Download pdf - Annual Review 2013 - Protecting life, giving hope - sanofi.no 4 SANOFI – ANNUAL REVIEW 2013 SANOFI – ANNUAL REVIEW 2013 5 SANOFI RETURNS TO GROWTH 2 013 was pivotal for Sanofi,

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 world’s 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 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.

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 Phase III study

Rheumatoid arthritis Positive Phase III 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 type 2 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 Genzyme’s 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 Genzyme’s 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 Merial’s 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 Phase III study

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

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

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.

MARCH

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.

DiabetesPositive Phase III results for investigational new insulin U300

Atopic dermatitis and asthma Positive Phase IIa Results of dupilumab in moderate to severe allergic asthma

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


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

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.

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”

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.


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

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.

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.

“WE HAVE MOVED FROM BEING A TRADITIONAL PHARMACEUTICAL COMPANY TO ONE OF THE WORLD’S LARGEST BIOPHARMACEUTICAL COMPANIES.”

A SOLID R&D PIPELINE 9

late-stage projects* are expected to be filed for approval over the next 4 years

7approvals throughout 2013*

*To learn more: Form 20-F 2013.*As of February 6, 2014.

SALES AND GROWTH AT CONSTANT EXCHANGE RATES (M€)

Emerging Markets 10,957 +4.4%Diabetes Solutions 6,568 +18.7%Vaccines 3,716 - 0.1%Consumer Healthcare 3,004 +5.2%Genzyme 2,142 +25.9%Animal Health 1,985 - 5.3%Other Innovative Products 705 +18.8%

GROWTH PLATFORMS NOW ACCOUNT FOR72.5% OF SALES

*See definitions, page 39.

9SANOFI – ANNUAL REVIEW 20138 SANOFI – ANNUAL REVIEW 2013

The 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.

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.

GOVERNANCE

THE BOARD OF DIRECTORS

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.

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

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 succeedin our mission, to bring innovative solutions to those in need.

Serge Weinberg*, Chairman of the Boardof Directors

Christopher Viehbacher, Chief Executive Officer

Laurent Attal

Uwe Bicker*

Robert Castaigne*

Thierry Desmarest

Lord Douro*

Jean-René Fourtou*

Claudie Haigneré*

Igor Landau

Fabienne Lecorvaisier*

Suet-Fern Lee*

Christian Mulliez

Carole Piwnica*

Klaus Pohle*

Gérard Van Kemmel*

AS OF DECEMBER 31, 2013, THE BOARD OF DIRECTORS IS COMPOSED OF THE 16 FOLLOWING MEMBERS.

*Independent Director.

“I BELIEVE OUR DENGUE VACCINE IS GOING TO BE AN IMPORTANT CONTRIBUTION TO PUBLIC HEALTH.”

To learn more: Form 20-Fwww.sanofi.com

Bill Gates, Dr Margaret Chan, Director General, WHO, and Christopher Viehbacher

for the “United to Combat Neglected Tropical Diseases” event—April 2014.


GOVERNANCE

EXECUTIVE COMMITTEE

Jérôme Contamine, Executive Vice President, Chief Financial Officer

Carsten Hellmann, Executive Vice President, Merial

Elias Zerhouni, President, Global R&D

David P. Meeker, Executive Vice President & Chief Executive Officer Genzyme

Pascale Witz, Executive Vice President, Global Divisions & Strategic Development

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

Karen Linehan, Executive Vice President, Legal Affairs and General Counsel

Philippe Luscan, Executive Vice President, Global Industrial Affairs

Olivier Charmeil, Executive Vice President, Vaccines

Peter Guenter, Executive Vice President, Global Commercial Operations

David-Alexandre Gros, Executive Vice President, Chief Strategy Officer

Roberto Pucci, Executive Vice President, Human Resources

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.

GENZYME,RARE DISEASES AND MULTIPLE

SCLEROSISThrough 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.

3rd largest consumer

healthcare player in the world*

EMERGING MARKETS

Emerging markets are the main driver of growth for the health industry. As an historical

leader in these fast growing economies, Sanofi is well positioned to capture their future growth.

Sanofi can rely on several assets: its balanced and historical presence, a product portfolio adapted

to local needs, its locally based industrial network and its commercial presence across a large

number of countries.

VACCINESSanofi Pasteur responds to the Group’s

primary objective: promoting and improving health around the world.

As one of the world leaders in vaccines, Sanofi plays an active role in the prevention of epidemics around the world. We provide

people with one of the largest ranges of vaccines, covering 20 infectious diseases

for children and adults.

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.

382 million people with diabetes

Source: IDF Atlas Sixth Edition, International Diabetes Federation 2013.

GROWTH PLATFORMS

7

ANIMAL HEALTHThrough 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.

80% of our development projects are biologics(2)

±7,000(2)

identified rare diseases

80% of the world’s* population

live in emerging markets

10 significant new products

expected to be launched over the next 3 years

STRATEGY

CONSUMER HEALTHCARE

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.

*Source: IMF 2010.

+1 billion vaccine doses produced

yearly

(1) See definitions, page 39.(2) Source: Global Genes Project.

*Source: IMS MAT Dec. 2013, Nicholas Hall & Company.

(1) See definitions, page 39.(2) 39 new molecular entities and

vaccines of a total of 49. Source: Sanofi annual results 2013.

EXPLORING THE BOUNDARIES OF MEDICAL INNOVATION

16

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.

PREVENTING DISEASE AND SUPPORTING PATIENTS

24

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.

IMPROVING ACCESS TO HEALTHCARE

30

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.

OUR COMMITMENTS

SANOFI, A GLOBAL HEALTHCARE LEADER


EXPLORING EXPLORING THE BOUNDARIES THE BOUNDARIES OF MEDICAL OF MEDICAL INNOVATIONINNOVATION

2.5 billion people worldwide are at risk of developing dengue fever

€4.8 bnof investment in R&D in 2013

OUR MAIN AREAS OF RESEARCH• Multiple Sclerosis• Diabetes• Oncology• Rare Diseases

• Cardiometabolic Diseases

• Immunology• Vaccines

9 late-stage projects*

MORE THAN 2 MILLION PEOPLE AROUND THE WORLD SUFFER FROM MULTIPLE SCLEROSIS

350 million people worldwide suffer from rare diseases

Meet Dean on sanofi.com and share

his hope.

*As of February 6, 2014.Source: World Health Organization. Source: Global Genes Project. Source: World Health Organization.

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.


A REINVENTED A REINVENTED R&D MODEL FOR R&D MODEL FOR SUSTAINABLE GROWTHSUSTAINABLE GROWTH

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

of patients. To complement its internal resources and access the best science, Sanofi has developed an open innovation approach. It has

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.

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.”

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 companySanofi 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 areasIn 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’

“9 LATE-STAGE PROJECTS ARE EXPECTED TO BE FILED FOR APPROVAL OVER THE NEXT 4 YEARS.”

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.

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.

80%OF BIOLOGIC MOLECULES

A STRONG PORTFOLIO, INCLUDING ADVANCES IN BIOTECHNOLOGY(1)

*Diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis and invasive infections caused by Haemophilus infl uenzae type b.

(1) Information provided as of February 6, 2014.(2) See defi nitions, page 39.

PHASE I

23molecules

being tested on a limited number

of healthy subjects

APPROVALSAND LAUNCHES

2014-20189 potential filings: U300, LixiLan, Lixisenatide (U.S.), dengue vaccine, C. diff vaccine, sarilumab, alirocumab, dupilumab, 6-in-1 vaccine (U.S.)

REGISTRATION

1solution has been submitted to health authorities for approval: Cerdelga® (EU and U.S.)

20137 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)

49pharmaceutical and vaccine

solutions currently at the research stage

PHASE II

14products

in clinic trials with patients

PHASE III

11biological molecules


LOWERING CHOLESTEROL: FROM PATIENT BEDSIDE

TO LAB BENCH

Marc, France, with familial hypercholesterolemia.

Any information provided on cited products is in no way intended to encourage their use.

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.

Two 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.

MULTIPLE SCLEROSIS: AUBAGIO® AND LEMTRADATM,

NEW HOPE FOR PATIENTS

David P. Meeker, Executive Vice President

& Chief Executive Officer Genzyme

“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.

“

Shani, Australia, with multiple sclerosis.

Control 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 lipoprotein-cholesterol, 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.

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,

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 PCSK9PCSK9 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 therapyWorking 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.

(1) See definitions, page 39.(2) Genzyme to resubmit LemtradaTM application for FDA review, March 2014.


Sanofi 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

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 challengeSanofi 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

DENGUE FEVER:A VACCINE ON THE HORIZON

2.5BILLION PEOPLE ARE AT RISK

OF DEVELOPING DENGUE

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.

“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.

Up 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 advanceIn a Phase IIa, a study of 104 patients with moderate-to-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 dermatitisAlong 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.

ASTHMA AND ATOPIC DERMATITIS: RELIEF FROM DUPILUMAB*

ALLERGIES AUVI-QTM*—A POTENTIAL LIFE-SAVERDistribution 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.

CLOSTRIDIUM DIFFICILE VACCINE IN DEVELOPMENT REACHES PHASE IIIAn 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.

Any information provided on cited products is in no way intended to encourage their use.

Immunization session for the clinical trial Phase IIb with our dengue vaccine in Thailand.

Zsombor, Hungary, with asthma.

POLIO VACCINES TO THE POLIO ERADICATIONSanofi 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.



Source: IDF Atlas Sixth Edition, International Diabetes Federation 2013.

382 MILLIONPEOPLE WORLDWIDE SUFFER FROM DIABETES

PREVENTING DISEASE AND SUPPORTING PATIENTSPREVENTING DISEASE AND SUPPORTING PATIENTS

OUR STAKEHOLDERS• Health professionals• Health authorities• Patients associations

PREVENTION

1 BILLION VACCINE DOSES ARE MADE AVAILABLE BY SANOFI PASTEUR EACH YEAR

Source: World Health Organization.

26infectious diseases can be prevented through vaccination

Meet Delphine on sanofi.com and share her hope.

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.”


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

vaccine in preventing influenza in older adults. The Group also conducts multiple preventive actions among populations, especially in resource-

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.

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.

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 GLOBAL APPROACH A GLOBAL APPROACH TO PATIENTSTO PATIENTS

“SANOFI CONCENTRATES ON EASING THE MANAGEMENT OF ILLNESS”

BGStar®, the blood glucose

monitoring.

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.

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,

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.

“We aim to provide patients with simpler,

better ways to manage

their disease.

“

Pascale Witz, Executive Vice President,

Global Divisions & Strategic Development

OUR INTEGRATED DIABETES CARE APPROACH TO HELP PATIENT BETTER LIVE

(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.

TREATING WITH FIRST-IN-CLASS SOLUTIONSBecause 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.

SIMPLIFYING DIABETES MANAGEMENT THROUGH TECHNOLOGYSanofi 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 AllSTARTM, 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.

LISTENING TO THE PATIENTSThe 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.

PREVENTING DIABETES WITH EDUCATION AND TRAININGSanofi 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.

40-54% OF PATIENTS WITH TYPE 2 DIABETES ARE NOT REACHING THEIR LONG-TERM GLUCOSE GOALS(1)

46%(2) UNDIAGNOSED PEOPLE WITH DIABETES IN THE WORLD

LANTUS®, ITS WORLD’S LEADING INSULIN BRAND

1 BILLION(3) OF SOLOSTAR® INSULIN PENS PRODUCED TILL 2013


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.

“

Mobile 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 basal-bolus 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 digitalplatforms 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

SANOFI MOVES INTO THE E-HEALTH ARENA

PHOSPHORUS MOBILE APPFor 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.

Lyxumia®* (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).

A6-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.

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®.

INFLUENZA VACCINEFOR CHILDREN AND ADULTS ALIKEVaccination 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.

DIABETES:LYXUMIA® EXTENDS ITS GLOBAL REACH

VACCINE:IMPROVED PROTECTION

DIABETESMORE INNOVATION IN INSULINSanofi’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 long-acting 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.

Isabelle, France, with diabetes.



Meet Arvind on sanofi.com and share

his hope.

IMPROVING ACCESS IMPROVING ACCESS TO HEALTHCARETO HEALTHCARE

STSanofi is the market leader in emerging markets

Source: IMS Health.

IN 2020, 2/3 OF THE PHARMACEUTICAL INDUSTRY’S GROWTH WILL COME FROM EMERGING MARKETS


1/3 of theworld’s population does not have access to healthcare

176 million people benefited from over 260 access to healthcare programs


50%patients regularly forget to take their medication

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!


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.

“

A GLOBAL PRESENCE A GLOBAL PRESENCE CLOSER TO PATIENTSCLOSER TO PATIENTS

Strengthening our position in emerging markets80% 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 Sanofi ’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, Sanofi celebrated its 30th year in China, a country identifi ed as the most important emerging region in terms of growth. Sanofi ’s success in emerging markets relies on a differentiated approach adapted

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 Sanofi 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, Sanofi concentrates its development centers on improving the well-being of

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 diffi cult.

… 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

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.

this goal, all our activities share a common culture of industrial excellence, enriched in the Sanofi 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 productsThe diversity of Sanofi ’s products is an important asset in striving to fulfi ll 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. Sanofi 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, Sanofi 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 partnersIn each country, Sanofi 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.

LOCAL PRODUCTION TO MEET PATIENT’S NEEDS

NORTH AMERICA 20 sites

AFRICA and MIDDLE EAST 7 sites

ASIA-PACIFIC (including Japan and Australia) 21 sites

LATIN AMERICA 12 sites

EUROPE 52 sites

112manufacturing sites worldwide, including 37 based in emerging markets

+11.5% Growing sales of vaccines in emerging markets in 2013

4new sites in 2013: Algeria, Vietnam, China and Saudi Arabia

3,153million boxes of pharmaceuticals produced and packaged worldwide in 2013

China 3.5 billion pills Production capacity for Sanofi’s new consumer products facility in Hangzhou


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 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.

Chad, to fight against sleeping sickness.

As 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.

SANOFI CONSUMER HEALTHCARE:

CONSUMERS AT HEART!

Merial 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

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.

ANIMAL HEALTH:APPROVAL OF NEXGARD®

PROVIDING ACCESS TO QUALITY HEALTHCARE

FOR EVERYONE

Today, 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.

SLEEPING SICKNESS:

27 MILLIONSCREENED PEOPLE,

175,000PATIENTS SAVED IN

A PARTNERSHIP WITH THE WHO*.

OUR GOAL: ELIMINATION OF THIS DISEASE IN 2020.

*World Health Organization.

NASAL ALLERGY SYMPTOMSNASACORT AVAILABLE OTCNasacort® 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 fi rst 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.

OF CONSUMER HEALTHCARE SALES ACHIEVED IN EMERGING MARKETS IN 2013

50%

Biscuit, cat, France.

2010 2013

2012

2013

2012

2013

2012

2013


CORPORATE SOCIAL RESPONSIBILITY

€32.9 bn in sales

37.8%Other Rx

drugs

39,000Other

countries

19.9%Diabetes 19,000

North America

11.3%Vaccines

9.1%Consumer healthcare

6.1%Animal health 54,000

Europe

6.5%Rare diseases and multiple sclerosis

4.9%Generics

4.4%Oncology

PERFORMANCE

RESEARCH AND MEDICAL INNOVATION OPENING ACCESS TO HEALTHCARE

PREVENTION AND GLOBAL DISEASE MANAGEMENT

33.3% of sales in emerging markets

23.8%29.6%

31.7%29.5%

33.3%29.9%

11.3%11.0%

Western Europe

United States

Emerging markets

Rest of the world

20 DISEASES COVERED BY SANOFI PASTEUR RANGE OF VACCINES

OVER 97 MILLION PATIENTS RECEIVED DIAGNOSIS, VACCINATION, TREATMENT OR SELF-DISEASE MANAGEMENT TRAINING

COMPANY IN EMERGING MARKETS WITH 5.7% MARKET SHARE

ST

HEALTHCOMPANY IN BRIC*

COUNTRIES*Brazil, Russia, India

and China.

ST

HEALTHCOMPANY

FOR CHC WITH3.1% MARKET SHARE

3RD

MORE THAN 79 MILLION INDIVIDUALS BENEFITED FROM AWARENESS CAMPAIGNS

EMPLOYEES BY GEOGRAPHIC ZONE

ENVIRONMENTAL INDICATORSSOCIAL INDICATORS

17,655,492

ENERGY CONSUMPTION (IN GIGAJOULES)

18,162,036

–2.8%

WATER CONSUMPTION (IN M3)

45,837,092

49,334,713

–7.1%

CO2 EMISSIONS (IN MILLIONS)

1.23

1.28

–3.9%

4 R&D HUBS*(NORTH AMERICA, ASIA, GERMANY AND FRANCE)

80% OF DEVELOPMENT PIPELINE PROJECTS ARE BIOLOGICS

17,000 COLLABORATIVE RESEARCH PROGRAMSWITH SCIENTIFIC PARTNERS WERE ACTIVE IN 2013

9 HIGH-POTENTIAL PROJECTSARE IN LATE-STAGEU300, 6-in-1 vaccine PR5i (U.S.), alirocumab, dengue vaccine, lixisenatide (U.S.), sarilumab, LixiLan, dupilumab, C. diff vaccine

€4.8 bn OF INVESTMENT IN R&D IN 2013

*Hub share capabilities across entities and provide access to regional expertise inside and outside of our company.

0:00 AMAM 0:00 AMAM

38 SANOFI – ANNUAL REVIEW 2013

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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. Photo creditsFront 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.

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Sanofi at a glance

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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-QTMQQ and Mozobil®.

Zaltrap® (aflibercept): Developed in collaboration with Regeneron.

Auvi-Q™ (epinephrin): Sanofi U.S. licensed the North American commercialization rights to Auvi-QTMQQ 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 netincome 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 ofacquisitions on associates and joint ventures); (v) restructuring costs (including restructuring costs relating to associates and jointventures); (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 taxon 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.

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