2. 2
Forward Looking Statements
This presentation 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.
3. 33
Agenda
Key Highlights
● Christopher A. Viehbacher, Chief Executive Officer
Financial Performance
● Jérôme Contamine, Executive Vice President, Chief Financial Officer
Conclusion
● Christopher A. Viehbacher, Chief Executive Officer
Q&A
5. Key Highlights for Q1 2014
Top and bottom line growth in line with expectations
– Net sales up +3.5% at CER
– Business EPS up +5.8% at CER
New product launches
– Nasacort® Allergy 24HR nasal spray in the U.S.
– NexGard™ chewables in the U.S.
Late stage R&D pipeline progress
– Dengue vaccine met primary endpoint in 1st Phase III study
– Significant advances with Lemtrada™, alirocumab, LixiLan, dupilumab
5
Increased value of open innovation
– Strengthened collaborations with Regeneron and Alnylam
– New collaborations with UCB and SK Chemical
1
2
3
4
6. Pharmaceuticals Delivered +4.7% Sales Growth at CER
6
(1) Q1 2014 sales were down -2.7% on a reported basis
(2) Q1 2014 sales for Pharmaceuticals were up +4,9% at CER and on a constant perimeter basis
€628m
€6,697m
€7,842m
€697m
€8,059m
Q1 2014
€6,808m
€517m
Q1 2013
€554m
Pharmaceuticals
Vaccines
Animal Health
+4.7% at CER
-4.2% at CER
-1.6% at CER
Q1 2014 Net Sales
(1)
1
(2)
7. 7
(1) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg,
Portugal, Holland, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark), Japan, Australia, and New Zealand
(2) Western Europe: France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Holland, Austria,
Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark
Q1 2014 Net Sales
(1)
(2)
Latin America: +13.1% at CER
Asia: +4.0% at CER
Eastern EU, Russia & Turkey: +4.0% at CER
Middle East & Africa: -1.0% at CER
€2,590m
+5.5% at CER
€2,415m
+7.5% at CER
€1,998m
-0.3% at CER
€839m
-4.0% at CER
Continued Solid Growth in our Two Largest Geographies1
Emerging Markets
United States
Western EU
RoW
8. +18.6%Consumer Healthcare(1)
€885m
Vaccines -4.2%€628m
Genzyme(2)
Growth Platforms Grew by +7.9% Reaching 73.7% of Sales
8
(1) Some products recorded in prescription pharmaceuticals in Q1 2013 were transferred as Consumer Healthcare products and totaled €68m in Q1 2014.
Excluding this change of perimeter, sales of Consumer Healthcare grew 9.4% in Q1 2014.
(2) Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises
(3) Includes products launched since 2009 which do not belong to the Growth Platforms listed above: Multaq®, Jevtana®, Auvi-Q™, Mozobil® and Zaltrap®
+13.2%
-4.2%
+21.5%
-1.6%
Other Innovative Products(3)
€190m +22.6%
+5.5%
Diabetes Solutions €1,662m
Animal Health
€566m
Emerging Markets €2,590m
€517m
Q1 2014
Growth at CER
1
9. New Launches Executed in Q1 2014
9
● First and only 24 HR full Rx strength nasal allergy
spray available OTC in the U.S.
● Up to 60m people in U.S. with allergies and up to
28m people using nasal sprays
● €36m sales in Q1 2014 in the U.S.
● First and only beef-flavored chew treating fleas
and ticks in dogs in the U.S.
● Launched in the U.S. and France
● €23m sales in Q1 2014
2
10. 10
First-in-Class Dengue Vaccine Met Primary Endpoint
in Phase III Trial in Asia
Significant Disease Burden(1)
● 2.5bn people at risk
● 100m symptomatic dengue cases
worldwide per year
● 500,000 people with severe dengue
requiring hospitalization
● 2.5% of people with severe dengue die
● Dengue is a public health priority
in Asia and Latin America
(1) Dengue and severe dengue; WHO Fact Sheet No. 117 updated Sep. 2013 http://www.who.int/mediacentre/factsheets/fs117/en/index.html
Dengue is under-reported and thus the burden is likely underestimated (Bhatt S et al. Nature. 2013 Apr 25;496(7446):504-7)
(2) Sabchareon A et al. Lancet. 2012 Nov 3;380(9853):1559-67.
Ambitious Development Program
● 1st Phase III in Asia (~10,000 children)
● 3 vaccinations at 0, 6, and 12 months
● 56% reduction of dengue disease cases
from first available data
● Good safety profile
● 2nd Phase III trial ongoing in LatAm
● >20,000 children and adolescents
● Results expected in Q3 2014
3
WHO objectives: Reduce dengue mortality by 50% and morbidity by at least 25% by 2020
11. Innovation - Significant Advances in Q1 2014
11
● Planned sBLA resubmission in Q2 2014
● FDA review timeframe: 2 or 6 months
once filing is accepted(1)
● 2 Phase III studies initiated in Q1 2014
● LixiLan-O: patients insufficiently controlled
on OADs
● LixiLan-L: patients not at goal on basal
insulin
● Positive Phase III monotherapy trial
results presented at ACC in Mar 2014
● 9 additional Phase III top-line readouts
expected from June through Q3 2014
● Strong Phase IIa results in AD presented
at AAAAI in March 2014(2)
● Phase IIb top-line results in AD expected
in Q2 2014 and in Asthma in Q1 2015
(1) FDA will assign a 2 month or 6 month review cycle within 14 calendar days of receipt of the resubmission
(2) Phase IIa presented at AAAAI (American Academy of Allergy, Asthma & Immunology) - Annual Meeting, March 4 2014
- Atopic Dermatitis / Asthma
Alirocumab and dupilumab are developed in collaboration with Regeneron
- Hypercholesterolemia
- Diabetes
- Multiple Sclerosis
3
R&D
12. Strengthened Relationship with Regeneron
12
● A model of global strategic R&D collaboration
● Secured access to therapeutic human antibody platform
● Sanofi ownership of Regeneron recently reached 20%
● Robert A. Ingram nominated by Sanofi and appointed
as a member of Regeneron's Board of Directors
● “Significant influence” under IFRS rules allows Sanofi
to account for its investment in Regeneron using the
Equity method from April 4, 2014
4
13. 13
Genzyme’s Leadership in Rare Diseases Increases through
Expansion of Alnylam Collaboration
(1) Proprietary technology that conjugates a sugar molecule called “GalNAc” to the siRNA (small interfering RNA)
(2) In January 2014, Genzyme purchased $700m of Alnylam common stock. On March 25, 2014, Genzyme exercised its
right to purchase additional shares of Alnylam for $23m as a result of Alnylam’s issuance of shares to Merck in
connection with the acquisition of Sirna Therapeutics. The exercise of this right to purchase the maximum number of
additional shares under the terms of the investor rights agreement allows Genzyme to maintain its current ownership
level of Alnylam common stock of approximately 12%.
● Alnylam’s RNAi technology to
provide a platform for sustained drug
development for rare genetic
diseases for Genzyme
● Focus is on genetically defined
diseases with a clear translational
model for RNAi
● Delivery platform enabling
subcutaneous administration of drug
candidates targeting hepatocytes(1)
● Genzyme now one of Alnylam’s main
shareholders with 12% stake(2)
PC P1 P2 P3
Patisiran (TTR-FAP) in expanded territory
AS1 (Hepatic Porphyria)
TTRsc (FAC)
Unnamed
AT3 (Hemophilia)
TTR-FAP: Transthyretin-Familial Amyloïd Polyneuropathy
FAC: Familial Amyloïd Cardiomyopathy
Program Rights*
*subject to opt-in
4
14. New R&D Collaborations Signed in Q1 2014
14
● A scientific and strategic collaboration
for the discovery and development
of innovative anti-inflammatory
small molecules
● Focused on immune-mediated diseases
currently treated by biologic agents such
as rheumatoid arthritis, ulcerative colitis
and Crohn’s disease, etc.
● A long-term strategic cooperation to
co-develop an innovative pneumococcal
conjugate vaccine (PCV) with enhanced
serotype coverage
● Potential access to the large and
growing global PCV market
4
15. Multiple Regulatory and Phase III Development
Milestones Are Expected in 2014
15
2014
Expected Regulatory Decisions Q1 Q2 Q3 Q4
● Shan5® 5-in-1 pediatric vaccine WHO pre-qualification
● Cerdelga™ in Gaucher disease (U.S. & EU)
● Lemtrada™ in Multiple Sclerosis (U.S.)
● Fluzone® QIV Intradermal (U.S.)
Expected Regulatory Submissions Q1 Q2 Q3 Q4
● Fluzone® QIV Intradermal (U.S.)
● Lemtrada™ in Multiple Sclerosis (U.S.)
● Toujeo™ (U300) in Diabetes (U.S. & EU)
● 6-in-1 pediatric vaccine PR5i (U.S.)
● Alirocumab in Hypercholesterolemia (EU)
Expected Headline Phase III Data Releases Q1 Q2 Q3 Q4
● Dengue vaccine 1st Phase III trial in Asia
● Alirocumab in Hypercholesterolemia (multiple ODYSSEY trials)
● Dengue vaccine 2nd Phase III trial in Latin America
Expected Phase III Starts Q1 Q2 Q3 Q4
● LixiLan (lixisenatide + insulin glargine) in Diabetes
● Dupilumab in Atopic Dermatitis
● Rotavirus vaccine
4
16. SI SBB
16
(1) Cumulated 2014 share buyback of €583m (7.8m shares) by April 25, 2014 (€355m by end of March).
(2) Cumulated 2014 proceeds from share issuance of €58m (1.6m shares) by April 25, 2014 (€37m by end of March)
(3) Cumulated 2014 shares acquired net of shares created of €525m (6.2m shares) by April 25, 2014
Evolution of Share Buyback
(1,2,3)
€583m
€58m
€1,641m
€1,004m
€823m
€646m
2012
: Share issuance
: Share buybackSBB
SI
● Opportunistic share buyback
in Q1 2014 above and beyond
anti-dilution purpose
● Share buyback of €583m in YTD
2014(1)
● Proceeds from share issuance of
€58m in YTD 2014(2)
Sanofi Continued Share Buyback in 2014
SI SBB
2013
SI SBB
2014
18. Q1 2014
-€0.11
FX ImpactIncremental
EPS at CER
Q1 2013
+€0.07
Net Sales Business EPS
Sanofi Delivered Top and Bottom Line Growth at CER,
in Line with Expectations
18
(1) On a reported basis, Q1 2014 sales were down -2.7% and Business EPS was down -3.3%
(2) With retroactive application of IFRIC21
+5.8%
at CER(1)
Incremental
Sales at CER
Q1 2014Q1 2013 FX Impact
+€280m
-€497m
+3.5%
at CER(1)
€8,059m
€7,842m
€1.21
€1.17
(2)
19. Net Sales(1)
Business EPS
19
Negative FX Impact given Strength of the Euro
vs. Other Currencies
(1) Main currency impact on sales in Q1 2014: U.S. Dollar (-€96m); Japanese Yen (-€87m); Brazilian Real (-€62m); Russian Ruble (-€39m); Argentine Peso
(-€29m); Turkish Lira(-€27m) and Australian Dollar (-€26m)
(2) Difference between variation on reported basis and variation at constant exchange rates
Quarterly Currency Impact
-2.5%
-€212m
-4.4%
-€0.08
-3.5%
-€305m
2013
-€0.08
-5.5%
-7.3%
-€662m -€0.17
-10.2%
Q4Q3Q2Q1
-7.3%
-€627m
2014
Q1
-€0.16
-13.7%
-6.2%
-€497m -9.1%
-€0.11
2013
Q4Q3Q2Q1
2014
Q1
Assuming Q1 2014 exchange rates for 2014, negative FX impact on 2014 Business EPS would be ~6%(2)
20. Sequential Improvement in Gross Margin in Q1 2014
vs. Q4 2013
● Cost of Sales (CoS) in Q1 2014:
€2,516m, up +4.3% at CER
● CoS ratio up 0.5 ppt in Q1 2014:
● CoS ratio improvement for
Pharmaceuticals (positive impact of
0.4 ppt at CER on the variation of the
Group CoS ratio)
● Dilutive impact of Vaccines and Animal
Health (negative impact of 0.3 ppt at
CER on the Group CoS ratio for each)
● Unfavorable currency variations
20
Gross Margin (%)
2013 2014
69.0%69.6% 67.7% 67.0% 66.8%
21. Stable R&D Expenses despite Significant Investment
in Phase III Trials
21
● Q1 2014 R&D expenses of
€1,139m, up +1.1% at CER
● Ongoing multiple Phase III trials
● Slight increase in R&D spend in line
with guidance
21
R&D Expenses (€m)
2013 2014
€1,139m€1,157m
(1) With retroactive application of IFRIC21
(1)
22. Modest Increase in SG&A Expenses in Q1 2014
Despite New Product Launch Costs
22
● Q1 2014 SG&A expenses of
€2,078m, up +2.5% at CER
● Sales & Marketing investment in
product launches (Aubagio®,
Lemtrada™, Nasacort® OTC,
NexGard™)
● Lower increase in SG&A than Sales
22
SG&A Expenses (€m)
2013 2014
€2,078m€2,140m
(1)
(1) With retroactive application of IFRIC21
23. CER: Constant Exchange Rates
23
€m Q1 2014 Q1 2013 % Change
(reported €)
% Change
(CER)
Business operating income 2,145 2,321 -7.6% +0.6%
Net financial expenses (76) (140) - -
Income tax expense (522) (583) - -
Effective tax rate -25.0% -26.5% - -
Business net income 1,547 1,598 -3.2% +5.6%
Net margin 19.7% 19.8% - -
Business EPS(2) €1.17 €1.21 -3.3% +5.8%
Average number of shares outstanding (m) 1,319.9 1,322.2 - -
Business EPS Growth of +5.8% in Line with Full Year
Financial Guidance
23
(1) With the retroactive application of IFRIC21
(2) Business EPS was down -7.8% at CER in Q1 2013 excluding Plavix® and Avapro®
Loss of Exclusivity in the U.S. - Avapro® on March 30, 2012 and Plavix® on May 17, 2012
(1)
24. Proceeds
from Issuance
of Shares
Share
Repurchase
€355m
Other Net Debt
Mar 31, 2014
€1,556m
Acquisitions,
Licensing, Net
of Disposals
€176m
€37m
CapEx
€279m
Net Cash from
Operating
Activities
Net Debt
Dec 31, 2013
FCF Increased by 20.6% and Sanofi Made Significant
Investments in Regeneron and Alnylam in Q1 2014
24
(1)
(2)
€6,043m
€6,697m€1,675m
(1)(4)
Net Debt (in €m)
FCF
€1,396m
(1) Including derivatives related to the financial debt +€290m at December 31st 2013 and +€317m at March 31st 2014
(2) Excluding Restructuring costs
(3) Including €954m in Regeneron and €530m in Alnylam
(4) Other including Restructuring costs
(3)
25. OWNERSHIP / INVESTOR AGREEMENT
Contribution of Regeneron Reflects Growing Importance
of Strategic Relationship
● Regeneron 20% ownership accounted for under the Equity method from April 4, 2014
● Limited differences between U.S. GAAP and IFRS
BNI expected to benefit by ~€45m in 2014(4)
● Sanofi funds clinical development cost(1)
● Regeneron funds 20% of Phase III costs
incurred after receipt of the first positive
results in a Phase III trial
● Sanofi retains 50% of profits in U.S. and
55% to 65% of profits ex-U.S.(2)
● Regeneron repays Sanofi for 50% of
development costs out of profits(3)
License and Collaboration Agreement (Post Opt-In)
COMMERCIALIZATIONDEVELOPMENT
(1) 100% development funding by Sanofi for all opted-in antibodies except 80% of an antibody’s Phase III costs incurred after receipt of the first positive
results in a Phase III trial for that antibody
(2) Regeneron has co-promotion rights in U.S. and other major market countries
(3) Repayment is capped in any year at 10% of Regeneron share of total antibody profits
(4) Based on Regeneron consensus estimates for US GAAP net income in FY2014; EUR/USD rate of $1.38 25
27. Good start into 2014
Q1 2014 results in line with expectations and guidance
Key pipeline assets in pre-launch phase
External R&D collaborations extended
Continued buyback of shares in Q1 2014
27
29. 29
Late Stage Pipeline – Pharma & Vaccines
Toujeo™ (U300)
Insulin glargine
Type 1+2 diabetes
alirocumab
Anti-PCSK-9 mAb
Hypercholesterolemia
Dengue
Mild-to-severe
dengue fever vaccine
Lemtrada™ (alemtuzumab)
Anti-CD52 mAb
Multiple sclerosis, U.S.
Lyxumia® (lixisenatide)
GLP-1 agonist
Type 2 diabetes, U.S.
Kynamro® (mipomersen)
Apolipoprotein B-100 antisense
Severe HeFH, U.S.
Clostridium difficile
Toxoid vaccine
Cerdelga™ (eliglustat tartrate)
Glucosylceramide synthetase inhibitor
Gaucher disease, U.S., EU
LixiLan
lixisenatide + insulin glargine
Fixed-Ratio / Type 2 diabetes
sarilumab
Anti-IL-6R mAb
Rheumatoid arthritis
DTP-HepB-Polio-Hib (PR5I)
Pediatric hexavalent vaccine
Quadracel®
Diphtheria, tetanus, pertussis
& polio vaccine; 4-6 y of age
patisiran SAR438037
mRNA inhibitor
Familial amyloid polyneuropathy
Jevtana® (cabazitaxel)
Metastatic prostate cancer (1L)
VaxiGrip® QIV IM
Quadrivalent inactivated
influenza vaccine
Fluzone® QIV ID
Quadrivalent inactivated
influenza vaccine intradermal
SYNVISC-ONE®
Medical device
Pain in hip OA
N
29
N
N
N
N New Molecular Entity Immune Mediated Diseases
Rare Diseases
Oncology
Diabetes Solutions
Vaccines
Infectious Diseases
Cardiovascular / Renal
Diseases
Age Related Degenerative
Diseases
Ophthalmology
Biosurgery
N
Phase III Registration
N
30. Early Stage Pipeline – Pharma & Vaccines
dupilumab
Anti-IL4Rα mAb
Atopic dermatitis; Asthma; Nasal polyposis
SAR391786
GDF8 mAb
Sarcopenia
SAR438714 (ALN-TTRsc)
RNAi
Familial amyloid cardiomyopathy
SAR339658
Anti-VLA 2 mAb
Multiple sclerosis
SAR3419
Maytansin-loaded anti-CD19 mAb
B-cell refractory/relapsed malignancies
(NHL)
Rotavirus
Live attenuated tetravalent
Rotavirus oral vaccine
SAR156597
IL4/IL13 Bi-specific mAb
Idiopathic pulmonary fibrosis
SAR256212 (MM121)
anti-ErbB3 mAb
Breast cancer (2L, 3L)
Rabies VRVg
Purified vero rabies vaccine
SAR100842
LPA-1 receptor antagonist
Systemic sclerosis
Combination
SAR245409 (XL765) / MSC1936369B
Oral dual inhibitor of PI3K & mTOR / pimasertib
Ovarian cancer
Meningitis ACYW conj.
2nd generation meningococcal
conjugate infant vaccine
sarilumab
Anti-IL-6R mAb
Uveitis
SAR279356 (F598)
Anti-PNAG mAb
Serious infections
Tuberculosis
Recombinant subunit vaccine
fresolimumab
TGFβ antagonist
Focal segmental glomerulosclerosis
Combination
ferroquine / OZ439
Antimalarial
Malaria
Phase II
N
N
N
N
NN
30
N
30
N
N New Molecular Entity Immune Mediated Diseases
Rare Diseases
Oncology
Diabetes Solutions
Vaccines
Infectious Diseases
Cardiovascular / Renal
Diseases
Age Related Degenerative
Diseases
Ophthalmology
Biosurgery
N
N
N
N
31. Early Stage Pipeline – Pharma & Vaccines
SAR650984
Anti-CD38 naked mAb
Hematological malignancies
SAR245408 (XL147)
Oral PI3K inhibitor
Solid tumors
GZ402663 (sFLT-01)
Gene therapy
Age-related macular degeneration (AMD)
Streptococcus pneumonia
Meningitis & pneumonia vaccine
SAR405838 (MI-773)
HDM2 / p53 antagonist
Solid tumors
Combination
SAR405838 / MSC1936369B
Solid tumors
StarGen®
Gene therapy
Stargardt disease
Pseudomonas aeruginosa
Antibody fragment product
Prevention of ventilator-associated pneumonia
SAR153192
Anti-DLL4 mAb
Solid tumors
SAR228810
Anti-protofibrillar AB mAb
Alzheimer’s disease
UshStat®
Gene therapy
Usher syndrome 1B
Herpes Simplex Virus Type 2
HSV-2 vaccine
SAR566658
Maytansin-loaded anti-CA6 mAb
Solid tumors
SAR252067
Anti-LIGHT mAb
Crohn’s disease
GZ402665
(rhASM)
Niemann-Pick type B
SAR125844
C-MET kinase inhibitor
Solid tumors
SAR113244
Anti-CXCR5 mAb
Systemic lupus erythematosus
GZ402671
Oral GCS Inhibitor
Fabry Disease
SAR307746
Anti-ANG2 mAb
Solid tumors
Insulin Biosimilar Program
Diabetes
GZ402666
neo GAA
Pompe Disease
SAR260301
PI3K β selective inhibitor
PTEN – Deficient tumors
SAR438151
Undisclosed target
SAR438584
Undisclosed target
Phase I
N
N
N
N
N N N
N
N
N
N N
3131
N
N
N
N
N New Molecular Entity Immune Mediated Diseases
Rare Diseases
Oncology
Diabetes Solutions
Vaccines
Infectious Diseases
Cardiovascular / Renal
Diseases
Age Related Degenerative
Diseases
Ophthalmology
Biosurgery
N
NN
32. 32
Phase I Phase II Phase III Registration TOTAL
Oncology 8 3 0 0 11
Diabetes Solutions 0 0 2 0 2
Cardiovascular / Renal
Diseases
0 1 1 0 2
Immune Mediated
Diseases
2 4 1 0 7
Infectious Diseases 0 2 0 0 2
Ophthalmology 3 0 0 0 3
Rare Diseases 3 1 1 1 6
Age Related
Degenerative Diseases
1 1 0 0 2
Vaccines 3 4 4 2 13
TOTAL 22(2)
16 9 3
R&D Pipeline Summary Table(1)
38 12 NMEs & Vaccines
50
32
37(2)
(1) Excluding life cycle management programs
(2) Includes 2 Phase I projects addressing an undisclosed target
33. 33
Expected R&D Milestones in 2014
33
Product Event Timing
Dengue vaccine Expected 1st Phase III results (Asia) Q2 2014
Shan5® 5-in-1 pediatric vaccine Expected WHO pre-qualification Q2 2014
Lemtrada™ (alemtuzumab) Expected U.S. regulatory submissions in Multiple Sclerosis Q2 2014
Toujeo™ (U300) Expected U.S. and EU regulatory submissions in Diabetes Q2 2014
Alirocumab (anti-PCSK9 mAb) Expected multiple Phase III readouts in Hypercholesterolemia Jun to Q3 2014
DTP-HepB-Polio-Hib (PR5i) Expected U.S. regulatory submission Q3 2014
Dengue vaccine Expected 2nd Phase III results (Latin America) Q3 2014
Dupilumab (anti-IL4Rα mAb) Expected start of Phase III trial in Atopic Dermatitis Q3 2014
Cerdelga™ (eliglustat tartrate) Expected U.S. and EU regulatory decisions in Gaucher disease H2 2014
Lemtrada™ (alemtuzumab) Expected U.S. regulatory decision in Multiple Sclerosis H2 2014
Rotavirus vaccine Expected start of Phase III trial Q4 2014
Fluzone® QIV ID Expected U.S. regulatory decision Q4 2014
Alirocumab (anti-PCSK9 mAb) Expected EU regulatory submission in Hypercholesterolemia Q4 2014
35. 35
Business Net Income Statement
* Net of tax
** Determined on the basis of Business income before tax, associates. and non-controlling interests.
*** Based on an average number of shares outstanding of 1,319.9 million in the first quarter of 2014 and 1,322.2 million in the first quarter of 2013.
(1) Including impact of transition to IFRIC 21.
First quarter Group Total Pharmaceuticals Vaccines Animal Health Others
€ million Q1 2014 Q1 2013(1)
Change Q1 2014 Q1 2013(1)
Change Q1 2014 Q1 2013(1)
Change Q1 2014 Q1 2013(1)
Change Q1 2014 Q1 2013(1)
Net sales 7,842 8,059 (2.7%) 6,697 6,808 (1.6%) 628 697 (9.9%) 517 554 (6.7%)
Other revenues 83 98 (15.3%) 68 83 (18.1%) 7 7 - 8 8 -
Cost of sales (2,516) (2,545) (1.1%) (1,988) (2,034) (2.3%) (350) (345) 1.4% (178) (166) 7.2%
As % of net sales (32.1%) (31.6%) (29.7%) (29.9%) (55.7%) (49.5%) (34.4%) (29.9%)
Gross profit 5,409 5,612 (3.6%) 4,777 4,857 (1.6%) 285 359 (20.6%) 347 396 (12.4%)
As % of net sales 69.0% 69.6% 71.3% 71.3% 45.4% 51.5% 67.1% 71.5%
Research and
development expenses
(1,139) (1,157) (1.6%) (995) (990) 0.5% (107) (128) (16.4%) (37) (39) (5.1%)
As % of net sales (14.5%) (14.4%) (14.9%) (14.5%) (17.0%) (18.4%) (7.2%) (7.0%)
Selling and general
expenses
(2,078) (2,140) (2.9%) (1,791) (1,836) (2.5%) (129) (141) (8.5%) (158) (163) (3.1%)
As % of net sales (26.5%) (26.6%) (26.7%) (27.0%) (20.6%) (20.2%) (30.5%) (29.5%)
Other current operating
income/expenses
(25) 29 (23) 30 (2) 2 6 (1) (6) (2)
Share of profit/loss of
associates* and joint
ventures
13 18 8 19 5 (1)
Net income attributable to
non-controlling interests
(35) (41) (35) (41)
Business operating
income
2,145 2,321 (7.6%) 1,941 2,039 (4.8%) 52 91 (42.9%) 158 193 (18.1%) (6) (2)
As % of net sales 27.4% 28.8% 29.0% 30.0% 8.3% 13.1% 30.6% 34.8%
Financial income and
expenses
(76) (140)
Income tax expense (522) (583)
Tax rate** 25.0% 26.5%
Business net income 1,547 1,598 (3.2%)
As % of net sales 19.7% 19.8%
Business earnings per
share*** (in euros)
1.17 1.21 (3.3%)
36. Reconciliation of Business Net Income to Consolidated
Net Income Attributable to Equity Holders of Sanofi
€ million Q1 2014 Q1 2013
(1)
Change
Business net income 1,547 1,598 (3.2%)
Amortization of intangible assets
(2)
(677) (775)
Impairment of intangible assets (3) (10)
Fair value remeasurement of contingent
consideration liabilities
(8) (41)
Expenses arising from the impact of acquisitions on inventories - (3)
Restructuring costs (51) (54)
Other gains and losses, litigation 35
(3)
-
Tax effect of items listed above: 248 280
Amortization of intangible assets 244 259
Impairment of intangible assets 1 -
Fair value remeasurement of contingent consideration liabilities 1 4
Expenses arising from the impact of acquisitions on inventories - 1
Restructuring costs 15 16
Other gains and losses, and litigations (13) -
Share of items listed above attributable to non-controlling interests
1 1
Restructuring costs of associates and joint ventures, and expenses arising
from the impact of acquisitions on associates and joint ventures
(8) (7)
Net income attributable to equity holders of Sanofi 1,084 989
Consolidated earnings per share
(4)
(in euros) 0.82 0.75 9.3%
(1) Including impact of transition to IFRIC 21.
(2) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations:
€657 million in the first quarter of 2014 and €749 million in the first quarter of 2013.
(3) Day one profit on Alnylam shares in Financial result.
(4) Based on an average number of shares outstanding of 1,319.9 million in the first quarter of 2014 and 1,322.2 million in the first quarter of 2013. 36
37. Consolidated Income Statement
37
37
(1) Including impact of transition to IFRIC 21.
€ million Q1 2014 Q1 2013(1)
Net sales 7,842 8,059
Other revenues 83 98
Cost of sales (2,516) (2,548)
Gross profit 5,409 5,609
Research and development expenses (1,139) (1,157)
Selling and general expenses (2,078) (2,140)
Other operating income 10 71
Other operating expenses (35) (42)
Amortization of intangible assets (677) (775)
Impairment of intangible assets (3) (10)
Fair value remeasurement of contingent consideration liabilities (8) (41)
Restructuring costs (51) (54)
Other gains and losses, and litigation - -
Operating income 1,428 1,461
Financial expense (147) (157)
Financial income 106 17
Income before tax and associates and joint ventures 1,387 1,321
Income tax expense (274) (303)
Share of profit/loss of associates and joint ventures 5 11
Net income 1,118 1,029
Net income attributable to non-controlling interests 34 40
Net income attributable to equity holders of Sanofi 1,084 989
Average number of shares outstanding (million) 1,319.9 1,322.2
Earnings per share (in euros) 0.82 0.75
38. Business EPS Currency Sensitivity
Currency Exposure on Q1 2014 Sales Currency Average Rates
2014 Currency Sensitivity
38
● 1% variation in €/$ corresponds to an impact of 0.5% on 2014 Business EPS
● 1% variation in €/Yen corresponds to an impact of 0.1% on 2014 Business EPS
Q1’13 Q1’14 % change
€/$ 1.32 1.37 3.7%
€/Yen 121.91 140.76 15.5%
€/Real 2.63 3.24 23.0%
€/Ruble 40.15 48.08 19.7%