LEERINK SWANN HEALTHCARE CONFERENCE David Meeker, Chief Executive Officer, Genzyme
New York, February 14, 2013
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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
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
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(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)
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
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% 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)
Sanofi Growth Platforms Grew by +9.9%(1) in 2012 and Constitute Long Life Assets to Drive Future Growth
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(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®
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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
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2
3
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(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
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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%
Quarterly Sales (€m)
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(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
Quarterly Sales (€m)
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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)
050
100150200250300350400450500550600
0 1 year 2 year 3 year 4 year 5 year 6 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
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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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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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Sanofi highlights to date
Rare disease opportunity
Agenda
Multiple sclerosis opportunity
Rare diseases and Genzyme
Eliglustat(1) - A Novel Oral Therapy in Gaucher Disease
● Novel substrate inhibitor
● Oral therapy ● Eliminating challenges of infusions
● Positive results from ENGAGE, Phase III study (vs. placebo) ● Primary endpoint and all secondary
endpoints met(2)
● No serious adverse events reported in the primary analysis period
● ENCORE Phase III study with eliglustat met its primary efficacy endpoint (vs. Cerezyme®)(3)
(1) Eliglustat tartrate is an investigational drug and not yet approved (2) Primary endpoint was change in spleen volume and secondary endpoints included improvements in
hemoglobin levels and platelet levels, as well as liver volumes (3) Detailed results of the ENCORE trial will be communicated during the upcoming Annual WORLD Symposium
(February 12-15, 2013)
+2%
-28%
Placebo
Eliglustat
30% Absolute
Difference
Change in Spleen Volume (% change at 9 months)
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: FDA Approved to Treat HoFH(1)
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(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™
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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 slows accumulation of
disability sustained for six months
● 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
Study Showed Slowing Sustained Accumulation of Disability for Six Months 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
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.