Q3 2011 Results
description
Transcript of Q3 2011 Results
Q3 2011 RESULTS
November 3, 2011
2
Forward Looking Statements
This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts.
These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product
development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”
and similar expressions.
Although Sanofi’s
management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties
inherent
in research
and development, future clinical
data and analysis, including
post marketing, decisions
by regulatory
authorities, such
as the FDA or the EMA, regarding
whether
and when
to approve
any
drug, device
or biological
application that
may
be
filed
for any
such
product
candidates as well
as their
decisions
regarding
labelling and other matters
that
could
affect the availability
or commercial potential
of such
products
candidates, the absence of guarantee
that
the products
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 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, 2010.
Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
33
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
Total Sales (€m)
Sanofi Demonstrates its Ability to Overcome the Patent Cliff in Q3 2011
€8,753m
Business EPS (€)
€1.79
5
€7,395m€7,779m
€8,349m
Q4 2010 Q1 2011 Q2 2011 Q3 2011
€1.41
€1.66 €1.64
Q4 2010 Q1 2011 Q2 2011 Q3 2011
6
Aprovel®
EU
Key Genericized Products(1)
Quarterly Sales (€m)
(1)
Key genericized
products include Lovenox®, Taxotere®, Ambien®, Eloxatin®, Allegra®, Xyzal®, Xatral®
and Nasacort®
in the U.S.
as well as Taxotere®, Plavix®
and Aprovel®
in Western Europe(2)
Eloxatin®
U.S. market exclusivity expected through August 9, 2012
Patent Cliff Sales Exposure Declines Slightly in Q3 2011 despite Recovery of U.S.
Eloxatin®
Sales
€744m
% of Total Sales 13.7% 12.1% 9.3% 8.5%
Eloxatin®
U.S.: €245m(2)
Lovenox®
U.S.
Plavix®
EU
€499m
Others
€773m
€945m
€1,072m
Q4 2010 Q1 2011 Q2 2011 Q3 2011
7
Growth Platforms and Genzyme Continue to Expand in Q3 2011
€5,996m
% of Total Sales 58.0% 59.2% 65.2% 68.5%
Growth Platforms and Genzyme(1)
Quarterly Sales (€m)
(1)
Growth platforms [Emerging Markets, Diabetes, Vaccines excluding
A/H1N1, CHC, New products (Multaq®
& Jevtana®), Animal Health] and Genzyme
€5,447m
€4,607m€4,563m
Q4 2010 Q1 2011 Q2 2011 Q3 2011
8
Growth
Platforms
Sustain
Double-Digit Sales Increase for Three Consecutive Quarters in 2011
Emerging Markets €2,565m, +6.8% excluding A/H1N1 vaccines and Genzyme sales(2)
Consumer Healthcare €665m, +20.3%
Vaccines €1,343m, +19.9% excluding A/H1N1 vaccines(3)
Animal Health €470m, -5.2%
Innovative Products(4)
€111m, +34.5%Diabetes Solutions €1,161m, +12.4%
Growth Platforms : +11.1% in Q3 2011 and +11.9% in first 9M 2011excluding A/H1N1 vaccines and Genzyme sales(1)
Growth is at CER (Constant Exchange Rates)(1)
Q3 2011 Growth
Platforms
sales increased
by +26.5% at
CER including
€33m of A/H1N1 vaccine sales in Q3 2010 and €768m of Genzyme sales in Q3 2011(2)
Q3 2011 Emerging
Markets
sales increased
by +12.0% at
CER including
€117m of Genzyme sales in Q3 2011(3)
Q3 2011 Vaccines sales increased
by +16.7% at
CER when
including
€33m of A/H1N1 vaccine sales in Q3 2010 (4)
Multaq®
and Jevtana®
9
Lyxumia® (lixisenatide)(2)
–
Type 2 diabetes in Oct 2011 in EU
Zaltrap™ (aflibercept)(3)
–
2L-mCRC in Oct 2011 in the U.S.
Five
NME’s
Recently
Submitted
to Regulatory
Agencies
Kynamro™ (mipomersen)(1)
–
hoFH
and Severe heFH
in Jul 2011 in EU
Visamerin® / Mulsevo® (semuloparin)–
VTE prevention in chemo-treated patients in Sep 2011 in the U.S. and EU
Aubagio™ (teriflunomide)–
RMS in Aug 2011 in the U.S.
NME: New Molecular EntityhoFH: Homozygous Familial HypercholesterolemiaheFH: Heterozygous Familial Hypercholesterolemia
RMS: Relapsing Forms of Multiple SclerosisVTE: Venous Thrombo
Embolismm‐CRC: Metastatic Colorectal Cancer
(1)
Licensed from Isis Pharmaceuticals(2)
Licensed from Zealand Pharma(3)
Partnership with Regeneron
10
Important R&D Milestones
Expected
Shortly
Expected Phase III Study Initiations
●
sarilumab -
Extension of MOBILITY trial into
Phase III in rheumatoid
arthritis
●
New formulation of insulin glargine -
Phase III in diabetes
(EDITION)
●
Anti-PCSK-9 mAb -
Phase III trials in hypercholesterolemia
Expected Headline Data Releases
●
Zaltrap™ (aflibercept) -
Phase II in 1st
line colorectal cancer (AFFIRM)
●
Lemtrada™ (alemtuzumab) -
Phase III in RMS (CARE-MS II)
●
Aubagio™ (teriflunomide) -
Phase III in RMS (TENERE)
Expected Regulatory Submissions
●
Kynamro™ (mipomersen) in hoFH
in the U.S.
●
Zaltrap™ (aflibercept) in 2L-mCRC in EU
●
Lemtrada™ (alemtuzumab) in RMS in the U.S. and EU
●
Aubagio™ (teriflunomide) in RMS in EU
Q4 2011
Q4 2011
Q4 2011
Q4 2011
Q4 2011
Q1 2012
Q1 2012
Q1 2012
Q2 2012
hoFH: Homozygous Familial Hypercholesterolemiam‐CRC: Metastatic Colorectal CancerRMS: Relapsing forms of Multiple Sclerosis 10
Zaltrap™, Lemtrada™, Aubagio™
and Kynamro™
are
registered trade names submitted to health authorities
for investigational agents
11
EPS Guidance for FY 2011 Confirmed
YTD September 2011 Q4 2011
●
Impact of multiple generic entries in H2 2010
●
Lack of H1N1 vaccines sales in Q1 2011
●
Loss of exclusivity of Taxotere®
in the U.S. in late Q1 2011
●
Benefit of Genzyme consolidation only as of Q2 2011
●
Expected solid overall sales from growth platforms
●
Low relative quarterly U.S. flu vaccines sales after strong Q3
●
Expected sales of Genzyme consistent with Q3 2011
2011 Business EPS to be 2 to 5% lower than 2010 Business EPS at CER(1,2)
barring major unforeseen adverse events
(1)
Growth is at CER (Constant Exchange Rates)(2)
FY 2010 Business EPS: €7.06 11
BUSINESS PERFORMANCE
12
Hanspeter Spek
President, Global Operations
13
Key Genericized Products(2)
-€471m●
Taxotere® U.S. & Western EU: -€308m
●
Lovenox® U.S.: -€108m
●
Ambien® U.S.: -€98m
●
Allegra® U.S.: -€38m
●
Xyzal® U.S.: -€34m
●
Plavix® Western EU: -€25m
●
Others(2): -€71m
●
Eloxatin® U.S.: +€211m(6)
Q3 2011 Sales Variations (€m)
(1)
Growth platforms: Emerging Markets, Diabetes, Vaccines excluding
A/H1N1, CHC, New products (Multaq®
and Jevtana®), Animal Health(2)
Other key genericized
products include Aprovel®
in Western EU, Nasacort®
and Xatral®
in the U.S. (3)
Incremental quarterly sales contribution from Emerging Markets excluding other Growth Platforms and Genzyme was €61m(4)
A/H1N1 vaccine sales were €33m in Q3 2010 (5)
Genzyme Q3 2011 sales at 2010 exchange rates(6)
Eloxatin®
U.S. market exclusivity expected through August 9, 2012
Growth Platforms and Genzyme Lead to 10.1% Sales Growth in Q3 2011 despite Generic Competition
Growth Platforms(1)
+ €555m●
Emerging Markets: +€291m(3)
●
Vaccines w/o A/H1N1(4): +€237m
●
Diabetes Solutions: +€136m
●
CHC: +€117m
●
Innovative Products: +€30m
●
Animal Health: -€27m
+ €839m(5)
14
(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(2)
Genzyme sales in Emerging Markets were €117m in Q3 2011
Sanofi Is Poised
to Continue Solid
Growth
in Emerging Markets
●
Q3 2011 Emerging Markets(1)
sales of €2,565m, +6.8% at CER without Genzyme or +12.0% at CER with Genzyme(2)
●
Strong sales in BRIC of €901m, +20.2% at CER without Genzyme
or +24.2% at CER with Genzyme
●
Eastern Europe & Turkey impacted by cost containment measures and Taxotere®
genericization●
Emerging Markets up
+11.5% at CER outside Eastern Europe and Turkey excluding Genzyme
Emerging Markets Q3 2011 Sales Split
Growth at CER excluding Genzyme
+12.0%
‐5.4% +17.5%
+3.4%
14
€457m
€631m€649m
€802m
LatinAmerica
EasternEurope &
Turkey
Asia Africa &Middle East
15
Sanofi Shows Impressive Double Digit Sales Growth in Diabetes for the Third Consecutive Quarter in 2011
Quarterly Sales (€m)2
Growth at CER€968m
●
Q3 2011 Diabetes sales of €1,161m, +12.4% at CER ●
[Lantus®
+ Apidra®] up +15.2% at CER in first 9 months of 2011, outpacing competition
●
Strong Q3 performance of Lantus®
●
+14.6% in the U.S. due to increased market penetration of SoloSTAR®
(47.2%)
●
Solid performance in Western Europe of +7.1%
●
Sustained growth in Emerging Markets with sales up +23.4%
+14.6%+14.5%
+13.2%
+8.8%
+6.7%
+10.6%+10.4%
Q1 2010 Q2 2010 Q3 2010 Q4 2010 Q1 2011 Q2 2011 Q3 2011
16
Q3 2009 Q3 2010 Q3 2011
●
Strong performance with Q3 2011 sales of €665m, +20.3 % at CER(1)
●
Successful first allergy season of Allegra®
OTC in the U.S.
●
Sales of €186m in YTD Sep 2011
●
Strong organic growth at CER of other key CHC brands
●
Essentiale®: +8.1%; Dorflex®: +11.3%; Lactacyd®: +25.8%; NoSpa®: +28.1%
Sanofi Delivers +20.3% Growth in CHC in Q3 2011
+20.3% at CER
€665m
Quarterly Sales (€m)
(1)
Growth at constant perimeter and exchange rate was +13.8% in Q3 2011
17
U.S.
Western
Europe
●
Solid Q3 sales of €410m, +9.2% at CER●
64.4% of Generics sales in Emerging Markets: €264m, +9.9% at CER
●
Authorized generics of Ambien®
CR and Taxotere®
in the U.S.
●
Medley expansion in Latin America
initiated●
+10.5%
at
CER in Brazil
and +37.2% at
CER in LatAm
excluding
Brazil
●
Launch
of our
authorized
generic
of Lovenox®
in October
in the U.S.
Sanofi Achieves Another Solid Performance in Generics in Q3 2011
€410mQuarterly Sales (€m)
17
Q3 2009 Q3 2010 Q3 2011
Emerging
Markets
Others
18
Cardio-Thrombosis
Leading Brands Generate Annualized ex-U.S. Sales of > €1.8bn in Q3 2011
●
Q3 2011 presence: ●
€1,738m, +6.5% at CER(1,2)
●
€554m,
+1.1% at CER outside the U.S.
●
Q3 2011 sales: ●
€494m,
-12,7% at CER●
€361m,
+9.9% at CER outside the U.S.
(1)
Includes sales consolidated by Bristol‐Myers Squibb(2)
The BMS alliance does not cover rights to Plavix®
in Japan; sales of Plavix®
in Japan are consolidated by Sanofi
Q3 2011 Lovenox®
salesQ3 2011 Plavix®
presence(1,2)
U.S. €133m-42.4%
Emerging Markets€137m +11.6%
Western EU €199m +8.7%
Others €25m +9.5%
U.S. €1,185m+9.0%
Japan + China €234m +22.6%
EU €143m -21.0%
Others €176m +0.8%
69%8%
13%
10% 27%
40%
28%
5%
19
Genzyme Driven
by Performance of Key Products in Q3 2011
●
Q3 2011 sales of €768m, +6.9% at constant rate and perimeter●
Strong
sales of Myozyme®
/ Lumizyme®
of €101m, +27.2%
●
Cerezyme®
growth still limited by reduced product availability
●
New Fabrazyme®
plant continues to be on track with internal and regulatory milestones
●
Solid performance of Renagel®
/ Renvela®
and Synvisc®
franchise
●
Two regulatory filings submitted: Kynamro™ in EU and Aubagio™
in the U.S.
+7.0%
+27.2%
+6.7%
Others -0.7% +24.9%
+11.3%
&
&
Quarterly Sales Split by Products
Growth at CER
Kynamro™
is the registered name submitted to health authorities for the investigational agent mipomersenAubagio™
is the registered name submitted to health authorities for the investigational agent teriflumomide
20
Temporary
Slowdown
of Merial
in Q3 2011 due to "At-Risk"
Generic
Launch
in the U.S. and Strong
Q2 2011
●
Q3 sales of €470m, -5.2% at CER
●
Solid sales in Production Animals of €175m, +5.4% at CER
●
Sales in Companion Animals of €295m impacted by temporary U.S. generic competitor of Frontline®
Plus●
Positive U.S. court ruling barring further sales of Cipla
and Velcera’s
generics
and ordering seizure of U.S. inventory in possession of generic makers
●
Launch
of Certifect®
in the U.S.
21
Early
Shipments
of U.S. Seasonal
Flu
Vaccines Boost Sanofi Pasteur Sales in Q3 2011
€1,343m
+19.9%
at
CER
excludingA/H1N1
●
Q3 2011 Vaccine sales of €1,343m, +19.9% at CER excluding A/H1N1(1)
●
Strong seasonal flu sales of €602m, +42.6% at CER excluding A/H1N1 ●
First U.S. doses shipped July 18 and ~90% of doses shipped in Q3 2011
●
Further differentiation with launch of Fluzone®
Intradermal
in the U.S.
●
Continued resilience of Menactra®
in Q3 2011: €195m, +10.2% at CER
●
Strong sales of Pentaxim®
in Emerging Markets: €52.6m,
+18.5% at CER
Vaccines Consolidated Sales (€m)
21(1)
A/H1N1 vaccines sales were €33m in Q3 2010
Q3 2010 Q3 2011Seasonal Influenza Pandemic InfluenzaPolio/Pertussis/Hib Meningitis/PneumoniaBoosters Travel & EndemicsOther
FINANCIAL PERFORMANCE
Jérôme
Contamine
Executive Vice President, Chief Financial Officer
22
23
€8,753m
€8,339m
Q3 2010 KeyGenericized
Brands
OthersincludingA/H1N1
GrowthPlatforms
Genzyme FX Impact Q3 2011
USD : -€299mVEF : -€42mTRY : -€26m
Others : -€59m
Genzyme Sales Add
to a Stable Base and More than Offset Negative
Fx Impact in Q3 2011 vs. Q3 2010
Q3 2011 sales (€m)
VEF: Venezuelan BolivarTRY: Turkish Lira
+0.0%
+10.1% ‐5.1%
+5.0%‐
€426m
‐
€471 + €555m
24
P&L Continues to Reflect
Genzyme Consolidation and Shift in Business Mix in Q3 2011
€m Q3 2011 Q3 2010 % Change
(reported €)
% Change
(CER)
Net sales 8,753 8,339 +5.0% +10.1%
Other
revenues 419 443 -5.4% +2.3%
Cost of sales (2,755) (2,444) +12.7% +17.4%
Gross profit 6,417 6,338 +1.2% +6.7%
R&D (1,221) (1,123) +8.7% +12.8%
SG&A (2,114) (2,004) +5.5% +10.4%
Other current operating income & expenses 40 33 - -
Share of Profit/Loss of associates 276 292 - -
Minority interests (54) (54) - -
Business operating income 3,344 3,482 -4.0% +2.8%
Business operating margin 38.2% 41.8% - -
CER: Constant Exchange Rates
25
Cost
of Sales of 30.9% in first 9M 2011 In-Line with
FY 2011 Estimate
Cost of Sales (%)●
Higher Cost of Sales in Q3 2011 vs. Q3 2010 due to:
●
Loss of sales of €471m from key genericized
products with relatively low Cost of Sales
●
Business mix impact from strong vaccines sales
●
Cost of Sales ratio in 9M 2011 aligned with expected Cost of Sales level for FY 2011
25
2010 2011
31.5%31.0%30.4%
Q1 Q2 Q3 Q4 Q1 Q2 Q3
26
2010 2011
Increase
in R&D Expenses
due to the Addition of Genzyme R&D Costs
in Q3 2011
R&D/Sales Ratio (%)●
Q3 2011 R&D expenses of €1,221m, up 12.8% at CER
●
Addition of €139m of R&D expenses from Genzyme
●
R&D expenses down 0.8% at CER excluding Genzyme
●
R&D/Sales ratio slightly down vs. Q2 2011 to 13.9%
26
13.9%14.3%14.1%
Q1 Q2 Q3 Q4 Q1 Q2 Q3
27
2010 2011
SG&A Expenses
Excluding
Genzyme
Decline
in Q3 2011
SG&A/Sales Ratio (%)●
Q3 2011 SG&A expenses of €2,114m, up +10.4% at CER
●
Tight control of SG&A expenses leading to 2% decline excluding Genzyme
●
SG&A/Sales ratio only slightly up
in Q3 2011 vs. last year reflecting:
●
Lower ratio of Selling & Marketing Expenses to Sales ratio
●
Start of implementation of Genzyme synergies
27
24.2%
27.2%24.8%
Q1 Q2 Q3 Q4 Q1 Q2 Q3
28
€m Q3 2011 Q3 2010 % Change
(reported €)
% Change
(CER)
Business operating income 3,344 3,482 -4.0% +2.8%
Net financial
expenses (121) (127) - -
Income
tax
expense (825) (883) - -
Effective tax rate -27.5% -28.3% - -
Business net income 2,398 2,472 -3.0% +4.1%
Net margin 27.4% 29.6% - -
Business EPS € 1.79 € 1.89 -5.3% +1.6%
Average number of shares outstanding (in million) 1,339.4 1,304.8 - -
Business Net Income up 4.1% at CER in Q3 2011 After Two Quarters of Declining BNI
CER: constant exchange rates 28
29
Net Debt Jun 30, 2011
Net Cashfrom
OperatingActivities CapEx
Acquisitions& Licensing
ShareRepurchase
RestructuringCosts &Others
Net Debt Sep 30, 2011
Strong
Free Cash Flow in Q3 2011
- €11,938m- €413m
+ €2,016m
- €57m
+ €3,326m
- €13,231m - €388m
(1)
Represents 10,195,453 shares at an average price of €49.03(2)
Excluding Restructuring Costs(3)
Including €989m Fx
translation effect on Net Debt vs. end of June 2011
(2)
- €1,175m
(3)
●
Strong Free Cash Flow of €2,913m, up +3.3% in Q3 2011
●
€500m of opportunistic share repurchases to date in 2011(1)
●
Low average cost of gross debt of 2.4% in Q3 2011
30
Successfully Navigating through the Patent Cliff and Investing in Sustainable Growth in first 9M 2011
Double-digit sales increase of growth platforms(1,2) in first 9M 2011
Significant generic headwind of >€1.7bn in first 9M 2011
On-track to deliver the €2.0bn cost savings objective by end of 2011(3)
Limited erosion of Business EPS of 3.5% at CER w/o A/H1N1 in first 9M 2011
(1)
Excluding Genzyme and A/H1N1 (2)
Growth platforms [Emerging Markets, Diabetes, Vaccines excluding
A/H1N1, CHC, New products (Multaq®
and Jevtana®), Animal Health](3)
Before inflation and tax on a constant structure basis vs. 2008(4)
In Q3 2009, Merial
Joint Venture sales of €443m were not consolidated by Sanofi
With a 50% share of Merial
Joint Venture sales, Sanofi pro forma growth platforms sales would have been €3,911m(5)
Q3 2010 and Q3 2011 sales include 100% of Merial
sales, respectively €518m and €470m(6)
Q3 2011 includes Genzyme sales of €768m
Proportion of Sales from
Growth
Platforms
and Genzyme(1)
Q3 2009 Q3 2010 Q3 2011(4) (5) (5, 6)
51.3% 60.2% 68.5%
APPENDICES
R&D Pipeline
32
Late Stage Pipeline –
Pharma & Vaccines
N New Molecular Entity
G GenzymeCentral Nervous System
Genetic diseases
OncologyMetabolic Disorders
Vaccines
Internal Medicine
RegistrationPhase III
Biosurgery
* ORIGIN: Evaluation of Lantus®
in reducing cardiovascular morbidity & mortality
iniparib (BSI-201)
squamous
NSCLC
MACI®Cell-based treatment
Articular
cartilage defects
Quadracel®
Diphtheria, tetanus, pertussis
& polio vaccine; 4-6 y of age
Hexaxim®
DTP-HepB-Polio-Hib
vaccine
aflibercept VEGF-Trap
2nd
line mCRC
EU; 1st line mHRPC
otamixaban Direct Xa
inhibitor ACS
Fluzone® QIV IM Quadrivalent
inactivated influenza
vaccine
Plavix®
clopidogrel
bisulfate Stent, Japan
ombrabulin (AVE8062)
Vascular disrupting agent
Sarcoma
Plavix®
clopidogrel
bisulfate PAD, Japan
Dengue Mild-to-severe
dengue fever vaccine
semuloparin (AVE5026)
Indirect Xa/IIa
inhibitor
VTE prevention in cancer patients
Clolar® / Evoltra®
Purine
nucleoside analogAdult acute myeloid leukemia (AML)
Lantus®
insulin glargine
ORIGIN*; Pediatric, EU
DTP-HepB-Polio-Hib Pediatric hexavalent
vaccine
teriflunomide Relapsing forms of multiple sclerosis
(RMS) –
monotherapy, U.S.
teriflunomide Multiple sclerosis
(monotherapy, adjunct therapy & CIS)
lixisenatide (AVE0010)
GLP-1 agonist Type 2 diabetes
Allegra®
fexofenadine
Dry syrup, Japan
mipomersenApolipoprotein
B-100 antisensehoFH
and severe heFH, EU
alemtuzumabAnti-CD52 mAb
Multiple sclerosis
mipomersenApolipoprotein
B-100 antisensehoFH
(U.S.)
sarilumab (SAR153191)
Anti-IL-6R mAb
RA
lixisenatide (AVE0010)
GLP-1 agonist Type 2 diabetes, EU
eliglustat tartrateGlucosylceramide
synthetase
inhibitorGaucher
disease
prochymalMesenchymal
stem cellGraft-versus-host disease
aflibercept VEGF-Trap
2nd
line mCRC, U.S.
N
G
G
G
N
N
N
N
N
N
G
N
G
Thrombosis
N
G
N
32
N
33
Early Stage Pipeline –
Pharma & Vaccines
N New Molecular Entity
G GenzymeCentral Nervous SystemCardiovascularGenetic diseases
OncologyMetabolic Disorders
VaccinesInternal Medicine
Phase II
Ophthalmology
iniparib (BSI-201)
Ovarian cancer, non-squamous
NSCLC, neoadjuvant
breast cancer
FOV1101 FDC prednisolone/ cyclosporine
Allergic conjunctivitis
Multaq®
Antiarrhythmic
agent
Atrial
fibrillation, Japan
aflibercept VEGF-Trap
1st line mCRC
FOV2302 Plasma kallikrein
inhibitor
Retinal vein occlusion induced macular edema
SAR231893 Anti-IL4 mAb
Asthma; Atopic dermatitis
SAR256212 (MM-121)
anti-ErbB3 mAb
Breast cancer
FOV2304 Bradykinin
B1 antagonist
Diabetic macular edema
ferroquine Antimalarial
Malaria
SAR245408 (XL147)
Oral PI3K inhibitor
Endometrial cancer
SAR164877 Anti-NGF mAb
Pain
(on clinical hold)
fresolimumabTGFβ
antagonistFibrosis
SAR245409 (XL765)
Oral dual inhibitor of PI3K & mTOR
Breast cancer
SAR110894 H3 antagonist
Alzheimer's disease
ACAM-Cdiff Clostridium difficile
Toxoid
vaccine
ombrabulin (AVE8062)
Vascular disrupting agent
Ovarian 2nd
line, NSCLC 1st
line
atalurenTranscription modulator
Cystic fibrosis
Rabies mAb
post exposure prophylaxis
SAR302503 JAK-2 inhibitor
Myelofibrosis
SAR236553 (REGN727)
Anti-PCSK-9 mAb
Hypercholesterolemia
Rabies VRVg Purified vero
rabies vaccine
Recombinant human TSH Modified (rhTSH-M)
Goiter
Meninge ACYW conj. 2nd
generation meningococcal
conjugate Infant vaccine
N
N
N
N
N
N
N
N
N
N
N
G N
G N
NG
33
N
34
Early Stage Pipeline –
Pharma & Vaccines
Phase ISAR153192
Anti-DLL4 mAb
Solid tumors
Genz644282 Topoisomerase-1 inhibitor
Solid tumors
Gene therapy (sFLT-01)
Age related Macular Degeneration
(AMD)
SAR114137 Cathepsin
S/K inhibitor
OA pain & Peripheral neuropathic pain
SAR3419 Maytansin-loaded anti-CD19 mAb
B-cell malignancies (NHL, ALL)
Mozobil® (plerixafor)
CXCR4 Antagonist
AML
Gene therapy (AAV-AADC)
Parkinson's disease
SAR411298 FAAH inhibitor
Cancer pain
SAR256212 (MM-121) anti-ErbB3 mAb
Solid tumors, ovarian cancer
GC1008 Anti-TGFβ
mAb
Solid tumors
SAR339658 VLA 2 antagonist
Inflammatory Bowel disease
Rotavirus Live Attenuated Tetravalent
Rotavirus oral vaccine
SAR103168 Multikinase
inhibitor
AML
Oral clofaribine Purine
nucleoside analog
Myelodysplastic
syndrome
SAR113945 IKK-β
inhibitor
Osteoarthritis
Streptococcus pneumonia Meningitis & pneumonia vaccine
SAR650984 Anti-CD38 naked mAb
Hematological malignancies
SAR407899 Rho kinase
inhibitor
Diabetic nephropathy
SAR292833 (GRC15300)
TRPV3 antagonist
Neuropathic pain, osteoarthritic
pain
Pseudomonas aeruginosa Antibody fragment product
Prevention of ventilator-associated pneumonia
SAR302503 (TG101348)
JAK-2 inhibitor
Polycythemia
vera, Incyte
resistant MF
lixisenatide + Lantus®
GLP-1 agonist + insulin glargine
Single pen device / Type 2 diabetes
SAR100842 LPA-1/LPA-3
Internal medicine
Tuberculosis Recombinant subunit vaccine
SAR566658 Maytansin-loaded anti-DS6
DS6 positive solid tumors
SAR101099 Urotensin
II receptor antagonist
Diabetic nephropathy
SAR279356 (F598)
Anti-PNAG mAb
Serious infections
RetinoStat®
Gene therapy
Wet
age-related
macular
degeneration
(AMD)
SAR307746 (REGN910)
Anti-Ang2 mAb
Solid tumors
New formulation Insulin
glargine
Type 1+2 diabetes
SAR97276 Antimalarial
Malaria
StarGen®
Gene therapy
Stargardt
disease
SAR125844 Met kinase
inhibitor
Solid tumors
SAR164653 Cathepsin
A inhibitor
CV-related
complications & deaths
in diabetic
patients
SAR156597 IL4/IL13 Bi-specific
mAb
Idiopathic
Pulmonary
Fibrosis
SAR104772/SAR126119 TAFIa
inhibitor
Acute ischemic stroke
Combinations SAR245408 / MSC1936369B
SAR245409 / MSC1936369B
Acid sphingomyelinase Niemann-Pick type B
N
N
N
N
N
N
N
N
G
G
N
N
G
G
N New Molecular EntityG Genzyme
Central Nervous SystemGenetic diseasesOncology
Metabolic DisordersVaccinesInternal Medicine
Thrombosis
Ophthalmology
N
N
N
N
N
N
N
N
N
N
N
N N
G
G N
NG
34
N
N
35
Phase I Phase II Phase III Registration TOTAL
Oncology 9 4 2 1 16
Metabolic Disorders 3 2 0 2 7
Thrombosis 1 0 1 1 3
Central Nervous System 2 2 0 1 5
Internal Medicine 7 3 2 0 12
Ophthalmology 2 3 0 0 5
Genetic Diseases 3 1 1 0 5
Vaccines 4 4 4 1 13
TOTAL 31 19 10 6
R&D Pipeline Summary Table New Molecular Entities (NMEs) and Vaccines
50 16NMEs
& Vaccines
53
66
35
36
Anticipated
R&D Newsflow
Q4 2011
Q4 2011
Q4 2011
Q1 2012
Q4 2011
Q4 2011
Q1 2012
Expected
Key Milestones
-
Pharmaceuticals Timing
Regulatory submission of ZaltrapTM in 2nd line mCRC in EU
Phase II results of ZaltrapTM in 1st line mCRC (AFFIRM)
Initiation of Phase III study with new insulin glargine formulation in diabetes (EDITION)
Phase III top-line results of LemtradaTM in multiple sclerosis (CARE-MS II)
Phase III top-line results of AubagioTM in multiple sclerosis (TENERE)
Regulatory submission of KynamroTM in U.S. for hoFH
Regulatory submission of AubagioTM in EU
36
Q1 2012Regulatory submission of LemtradaTM in MS in U.S. and EU
Q2 2012Initiation of Phase III study with anti-PCSK-9 mAb in hypercholesterolemia
37
Anticipated R&D Newsflow
37
Q4 2012
Q4 2011
Q2 2012
Expected
Key Milestones
-
Vaccines
Scientific opinion for HexaximTM issued by EMA
Start of Phase III for Fluzone® QIV ID
Start of Phase III for Vaxigrip® QIV IM
File Submission in US for Fluzone® QIV IM Q3 2012
File Submission in EU for HexaximTM Q3 2012
Timing
APPENDICES
FINANCE
39
Business Net Income Statement -
Q3 2011
* 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 1,339.4 million in the third quarter of 2011 and 1,304.8 million in the third quarter of 2010(1)
In 2010, the results of operations of the Merial
business previously presented as "held‐for‐exchange" were reclassified and included in income from
continuing operations in accordance with IFRS5 § 36, following the announcement to maintain Merial
and Intervet/Schering‐Plough as two
separate organizations.
Third quarter 2011
Net sales 6,940 6,595 5.2% 1,343 1,226 9.5% 470 518 (9.3%) 8,753 8,339 5.0%Other revenues 406 429 (5.4%) 8 9 (11.1%) 5 5 419 443 (5.4%)Cost of sales (2,094) (1,843) 13.6% (502) (451) 11.3% (159) (150) 6.0% (2,755) (2,444) 12.7%As % of net sales (30.2%) (27.9%) (37.4%) (36.8%) (33,9%) (29.0%) (31.5%) (29.3%)Gross profit 5,252 5,181 1.4% 849 784 8.3% 316 373 (15.3%) 6,417 6,338 1.2%As % of net sales 75.7% 78.6% 63.2% 63.9% 67.2% 72.0% 73.3% 76.0%Research and development expenses (1,031) (954) 8.1% (154) (131) 17.6% (36) (38) (5.3%) (1,221) (1,123) 8.7%As % of net sales (14.9%) (14.5%) (11.5%) (10.7%) (7,7%) (7.3%) (13.9%) (13.5%)Selling and general expenses (1,827) (1,707) 7.0% (140) (144) (2.8%) (147) (153) (3.9%) (2,114) (2,004) 5.5%As % of net sales (26.3%) (25.9%) (10.4%) (11.7%) (31.2%) (29.5%) (24.2%) (24.0%)Other current operating income/expenses (1) 54 2 10 (4) (6) 43 (25) 40 33Share of profit/loss of associates* 269 267 7 25 276 292Net income attributable to non-controlling interests (55) (53) 1 (1) (54) (54)Business operating income 2,607 2,788 (6,5%) 564 544 3.7% 130 175 (25.7%) 43 (25) 3,344 3,482 (4.0%)As % of net sales 37.6% 42.3% 42.0% 44.4% 27.7% 33.8% 38.2% 41.8%Financial income and expenses (121) (127)Income tax expense (825) (883)Tax rate** 27.5% 28.3%
Business net income 2,398 2,472 (3.0%)As % of net sales 27.4% 29.6%Business earnings per share*** (in euros) 1.79 1.89
% changeQ3 2011 Q3 2011 Q3 2010Q3 2010
Pharmaceuticals%
change
Group Total
Millions of euros Q3 2011 Q3 2010 Q3 2010 Q3 2011Q3
2010(1) Q3 2011% change
Other%
change
Vaccines Animal health
40
Nine months 2011
Net sales 20,670 20,071 3.0% 2,651 2,918 (9.2%) 1,560 1,555 0.3% 24,881 24,544 1.4%Other revenues 1,222 1,215 0.6% 18 21 (14.3%) 14 14 1,254 1,250 0.3%Cost of sales (6,167) (5,374) 14.8% (1,052) (1,003) 4.9% (486) (453) 7.3% (7,705) (6,830) 12.8%As % of net sales (29.8%) (26.8%) (39.7%) (34.4%) (31.2%) (29.1%) (30.9%) (27.8%)Gross profit 15,725 15,912 (1.2%) 1,617 1,936 (16.5%) 1,088 1,116 (2.5%) 18 430 18,964 (2.8%)As % of net sales 76.1% 79.3% 61.0% 66.3% 69.7% 71.8% 74.1% 77.3%Research and development expenses (2,994) (2,897) 3.3% (418) (378) 10.6% (106) (113) (6.2%) (3,518) (3,388) 3.8%As % of net sales (14.5%) (14.4%) (15.8%) (13.0%) (6.8%) (7.3%) (14.1%) (13.8%)Selling and general expenses (5,441) (5,080) 7,1% (404) (428) (5,6%) (469) (459) 2,2% (1) (2) (6,315) (5,969) 5.8%As % of net sales (26.3%) (25.3%) (15.2%) (14.6%) (30.1%) (29.5%) (25.4%) (24.3%)Other current operating income/expenses 41 222 1 8 (11) 32 (95) 63 135Share of profit/loss of associates* 828 758 5 17 13 8 846 783Net income attributable to non-controlling interests (191) (203) 1 1 (190) (202)Business operating income 7,968 8,712 (8,5%) 801 1,156 (30,7%) 503 544 (7,5%) 44 (89) 9,316 10,323 (9.8%)As % of net sales 38.5% 43.4% 30.2% 39.6% 32.2% 35.0% 37.4% 42.1%Financial income and expenses (299) (267)Income tax expense (2,299) (2,679)Tax rate** 27.5% 28.3%Business net income 6,718 7,377 (8.9%)As % of net sales 27.0% 30.1%Business earnings per share*** (in euros) 5.09 5.65
Other%
change
Vaccines Animal health Group Total
Millions of euros 9M 2011 9M 2010 9M 2010 9M 20119M
2010(1) 9M 2011% change
% change9M 2011 9M 2011 9M 20109M 2010
Pharmaceuticals%
change
Business Net Income Statement -
YTD Sep 2011
* 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 1,318.9 million in the first 9 months of 2011 and 1,305.5 million in the
first 9 months of 2010(1)
In 2010, the results of operations of the Merial
business previously presented as "held‐for‐exchange" were reclassified and included in income from
continuing operations in accordance with IFRS5 § 36, following the announcement to maintain Merial
and Intervet/Schering‐Plough as two
separate organizations.
41
Reconciliation of Business Net Income to Consolidated Net Income -
Q3 2011
(1)
The results of operations of the Merial
business previously presented as “held‐for‐exchange”
were reclassified and included in income from
continuing operations in accordance with IFRS5 §36, following the announcement to maintain Merial
and Intervet/Schering Plough as two
separate organizations. (2)
Of which amortization expense generated by the remeasurement of intangible assets as part of business combinations: €
760 million in the
third quarter of 2011 and €
831 million in the third quarter of 2010(3)
In 2011: “Catch up”
in respect of 2009 and 2010 depreciation and amortization expense on PP&E* and intangible assets of Merial, previously
classified as “Assets held for sale or exchange”
(IFRS5 § 27).(4)
Based on an average number of shares outstanding of 1,339.4 million in the third quarter of 2011 and 1,304.8 in the third quarter of 2010.* Property, Plant and Equipment.
Millions of euros Q3 2011 Q3 2010 % changeBusiness net income 2 398 2 472 (3,0%)Amortization of intangible assets (2) (804) (879)
Impairment of intangible assets (7) (171)
Fair value remeasurement of contingent consideration liabilities 233
Expenses arising from the impact of acquisitions on inventories (140) (2)
Restructuring costs (70) (302)
Other gains and losses, and litigation (3)
Discontinuation of depreciation of PP&E* (IFRS5) 19
Tax effect of: 427 478
amortization of intangible assets 354 319 impairment of intangible assets 2 60 fair value remeasurement of contingent consideration liabilities 5 expenses arising on the workdown of acquired inventories 42 restructuring costs 24 104 other gains and losses, and litigation discontinuation of depreciation of PP&E* (IFRS5) (5)
Other tax items
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 (7) (7)
Net income attributable to equity holders of sanofi 2 030 1 609 26,2%
Consolidated earnings per share (4) (in euros) 1,52 1,23 23,6%
42
Reconciliation of Business Net Income to Consolidated Net Income -
YTD Sep 2011
(1)
The results of operations of the Merial
business previously presented as “held‐for‐exchange”
were reclassified and included in income from
continuing operations in accordance with IFRS5 §36, following the announcement to maintain Merial
and Intervet/Schering Plough as two
separate organizations. (2)
Of which amortization expense generated by the remeasurement of intangible assets as part of business combinations: €
2,367 million in the
first 9 months of 2011 and €
2,532 million in the first 9 months of 2010(3)
In 2011: “Catch up”
in respect of 2009 and 2010 depreciation and amortization expense on PP&E* and intangible assets of Merial, previously
classified as “Assets held for sale or exchange”
(IFRS5 § 27).(4)
Based on an average number of shares outstanding of 1,318.9 million in the first 9 months of 2011 and 1,305.5 in the first 9 months of 2010.* Property, Plant and Equipment.
Millions of euros 9M 2011 9M 2010 % changeBusiness net income 6 718 7 377 (8,9%)Amortization of intangible assets (2) (2 505) (2 681)
Impairment of intangible assets (76) (279)
Fair value remeasurement of contingent consideration liabilities 167
Expenses arising from the impact of acquisitions on inventories (404) (136)
Restructuring costs (537) (492)
Other gains and losses, and litigation (3) (517)
Discontinuation of depreciation of PP&E* (IFRS5) 58
Tax effect of: 1 429 1 203
amortization of intangible assets 913 918 impairment of intangible assets 22 93 fair value remeasurement of contingent consideration liabilities 10 expenses arising on the workdown of acquired inventories 120 43 restructuring costs 174 167 other gains and losses, and litigation 190 discontinuation of depreciation of PP&E* (IFRS5) (18)
Other tax items
Share of items listed above attributable to non-controlling interests 2
Restructuring costs of associates and joint ventures, and expenses arising from the impact of acquisitions on associates and joint ventures (21) (22)
Net income attributable to equity holders of sanofi 4 254 5 030 (15,4%)
Consolidated earnings per share (4) (in euros) 3,23 3,85 (16,1%)
43
Consolidated Income Statements
(1)
The results of operations of the Merial
business previously presented as “held‐for‐exchange”
were reclassified and included in income from
continuing operations in accordance with IFRS5 §36, following the announcement to maintain Merial
and Intervet‐Schering Plough as two
separate organizations.
Millions of euros
Net sales 8,753 8,339 24,881 24,544
Other revenues 419 443 1,254 1,250
Cost of sales (2,895) (2,433) (8,109) (6,929)
Gross profit 6,277 6,349 18,026 18,865
Research and development expenses (1,221) (1,120) (3,518) (3,380)
Selling and general expenses (2,114) (2,001) (6,315) (5,956)
Other operating income 90 96 281 339
Other operating expenses (50) (63) (218) (204)
Amortization of intangible assets (804) (879) (2,505) (2,681)
Impairment of intangible assets (7) (171) (76) (279)
Fair value remeasurement of contingent consideration liabilities 233 167
Restructuring costs (70) (302) (537) (492)
Other gains and losses, and litigation (517)
Operating income 2,334 1,909 4,788 6,212
Q3 2010 (1)Q3 2011 9M 2010 (1)9M 2011
44
Consolidated Income Statements
(1)
The results of operations of the Merial
business previously presented as “held‐for‐exchange”
were reclassified and included in income from
continuing operations in accordance with IFRS5 §36, following the announcement to maintain Merial
and Intervet‐Schering Plough as two
separate organizations.
Millions of euros
Operating income 2,334 1,909 4,788 6,212
Financial expenses (153) (116) (387) (330)
Financial income 32 (11) 88 63Income before tax and associates and joint ventures 2,213 1,782 4,489 5,945
Income tax expense (398) (405) (870) (1 476)
Share of profit / loss of associates and joint ventures 269 285 825 761
Net income 2,084 1,662 4,444 5,230
Net income attributable to non-controlling interests 54 53 190 200
Net income attributable to equity holders of sanofi 2,030 1,609 4,254 5,030
Average number of shares outstanding (million) 1,339.4 1,304.8 1,318.9 1,305.5
Consolidated earnings per share (in euros) 1.52 1.23 3.23 3.85
Q3 2010 (1)Q3 2011 9M 2010 (1)9M 2011