ANNUAL REVIEW 2013
PROTECTING LIFE, GIVING HOPE
CONTENTS
PREVENTING DISEASE AND SUPPORTING PATIENTS
24
IMPROVING ACCESS TO HEALTHCARE
30
EXPLORING THE BOUNDARIES OF MEDICAL INNOVATION
162
36
GROWTH
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
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.
PROFILE
2 SANOFI – ANNUAL REVIEW 2013
HIGHLIGHTS
2013 was a solid year with new approvals, regulatory submissions and a robust R&D pipeline.
2013: A YEAR OF ACHIEVEMENT
JANUARY FEBRUARY APR IL MAY JUNE JULY
AP
PR
OV
ALS
R&
D
Diabetes
Once-daily Lyxumia® approval for treatment of type 2 diabetes in Europe
Colorectal cancer
Zaltrap® approved in Europe (metastatic colorectal cancer)
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
Multiple sclerosis
Oral multiple sclerosis treatment Aubagio® approved in Europe
Homozygous familial hypercholesterolemia
U.S. FDA approved of KynamroTM injection
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
Diabetes
Positive Phase III results for investigational new insulin U300
Atopic dermatitis and asthma
Positive Phase IIa Results of dupilumab in moderate to severe allergic asthma
3SANOFI – ANNUAL REVIEW 2013
SANOFI PASTEUR AND THE BILL & MELINDA GATES FOUNDATION COLLABORATE TO ACCELERATE DISCOVERY OF NEW VACCINES
The objective of this collaboration, announced in 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.
Hypercholesterolemia
Positive top-line results with alirocumab from first Phase III study
Rheumatoid arthritis
Positive Phase III results for sarilumab
AUGUST SEPTEMBER OCTOBER NOVEMBER DECEMBER
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)
Multiple sclerosis
Genzyme’s multiple sclerosis treatment LemtradaTM approved in Europe
Animal Health
BroadlineTM (parasite treatment and prevention in cats) approved in Europe
Gaucher disease
U.S. FDA granted acceptance filed for Genzyme’s CerdelgaTM (eliglustat)
Animal Health
U.S. FDA approved Merial’s NexGardTM (treatment and prevention of fleas and ticks in dogs)
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.
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.
To learn more: www.sanofi.com See definitions, page 39.
4 SANOFI – ANNUAL REVIEW 2013
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
AN EFFICIENT STRATEGY
€33 BN IN SALES
PRESENT IN
100COUNTRIES
MORE THAN
110,000EMPLOYEES
MESSAGE
SERGE WEINBERG,
CHAIRMAN OF THE BOARD OF DIRECTORS
*See definitions, page 39.*See definitions, page 39.
5SANOFI – ANNUAL REVIEW 2013
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”
BUSINESS NET INCOME* (M€)
8,101
6,687
8,748
2012
2011
2013
EVOLUTION OF DIVIDEND (€)
BUSINESS EARNINGS PER SHARE* (€)
2.772.80*
2.65
2012
2011
2013
6.14
5.05
6.62
2011
2012
2013
*Proposed for approval at the annual general meeting.
*See definitions, page 39. *See definitions, page 39.
6 SANOFI – ANNUAL REVIEW 2013
INTERVIEW
ENTERING A NEW PHASE OF INNOVATION
CHRISTOPHER VIEHBACHER,
CHIEF EXECUTIVE OFFICER SANOFI, CHAIRMAN GENZYME
What are the major events of 2013 that marked
the future for Sanofi?
CHRISTOPHER VIEHBACHER: 2013 marked the
inflection point for Sanofi. Throughout the year,
we left the patent cliff further behind us and took
decisive action to resolve temporary operational
challenges in trade distribution channels in Brazil
and production in the Toronto vaccines plant.
We were able to return to sales growth in the
second half of the year. Our growth platforms,
which now represent 72.5% of sales, have been
fuelling our growth for a number of years
and enabled us to deliver the sustainable growth
necessary to continue to invest in businesses,
acquire, diversify and build 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
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.
*See definitions, page 39.
7SANOFI – ANNUAL REVIEW 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.
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.”
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
8 SANOFI – ANNUAL REVIEW 2013
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 succeed
in our mission, to bring innovative solutions to those
in need.
“I BELIEVE OUR DENGUE VACCINE IS GOING TO BE AN IMPORTANT CONTRIBUTION TO PUBLIC HEALTH.”
Bill Gates, Dr Margaret Chan, Director General, WHO, and Christopher Viehbacher
for the “United to Combat Neglected Tropical Diseases” event—April 2014.
9SANOFI – 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
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.
To learn more: Form 20-Fwww.sanofi.com
10 SANOFI – ANNUAL REVIEW 2013
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
11SANOFI – ANNUAL REVIEW 2013
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.
EMEMA
Emerging marketgrowth for the healt
leader in these fast grwell positioned to ca
Sanofi can rely on sevehistorical presence, a
to local needs, its locaand its commercia
numbe
VACCSanofi Pasteur respo
primary objectiveimproving health
As one of the world Sanofi plays an activeof epidemics around
people with one ofof vaccines, covering
for children
GROWTH PLATFORMS
7
80% of our development projects are biologics(2)
80% live in em
STRATEGY
*
+1 billiodose
yearl(1) See definitions, page 39.
(2) 39 new molecular entities and vaccines of a total of 49.
Source: Sanofi annual results 2013.
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*
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.
CINESonds 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.
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.
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.
±7,000(2)
identified rare diseases
of the world’s* population erging markets
10 significant new products
expected to be launched over the next 3 years
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.
n vaccine es producedly
(1) See definitions, page 39.(2) Source: Global Genes Project.
*Source: IMS MAT Dec. 2013, Nicholas Hall & Company.
SANOFI, A GLOBAL HEALTHCARE LEADER
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
16 SANOFI – ANNUAL REVIEW 2013
EXPLORING EXPLORING THE BOUNDARIES THE BOUNDARIES OF MEDICAL OF MEDICAL INNOVATIONINNOVATION
2.5 billion people worldwide are at risk of developing dengue fever
MORE THAN 2 MILLION PEOPLE AROUND THE WORLD SUFFER FROM MULTIPLE SCLEROSIS
350 million people worldwide suffer from rare diseases
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.
17SANOFI – ANNUAL REVIEW 2013
€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*
Meet Dean on sanofi.com and share
his hope.
*As of February 6, 2014.
18 SANOFI – ANNUAL REVIEW 2013
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.
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.”
19SANOFI – ANNUAL REVIEW 2013
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.”
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 inl uenzae type b.
(1) Information provided as of February 6, 2014.(2) See dei 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
20 SANOFI – ANNUAL REVIEW 2013
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.
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.
21SANOFI – ANNUAL REVIEW 2013
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.
(1) See definitions, page 39.(2) Genzyme to resubmit LemtradaTM application for FDA review, March 2014.
22 SANOFI – ANNUAL REVIEW 2013
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.
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.
*See definitions, page 39.
23SANOFI – ANNUAL REVIEW 2013
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.
Immunization session for the clinical trial Phase IIb with our dengue vaccine in Thailand.
24 SANOFI – ANNUAL REVIEW 2013
PREVENTING DISEASE AND PREVENTING DISEASE AND
PREVENTION
1 BILLION VACCINE DOSES ARE MADE AVAILABLE BY SANOFI PASTEUR EACH YEAR
Source: World Health Organization.
26infectious diseases can be prevented through vaccination
25SANOFI – ANNUAL REVIEW 2013
Source: IDF Atlas Sixth Edition, International Diabetes Federation 2013.
382 MILLIONPEOPLE WORLDWIDE SUFFER FROM DIABETES
SUPPORTING PATIENTS SUPPORTING PATIENTS
OUR STAKEHOLDERS• Health professionals• Health authorities• Patients associations
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.”
26 SANOFI – ANNUAL REVIEW 2013
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.
27SANOFI – ANNUAL REVIEW 2013
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 SOLUTIONS
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.
SIMPLIFYING DIABETES MANAGEMENT THROUGH TECHNOLOGY
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 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
28 SANOFI – ANNUAL REVIEW 2013
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.
*See definitions, page 39.
29SANOFI – ANNUAL REVIEW 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 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.
30 SANOFI – ANNUAL REVIEW 2013
IMPROVING ACCESS IMPROVING ACCESS TO HEALTHCARETO HEALTHCARE
Source: IMS Health.
IN 2020, 2/3 OF THE PHARMACEUTICAL INDUSTRY’S GROWTH WILL COME FROM EMERGING MARKETS
Source: World Health Organization.
1/3 of theworld’s population does not have access to healthcare
Source: World Health Organization.
50%patients regularly forget to take their medication
31SANOFI – ANNUAL REVIEW 2013
Meet Arvind on sanofi.com and share
his hope.
STSanofi is the market leader in emerging markets
176 million people benefited from over 260 access to healthcare programs
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!
32 SANOFI – ANNUAL REVIEW 2013
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 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 identii ed
as the most important emerging region
in terms of growth. Sanoi ’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 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
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 difi 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.
33SANOFI – ANNUAL REVIEW 2013
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 productsThe diversity of Sanoi ’s products is an
important asset in striving to fuli 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.
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 partnersIn 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.
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
34 SANOFI – ANNUAL REVIEW 2013
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®
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 i 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.
35SANOFI – ANNUAL REVIEW 2013
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.
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.
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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 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.
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DEFINITIONS
Emerging Markets: The worldexcluding 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 growthplatforms, Multaq®, Jevtana®, Zaltrap®, Auvi-QTMQQ and Mozobil®.
Zaltrap® (aflibercept): Developedin collaboration with Regeneron.
Auvi-Q™ (epinephrin): Sanofi U.S. licensed the North Americancommercialization rights toAuvi-QTMQQ from Intelliject, Inc.
Lemtrada™ (alemtuzumab):Developed in collaboration withBayer HealthCare.
Kynamro™ (mipomersen sodium):Development partnership with IsisPharmaceuticals.Lyxumia® (lixisenatide): Lixisenatidehas not yet been authorized orapproved in all world markets.
Business EPS: Business earnings pershare is a specific financial indicatorthat we define as business netincome divided by the weightedaverage number of sharesoutstanding.
Business net income is defined as net income attributable to equityholders 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 withacquisitions (including impacts ofacquisitions on associates and jointventures); (v) restructuring costs(including restructuring costsrelating to associates and jointventures); (vi) other gains and losses,and litigation; (vii) the tax effectrelated to the items listed in (i)through (vi); as well as (viii) the effects of major tax disputes, the taxon dividends distributed to Sanofishareholders starting in 2013,and as an exception for 2011, theretroactive effect (2006-2010) on thetax liability resulting from theagreement signed on December 22,2011 by France and the United Stateson transfer prices (APA-AdvancePricing Agreement), for which theamount 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 theincome statement line items‘‘Amortization of intangible assets’’,‘‘Impairment of intangible assets’’,‘‘Fair value remeasurement ofcontingent consideration liabilities’’,‘‘Restructuring costs’’ and ‘‘Othergains 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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