Download annual review 2013

ANNUAL REVIEW 2013
PROTECTING LIFE, GIVING HOPE
CONTENTS
2
16
4
6
Message from
the Chairman,
Serge Weinberg
Interview of
Christopher Viehbacher
SANOFI RETURNS
TO GROWTH
EXPLORING
THE BOUNDARIES
OF MEDICAL
INNOVATION
2013
HIGHLIGHTS
24
PREVENTING
DISEASE AND
SUPPORTING
PATIENTS
ENTERING A NEW
PHASE OF
INNOVATION
30
9
Board of Directors
10
Executive Committee
12
Strategy
IMPROVING
ACCESS
TO HEALTHCARE
36
7
GROWTH
PLATFORMS
Performance,
key figures
2013
38
To keep
in contact…
PROFILE
COMMITTED
TO 7 BILLION PEOPLE
Over the years, Sanofi has evolved to meet the new
challenges of healthcare worldwide. Today, Sanofi is a global
healthcare leader focused on one ultimate goal: to improve
the lives of patients around the world. Patients are at the
heart of our approach. We listen to their needs, support them in
their disease and treat them. We have reinvented our research
& development approach to accelerate both the pace of
innovation and the development of breakthrough health solutions
for patients.
Through our diversified portfolio of medicines, vaccines and
innovative therapeutic solutions, we strive to protect the health
and meet the needs and hopes of the world’s 7 billion people.
SANOFI – ANNUAL REVIEW 2013
1
HIGHLIGHTS
2013: A YEAR OF
ACHIEVEMENT
2013 was a solid year with
new approvals, regulatory
submissions and a robust
R&D pipeline.
Diabetes
Once-daily Lyxumia®
approval for
treatment of type 2
diabetes in Europe
Vaccines
Multiple sclerosis
HexyonTM/Hexacima®
6-in-1 pediatric vaccine
approved in Europe
Oral multiple sclerosis
treatment Aubagio®
approved in Europe
APPROVALS
Diabetes
Homozygous familial
hypercholesterolemia
U.S. FDA approved of
KynamroTM injection
Zaltrap® approved
in Europe (metastatic
colorectal cancer)
F E B R UA R Y
MARCH
APRIL
M AY
JUNE
R&D
JA N UA R Y
Lyxumia® is the first
diabetes therapy of its
class approved in Japan
for use in combination
with basal insulin
Colorectal cancer
SANOFI AND REGENERON’S
LONG-TERM RELATIONSHIP
ACHIEVE FURTHER PROGRESS
Sanofi’s relationship with Regeneron,
a major U.S. biopharmaceutical
company, has grown steadily since
2003. Strong ties have been forged,
leading to the development of
potential new products in various
therapeutic areas. In 2013, the
partners have achieved great
progress on the development
of alirocumab, dupilumab and
2
SANOFI – ANNUAL REVIEW 2013
Atopic dermatitis and asthma
Diabetes
Positive Phase IIa Results
of dupilumab in moderate
to severe allergic asthma
Positive Phase III
results for
investigational
new insulin U300
sarilumab, three key co-developed
products. Dupilumab, which is in
clinical development in Phase II for
the treatment of asthma and atopic
dermatitis, is one of the most exciting
emerging clinical candidates in
the industry. Sanofi and Regeneron
reported positive results for sarilumab
in the first Phase III rheumatoid arthritis
registration trial. Positive top-line results
were also reported by Sanofi and
Regeneron on alirocumab in the first
Phase III study for patients with high
cholesterol.
J U LY
AWARDS
The new Lyxumia® injection pen for patients
with type 2 diabetes, received the Good
Design Award 2013 from the Japan Institute
of Design Promotion. It recognizes Sanofi’s
patient-centric approach.
Multiple sclerosis
Gaucher disease
Allergies
Genzyme’s multiple
sclerosis treatment
LemtradaTM approved
in Europe
Gastro-intestinal
(Consumer
Healthcare)
Rolaids®
re-introduced
in the United States
AU G U S T
U.S. FDA granted
acceptance filed for
Genzyme’s CerdelgaTM
(eliglustat)
U.S. FDA approved Nasacort®
Allergy 24HR for over-thecounter use (nasal spray)
Animal Health
Animal Health
U.S. FDA approved Merial’s
NexGardTM (treatment
and prevention of fleas
and ticks in dogs)
SEPTEMBER
BroadlineTM (parasite
treatment and prevention in
cats) approved in Europe
O CTO B E R
N OV E M B E R
DECEMBER
Vaccines
Hypercholesterolemia
Rheumatoid arthritis
Fluzone® HD vaccines topline
result of a large-scale in preventing
influenza in adults 65 years of age
and older.
Positive top-line results
with alirocumab from
first Phase III study
Positive Phase III results
for sarilumab
Clostridium
difficile vaccine
Initiated Phase III
study
SANOFI PASTEUR AND THE BILL & MELINDA GATES
FOUNDATION COLLABORATE TO ACCELERATE
DISCOVERY OF NEW VACCINES
The objective of this collaboration, announced in
October 2013, is to explore and develop new platforms
and methods so as to accelerate R&D in vaccines.
With this collaboration, both allies intend to accelerate the
research and development of effective and affordable
vaccines that will ultimately benefit the world’s poorest
people. It will also allow the development and
testing of new technologies that help advance
other R&D programs.
To learn more: www.sanofi.com
See definitions, page 39.
SANOFI – ANNUAL REVIEW 2013
3
MESSAGE
SANOFI RETURNS
TO GROWTH
2 013 was pivotal for Sanofi, marked
by the end of the impact of generification
of some of our key products in the U.S.,
such as Plavix®.
The return to sales growth in September
demonstrated the pertinence of the strategic
choices implemented by the company since 2008.
Our seven growth platforms—Emerging Markets*,
Vaccines, Diabetes Solutions, Consumer
Healthcare, Genzyme (rare diseases and mutiple
sclerosis), Animal Health and Other Innovative
Products*—represented 72.5% of total sales
for the year. Genzyme’s strong growth in rare
diseases and multiple sclerosis should be
particularly noted. The occasional difficulties
encountered in certain emerging markets
have not altered our position: on the contrary,
the lessons learned will enable us to advance
to new levels on strengthened foundations.
In this context, the Board spent several days
SERGE WEINBERG,
CHAIRMAN OF THE BOARD OF DIRECTORS
*See definitions, page 39.
AN EFFICIENT
STRATEGY
MORE THAN
110,000
EMPLOYEES
4
SANOFI – ANNUAL REVIEW 2013
PRESENT IN
100
COUNTRIES
€33
IN SALES
BN
Although the year’s results were below our
expectations, we recognize the considerable
efforts made to adapt to markets and prepare
Sanofi for its future.
For this reason, the Board has decided
to propose a dividend of 2.80 euros per share
to shareholders, reflecting its confidence
in Sanofi’s future.
On behalf of the Board, I thank all of Sanofi’s
employees for their commitment and the quality
of their work.
“THE RETURN TO SALES
GROWTH IN SEPTEMBER
DEMONSTRATED THE
PERTINENCE OF THE
STRATEGIC CHOICES
IMPLEMENTED BY THE
COMPANY SINCE 2008”
in China in October to further explore strategic
opportunities in the country.
2013 also saw progress in the organisation of R&D
and the evolution of several key projects: U300,
alirocumab, sarilumab and Fluzone®.
Our late-stage product portfolio further progressed
with nine projects potentially being filed over the
next four years. Further strengthening R&D remains
a major priority as it is key to the Group’s future.
*See definitions, page 39.
2.80*
2.65
2013
2012
5.05
2011
2013
2012
2011
6,687
*See definitions, page 39.
2.77
6.14
2012
6.62
8,101
EVOLUTION OF DIVIDEND
(€)
2011
8,748
BUSINESS EARNINGS
PER SHARE* (€)
2013
BUSINESS NET INCOME*
(M€)
*Proposed for approval at
the annual general meeting.
SANOFI – ANNUAL REVIEW 2013
5
INTERVIEW
ENTERING A NEW PHASE
OF INNOVATION
CHRISTOPHER VIEHBACHER,
CHIEF EXECUTIVE OFFICER SANOFI, CHAIRMAN GENZYME
What are the major events of 2013 that marked
the future for Sanofi?
CHRISTOPHER VIEHBACHER: 2013 marked the
inflection point for Sanofi. Throughout the year,
we left the patent cliff further behind us and took
decisive action to resolve temporary operational
challenges in trade distribution channels in Brazil
and production in the Toronto vaccines plant.
We were able to return to sales growth in the
second half of the year. Our growth platforms,
which now represent 72.5% of sales, have been
fuelling our growth for a number of years
and enabled us to deliver the sustainable growth
necessary to continue to invest in businesses,
acquire, diversify and build a “new” Sanofi,
ready for future success.
These growth platforms—Diabetes Solutions,
Vaccines, Emerging Markets*, Consumer
Healthcare, Genzyme (rare diseases and multiple
sclerosis), Animal Health and Other Innovative
Products*—are less exposed overall to patent
expiries and are now the predominant factor
in our performance. In 2013, growth was led by
diabetes. Genzyme had a very strong
*See definitions, page 39.
A SOLID R&D
PIPELINE
9
7
*As of February 6, 2014.
*To learn more: Form 20-F 2013.
late-stage projects* are
expected to be filed for
approval over the next 4 years
6
SANOFI – ANNUAL REVIEW 2013
approvals
throughout 2013*
performance, driven primarily by the rare disease
segment where we regained leadership in
all products, but also the successful launch
of multiple sclerosis treatment, Aubagio®.
When you look to the future, one of the most
important elements is innovation, in particular,
to have new products to launch and a healthy
pipeline. This is an area in which we made great
progress. We had 7 approvals throughout 2013
including in multiple sclerosis, diabetes, vaccines
and cardiovascular. We now have a strong and
credible late-stage development pipeline.
What are the key assets that Sanofi has
to ensure success?
C. V.: We are entering the second phase of
renewal for Sanofi, that of Innovation. We have
moved from being a traditional pharmaceutical
company in 2008 to one of the world’s largest
biopharmaceutical companies. 45% of our sales
are from biologics and 80% of our development
pipeline is now in biologics. This is up from
26% in 2008 and demonstrates the significant
change in our approach.
We now have one of the strongest development
portfolios in our industry with the possibility
of 9 launches over the next 4 years.
These new investigational products are exciting
and would respond to unmet needs of millions
of patients.
“WE HAVE MOVED FROM
BEING A TRADITIONAL
PHARMACEUTICAL
COMPANY TO ONE OF
THE WORLD’S LARGEST
BIOPHARMACEUTICAL
COMPANIES.”
Can you bring us through some of the key
products in late-stage development pipeline?
C. V.: Alirocumab, a PCSK9 inhibitor developed
with our partner Regeneron, shows encouraging
first Phase III results in hypercholesterolemia.
SALES AND GROWTH AT CONSTANT EXCHANGE RATES (M€)
GROWTH
PLATFORMS NOW
ACCOUNT FOR
72.5%
OF SALES
Emerging Markets
10,957
Diabetes Solutions
6,568
Vaccines
3,716
Consumer Healthcare
3,004
Genzyme
2,142
Animal Health
1,985
Other Innovative Products
705
+4.4%
+18.7%
- 0.1%
+5.2%
+25.9%
- 5.3%
+18.8%
SANOFI – ANNUAL REVIEW 2013
7
Bill Gates, Dr Margaret Chan, Director
General, WHO, and Christopher Viehbacher
for the “United to Combat Neglected
Tropical Diseases” event—April 2014.
We have 2 monoclonal antibodies in clinical
development. One, the IL-4, with really interesting
first results in both severe asthma and atopic
dermatitis. In fact, once you have a drug like
this, in 2 auto-immune diseases, it could often
work in other diseases.
We have a list of multiple potential indications
that we are investigating for this product. We also
are developing an IL-6 for rheumatoid arthritis.
This is a $21 billion worldwide biologics market
and the IL-6 part of that market is rapidly growing,
so the future outlook is promising.
We have our potential dengue vaccine coming
down the line. Dengue affects half the world’s
population right across Africa, Asia and Latin
America. We have been working on it for 20 years
and I believe it is going to be an important
contribution to public health. Another important
vaccine will be for Clostridium difficile. This vaccine
in development would be used to fight antibiotic
resistant infections acquired in hospitals,
which is becoming increasingly challenging.
I am also looking forward to seeing the approval
of PR5i vaccine, the first 6-in-1 vaccine to be made
available in the U.S., protecting children from
diphtheria, tetanus, pertussis, polio, Hib and
hepatitis B.
8
SANOFI – ANNUAL REVIEW 2013
In diabetes, we continue to endeavor to bring
innovative products to the market to provide better
management of this worldwide epidemic. Lyxumia®,
our GLP-1, is already launched in Europe and
Japan and we intend to submit to the FDA upon
completion of the ELIXA trial in 2015. We have
a new investigational insulin, U300, which has
demonstrated strong results in trials to date and
we also have LixiLan, which is a combined insulin
and GLP-1. If approved, all of these will continue
to reinforce our leadership in diabetes.
It is also important to mention our strong
commitment to rare diseases through our Genzyme
division. While each disease impacts a small
“I BELIEVE OUR DENGUE
VACCINE IS GOING
TO BE AN IMPORTANT
CONTRIBUTION TO PUBLIC
HEALTH.”
number of individuals, there are nearly 7,000 rare
diseases that affect an estimated 350 million
people worldwide. We have a rich development
portfolio in this area and we are currently working
on a new potential oral therapy for Gaucher’s
disease, CerdelgaTM. This would be an important
product in development for patients’ quality of life,
as they currently have to spend hours getting
an infusion every 2 weeks.
In Animal Health we have 2 new products
launching to protect our pets. One is NexGardTM
for dogs and the other is BroadlineTM for cats.
In the Consumer Healthcare division, we have
launched Nasacort® without prescription in the U.S.
which will complement Allegra® to help people fight
the effects of allergies.
All in all, I am proud of the progress achieved
over the last 5 years which ensure we succeed
in our mission, to bring innovative solutions to those
in need.
GOVERNANCE
THE BOARD
OF DIRECTORS
T
he Company’s corporate
governance agenda is founded
on the Afep-Medef code, available
on the Medef (www.medef.fr)
and Sanofi (www.sanofi.com) websites.
Sanofi is administered by a Board
of Directors currently comprising
16 members, including 4 women;
11 members are considered independent.
Each year, the Board of Directors conducts
a review to ensure that there is an
appropriate balance in its composition
and the composition of its Committees.
In particular, the Board seeks to ensure
a balanced representation of men
and women with diverse backgrounds
and countries of origin, to reflect
the diversified and global nature
of the Group’s business.
AS OF DECEMBER 31,
2013, THE BOARD
OF DIRECTORS IS
COMPOSED OF
THE 16 FOLLOWING
MEMBERS.
*Independent Director.
Subject to the authority expressly reserved
by law to the shareholders’ meetings
and within the scope of the corporate
purpose, the Board of Directors deals
with and decides upon all issues relating
to the proper management of the
Company and other matters concerning
the Board. It determines the general
direction of the Company’s activities and
ensures that they are implemented.
Recently, the Board of Directors proposed
the appointment of a new independent
Director at the General Meeting of
Shareholders to be held on May 5, 2014:
Patrick Kron. He would replace Lord Douro,
who has served on the Board for 12 years
and will not seek another term.
Serge Weinberg*,
Chairman of the Board
of Directors
Christopher Viehbacher,
Chief Executive Officer
Jean-René Fourtou*
Claudie Haigneré*
Igor Landau
Fabienne Lecorvaisier*
Laurent Attal
Suet-Fern Lee*
Uwe Bicker*
Christian Mulliez
Robert Castaigne*
Carole Piwnica*
Thierry Desmarest
Klaus Pohle*
Lord Douro*
Gérard Van Kemmel*
To learn more:
Form 20-F
www.sanofi.com
SANOFI – ANNUAL REVIEW 2013
9
GOVERNANCE
EXECUTIVE
COMMITTEE
Jérôme Contamine,
Executive Vice President,
Chief Financial Officer
Carsten Hellmann,
Executive Vice
President, Merial
David P. Meeker,
Executive Vice President
& Chief Executive Officer Genzyme
Pascale Witz,
Executive Vice President,
Global Divisions &
Strategic Development
10
SANOFI – ANNUAL REVIEW 2013
Elias Zerhouni,
President, Global R&D
Karen Linehan,
Executive Vice President, Legal
Affairs and General Counsel
Philippe Luscan,
Executive Vice President,
Global Industrial Affairs
David-Alexandre Gros,
Executive Vice President,
Chief Strategy Officer
I am proud of the
progress achieved
over the last 5 years
which ensure
we succeed in our
mission, to bring
innovative solutions
to those in need.
Christopher Viehbacher,
Chief Executive Officer Sanofi,
Chairman Genzyme
Olivier Charmeil,
Executive Vice President,
Vaccines
Roberto Pucci,
Executive Vice President,
Human Resources
Peter Guenter,
Executive Vice President,
Global Commercial Operations
SANOFI – ANNUAL REVIEW 2013
11
EME
MA
STRATEGY
Emerging market
growth for the healt
leader in these fast gr
well positioned to ca
Sanofi can rely on seve
historical presence, a
to local needs, its loca
and its commercia
numbe
80%
live in em
*
7
GROWTH
PLATFORMS
OTHER
INNOVATIVE
PRODUCTS(1)
Sanofi has reinvented its R&D approach.
We now have a more open R&D model with
increased external collaborations. We put patients
at the core of our approach and focus on the
development of biologic medicines.
This transformation has led to significant
improvement in our capacity to accelerate
the pace of research and to develop more
effective health solutions for patients in various
therapeutic areas.
our development
80% ofprojects
are biologics
(2)
(1) See definitions, page 39.
(2) 39 new molecular entities and
vaccines of a total of 49.
Source: Sanofi annual results 2013.
VACC
Sanofi Pasteur respo
primary objective
improving health
As one of the world
Sanofi plays an active
of epidemics around
people with one of
of vaccines, covering
for children
+1billio
dose
yearl
ERGING
ARKETS
ts are the main driver of
th industry. As an historical
rowing economies, Sanofi is
apture their future growth.
eral assets: its balanced and
a product portfolio adapted
ally based industrial network
l presence across a large
er of countries.
of the world’s*
population
erging markets
DIABETES
SOLUTIONS
To respond to the increasing number
of people with diabetes around the world,
Sanofi offers integrated and personalized
solutions, based on innovation and proximity
to patients. Our solutions aim to simplify their
lives. We constantly innovate to offer patients new
treatments and advanced medical devices that
facilitate the management of diabetes. With
innovation at its foundation, Sanofi has shaped
the future of diabetes care for 90 years.
people
382 million
with diabetes
*Source: IMF 2010.
Source: IDF Atlas Sixth Edition,
International Diabetes Federation 2013.
CONSUMER
HEALTHCARE
GENZYME,
RARE DISEASES
AND MULTIPLE
SCLEROSIS
Through Genzyme, Sanofi provides hope to
patients affected by rare diseases and multiple
sclerosis around the world. Over the past three
years, Genzyme has strengthened its leadership
thanks to the development of new targeted
therapeutic solutions for rare diseases and global
approvals of Aubagio® and LemtradaTM(1)
for multiple sclerosis.
CINES
onds to the Group’s
e: promoting and
around the world.
leaders in vaccines,
e role in the prevention
the world. We provide
f the largest ranges
20 infectious diseases
and adults.
n vaccine
es produced
ly
±7,000
identified rare
(2)
Thanks to consumer insight-driven
innovation, Sanofi CHC provides people
around the world with solutions such as
Allegra®, Lactacyd®/Dermacyd®, No-Spa®,
Enterogermina®, SuperVita 21 to name a few to help
them manage their health and well-being in their
daily life. Being directly in touch with consumers allows
us to better capture their thoughts to better address
their needs, research the trends and target the most
relevant product categories for us to invest in.
rd largest
3
consumer
healthcare player
in the world*
*Source: IMS MAT Dec. 2013,
Nicholas Hall & Company.
diseases
(1) See definitions, page 39.
(2) Source: Global Genes Project.
ANIMAL HEALTH
Through Merial, Sanofi is a world leader
in animal health. Merial is increasing its
presence in emerging markets and launching
innovative products for pets and production
animals. The launch of the next generation of flea
and tick control for pets is expected to significantly
strengthen its position.
significant
10
expected
new products
to be
launched over
the next 3 years
SANOFI, A GLOBAL HEALTHCARE LEADER
OUR COMMITMENTS
16
EXPLORING THE BOUNDARIES
OF MEDICAL INNOVATION
Sanofi has created an open innovation model,
based on solid collaborations with its partners and
the scientific community. With this new R&D approach,
Sanofi can meet its main challenges: accelerating
the transformation of scientific innovation into
targeted therapeutic solutions for patients and
developing new biologic entities.
24
PREVENTING DISEASE
AND SUPPORTING PATIENTS
By preventing disease, we protect health.
By supporting patients, we can help to improve
their quality of life. Sanofi is committed to supporting
patients at every stage of their life. We offer
a complete range of integrated and personalized
health solutions that give patients hope of
a better life.
30
IMPROVING ACCESS
TO HEALTHCARE
The global spread of chronic diseases and
greater access to healthcare in developing
countries creates new challenges. As a world
leader in healthcare, Sanofi is convinced that
it is its responsibility to provide improved access
to healthcare in the more than 100 developed
and emerging markets in which it operates.
Dean,
aged 45, married with two
daughters, lives in Queensland, Australia.
Account manager in an advertising agency,
Dean wakes up every day at 6.00 a.m.
for his morning jog before going to work.
In 2007, he discovered that he was suffering
from multiple sclerosis, but thanks to his
treatment, he continues to lead the life that
he chose and to pursue his passions.
EXPLORING
THE BOUNDARIES
OF MEDICAL
INNOVATION
MORE THAN
2 MILLION PEOPLE
350
2.5
Source: World Health Organization.
Source: Global Genes Project.
Source: World Health Organization.
AROUND THE WORLD SUFFER
FROM MULTIPLE SCLEROSIS
16
SANOFI – ANNUAL REVIEW 2013
million people
worldwide suffer
from rare diseases
billion
people worldwide are
at risk of developing
dengue fever
Meet Dean on
sanofi.com
and share
his hope.
€4.8bn
of investment
in R&D in 2013
OUR MAIN AREAS
OF RESEARCH
9
late-stage
projects*
•
•
•
•
Multiple Sclerosis
Diabetes
Oncology
Rare Diseases
• Cardiometabolic
Diseases
• Immunology
• Vaccines
*As of February 6, 2014.
SANOFI – ANNUAL REVIEW 2013
17
A REINVENTED
R&D MODEL FOR
SUSTAINABLE GROWTH
2013 was a milestone year for Research & Development.
It marked the positive result of its transformation into a more
open and productive model, centered on patients
and focused on biotechnologies. Sanofi’s growing
portfolio of high potential products in late-stage development
demonstrates the success of its new R&D approach.
Building a new R&D model
Over the past years, Sanofi has taken
significant steps to build a new R&D
founded on two pillars: translational
medicine and open innovation based
on outstanding science.
The translational medicine approach
puts a focus on patients earlier
in the disease discovery phase.
Through the insights of patients,
scientists can better understand
the disease and its molecular system.
They can thus accelerate the pace
of research and the development
of medicines that better fit the needs
“9 LATE-STAGE
PROJECTS ARE
EXPECTED TO BE FILED
FOR APPROVAL OVER
THE NEXT 4 YEARS.”
of patients. To complement its internal
resources and access the best
science, Sanofi has developed
an open innovation approach. It has
18
SANOFI – ANNUAL REVIEW 2013
created hubs in each of its main
locations to provide the assets for its
researchers and scientists to interact
together and to work in networks with
the scientific and medical community.
Sanofi has also built solid relationships
with biotechnology companies,
research institutes, universities,
hospitals and patients, across many
geographic regions.
Accelerating our move
towards becoming
a biopharmaceutical company
Sanofi has also accelerated its transition
from a chemical into a biologic
company. This growing footprint in
biopharmaceutical is a very promising
move, as biologic products offer higher
chances of success than traditional
chemical molecules. In 2013, the Group
achieved tremendous progress:
80% of its overall development pipeline
products are biologics. These successes
illustrate the Group’s collaboration
strategy with key players, such
as Regeneron, a leading
U.S. biotechnology company.
Their long-term collaboration has led
innovative investigational products, such
as alirocumab for cholesterol related
diseases, sarilumab for rheumatoid
arthritis and dupilumab for atopic
dermatitis or severe allergic asthma.
Developing first-in-class
products in key therapeutic
areas
In 2013, Sanofi has demonstrated its
capacity to innovate, with the building
of a robust and innovative Phase III
pipeline. Nine late-stage projects are
expected to be filed for approval over
the next four years. Addressing patients’
A STRONG PORTFOLIO,
INCLUDING ADVANCES IN BIOTECHNOLOGY(1)
PHASE I
23
molecules
being tested on
a limited number
of healthy subjects
49
pharmaceutical and vaccine
solutions currently
at the research stage
APPROVALS
AND LAUNCHES
2014-2018
9 potential filings: U300, LixiLan,
Lixisenatide (U.S.), dengue vaccine,
C. diff vaccine, sarilumab, alirocumab,
dupilumab, 6-in-1 vaccine (U.S.)
2013
7 approvals and launches: Aubagio ®
(EU), LemtradaTM(2) (EU), Lyxumia ®(2) (EU
and Japan), Zaltrap ®(2) (EU), Kynamro ®(2)
(U.S.), Fluzone ® QIV (U.S.), HexyonTM/
Hexacima ® (EU)
PHASE II
14
products
in clinic trials
with patients
REGISTRATION
PHASE III
11
biological molecules
1
solution has been submitted to health
authorities for approval: Cerdelga ®
(EU and U.S.)
(1) Information provided as of February 6, 2014.
(2) See deinitions, page 39.
need, these potential future launches
reflect the efficiency of a more
productive R&D, which allocates
its resources dynamically across
the Group.
Sanofi is working to improve its range
of therapeutic solutions with U300,
a new investigational basal insulin,
with the goal of enabling people to take
control of their diabetes with less low
blood sugar events and well-tolerated
titration-to-target.
80%
OF BIOLOGIC MOLECULES
The LixiLan Phase III development
program has been initiated for the
fixed-ratio combination of Lantus®
(insulin glargin) with Lyxumia®
(lixisenatide) in a single daily injection.
If approved, the fixed-ratio combination
of Lantus® and Lyxumia® could be
a fixed-ratio product combining basal
insulin with a GLP-1 receptor agonist
to control both fasting hyperglycemia
and meal related hyperglycemia.
Sanofi Pasteur has initiated Phase III
trials in three vaccines. The first one
is a potential first-in-class dengue
vaccine, which is a major health issue
affecting almost 2.5 billion people at risk
worldwide. The Clostridium difficile
vaccine, in development, prevents
nosocomial diseases. The third,
hexavalent, is the only fully liquid,
ready-to-use, 6-in-1 pediatric
vaccine* in development, highly
improving comfort for infants.
Other key strategic products in clinical
development include sarilumab, in
rheumatoid arthritis and alirocumab,
the PCSK9 antibody tested in patients
with high cholesterol levels and at high
cardiovascular. Finally, dupilumab,
an investigational antibody for atopic
dermatitis and severe asthma, was
named “Clinical Advance of the Year”
by Scrip Intelligence at the 9th annual
Scrip Awards.
*Diphtheria, tetanus, pertussis (whooping cough),
hepatitis B, poliomyelitis and invasive infections caused
by Haemophilus inluenzae type b.
Elias Zerhouni,
President of Global
Research & Development
“We have great teams and
scientific expertise at Sanofi.
However, the complexity of human
disease is such that no single
institution, company or country has
all the internal resources to solve
global health issues by itself. I believe
that good research is done in an
ecosystem of intellectual ventures,
composed of associations, hospitals,
patients, biotech companies, research
institutes, and many others.
With our open innovation approach,
our researchers and scientists have
the ability to interact together and
with their environment to facilitate
and accelerate the discovery and
development of new treatments. With
such good foundations in place,
I am confident in our ability to better
execute our core mission: improving
the lives of patients and inspiring
hope around the world.”
SANOFI – ANNUAL REVIEW 2013
19
LOWERING CHOLESTEROL:
FROM PATIENT BEDSIDE
TO LAB BENCH
Marc, France, with familial
hypercholesterolemia.
C
ontrol of cholesterol
levels is a key issue
in the prevention of heart
disease and many patients
are unable to achieve their desired
LDL-C (low-density lipoproteincholesterol, or “bad” cholesterol)
levels despite treatment with
standard of care (lipid-lowering
agents) and appropriate diet and
physical exercice.
The discovery of PCSK9 (proprotein
convertase subtilisin/kexin type 9)
involvement in hypercholesterolemia
illustrates the transfer of knowledge
from patient bedside to lab bench,
leading to the development of
a potential treatment.
Texas, a genetic study of
300 patients with very low serum
cholesterol levels demonstrated
a PCSK9 protein deficiency.
The role of this protein in
hypercholesterolemia was thus
evidenced.
DNA talks
Genetics researchers took DNA
samples from patients with low
cholesterol levels and found
that subjects bearing a PCSK9
mutation had lower LDL-C
(“bad” cholesterol) levels. It also
corresponded to a significant
drop in coronary disease for this
population over a 15 years period.
Getting to know PCSK9
2003
Patients
A patient consulted at
Necker in Paris, France, for severe
hypercholesterolemia: a genetic
study revealed a hyperactive PCSK9
gene. The same year, in Dallas,
20
SANOFI – ANNUAL REVIEW 2013
PCSK9 plays an important role
in the LDL-C metabolism.
It regulates the LDL receptors
density at the surface of the liver
cells by promoting their degradation.
Inhibition of PCSK9 increases
availability of LDL receptors and
represents a potentially novel
mechanism for lowering LDL-C.
A potential future therapy
Working with our collaborator
Regeneron we have since
developed a potential PCSK9
inhibitor, alirocumab. The first
Phase III results are encouraging.
Results of Phase III clinical trials
of alirocumab with statins and
different background therapies,
in a variety of patient populations,
are expected in 2014.
2015
Expected submission
of alirocumab
The ODYSSEY program, involving
23,000 patients, is running
to schedule, with expected
regulatory submissions for
alirocumab in early 2015 outside
the U.S. and in 2015 in the U.S.
Any information provided on cited products
is in no way intended to encourage their use.
MULTIPLE SCLEROSIS:
AUBAGIO® AND LEMTRADA ,
NEW HOPE FOR PATIENTS
TM
David P. Meeker,
Executive Vice President
& Chief Executive Officer Genzyme
“
Shani, Australia,
with multiple sclerosis.
T
wo new treatments
for multiple sclerosis
were approved by the
European Commission
during the second half of 2013.
Aubagio® (teriflunomide) and
Lemtrada™(1) (alemtuzumab)
provide new options for meeting
the diverse needs of patients.
Both address relapsing remitting
multiple sclerosis in adults, and
demonstrated positive effects in
Phase III clinical trials.
The EU approval of Aubagio®
was based on two trials
that showed the treatment
significantly reduced
annualized relapse rates and
time to disability progression
at two years versus a placebo.
As a once-daily oral therapy,
Aubagio® also offers patients
an attractive alternative
to traditional injectable
treatments. Lemtrada™ has
a novel dosing and
administration schedule,
with the first treatment course
administered via intravenous
infusion on five consecutive
days. The second course
is administered on three
consecutive days, 12 months
later. Two clinical trials in
patients who were either new
to treatment or had relapsed
on a previous therapy,
showed that Lemtrada™ was
significantly more effective
at reducing annualized relapse
rates than interferon beta-1a.
Lemtrada™(2) and Aubagio® are
currently approved in more than
30 countries.
(1) See definitions, page 39.
(2) Genzyme to resubmit LemtradaTM application
for FDA review, March 2014.
The approvals
of Lemtrada™ and
Aubagio® in the
European Union
represent an
important milestone
for Genzyme and
demonstrate our
focus on scientific
innovation and
commitment
to multiple sclerosis
patients.
“
LEMTRADA™ AND AUBAGIO®
ARE CURRENTLY APPROVED
IN MORE THAN
30 COUNTRIES
IN JANUARY 2014,
GENZYME AND ALNYLAM,
a biopharmaceutical company
developing novel therapeutics
based on RNA interference,
or RNAi, expanded their strategic
agreement to develop and
commercialize treatments for rare
genetic diseases.
SANOFI – ANNUAL REVIEW 2013
21
ASTHMA AND ATOPIC
DERMATITIS: RELIEF
FROM DUPILUMAB*
U
p to 300 million people
around the world are
estimated to suffer from
asthma, and its debilitating
effects account for between 1%
and 2% of healthcare spending
in developed countries.
Between 10% and 20% of these
patients are unable to properly
control the disease with the
treatments currently available.
Sanofi and Regeneron are
now testing a new monoclonal
antibody, dupilumab.
Asthma: a clinical advance
In a Phase IIa, a study of
104 patients with moderateto-severe allergic asthma
investigational product dupilumab
achieved an 87% reduction in the
incidence of asthma exacerbation
after withdrawal of background
medication, compared to patients
given a placebo. Improvements
in lung function, clinical symptoms
of asthma and other parameters
were also noted during the trial,
whose results were published
in the New England Journal of
Medicine in May 2013. Dupilumab
was subsequently voted
“Clinical Advance of the Year”
by the industry publication
Scrip Intelligence.
Atopic dermatitis
Along with asthma investigational
product, dupilumab is currently
in Phase IIb trials for the treatment
for atopic dermatitis,
an inflammatory skin condition
that can affect the overall quality
of patients’ lives.
Sanofi and Regeneron aim
to satisfy an unmet medical need;
there is currently no well-tolerated,
long-term treatment for moderate
to severe cases of patients with
atopic dermatitis uncontrolled
with topical treatments.
ALLERGIES
AUVI-QTM*—A POTENTIAL
LIFE-SAVER
Distribution has begun in the United
States of Auvi-QTM, a breakthrough
device for self-injecting epinephrine
to treat life-threatening allergic
reactions. The size and shape
of a credit card, with the thickness
of a smartphone, the Auvi-QTM
is unique in that it talks patients
and care-givers through the injection
process, and also provides visual
cues. Up to six million Americans
could be at risk of anaphylaxis,
typically from food allergies, and
surveys indicate that half of allergy
sufferers worry that their existing
auto-injector may not be used
correctly. Sanofi has licensed the
commercialization rights for North
America from Intelliject, Inc. Auvi-QTM
was created by teams of scientists led
by twin brothers who were born with
potentially life-threatening allergies.
POLIO VACCINES
TO THE POLIO ERADICATION
Sanofi Pasteur is committed to provide
the majority of the injectable inactived
polio vaccines, in response to a Unicef
tender, to achieve polio eradication
by 2018.
*Investigational product.
Zsombor, Hungary,
with asthma.
CLOSTRIDIUM DIFFICILE
VACCINE IN DEVELOPMENT
REACHES PHASE III
An investigational vaccine to prevent
Clostridium difficile (C. diff),
a major cause of life-threatening
infections in hospitals and nursing
homes, moved into Phase III trial
stage during the summer of 2013.
C. diff is a spore-forming bacterium
that causes intestinal disease. The
toxins lead to death in 8 to 15%
of those infected. The vaccine is
designed to produce an immune
response that targets these toxins.
Entitled Cdiffense, the Phase III study
will eventually involve 15,000 adults
at 200 sites across 17 countries
and is excepted to be completed
by end of 2017.
*See definitions, page 39.
22
SANOFI – ANNUAL REVIEW 2013
Any information provided on cited products
is in no way intended to encourage their use.
DENGUE FEVER:
A VACCINE ON THE HORIZON
Immunization session for
the clinical trial Phase IIb
with our dengue vaccine
in Thailand.
Olivier Charmeil,
Executive Vice President, Vaccines
“
Dengue represents
an increased public
health problem…
and we are in
a very good position
to provide
a solution where
none currently exists.
“
S
anofi is hopeful to become
the first company to offer
a vaccine against dengue
fever, a potentially fatal
disease that infects 100 million
people a year around the world.
A public health priority in Asia and
Latin America, some 2.5 billion
people in the world are at risk of
developing one of four serotypes
2.5
BILLION PEOPLE ARE AT RISK
OF DEVELOPING DENGUE
of the disease after being bitten
by a mosquito.
Of those infected, around
500,000—including children—
go on to develop dengue
hemorrhagic fever, with 2.5%
of these cases proving fatal.
There is currently no specific
treatment available for the disease.
Dengue is a major source of
hospitalization and places great
strain on medical resources,
particularly in developing
countries. It has also damaging
societal and economic impacts.
Worse still, a combination of global
warming, increased air travel and
greater urbanization in developing
economies means that infection
rates are likely to rise further.
Taking up the challenge
Sanofi is determined to meet the
challenge of combating this
disease and has developed
a vaccine candidate, following
an accelerated R&D program.
Already, the vaccine has delivered
promising results in Phase II clinical
trials. Efficacy rates among
4,000 children ranged from 60%
to 90% against three of the disease
serotypes, with results of the fourth
proving inconclusive. Equally
importantly, the trials demonstrated
the treatment to be safe and
well-tolerated by patients.
Today, the vaccine candidate is
undergoing Phase III trials with
two large-scale studies being
carried out in Asia and Latin
America. Results of these studies
among a population of
31,000 children and adolescents
in 10 countries are expected
in the second half of 2014.
The World Health Organization
has set itself the goal of reducing
dengue mortality rates by half
and morbidity rates by a quarter
within the next six years.
If Sanofi successfully develops
the world’s first vaccine against
the disease, Sanofi stands
to make a significant contribution
to achieving that goal.
SANOFI – ANNUAL REVIEW 2013
23
PREVENTING DISEASE AND
26
infectious diseases
can be prevented
through vaccination
Source: World Health Organization.
24
SANOFI – ANNUAL REVIEW 2013
PREVENTION
1 BILLION
VACCINE DOSES
ARE MADE AVAILABLE BY
SANOFI PASTEUR EACH YEAR
Delphine,
35 years old,
Agro-food engineer, nutritionist, living
in Saint-Restitut, France.
Delphine has led an international team
of 12 people to the top of Kilimanjaro
(19,341 feet), the highest peak of Africa.
All of them were affected by type 1 diabetes.
The expedition proved that diabetes
can be managed in extreme conditions
and that it is not an obstacle. It also
brought hope to all people living with
the disease. The team had one motto:
“Take control, dare to dream.”
Meet Delphine on
sanofi.com and
share her hope.
SUPPORTING PATIENTS
382 MILLION
PEOPLE WORLDWIDE SUFFER
FROM DIABETES
Source: IDF Atlas Sixth Edition,
International Diabetes Federation 2013.
OUR STAKEHOLDERS
• Health professionals
• Health authorities
• Patients associations
SANOFI – ANNUAL REVIEW 2013
25
A GLOBAL APPROACH
TO PATIENTS
With the rise of more and more difficult-to-treat
diseases, Sanofi offers global therapeutic solutions.
The Group is engaged in the prevention of diseases
and accompanies patients at every stage of their life,
with a complete range of integrated and personalized
health solutions. Sanofi also collaborates with
healthcare professionals to enhance quality of care.
A preventive medicine
Sanofi strives to develop a more
preventive medicine in order to delay
the onset of disease. This predictive
medicine starts upstream, with the
innovation phase. The R&D teams
work with patients associations
to identify and better understand
patient’s needs. Sanofi Pasteur
plays a major role in helping
to prevent avoidable diseases, with
its large range of vaccines covering
20 infectious diseases. Its ongoing
innovation efforts have recently led to
the first candidate vaccine for dengue
disease and to a more effective
“SANOFI
CONCENTRATES
ON EASING
THE MANAGEMENT
OF ILLNESS”
vaccine in preventing influenza in
older adults. The Group also conducts
multiple preventive actions among
populations, especially in resource-
26
SANOFI – ANNUAL REVIEW 2013
limited countries. Implemented
in collaboration with local health
authorities, these initiatives include
screening, awareness and information
campaigns. Sanofi also participates
in the education of health
professionals through dedicated
training, sharing of know-how and
interactive exchange platforms.
Some global healthcare
solutions
With its pharmaceutical activities,
Sanofi can support patients
throughout every stage of their life.
To help to improve their condition,
the Group goes beyond innovative
medicines: it offers integrated and
personalized healthcare solutions.
Sanofi concentrates on easing the
management of illness, which, in the
case of chronic diseases, could be
for a lifetime. In diabetes for instance,
Sanofi has delivered advanced
medical devices designed to facilitate
the daily management of this chronic
disease. By involving the patient in his
treatment, these tools present another
key merit: to drive behavioral change
and to empower patients.
BGStar ®, the
blood glucose
monitoring.
E-health solutions: innovation
in patient management
Driven by valuable insights from
people living with diabetes and their
health care practitioners, Sanofi is
forming collaborations with a variety
of organizations to offer innovative
services for diabetes management
through technological advances.
E-health solutions can help health
care practitioners to make more
informed decisions and provide
personalized patient care—even
from a distance. In return, patients
may be able to better follow their
prescribed treatments between doctor
visits, aiming for a stronger patient
commitment and improved treatment
compliance.
OUR INTEGRATED DIABETES CARE APPROACH
TO HELP PATIENT BETTER LIVE
LISTENING TO THE PATIENTS
The Group involves patients
with diabetes in the design
phase of insulin pens or
glucose meters, in order
to identify their needs and
gather their opinions on the
prototypes. Tests performed
on patients also allow the
adaptation of instructions
for use, so that they are
as educational as possible.
40-54%
LANTUS®,
OF PATIENTS
WITH TYPE 2
DIABETES
ARE NOT
REACHING
THEIR LONGTERM GLUCOSE
GOALS(1)
ITS WORLD’S
LEADING
INSULIN
BRAND
46%(2)
1 BILLION(3)
UNDIAGNOSED
PEOPLE WITH
DIABETES
IN THE WORLD
OF SOLOSTAR ®
INSULIN PENS
PRODUCED
TILL 2013
(1) Giugliano D and al., Diabetes Res Clin
Pract. 2011; 92:1-10.
(2) IDF Atlas Sixth Edition, International
Diabetes Federation 2013.
(3) Internal data.
SIMPLIFYING DIABETES MANAGEMENT
THROUGH TECHNOLOGY
What are you doing to build better integrated
patient care solutions in diabetes?
Today, a diabetic patient on insulin never gets
a day off. Blood glucose must be measured,
Sanofi works closely with
patients associations
according to the national
regulations to improve
the diagnosis of diabetes.
Together, they organize
information campaigns for
populations and provide
trainings to the health
professionals. T1DStars
is an example. It is
an education website
customized for type 1
diabetes teenagers.
It helps them deal with
their feelings and better fit
diabetes into their life.
TREATING WITH FIRST-IN-CLASS SOLUTIONS
Sanofi combines the latest technology with patient
insights in a new integrated approach: MyStar™.
This one offers smart devices, services and
guidance designed to help simplify and enhance
diabetes management. Key solutions include the
insulin pens JuniorSTAR ®, SoloSTAR ® and AllSTAR TM,
and the blood glucose meters BGStar ®, iBGStar ®
and MyStar Extra™, the first self-monitoring device
that provides an estimated A1c value—a key
indicator for long-term blood sugar control.
How can integrated solutions help
patients?
Integrated Care encompasses the medical,
social, and economic aspects of patient care.
We aim to adopt a holistic approach
to patients, focused on one goal: to ease
the management of their disease.
Simplicity drives behavior change. This is why
we strive to support our patients with better
tools and solutions, and thereby, improve
their adherence to medications and health
outcomes.
PREVENTING DIABETES
WITH EDUCATION
AND TRAINING
Because diabetes is such a complex and
progressive disease, Sanofi never ceases its
innovation efforts and works in collaborations
with the world’s leading research institutes.
Building on the success of Lantus ®,
its number one insulin brand worldwide,
Sanofi continues to evolve its insulin portfolio
with its new investigational insulin U300.
Pascale Witz,
Executive Vice President,
Global Divisions & Strategic Development
“
We aim to provide
patients with simpler,
better ways
to manage
their disease.
food intake monitored, and insulin injected,
often multiple times a day. Everything must be
written down and tracked. It is complicated.
We imagine a future where Sanofi could offer
a simpler solution to a patient by combining
advances in technology and services.
By listening to patients, caregivers and
physicians, as well as experts in healthcare
and technology, we are developing
the products of the future to support patients
in their daily lives.
“
SANOFI – ANNUAL REVIEW 2013
27
DIABETES:
LYXUMIA® EXTENDS
ITS GLOBAL REACH
L
yxumia®* (lixisenatide),
the latest Sanofi medicine
for the treatment of type 2
diabetes, has now been
approved for use in over
40 countries in the European
Union, Asia, Australia and
Latin America.
GLP-1 is a naturally occurring
hormone that is secreted within
minutes of eating a meal and
is known to stimulate the release
of insulin in a glucose
dependent manner. Lyxumia®,
its regulatory filings were
supported by the GetGoal
clinical program, which
featured 11 clinical trials and
more than 5,000 patients.
Lyxumia® is a once-daily
injectable approved for the
treatment of adults with type 2
diabetes mellitus to achieve
glycemic control in combination
with oral glucose-lowering
medicinal products and/or basal
insulin when these, together with
diet and exercise, do not provide
adequate glycemic control.
This lack of control is common
as the disease progresses.
Lyxumia® has been shown
to significantly lower HbA1c
(glycated hemoglobin) levels
through its post prandial
glucose lowering effect.
It also demonstrated to have
a beneficial effect on body
weight, limited risk of
hypoglycemia, and mild and
transient gastrointestinal effects
(nausea and vomiting).
*See definitions, page 39.
VACCINE:
IMPROVED PROTECTION
A
6-in-1 pediatric vaccine
developed by Sanofi
Pasteur is now offering
enlarged protection
for millions of children after being
authorized by the European
Commission. Commercialized
as Hexyon™ in Western Europe
and Hexacima® in Eastern
Europe, the product is a primary
vaccination and booster
for diphtheria, tetanus, whooping
cough, hepatitis B, polio and
invasive infections caused by
Haemophilus influenzae type b.
28
SANOFI – ANNUAL REVIEW 2013
Hexyon™/Hexacima® reduces
the number of vaccination visits,
making it easier for parents
to complete the schedule.
It is a fully liquid ready-to-use
vaccine; no reconstitution is
needed prior to administration
which improves convenience
for healthcare professionnals.
It is also commercialized
in emerging markets as
Hexaxim®.
Isabelle, France,
with diabetes.
DIABETES
MORE INNOVATION IN INSULIN
Sanofi’s new investigational insulin
U300 has been shown to reduce
night-time dips in blood sugar levels
among patients with diabetes in one
of the Phase III study. The patients,
who were already receiving longacting insulin to treat type 2 diabetes,
were given either U300 or Lantus®
in a six-month study. Both products
provided similar blood sugar control,
but those taking U300 experienced
23% fewer cases of nocturnal
hypoglycemia. The first encouraging
results were achieved among
a challenging patient population
in terms of age, duration of diabetes
and Body Mass Index.
INFLUENZA VACCINE
FOR CHILDREN
AND ADULTS ALIKE
Vaccination against 4 strains of
influenza was made available by
Sanofi Pasteur during the 2013 season
in the U.S. following FDA approval of
Fluzone® Quadrivalent. The vaccine,
which protects against 2 A strains
and 2 B strains, can be administered
to adults and children as young as
6 months. The addition of a second
B strain to trivalent vaccines is a
response to the difficulty in predicting
the dominant strain in the coming
influenza season B strain.
SANOFI MOVES INTO
THE E-HEALTH ARENA
M
obile apps, now a
part of many people’s
everyday lives, are also
proving to be valuable
tools in healthcare. Sanofi is
supporting two developments in
the field of diabetes and chronic
kidney disease (CKD) to improve
patients’ quality of life and also
disease monitoring by healthcare
professionals.
Diabeo was jointly developed
in France by CERITD (Center
of Research of the Intensification
of the Treatment for Diabetes),
Voluntis and Sanofi and is
currently in development in the
clinical study Télésage. Designed
for type 1 and type 2 diabetes
patients treated with a basalbolus insulin regimen, Diabeo
combines a mobile application for
patients to titrate their insulin and
a web interface for healthcare
professionals (HCPs). “It is the first
solution offering patients real-time
insulin dose suggestions and
treatment adjustments based on
patient history,” said Dr. Guillaume
Charpentier (CERITD). “Thanks
to its automated telemonitoring
system, HCPs can intervene at
the right moment, with better
patient outcomes.” The current
clinical study Télésage should
demonstrate a reinforcement of
patients’ adherence to healthcare
professionals’ guidance on
glucose monitoring, thanks to
the mobile app which provides
patients with coaching messages.
The web interface should
also enable HCPs to remotely
follow patients with automated
messages to analyze and
evaluate patient data.
Sanofi is also using digital
platforms and social media
to highlight nursing innovation
with the Connecting Nurses
portal*. Developed in partnership
with leading nurses’ organizations,
this portal is a forum for 16 million
nurses to share ideas and best
practice in patient education,
practice and research.
*www.connecting-nurses.com
PHOSPHORUS MOBILE APP
For chronic kidney disease (CKD)
patients, Sanofi has developed
a smartphone/tablet game called
Phosphorus Mission—designed
to educate them about dialysis
and the role of minerals, particularly
phosphorus. The app provides
a guide to the condition and its
treatment, and also helps patients
to understand the role of nutrition.
Between 5%-10% of the world’s
population is estimated to suffer
from CKD.
Daniel Kraft,
Physician, scientist and inventor.
Medicine and Neuroscience Chair,
Singularity University, California
“
The mobile
smartphone is the
epitome of exponential
technologies coming
together (including
low cost computing,
mobile bandwidth,
user interface, apps)
generating disruption
and innovation,
as is quickly becoming
a key platform for
mobile, connected
and digital healthcare.
“
SANOFI – ANNUAL REVIEW 2013
29
IMPROVING ACCESS
TO HEALTHCARE
of the
world’s population
does not have
access to healthcare
IN 2020, 2/3 OF
THE PHARMACEUTICAL
INDUSTRY’S GROWTH
WILL COME FROM
EMERGING MARKETS
Source: World Health Organization.
Source: IMS Health.
1/3
30
SANOFI – ANNUAL REVIEW 2013
50%
patients regularly
forget to take
their medication
Source: World Health Organization.
Meet Arvind on
sanofi.com
and share
his hope.
Arvind,
AGED 55, LIVES IN NEW DELHI, INDIA.
When this energetic Consultant is not working,
he engages into a multitude of sports, golfing, cycling,
motorcycling and bowls, as well as long walks with his
two dogs. Arvind suffers from eosinophilia, a condition
that occurs at each change of season and leaves
him with no energy. Today, thanks to improved access
to healthcare in India, Arvind can live the life he wants
to lead, with nothing to hold him back!
ST
Sanofi is the
market leader
in emerging
markets
176
million people
benefited from over
260 access to
healthcare programs
SANOFI – ANNUAL REVIEW 2013
31
A GLOBAL PRESENCE
CLOSER TO PATIENTS
Access to healthcare around the world is a true
challenge. Working closely with local health
partners, Sanofi strives to reach this goal by
strengthening its presence in emerging markets
and offering a diversified range of medicine
accessible to those most in need.
Strengthening our position
in emerging markets
80% of the world’s population lives in
emerging markets. They are gaining
greater access to healthcare through a
combination of factors: growing
urbanization and steady expansion of the
middle class, leading to higher
disposable income. Local governments
are also strongly committed to develop
public health infrastructure in their
countries. Responding to these growing
health needs is one of Sanoi’s top
priorities. Since entering India back in
1951, the Group has strongly expanded
its emerging markets footprint. Today,
it is the leader in Emerging Markets with
a presence close to 100 emerging
countries. Besides the BRIC markets
(Brazil, Russia, India and China), the
Group has extended its geographical
coverage to countries such as Vietnam,
Indonesia or Colombia, in order to meet
the future health needs of the local
population. In 2013, Sanoi celebrated its
30th year in China, a country identiied
as the most important emerging region
in terms of growth. Sanoi’s success in
emerging markets relies on
a differentiated approach adapted
32
SANOFI – ANNUAL REVIEW 2013
to the local characteristics and needs of
each market. This local approach
concerns all of the Group’s resources: the
management and commercial teams as
well as the R&D and industrial networks.
Developing a local industrial
network…
Like in Europe and North America,
the expansion of Sanoi in emerging
markets has been supported
by the development of a local industrial
network. Today, the Group has
112 manufacturing sites in
41 countries, including 37 sites in
emerging markets. Producing locally is
the best way to better understand and
meet the local needs of patients.
It helps to enable a better understanding
of the local markets, a closer proximity
with patients and international
standards of quality and safety. Other
key advantages include the ability
to adapt the medicines to the regional
characteristics and to comply with local
regulation. Industrial innovation is
another key element of the Group’s
industrial culture. All over the world,
Sanoi concentrates its development
centers on improving the well-being of
Philippe Luscan,
Executive Vice President,
Global Industrial Affairs
“
In Sanofi is one of the
few pharmaceutical
groups to have full
control over its
production chain, from
the active ingredient
to distribution.
“
patients, by working on the dosage
forms. It also endeavors to develop
solutions adapted to the local market
constraints, such as the development of
orodispersible drug delivery when
access to water is dificult.
… based on a common culture
of excellence…
The ambition of our Industrial Affairs
is to continue to raise quality standards
in the Group’s production activities,
and to remain a world leader
and a benchmark in the global
pharmaceutical industry. To achieve
LOCAL PRODUCTION TO MEET
PATIENT’S NEEDS
ASIA-PACIFIC
(including Japan
and Australia)
21 sites
NORTH AMERICA
20 sites
112
EUROPE
52 sites
manufacturing sites
worldwide, including
37 based in emerging
markets
3,153
million boxes of
pharmaceuticals
produced and
packaged worldwide
in 2013
LATIN AMERICA
12 sites
4
new sites in 2013:
Algeria, Vietnam, China
and Saudi Arabia
AFRICA and
MIDDLE EAST
7 sites
+11.5%
Growing sales of
vaccines in emerging
markets in 2013
China
3.5 billion pills
Production capacity for
Sanofi’s new consumer
products facility in Hangzhou
this goal, all our activities share
a common culture of industrial
excellence, enriched in the Sanoi
Manufacturing System. This sets out
a series of priorities (such as customer
service, continuous improvement, site
network optimization and transverse
optimization) that constitute our
industrial vision and will be crucial
to our mutual success.
… and accessible portfolio
of products
The diversity of Sanoi’s products is an
important asset in striving to fulill the
needs of the 7 billion people around the
world. The Group strives to develop
medicines and healthcare solutions
accessible to those most in need. It offers
a wide range of quality medicines at
affordable prices through generics,
as well as OTC products to meet
the growing trend of self-medication.
Sanoi Pasteur is committed
to endeavoring to make vaccines
accessible to as many people as
possible, by participating in many
public health projects and applying
a differentiated pricing policy. It also
continuously innovates to develop new
vaccines. To promote access
to healthcare for the patients most in
need, especially in emerging markets,
Sanoi has created a dedicated Access
to Medicines Department. It aims
to adapt the Group’s strategy to each
country, such as a market differentiated
pricing policy to ensure the affordability
of medicines.
Working closely with the local
health partners
In each country, Sanoi works in close
collaboration with local health partners
to improve access to healthcare.
The Group cooperates with local
governments, health authorities,
NGOs and other key players such as
the Worldwide Health Organization.
This collaborative approach is one of
the reasons for the Group’s longevity
and success throughout the world.
Peter Guenter,
Executive Vice President,
Global Commercial Operations
What is the recipe to successfully
adapt your offer to each market?
A complete understanding of
the local environment and the
knowledge of the needs of patients
are key for us to adapt our offers.
This makes the upstream preparation
work even more essential. Develop
win-win collaborations with key
stakeholders in implementing health
policy is also very important.
What is the best illustration of your
differentiated approach?
In certain African countries, we have
the classic offer of our portfolio that
is similar to the rest of the world.
We have also an Access to
Medicines program that enables
access to medicines for some local
pandemic diseases such a malaria
on a no profit/no loss basis.
SANOFI – ANNUAL REVIEW 2013
33
SANOFI CONSUMER
HEALTHCARE:
CONSUMERS AT HEART!
A
s the third largest
supplier worldwide of
OTC medicines
and supplements,
Consumer Healthcare (CHC) is
a strategically important business
to Sanofi. Sales increased by 5.2%
in 2013 to more than €3 billion,
with consumer products
including painkillers, digestive
disorder remedies, VMS (vitamins
and mineral supplements),
feminine care products and
treatments for cough and cold or
allergies. To reflect the portfolio’s
importance, a global CHC
division established in 2014 and
mainly focuses on global brands
growth, future businesses as well
as targeted external growth
opportunities.
The global CHC division is
operating along three key
strategic directions: generating
consumer insight-driven
innovation, drawing on Sanofi’s
scientific heritage and leveraging
the company’s worldwide
manufacturing network and
its pharmaceutical quality
standards. Furthermore, beyond
putting consumers first, Sanofi
CHC builds on its in-depth
understanding of the role of
physicians and pharmacists in
the area of selfcare.
ANIMAL HEALTH:
APPROVAL OF NEXGARD®
M
erial has a long
tradition and expertise
in launching
innovative and
preventive treatments for animals.
The company is currently
introducing two novel, convenient
parasite treatments for pets:
Broadline™ for cats and
NexGard® for dogs. Broadline™,
approved in Europe, is a unique
topical product combining
4 active ingredients to prevent
and treat both internal and
external parasites in cats.
NexGard®, already approved
in the United States, Europe
and Japan, is the first and only,
monthly beefflavored soft chew
for dogs that kills fleas and ticks.
Its innovative formulation and
34
SANOFI – ANNUAL REVIEW 2013
distinct mode of action provide
excellent efficacy at a low dose
monthly treatment, while being
highly palatable for dogs. Both
are veterinarian prescription
only products. For cattle, Merial
delivered a brand new way in
thinking about parasite control,
resulting in less labor for producers
and less stress for their cattle.
Instead of treating cattle up to
three to four times during the
grazing season, its Longrange®
product gives producers the
option of a single treatment that
will last all season. This persistent
parasite control is possible
because of the unique
Theraphase® technology, which
releases the active ingredient for
an extended period after injection.
50%
OF CONSUMER HEALTHCARE
SALES ACHIEVED IN
EMERGING MARKETS IN 2013
NASAL ALLERGY SYMPTOMS
NASACORT AVAILABLE OTC
Nasacort® Allergy 24HR is now
available over-the-counter (OTC)
in the U.S. to relieve the full range
of seasonal and year-round nasal
allergy symptoms, in adults and
children 2 years of age and older.
It is the irst and only medicine
in its class to be available OTC in
the U.S. at full prescription strength.
This milestone builds on our expertise
in prescription-to-OTC switches as
we continue to expand our global
consumer healthcare portfolio
according to the national regulations.
Biscuit,
cat,
France.
PROVIDING ACCESS
TO QUALITY HEALTHCARE
FOR EVERYONE
SANOFI’S CSR ACHIEVEMENTS
RECOGNIZED BY 2 GLOBAL
INDICES
In 2013, Sanofi was listed on two
prestigious global CSR indices.
For the 7th consecutive year, it has
been included in the Dow Jones
Sustainability Index (DJSI), the most
recognized international sustainability
index for investors. Sanofi was also in
the Climate Disclosure Leadership
Index (CDLI) where its ranking
improved over the previous year. These
successes highlight the employees’
ongoing commitment to sustainability.
MY CHILD MATTERS: RENEWED
FORCES TO FIGHT CHILDHOOD
CANCER
Chad, to fight against sleeping sickness.
T
oday, 2.5 billion people
representing over one third
of the worldwide population
has no access to essential
healthcare. Corporate Social
Responsibility (CSR) is part of
our DNA: as a world leader in
healthcare, we consider that it
is our responsibility to improve
access to quality healthcare for
everyone, regardless of their origin.
An estimated 176 million people
benefited from over 260 programs.
We currently concentrate our
efforts on three main priorities,
in collaboration with our partners:
– Promoting access to medicine
for the patients most in need in
resource-poor countries. We adapt
our commercial offerings to
the economic conditions of the
targeted countries. Our main
initiatives cover information and
education, targeted medicines,
differentiated pricing policies and
industrial expertise. As an example:
we are committed to fight against
neglected tropical disease,
sleeping sickness and malaria, with
hope to be eliminated by 2020.
– Reducing inequalities, through
the Sanofi Espoir Foundation.
The Foundation focuses on
fighting against childhood cancer,
reducing maternal and child
mortality and providing healthcare
access for the poorest.
– Promoting access to quality
healthcare and protecting the
safety of patients by fighting
counterfeiting. Sanofi cooperates
closely with law enforcement
authorities and professional
organizations in many countries.
The Group analyses suspected
products in its own anti-counterfeit
laboratory. It also develops mobile
technologies to inform travelers on
the dangers of counterfeit drugs.
In February 2013, the Union for
International Cancer Control (UICC)
and the Sanofi Espoir Foundation
renewed their My Child Matters
partnership for another three years.
This partnership is dedicated to fighting
childhood cancer in low-income
countries. Initiated in 2005, this
program combines financial support,
advice from international experts and
networking activities, with significant
impacts for childhood cancer.
The new partnership focuses on
three priorities: enhanced support
and evaluation of ongoing projects
in 15 emerging economies; backing
from international care networks;
and awareness-raising actions
to make childhood cancer a priority
on the global health agenda.
SLEEPING SICKNESS:
27
MILLION
SCREENED PEOPLE,
175,000
PATIENTS SAVED IN
A PARTNERSHIP WITH THE WHO*.
OUR GOAL: ELIMINATION
OF THIS DISEASE IN 2020.
*World Health Organization.
SANOFI – ANNUAL REVIEW 2013
35
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IN CONTACT…
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handbook
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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 –
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38
SANOFI – ANNUAL REVIEW 2013
DEFINITIONS
Emerging Markets: The world
excluding the United States,
Canada, Western Europe (France,
Germany, United Kingdom, Italy,
Spain, Greece, Cyprus, Malta,
Belgium, Luxembourg, Sweden,
Portugal, the Netherlands, Austria,
Switzerland, Ireland, Finland,
Norway, Island, Denmark), Japan,
Australia and New Zealand.
Other Innovative Products: Includes
products launched since 2009
which do not belong to other growth
platforms, Multaq®, Jevtana®,
Zaltrap®, Auvi-Q
QTM and Mozobil®.
Zaltrap® (aflibercept): Developed
in collaboration with Regeneron.
Auvi-Q™ (epinephrin): Sanofi U.S.
licensed the North American
commercialization rights to
Auvi-Q
QTM from Intelliject, Inc.
Lemtrada™ (alemtuzumab):
Developed in collaboration with
Bayer HealthCare.
Kynamro™ (mipomersen sodium):
Development partnership with Isis
Pharmaceuticals.
Lyxumia® (lixisenatide): Lixisenatide
has not yet been authorized or
approved in all world markets.
Business EPS: Business earnings per
share is a specific financial indicator
that we define as business net
income divided by the weighted
average number of shares
outstanding.
Business net income is defined as
net income attributable to equity
holders of Sanofi excluding
(i) amortization of intangible assets,
(ii) impairment of intangible assets,
(iii) fair value remeasurement of
contingent consideration liabilities;
(iv) other impacts associated with
acquisitions (including impacts of
acquisitions on associates and joint
ventures); (v) restructuring costs
(including restructuring costs
relating to associates and joint
ventures); (vi) other gains and losses,
and litigation; (vii) the tax effect
related to the items listed in (i)
through (vi); as well as (viii) the
effects of major tax disputes, the tax
on dividends distributed to Sanofi
shareholders starting in 2013,
and as an exception for 2011, the
retroactive effect (2006-2010) on the
tax liability resulting from the
agreement signed on December 22,
2011 by France and the United States
on transfer prices (APA-Advance
Pricing Agreement), for which the
amount is deemed to be significant;
and (ix) the share of non-controlling
interests in items (i) through (viii).
Items (i), (ii), (iii), (v) and (vi)
correspond to those reported in the
income statement line items
‘‘Amortization of intangible assets’’,
‘‘Impairment of intangible assets’’,
‘‘Fair value remeasurement of
contingent consideration liabilities’’,
‘‘Restructuring costs’’ and ‘‘Other
gains and losses, and litigation’’.
This document contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements
are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and
statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements
are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are
difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties
inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as
their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates, the absence of
guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives,
the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment
policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the
SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s
annual report on Form 20-F for the year ended December 31, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to
update or revise any forward-looking information or statements.
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