Teresa, Multiple Sclerosis, United States IR Thematic Call on Multiple Sclerosis October 3 rd, 2013
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Agenda Key Highlights on Multiple Sclerosis Market Bill Sibold - Senior Vice President, Head of Multiple Sclerosis - Genzyme Clinical Data Highlights Michael Panzara, MD, MPH - Therapeutic Area Head of MS & Neurology - Genzyme Genzyme MS Global Launch Update Bill Sibold - Senior Vice President, Head of Multiple Sclerosis - Genzyme Q&A Session 3
Multiple Sclerosis Market: Key Highlights Bill Sibold SVP, Head of Multiple Sclerosis - Genzyme 4
Global MS Market - Significant and Growing Market Key Multiple Facts Sclerosis about MS Serious disease with significant unmet medical needs Multiple Sclerosis Market Global Sales (3) > 14bn Symptoms include fatigue, weakness, walking and balance difficulties, vision problems ~ 11bn ~40% ~60% A major impact on family, social and professional life ~ 5bn ~2.1m patients worldwide (1) 2017e ~410,000 patients in the U.S. (1) ~630,000 patients in EU (2) ~50% ~50% 2007 2012 U.S. ROW 2012-17 growth driven by new therapies, satisfying the unmet needs of convenient administration and more efficacious therapy (1) National Multiple Sclerosis Society (2) http://msj.sagepub.com/content/18/5/628.full.pdf (3) Adapted from Evaluate Pharma July 2013; Reported sales of Copaxone, Avonex, Rebif, Betaseron/Betaferon, Extavia, Tysabri and Gilenya for 2012; 2007 sales converted using /$ of 1.37, 2012 sales and 2017e sales converted using /$ of 1.29 5
MS Market in a State of Transition Presents Opportunities Multiple Sclerosis Market Features In 2005 Today 2 Mechanisms of Action 4 Marketed Products 1 Mode of Administration More Acceptance of Disease Activity 7 Mechanisms of Action 10 Marketed Products 3 Modes of Administration Greater Treatment Urgency Increasing diversity of therapeutic options allowing a more individualized treatment approach 6
MS Treatment Options Have Increased: Oral and Intravenous Products Share Has Grown Evolution of MS Market H1 2007 (1) H1 2013 (2) 96% 4% Injectable Therapies (3) Intravenous Therapies (4) Orals (5) 74% 15% 11% Total Half Year Sales 2.4bn Total Half Year Sales 5.9bn (1) Company reported sales of Avonex, Betaseron /Betaferon, Copaxone, Rebif and Tysabri converted using /$ rate of 1.33 (2) Company reported sales of MS products in H1 2013. Aubagio, Betaseron, Copaxone, Rebif converted using /$ rate of 1.31 (3) Injectable therapies include Avonex, Betaseron /Betaferon, Copaxone, Rebif, Extavia (4) Intravenous therapies include Tysabri (5) Oral therapies include Aubagio, Gilenya and Tecfidera 7
Transition to Oral and Intravenous Therapies Expected to Continue Oral therapy (2) share projected to increase four-fold to nearly 40% of the MS market by 2017 driven by new entrants Intravenous therapies (3) expected to approach 20% of the market Injectable therapies (4) (ABCRE s) projected to decline by roughly half of current usage by 2017 90% 75% 60% 45% 30% 15% MS Market Evolution (1,2,3,4) (% market share) 59% Injectables Orals Intravenous 0% 2012 2017e (1) Evaluate Pharma July 2013 (2) Oral category includes Aubagio, Gilenya, Tecfidera, laquinimod, 2 nd Gen S1Ps (3) Intravenous category includes Tysabri, Lemtrada, ocrelizumab, daclizumab (4) Injectable category includes Avonex, Betaseron/Betaferon, Copaxone, Rebif, Extavia, Plegridy 8
Clinical Data Highlights Michael Panzara, MD, MPH Therapeutic Area Head of MS & Neurology - Genzyme 9
Multiple Sclerosis Results in Significant Brain Injury with Irreversible Consequences Brain MRI Reveals Significant Progression of Atrophy Over 10 Years (1) 42 years-old 52 years-old (1) Courtesy of Beth Fisher and Rick Rudick Cleveland Clinic 10
New Treatment Goals - Focus on Patient Outcomes Unmet Needs Symptom Alleviation Halt or reverse damage and disability Improve disease control Convenient treatment regimens to improve compliance Maximize patient outcomes New Goals Decrease MS activity and improve quality of life Promote repair, remyelination, durable disability improvement Freedom from disease activity Dosing options, new routes of administration, less frequent dosing Superior effectiveness and favorable benefit/risk vs. existing treatment 11
Once-Daily Oral Therapy with Robust Efficacy TEMSO STUDY (1) TOWER STUDY (3) Annualized Relapse Rate (2) Annualized Relapse Rate (2) 0.539-31.5% p=0.0005 0.501-36.3% p=0.0001 0.369 0.319 n=363 n=358 n=388 n=370 Placebo Aubagio 14mg Placebo Aubagio 14mg (1) O Connor PW et al. N Engl J Med 2011;365:1293-1303 (2) Adjusted for Expanded Disability Status Scale score strata and region at baseline and takes duration of treatment into account (3) Kappos L et al. Mult Scler J 2012;18:(S4)9-53(153) 12
Only Oral Therapy to Show Significant Effect on Disability in Two Phase III Trials TEMSO STUDY (1) TOWER STUDY (5) Reduction in Progression of Disability (2) Reduction in Progression of Disability (2) 0.273-29.8% (3) p=0.0279 (4) -31.5% (3) p=0.0442 (4) 0.202 0.197 0.158 n=363 n=358 n=388 n=370 Placebo Aubagio 14mg Placebo Aubagio 14mg (1) O Connor PW et al. N Engl J Med 2011;365:1293-1303 (2) At Week 108 (3) Derived using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates (4) Derived from log-rank test with stratification of EDSS strata at baseline and region (5) Kappos L et al. Mult Scler J 2012;18:(S4)9-53(153) 13
Long-term Efficacy and Safety Supported by TEMSO Extension Trial TEMSO extension trial included patients receiving Aubagio for up to 9 years (up to 7 years extension treatment) No new or unexpected safety signals emerged during the study TEMSO (1) Annualized Relapse Rate 0.539 0.369 TEMSO Extension Study (2) Annualized Relapse Rate Measured clinical and MRI disease activity remained low in patients continuing on study treatment 0.177 0.171 Placebo 14mg Placebo/ 14mg 14mg/ 14mg (1) Adjusted for Expanded Disability Status Scale score strata and region at baseline and takes duration of treatment into account (2) Freedman, M et al. Mult Scler J 2013; 19:(S1)74-558 14
Similar Incidence of SAEs Among Aubagio and Placebo-treated Patients in Clinical Trials The Aubagio label (1) includes: Risk of teratogenicity (based on animal data) and hepatotoxicity ALT elevations Alopecia Diarrhea Influenza Nausea Paresthesia SAE: Serious Adverse Event (1) Adapted from U.S. Prescribing Information and European SmPC 15
Potentially Rebalances the Immune System Selectively targets CD52 protein, depleting B and T cells responsible for MS inflammatory process A distinctive pattern of lymphocyte repopulation occurs over time (1) May reduce inflammatory processes in MS and have disease modifying effects Supported by durable efficacy after two short treatment courses CD4 Treg Cell Counts (%) Relative Proportion of T Cells Increased with T-Reg Phenotype (2) Months on Therapy Lemtrada 12 mg/day Rebif Lemtrada has been granted marketing authorization by the European Commission and is under review by the regulatory authorities in the U.S. The mechanism by which it exerts therapeutic effect in multiple sclerosis is unknown. Lemtrada is developed in collaboration with Bayer HealthCare (1) Cox AL et al. Eur J Immunol 2005;35:3332-42., Hu Y et al. Immunology 2009;128:260-70, Havari E et al. ECTRIMS 2010, Jones JL et al. Brain 2010;133:2232-47 (2) Hartung HP et al. Mult Scler J 2012; 18:(S4)279-508 16
Active Comparator Set High Bar for Success CARE-MS I (1) CARE-MS II (2) Randomized Patients 581 840 Study Duration 2 years 2 years Patient Population Treatment naïve Relapsed on prior treatment Treatment Arms Lemtrada vs. Rebif Lemtrada vs. Rebif (1) Coles AJ et al. Lancet. 2012;380(9856):1829-1839 (2) Cohen JA et al. Lancet. 2012;380(9856):1819-1828 17
Significant Comparative Efficacy Results with Unique Annual Dosing Regimen CARE-MS I (1) CARE-MS II (2) Annualized Relapse Rate Annualized Relapse Rate 0.39-55% p<0.0001 0.52-49% p<0.0001 0.26 0.18 n=187 n=376 n=202 n=426 Rebif Lemtrada Rebif Lemtrada (1) Coles AJ et al. Lancet. 2012;380(9856):1829-1839 (2) Cohen JA et al. Lancet. 2012;380(9856):1819-1828 18
Percentage of Patients with SAD Slowed Accumulation of Disability vs. Rebif (1) HR 0.58 Time to SAD (1,2) CARE-MS II Treatment effect: 42% p=0.0084 Rebif Lemtrada 12 mg/day 21.1% 12.7% HR: Hazard Ratio SAD: Sustained Accumulation of Disability (1) CARE-MS I study in treatment-naïve patients did not show a significant reduction in sustained accumulation of disability (2) Cohen J et al. AAN 2012:platform presentation of CARE-MS II. 19
Percentage of Patients with SRD Improvement in Pre-Existing Disability: 6-Month Sustained Reduction in Disability Data suggests that improvement in pre-existing disability was more likely with Lemtrada than Rebif regardless of which functional system was impaired by prior MS disease activity (1) All functional systems contributed to EDSS improvement (1) 50 40 30 20 10 HR: 2.57 p=0.0002 6-Month SRD CARE-MS II (2) Rebif Lemtrada 12 mg 28.8% 12.9% 0 0 3 6 9 12 15 18 21 24 Follow-up Month RRMS: Relapse Remitting Multiple Sclerosis (1) Brinar, V ECTRIMS 2013 (P649) (2) Cohen J AAN 2012:platform presentation of CARE-MS-II 20
Percentage of Patients with SRD Durable Effect on Sustained Reduction in Disability Through Year 3 More than 1/3 of Lemtrada treated patients in CARE-MS II extension study attained sustained disability improvement by Year 3 50 40 6-Month SRD (1) CARE-MS II Extension Study 29% 35% Approximately 80% of patients did not receive re-treatment during Year 3 30 20 Fewer than 3% received another disease modifying treatment in Year 3 10 0 0 6 12 18 24 30 36 Follow-up Month (1) Hartung HP ECTRIMS 2013(P592) 21
Safety Experience from MS Development Program Infusion-associated reactions very common Premedication reduced/alleviated symptoms Infections common in both groups More common with Lemtrada, low number of serious events Autoimmune events, some serious Detected via risk management plan allowing early diagnosis and treatment 22
Significant Global Regulatory Milestones Achieved EU approved for adult patients with RRMS New Active Substance designated by EMA providing 10 years of data exclusivity in the EU EU approved for patients with RRMS with active disease as defined by clinical or imaging features (1) FDA approved for adult patients with relapsing forms of multiple sclerosis FDA decision expected in late Q4 2013 Also approved in Australia, Mexico, Argentina, Chile, South Korea Regulatory reviews ongoing in several other regions RRMS: Relapse Remitting Multiple Sclerosis (1) Not indicated for treating non-active patients and those stable on therapy 23
Global Launch Update Bill Sibold SVP, Head of Multiple Sclerosis - Genzyme 24
Genzyme s Critical Success Factors in MS Products People Approach Lemtrada and Aubagio are highly differentiated novel products Fulfill unmet needs Well positioned for an evolving market Accomplished team Leveraging experienced Sanofi MS sales reps in European countries Strong commitment and relationships Science driven and patient focused Long term partners Be leaders 25
Encouraging U.S. Launch Trends Cumulative U.S. Weekly TRx (1) Aubagio : Quarterly Sales 60,000 Tecfidera 44m (2) Gilenya 33m 40,000 Aubagio 20m 20,000 7m Week 1 Tecfidera Launch Week 48 Q4 2012 Q1 2013 Q2 2013 Q3 2013e (1) IMS Weekly Total Prescriptions (2) Q3 2013 Aubagio quarterly sales figure is an estimate to be validated when company earnings are released on October 30, 2013 26
Broad Based Patient Demand ~20% patients prescribed Aubagio were treatmentnaïve (2) Aubagio Prior Therapy (1) (Enrolled Patients) >80% of patients switched to Aubagio were most recently on ABCR s Most frequently cited reasons for initiating Aubagio (2) Oral administration Once-daily dosing Needle Fatigue/Phobia 14.1% 22.0% Other 2.2% 8.5% 30.6% 17.4% 3.9% 1.3% DMT: Disease Modifying Therapy (1) Based on data collected at Genzyme's MS One to One Patient and Provider Support Center, Sep 2012-Sep 2013 (2) BioTrends Research Group, LaunchTrends : Aubagio (teriflunomide) - Multiple Sclerosis (Wave 3) 2013 27
Launching a Global MS Franchise (1) 2012 Selected Markets 2014 2012 Selected Markets 2014 (1) Timing of regulatory approvals and country reimbursement policies may impact projected launch timelines 28
Ready to Launch Our MS Franchise in the EU Aubagio and Lemtrada approved Field forces hired and trained Patient support infrastructure and programs in-place First product shipments First EU sales in October 2013 29
Committed to Being Leaders in MS Multiple Sclerosis market is significant and growing New therapies, satisfying the unmet needs of convenient administration and increased efficacy, to drive growth Genzyme uniquely placed to seize opportunities in Multiple Sclerosis Multiple Sclerosis team with proven track record Aubagio and Lemtrada are positioned for success in an evolving market 30
Q&A SESSION 31