2013 - cowen-meeker hc

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COWEN & CO. HEALTHCARE CONFERENCE David Meeker, Chief Executive Officer, Genzyme Boston, March 4, 2013

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2013 - Cowen-Meeker HC

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Page 1: 2013 - Cowen-Meeker HC

COWEN & CO. HEALTHCARE CONFERENCE David Meeker, Chief Executive Officer, Genzyme

Boston, March 4, 2013

Page 2: 2013 - Cowen-Meeker HC

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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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Sanofi highlights to date

Rare disease opportunity

Agenda

Multiple sclerosis opportunity

Rare diseases and Genzyme

Page 4: 2013 - Cowen-Meeker HC

Sanofi Has Delivered Sales Growth for the Last Four Years Despite the Loss of Several Mega Blockbusters

€32,367m

2011

€33,389m

2010 2009

€29,306m

2008

€27,568m

2012

€34,947m

Sales

4

(1) On a reported basis, FY 2012 sales were up +4.7% (2) In 2008 and 2009, Merial Joint Venture sales were not consolidated by Sanofi (3) In 2010, excluding non-consolidated sales from Merial, Sanofi reported sales of €30,384m

+0.5% at CER(1)

(2) (2) (3)

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2008 2009 2011 2010 2012

% of Total

42.7% 67.4%

Sales of Growth Platforms(1)

Sanofi Growth Platforms Have Doubled Over Four Years While the Patent Cliff Enters the Rear-view Mirror

2011 2010 2009 2008 2012

5

% of Total

27.4% 6.4%

Sales of Key Genericized Products(2)

€23,548m

€11,783m

€2,222m

€7,565m

(1) 2010 include sales of Merial. In 2008 and 2009, Merial Joint Venture sales were not consolidated by Sanofi (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)

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Sanofi Growth Platforms Grew by +9.9%(1) in 2012 and Constitute Long Life Assets to Drive Future Growth

6

(1) Sales of Growth Platforms were up +7.8% in 2012 with Genzyme pro forma. Genzyme products were not consolidated in Q1 2011 (2) Emerging Markets sales were up +7.2% in 2012 with Genzyme pro forma. Genzyme products were not consolidated in Q1 2011 (3) New Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises (4) Growth is at constant exchange rates and at comparable perimeter - Genzyme sales were not consolidated in Q1 2011 (5) Includes new product launches which do not belong to the other Growth Platforms listed above: Multaq®, Jevtana®, Mozobil® and Zaltrap®

+16.7%

+5.7%

+9.9%

+3.1%

+16.9%

Other Innovative Products(4,5) €611m +10.5%

+8.3%

Vaccines €3,897m

Diabetes Solutions €5,782m

Consumer Healthcare €3,008m

Animal Health €2,179m

Emerging Markets(2) €11,145m

New Genzyme(3,4) €1,785m

2012 growth at CER

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2012 Was a Turning Point for Unleashing the Full Potential of Genzyme

● Regulatory approval of Framingham plant ● All 2012 numbered steps for Consent Decree met ● Full supply of Cerezyme® & Fabrazyme®

7

Supply Recovery

Business Growth

Late-stage Pipeline

● Double-digit growth of Rare Diseases franchise ● Creation of a new Multiple Sclerosis business unit ● Very encouraging U.S. launch of Aubagio®

● FDA approvals(1,2) of Aubagio® and Kynamro™ ● Filing of Lemtrada™ in EU and the U.S. ● Positive results of two Phase III studies with eliglustat

Transformation Catalyst

● Significant OPEX synergies ● New Research hub created in Cambridge, MA ● Legacy business(3) enhanced through transfer to Sanofi

1

2

3

4

(1) Aubagio® was approved in the U.S. on September 12, 2012 (2) Kynamro™ was approved in the U.S. on January 29, 2013 (3) Oncology, Biosurgery and Renal businesses

Lemtrada™ is the a registered trade name for alemtuzumab submitted to health authorities Kynamro™ is developed in collaboration with Isis Pharmaceuticals and Lemtrada™ with Bayer HealthCare

Page 8: 2013 - Cowen-Meeker HC

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Sanofi highlights to date

Rare disease 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)

(1) BioWorld Today, 2011 (2) Food and Drug Administration, "Office of Orphan Products Development," Budget 2010 (3) EvaluatePharma; internal analysis

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Creation of the Genzyme

R&D Center

Leveraging Genzyme’s Innovative Capabilities

● Strong expertise in rare disease and multiple sclerosis

● Unique biologics platform

● Commitment to open innovation

● Integrated innovation hub in the Boston area

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1983

2001

Cerezyme® is the Foundation of the Genzyme Model

Transformative Therapy

2012 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

34%

40% 26%

Page 12: 2013 - Cowen-Meeker HC

Quarterly Sales (€m)

12

(1) Growth is at constant exchange rates and at comparable perimeter - Genzyme sales were not consolidated in Q1 2011 (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

€171m

Q4 2012

Q4 2011

€131m

● Cerezyme® maintained market share with 2012 sales up +6.0%(1) to €633m in a growing market

● Patients in major markets returned to normal dosing

● Gold-standard product: ● 20 years of proven safety and

efficacy ● Demonstrated bone benefits(2)

● Currently treating ~5,000 patients

Cerezyme® Treating Gaucher Disease for Over 20 years

Page 13: 2013 - Cowen-Meeker HC

Quarterly Sales (€m)

13

Fabrazyme® Delivered Very Strong Performance in 2012

● Fabrazyme® sales almost doubled growing 96.4% to €292m in 2012 ● Supply from new Framingham plant

● Shire’s withdrawal of Replagal® BLA(1)

in the U.S. in early 2012

● Patients in major markets returned to normal dosing

● Regain significant market share by: ● Restoring supply

● Driving importance of dose in clinical outcomes

● Currently treating ~2,000 patients

Q4 2012

Q4 2011

(1) BLA: Biologics License Application

€47m

€84m

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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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&

(1) Growth is at constant exchange rates and at comparable perimeter - Genzyme sales were not consolidated in Q1 2011

Q4 2012

Q4 2011

€108m

Myozyme®/Lumizyme®: Only Approved Treatment for Pompe Disease

● Myozyme® grew at a double-digit rate of +11.4 %(1) to €462m in 2012

● Long-term potential commercial opportunities similar to Cerezyme®

● Focus is on: ● Driving disease awareness

● Partnering with physicians to increase early diagnosis

● Currently treating ~1,700 patients

€121m

Quarterly Sales (€m)

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050

100150200250300350400450500550600

0 1 year 2 year 3 year 4 year 5 year 6 year

16

Myozyme®: Our Most Successful Launch

(1) Reflects the first full fiscal year after launch

Ceredase®/ Cerezyme®

Fabrazyme®

Aldurazyme®

Myozyme®/ Lumizyme®

(1)

$m

16

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Expanding Manufacturing Capacity is Key to Future Growth

Sites 2011 2012 2015e Capacity

12,000L

20,000L

Framingham, MA new plant

8,000L

Allston, MA

Geel, Belgium

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Sanofi highlights to date

Rare disease opportunity

Agenda

Multiple sclerosis opportunity

Rare diseases and Genzyme

Page 19: 2013 - Cowen-Meeker HC

ENGAGE ENCORE

Patients 40 160

Study Duration 9 months 12 months

Patient Population

Treatment naïve

Stabilized on ERT treatment

Treatment Arms

eliglustat vs. placebo

eliglustat vs. Cerezyme®

Primary endpoint met

Secondary endpoints met

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Phase III Registration Trials

Eliglustat(1) - A Novel Oral Therapy in Gaucher Disease

● Innovative substrate inhibitor

● Oral therapy ● Eliminating challenges of infusions

● Positive phase III results ● ENGAGE(2): 30% absolute difference

in spleen volume vs. placebo ● ENCORE(3): non-inferiority efficacy

criteria met

● No serious adverse events reported in the primary analysis period

(1) Eliglustat tartrate is an investigational drug and not yet approved (2) Primary endpoint was change in spleen volume. Secondary endpoints included improvements in hemoglobin levels, platelet levels and

liver volume. Absolute difference in spleen volume p<0.0001. (3) Primary endpoint was stability of all composite endpoints for spleen volume, hemoglobin levels, platelet counts, and liver volumes.

Secondary endpoints included stability criteria for the individual components of the composite endpoints including spleen volume, hemoglobin levels, platelet levels and liver volume

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Eliglustat Clinical Data Compared to Cerezyme® Registry Data

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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: FDA Approved to Treat HoFH(1)

21

(1) Kynamro™ is developed in collaboration with Isis Pharmaceuticals (2) National Institutes of Health. 40,000 patient number includes those with 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

● Largest clinical trial conducted in HoFh patient population

● Reduction in LDL-C by 25% when added to maximally tolerated statin dose and other lipid lowering therapies

● Sustained reduction in apo B production decreased LDL and Lp(a)

● Phase III ongoing in HeFh patient population

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Sanofi highlights to date

Rare disease 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) ● ~2.1m multiple sclerosis patients worldwide(2)

● Prevalent in young women (~2:1 female/male ratio)

● A major impact on family, social and professional life ● Symptoms include fatigue, weakness,

walking and balance difficulties, vision problems

● “ABCRE” products(3) represented >80% of the global MS market value in 2011(1)

● Require frequent injections

CAGR ~6%

(1) Evaluate Pharma, February 2013 (2) National MS Society (3) ABCRE stands for Avonex®, Betaseron®/Betaferon®, Copaxone®, Rebif® and Extavia® . Avonex® is a registered trademark of Biogen Idec; Betaseron® is a registered trademarks of Bayer Healthcare; Copaxone® is a registered trademark of Teva Pharmaceuticals Inc; Gilenya® is a registered trademark of Novartis; Rebif® is a registered trademark of EMD Serono, Inc.; Tysabri® is a registered trademark of Biogen Idec.

ROW

U.S.

2016e

~$16.6bn

2011

~$12.5bn

60%

57%

40% 43%

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Unmet need 3

Efficacy with manageable safety

Unmet need 2

Convenience & efficacy

Early MS RRMS(1) and early active MS

RMS(2) severe/ highly active

Creation of a Franchise Addressing the Full Spectrum of Patient Needs in Multiple Sclerosis

Lemtrada™

24

Aubagio®

Unmet need 1

Convenience & safety

Rebif®

Lemtrada™

Aubagio™

(1) RRMS – Relapse Remitting Multiple Sclerosis (2) RMS – Relapsing Multiple Sclerosis

24

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®

Reduction in Progression of Disability

CARE-MS I CARE-MS II

Annualized Relapse Rate

● Significant efficacy results vs Rebif®

● Notably reduces ARR ● Meaningfully reduces risk of six-

month sustained accumulation for disability

● Manageable safety profile(2)

● Infusion-associated reactions(3)

● Infections higher on Lemtrada™ though common in both groups(4)

● Autoimmune events (thyroid disorders and ITP) detected via routine monitoring and generally managed using conventional therapies

● Convenient annual dosing

Superior Efficacy vs. Active Comparator(1)

Lemtrada™ is not yet commercially marketed ARR: Annualized Relapse Rate ITP: Idiopathic Thrombocytopenic Purpura CARE-MS I and CARE-MS II were both head-to-head trials comparing Lemtrada™ versus Rebif® (1) Based on CARE-MS II study (2) Safety profile generally managed with monitoring and conventional therapies (3) Infusion-associated reactions were most common AE and were effectively managed with standard therapies (4) Risk of infections higher with Lemtrada™ and majority were mild to moderate

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26 26 (1) Based on data collected at Genzyme's MS One to One Patient and Provider Support Center, Sep 2012-Jan 2013 (2) IMS Weekly Total Prescriptions

®

● Very encouraging early launch indicators in the U.S.(1) ● >80% of MS specialists in the U.S.

have prescribed AUBAGIO®

● ~1 in 5 patients prescribed AUBAGIO® were treatment-naïve

● >50% of patients switched to AUBAGIO® were most recently on Copaxone® or Avonex®

● Q4 2012 sales of €7m following October launch

Cumulative U.S. Weekly TRx(2)

A “Platform” Therapy in a Pill for Relapsing MS

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2013-2015: Genzyme Key Growth Drivers

● Maximize market opportunity for rare disease business

● Build inventory for Cerezyme® & Fabrazyme® Products

● Increase Pompe disease awareness/diagnosis

● Launch of Kynamro™(1)

● Expected launch of eliglustat

● Further expand rare disease business through internal and external opportunities

● Establish leading MS franchise

● Continue momentum of Aubagio® launch

● Expected launch of Lemtrada™

(1) Kynamro™ was approved in the U.S. on January 29, 2013.