LEERINK SWAN HEALTHCARE CONFERENCE David Meeker, Chief Executive Officer, Genzyme
February 16, 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 labelling 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, 2010. 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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Highlights of key achievements to date
Rare diseases opportunity
Agenda
Multiple sclerosis opportunity
Rare diseases and Genzyme
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Sanofi Grew Sales in 2011 due to Genzyme Acquisition and Growth Platforms
2011
€33,389m
2010
€32,367m
2009
€29,306m
2008
€27,568m
Sales
+5.3% at CER
4 (1) In 2008 and 2009, Merial Joint Venture sales were not consolidated by Sanofi (2) In 2010, excluding non-consolidated sales from Merial, Sanofi reported sales of €30,384m
(1) (1) (2)
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2009 2011 2010 2008
% of Total
42.7% 65.0%
Sales of Growth Platforms(1) & Genzyme
Sanofi Boosted Sales of its Growth Platforms and Significantly Reduced its Patent Cliff Exposure in 2011
(1) 2010 include sales of Merial. In 2008 and 2009, Merial Joint Venture sales were not consolidated by Sanofi (2) Lovenox® U.S., Plavix® Western EU, Taxotere® Western EU & U.S., Eloxatin® U.S., Ambien CR® U.S., Allegra® U.S., Aprovel® Western EU, Xyzal® U.S., Xatral® U.S., Nasacort® U.S. - Generic makers of oxaliplatin required to cease selling in the U.S. since June 30, 2010 but judgement is under appeal by Sun.
2011 2009 2010 2008
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% of Total
27.4% 9.4%
Sales of Key Genericized Products(2)
€21,703m
€11,783m
€3,152m
€7,565m
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€6.61
2011
€6.65
2010
€7.06
2009 2008
€5.59
Patent Cliff Impact on EPS Mitigated in 2011
Business EPS
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-3.8% at CER
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Successful Acquisition of Genzyme in 2011
Strong management team in place Focus on Rare Diseases and Multiple Sclerosis
Completing the integration
Ensuring manufacturing recovery
Creating synergies Achieved synergies of $230m in 2011
Advancing R&D pipeline Strong Phase III results with LemtradaTM
Oral eliglustat Phase III program fully recruited Cambridge positioned as primary U.S. research site
A SANOFI COMPANY
FDA and EMA approvals granted for Framingham plant to supply Fabrazyme®
Progress towards focusing Allston plant on Cerezyme® Target inventory increase of Cerezyme® and Fabrazyme®
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Q2 2011 Q3 2011 Q4 2011
Genzyme Recovery On Track
Quarterly Sales(1) (€m)
&
● FY 2011 Genzyme consolidated sales reached €2,395m, +7.7%(1,2)
● Q4 2011 sales of €831m, +0.8%(2) ● Rare Diseases sales of €346m
• Solid performance of Myozyme®/ Lumizyme® of €108m, +15.9%
• Cerezyme® and Fabrazyme® sales constrained by supply
● Good performance of Renagel®/ Renvela® and Synvisc® franchise
● EMA and FDA approvals granted for Framingham plant in Jan 2012 ● Complete return to normal supply
levels of Fabrazyme® to begin in Q2 2012
& Others
(1) Genzyme sales are consolidated since April 1, 2011 (2) Change on a constant structure basis and at constant exchange rates
€796m €768m €831m
Others
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Highlights of key achievements to date
Rare diseases opportunity
Agenda
Multiple sclerosis opportunity
Rare diseases and Genzyme
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Orphan Drug Market
Orphan Drug Market is Attractive and Offers Growth Potential Due to Significant Unmet Needs
● Significant unmet needs create strong growth potential ● Under-served patient population
● Drugs available for only ~200 out of >6,000 orphan diseases(1)
● 85% orphan diseases are life threatening and 50% are pediatric(2)
● Several attractive market characteristics ● Unique development challenges
● Regulatory exclusivity period
● >$10bn sales for orphan-only drugs growing at high single digit since 2000 ● Expected to reach $18bn in 2015(3)
10 (1) BioWorld Today, 2011 (2) Food and Drug Administration, "Office of Orphan Products Development," Budget 2010 (3) EvaluatePharma; internal analysis
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Unleashing the Full Potential of Genzyme within Sanofi
Develop MS
franchise
Escalate existing
R&D programs
Broaden biologics
experience
Leverage global
scope and manufacturing
expertise
Create R&D hub in Boston
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Highlights of key achievements to date
Rare diseases opportunity
Agenda
Multiple sclerosis opportunity
Rare diseases and Genzyme
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1983
2001
Cerezyme® is the Foundation of the Genzyme Model
Transformative Therapy
2011 Sales Split
Ensure Market Access Extensive Global Reach
● Increase awareness
● Enable access to diagnostic testing
● Identify and train experts
● Support patient advocacy
● Partner with healthcare systems
EU
U.S. ROW
47%
28% 25%
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Untapped Cerezyme® Opportunity in Gaucher Disease
(1) Symptomatic prevalence and diagnosed patient estimates from 2010 rare disease Market Models / Epidemiology Database. (2) Sims K, Pastores G, Weinreb N, Barranger J, Rosenbloom B, Packman S, et al. Improvement of bone disease by imiglucerase (Cerezyme®) therapy
in patients with skeletal manifestations of type 1 Gaucher disease: results of a 48-month longitudinal cohort study. Clin Genet 2008; 73:430-40.
● Focus is on supplying patients ● Expect improving supply outlook
from February 2012 forward
● Differentiated profile: ● 20 years of proven safety and
efficacy ● Demonstrated bone benefits(2)
● Significant additional opportunity exists with undiagnosed patients
Total treated Diagnosed
~7,000 ~6,400
CZ treated
~4,600
Large population of undiagnosed
patients(1) 9% of diagnosed
patients not treated
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Myozyme®/Lumizyme®: Only Approved Treatment for Pompe
15 (1) Symptomatic Prevalence based on 2011 Pompe Epi Model in 92 countries (excluding China and India). (2) Identified and treated patient numbers from regional patient trackers and LSD WW Report as of December 2010
MZ/LZ treated
~1,600
Total treated
~1,600
Diagnosed
~2,000
Large population of undiagnosed
patients(1)
19% of diagnosed
patients not treated(2)
● Long-term potential commercial opportunity similar to Cerezyme®
● Documented clinical benefit across disease spectrum
● Focus is on:
● Driving disease awareness
● Partnering with physicians to increase early diagnosis
050
100150200250300350400450500550600
0 1 year 2 year 3 year 4 year 5 year
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Myozyme®: Our Most Successful Launch
(1) Reflects the first full fiscal year after launch
Ceredase®/Cerezyme®
Fabrazyme®
Aldurazyme®
Myozyme®/Lumizyme®
(1)
$m Sales
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Fabrazyme® Potential Unleashed when Supply is Restored
(1) Symptomatic prevalence and diagnosed patient estimates from 2010 rare disease Market Models / Epidemiology Database.
Total treated
~4,200
FZ treated
~6,000
Diagnosed
Large population of undiagnosed
patients(1)
30% of diagnosed
patients not treated
~1,600
● Efficacy demonstrated at 1mg/kg ● Regain significant market share by:
● Restoring supply ● Driving importance of dose in
clinical outcomes ● Growing patient awareness
● Framingham plant received regulatory approval from FDA and EMA January 2012 ● Begins the process of
returning patients to full dosing levels
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Fabrazyme® – Treating the Family
Finding 1 new index patient leads, on average, to diagnosis of another 5 patients in that family
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Expanding Manufacturing Capacity is Key to Future Growth
Sites 2011 2012e 2015e Capacity
12,000L
20,000L
Framingham, MA new plant
8,000L
Allston, MA
Geel, Belgium
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Creation of the Genzyme
R&D Center
Leveraging Genzyme’s Innovative Capabilities
● Strong expertise in rare diseases and multiple sclerosis
● Unique biologics platform
● Commitment to open innovation
● Integrated innovation hub in the Boston area
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Eliglustat Clinical Data Comparable to Cerezyme®
Platelets +95%
Hemoglobin +2.3 g/dL
-4
-2
0
2
4
Hb Change from Baseline
(g/dL)
-100%
-50%
0%
50%
100%
Mean % Change
from Baseline
Liver -28%
Spleen -63%
Year 1
Year 2 Year 3 Year 4 Baseline
(1) Cerezyme® Registry Data on File – Upper and Lower 95% Confidence Interval around Mean
Eliglustat Phase 2 Trial Results: Treatment Changes to 4 Years(1)
Cerezyme® Range
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Eliglustat: a Novel Oral Therapy in Gaucher Disease(1)
● Potent, novel substrate inhibitor
● Convenience of oral therapy ● Eliminating challenges of
infusing patients
● Clinical profile expected to be similar to Cerezyme®
● 4-year Phase II data at WORLD congress in February 2012
● Phase III trials fully recruited
(1) Investigational drug (2) Patient from Phase II clinical trial WORLD – World Organization of Research on Lysosomal Diseases
December 2006 pre-treatment (18 years)
December 2009 3 years post treatment (21 years)(2)
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Kynamro™: Targeting Rare Familial Hypercholesterolemias
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(1) Patients for hoFH and Severe FH in US and EU markets hoFH – Homozygous Familial Hypercholesterolemia Severe FH – Severe Familial Hypercholesterolemia = treated LDL-C CHD – Coronary Heart Disease heFH – Heterozygous familial hypercholesterolemia
● Four Phase III trials conducted in severe FH forms ● Significant reduction in LDL-C
when added to a regimen of maximally tolerated statin dose and other lipid lowering therapies
● Liver fat stabilized or decreased in some patients with treatment beyond 12 months
● Sustained reduction in apo B production decreased LDL and Lp(a) HeFH:
1 million patients
HoFH Severe FH
Understanding Rarity
~40,000 patients(1)
On statins: 60 million patients
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Highlights of key achievements to date
Rare diseases opportunity
Agenda
Multiple sclerosis opportunity
Rare diseases and Genzyme
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Global MS Market Expected to Continue to Grow
MS Market Sales(1) Key Facts about MS
● ~2.1m patients worldwide
● Prevalent in young women (~2:1 female/male ratio)
● Life expectancy 5-10 years lower than unaffected people
● A major impact on family, social and professional life
● Symptoms include fatigue, weakness, walking and balance difficulties, vision problems
Multiple Sclerosis CAGR
~6%
(1) Evaluate Pharma
2010 2015e
U.S.
ROW
$11.2bn
~$15.3bn
53%
57%
47% 43%
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Unmet need 3
Efficacy with manageable safety
Unmet need 2
Convenience & efficacy
Early MS/CIS(1) RRMS(2) and early active MS
RMS(3) severe/ highly active
Emergence of a Franchise Addressing the Full Spectrum of Patient Needs in Multiple Sclerosis
Lemtrada™
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Aubagio®
Unmet need 1
Convenience & safety
Rebif®
Lemtrada™
Aubagio™
(1) CIS – Clinically Isolated Syndrome, TOPIC Phase III study presently ongoing (2) RRMS – Relapse Remitting Multiple Sclerosis (3) RMS – Relapsing Multiple Sclerosis 26
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A Unique Value Proposition: Superior Efficacy with Convenient Annual Dosing
CARE-MS I CARE-MS II
Patients 581 840
Study Duration 2 years 2 years
Patient Population
Treatment naïve
Relapsed on prior treatment
Treatment Arms
Alemtuzumab vs. IFNβ 1a
Alemtuzumab vs. IFNβ 1a
Relapse Rate Reduction at 2 Years(1)
55% (p<0.0001)
49% (p<0.0001)
Sustained Accumulation of Disability Reduction in
6 Months(1) 30%
(ns) 42%
(p=0.0084)
● Superior efficacy demonstrated in Phase III vs. Rebif®
● Manageable safety:
● Well-characterized and consistent across studies
● Effective risk management procedures in place
● FDA Fast Track designation granted
ANN – American Academy of Neurology (1) Co-primary endpoints in CARE-MS I and CARE-MS II
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Aubagi A Once-Daily Oral Therapy with Comparable Efficacy to Injectable Interferon
● Efficacy demonstrated in TEMSO on both Relapse Rate and Disability Progression at 14mg
● No superiority vs. Rebif® in TENERE but lower rate of TEAE-related discontinuation
● Manageable safety with up to 10 years of follow-up
(1) Adjusted for Expanded Disability Status Scale score strata at baseline and takes duration of treatment into account. TEAE – Treatment Emergent Adverse Events, ACTRIMS - Americas Committee for Treatment and Research in Multiple Sclerosis ENS – European Neurological Society, ARR – Annualized Relapse Rate, RRR – Relative risk reduction, HRR – Hazard ratio reduction
0 0,1 0,2 0,3 0,4 0,5 0,6
T. 14 mg
T. 7 mg
Placebo
TEMSO: Reduction in Adjusted(1) ARR
RRR: 31.2% p=0.0002
RRR: 31.5% p=0.0005
0 12 24 36 48 60 72 84 96 1080%
20%
10%
HRR: 23.7% p=ns
HRR: 29.8% p=0.0279
30% Placebo T. 7 mg T. 14 mg
Week
TEMSO: Reduction in Disability Progression (%)
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2012-2015: Genzyme Key Growth Drivers
● Maximize market opportunity for rare disease business
● Increase manufacturing capabilities for Cerezyme® & Fabrazyme®
● Increase Pompe disease awareness/diagnosis
● Launch eliglustat and Kynamro™
● Further expand rare diseases business through internal and external opportunities
● Establish leading MS franchise
● Launch Aubagio™ and Lemtrada™
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