Q3 2013 Results
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Transcript of Q3 2013 Results
Q3 2013 RESULTSOctober 30, 2013
2
Forward Looking Statements
This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of1995, as amended. Forward-looking statements are statements that are not historical facts. These statements includeprojections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions andexpectations 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'smanagement believes that the expectations reflected in such forward-looking statements are reasonable, investors arecautioned that forward-looking information and statements are subject to various risks and uncertainties, many of whichare difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments todiffer 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 theEMA, regarding whether and when to approve any drug, device or biological application that may be filed for any suchproduct candidates as well as their decisions regarding labeling and other matters that could affect the availability orcommercial potential of such product candidates, the absence of guarantee that the product candidates if approved willbe commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's abilityto benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of costcontainment policies and subsequent changes thereto, the average number of shares outstanding, as well as thosediscussed 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 Form20-F for the year ended December 31, 2012. Other than as required by applicable law, Sanofi does not undertake anyobligation to update or revise any forward-looking information or statements.
33
Agenda
Key Highlights
● Christopher A. Viehbacher, Chief Executive Officer
Financial Performance
● Jérôme Contamine, Executive Vice President, Chief Financial Officer
Q&A
KEY HIGHLIGHTS
4
Q2 2013Q1 2013Q4 2012Q3 2012
No Further Sales Erosion at CER in Q3 2013 for the First Time in Five Quarters
Quarterly Sales Growth(1)
5
Q3 2013
-3.1%
-1.7%
-2.8%
-6.3%
(1) Growth at Constant Exchange Rates(2) On a reported basis, Q3 2013 sales were €8,432m down -6.7%(3) At constant exchange rates and constant structure basis
+0.6%(2)
Sales growth of +6.1% in September 2013(3)
Residual Effect from the Cliff Was Further Reducedto €191m in Q3 2013
2012 20132012 2013 2012 2013 2012 2013
6
Key Genericized Products(1) - Quarterly Sales (€m)
-€553mat CER -€481m
at CER
€813m
€259m
€752m
€267m
€399m
Q1 Q2 Q3
€207m
-€191mat CER
(1) Key genericized products include Lovenox® U.S., Plavix® Western EU, Taxotere® Western EU & U.S., Eloxatin® U.S., Ambien® family U.S., Allegra® U.S., Aprovel® Western EU, Xyzal® U.S., Xatral® U.S., Nasacort® U.S. and BMS Alliance (active ingredients of Plavix® and Avapro® sold to BMS)
(2) Loss of exclusivity for Eloxatin® in the U.S. was August 9, 2012(3) Aprovel® compound patent expired in August 15, 2012 in most EU countries. Co-Aprovel® compound patent expired in October 15, 2013 in EU.
In France, Co-Aprovel® has been facing generic competition since September 2012. Sanofi continues to defend its rights to have the validity and infringement of the patent recognized.
€72m from Eloxatin®
in the U.S.(2)
€65m from Aprovel®
and Co-Aprovel® in EU(3)
ILLUSTRATIVE
€257m
Q4
7
Sales Trends Improved in the U.S. and Western EU in Q3 2013
(1) Growth at Constant Exchange Rates(2) Western Europe: France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Holland, Austria, Switzerland,
Sweden, Ireland, Finland, Norway, Iceland, Denmark
Q4Q3 Q3Q2Q1
-8.5%
-3.6%
-9.7% -10.0%
+5.2%
2012 2013Q4Q3 Q3Q2Q1
-11.6%-13.2%
-10.0%
-7.9%
-4.8%
2012 2013
U.S. Sales Growth(1) Western EU Sales Growth(1,2)
Genzyme(1)
Vaccines
Growth Platforms Grew by +5.5% Reaching 74.7% of Sales in Q3 2013
8(1) Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises(2) Includes products launched since 2009 which do not belong to the Growth Platforms listed above: Multaq®, Jevtana®, Auvi-Q™, Mozobil® and Zaltrap®
+20.1% +20.1%
-7.2%-7.2%
+9.8%+9.8%
+21.1%+21.1%
-6.4% -6.4%
Other Innovative Products(2) €191m +31.2%+31.2%
+2.8%+2.8%
Consumer Healthcare
€1,300m
Diabetes Solutions €1,670m
€742m
Animal Health
€529m
Emerging Markets €2,652m
€458m
Q3 2013Growth at CER
9M 2013Growth at CER
+18.6% +18.6%
-0.2%-0.2%
+4.8%+4.8%
+23.9%+23.9%
-5.0% -5.0%
+20.0%+20.0%
+2.2%+2.2%
(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
Emerging Markets Sales Continue to GrowAlbeit at a Lower Pace
31.5%
35.4%
22.9%10.3%
9
(1)
+5.2%+2.2% +4.0% +2.2%Growth
at CER
Q3 2013 Sales (€m)
-4.8%
-7.0%
+3.6%
+2.8%
10
€ millionQ3 2013
salesQ3 2013
change at CER9M 2013
change at CER
Flu Vaccines (incl. Vaxigrip® and Fluzone®) 559 -3.9% -2.4%
Polio/Pertussis/Hib Vaccines (incl. Pentacel®, Pentaxim® and Imovax®) 244 -17.2% +2.1%
Meningitis/Pneumonia Vaccines (incl. Menactra®) 211 -3.5% -0.7%
Travel and Other Endemics Vaccines 101 +31.3% +9.6%
Adult Booster Vaccines (incl. Adacel®) 84 -36.4% -19.3%
Other Vaccines 101 +6.0% +22.9%
Total Vaccines Sales 1,300 -7.2% -0.2%
(1) 9M 2013 sales were €2,757m, down -0.2% at CER
Q3 2013 Vaccines Performance Affected by Flu Vaccine Phasing and Pentacel®/Adacel® Shortage
Significant Achievements in Q3 2013
11
● Double-digit growth for eleven consecutive quarters● U300 EDITION III & IV data imminent; U.S. & EU filings expected in H1 2014
Diabetes
Genzyme
CHC
FluVaccines
Alirocumab
● Aubagio® & Lemtrada™ granted EU approval; Lemtrada™ FDA Ad Com in Nov● Cerdelga™ (eliglustat) regulatory file accepted for review by EMA
● Relaunch of Rolaids® in the U.S. and gradual recovery in China● FDA approval of Nasacort® Rx-to-OTC switch
● Positive results from large study with Fluzone® High Dose ● Expected record flu sales in Northern Hemisphere in H2 2013
● Positive top-line results from first Phase III study with an anti-PCSK9 mAb
Alirocumab: First in Class Fully-Human PCSK9 mAb
12
Alirocumab (SAR236553 / REGN727) is developed in collaboration with RegeneronODYSSEY MONO is the first study to report data from the 12 Phase 3 trials initiated so far as part of the >23,000 patient ODYSSEY clinical trial programPCSK9: proprotein convertase subtilisin/kexin type 9, an enzyme that can contribute to elevated LDL-C levels through degradation of LDL-C receptorsLDL-C : Low Density Lipoprotein-Cholesterol
● ODYSSEY MONO: first Phase III study with alirocumab to report data● Reduced mean LDL-C three times
more than ezetimibe
● Most patients remained on the initial low dose (75mg) in this treat-to-goal study
● Injection-site reactions in less than 2% of patients in both groups
● 1mL SC auto-injector for both Q2W doses, 75mg and 150mg
-15.6%
-47.2%
ezetimibe
alirocumab
p<0.0001
Mean LDL-C change (at week 24)
● Extended shortage of Pentacel®, Adacel® and Daptacel® through mid-Oct(1)
● Progressive U.S. supply improvement delayed to Q4 2013Vaccines
Animal Health
Pharmain China
BrazilGenerics
● Frontline® competition from Rx-only products and fipronil branded generics● Expected launch of NexGard® for next flea and tick season
● Slowdown in pharmaceutical market● Promotional activities and sales progressively coming back to normal
● Excess stock in the channel cleaned up, trade inventory back to normal● Re-order point reached in mid-August, sales gradually improving
Select Areas of Focus to Fully Get Back on Track
13(1) Pertussis‐containing vaccines manufactured in Toronto
14
Q3 2013 Performance Affected by the Strength of the Euro vs. Other Currencies
(1) Main currency impact on sales in Q3 2013:Japanese Yen (-€180m); U.S. Dollar (-€176m); Brazilian Real (-€50m); Venezuelan Bolivar (-€48m); Australian Dollar (-€30m)
Quarterly Currency Impact (in €m)
+2.4%
+5.8%
+3.6%
+8.0%€486m
€187m
€0.13
€0.06
+6.4%€561m
+8.4%€0.15
Sales(1) Business EPS
+1.9%€166m
+2.6%€0.04
-2.5%-€212m
-4.4%-€0.08
-3.5%-€305m
2012 2013
-€0.08
-5.5%
-7.3%-€662m -€0.17
-10.2%Q4Q3Q2Q1 Q3Q2Q1
2012 2013Q4Q3Q2Q1 Q3Q2Q1
Business EPS Less Impacted by Patent Cliff in Q3 2013
15
Quarterly Business EPS Growth(1)
Q2 2013Q1 2013Q4 2012Q3 2012 Q3 2013
-14.9%
-27.2%-29.0%
-18.5%
-9.0%
(3)(2) (2)
(1) Growth at Constant Exchange Rates(2) With the retroactive application of IAS19R(3) On a reported basis, Q3 2013 Business EPS was €1.35 down -19.2%
Guidance
Outlook for 2013
16(1) FY 2012 Business EPS of €6.14 with the retroactive application of IAS19R
16
Taking into account the expected return to growth in Q4and including the impact of extended vaccines shortage in Q3,
the outlook for 2013 is now expected to be at the lower end of previous guidance range
2013 business EPS is therefore expected to bearound 10% lower than 2012 at CER(1),
barring major unforeseen adverse events
FINANCIAL PERFORMANCE
Jérôme Contamine
Executive Vice President, Chief Financial Officer
17
Q3 2013FX Impact
-€662m
Growth Platforms
-€56m
+€411m
Brazil generics
Q3 2012
€9,040m
Others
-€110m
Key Genericized
Products
-€191m
Q3 2013 Sales Grew Slightly at CER but Were Significantly Affected by Currency Headwinds
(1) “Others” includes - €50m from EU tail products (Other Rx Drugs), - €36m on three genericized brands in Japan (Allegra®, Myslee® and Amaryl®) (2) Reported sales of Brazil generics were €76m in Q3 2012 and €17m in Q3 2013(3) On a reported basis, sales in Q3 2013 were down -6.7%
Q3 2013 Sales
(2)
€8,432m
excluding Brazil generics
+0.6%at CER(3)
(1)
JPY: -€180mUSD: -€176mBRL: -€50mVEF: -€48mAUD: -€30m
(1)
18
(1) With the retroactive application of IAS19R19
Q3 2013 Was the Last Quarter Impacted by the Residual Effect of the Patent Cliff
€m Q3 2013 Q3 2012 % Change(reported €)
% Change(CER)
Net sales 8,432 9,040 -6.7% +0.6%
Other revenues 86 200 -57.0% -55.0%
Cost of sales (2,873) (2,877) -0.1% +6.0%
Gross profit 5,645 6,363 -11.3% -3.6%
R&D (1,183) (1,144) +3.4% +7.4%
SG&A (2,016) (2,176) -7.4% -0.8%
Other current operating income & expenses 28 76 - -
Share of Profit/Loss of associates 38 6 - -
Minority interests (36) (39) - -
Business operating income 2,476 3,086 -19.8% -10.4%
Business operating margin 29.4% 34.1% - -
CER: Constant Exchange Rates
(1)
Mix Factors and FX Impacted Q3 2013 CoS Ratio
● Cost of Sales (CoS) in Q3 2013 of €2,873m, up +6.0% at CER
● CoS ratio of 34.1% in Q3 2013 vs. 31.8% in Q3 2012 reflecting:● Mix effects from lower sales of high
margin vaccines and companion animal brands(1)
● Unfavourable currency impact ● Loss of sales from Key Genericized
Products● Lower sales of generics in Brazil
20
Cost of Sales (%)
2012 2013
31.8%
(1) Frontline® and Heartgard®
(1)
34.1%
(1)
Spending More on Late Stage Programs While Reducing Fixed R&D Costs
21
● Q3 2013 R&D expenses of €1,183m ● Large Phase III / IIb development
programs (e.g. Dengue, C. Diff, alirocumab, sarilumab, U300, dupilumab)
● Q3 2013 R&D up +2.3% at CER(1)
when correcting for: ● Reclassification of expenses from
Vaccines R&D JV(2)
● Hexyon® payment by the SPMSD JV in Q3 2012(3)
21
R&D Expenses (€m)
€1,183m€1,144m
2012 2013
(1) Q3 R&D expenses were up +7.4% at CER(2) Reclassification in Q3 2013 increased R&D expenses by €14m and share of profit of associates by the same amount(3) Reimbursement of €44m by the SPMSD JV related to Hexyon®, a 6-in-1 paediatric vaccine
(1)
Good Control of SG&A Expenses in Q3 2013
22
● Q3 2013 SG&A expenses of €2,016m, down -0.8% at CER reflecting:
● Sales & Marketing investment in Genzyme’s MS franchisee.g. Aubagio® and Lemtrada™
● Sustained investment in Diabetes
● SG&A ratio of 23.9% in Q3 2013
22
SG&A Expenses (€m)
€2,016m€2,176m
2012 2013
23
€m Q3 2013 Q3 2012 % Change(reported €)
% Change(CER)
Business operating income 2,476 3,086 -19.8% -10.4%
Net financial expenses (123) (135) - -
Income tax expense (564) (750) - -
Effective tax rate -24.0% -25.1% - -
Business net income 1,789 2,201 -18.7% -8.9%
Net margin 21.2% 24.3% - -
Business EPS €1.35 €1.67 -19.2% -9.0%
Average number of shares outstanding (m) 1,323.5 1,318.4 - -
Q3 2013 Business EPS Reflecting €0.17 Negative FX Impact
23(1) With the retroactive application of IAS19RCER: Constant Exchange Rates
(1)
-1,391
Proceeds from Issuance
of Shares
+796
Net Cash from Operating Activities
Net Debt Dec 31, 2012
Net Debt Sep 30, 2013
Other
-334Acquisitions, Licensing & Disposals
-164
-3,638
Dividend Payment
-865
CapExShare Repurchase
Free Cash Flow Stability and €1.4bn Net Debt Reduction in Q3 2013
24
(1)
(2)
-7,719
-8,788
+4,527
(1)
9M 2013 (€m)
(1) Including derivatives related to the financial debt +€431m at Dec. 31, 2012 and +€331m at Sep 30, 2013 (2) Excluding Restructuring costs(3) Other including Restructuring costs
(3)
Sanofi’s Growth Profile Expected to Emerge in Q4 2013
● Q3 2013 marks an inflection point as the impact of the patent cliff is now behind us and we returned to growth in September(1)
● Growth Platforms accounted for 74.7% of sales and were up +5.5% in Q3 2013 demonstrating the value of Sanofi’s integrated business model
● Several high potential R&D projects progressed in Q3 2013
● EMA approvals for Aubagio® and Lemtrada™ in MS
● FDA approval of NexGard® for fleas and ticks for dogs
● Positive first Phase III results for alirocumab in hypercholesterolemia
● Cerdelga™ (eliglustat) file accepted for review by EMA for Gaucher disease
● FDA approval of Nasacort® Allergy 24HR for OTC use
1
2
3
25(1) Sales growth of +6.1% in September 2013 at constant exchange rates and constant structure basis
APPENDICES
R&D Pipeline
26
27
Late Stage Pipeline – Pharma & Vaccines
U300Insulin glargine
Type 1+2 diabetes
Cerdelga™ (eliglustat tartrate) Glucosylceramide synthetase inhibitor
Gaucher disease, U.S.
DengueMild-to-severe
dengue fever vaccine
Lemtrada™ (alemtuzumab) Anti-CD52 mAb
Multiple sclerosis, U.S.
Lyxumia® (lixisenatide) GLP-1 agonist
Type 2 diabetes, U.S.
fedratinibJAK2 inhibitor
Myelofibrosis (1L)
Clostridium difficile Toxoid vaccine
Cerdelga™ (eliglustat tartrate) Glucosylceramide synthetase inhibitor
Gaucher disease, EU
alirocumabAnti-PCSK-9 mAb
Hypercholesterolemia
Jevtana® (cabazitaxel) Metastatic prostate cancer (1L)
DTP-HepB-Polio-Hib (PR5I)Pediatric hexavalent vaccine
VaxiGrip® QIV IMQuadrivalent inactivated
influenza vaccine
Kynamro® (mipomersen)Apolipoprotein B-100 antisense
Severe HeFH, U.S.
SYNVISC-ONE®
Medical device Pain in hip OA
Fluzone® QIV IDQuadrivalent inactivated
influenza vaccine intradermal
sarilumabAnti-IL-6R mAb
Rheumatoid arthritis
MACI®Cell-based treatment
Femoral chondyle cartilage defects, U.S.
Quadracel®Diphtheria, tetanus, pertussis& polio vaccine; 4-6 y of age
N
27
N
N
N
N
N New Molecular Entity Immune Mediated Diseases
Rare Diseases
OncologyDiabetes Solutions
VaccinesInfectious DiseasesCardiovascular / Renal Diseases
Age Related Degenerative Diseases
Ophthalmology
Biosurgery
N
Phase III Registration
Early Stage Pipeline – Pharma & Vaccines
LixiLan lixisenatide+ insulin glargine
Fixed-Ratio / Type 2 diabetes
SAR3419Maytansin-loaded anti-CD19 mAb
B-cell malignancies refractory/relapsed (NHL, ALL)
GENZ438027 (ALN-TTR02)mRNA inhibitor
Familial amyloid polyneuropathy
Meningitis ACYW conj.2nd generation meningococcal
conjugate infant vaccine
dupilumabAnti-IL4Rα mAb
Asthma; Atopic dermatitis; Nasal polyposis
SAR256212 (MM121) anti-ErbB3 mAb
Breast cancer (2L, 3L)
fresolimumabTGFβ antagonist
Focal segmental glomerulosclerosis
Rabies VRVgPurified vero rabies vaccine
SAR339658Anti-VLA 2 mAb
Inflammatory bowel disease
CombinationSAR245409 (XL765) / MSC1936369BOral dual inhibitor of PI3K & mTOR / pimasertib
Ovarian cancer
SAR279356 (F598)Anti-PNAG mAb
Serious infections
RotavirusLive attenuated tetravalent
Rotavirus oral vaccine
SAR156597IL4/IL13 Bi-specific mAb
Idiopathic pulmonary fibrosis
fedratinibJAK-2 inhibitor
Ruxolitinib resistant/intolerant MF
ferroquineAntimalarial
Malaria
SAR100842LPA-1 receptor antagonist
Systemic sclerosis
sarilumabAnti-IL-6R mAb
Uveitis
SAR292833 (GRC15300)TRPV3 antagonist
Chronic disabling pain
Phase II
N N
N
N
N
N
28
N
28
N
N
N New Molecular Entity Immune Mediated Diseases
Rare Diseases
OncologyDiabetes Solutions
VaccinesInfectious DiseasesCardiovascular / Renal Diseases
Age Related Degenerative Diseases
Ophthalmology
Biosurgery
N
N
N
Early Stage Pipeline – Pharma & Vaccines
SAR153192Anti-DLL4 mAb
Solid tumors
GZ404477(AAV-hAADC)Gene therapy
Parkinson's disease
RetinoStat®
Gene therapy Wet age-related macular degeneration (AMD)
Streptococcus pneumoniaMeningitis & pneumonia vaccine
SAR405838 (MI-773)HDM2 / p53 antagonist
Solid tumors
SAR391786GDF8 mAbSarcopenia
StarGen®
Gene therapyStargardt disease
Pseudomonas aeruginosaAntibody fragment product
Prevention of ventilator-associated pneumonia
SAR650984Anti-CD38 naked mAb
Hematological malignancies
SAR228810Anti-protofibrillar AB mAb
Alzheimer’s disease
GZ402663 (sFLT-01)Gene therapy
Age-related macular degeneration(AMD)
Tuberculosis Recombinant subunit vaccine
SAR566658Maytansin-loaded anti-CA6 mAb
Solid tumors
SAR438151Undisclosed target
UshStat®
Gene therapyUsher syndrome 1B
Herpes Simplex Virus Type 2HSV-2 vaccine
SAR125844C-MET kinase inhibitor
Solid tumors
SAR252067Anti-LIGHT mAbCrohn’s disease
GZ402665(rhASM)
Niemann-Pick type B
SAR307746Anti-ANG2 mAb
Solid tumors
SAR113244Anti-CXCRS mAb
Systemic lupus erythematosus
GZ402671Oral GCS Inhibitor
Fabry Disease
SAR260301PI3K β selective inhibitorPTEN – Deficient tumors
Insulin Biosimilar ProgramDiabetes
GZ402666neo GAA
Pompe Disease
SAR245408 (XL147)Oral PI3K inhibitor
Solid tumors
CombinationSAR245409 / MSC1936369B
Solid tumors
Phase IN
N
N
N
N
N
N
NN
N
N
N
N
N
2929
N
N
N
N
N
N
N New Molecular Entity Immune Mediated Diseases
Rare Diseases
OncologyDiabetes Solutions
VaccinesInfectious DiseasesCardiovascular / Renal Diseases
Age Related Degenerative Diseases
Ophthalmology
Biosurgery
N
30
Phase I Phase II Phase III Registration TOTAL
Oncology 8 3 1 0 12
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 4 0 0 0 4
Rare Diseases 3 1 0 1 5
Age Related Degenerative Diseases 3 1 0 0 4
Vaccines 4 3 5 1 13
TOTAL 25(2) 15 10 2
R&D Pipeline Summary Table(1)
40 12 NMEs & Vaccines
52
30
39(2)
(1) Excluding life cycle management programs(2) Includes one Phase I project addressing an undisclosed target
31
Expected R&D Milestones
31
Product Event TimingInvestigational new insulin U300 Expected EDITION III & IV Phase III results in Diabetes Q4 2013
Cerdelga™ (eliglustat) Expected U.S. regulatory submission in Gaucher disease Q4 2013
Fedratinib (JAK2 inhibitor) Expected U.S. and EU regulatory submissions in Myelofibrosis Q4 2013
Lemtrada™ (alemtuzumab) Expected FDA decision in RMS in the U.S.(1) Q4 2013
Sarilumab Expected 1st Phase III headline results in Rheumatoid Arthritis (SARIL-RA Mobility) Q4 2013
MACI® Expected U.S. regulatory submission in Cartilage Defects Q4 2013
Vaxigrip® QIV Expected license in EU Q1 2014
Fluzone® QIV ID Expected U.S. regulatory submission Q1 2014
Investigational new insulin U300 Expected U.S. and EU regulatory submissions in Diabetes H1 2014
LixiLan (lixisenatide + insulin glargine) Expected start of Phase III program in Diabetes H1 2014
(1) An FDA Advisory Committee meeting is scheduled on Nov 13, 2013
APPENDICES
FINANCE
32
33
Q3 2013 Business Net Income Statement
Third quarter 2013
Net sales 8,432 9,040 (6.7%) 6,674 7,040 (5.2%) 1,300 1,481 (12.2%) 458 519 (11.8%)Other revenues 86 200 (57.0%) 69 184 (62.5%) 9 7 28.6% 8 9 (11.1%)Cost of sales (2,873) (2,877) (0.1%) (2,136) (2,130) 0.3% (580) (577) 0.5% (157) (170) (7.6%)As % of net sales (34.1%) (31.8%) (32.0%) (30.3%) (44.6%) (39.0%) (34.2%) (32.7%)Gross profit 5,645 6,363 (11.3%) 4,607 5,094 (9.6%) 729 911 (20.0%) 309 358 (13.7%)As % of net sales 66.9% 70.4% 69.0% 72.4% 56.1% 61.5% 67.5% 69.0%Research and development expenses
(1,183) (1,144) 3.4% (1,012) (1,011) 0.1% (133) (97) 37.1% (38) (36) 5.6%
As % of net sales (14.0%) (12.7%) (15.2%) (14.4%) (10.2%) (6.5%) (8.3%) (6.9%)Selling and general expenses
(2,016) (2,176) (7.4%) (1,708) (1,867) (8.5%) (156) (153) 2.0% (152) (156) (2.6%)
As % of net sales (23.9%) (24.1%) (25.6%) (26.5%) (12.0%) (10.3%) (33.2%) (30.1%)Other current operating income/expenses
28 76 32 64 (1) 7 (3) 5
Share of profit/loss of associates* 38 6 3 10 36 (4) (1) -
Net income attributable to non-controlling interests
(36) (39) (37) (39) 1 - - -
Business operating income 2,476 3,086 (19.8%) 1,885 2,251 (16.3%) 477 657 (27.4%) 117 173 (32.4%) (3) 5
As % of net sales 29.4% 34.1% 28.2% 32.0% 36.7% 44.4% 25.5% 33.3%Financial income and expenses
(123) (135)
Income tax expense (564) (750)
Tax rate** 24.0% 25.1%
Business net income 1,789 2,201 (18.7%)As % of net sales 21.2% 24.3%Business earnings per share*** (in euros)
1.35 1.67 (19.2%)
* 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 1,323.5 million in the third quarter of 2013 and 1,318.4 million in the third quarter of 2012(1) Including impact of transition to IAS19R
Q3 2013 Q3 2012(1) Q3 2013
Pharmaceuticals
change
OtherVaccines Animal health
Q3 2012(1)change
Group Total
€ million Q3 2013 Q3 2012(1) Q3 2012(1) change Q3 2013Q3 2013 Q3 2012(1) change
9M 2013 Business Net Income Statement
Nine months 2013
Net sales 24,494 26,421 (7.3%) 20,196 21,867 (7.6%) 2,757 2,881 (4.3%) 1,541 1,673 (7.9%)Other revenues 267 873 (69.4%) 224 829 (73.0%) 21 17 23.5% 22 27 (18.5%)Cost of sales (8,081) (8,210) (1.6%) (6,303) (6,554) (3.8%) (1,275) (1,140) 11.8% (503) (516) (2.5%)As % of net sales (33.0%) (31.1%) (31.2%) (30.0%) (46.3%) (39.6%) (32.6%) (30.8%)Gross profit 16,680 19,084 (12.6%) 14,117 16,142 (12.5%) 1,503 1,758 (14.5%) 1,060 1,184 (10.5%)As % of net sales 68.1% 72.2% 69.9% 73.8% 54.5% 61.0% 68.8% 70.8%Research and development expenses
(3,524) (3,551) (0.8%) (3,019) (3,055) (1.2%) (382) (380) 0.5% (123) (116) 6.0%
As % of net sales (14.4%) (13.4%) (14.9%) (14.0%) (13.9%) (13.2%) (8.0%) (6.9%)Selling and general expenses
(6,454) (6,577) (1.9%) (5,504) (5,622) (2.1%) (455) (440) 3.4% (495) (514) (3.7%) - (1)
As % of net sales (26.3%) (24.9%) (27.3%) (25.7%) (16.5%) (15.3%) (32.1%) (30.7%)Other current operating income/expenses
198 92 163 63 7 (2) (3) 8 31 23
Share of profit/loss of associates* 59 425 30 435 32 (10) (3) -
Net income attributable to non-controlling interests
(122) (143) (123) (143) 1 - - -
Business operating income 6,837 9,330 (26.7%) 5,664 7,820 (27.6%) 706 926 (23.8%) 436 562 (22.4%) 31 22
As % of net sales 27.9% 35.3% 28.0% 35.8% 25.6% 32.1% 28.3% 33.6%Financial income and expenses
(400) (460)
Income tax expense (1,560) (2,319)
Tax rate** 24.0% 27.0%
Business net income 4,877 6,551 (25.6%)As % of net sales 19.9% 24.8%Business earnings per share*** (in euros)
3.68 4.97 (26.0%)
* 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 1,323.8 million in the first nine months of 2013 and 1,319 million in the first nine months of 2012(1) Including impact of transition to IAS19R
9M 2012(1)€ million 9M 2013 9M 2012(1) change 9M 2013 change 9M 2013 9M 2012(1)change 9M 2013 9M 2012(1) change 9M 2013 9M 2012(1)
OtherGroup Total Pharmaceuticals Vaccines Animal health
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Q3 2013 Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi
€ million Q3 2013 Q3 2012(3) change
Business net income 1,789 2,201 (18.7%)
Amortization of intangible assets(1) (689) (816)
Impairment of intangible assets (28) 12
Fair value remeasurement of contingent consideration liabilities (68) (86)
Expenses arising from the impact of acquisitions on inventories (1) (3)
Restructuring costs (71) (57)
Tax effect of: 289 294
amortization of intangib le assets 233 277 impairment of intangib le assets 9 (4) fair value remeasurement of contingent consideration liab ilities 23 3 expenses arising from the impact of acquisitions on inventories - 1 restructuring costs 24 17
Other tax items - -
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
(9) (7)
Net income attributable to equity holders of Sanofi 1,213 1,539 (21.2%)
Consolidated earnings per share(2) (in euros) 0.92 1.17(1) Of w hich related to amortization expense generated by the remeasurement of intangible assets as part of business combinations:
€658 million in the third quarter of 2013 and €787 million in the third quarter of 2012.(2) Based on an average number of shares outstanding of 1,323.5 million in the third quarter of 2013 and 1,318.4 in the third quarter of 2012.(3) Including impact of transition to IAS19R.
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9M 2013 Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi
€ million 9M 2013 9M 2012(4) change
Business net income 4,877 6,551 (25.6%)
Amortization of intangible assets(1) (2,232) (2,491)
Impairment of intangible assets (468) (28)
Fair value remeasurement of contingent consideration liabilities (185) (192)
Expenses arising from the impact of acquisitions on inventories (7) (20)
Restructuring costs (230) (307)
Tax effect of: 1,038 1,008
amortization of intangib le assets 723 892 impairment of intangib le assets 189 10 fair value remeasurement of contingent consideration liab ilities 43 6 expenses arising from the impact of acquisitions on inventories 2 6 restructuring costs 81 94
Other tax items(2) (109) -
Share of items listed above attributable to non-controlling interests 3 2
Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures
(26) (22)
Net income attributable to equity holders of Sanofi 2,661 4,501 (40.9%)
Consolidated earnings per share(3) (in euros) 2.01 3.41(1) Of w hich related to amortization expense generated by the remeasurement of intangible assets as part of business combinations:
€2,147 million in the f irst nine months of 2013 and €2,389 million in the f irst nine months of 2012.(2) Tax on dividends paid to shareholders of Sanofi.(3) Based on an average number of shares outstanding of 1,323.8 million in the f irst nine months of 2013 and 1,319 million in the first nine months of 2012.(4) Including impact of transition to IAS19R.
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Q3 2013 & 9M 2013 Consolidated Income Statements
€ million
Net sales 8,432 9,040 24,494 26,421Other revenues 86 200 267 873
Cost of sales (2,874) (2,880) (8,088) (8,230)
Gross profit 5,644 6,360 16,673 19,064
Research and development expenses (1,183) (1,144) (3,524) (3,551)
Selling and general expenses (2,016) (2,176) (6,454) (6,577)
Other operating income 56 117 403 436
Other operating expenses (28) (41) (205) (344)
Amortization of intangible assets (689) (816) (2,232) (2,491)
Impairment of intangible assets (28) 12 (468) (28)
Fair value remeasurement of contingent consideration liabilities (68) (86) (185) (192)
Restructuring costs (71) (57) (230) (307)
Other gains and losses, and litigation - - - -
Operating income 1,617 2,169 3,778 6,010Financial expense (147) (186) (458) (556)
Financial income 24 51 58 96
Income before tax and associates and joint ventures 1,494 2,034 3,378 5,550
Income tax expense (2) (275) (456) (631) (1,311)
Share of profit / loss of associates and joint ventures 29 (1) 33 403
Net income 1,248 1,577 2,780 4,642Net income attributable to non-controlling interests 35 38 119 141
Net income attributable to equity holders of Sanofi 1,213 1,539 2,661 4,501Average number of shares outstanding (million) 1,323.5 1,318.4 1,323.8 1,319.0
Consolidated earnings per share (in euros) 0.92 1.17 2.01 3.41
(2) In 2013, including a tax on dividends paid to shareholders of Sanofi: (109) M€
(1) Including impact of transition to IAS19R
Q3 2012(1)Q3 2013 9M 2012(1)9M 2013
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