IR Thematic Call on Multiple Sclerosis

Transcription

1 Teresa, Multiple Sclerosis, United States IR Thematic Call on Multiple Sclerosis October 3 rd, 2013

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 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, Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. 2

3 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

4 Multiple Sclerosis Market: Key Highlights Bill Sibold SVP, Head of Multiple Sclerosis - Genzyme 4

5 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% U.S. ROW growth driven by new therapies, satisfying the unmet needs of convenient administration and more efficacious therapy (1) National Multiple Sclerosis Society (2) (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

6 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

7 MS Treatment Options Have Increased: Oral and Intravenous Products Share Has Grown Evolution of MS Market H (1) H (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 H 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

8 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 % 75% 60% 45% 30% 15% MS Market Evolution (1,2,3,4) (% market share) 59% Injectables Orals Intravenous 0% e (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

9 Clinical Data Highlights Michael Panzara, MD, MPH Therapeutic Area Head of MS & Neurology - Genzyme 9

10 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

11 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

12 Once-Daily Oral Therapy with Robust Efficacy TEMSO STUDY (1) TOWER STUDY (3) Annualized Relapse Rate (2) Annualized Relapse Rate (2) % p= % p= 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: (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

13 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) % (3) p= (4) -31.5% (3) p= (4) 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: (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

14 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 TEMSO Extension Study (2) Annualized Relapse Rate Measured clinical and MRI disease activity remained low in patients continuing on study treatment 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)

15 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

16 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: , Hu Y et al. Immunology 2009;128:260-70, Havari E et al. ECTRIMS 2010, Jones JL et al. Brain 2010;133: (2) Hartung HP et al. Mult Scler J 2012; 18:(S4)

17 Active Comparator Set High Bar for Success CARE-MS I (1) CARE-MS II (2) Randomized Patients 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): (2) Cohen JA et al. Lancet. 2012;380(9856):

18 Significant Comparative Efficacy Results with Unique Annual Dosing Regimen CARE-MS I (1) CARE-MS II (2) Annualized Relapse Rate Annualized Relapse Rate % p< % p< n=187 n=376 n=202 n=426 Rebif Lemtrada Rebif Lemtrada (1) Coles AJ et al. Lancet. 2012;380(9856): (2) Cohen JA et al. Lancet. 2012;380(9856):

19 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= 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

20 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) HR: 2.57 p= Month SRD CARE-MS II (2) Rebif Lemtrada 12 mg 28.8% 12.9% 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

21 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 Month SRD (1) CARE-MS II Extension Study 29% 35% Approximately 80% of patients did not receive re-treatment during Year Fewer than 3% received another disease modifying treatment in Year Follow-up Month (1) Hartung HP ECTRIMS 2013(P592) 21

22 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

23 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 Q 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

24 Global Launch Update Bill Sibold SVP, Head of Multiple Sclerosis - Genzyme 24

25 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

26 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 Q Q Q Q3 2013e (1) IMS Weekly Total Prescriptions (2) Q Aubagio quarterly sales figure is an estimate to be validated when company earnings are released on October 30,

27 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)

28 Launching a Global MS Franchise (1) 2012 Selected Markets Selected Markets 2014 (1) Timing of regulatory approvals and country reimbursement policies may impact projected launch timelines 28

29 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

30 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

31 Q&A SESSION 31