Q2 2012 Results
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Transcript of Q2 2012 Results
Q2 2012 RESULTS
July 26th, 2012
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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, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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Agenda
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Key Highlights
● Christopher A. Viehbacher, Chief Executive Officer
Business Performance ● Hanspeter Spek, President, Global Operations
● Olivier Charmeil, Senior Vice President, Vaccines
Financial Performance
● Jérôme Contamine, Executive Vice President, Chief Financial Officer
Q&A
KEY HIGHLIGHTS
Christopher A. Viehbacher Chief Executive Officer
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Q2 2012 Performance Was In-Line With Our Expectations
(1) On a reported basis, total sales w ere up +6.2% and business EPS w as down -9.8% in Q2 2012 (2) When excluding changes in structure (primarily the complete transfer of Copaxone® to Teva in Q1 2012
and the disposal of Dermik in Q4 2011), sales grow th at constant exchange rates and constant structure basis w as +2.5% in Q2 2012 5
€1.64
Q2 2011 Q2 2012
Total Sales (€m)
€8,349m
Q2 2011 Q2 2012
Business EPS (€)
€1.48
€8,870m
-17.7%at CER(1)
+0.4%at CER(1,2)
Patent Cliff(1) Exposure on Sales Will Be Limited after Eloxatin® Loss of Exclusivity in the U.S. in Aug 2012
(1) The patent clif f is the effect of the loss of exclusivity of key genericized products. (2) 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) 6
Growth Platforms Sales(€m and % of Total Sales)
64.9%
44.9%
Q2 2009 Q2 2010 Q2 2011 Q2 2012
€5,753m
€3,341m
8.5%
29.7%
Q2 2009 Q2 2010 Q2 2011 Q2 2012
4.9%when excluding
€314m of Eloxatin® U.S.€2,207m
€752m
Key Genericized Products Sales(€m and % of Total Sales) (2)
Growth Platforms Accounted for 64.9% of Group Sales and Grew by +7.6% in Q2 2012
7 (1) New Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises (2) Multaq®, Jevtana® and Mozobil®
+13.7%
+3.0%
+11.3%
+9.1%
+9.1%
Innovative Products(2) €152m +4.5%
+9.8%
Vaccines €783m
Diabetes Solutions €1,436m
Consumer Health Care €738m
Animal Health €576m
Emerging Markets €2,823m
New Genzyme(1) €434m
Growth at CER
Q2 2012 Q2 2011 Q2 2011
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As Expected, Loss of Exclusivity of Plavix® and Avapro® in the U.S. Impacted Business Net Income in Q2 2012
(1) Avapro® on March 30, 2012 and Plavix® on May 17, 2012
Q2 2012Q2 2011 Q2 2011
Evolution of "Other Revenues"
Evolution of“Income from Associates"
Q2 2012
€422m
Loss of Exclusivity of Plavix® and Avapro® in the U.S.(1)
€278mImpact onQ2 2012
Business Net Income:
€331m
€247m
€122m
-45.7%at CER
-60.1%at CER
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Genzyme - Recovery of Fabrazyme® confirmed in Q2 2012 and Entry into Multiple Sclerosis Underway
● Q2 2012 rare diseases sales reached €434m, up +9.1% at CER
● Strong recovery of Fabrazyme® following Framingham plant approval
● Significant progress made towards building leading franchise in MS
● Solid TOWER Phase 3 results with Aubagio ® (teriflunomide)
● Lemtrada™ (alemtuzumab) filed in the U.S. and EU in June 2012
● U.S. sales team being hired
Quarterly Sales (€m)
141
101
32
74
113
150
&
Q22012
Q12012
Q32011
Q42011
Q22012
Q12012
Q32011
Q42011
Q22012
Q12012
Q32011
Q42011
Key Regulatory Milestones Expected in H2 2012
hoFH: Homozygous Familial Hypercholesterolemia heFH: Heterozygous Familial Hypercholesterolemia 10
Zaltrap®, Kynamro™, Aubagio®, Lyxumia® and Lemtrada™ are registered trade names submitted to health authorities for investigational agents Zaltrap® is developed in collaboration w ith Regeneron, Kynamro™ w ith Isis Pharmaceuticals and Lyxumia® is in-licensed from Zealand Pharma
PDUFA: Prescription Drug User Fee Act CHMP: Committee for Medicinal Products for Human Use
Expected Milestones
PDUFA Date: Aug 4th 2012CHMP Opinion: Q4 2012
CHMP Opinion: Q4 2012FDA Submission: Dec 2012
PDUFA Date: Q2 2013CHMP Opinion: Q2 2013
PDUFA Date: Sep 12th 2012CHMP Opinion: Q1 2013
Relapsing Forms ofMultiple Sclerosis
MetastaticColorectal Cancer
Type 2 Diabetes
CHMP Opinion: Q4 2012PDUFA Date: Jan 29th 2013
hoFH/severe heFH in EU and hoFH in the U.S
Relapsing Forms ofMultiple Sclerosis
Products Targeted Indications
®
®
®
TM
Sanofi Recently Started the First Ever Phase 3 Program for an Anti-PCSK9 mAb
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● First-in-class fully-human antibody targeting PCSK9(1)
● Injected subcutaneously as one single injection every two weeks
● ODYSSEY: a large global Phase 3 clinical program evaluating the safety and efficacy of SAR236553
● 22,000 patients, including those with elevated cardiovascular risk, intolerant to statins or patients with FH
● Creation of a PCSK9 Development & Launch Unit
(1) PCSK9: proprotein convertase subtilisin/kexin type 9), an enzyme that can contribute to elevated low -density lipoprotein cholesterol (LDL-C) levels through degradation of LDL-C receptors
(2) Adapted from Decision Resources 2008, Decision Resources 2010 and CVReg 2011 (3) heFH: Heterozygous Familial Hypercholesterolemia
SAR236553 / REGN727 is developed in collaboration w ith Regeneron
Target Population
Statin Intolerant
heFH (3)
SecondaryPrevention
PrimaryPrevention
21m patients globallyestimated not at goal for LDL-C(2)
(mainly at high cardiovascular risk)
BUSINESS PERFORMANCE
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Hanspeter Spek President, Global Operations Olivier Charmeil Senior Vice President, Vaccines
Growth Platforms and FX Drove Sales Growth in Q2 2012
13 (1) Sales impact from end of Copaxone® agreement and Dermik disposal: -€148m (2) JPY: Japanese Yen; CNY: Chinese Yuan
Q2 2012 sales (€m)+6.2%
+ €486m
- €163m- €187m
®(1)
(2)
(2)
+ €386m
(1) World excluding North America (USA, 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 - Record Sales and Strong Growth in Q2 2012 Confirm our Leadership
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● Q2 2012 Emerging Markets sales of €2,823m, up +9.8% at CER
Q2 2012 Geographic Sales Split
31.8%31.5%
24.1%12.6%
(1)
Non-BRIC Accounted for 65% of Emerging Markets Sales in Q2 2012 Highlighting our Broad Geographic Scope
(1) BRIC: Brazil, Russia, India and China 15
● Q2 2012 BRIC sales of €995m, up +15.2% at CER (1)
● Q2 2012 Other Emerging Markets sales of €1,828m, up +7.1% at CER
+12.7% +12.7% -0.1% +16.5%
Emerging Markets Q2 2012 Sales Split(Growth at CER)
Brazil: €405m +14.0%
Russia: €203m +9.0%
India: €66m +20.2%
China: €320m +20.9%
BRIC Q2 2012 Sales(Growth at CER)
+9.8%
Growth
Diabetes Continued its Impressive Double Digit Growth in Q2 2012
● Q2 2012 Diabetes sales of €1,436m, up +13.7% at CER
● Great performance of Lantus®, up +16.5% at CER
● Strong growth in the U.S. and Emerging Markets of +19.4% and +20.6% at CER, respectively
● Broad presence at ADA:
● Results of ORIGIN and retrospective cohort studies reinforce Lantus® as the most-studied basal insulin
● New supportive data on Lyxumia® on top of basal insulins
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Quarterly Sales (€m)
Q12010
Q22010
Q32010
Q42010
Q12011
Q22011
Q32011
Q42011
Q12012
Q22012
1,228
969926
Oncology Delivered Another Good Quarter in Q2 2012 prior to Losing Eloxatin® and Launching Zaltrap® in the U.S.
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● Q2 2012 Oncology sales of €751m, up +7.0% at CER
● Sales of Jevtana® reached €65m, up +27.1% at CER
● Taxotere® sales of €159m stabilized versus Q1 2012
● Eloxatin® U.S. market exclusivity
● As expected through August 9, 2012
● Zaltrap® (aflibercept) in 2L-mCRC
● PDUFA date: August 4, 2012 given Priority Review
Zaltrap® is the registered trade name submitted to health authorities for aflibercept in cancer 2L-mCRC: Second Line Metastatic Colorectal Cancer
Q3 2011 Q4 2011 Q1 2012 Q2 2012
Oncology Others Eloxatin® U.S.
Quarterly Sales (€m)751
41.8%
58.2%
● Solid Q2 2012 sales of €738m, up +11.3% at CER
● Double digit growth of Doliprane®, Maalox® and MagneB6® in Western Europe resulting from greater promotional focus
● Lower U.S. sales of Allegra® OTC reflecting inventory build in Q2 2011 to ensure proper supply during launch
● Strong performance in Emerging Markets, up +26.9% at CER
● Double digit growth of Haowawa®, Lactacyd®, Enterogermina® and NoSpa®
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Strong Consumer Health Care Sales Growth in Q2 2012
644578
321
Q2 2009 Q2 2010 Q2 2011 Q2 2012
738
Quarterly Sales (€m)
Merial Sales Growth Showed Strong Rebound in Q2 2012
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● Strong Q2 2012 sales of €576m, up +9.1% at CER
● Companion Animals segment sales of €385m, up +10.1% at CER
● Good Frontline® sales performance
● Velcera recently enjoined from selling their generic combination (fipronil + methoprene) in the U.S.(1)
● Production Animals segment sales of €191m, up +6.9% at CER
● Swine presence enlarged by recent acquisition of Newport
(1) Merial w as granted a preliminary injunction motion on June 29, 2012 against Velcera. This decision is under appeal by Velcera. The patent infringement trial is now scheduled for November 2012.
Q12010
Q22010
Q32010
Q42010
Q12011
Q22011
Q32011
Q42011
Q12012
Q22012
576
496524
Quarterly Sales (€m)
Sanofi Pasteur Growth in Q2 2012 Benefited from Seasonal Flu Campaign in Emerging Markets
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● Q2 2012 sales of €783m, up +3.0% at CER
● Strong sales in Emerging Markets, up +22.9% at CER
● Another record flu season in H1 2012 in the Southern Hemisphere
● Mixed performance in Mature Markets
● Strong Adacel® sales (+30.7% at CER) and good resilience of Menactra®
● Temporary order limitations for Pentacel® in the U.S.
● Imovax® Polio (IPV) added to Japan immunization policy on Sep 1st, 2012
Q2 2011 Q2 2012
476-7.5% at CER
MatureMarkets
EmergingMarkets
+22.9% at CER307
783706
Quarterly Sales (€m)
FINANCIAL PERFORMANCE
Jérôme Contamine Executive Vice President, Chief Financial Officer
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BOI Decline in Q2 2012 Reflects Loss of Exclusivity of Plavix® and Avapro® in the U.S.
22 CER: Constant Exchange Rates
€m Q2 2012 Q2 2011 % Change(reported €)
% Change(CER)
Net sales 8,870 8,349 +6.2% +0.4%
Other revenues 247 422 -41.5% -45.7%
Cost of sales (2,730) (2,588) +5.5% +2.4%
Gross profit 6,387 6,183 +3.3% -3.5%
R&D (1,239) (1,197) +3.5% -1.2%
SG&A (2,289) (2,268) +0.9% -4.3%
Other current operating income & expenses (152) 7 - -
Share of Profit/Loss of associates 122 278 -56.1% -60.1%
Non controlling interests (50) (58) - -
Business operating income 2,779 2,945 -5.6% -13.6%
Business operating margin 31.3% 35.3% - -
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Sales and BOI Benefited from a Very Favorable Currency Tailwind in Q2 2012
(1) Currency impact on sales in Q2 2012: USD / US dollar (+€316m); JPY / Japanese Yen (+€96m); CNY / Chinese Yuan (+€42m)
Q2 2012Q1 2012 Q2 2012Q1 2012
Sales Business Operating Income
Quarterly Currency Impact (in % points)
+2.4%
+5.8%
+4.0%
+8.0%
€486m
€187m
>90%(1)
from USD,JPY & CNY
€235m
€120m
Cost of Sales Ratio Virtually Flat in Q2 2012
● Q2 2012 Cost of Sales (CoS) of €2,730m, up +2.4% at CER
● Stable CoS ratio in H1 2012 vs. H1 2011 (30.8% vs. 30.7%) reflecting:
● Productivity enhancement (LEAN and standardization initiatives) compensating for product mix evolution
● Favourable currency impact
● CoS ratio in-line with guidance of around 31.5% for FY 2012
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Cost of Sales (%)
Q12011
Q22011
Q32011
Q42011
Q12012
Q22012
32.0%31.5%31.0% 30.7%30.4% 30.8%
Stable R&D Expenses in Q2 2012
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● Q2 2012 R&D expenses of €1,239m, down -1.2% at CER
● R&D/Sales ratio down 0.3 points vs. Q2 2011 reflecting:
● Good internal cost management
● Ongoing transforming initiatives
● Significant investment in late-stage R&D pipeline
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Q12011
Q22011
Q32011
Q42011
Q12012
Q22012
13.9%
R&D/Sales Ratio (%)
15.2%13.8%14.1% 14.3% 14.0%
Significant Improvement in SG&A to Sales Ratio in Q2 2012
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● Q2 2012 SG&A expenses of €2,289m, down -4.3% at CER
● SG&A/Sales ratio down 1.4 points vs. Q2 2011 reflecting:
● Continued investment in Growth Platforms
● Genzyme integration synergies
● Tight control of G&A expenses
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Q12011
Q22011
Q32011
Q42011
Q12012
Q22012
SG&A/Sales Ratio (%)
24.2%26.1% 24.9%24.8%
27.2% 25.8%
Business Net Income Down 17.6% in Q2 2012
27 CER: Constant Exchange Rates
€m Q2 2012 Q2 2011 % Change(reported €)
% Change(CER)
Business operating income 2,779 2,945 -5.6% -13.6%
Net financial expenses (108) (100) - -
Income tax expense (727) (695) - -
Effective tax rate -28.0% -26.5% - -
Business net income 1,944 2,150 -9.6% -17.6%
Net margin 21.9% 25.8% - -
Business EPS € 1.48 € 1.64 -9.8% -17.7%
Average number of shares outstanding (in million) 1,317.4 1,311.6 - -
Solid Free Cash Flow Generated in H1 2012
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(1) Represents 8,014,849 shares at an average price of €56.63 (2) Including derivatives related to the f inancial debt: €503m at March 31, 2012, and €528m at June 30, 2012 (3) Excluding Restructuring costs
● Free Cash Flow of €3,938m, up +9.6% in H1 2012
● Dividend of €3,487m paid in Q2 2012
● €454m of opportunistic share repurchases in H1 2012(1)
● Net debt increased by €488m in H1 2012
Net Debt Jun 30, 2012
Restructuring Costs & Others
CapEx
-231
- 711
Dividend & Share
Repurchase
Net Cash from Operating Activities
-3,941
Net Debt Dec 31, 2011
Acquisitions & Licensing
-254
(2)
(3)
In €m
-10,859 -11,347
FCF+3,938
+4,649
(2)
H1 2012
Underlying Performance in H1 2012 Underpins our Confidence in our Ability to Deliver Sustainable Growth in a Post-Cliff Era
Solid sales growth excluding Key Genericized Products
Industry-leading performance in Emerging Markets
Continued focus on managing our cost base
BNI impact of Plavix® and Avapro® loss of exclusivity in the U.S. as expected
Confident in delivering on guidance despite challenging global environment
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APPENDICES R&D Pipeline
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Late Stage Pipeline – Pharma & Vaccines
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eliglustat tartrateGlucosylceramide synthetase inhibitor
Gaucher disease
otamixabanDirect Xa inhibitor
ACS
Quadracel®Diphtheria, tetanus, pertussis& polio vaccine; 4-6 y of age
Hexaxim®
DTP-HepB-Polio-Hib vaccine
iniparib(BSI-201)
squamous NSCLC (1L)
lixisenatide (AVE0010)GLP-1 agonist
Type 2 diabetes, U.S.
Fluzone® QIV IMQuadrivalent inactivated
influenza vaccines
Plavix®
clopidogrel bisulfate PAD, STEMI, Japan
ombrabulin (AVE8062)Vascular disrupting agent
Soft tissue sarcoma (2L/3L)
New formulationInsulin glargine
Type 1+2 diabetes
VaxiGrip® QIV IMQuadrivalent inactivated
influenza vaccines
teriflunomideRelapsing forms of multiple sclerosis
(RMS) – monotherapy, U.S. / EU
SAR302503 (TG101348)JAK-2 inhibitor
Myelofibrosis (1L)
mipomersenApolipoprotein B-100 antisense
Severe HeFH, U.S.
alemtuzumab Anti-CD52 mAb
Multiple sclerosis, U.S. / EU
Jevtana®
Cabazitaxel Metastatic prostate cancer (1L)
SAR236553Anti-PCSK-9 mAb
Hypercholesterolemia
Allegra®
fexofenadineDry syrup, Japan
SYNVISC-ONE™Medical device Pain in hip OA
sarilumab (SAR153191)Anti-IL-6R mAb
RA
mipomersenApolipoprotein B-100 antisenseHoFH and severe HeFH in EU;
HoFH in U.S.
MACI®Cell-based treatment
Articular cartilage defects
DengueMild-to-severe
dengue fever vaccine
lixisenatide (AVE0010)GLP-1 agonist
Type 2 diabetes, EU / Japan
teriflunomideMultiple sclerosis
(adjunct therapy & CIS)
DTP-HepB-Polio-HibPediatric hexavalent vaccine
afliberceptVEGF-Trap
2nd line mCRC, U.S. / EU
RegistrationPhase III
N
N
N N
N
N
N
N
N
N N
N
N New Molecular EntityCentral Nervous System
Genetic diseases
OncologyMetabolic Disorders
VaccinesInternal Medicine
Biosurgery
Thrombosis
AgingOphthalmology
Early Stage Pipeline – Pharma & Vaccines
32 32
iniparib (BSI-201)
Ovarian cancer (2L)
FOV1101FDC prednisolone/cyclosporine
Allergic conjunctivitis
SAR231893Anti-IL4 mAb
Asthma; Atopic dermatitis
SAR3419Maytansin-loaded anti-CD19 mAb
B-cell malignancies refractory/relapsed (DLBCL, ALL)
safotibant (FOV2304)Bradykinin B1 antagonistDiabetic macular edema
ferroquineAntimalarial
Malaria
SAR256212 (MM121)anti-ErbB3 mAb
Breast cancer (2L, 3L)
SAR110894H3 antagonist
Alzheimer's disease
fresolimumabTGFβ antagonist
Fibrosis
SAR245408 (XL147)Oral PI3K inhibitor
Endometrial cancer (1L)
SAR113945IKK-β inhibitorOsteoarthritis
SAR97276Antimalarial
Malaria
SAR245409 (XL765)Oral dual inhibitor of PI3K & mTOR
Breast cancer (1L)
SAR292833 (GRC15300)TRPV3 antagonist
Neuropathic pain, osteoarthritic pain
SAR279356 (F598)Anti-PNAG mAb
Serious infections
ombrabulin (AVE8062)Vascular disrupting agent
Ovarian cancer (2L)
ACAM-CdiffClostridium difficile
Toxoid vaccine
SAR302503 (TG101348)JAK-2 inhibitor
Polycythemia vera (2L)Incyte (ruxolitinib) resistant/intolerant MF
Rabies VRVgPurified vero rabies vaccine
Jevtana®
Cabazitaxel, Microtubule inhibitorSmall cell lung cancer (2L)
Meninge ACYW conj.2nd generation meningococcal
Conjugate infant vaccine
Phase II
N
N
N
N
N
N
N
N
N
N
N N
NN
N New Molecular EntityCentral Nervous System
Genetic diseases
OncologyMetabolic Disorders
VaccinesInternal Medicine
Biosurgery
Thrombosis
AgingOphthalmology
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Early Stage Pipeline – Pharma & Vaccines
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SAR153192Anti-DLL4 mAb
Solid tumors
SAR405838 (MI-773)MDM2 / p53 antagonist
Solid tumors and hematological malignancies
SAR252067Anti-LIGHT mAb
Crohn’s disease & Ulcerative colitis
RotavirusLive Attenuated Tetravalent
Rotavirus oral vaccine
GZ402674Non-camptothecin topo1 inhibitor
Solid tumors
SAR127963P75 receptor antagonist
Trauma brain injury
SAR339658VLA 2 antagonist
Inflammatory Bowel disease
Streptococcus pneumoniaMeningitis & pneumonia vaccine
SAR650984Anti-CD38 naked mAb
Hematological malignancies
GZ404477(AAV-hAADC)Gene therapy
Parkinson's disease
SAR100842LPA-1/LPA-3
Skin manifestation of scleroderma
Pseudomonas aeruginosaAntibody fragment product
Prevention of ventilator-associated pneumonia
SAR566658Maytansin-loaded anti-DS6 mAb
DS6 positive solid tumors
SAR391786Rehabilitation post orthopedic surgery
SAR156597IL4/IL13 Bi-specific mAb
Idiopathic Pulmonary Fibrosis
Tuberculosis Recombinant subunit vaccine
SAR307746Anti-Ang2 mAb
Solid tumors
SAR228810Anti-protofibrillar AB mAb
Alzheimer’s disease
SAR407899Rho kinase inhibitor
Diabetic nephropathy
RetinoStat®
Gene therapy Wet age-related macular degeneration (AMD)
SAR125844C-Met kinase inhibitor
Solid tumors
SAR399063DHA-GLP + vit DPre-sarcopenia
lixisenatide + Lantus®
GLP-1 agonist + insulin glargineFix-Flex / Type 2 diabetes
StarGen®
Gene therapyStargardt disease
CombinationsSAR245409 / MSC1936369B
SAR245408/SAR256212 (MM121)Solid tumors
SAR404460DHA-GPL + Vit DPre-sarcopenia
SAR164653Cathepsin A inhibitor
CV-related complications & deaths in diabetic patients
GZ402663 (sFLT-01)Gene therapy
Age related Macular Degeneration(AMD)
SAR393590 (Oral clofaribine)DNA synthesis inhibitor
Hematological malignancies
GZ402665(rhASM)
Niemann-Pick type B
SAR126119TAFIa inhibitor
Acute ischemic stroke
UshStat®
Gene therapyUsher syndrome 1B
Jevtana®
Cabazitaxel, Microtubule inhibitorGastric cancer (2L)
Phase IN
N
N
N
N
N
N
N
N
N
N
N
NN
N
N
N
N
N
N
N
N New Molecular EntityCentral Nervous System
Genetic diseases
OncologyMetabolic Disorders
VaccinesInternal Medicine
Biosurgery
Thrombosis
AgingOphthalmology
N
NN
N
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R&D Pipeline Summary Table New Molecular Entities (NMEs) and Vaccines
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Phase I Phase II Phase III Registration TOTAL
Oncology 7 4 3 1 15
Metabolic Disorders 2 0 1 2 5
Thrombosis 1 0 1 0 2
Central Nervous System 2 0 0 2 4
Internal Medicine 4 5 1 0 10
Ophthalmology 4 2 0 0 6
Genetic Diseases 1 0 1 0 2
Aging 4 3 0 0 7
Vaccines 4 3 5 1 13
TOTAL 29 17 12 6
46 18NMEs & Vaccines
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51
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Expected R&D Milestones – Pharmaceuticals
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Product Event Timing Zaltrap® (aflibercept) Expected regulatory decision in 2nd line mCRC in the U.S. Q3 2012
AubagioTM (teriflunomide) Expected regulatory decision in RMS in the U.S. Q3 2012
Lyxumia® (lixisenatide) Expected regulatory decision in type 2 diabetes in EU Q4 2012
Zaltrap® (aflibercept) Expected regulatory decision in 2nd line mCRC in EU Q4 2012
KynamroTM (mipomersen) Expected regulatory decision in hoFH and severe heFH in EU Q4 2012
Lyxumia® (lixisenatide) Regulatory FDA submission in type 2 diabetes in U.S. Q4 2012
ombrabulin Phase III headline results in sarcoma Q4 2012
AubagioTM (teriflunomide) Expected regulatory decision in RMS in EU Q1 2013
KynamroTM (mipomersen) Expected regulatory decision in hoFH in the U.S. Q1 2013
LemtradaTM (alemtuzumab) Expected regulatory decisions in RMS in EU and the U.S. Q2 2013
iniparib Phase III headline results in 1st line squamous NSCLC Q2 2013
otamixaban Phase III headline results in ACS Q2 2013
JAK2 inhibitor Phase III headline results in myelofibrosis Q2 2013
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Expected R&D Milestones – Vaccines
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Product Event Timing Shan5® Start of Phase III study Q3 2012
Fluzone® QIV IM Submission of regulatory file in the U.S. Q3 2012
HexaximTM Submission of regulatory file in EU Q3 2012
Fluzone® QIV ID Start of Phase III study Q4 2012
Vaxigrip® QIV IM Submission of regulatory file in EU Q1 2013
Fluzone® QIV IM Expected licensure in the U.S. Q2 2013
HexaximTM Expected licensure in EU and international countries Q2 2013
APPENDICES FINANCE
37
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 1,317.4 mi llion in the second quarter of 2012 and 1,311.6 mi llion in the second quarter of 2011
Second quarter 2012
Net sales 7,511 7,147 5.1% 783 706 10.9% 576 496 16.1% 8,870 8,349 6.2%Other revenues 233 412 (43.4%) 5 5 - 9 5 80.0% 247 422 (41.5%)Cost of sales (2,249) (2,146) 4.8% (303) (282) 7.4% (178) (160) 11.3% (2,730) (2,588) 5.5%As % of net sales (29.9%) (30.0%) (38.7%) (39.9%) (30.9%) (32.3%) (30.8%) (31.0%)Gross profit 5,495 5,413 1.5% 485 429 13.1% 407 341 19.4% 6,387 6,183 3.3%As % of net sales 73.2% 75.7% 61.9% 60.8% 70.7% 68.8% 72.0% 74.1%Research and development expenses (1,057) (1,023) 3.3% (143) (139) 2.9% (39) (35) 11.4% (1,239) (1,197) 3.5%
As % of net sales (14.1%) (14.3%) (18.3%) (19.7%) (6.8%) (7.1%) (14.0%) (14.3%)Selling and general expenses (1,939) (1,969) (1.5%) (158) (137) 15.3% (191) (161) 18.6% (1) (1) (2,289) (2,268) 0.9%
As % of net sales (25.8%) (27.6%) (20.1%) (19.4%) (33.1%) (32.5%) (25.8%) (27.2%)Other current operating income/expenses (165) (20) (2) 10 13 19 (152) 7
Share of profit/loss of associates and joint ventures*
123 276 (1) 2 122 278
Net income attributable to non-controlling interests (49) (58) (1) (50) (58)
Business operating income 2,408 2,619 (8.1%) 183 153 19.6% 176 155 13.5% 12 18 2,779 2,945 (5.6%)
As % of net sales 32.1% 36.6% 23.4% 21.7% 30.6% 31.3% 31.3% 35.3%Financial income and expenses (108) (100)
Income tax expense (727) (695)
Tax rate** 28.0% 26.5%Business net income 1,944 2,150 (9.6%)As % of net sales 21.9% 25.8%Business earnings per share*** (in euros) 1.48 1.64 (9.8%)
Other
% change
Vaccines Animal Health Group Total
Millions of euros Q2 2012 Q2 2011 Q2 2011 Q2 2012 Q2 2011 Q2 2012% change % changeQ2 2012 Q2 2012 Q2 2011Q2 2011
Pharmaceuticals
% change
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 1,319.3 mi llion in the first semester of 2012 and 1,308.6 mi llion in the first semester of 2011
First-half 2012
Net sales 14,827 13,730 8.0% 1,400 1,308 7.0% 1,154 1,090 5.9% 17,381 16,128 7.8%Other revenues 645 816 (21.0%) 10 10 - 18 9 100.0% 673 835 (19.4%)Cost of sales (4,431) (4,073) 8.8% (566) (550) 2.9% (346) (327) 5.8% (5,343) (4,950) 7.9%As % of net sales (29.9%) (29.7%) (40.4%) (42.1%) (30.0%) (30.0%) (30.8%) (30.7%)Gross profit 11,041 10,473 5.4% 844 768 9.9% 826 772 7.0% 12,711 12,013 5.8%As % of net sales 74.5% 76.3% 60.3% 58.7% 71.6% 70.8% 73.1% 74.5%Research and development expenses (2,051) (1,963) 4.5% (284) (264) 7.6% (80) (70) 14.3% (2,415) (2,297) 5.1%
As % of net sales (13.8%) (14.3%) (20.3%) (20.2%) (6.9%) (6.4%) (13.9%) (14.2%)Selling and general expenses (3,763) (3,614) 4.1% (288) (264) 9.1% (358) (322) 11.2% (1) (1) (4,410) (4,201) 5.0%
As % of net sales (25.4%) (26.3%) (20.6%) (20.2%) (31.1%) (29.6%) (25.4%) (26.0%)Other current operating income/expenses (21) 42 (1) (1) 1 (7) 16 (11) (5) 23
Share of profit/loss of associates and joint ventures*
425 559 (6) (2) 13 419 570
Net income attributable to non-controlling interests (104) (136) (104) (136)
Business operating income 5,527 5,361 3.1% 265 237 11.8% 389 373 4.3% 15 1 6,196 5,972 3.8%
As % of net sales 37.3% 39.0% 18.9% 18.1% 33.7% 34.2% 35.6% 37.0%Financial income and expenses (227) (178)
Income tax expense (1,583) (1,474)
Tax rate** 28.0% 27.5%Business net income 4,386 4,320 1.5%As % of net sales 25.2% 26.8%Business earnings per share*** (in euros) 3.32 3.30 0.6%
% changeH1 2012 H1 2012 H1 2011H1 2011
Pharmaceuticals
% change
Group Total
Millions of euros H1 2012 H1 2011 H1 2011 H1 2012 H1 2011 H1 2012% change
Other
% change
Vaccines Animal Health
40 40
Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi
Millions of euros Q2 2012 Q2 2011 % changeBusiness net income 1,944 2,150 (9.6%)Amortization of intangible assets (842) (965)
Impairment of intangible assets (39) (37)
Fair value remeasurement of contingent consideration liabilities (73) (20)
Expenses arising from the impact of acquisitions on inventories (3) (262)
Restructuring costs (163) (345)
Other gains and losses, and litigation
Tax effect of: 354 492
amortization of intangible assets 283 296 impairment of intangible assets 14 10 fair value remeasurement of contingent consideration liabilities 1 5 expenses arising on the workdown of acquired inventories 1 78 restructuring costs 55 108 other gains and losses, and litigation (5)
Share of items listed above attributable to non-controlling interests
Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures (7) (7)
Net income attributable to equity holders of sanofi 1,171 1,006 16.4%Consolidated earnings per share (in euros) 0.89 0.77 15.6%
41 41
Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of Sanofi
Millions of euros H1 2012 H1 2011 % changeBusiness net income 4,386 4,320 1.5%Amortization of intangible assets (1,675) (1,701)
Impairment of intangible assets (40) (69)
Fair value remeasurement of contingent consideration liabilities (106) (66)
Expenses arising from the impact of acquisitions on inventories (17) (264)
Restructuring costs (250) (467)
Other gains and losses, and litigation (517)
Tax effect of: 714 1,002
amortization of intangible assets 615 559 impairment of intangible assets 14 20 fair value remeasurement of contingent consideration liabilities 3 5 expenses arising on the workdown of acquired inventories 5 78 restructuring costs 77 150 other gains and losses, and litigation 190
Share of items listed above attributable to non-controlling interests 1
Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures (15) (14)
Net income attributable to equity holders of sanofi 2,998 2,224 34.8%Consolidated earnings per share (in euros) 2.27 1.70 33.5%
Consolidated Income Statements
€ million
Net sales 8,870 8,349 17,381 16,128
Other revenues 247 422 673 835
Cost of sales (2,733) (2,850) (5,360) (5,214)
Gross profit 6,384 5,921 12,694 11,749
Research and development expenses (1,239) (1,197) (2,415) (2,297)
Selling and general expenses (2,289) (2,268) (4,410) (4,201)
Other operating income 113 73 319 191
Other operating expenses (265) (66) (324) (168)
Amortization of intangible assets (842) (965) (1,675) (1,701)
Impairment of intangible assets (39) (37) (40) (69)
Fair value remeasurement of contingent consideration liabilities (73) (20) (106) (66)
Restructuring costs (163) (345) (250) (467)
Other gains and losses, and litigation (517)
Operating income 1,587 1,096 3,793 2,454
Q2 2011Q2 2012 H1 2011H1 2012
Consolidated Income Statements
€ million
Operating income 1,587 1,096 3,793 2,454
Financial expenses (133) (133) (272) (234)
Financial income 25 33 45 56Income before tax and associates and joint ventures 1,479 996 3,566 2,276
Income tax expense (373) (203) (869) (472)Share of profit / loss of associates and joint ventures 115 271 404 556
Net income 1,221 1,064 3,101 2,360
Net income attributable to non-controlling interests 50 58 103 136
Net income attributable to equity holders of sanofi 1,171 1,006 2,998 2,224
Average number of shares outstanding (million) 1,317.4 1,311.6 1,319.3 1,308.6
Consolidated earnings per share (in euros) 0.89 0.77 2.27 1.70
Q2 2011Q2 2012 H1 2011H1 2012
44 44
Change in Net Debt
(1) Excluding restructuring costs. (2) In 2011: (13,528)M€ related to Genzyme acquisition (3) In 2012 : of which foreign exchange effect on net debt (68M€).
(€ million)H1
2012H1
2011Business net income 4,386 4,320Depreciation, amortization and impairment of property, plant and equipment and intangible assets 627 555
Gains and losses on disposals of non-current assets, net of tax (40) (35)Other non cash items 360 276
Operating cash flow before changes in working capital (1) 5,333 5,116
Changes in working capital (1) (684) (754)
Acquisitions of property, plant and equipment and software (711) (768)
Free cash flow (1) 3,938 3,594
Acquisitions of intangible assets excluding software (75) (64)
Acquisitions of investments in consolidated undertakings including assumed debt (2) (179) (13,935)
Restructuring costs (504) (353)Proceeds from disposals of property, plant and equipment, intangible assets and other non-current assets, net of tax 71 71
Issuance of Sanofi shares 74 28Dividends paid to shareholders of Sanofi (3,487) (1,372)Acquisition of treasury shares (454) (113)Disposals of treasury shares 1Other items (3) 128 489
Change in net debt (488) (11,654)
45 45
Simplified Consolidated Balance Sheets
ASSETS € million
06/30/2012 12/31/2011* LIABILITIES & EQUITY € million
06/30/2012 12/31/2011*
Property, plant and equipment 10,723 10,750 Equity attributable to equity holders of sanofi 56,208 56,203
Intangible assets (including goodwill) 61,462 62,221 Equity attributable to non-controlling interests 146 170
Non-current financial assets & investments in associates and deferred tax assets
7,859 6,839 Total equity 56,354 56,373
Non-current assets 80,044 79,810 Long-term debt 10,270 12,499
Inventories, accounts receivable and other current assets 17,141 16,667 Non-current liabilities related to business
combinations and to non-controlling interests 1,449 1,336
Cash and cash equivalents 4,307 4,124 Provisions and other non-current liabilities 11,175 10,346 Current assets 21,448 20,791 Deferred tax liabilities 6,398 6,530
Non-current liabilities 29,292 30,711 Accounts payable & Other current liabilities 10,008 10,404 Current liabilities related to business combinations and to non-controlling interests 154 220
Short-term debt and current portion of long-term debt 5,912 2,940
Current liabilities 16,074 13,564
Assets held for sale or exchange 251 67 Liabilities related to assets held for sale or exchange 23 20
TOTAL ASSETS 101,743 100,668 TOTAL LIABILITIES & EQUITY 101,743 100,668 * In accordance with IFRS 3, sanofi has revised during the measurement period certain provisional amounts recognized in 2011.