100 million people a year around the world. A public health priority in Asia and Latin America, some 2.5 billion people in the world are at risk of developing one of four serotypes 2.5 BILLION PEOPLE ARE AT RISK OF DEVELOPING DENGUE of the disease after being bitten by a mosquito. Of those infected, around 500,000—including children— go on to develop dengue hemorrhagic fever, with 2.5% of these cases proving fatal. There is currently no specific treatment available for the disease. Dengue is a major source of hospitalization and places great strain on medical resources, particularly in developing countries. It has also damaging societal and economic impacts. Worse still, a combination of global warming, increased air travel and greater urbanization in developing economies means that infection rates are likely to rise further. Taking up the challenge Sanofi is determined to meet the challenge of combating this disease and has developed a vaccine candidate, following an accelerated R&D program. Already, the vaccine has delivered promising results in Phase II clinical trials. Efficacy rates among 4,000 children ranged from 60% to 90% against three of the disease serotypes, with results of the fourth proving inconclusive. Equally importantly, the trials demonstrated the treatment to be safe and well-tolerated by patients. Today, the vaccine candidate is undergoing Phase III trials with two large-scale studies being carried out in Asia and Latin America. Results of these studies among a population of 31,000 children and adolescents in 10 countries are expected in the second half of 2014. The World Health Organization has set itself the goal of reducing dengue mortality rates by half and morbidity rates by a quarter within the next six years. If Sanofi successfully develops the world’s first vaccine against the disease, Sanofi stands to make a significant contribution to achieving that goal. SANOFI – ANNUAL REVIEW 2013 23 PREVENTING DISEASE AND 26 infectious diseases can be prevented through vaccination Source: World Health Organization. 24 SANOFI – ANNUAL REVIEW 2013 PREVENTION 1 BILLION VACCINE DOSES ARE MADE AVAILABLE BY SANOFI PASTEUR EACH YEAR Delphine, 35 years old, Agro-food engineer, nutritionist, living in Saint-Restitut, France. Delphine has led an international team of 12 people to the top of Kilimanjaro (19,341 feet), the highest peak of Africa. All of them were affected by type 1 diabetes. The expedition proved that diabetes can be managed in extreme conditions and that it is not an obstacle. It also brought hope to all people living with the disease. The team had one motto: “Take control, dare to dream.” Meet Delphine on sanofi.com and share her hope. SUPPORTING PATIENTS 382 MILLION PEOPLE WORLDWIDE SUFFER FROM DIABETES Source: IDF Atlas Sixth Edition, International Diabetes Federation 2013. OUR STAKEHOLDERS • Health professionals • Health authorities • Patients associations SANOFI – ANNUAL REVIEW 2013 25 A GLOBAL APPROACH TO PATIENTS With the rise of more and more difficult-to-treat diseases, Sanofi offers global therapeutic solutions. The Group is engaged in the prevention of diseases and accompanies patients at every stage of their life, with a complete range of integrated and personalized health solutions. Sanofi also collaborates with healthcare professionals to enhance quality of care. A preventive medicine Sanofi strives to develop a more preventive medicine in order to delay the onset of disease. This predictive medicine starts upstream, with the innovation phase. The R&D teams work with patients associations to identify and better understand patient’s needs. Sanofi Pasteur plays a major role in helping to prevent avoidable diseases, with its large range of vaccines covering 20 infectious diseases. Its ongoing innovation efforts have recently led to the first candidate vaccine for dengue disease and to a more effective “SANOFI CONCENTRATES ON EASING THE MANAGEMENT OF ILLNESS” vaccine in preventing influenza in older adults. The Group also conducts multiple preventive actions among populations, especially in resource- 26 SANOFI – ANNUAL REVIEW 2013 limited countries. Implemented in collaboration with local health authorities, these initiatives include screening, awareness and information campaigns. Sanofi also participates in the education of health professionals through dedicated training, sharing of know-how and interactive exchange platforms. Some global healthcare solutions With its pharmaceutical activities, Sanofi can support patients throughout every stage of their life. To help to improve their condition, the Group goes beyond innovative medicines: it offers integrated and personalized healthcare solutions. Sanofi concentrates on easing the management of illness, which, in the case of chronic diseases, could be for a lifetime. In diabetes for instance, Sanofi has delivered advanced medical devices designed to facilitate the daily management of this chronic disease. By involving the patient in his treatment, these tools present another key merit: to drive behavioral change and to empower patients. BGStar ®, the blood glucose monitoring. E-health solutions: innovation in patient management Driven by valuable insights from people living with diabetes and their health care practitioners, Sanofi is forming collaborations with a variety of organizations to offer innovative services for diabetes management through technological advances. E-health solutions can help health care practitioners to make more informed decisions and provide personalized patient care—even from a distance. In return, patients may be able to better follow their prescribed treatments between doctor visits, aiming for a stronger patient commitment and improved treatment compliance. OUR INTEGRATED DIABETES CARE APPROACH TO HELP PATIENT BETTER LIVE LISTENING TO THE PATIENTS The Group involves patients with diabetes in the design phase of insulin pens or glucose meters, in order to identify their needs and gather their opinions on the prototypes. Tests performed on patients also allow the adaptation of instructions for use, so that they are as educational as possible. 40-54% LANTUS®, OF PATIENTS WITH TYPE 2 DIABETES ARE NOT REACHING THEIR LONGTERM GLUCOSE GOALS(1) ITS WORLD’S LEADING INSULIN BRAND 46%(2) 1 BILLION(3) UNDIAGNOSED PEOPLE WITH DIABETES IN THE WORLD OF SOLOSTAR ® INSULIN PENS PRODUCED TILL 2013 (1) Giugliano D and al., Diabetes Res Clin Pract. 2011; 92:1-10. (2) IDF Atlas Sixth Edition, International Diabetes Federation 2013. (3) Internal data. SIMPLIFYING DIABETES MANAGEMENT THROUGH TECHNOLOGY What are you doing to build better integrated patient care solutions in diabetes? Today, a diabetic patient on insulin never gets a day off. Blood glucose must be measured, Sanofi works closely with patients associations according to the national regulations to improve the diagnosis of diabetes. Together, they organize information campaigns for populations and provide trainings to the health professionals. T1DStars is an example. It is an education website customized for type 1 diabetes teenagers. It helps them deal with their feelings and better fit diabetes into their life. TREATING WITH FIRST-IN-CLASS SOLUTIONS Sanofi combines the latest technology with patient insights in a new integrated approach: MyStar™. This one offers smart devices, services and guidance designed to help simplify and enhance diabetes management. Key solutions include the insulin pens JuniorSTAR ®, SoloSTAR ® and AllSTAR TM, and the blood glucose meters BGStar ®, iBGStar ® and MyStar Extra™, the first self-monitoring device that provides an estimated A1c value—a key indicator for long-term blood sugar control. How can integrated solutions help patients? Integrated Care encompasses the medical, social, and economic aspects of patient care. We aim to adopt a holistic approach to patients, focused on one goal: to ease the management of their disease. Simplicity drives behavior change. This is why we strive to support our patients with better tools and solutions, and thereby, improve their adherence to medications and health outcomes. PREVENTING DIABETES WITH EDUCATION AND TRAINING Because diabetes is such a complex and progressive disease, Sanofi never ceases its innovation efforts and works in collaborations with the world’s leading research institutes. Building on the success of Lantus ®, its number one insulin brand worldwide, Sanofi continues to evolve its insulin portfolio with its new investigational insulin U300. Pascale Witz, Executive Vice President, Global Divisions & Strategic Development “ We aim to provide patients with simpler, better ways to manage their disease. food intake monitored, and insulin injected, often multiple times a day. Everything must be written down and tracked. It is complicated. We imagine a future where Sanofi could offer a simpler solution to a patient by combining advances in technology and services. By listening to patients, caregivers and physicians, as well as experts in healthcare and technology, we are developing the products of the future to support patients in their daily lives. “ SANOFI – ANNUAL REVIEW 2013 27 DIABETES: LYXUMIA® EXTENDS ITS GLOBAL REACH L yxumia®* (lixisenatide), the latest Sanofi medicine for the treatment of type 2 diabetes, has now been approved for use in over 40 countries in the European Union, Asia, Australia and Latin America. GLP-1 is a naturally occurring hormone that is secreted within minutes of eating a meal and is known to stimulate the release of insulin in a glucose dependent manner. Lyxumia®, its regulatory filings were supported by the GetGoal clinical program, which featured 11 clinical trials and more than 5,000 patients. Lyxumia® is a once-daily injectable approved for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. This lack of control is common as the disease progresses. Lyxumia® has been shown to significantly lower HbA1c (glycated hemoglobin) levels through its post prandial glucose lowering effect. It also demonstrated to have a beneficial effect on body weight, limited risk of hypoglycemia, and mild and transient gastrointestinal effects (nausea and vomiting). *See definitions, page 39. VACCINE: IMPROVED PROTECTION A 6-in-1 pediatric vaccine developed by Sanofi Pasteur is now offering enlarged protection for millions of children after being authorized by the European Commission. Commercialized as Hexyon™ in Western Europe and Hexacima® in Eastern Europe, the product is a primary vaccination and booster for diphtheria, tetanus, whooping cough, hepatitis B, polio and invasive infections caused by Haemophilus influenzae type b. 28 SANOFI – ANNUAL REVIEW 2013 Hexyon™/Hexacima® reduces the number of vaccination visits, making it easier for parents to complete the schedule. It is a fully liquid ready-to-use vaccine; no reconstitution is needed prior to administration which improves convenience for healthcare professionnals. It is also commercialized in emerging markets as Hexaxim®. Isabelle, France, with diabetes. DIABETES MORE INNOVATION IN INSULIN Sanofi’s new investigational insulin U300 has been shown to reduce night-time dips in blood sugar levels among patients with diabetes in one of the Phase III study. The patients, who were already receiving longacting insulin to treat type 2 diabetes, were given either U300 or Lantus® in a six-month study. Both products provided similar blood sugar control, but those taking U300 experienced 23% fewer cases of nocturnal hypoglycemia. The first encouraging results were achieved among a challenging patient population in terms of age, duration of diabetes and Body Mass Index. INFLUENZA VACCINE FOR CHILDREN AND ADULTS ALIKE Vaccination against 4 strains of influenza was made available by Sanofi Pasteur during the 2013 season in the U.S. following FDA approval of Fluzone® Quadrivalent. The vaccine, which protects against 2 A strains and 2 B strains, can be administered to adults and children as young as 6 months. The addition of a second B strain to trivalent vaccines is a response to the difficulty in predicting the dominant strain in the coming influenza season B strain. SANOFI MOVES INTO THE E-HEALTH ARENA M obile apps, now a part of many people’s everyday lives, are also proving to be valuable tools in healthcare. Sanofi is supporting two developments in the field of diabetes and chronic kidney disease (CKD) to improve patients’ quality of life and also disease monitoring by healthcare professionals. Diabeo was jointly developed in France by CERITD (Center of Research of the Intensification of the Treatment for Diabetes), Voluntis and Sanofi and is currently in development in the clinical study Télésage. Designed for type 1 and type 2 diabetes patients treated with a basalbolus insulin regimen, Diabeo combines a mobile application for patients to titrate their insulin and a web interface for healthcare professionals (HCPs). “It is the first solution offering patients real-time insulin dose suggestions and treatment adjustments based on patient history,” said Dr. Guillaume Charpentier (CERITD). “Thanks to its automated telemonitoring system, HCPs can intervene at the right moment, with better patient outcomes.” The current clinical study Télésage should demonstrate a reinforcement of patients’ adherence to healthcare professionals’ guidance on glucose monitoring, thanks to the mobile app which provides patients with coaching messages. The web interface should also enable HCPs to remotely follow patients with automated messages to analyze and evaluate patient data. Sanofi is also using digital platforms and social media to highlight nursing innovation with the Connecting Nurses portal*. Developed in partnership with leading nurses’ organizations, this portal is a forum for 16 million nurses to share ideas and best practice in patient education, practice and research. *www.connecting-nurses.com PHOSPHORUS MOBILE APP For chronic kidney disease (CKD) patients, Sanofi has developed a smartphone/tablet game called Phosphorus Mission—designed to educate them about dialysis and the role of minerals, particularly phosphorus. The app provides a guide to the condition and its treatment, and also helps patients to understand the role of nutrition. Between 5%-10% of the world’s population is estimated to suffer from CKD. Daniel Kraft, Physician, scientist and inventor. Medicine and Neuroscience Chair, Singularity University, California “ The mobile smartphone is the epitome of exponential technologies coming together (including low cost computing, mobile bandwidth, user interface, apps) generating disruption and innovation, as is quickly becoming a key platform for mobile, connected and digital healthcare. “ SANOFI – ANNUAL REVIEW 2013 29 IMPROVING ACCESS TO HEALTHCARE of the world’s population does not have access to healthcare IN 2020, 2/3 OF THE PHARMACEUTICAL INDUSTRY’S GROWTH WILL COME FROM EMERGING MARKETS Source: World Health Organization. Source: IMS Health. 1/3 30 SANOFI – ANNUAL REVIEW 2013 50% patients regularly forget to take their medication Source: World Health Organization. Meet Arvind on sanofi.com and share his hope. Arvind, AGED 55, LIVES IN NEW DELHI, INDIA. When this energetic Consultant is not working, he engages into a multitude of sports, golfing, cycling, motorcycling and bowls, as well as long walks with his two dogs. Arvind suffers from eosinophilia, a condition that occurs at each change of season and leaves him with no energy. Today, thanks to improved access to healthcare in India, Arvind can live the life he wants to lead, with nothing to hold him back! ST Sanofi is the market leader in emerging markets 176 million people benefited from over 260 access to healthcare programs SANOFI – ANNUAL REVIEW 2013 31 A GLOBAL PRESENCE CLOSER TO PATIENTS Access to healthcare around the world is a true challenge. Working closely with local health partners, Sanofi strives to reach this goal by strengthening its presence in emerging markets and offering a diversified range of medicine accessible to those most in need. Strengthening our position in emerging markets 80% of the world’s population lives in emerging markets. They are gaining greater access to healthcare through a combination of factors: growing urbanization and steady expansion of the middle class, leading to higher disposable income. Local governments are also strongly committed to develop public health infrastructure in their countries. Responding to these growing health needs is one of Sanoi’s top priorities. Since entering India back in 1951, the Group has strongly expanded its emerging markets footprint. Today, it is the leader in Emerging Markets with a presence close to 100 emerging countries. Besides the BRIC markets (Brazil, Russia, India and China), the Group has extended its geographical coverage to countries such as Vietnam, Indonesia or Colombia, in order to meet the future health needs of the local population. In 2013, Sanoi celebrated its 30th year in China, a country identiied as the most important emerging region in terms of growth. Sanoi’s success in emerging markets relies on a differentiated approach adapted 32 SANOFI – ANNUAL REVIEW 2013 to the local characteristics and needs of each market. This local approach concerns all of the Group’s resources: the management and commercial teams as well as the R&D and industrial networks. Developing a local industrial network… Like in Europe and North America, the expansion of Sanoi in emerging markets has been supported by the development of a local industrial network. Today, the Group has 112 manufacturing sites in 41 countries, including 37 sites in emerging markets. Producing locally is the best way to better understand and meet the local needs of patients. It helps to enable a better understanding of the local markets, a closer proximity with patients and international standards of quality and safety. Other key advantages include the ability to adapt the medicines to the regional characteristics and to comply with local regulation. Industrial innovation is another key element of the Group’s industrial culture. All over the world, Sanoi concentrates its development centers on improving the well-being of Philippe Luscan, Executive Vice President, Global Industrial Affairs “ In Sanofi is one of the few pharmaceutical groups to have full control over its production chain, from the active ingredient to distribution. “ patients, by working on the dosage forms. It also endeavors to develop solutions adapted to the local market constraints, such as the development of orodispersible drug delivery when access to water is dificult. … based on a common culture of excellence… The ambition of our Industrial Affairs is to continue to raise quality standards in the Group’s production activities, and to remain a world leader and a benchmark in the global pharmaceutical industry. To achieve LOCAL PRODUCTION TO MEET PATIENT’S NEEDS ASIA-PACIFIC (including Japan and Australia) 21 sites NORTH AMERICA 20 sites 112 EUROPE 52 sites manufacturing sites worldwide, including 37 based in emerging markets 3,153 million boxes of pharmaceuticals produced and packaged worldwide in 2013 LATIN AMERICA 12 sites 4 new sites in 2013: Algeria, Vietnam, China and Saudi Arabia AFRICA and MIDDLE EAST 7 sites +11.5% Growing sales of vaccines in emerging markets in 2013 China 3.5 billion pills Production capacity for Sanofi’s new consumer products facility in Hangzhou this goal, all our activities share a common culture of industrial excellence, enriched in the Sanoi Manufacturing System. This sets out a series of priorities (such as customer service, continuous improvement, site network optimization and transverse optimization) that constitute our industrial vision and will be crucial to our mutual success. … and accessible portfolio of products The diversity of Sanoi’s products is an important asset in striving to fulill the needs of the 7 billion people around the world. The Group strives to develop medicines and healthcare solutions accessible to those most in need. It offers a wide range of quality medicines at affordable prices through generics, as well as OTC products to meet the growing trend of self-medication. Sanoi Pasteur is committed to endeavoring to make vaccines accessible to as many people as possible, by participating in many public health projects and applying a differentiated pricing policy. It also continuously innovates to develop new vaccines. To promote access to healthcare for the patients most in need, especially in emerging markets, Sanoi has created a dedicated Access to Medicines Department. It aims to adapt the Group’s strategy to each country, such as a market differentiated pricing policy to ensure the affordability of medicines. Working closely with the local health partners In each country, Sanoi works in close collaboration with local health partners to improve access to healthcare. The Group cooperates with local governments, health authorities, NGOs and other key players such as the Worldwide Health Organization. This collaborative approach is one of the reasons for the Group’s longevity and success throughout the world. Peter Guenter, Executive Vice President, Global Commercial Operations What is the recipe to successfully adapt your offer to each market? A complete understanding of the local environment and the knowledge of the needs of patients are key for us to adapt our offers. This makes the upstream preparation work even more essential. Develop win-win collaborations with key stakeholders in implementing health policy is also very important. What is the best illustration of your differentiated approach? In certain African countries, we have the classic offer of our portfolio that is similar to the rest of the world. We have also an Access to Medicines program that enables access to medicines for some local pandemic diseases such a malaria on a no profit/no loss basis. SANOFI – ANNUAL REVIEW 2013 33 SANOFI CONSUMER HEALTHCARE: CONSUMERS AT HEART! A s the third largest supplier worldwide of OTC medicines and supplements, Consumer Healthcare (CHC) is a strategically important business to Sanofi. Sales increased by 5.2% in 2013 to more than €3 billion, with consumer products including painkillers, digestive disorder remedies, VMS (vitamins and mineral supplements), feminine care products and treatments for cough and cold or allergies. To reflect the portfolio’s importance, a global CHC division established in 2014 and mainly focuses on global brands growth, future businesses as well as targeted external growth opportunities. The global CHC division is operating along three key strategic directions: generating consumer insight-driven innovation, drawing on Sanofi’s scientific heritage and leveraging the company’s worldwide manufacturing network and its pharmaceutical quality standards. Furthermore, beyond putting consumers first, Sanofi CHC builds on its in-depth understanding of the role of physicians and pharmacists in the area of selfcare. ANIMAL HEALTH: APPROVAL OF NEXGARD® M erial has a long tradition and expertise in launching innovative and preventive treatments for animals. The company is currently introducing two novel, convenient parasite treatments for pets: Broadline™ for cats and NexGard® for dogs. Broadline™, approved in Europe, is a unique topical product combining 4 active ingredients to prevent and treat both internal and external parasites in cats. NexGard®, already approved in the United States, Europe and Japan, is the first and only, monthly beefflavored soft chew for dogs that kills fleas and ticks. Its innovative formulation and 34 SANOFI – ANNUAL REVIEW 2013 distinct mode of action provide excellent efficacy at a low dose monthly treatment, while being highly palatable for dogs. Both are veterinarian prescription only products. For cattle, Merial delivered a brand new way in thinking about parasite control, resulting in less labor for producers and less stress for their cattle. Instead of treating cattle up to three to four times during the grazing season, its Longrange® product gives producers the option of a single treatment that will last all season. This persistent parasite control is possible because of the unique Theraphase® technology, which releases the active ingredient for an extended period after injection. 50% OF CONSUMER HEALTHCARE SALES ACHIEVED IN EMERGING MARKETS IN 2013 NASAL ALLERGY SYMPTOMS NASACORT AVAILABLE OTC Nasacort® Allergy 24HR is now available over-the-counter (OTC) in the U.S. to relieve the full range of seasonal and year-round nasal allergy symptoms, in adults and children 2 years of age and older. It is the irst and only medicine in its class to be available OTC in the U.S. at full prescription strength. This milestone builds on our expertise in prescription-to-OTC switches as we continue to expand our global consumer healthcare portfolio according to the national regulations. Biscuit, cat, France. PROVIDING ACCESS TO QUALITY HEALTHCARE FOR EVERYONE SANOFI’S CSR ACHIEVEMENTS RECOGNIZED BY 2 GLOBAL INDICES In 2013, Sanofi was listed on two prestigious global CSR indices. For the 7th consecutive year, it has been included in the Dow Jones Sustainability Index (DJSI), the most recognized international sustainability index for investors. Sanofi was also in the Climate Disclosure Leadership Index (CDLI) where its ranking improved over the previous year. These successes highlight the employees’ ongoing commitment to sustainability. MY CHILD MATTERS: RENEWED FORCES TO FIGHT CHILDHOOD CANCER Chad, to fight against sleeping sickness. T oday, 2.5 billion people representing over one third of the worldwide population has no access to essential healthcare. Corporate Social Responsibility (CSR) is part of our DNA: as a world leader in healthcare, we consider that it is our responsibility to improve access to quality healthcare for everyone, regardless of their origin. An estimated 176 million people benefited from over 260 programs. We currently concentrate our efforts on three main priorities, in collaboration with our partners: – Promoting access to medicine for the patients most in need in resource-poor countries. We adapt our commercial offerings to the economic conditions of the targeted countries. Our main initiatives cover information and education, targeted medicines, differentiated pricing policies and industrial expertise. As an example: we are committed to fight against neglected tropical disease, sleeping sickness and malaria, with hope to be eliminated by 2020. – Reducing inequalities, through the Sanofi Espoir Foundation. The Foundation focuses on fighting against childhood cancer, reducing maternal and child mortality and providing healthcare access for the poorest. – Promoting access to quality healthcare and protecting the safety of patients by fighting counterfeiting. Sanofi cooperates closely with law enforcement authorities and professional organizations in many countries. The Group analyses suspected products in its own anti-counterfeit laboratory. It also develops mobile technologies to inform travelers on the dangers of counterfeit drugs. In February 2013, the Union for International Cancer Control (UICC) and the Sanofi Espoir Foundation renewed their My Child Matters partnership for another three years. This partnership is dedicated to fighting childhood cancer in low-income countries. Initiated in 2005, this program combines financial support, advice from international experts and networking activities, with significant impacts for childhood cancer. The new partnership focuses on three priorities: enhanced support and evaluation of ongoing projects in 15 emerging economies; backing from international care networks; and awareness-raising actions to make childhood cancer a priority on the global health agenda. SLEEPING SICKNESS: 27 MILLION SCREENED PEOPLE, 175,000 PATIENTS SAVED IN A PARTNERSHIP WITH THE WHO*. OUR GOAL: ELIMINATION OF THIS DISEASE IN 2020. *World Health Organization. SANOFI – ANNUAL REVIEW 2013 35 TO KEEP IN CONTACT… Shareholder handbook Form 20-F Sanofi at a glance CSR Report PUBLICATIONS Corporate site: www.sanofi.com IR mobile application Sanofi at a glance mobile application 0:00 AM 0:00 AM ONLINE FOLLOW US www.twitter.com/sanofi www.youtube.com/ user/sanofiaventisTVfr www.linkedin.com/ company/sanofi- The Sanofi 2013 Annual Review was designed and produced by the Sanofi Communications Department and the communication company . We would like to thank all those who contributed to the articles and agreed to be photographed for this Annual Review. www.flickr.com/ photos/sanofi e-accessibility publication e-accessible version by Photo credits Front cover: Blue Images/Corbis – ooyoo/Getty Images – Inside front cover: Palani Mohan – Delphine Arduini – Atul Sharma/CAPA Pictures – p. 2: Bopp Lou/CAPA Pictures – Christian Fleury/CAPA Pictures – p. 3: Pierre-Olivier Callede/CAPA Pictures – Akos Stiller/Capa Pictures – p. 4: Marthe Lemelle – p. 6, 10-11: Atmos’faire – p. 8: G. Petipas - p. 15: Palani Mohan – Delphine Arduini – Atul Sharma/CAPA Pictures – p. 16-17: Palani Mohan – p. 18: Denis Félix/Corbis – p. 19: Marthe Lemelle – p. 20: Sanofi Pasteur/Norbert Domy – p. 21: Palani Mohan – Roger Farrington – p. 22: Akos Stiller/CAPA Pictures – p. 23: Frank Parisot – p. 24-25: Delphine Arduini – p. 26: Sanofi – p. 27: N. Djamal/CAPA Pictures – Céline Clanet/Interlinks Image – p. 28: Pierre-Olivier Callede/CAPA Pictures – p. 29: franckreporter/E+/Getty Images – Singularity University – p. 30-31: Atul Sharma/CAPA Pictures – p. 32-33: Romain Baltz – p. 34: Sanofi – Guillaume Ramon/CAPA Pictures – p. 35: Sanofi. 38 SANOFI – ANNUAL REVIEW 2013 DEFINITIONS Emerging Markets: The world excluding the United States, Canada, Western Europe (France, Germany, United Kingdom, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Sweden, Portugal, the Netherlands, Austria, Switzerland, Ireland, Finland, Norway, Island, Denmark), Japan, Australia and New Zealand. Other Innovative Products: Includes products launched since 2009 which do not belong to other growth platforms, Multaq®, Jevtana®, Zaltrap®, Auvi-Q QTM and Mozobil®. Zaltrap® (aflibercept): Developed in collaboration with Regeneron. Auvi-Q™ (epinephrin): Sanofi U.S. licensed the North American commercialization rights to Auvi-Q QTM from Intelliject, Inc. Lemtrada™ (alemtuzumab): Developed in collaboration with Bayer HealthCare. Kynamro™ (mipomersen sodium): Development partnership with Isis Pharmaceuticals. Lyxumia® (lixisenatide): Lixisenatide has not yet been authorized or approved in all world markets. Business EPS: Business earnings per share is a specific financial indicator that we define as business net income divided by the weighted average number of shares outstanding. Business net income is defined as net income attributable to equity holders of Sanofi excluding (i) amortization of intangible assets, (ii) impairment of intangible assets, (iii) fair value remeasurement of contingent consideration liabilities; (iv) other impacts associated with acquisitions (including impacts of acquisitions on associates and joint ventures); (v) restructuring costs (including restructuring costs relating to associates and joint ventures); (vi) other gains and losses, and litigation; (vii) the tax effect related to the items listed in (i) through (vi); as well as (viii) the effects of major tax disputes, the tax on dividends distributed to Sanofi shareholders starting in 2013, and as an exception for 2011, the retroactive effect (2006-2010) on the tax liability resulting from the agreement signed on December 22, 2011 by France and the United States on transfer prices (APA-Advance Pricing Agreement), for which the amount is deemed to be significant; and (ix) the share of non-controlling interests in items (i) through (viii). Items (i), (ii), (iii), (v) and (vi) correspond to those reported in the income statement line items ‘‘Amortization of intangible assets’’, ‘‘Impairment of intangible assets’’, ‘‘Fair value remeasurement of contingent consideration liabilities’’, ‘‘Restructuring costs’’ and ‘‘Other gains and losses, and litigation’’. This document 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 policies 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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. 54, rue La Boétie 75008 Paris – France – Tel.: +33 (0)1 53 77 40 00 – www.sanofi.com