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. ● Net sales up +6.4% at CER and Business EPS up +13.4% at CER
● Free Cash Flow up +33% in H1 2014
● €3.7bn dividend payment and €1.1bn share buyback
● 76.3% of Group sales
● Solid execution in Emerging Markets
● Merial back to growth
● 3 significant regulatory reviews ongoing
● 4 major projects with Phase IIb/III readouts
● 2 new important collaborations
Sanofi Delivered Solid Results in Q2 2014
5
3
2
1
Solid financial
performance
Strong
performance
of Growth
Platforms
Significant
progress
in late stage
pipeline
FCF: Free Cash Flow
(1) Excluding Generics in Brazil, Q2 2014 sales were up +3.9% at CER
(2) Dividend payment of €3,676m on full-year 2013 results made in Q2 2014
(3) As of July 15th 2014, Sanofi bought back shares for €1,100m in YTD 2014
(1)
(3)(2)
6. Q2 2014
-€0.10
FX ImpactIncremental
EPS at CER
Q2 2013
+€0.15
Net Sales(1)
Business EPS(1)
Solid Q2 2014 Financial Performance Reflects
Consistent Execution of our Growth Strategy
6
(1) On a reported basis, Q2 2014 sales were up +0.9% and Business EPS was up +4.5%
(2) With retroactive application of IFRIC21
+13.4%
at CER(1)
Incremental
Sales at CER
Q2 2014Q2 2013 FX Impact
+€515m -€443m
+6.4%
at CER(1)
€8,003m €8,075m
€1.12
€1.17
(2)
1
(2)
7. 2014 Business EPS Guidance Adjusted Slightly Upwards
7
(1) FY 2013 Business EPS of €5.05 with retroactive application of IFRIC21
7
Given our financial performance in H1 2014 and
despite increasing U.S. competitive pressure at the payor level,
2014 business EPS is expected to be
between 6% to 8% higher than 2013 at CER(1)
,
barring major unforeseen adverse events
1
FY 2014 Guidance
8. Evolution of Share Buyback(1,2)
8
SBB: Share Buyback
(1) As of July 15th 2014, YTD 2014 share buyback of €1,100m and YTD 2014 proceeds from share issuance of €252m
(2) Number of shares outstanding in million on Dec 31st 2012, Dec 31st 2013 and June 30th 2014
€646m
€1,100m
€252m
€823m
€1,641m
€1,004m
2012
Sanofi Increased Buyback Activity in H1 2014
2013 YTD 2014
€177m
Net SBB
€637m
Net SBB
€848m
Net SBB
Share count (m) 1,323.2 1,320.7 1,312.1
1
Issuance Issuance IssuanceBuyback Buyback Buyback
9. Quarterly Sales Growth from Growth Platforms(1)
+6.2%
Q1 2013
+8.6%
Q4 2012
+11.5%
Q3 2012
+6.4%
Q2 2012
+7.6%
Q1 2012
+5.7%
Q4 2013
+10.0%
Q3 2013Q2 2013
+5.5%
+7.9%
Q1 2014 Q2 2014
+10.7%
(1) Growth at CER. Q1 2012 growth restated for Genzyme Q1 2011 (€396m)
(2) Growth at CER including Generics in Brazil was +2.5% in Q2 2013 and +14.5% in Q2 2014 9
Growth Platforms Show Consistent Strong Performance
Demonstrating the Value of our Business Model
(2)
(2)
+5%
at CER
+10%
at CER
2
% of Group sales 63.2% 76.3%
10. +9.2%Consumer Healthcare(3)
€816m
Vaccines -4.2%€718m
Genzyme(4)
Growth Platforms Grew +14.5%(1)
in Q2 2014
Reaching 76.3% of Sales
10
(1) Excluding Generics in Brazil, Growth Platforms grew +10.7% in Q2 2014 and +9.0% in H1 2014 at CER
(2) Excluding Generics in Brazil, Emerging Markets grew +8.6% in Q2 2014 and +6.5% in H1 2014 at CER
(3) Some products recorded in prescription pharmaceuticals in 2013 were transferred as Consumer Healthcare products and totaled €73m in Q2 2013
Including this category change, sales of Consumer Healthcare grew +20.2% in Q2 2014 and +19.4% in H1 2014 at CER
(4) Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises
(5) Includes products launched since 2009 which do not belong to the Growth Platforms listed above: Multaq®, Jevtana®, Auvi-Q™, Mozobil® and Zaltrap®
+16.2%
-0.4%
+29.1%
+6.2%
Other Innovative Products(5)
€189m +13.3%
+16.5%
Diabetes Solutions €1,788m
Animal Health
€643m
Emerging Markets(2)
€2,855m
€537m
Q2 2014
Growth at CER
2
-4.2%
H1 2014
Growth at CER
+9.3%
+14.7%
-2.2%
+25.4%
+2.2%
+17.8%
+11.0%
11. H1 2014 Geographic Sales Mix
(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) Pharmaceuticals sales growth at CER was +2.2% in Africa & Middle East, +4.3% in Eastern Europe, Russia & Turkey, +10.6% in Asia and
+18.2% in Latin America excluding Generics in Brazil in H1 2014
Solid Sales Performance in Emerging Markets in H1 2014
as Operational Issues from 2013 Have Been Addressed
Emerging
Markets
€5,445m
U.S.
€4,984m
Western EU
€3,906m
RoW
€1,582m
34.2%
31.3%
24.5%
10.0%
11
(1)
€1,006m
€1,239m
€1,519m
€1,618m
Africa & Middle
East
Eastern Europe,
Russia & Turkey
Asia Latin America
+8.5%
+4.7% +5.4% +14.6%Growth at CER
-1.5%
-7.4%
-0.7%
+11.0%
2
Emerging Markets Total Sales by Region
excluding Brazil Generics
(2)
12. Merial Returned to Growth in Q2 2014
12
● Successful launch of NexGard®
● First soft, beef-flavored chew treating
fleas and ticks for dogs in the U.S.
● €58m sales in H1 2014
● Frontline® family sales stabilized
in Q2 2014
● Start of flea and tick season not
disrupted by weather conditions
except in Northern U.S.
● Effective investment in ad campaign
reinforcing strong Frontline® brand
2
Q2Q1 Q4Q3
-3.1%
-5.7%
-6.3%
2013
Merial Sales Growth at CER
-6.4%
-1.6%
+6.2%
Q2Q1
2014
13. ● Filed in the U.S. and EU
in Q2 2014 and recently
in Japan
● Regulatory decisions for
marketing authorization
in the U.S. and EU
anticipated in H1 2015
Three New Medicines Under Regulatory Review
with the Potential to Meaningfully Improve Patient Lives
13
● U.S. and EU regulatory
reviews ongoing
● Regulatory decisions
expected in Q3 and Q4
2014, respectively
● NDA submitted in Japan
in June, 2014
● sBLA resubmission
accepted for review
by FDA in May 2014
● FDA action expected
in Q4 2014
● New dedicated salesforce
being recruited
3
Three major new drug approvals expected over the next 12 months
14. 14
● Primary efficacy endpoint met in all 9 trials(1)
● LDL reduction consistent with previous trials
● Generally well tolerated in the 9 ODYSSEY trials
(2)
● Lower rate of adjudicated major CV events(3, 4)
observed in a post-hoc analysis of ODYSSEY
LONG TERM (p-value <0.05)
● Potential to demonstrate CV benefit being
prospectively assessed in an 18,000-patient
ODYSSEY OUTCOMES trial
● U.S. and EU regulatory submissions expected
by end of 2014
Alirocumab is developed in collaboration with Regeneron
(1) The nine trials included ODYSSEY LONG TERM, FH I, FH II, HIGH FH, COMBO I, COMBO II, OPTIONS I, OPTIONS II and ALTERNATIVE
(2) The most common adverse events were nasopharyngitis and upper respiratory tract infections, which were generally balanced between treatment
groups. Injection site reactions occurred more often in the alirocumab group compared to placebo. Serious adverse events and deaths were generally
balanced between treatment groups as were other key adverse events including musculoskeletal, neurocognitive and liver-related events.
(3) Major CV events included cardiac death, myocardial infarction, stroke, and unstable angina requiring hospitalization
(4) Based on a pre-specified interim safety analysis performed when all patients reached one year and approximately 25% of patients reached 18 months
of treatment in the ongoing ODYSSEY LONG TERM trial with 2,341 patients at high or very high cardiovascular (CV) risk
Positive Top-Line Results across 9 Phase III Trials
of Alirocumab in People with Hypercholesterolemia
3
15. 15
Sarilumab and dupilumab are developed in collaboration with Regeneron
NEJM: New England Journal of Medicine
(1) The measured efficacy of the vaccine is consistent across countries and appears to vary by dengue serotype (between 34.7% and 72.4%) and by age
(2) Mean % change in EASI score from baseline to Week 16 / Clearing or near-clearing of skin lesions, measured by an investigator's global assessment
(IGA) score of 0 or 1 / Mean reduction in itching measured by the pruritus numerical-rating scale (NRS) score
(3) Improvement in signs and symptoms of RA / Improvement in physical function / Inhibition of progression of structural damage
Strong Late Stage Pipeline of Biologics Demonstrates
the Shift of our Portfolio towards Innovative Products
3
● First Phase III published in
The Lancet
● 56.5% reduction in
symptomatic dengue(1)
● 88.5% reduction of
haemorrhagic fever
● 67.2% reduction in
hospitalization
DengueVaccine
● Detailed data from positive
Phase III MOBILITY trial
presented at EULAR
● Statistically significant
improvements
in all three co-primary
endpoints(3)
Sarilumab
Rheumatoid Arthritis
● Strong Phase IIa data
published in the NEJM
● Positive Phase IIb top-line
results
● Statistically significant and
dose-dependent
improvements in all key
efficacy measures(2)
Atopic Dermatitis
16. Two New Collaborations Signed in Q2 2014
Strengthening our CHC and Diabetes Growth Platforms
16
● Licensing agreement with Lilly
● Opportunity to switch Cialis® from Rx to OTC in the U.S., Europe,
Canada and Australia(1)
● Ambition to transform how this important medicine for erectile
dysfunction (ED) is offered to millions of men in the world
● Global strategic alliance(2)
in diabetes structured as open-innovation model
● Initial focus on novel drug-device combinations and care management
● Objective to improve adherence, simplify insulin treatment and help patients
better manage their condition
3
(1) Subject to Sanofi's receipt of all necessary regulatory approvals
(2) Implementation of the alliance is subject to the negotiation and execution of a definitive agreement between the companies
17. Strong Innovation Momentum Expected to Be Maintained
in H2 2014
17
2014
Expected Regulatory Decisions Q3 Q4
● Cerdelga™ (eliglustat) in Gaucher disease (U.S.)
● Lemtrada™ (alemtuzumab) in Multiple Sclerosis (U.S.)
● Cerdelga™ (eliglustat) in Gaucher disease (EU)
● Fluzone® QIV Intradermal (U.S.)
Expected Regulatory Submissions Q3 Q4
● PR5i 6-in-1 pediatric vaccine (U.S.)
● Alirocumab in Hypercholesterolemia (U.S. & EU)
Expected Headline Phase III Data Releases Q3 Q4
● Alirocumab in Hypercholesterolemia (9 ODYSSEY trials)
● Dengue vaccine 2nd Phase III trial in Latin America
Expected Phase III Starts Q3 Q4
● Dupilumab in Atopic Dermatitis
● Rotavirus vaccine
● Insulin lispro in Diabetes
3
18. Sanofi to Organize an IR Thematic Seminar
on New Medicines and Vaccines
18
3
● Discussing the market opportunity for key pipeline projects
● Emphasizing the shift of our portfolio to biologics
● Presenting further progress of our innovative R&D assets
IR Thematic
Seminar
on New
Medicines
Thursday November 20th, 2014 in Genzyme HQ - Cambridge, MA
20. Net Sales(1)
Business EPS
20
FX Impact in Q2 2014 Was Comparable to Q1 2014
and In Line with our Expectations
(1) Main currency impact on sales in Q2 2014: U.S. Dollar (-€129m); Brazilian Real (-€48m); Japanese Yen (-€39m); Russian Ruble (-€33m);
Argentine Peso (-€32m); Turkish Lira (-€23m), Canadian Dollar (-€15m) and Australian Dollar (-€14m)
(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
Assuming June exchange rates remain stable in H2 2014,
negative FX impact on full-year Business EPS would be ~5%(2)
Q2
-5.5%
-€443m
2013
Q4Q3Q2Q1
2014
Q1 Q2
-8.9%
-€0.10
21. (1) With the retroactive application of IAS19R
(2) Includes a payment of €62m before tax resulting from the return of U.S. rights for Eligard® to TOLMAR Pharmaceuticals
(3) Includes a payment of €165m before tax associated to the sale of U.S. tail products to Covis Pharmaceuticals 21
BOI Increased Faster than Sales in Q2 2014
€m Q2 2014 Q2 2013 % Change
(reported €)
% Change
(CER)
Net sales 8,075 8,003 +0.9% +6.4%
Other revenues 71 83 -14.5% -12.0%
Cost of sales (2,608) (2,670) -2.3% +2.2%
Gross profit 5,538 5,416 +2.3% +8.2%
R&D (1,188) (1,185) +0.3% +3.2%
SG&A (2,255) (2,306) -2.2% +2.6%
Other current operating income & expenses 54 141 - -
Share of Profit/Loss of associates 26 3 - -
Minority interests (30) (45) - -
Business operating income 2,145 2,024 +6.0% +15.0%
Business operating margin 26.6% 25.3% - -
CER: Constant Exchange Rates
(1)
(2) (3)
22. Improvement in Gross Margin in Q2 2014 vs. Q2 2013
● Cost of Sales (CoS) in Q2 2014:
€2,608m, up +2.2% at CER
● CoS ratio down 1 percentage point
in Q2 2014 vs. Q2 2013
● Reflecting recovery of Generics
in Brazil and higher margin from
Genzyme
● Slight negative mix impact from
Vaccines and Animal Health
● Unfavorable currency variations
22
Gross Margin (%)
Q1 Q2 Q3 Q4 Q1 Q2
2013 2014
69.0%69.6% 67.7% 67.0% 66.8% 68.6%
23. Q1 Q2 Q3 Q4 Q1 Q2
R&D Expenses Slightly Increased in Q2 2014
Despite Significant Investment in Phase III Trials
23
● Q2 2014 R&D expenses of
€1,188m, up +3.2% at CER
● Slight increase in R&D spend in line
with guidance
● Higher spend in three large
development programs for mAbs
(alirocumab, sarilumab, dupilumab)
● More than offsetting internal costs
savings
23
R&D Expenses (€m)
€1,188m€1,185m
(1) With retroactive application of IFRIC21
(1)
2013 2014
24. Lower SG&A to Sales Ratio in Q2 2014 vs. Q2 2013
24
● Q2 2014 SG&A expenses of
€2,255m, up +2.6% at CER
● Lower increase in SG&A than Sales
● Modest SG&A increase driven
by investment in product launches
● NexGard™, Nasacort® OTC and
Genzyme MS franchise
24
SG&A Expenses (€m)
Q1 Q2 Q3 Q4 Q1 Q2
€2,255m€2,306m
(1)
(1) With retroactive application of IFRIC21
2013 2014
25. CER: Constant Exchange Rates
25
€m Q2 2014 Q2 2013 % Change
(reported €)
% Change
(CER)
Business operating income 2,145 2,024 +6.0% +15.0%
Net financial expenses (94) (137) - -
Income tax expense (514) (408) - -
Effective tax rate -25.0% -21.2% - -
Business net income 1,537 1,479 +3.9% +13.0%
Net margin 19.0% 18.5% - -
Business EPS €1.17 €1.12 +4.5% +13.4%
Average number of shares outstanding (m) 1,314.5 1,325.7 - -
Strong Business EPS Growth of +10% in H1 2014
25
(1) With the retroactive application of IFRIC21
(2) Included a capital gain of €31m before tax resulting from the sale of several financial investments
(1)
(2)
27. Net Debt (in €m)
Dividend
€487m
Other Net Debt
Jun 30, 2014
€3,676m
Acquisitions,
Licensing, Net
of Disposals
€1,608m
Share
Repurchase
€1,010m
Proceeds
from Issuance
of Shares
€240m
CapEx
€529m
Net Cash from
Operating
Activities
Net Debt
Dec 31, 2013
Free Cash Flow (FCF) Increased by 33% in H1 2014
27
(1)
(2)
€6,043m
€10,194m
€2,919m
(4) (1)
FCF
€2,390m
FCF: Free Cash Flow
(1) Including derivatives related to the financial debt +€290m at December 31st 2013 and +€296m at June 30th 2014
(2) Excluding Restructuring costs
(3) Including €1,050m in Regeneron and €530m in Alnylam
(4) Other including Restructuring costs
(3)
29. Solid H1 Performance Reflects Consistent Execution
of our Growth Strategy
Over 75% of sales now being generated by Growth Platforms
Business EPS guidance for 2014 adjusted slightly upwards
Late stage pipeline moving to launch execution
Expected new medicine launches to further redefine Sanofi
as a biopharmaceutical leader
29
31. 31
Late Stage Pipeline – Pharma & Vaccines
LixiLan
lixisenatide + insulin glargine
Fixed-Ratio / Type 2 diabetes
alirocumab
Anti-PCSK-9 mAb
Hypercholesterolemia
Toujeo® (U300)
Insulin glargine
Type 1+2 diabetes, U.S., EU
Lyxumia® (lixisenatide)
GLP-1 agonist
Type 2 diabetes, U.S.
Kynamro® (mipomersen)
Apolipoprotein B-100 antisense
Severe HeFH, U.S.
Lemtrada™ (alemtuzumab)
Anti-CD52 mAb
Multiple sclerosis, U.S.
sarilumab
Anti-IL-6R mAb
Rheumatoid arthritis
Dengue
Mild-to-severe
dengue fever vaccine
Cerdelga™ (eliglustat tartrate)
Glucosylceramide synthetase inhibitor
Gaucher disease, U.S., EU
patisiran SAR438037
mRNA inhibitor
Familial amyloid polyneuropathy
Clostridium difficile
Toxoid vaccine
Quadracel®
Diphtheria, tetanus, pertussis
& polio vaccine; 4-6 y of age
Jevtana® (cabazitaxel)
Metastatic prostate cancer (1L)
PR5i
DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine
Fluzone® QIV ID
Quadrivalent inactivated
influenza vaccine intradermal
SYNVISC-ONE®
Medical device
Pain in hip OA
VaxiGrip® QIV IM
Quadrivalent inactivated
influenza vaccine
N
31
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
32. Early Stage Pipeline – Pharma & Vaccines
dupilumab
Anti-IL4Rα mAb
Atopic dermatitis; Asthma; Nasal polyposis
SAR391786
GDF8 mAb
Sarcopenia
Rotavirus
Live attenuated tetravalent
Rotavirus oral vaccine
SAR339658
Anti-VLA 2 mAb
Multiple sclerosis
SAR650984
Anti-CD38 naked mAb
Multiple myeloma
Rabies VRVg
Purified vero rabies vaccine
SAR156597
IL4/IL13 Bi-specific mAb
Idiopathic pulmonary fibrosis
SAR3419
Maytansin-loaded anti-CD19 mAb
B-cell refractory/relapsed malignancies
Meningitis ACYW conj.
2nd generation meningococcal
conjugate infant vaccine
SAR438714 (ALN-TTRsc)
RNAi
Familial amyloid cardiomyopathy
Combination
SAR245409 (XL765) / MSC1936369B
Oral dual inhibitor of PI3K & mTOR / pimasertib
Ovarian cancer
Tuberculosis
Recombinant subunit vaccine
sarilumab
Anti-IL-6R mAb
Uveitis
Combination
ferroquine / OZ439
Antimalarial
Malaria
fresolimumab
TGFβ antagonist
Focal segmental glomerulosclerosis
SAR279356 (F598)
Anti-PNAG mAb
Serious infections
Phase II
N
N
N
N
NN
32
N
32
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
33. Early Stage Pipeline – Pharma & Vaccines
SAR405838 (MI-773)
HDM2 / p53 antagonist
Solid tumors
SAR113244
Anti-CXCR5 mAb
Systemic lupus erythematosus
GZ402663 (sFLT-01)
Gene therapy
Age-related macular degeneration (AMD)
Streptococcus pneumonia
Meningitis & pneumonia vaccine
SAR566658
Maytansin-loaded anti-CA6 mAb
Solid tumors
SAR252067
Anti-LIGHT mAb
Crohn’s disease
StarGen®
Gene therapy
Stargardt disease
Herpes Simplex Virus Type 2
HSV-2 vaccine
SAR125844
C-MET kinase inhibitor
Solid tumors
SAR228810
Anti-protofibrillar AB mAb
Alzheimer’s disease
UshStat®
Gene therapy
Usher syndrome 1B
SAR260301
PI3K β selective inhibitor
PTEN – Deficient tumors
SAR425899
GLP-1 / GCGR agonist
Diabetes
GZ402665
(rhASM)
Niemann-Pick type B
SAR307746
Anti-ANG2 mAb
Solid tumors
SAR342434
Insulin Lispro
Diabetes
GZ402671
Oral GCS Inhibitor
Fabry Disease
SAR245408 (XL147)
Oral PI3K inhibitor
Solid tumors
SAR438584
Undisclosed target
GZ402666
neo GAA
Pompe Disease
Combination
SAR405838 / MSC1936369B
Solid tumors
Phase I
N
N
N
N
N
N
N
N
N N
N N
3333
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
N
N
34. 34
Phase I Phase II Phase III Registration TOTAL
Oncology 6 3 0 0 9
Diabetes Solutions 1 0 1 1 3
Cardiovascular / Renal
Diseases
0 1 1 0 2
Immune Mediated
Diseases
2 3 1 0 6
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 2 4 4 2 12
TOTAL 19(2)
15 8 4
R&D Pipeline Summary Table(1)
34 12 NMEs & Vaccines
46
34
34(2)
(1) Excluding life cycle management programs
(2) Includes 1 Phase I project addressing an undisclosed target
35. 35
Expected R&D Milestones in H2 2014 / H1 2015
35
Product Event Timing
Cerdelga™ (eliglustat tartrate) Expected U.S. regulatory decision in Gaucher disease Q3 2014
Dengue vaccine Expected 2nd Phase III results (Latin America) Q3 2014
PR5i (DTP-HepB-Polio-Hib) Expected U.S. regulatory submission Q3 2014
Dupilumab (anti-IL4Rα mAb) Expected start of Phase III trial in Atopic Dermatitis H2 2014
New Insulin Lispro (SAR342434) Expected start of Phase III trial in Diabetes H2 2014
Lemtrada™ (alemtuzumab) Expected U.S. regulatory decision in Multiple Sclerosis Q4 2014
Cerdelga™ (eliglustat tartrate) Expected EU regulatory decision in Gaucher disease Q4 2014
Alirocumab (anti-PCSK9 mAb) Expected U.S. and EU regulatory submissions in Hypercholesterolemia Q4 2014
Fluzone® QIV ID Expected U.S. regulatory decision Q4 2014
Rotavirus vaccine Expected start of Phase III trial Q4 2014
Fluzone® High Dose Expected U.S. label upgrade Q4 2014
Dengue vaccine Expected regulatory submission in priority countries Q1 2015
Dupilumab (anti-IL4Rα mAb) Expected Phase IIb top-line results in Asthma Q1 2015
Lyxumia® (lixisenatide) Expected ELIXA CV outcome trial top-line results H1 2015
Toujeo® (U300) Expected U.S. and EU regulatory decisions in Diabetes H1 2015
37. 37
Business Net Income Statement
Second quarter 2014
Net sales 8,075 8,003 0.9% 6,820 6,714 1.6% 718 760 (5.5%) 537 529 1.5%
Other revenues 71 83 (14.5%) 58 72 (19.4%) 7 5 40.0% 6 6 - - -
Cost of sales (2,608) (2,670) (2.3%) (2,058) (2,140) (3.8%) (350) (350) - (200) (180) 11.1% - -
As % of net sales (32.3%) (33.4%) (30.2%) (31.9%) (48.8%) (46.1%) (37,2%) (34.0%)
Gross profit 5,538 5,416 2.3% 4,820 4,646 3.7% 375 415 (9.6%) 343 355 (3.4%)
As % of net sales 68.6% 67.7% 70.7% 69.2% 52.2% 54.6% 63.9% 67.1%
Research and development
expenses
(1,188) (1,185) 0.3% (1,030) (1,018) 1.2% (123) (121) 1.7% (35) (46) (23.9%) - -
As % of net sales (14.7%) (14.8%) (15.1%) (15.2%) (17.1%) (15.9%) (6.5%) (8.7%)
Selling and general
expenses
(2,255) (2,306) (2.2%) (1,930) (1,965) (1.8%) (142) (160) (11.3%) (183) (181) 1.1% - -
As % of net sales (27.9%) (28.8%) (28.3%) (29.3%) (19.8%) (21.1%) (34.1%) (34.2%)
Other current operating
income/expenses
54 141 42 100 3 5 11 - (2) 36
Share of profit/loss of
associates* 26 3 25 8 1 (3) - (2) - -
Net income attributable to
non-controlling interests
(30) (45) (30) (45) - - - - - -
Business operating
income
2,145 2,024 6.0% 1,897 1,726 9.9% 114 136 (16.2%) 136 126 7.9% (2) 36
As % of net sales 26.6% 25.3% 27.8% 25.7% 15.9% 17.9% 25.3% 23.8%
Financial income and
expenses
(94) (137)
Income tax expense (514) (408)
Tax rate** 25.0% 21.2%
Business net income 1,537 1,479 3.9%
As % of net sales 19.0% 18.5%
Business earnings per
share***
(in euros)
1.17 1.12 4.5%
(1)
Including impact of transition to IFRIC 21.
* 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 1,314.5 million in the second quarter of 2014 and 1,325.7 million in the second quarter of 2013.
Q2 2013 (1)
€ million Q2 2014 Q2 2013 (1)
change Q2 2014 change Q2 2014 Q2 2013 (1)
change Q2 2014 Q2 2013 (1)
change Q2 2014 Q2 2013 (1)
OtherGroup Total Pharmaceuticals Vaccines Animal health
* 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 1,314.5 million in the second quarter of 2014 and 1,325.7 million in the second quarter of 2013
(1) Including impact of transition to IFRIC 21
38. Business Net Income Statement
38
First-half 2014
Net sales 15,917 16,062 (0.9%) 13,517 13,522 - 1,346 1,457 (7.6%) 1,054 1,083 (2.7%)
Other revenues 154 181 (14.9%) 126 155 (18.7%) 14 12 16.7% 14 14 -
Cost of sales (5,124) (5,215) (1.7%) (4,046) (4,174) (3.1%) (700) (695) 0.7% (378) (346) 9.2%
As % of net sales (32.2%) (32.5%) (29.9%) (30.9%) (52.0%) (47.7%) (35.8%) (32.0%)
Gross profit 10,947 11,028 (0.7%) 9,597 9,503 1.0% 660 774 (14.7%) 690 751 (8.1%)
As % of net sales 68.8% 68.7% 71.0% 70.3% 49.0% 53.1% 65.5% 69.3%
Research and development
expenses
(2,327) (2,342) (0.6%) (2,025) (2,008) 0.8% (230) (249) (7.6%) (72) (85) (15.3%)
As % of net sales (14.6%) (14.6%) (15.0%) (14.8%) (17.1%) (17.1%) (6.8%) (7.8%)
Selling and general
expenses
(4,333) (4,446) (2.5%) (3,721) (3,801) (2.1%) (271) (301) (10.0%) (341) (344) (0.9%)
As % of net sales (27.2%) (27.7%) (27.5%) (28.1%) (20.1%) (20.7%) (32.4%) (31.8%)
Other current operating
income/expenses
29 170 19 130 1 7 17 (1) (8) 34
Share of profit/loss of
associates* 39 21 33 27 6 (4) - (2)
Net income attributable to
non-controlling interests
(65) (86) (65) (86)
Business operating
income
4,290 4,345 (1.3%) 3,838 3,765 1.9% 166 227 (26.9%) 294 319 (7.8%) (8) 34
As % of net sales 27.0% 27.1% 28.4% 27.8% 12.3% 15.6% 27.9% 29.5%
Financial income and
expenses
(170) (277)
Income tax expense (1,036) (991)
Tax rate** 25.0% 24.0%
Business net income 3,084 3,077 0.2%
As % of net sales 19.4% 19.2%
Business earnings per
share***
(in euros)
2.34 2.32 0.9%
(1)
Including impact of transition to IFRIC 21.
* 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 1,317.2 million in the first semester of 2014 and 1,323.9 million in the first semester of 2013.
6M 2013 (1)
6M 2014 6M 2013 (1)
Other
6M 2013 (1)
change 6M 2014 6M 2013 (1)
6M 2014change change
Group Total Pharmaceuticals Vaccines Animal health
€ million 6M 2014 6M 2013 (1)
change 6M 2014
* 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 1,317.2 million in the first semester of 2014 and 1,323.9 million in the semester of 2013
(1) Including impact of transition to IFRIC 21
39. 3939
Reconciliation of Business Net Income to Consolidated
Net Income Attributable to Equity Holders of Sanofi
(1) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €601 million
in the second quarter of 2014 and €740 million in the second quarter of 2013
(2) Tax on dividends paid to shareholders of Sanofi
(3) Based on an average number of shares outstanding of 1,314.5 million in the second quarter of 2014 and 1,325.7 in the second quarter of 2013
(4) Impact of transition to IFRIC 21
€ million Q2 2014 Q2 2013
(4)
Change
Business net income 1,537 1,479 3.9%
Amortization of intangible assets
(1)
(624) (768)
Impairment of intangible assets (71) (430)
Fair value remeasurement of contingent consideration liabilities (124) (76)
Expenses arising from the impact of acquisitions on inventories - (3)
Restructuring costs (84) (105)
Tax effect of items listed above: 274 469
Amortization of intangible assets 207 231
Impairment of intangible assets 25 180
Fair value remeasurement of contingent consideration liabilities 13 16
Expenses arising from the impact of acquisitions on inventories - 1
Other gains and losses, and litigation - -
Restructuring costs 29 41
Other tax items
(2)
(110) (109)
Share of items listed above attributable to non-controlling interests
3 1
Restructuring costs of associates and joint ventures, and expenses arising
from the impact of acquisitions on associates and joint ventures
(24) (10)
Net income attributable to equity holders of Sanofi 777 448 73.4%
Consolidated earnings per share
(3)
(in euros) 0.59 0.34
40. 4040
Reconciliation of Business Net Income to Consolidated
Net Income Attributable to Equity Holders of Sanofi
(1) Of which related to amortization expense generated by the remeasurement of intangible assets as part of business combinations: €1,258 million in
the first semester of 2014 and €1,489 million in the first semester of 2013
(2) Tax on dividends paid to shareholders of Sanofi
(3) Based on an average number of shares outstanding of 1,317.2 million in the first semester of 2014 and 1,323.9 million in the first semester of 2013
(4) Impact of transition to IFRIC 21
€ million H1 2014 H1 2013
(4)
Change
Business net income 3,084 3,077 0.2%
Amortization of intangible assets
(1)
(1,301) (1,543)
Impairment of intangible assets (74) (440)
Fair value remeasurement of contingent consideration liabilities (132) (117)
Expenses arising from the impact of acquisitions on inventories - (6)
Restructuring costs (135) (159)
Other gains and losses, and litigation 35 -
Tax effect of items listed above: 522 749
Amortization of intangible assets 451 490
Impairment of intangible assets 26 180
Fair value remeasurement of contingent consideration liabilities 14 20
Expenses arising from the impact of acquisitions on inventories - 2
Other gains and losses, and litigation (13) -
Restructuring costs 44 57
Other tax items
(2) (110) (109)
Share of items listed above attributable to non-controlling interests
4 2
Restructuring costs of associates and joint ventures. and expenses arising
from the impact of acquisitions on associates and joint ventures
(32) (17)
Net income attributable to equity holders of Sanofi 1,861 1,437 29.5%
Consolidated earnings per share
(3)
(in euros) 1.41 1.09
41. 4141
Consolidated Income Statements
(1) Including impact of transition to IFRIC 21
(2) In 2014, including a tax on dividends paid to shareholders of Sanofi: (110) M€ compared to (109) M€ in 2013
€ million Q2 2014 Q2 2013
(1)
H1 2014 H1 2013
(1)
Net sales 8,075 8,003 15,917 16,062
Other revenues 71 83 154 181
Cost of sales (2,608) (2,673) (5,124) (5,221)
Gross profit 5,538 5,413 10,947 11,022
Research and development expenses (1,188) (1,185) (2,327) (2,342)
Selling and general expenses (2,255) (2,306) (4,333) (4,446)
Other operating income 106 276 116 347
Other operating expenses (52) (135) (87) (177)
Amortization of intangible assets (624) (768) (1,301) (1,543)
Impairment of intangible assets (71) (430) (74) (440)
Fair value remeasurement of contingent consideration liabilities (124) (76) (132) (117)
Restructuring costs (84) (105) (135) (159)
Operating income 1,246 684 2,674 2,145
Financial expense (145) (154) (292) (311)
Financial income 51 17 157 34
Income before tax and associates and joint ventures 1,152 547 2,539 1,868
Income tax expense
(2)
(350) (48) (624) (351)
Share of profit/loss of associates and joint ventures 2 (7) 7 4
Net income 804 492 1,922 1,521
Net income attributable to non-controlling interests 27 44 61 84
Net income attributable to equity holders of Sanofi 777 448 1,861 1,437
Average number of shares outstanding (million) 1,314.5 1,325.7 1,317.2 1,323.9
Earnings per share (in euros) 0.59 0.34 1.41 1.09
42. 4242
Cash Flow Statements
(1) Including impact of transition to IFRIC 21
(2) Excluding restructuring costs
€ million H1 2014 H1 2013
(1)
Business net income 3,084 3,077
Depreciation amortization and impairment of property. plant and equipment and software 582 594
Net gains and losses on disposals of non-current assets, net of tax (97) (154)
Other non-cash items (98) (277)
Operating cash flow before changes in working capital
(2)
3,471 3,240
Changes in working capital
(2)
(552) (859)
Acquisitions of property, plant and equipment and software (529) (586)
Free cash flow
(2)
2,390 1,795
Acquisitions of intangibles, excluding software (108) (142)
Acquisitions of investments, including assumed debt
(2)
(1,679) (273)
Restructuring costs paid (382) (325)
Proceeds from disposals of property, plant and equipment, intangibles, and other non-current assets.
net of tax
179 266
Issuance of Sanofi shares 240 741
Dividends paid to shareholders of Sanofi (3,676) (3,638)
Acquisition of treasury shares (1,010) (890)
Disposals of treasury shares, net of tax - 2
Transactions with non-controlling interests including dividends (6) (10)
Foreign exchange impact (37) 17
Other items (62) 4
Change in net debt (4,151) (2,453)
43. 4343
Balance Sheets
(1) Including impact of transition to IFRIC 21
ASSETS
€ million
06/30/14 12/31/13
(1) LIABILITIES
€ million
06/30/14 12/31/13
(1)
Property, plant and equipment 10,090 10,182
Equity attributable to equity-holders of
sanofi
51,637 56,904
Intangible assets (including goodwill) 51,675 52,529
Equity attributable to non-controlling
interests
130 129
Non-current financial assets, investments
in associates, and deferred tax assets
8,568 9,418 Total equity 51,767 57,033
Long-term debt 10,113 10,414
Non-current liabilities related to business
combinations and to non-controlling
interests
974 884
Non-current assets 70,333 72,129
Provisions and other non-current
liabilities
9,066 8,735
Deferred tax liabilities 4,600 5,060
Inventories, accounts receivable and other
current assets
16,063 15,655 Non-current liabilities 24,753 25,093
Cash and cash equivalents 4,306 8,257
Accounts payable and other current
liabilities
9,408 9,728
Current liabilities related to business
combinations and to non-controlling
interests
109 24
Short-term debt and current portion of
long-term debt
4,683 4,176
Current assets 20,369 23,912 Current liabilities 14,200 13,928
Assets held for sale or exchange 18 14
Liabilities related to assets held for sale
or exchange
- 1
Total ASSETS 90,720 96,055 Total LIABILITIES & EQUITY 90,720 96,055
44. Business EPS Currency Sensitivity
€
25.0%
US $
32.6%
Japanese Yen
5.6%
£
2.2%
Australian $
1.5%
Canadian $
1.5%
Brazilian Real
4.5%
Chinese Yuan
4.3%
Russian
Ruble
2.5%
Others
19%
Mexican Peso
1.7%
Currency Exposure on Q2 2014 Sales Currency Average Rates
2014 Currency Sensitivity
44
● 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
Q2’13 Q2’14 % change
€/$ 1.31 1.37 4.6%
€/Yen 129.02 140.03 8.5%
€/Real 2.70 3.06 13.3%
€/Ruble 41.38 47.96 15.9%