Download - Q1 2012 Results
Q1 2012 RESULTS
April 27th, 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
Key Highlights
● Christopher A. Viehbacher, Chief Executive Officer
Business Performance
● Hanspeter Spek, President, Global Operations
Financial Performance
● Jérôme Contamine, Executive Vice President, Chief Financial Officer
Q&A
KEY HIGHLIGHTS
Christopher A. Viehbacher
Chief Executive Officer
4
5
€1.66
Q1 2011 Q1 2012
Total Sales (€m)
2012 - A Good Start to the Year
€7,779m
Q1 2011 Q1 2012
Business EPS (€)
€1.85
5
€8,511m
+7.2% at CER
+7.0% at CER
2012 - Entering Final Phase of the Patent Cliff(1)
6
Q32008
Q42008
Q12009
Q22009
Q32009
Q42009
Q12010
Q22010
Q32010
Q42010
Q12011
Q22011
Q32011
Q42011
Q12012
Q22012
Q32012
Q42012
Key Genericized Products(1) - Quarterly Sales (€m)
€813m
€2,207m
(1) The patent cliff is the effect of the loss of exclusivity of key genericized products. 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)
7
2011
The Most Significant Headwind from the Patent Cliff in 2012 Will Impact Earnings but Not Sales
Evolution of Group "Other Revenues"
Evolution of Group “Income from Associates"
(1) Avapro® on March 30, 2012 and Plavix® on May 17, 2012
2012e 2011 2012e
€1,669m
Loss of Exclusivity of Plavix® and Avapro® in the U.S.(1)
- 54% - 62%
€1,102m Expected Impact on
2012 Business Net Income ~ €1.4bn
Growth Platforms Accounted for 63.2% of Sales in Q1 2012
8
Growth is at CER (Constant Exchange Rates) (1) With Genzyme pro forma in Q1 2011, Emerging Market sales grew by 5,6%, and by 7,9% excluding vaccines (2) New Genzyme perimeter include Rare Diseases and Multiple Sclerosis franchises (3) Change on a constant structure basis and at constant exchange rates (4) Multaq®, Jevtana®, and Mozobil®
+14.4%
+11.4%
-0.2%
-5.4%
+13.7%(3)
Innovative Products(4) €139m +6.3%(3)
+9.9%(1)
Consumer Health Care €805m
Diabetes Solutions €1,311m
Vaccines €617m
Animal Health €578m
Emerging Markets €2,624m
New Genzyme(2) €400m
Growth at CER
9
€81m
€30m
€94m
€139m
€93m
€47m
€112m
€149m
Genzyme Rare Diseases On Track
Quarterly Sales(1) (€m)
● Q1 2012 Genzyme rare diseases sales reached €400m, +13.7%(1,2)
● Framingham plant granted EMA and FDA approvals in January 2012
● U.S. patients and most severely affected EU patients moved to full Fabrazyme® dose starting March 2012
● Complete return to normal supply levels of Fabrazyme® starting this quarter
● Phase 3 studies of eliglustat in Gaucher disease fully enrolled
& Others
(1) Genzyme sales are consolidated since April 1, 2011 (2) Change on a constant structure basis and at constant exchange rates
Other Rare Diseases products
Q1 2012
Q1 2011
Q1 2012
Q1 2011
Q1 2012
Q1 2011
Q1 2012
Q1 2011
Significant Pipeline Progress over Last 9 Months
Kynamro™ (mipomersen) – hoFH and severe heFH in Jul 2011 in EU and hoFH in Mar 2012 in the U.S.
Aubagio™ (teriflunomide) – RMS in Aug 2011 in the U.S. and Feb 2012 in EU
Lyxumia® (lixisenatide) – Type 2 diabetes in Oct 2011 in EU
Zaltrap® (aflibercept) – 2L-mCRC in Dec 2011 in EU and Feb 2012 in the U.S.
hoFH: Homozygous Familial Hypercholesterolemia heFH: Heterozygous Familial Hypercholesterolemia VTE: Venous Thrombo Embolism
RMS: Relapsing Forms of Multiple Sclerosis mCRC: Metastatic Colorectal Cancer
Visamerin® / Mulsevo® (semuloparin) – VTE prevention in chemo-treated patients in Sep 2011 in the U.S. and EU
10
Five new molecular entities submitted in last 9 months:
Kynamro™, Aubagio™, Visamerin® / Mulsevo®, Lyxumia® and Zaltrap® are registered trade names submitted to health authorities for investigational agents
Zaltrap® aflibercept
● First in class agent addressing unmet needs in hypercholesterolemia
● Very encouraging Phase II data
Phase III program targeted to start in Q2 2012
New Data on Exciting R&D Assets in Q1 2012
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Anti-PCSK9 mAb(1)
● Significant efficacy in RMS(2) with convenient annual dosing, and favorable benefit/risk balance in clinical studies
FDA & EMA submissions expected in Q2 2012
(1) Partnership with Regeneron (2) RMS: Relapsing Forms of Multiple Sclerosis Lemtrada is a trade name submitted to health authorities for the investigational agent alemtuzumab in Multiple Sclerosis
11
Only Therapy(1) Slowing Accumulation of Disability Sustained for 6 months vs. Active Comparator
3 month
Active Comparators
Placebo
6 month EDSS
Higher Hurdle
12
(1) Investigational compound (2) Based on CARE-MS II
Higher Hurdle
(2)
For Illustrative Purposes
Typical Threshold for Approval
13 Coles A ECTRIMS 2011; platform presentation
CARE-MS I - Strong Effect on Relapse
Proportion of Relapse-Free Patients at Year 2
59%
78%
Lemtrada™ 12 mg/day Rebif®
HR 0.45 P<0.001
CARE-MS II - Reversing Disability in Some Patients
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Mean EDSS Change from Baseline
p<0.0001
0.24 p=0.0064
‒0.17 p=0.0044
Rebif®
Lemtrada™ 12 mg/day
EDSS: Expanded Disability Status Score Cohen J AAN 2012; platform presentation
Key R&D Milestones for the Remainder of 2012
15
Lemtrada™, Aubagio™ and Lyxumia® are registered trade names submitted to health authorities for investigational agents
2012 Expected Regulatory Submissions Q2 Q3 Q4 ● Lemtrada™ (alemtuzumab) in RMS(1) in the U.S. and EU ● Lyxumia® (lixisenatide) in Type 2 diabetes in the U.S.(2) Expected Headline Data Releases
● Lantus® - ORIGIN study results ● Lantus® - Retrospective cohort studies results ● Aubagio™ (teriflunomide) – TOWER headline Phase III results in RMS
● Dengue vaccine - Phase IIb efficacy results Expected Phase III Study Initiations
● Anti-PCSK-9 mAb - Phase III program in hypercholesterolemia ● Sarilumab (Anti-IL-6R mAb) - Second Phase III trial
(1) RMS: Relapsing Forms of Multiple Sclerosis (2) Partnership with Zealand Pharma (3) Mid year 2012
(3)
BUSINESS PERFORMANCE
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Hanspeter Spek President, Global Operations
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(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
Double Digit Growth in Key Emerging Markets in Q1 2012
● Q1 2012 Emerging Markets(1) sales of €2,624m, up +9.9% at CER
● Strong sales in BRIC of €917m, +16.5% at CER
Emerging Markets Q1 2012 Sales Split (Growth at CER)
+16.0%
+11.7% +2.1%
+8.1%
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Impressive Double Digit Growth in Diabetes Sustained for Five Consecutive Quarters
Quarterly Sales (€m) ● Q1 2012 Diabetes sales of €1,311m, +17.8% or +14.4% at CER
● Strong performance of Lantus®, up +17.2% at CER ● SoloSTAR® accounted for 51.1% of
quarterly sales in the U.S. ● Solid performance in Western Europe
of +8.0% at CER ● Strong growth in Emerging Markets
with sales up +32.4% at CER
● Results of ORIGIN outcome study and two retrospective cohort studies to be presented at ADA in June Q1
10Q111
Q112
Q210
Q211
Q212
Q310
Q311
Q312
Q410
Q411
Q412
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€1,118m
Q1 2012 - Good Quarter for Oncology
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● Q1 2012 Oncology sales of €741m, +16.7% or +12.8% at CER ● Sales of Jevtana® reached €54m,
up +10.4% at CER ● Taxotere® sales of €150m despite loss
of exclusivity in the U.S. and EU ● Sales of €133m from ex-Genzyme
oncology brands, up +8.4%(1)
● Zaltrap® (aflibercept) granted Priority Review by the FDA ● First anti-angiogenic agent to
demonstrate a survival advantage in mCRC patients previously treated with oxaliplatin(2,3)
Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012
Oncology Others Eloxatin
Quarterly Sales (€m)
€741m
51.8%
48.2%
(1) Change on a constant structure basis and at constant exchange rates (2) m-CRC – Metastatic Colorectal Cancer (3) When combined with FOLFIRI (irinotecan-5-fluorouracil-leucovorin) - Phase III VELOUR study (4) Eloxatin® U.S. market exclusivity expected through August 9, 2012
® (4)
Q1 2010 Q1 2011 Q1 2012
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Flagship Brands Continue to Grow in Key Geographies outside the U.S. in Q1 2012
Quarterly Sales (€m)
€404m
Quarterly Sales (€m)
€359m
Q1 2010 Q1 2011 Q1 2012
Emerging Markets Japan Ex-US
€168m +11.9%
at CER
€191m +5.2% at CER
+11.9% at CER
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€711m
€491m
€339m
Q1 2009 Q1 2010 Q1 2011 Q1 2012
● Strong Q1 2012 sales of €805m, +13.1% or +11.4 % at CER
● Good start of 2nd year for Allegra® OTC in the U.S. with sales of €87m, +5.0% at CER
● Strong performance in Emerging Markets, up +21.9% at CER ● Double digit growth of Dorflex®,
Lactacyd®, Maalox®, NoSpa® and Enterogermina®
● Contribution of BMP Sunstone in China and Universal Medicare in India(1)
Record Consumer Health Care Sales in Q1 2012
€805m
Quarterly Sales (€m)
USA
Emerging Markets
Western Europe
Others
+4.3%
+3.6%
+21.9%
+1.8%
(1) CHC Sales from BMP Sunstone in China and Universal Medicare in India were €22m in Q1 2012
● Q1 2012 sales of €617m, +2.5% or -0.2% at CER
● Strong sales in mature markets
● Solid performance of Pentacel® and Menactra® in the U.S.
● Emerging markets impacted by supply phasing issues
● Seasonal flu sales down -15.6% at CER due to timing of Southern Hemisphere (SH) campaign
● Strong flu season expected in H1 2012 in Southern Hemisphere
● Good performance of SPMSD JV(1)
22
Sanofi Pasteur Growth in Q1 2012 Impacted by Timing of Seasonal Flu Campaign in Emerging Markets
€371m +11.2%
at CER
22
Quarterly Sales (€m)
Q1 2011 Q1 2012 Q1 2011 Q1 2012
Mature Markets Emerging Markets
-13.1% at CER
€246m
(1) Sales from SPMSD, the JV with Merck & Co in Europe, are not consolidated by Sanofi Pasteur
23
Merial Sales In-Line with Expected Quarterly Phasing in Q1 2012
● Solid Q1 2012 sales of €578m, but performance impacted by tough comparable (-2.7% or -5.4% at CER)
● Return to growth expected for the remainder of 2012
● Companion Animals sales of €398m (-6.1% at CER)
● Strong Frontline® buying pattern in U.S. veterinary channels in Q1 2011
● Production Animals sales of €180m -3.7% at CER or +5,4% at CER excluding FMD and BTV vaccines sales(1)
● Newport acquisition to enlarge presence in Swine market(2)
Q12010
Q22010
Q32010
Q42010
Q12011
Q22011
Q32011
Q42011
Q12012
Quarterly Sales (€m)
(1) Q1 2011 benefited from one-off sales of Foot-and-mouth and Bluetongue vaccines sales (2) Newport sales were not consolidated by Merial in Q1 2012
FINANCIAL PERFORMANCE
Jérôme Contamine
Executive Vice President, Chief Financial Officer
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25
€8,511m
€7,779m
8,349
Q1 2011 KeyGenericized
Products
OthersincludingCopaxone
and Dermik
GrowthPlatforms
Genzyme FX Impact Q1 2012
USD : +€110mJPY : +€51mCNY : +€22mOthers : +€4m
Growth Platforms and Genzyme More than Offset Impact of Key Genericized Products in Q1 2012
Q1 2012 sales (€m)
(1) Sales impact from end of Copaxone® agreement and Dermik disposal: -€131m (2) JPY: Japanese Yen; CNY: Chinese Yuan (3) Genzyme pro forma Q1 2011
+9.4% + €187m
- €235m
+ €287m - €240m
® (1)
(2) (2)
+ €733m
(3)
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BOI Double Digit Growth in Q1 2012 Reflects Genzyme Consolidation and Cost Savings
€m Q1 2012 Q1 2011 % Change (reported €)
% Change (CER)
Net sales 8,511 7,779 +9.4% +7.0%
Other revenues 426 413 +3.1% -0.5%
Cost of sales (2,613) (2,362) +10.6% +9.5%
Gross profit 6,324 5,830 +8.5% +5.5%
R&D (1,176) (1,100) +6.9% +5.2%
SG&A (2,121) (1,933) +9.7% +7.4%
Other current operating income & expenses 147 16 - -
Share of Profit/Loss of associates 297 292 - -
Non controlling interests (54) (78) - -
Business operating income 3,417 3,027 +12.9% +8.9%
Business operating margin 40.1% 38.9% - -
CER: Constant Exchange Rates
27
Cost of Sales Ratio Improved in Q1 2012
Cost of Sales (%)
Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012
● Q1 2012 Cost of Sales of €2,613m
● Cost of Sales ratio improvement reflecting:
● Positive impact from productivity improvements and reduced cost of crude heparin
● Negative impact from loss of sales from key genericized products(1), in particular Taxotere® in the U.S.
27
32.0% 31.5% 31.0% 30.7% 30.4%
(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)
Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012
13.9%
28
R&D to Sales Ratio Down in Q1 2012
● Q1 2012 R&D expenses of €1,176m
● R&D spend in line with quarterly average of last 2 years
● Integration of Genzyme R&D
● Ongoing transforming initiatives
● R&D/Sales ratio down 0.7 point vs. Q1 2010
28
R&D/Sales Ratio (%)
15.2% 13.8% 14.1% 14.3%
Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012
29
SG&A to Sales Ratio Stable in Q1 2012
SG&A/Sales Ratio (%) ● Q1 2012 SG&A expenses of €2,121m, up +7.4% at CER
● SG&A expenses down 4.9% with Genzyme pro forma
● SG&A/Sales ratio stable vs. Q1 2011 reflecting:
● Tight control of SG&A expense
● Genzyme synergies
29
24.2% 26.1% 24.9% 24.8%
27.2%
30
€m Q1 2012 Q1 2011 % Change (reported €)
% Change (CER)
Business operating income 3,417 3,027 +12.9% +8.9%
Net financial expenses (119) (78) - -
Income tax expense (856) (779) - -
Effective tax rate -28.0% -28.5% - -
Business net income 2,442 2,170 +12.5% +8.4%
Net margin 28.7% 27.9% - -
Business EPS € 1.85 € 1.66 +11.4% +7.2%
Average number of shares outstanding (in million) 1,321.2 1,305.2 - -
Business Net Income up 12.5% in Q1 2012
30 CER: Constant Exchange Rates
Net Debt Mar 31, 2012
Restructuring Costs & Others
+295
Dividend & Share
Repurchase
-104
CapEx
-404
Net Debt Dec 31, 2011
Acquisitions & Licensing
-360
Net Cash from Operating Activities
31
Strong Free Cash Flow Generated in Q1 2012
+ €2,016m
(2) (3)
● Strong Free Cash Flow of €2,467m, up +23.0% in Q1 2012
● €404m of opportunistic share repurchases in Q1 2012(1)
● Net debt reduced by €2,254m in Q1 2012
● Gearing of 14.9% by end of March 2012
In €m
-10,859
-8,605
FCF 2,467
(1) Represents 7,137,719 shares at an average price of €56.67 (2) Excluding Restructuring Costs (3) Including derivatives related to the financial debt: €456m at Dec 31, 2011 and €503m at Mar 31, 2012
Continued Strong Execution of Strategy in Q1 2012
Good performance from growth platforms
Positive contribution from Genzyme integration
Significant progress on late stage pipeline
Sustained cost control
Guidance for FY 2012 reaffirmed
1
2
3
4
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5
APPENDICES R&D Pipeline
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34
Late Stage Pipeline – Pharma & Vaccines
N New Molecular Entity Central Nervous System
Genetic diseases
Oncology Metabolic Disorders
Vaccines Internal Medicine
Registration Phase III
Biosurgery
* ORIGIN: Evaluation of Lantus® in reducing cardiovascular morbidity & mortality
eliglustat tartrate Glucosylceramide synthetase inhibitor
Gaucher disease
SYNVISC-ONE™
Medical device Pain in hip OA
Quadracel® Diphtheria, tetanus, pertussis & polio vaccine; 4-6 y of age
Hexaxim® DTP-HepB-Polio-Hib vaccine
iniparib (BSI-201)
squamous NSCLC (1L)
MACI®
Cell-based treatment Articular cartilage defects
Fluzone® QIV IM Quadrivalent inactivated
influenza vaccines
Plavix® clopidogrel bisulfate PAD, STEMI, Japan
ombrabulin (AVE8062) Vascular disrupting agent
Soft tissue sarcoma (2L/3L)
otamixaban Direct Xa inhibitor
ACS
VaxiGrip® QIV IM Quadrivalent inactivated
influenza vaccines
teriflunomide Relapsing forms of multiple sclerosis
(RMS) – monotherapy, U.S. / EU
Clolar® / Evoltra®
DNA synthesis inhibitor Adult acute myeloid leukemia (AML) (1L)
Lantus® insulin glargine
ORIGIN*
Dengue Mild-to-severe
dengue fever vaccine
mipomersen Apolipoprotein B-100 antisense HoFH and severe HeFH in EU;
HoFH in US
SAR302503 (TG101348) JAK-2 inhibitor
Myelofibrosis (1L)
lixisenatide (AVE0010) GLP-1 agonist
Type 2 diabetes, U.S.
DTP-HepB-Polio-Hib Pediatric hexavalent vaccine
lixisenatide (AVE0010) GLP-1 agonist
Type 2 diabetes, EU
Jevtana®
Cabazitaxel Metastatic prostate cancer (1L)
New formulation Insulin glargine
Type 1+2 diabetes
sarilumab (SAR153191) Anti-IL-6R mAb
RA
Lantus® insulin glargine Pediatric, EU
teriflunomide Multiple sclerosis
(adjunct therapy & CIS)
mipomersen Apolipoprotein B-100 antisense
Severe HeFH (U.S.)
Allegra® fexofenadine
Dry syrup, Japan
semuloparin (AVE5026) Indirect Xa/IIa inhibitor
VTE prevention in cancer patients
alemtuzumab Anti-CD52 mAb
Multiple sclerosis
aflibercept VEGF-Trap
2nd line mCRC, U.S. / EU
N
N
N N N
N
N
Thrombosis
N
N
34
N N
Aging
Ophthalmology
N
35
Early Stage Pipeline – Pharma & Vaccines
Phase II iniparib (BSI-201)
Ovarian cancer (2L)
FOV1101 FDC prednisolone/cyclosporine
Allergic conjunctivitis
SAR231893 Anti-IL4 mAb
Asthma; Atopic dermatitis
SAR3419 Maytansin-loaded anti-CD19 mAb
B-cell malignancies refractory/relapsed (DLBCL, ALL)
safotibant (FOV2304) Bradykinin B1 antagonist Diabetic macular edema
ferroquine Antimalarial
Malaria
SAR256212 (MM121) anti-ErbB3 mAb
Breast cancer (2L, 3L)
SAR110894 H3 antagonist
Alzheimer's disease
fresolimumab TGFβ antagonist
Fibrosis
SAR245408 (XL147) Oral PI3K inhibitor
Endometrial cancer (1L)
SAR113945 IKK-β inhibitor Osteoarthritis
SAR97276 Antimalarial
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), NSCLC (1L)
ACAM-Cdiff Clostridium difficile
Toxoid vaccine
SAR236553 Anti-PCSK-9 mAb
Hypercholesterolemia
SAR302503 (TG101348) JAK-2 inhibitor
Polycythemia vera (2L) Incyte (ruxolitinib) resistant/intolerant MF
Rabies VRVg Purified vero rabies vaccine
Jevtana®
Cabazitaxel, Microtubule inhibitor Small cell lung cancer (2L)
Meninge ACYW conj. 2nd generation meningococcal
Conjugate infant vaccine
N
N
N
N
N
N
N
N
N
N
35
N
N N
N
N New Molecular Entity Central Nervous System
Genetic diseases
Oncology Metabolic Disorders
Vaccines Internal Medicine
Biosurgery
Thrombosis
Aging
N
Ophthalmology
36
Early Stage Pipeline – Pharma & Vaccines
Phase I SAR153192
Anti-DLL4 mAb Solid tumors
Jevtana®
Cabazitaxel, Microtubule inhibitor Gastric cancer (2L)
SAR402665 (rhASM)
Niemann-Pick type B
Rotavirus Live Attenuated Tetravalent
Rotavirus oral vaccine
SAR402674 (Genz644282) Non-camptothecin topo1 inhibitor
Solid tumors
SAR127963 P75 receptor antagonist
Trauma brain injury
SAR339658 VLA 2 antagonist
Inflammatory Bowel disease
Streptococcus pneumonia Meningitis & pneumonia vaccine
SAR650984 Anti-CD38 naked mAb
Hematological malignancies
SAR404477 (AAV-hAADC) Gene therapy
Parkinson's disease
SAR100842 LPA-1/LPA-3
Skin manifestation of scleroderma
Pseudomonas aeruginosa Antibody fragment product
Prevention of ventilator-associated pneumonia
SAR566658 Maytansin-loaded anti-DS6 mAb
DS6 positive solid tumors
SAR126119 TAFIa inhibitor
Acute ischemic stroke
SAR156597 IL4/IL13 Bi-specific mAb
Idiopathic Pulmonary Fibrosis
Tuberculosis Recombinant subunit vaccine
SAR307746 Anti-Ang2 mAb
Solid tumors
SAR391786 Rehabilitation post orthopedic surgery
SAR407899 Rho kinase inhibitor
Diabetic nephropathy
RetinoStat® Gene therapy
Wet age-related macular degeneration (AMD)
SAR125844 C-Met kinase inhibitor
Solid tumors
SAR228810 Anti-protofibrillar AB mAb
Alzheimer’s disease
lixisenatide + Lantus® GLP-1 agonist + insulin glargine
Single pen device / Type 2 diabetes
StarGen® Gene therapy
Stargardt disease
Combinations SAR245409 / MSC1936369B
SAR245408/SAR256212 (MM121) SAR245408/MSC1936369B
Solid tumors
SAR399063 DHA-GLP + vit D Pre-sarcopenia
SAR164653 Cathepsin A inhibitor
CV-related complications & deaths in diabetic patients
SAR402663 (sFLT-01) Gene therapy
Age related Macular Degeneration (AMD)
SAR393590 (Oral clofaribine) DNA synthesis inhibitor
Hematological malignancies
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
36
N
N
N New Molecular Entity Central Nervous System
Genetic diseases
Oncology Metabolic Disorders
Vaccines Internal Medicine
Biosurgery
Thrombosis
Aging
N
N
N
N
Ophthalmology
37
Phase I Phase II Phase III Registration TOTAL
Oncology 6 4 3 2 15
Metabolic Disorders 2 1 0 2 5
Thrombosis 1 0 1 0 2
Central Nervous System 2 0 1 1 4
Internal Medicine 3 5 1 0 9
Ophthalmology 3 2 0 0 5
Genetic Diseases 1 0 1 0 2
Aging 3 3 0 0 6
Vaccines 4 3 5 1 13
TOTAL 25 18 12 6
R&D Pipeline Summary Table New Molecular Entities (NMEs) and Vaccines
43 18 NMEs & Vaccines
61
37
48
38
Expected R&D Milestones – Pharmaceuticals
38
Product Event Timing
LemtradaTM Regulatory submission in RMS in EU and U.S. Q2 2012
anti-PCSK-9 mAb Initiation of Phase III program in hypercholesterolemia Q2 2012
Lantus® ORIGIN Phase III results Q2 2012
AubagioTM TOWER headline Phase III results in RMS Mid year 2012
AubagioTM Expected approval in RMS in U.S. Q3 2012
Zaltrap® Expected approval in 2nd line mCRC in U.S. Q3 2012
KynamroTM Expected approval in hoFH and severe heFH in EU Q3 2012
Visamerin®/Mulsevo® Expected approval in VTE prevention in cancer patients in U.S. and EU Q3 2012
ombrabulin Phase III results in sarcoma Q3 2012
MACI® Regulatory submission in articular cartilage defects in EU Q3 2012
39
Expected R&D Milestones – Pharmaceuticals
39
Product Event Timing
Lyxumia® Expected approval in type 2 diabetes in EU Q4 2012
Zaltrap® Expected approval in 2nd line mCRC in EU Q4 2012
Lyxumia® Regulatory submission in type 2 diabetes in U.S. Q4 2012
sarilumab Additional Phase III in rheumatoid arthritis Q4 2012
iniparib Phase II results in 2nd line ovarian platinum resistant cancer Q1 2013
SAR110894 Phase II results in Alzheimer’s disease Q1 2013
40
Expected R&D Milestones – Vaccines
40
Product Event Timing
HexaximTM Scientific opinion issued by EMA Q2 2012
Shan5® Start Phase III clinical study Q2 2012
Fluzone® QIV IM File submission in U.S. Q3 2012
Rotavirus Start Phase I clinical study Q3 2012
HexaximTM File submission in EU Q3 2012
Dengue vaccine First efficacy results from Phase IIb Q3 2012
Fluzone® QIV ID Start of Phase III Q4 2012
Vaxigrip® QIV IM File submission Q1 2013
HPV Start Phase I clinical study Q1 2013
APPENDICES FINANCE
41
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 1,321.2 million in the first quarter of 2012 and 1,305.2 million in the first quarter of 2011
First quarter 2012
Net sales 7,316 6,583 11.1% 617 602 2.5% 578 594 (2.7%) 8,511 7,779 9.4%Other revenues 412 404 2.0% 5 5 9 4 125.0% 426 413 3.1%Cost of sales (2,182) (1,927) 13.2% (263) (268) (1.9%) (168) (167) 0.6% (2,613) (2,362) 10.6%As % of net sales (29.8%) (29.3%) (42.6%) (44.5%) (29.1%) (28.1%) (30.7%) (30.4%)Gross profit 5,546 5,060 9.6% 359 339 5.9% 419 431 (2.8%) 6,324 5,830 8.5%As % of net sales 75.8% 76.9% 58.2% 56.3% 72.5% 72.6% 74.3% 74.9%Research and development expenses (994) (940) 5.7% (141) (125) 12.8% (41) (35) 17.1% (1,176) (1,100) 6.9%As % of net sales (13.6%) (14.3%) (22.9%) (20.8%) (7.1%) (5.9%) (13.8%) (14.1%)Selling and general expenses (1,824) (1,645) 10.9% (130) (127) 2.4% (167) (161) 3.7% (2,121) (1,933) 9.7%As % of net sales (24.9%) (25.0%) (21.1%) (21.1%) (28.9%) (27.1%) (24.9%) (24.8%)Other current operating income/expenses 144 62 (1) 1 1 (17) 3 (30) 147 16Share of profit/loss of associates* 302 283 (5) (4) 13 297 292Net income attributable to non-controlling interests (55) (78) 1 (54) (78)Business operating income 3,119 2,742 13.7% 82 84 (2.4%) 213 218 (2.3%) 3 (17) 3,417 3,027 12.9%
As % of net sales 42.6% 41.7% 13.3% 14.0% 36.9% 36.7% 40.1% 38.9%Financial income and expenses (119) (78)
Income tax expense (856) (779)
Tax rate** 28.0% 28.5%Business net income 2,442 2,170 12.5%As % of net sales 28.7% 27.9%Business earnings per share*** (in euros) 1.85 1.66 11.4%
Group Total
Millions of euros Q1 2012 Q1 2011 Q1 2011 Q1 2012 Q1 2011 % changeQ1 2012 Q1 2012 Q1 2011Q1 2011
Pharmaceuticals
% change
Vaccines Animal health Other
% change Q1 2012% change
43 43
Reconciliation of Business Net Income to Consolidated Net Income Attributable to Equity Holders of sanofi
Millions of euros Q1 2012 Q1 2011 % changeBusiness net income 2,442 2,170 12.5%Amortization of intangible assets (1) (833) (736)
Impairment of intangible assets (1) (32)
Fair value remeasurement of contingent consideration liabilities (33) (46)
Expenses arising from the impact of acquisitions on inventories (14) (2)
Restructuring costs (87) (122)
Other gains and losses, and litigation (517)
Tax effect of: 360 510
amortization of intangible assets 332 263 impairment of intangible assets 10 fair value remeasurement of contingent consideration liabilities 2 expenses arising on the workdown of acquired inventories 4 restructuring costs 22 42 other gains and losses, and litigation 195
Other (7) (7)
Net income attributable to equity holders of sanofi 1,827 1,218 50.0%Consolidated earnings per share(2) (in euros) 1.38 0.93 48.4%
Consolidated Income Statements
€ million
Net sales 8,511 7,779
Other revenues 426 413
Cost of sales (2,627) (2,364)
Gross profit 6,310 5,828
Research and development expenses (1,176) (1,100)
Selling and general expenses (2,121) (1,933)
Other operating income 206 118
Other operating expenses (59) (102)
Amortization of intangible assets (833) (736)
Impairment of intangible assets (1) (32)
Fair value remeasurement of contingent consideration liabilities (33) (46)
Restructuring costs (87) (122)
Other gains and losses, and litigation (517)
Operating income 2,206 1,358
Q1 2011Q1 2012
Consolidated Income Statements
€ million
Operating income 2,206 1,358
Financial expenses (139) (101)
Financial income 20 23Income before tax and associates and joint ventures 2,087 1,280
Income tax expense (496) (269)Share of profit / loss of associates and joint ventures 289 285
Net income 1,880 1,296
Net income attributable to non-controlling interests 53 78
Net income attributable to equity holders of sanofi 1,827 1,218
Average number of shares outstanding (million) 1 321.2 1 305.2
Consolidated earnings per share (in euros) 1.38 0.93
Q1 2011Q1 2012