2012 - Leerink Swann Global HC Conference

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2012 - Leerink Swann Global HC Conference

2012 - Leerink Swann Global HC Conference

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  • 1. LEERINK SWAN HEALTHCARE CONFERENCEDavid Meeker, Chief Executive Officer, Genzyme February 16, 2012
  • 2. Forward Looking StatementsThis presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of1995, as amended. Forward-looking statements are statements that are not historical facts. These statementsinclude projections and estimates and their underlying assumptions, statements regarding plans, objectives,intentions and expectations with respect to future financial results, events, operations, services, productdevelopment and potential, and statements regarding future performance. Forward-looking statements aregenerally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similarexpressions. Although Sanofi’s management believes that the expectations reflected in such forward-lookingstatements are reasonable, investors are cautioned that forward-looking information and statements are subjectto 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 orprojected by, the forward-looking information and statements. These risks and uncertainties include among otherthings, the uncertainties inherent in research and development, future clinical data and analysis, including postmarketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when toapprove any drug, device or biological application that may be filed for any such product candidates as well astheir decisions regarding labelling and other matters that could affect the availability or commercial potential ofsuch product candidates, the absence of guarantee that the product candidates if approved will be commerciallysuccessful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefitfrom external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of costcontainment policies and subsequent changes thereto, the average number of shares outstanding as well asthose discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listedunder “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annualreport on Form 20-F for the year ended December 31, 2010. Other than as required by applicable law, Sanofidoes not undertake any obligation to update or revise any forward-looking information or statements. 2
  • 3. AgendaHighlights of key achievements to dateRare diseases and GenzymeRare diseases opportunityMultiple sclerosis opportunity 3
  • 4. Sanofi Grew Sales in 2011 due to Genzyme Acquisition andGrowth Platforms Sales €33,389m €32,367m €29,306m €27,568m +5.3% at CER (1) (1) (2) 2008 2009 2010 2011 (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 4
  • 5. Sanofi Boosted Sales of its Growth Platforms and SignificantlyReduced its Patent Cliff Exposure in 2011 Sales of Sales of Growth Platforms(1) & Genzyme Key Genericized Products(2) €21,703m €11,783m €7,565m €3,152m 2008 2009 2010 2011 2008 2009 2010 2011% of 42.7% % of 27.4% 65.0% 9.4%Total Total (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 5 under appeal by Sun.
  • 6. Patent Cliff Impact on EPS Mitigated in 2011 Business EPS €7.06 €6.61 €6.65 €5.59 -3.8% at CER 2008 2009 2010 2011 6
  • 7. Successful Acquisition of Genzyme in 2011 1 Completing the integration Strong management team in place Focus on Rare Diseases and Multiple Sclerosis 2 Ensuring manufacturing recovery 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® A SANOFI COMPANY 3 Creating synergies Achieved synergies of $230m in 2011 4 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 77
  • 8. Genzyme Recovery On Track ● FY 2011 Genzyme consolidated Quarterly Sales(1) (€m) sales reached €2,395m, +7.7%(1,2) €831m €796m ● Q4 2011 sales of €831m, +0.8%(2) €768m ● Rare Diseases sales of €346m & • Solid performance of Myozyme®/ Other Lumizyme® of €108m, +15.9% s • Cerezyme® and Fabrazyme® sales constrained by supply & ● Good performance of Renagel®/ Renvela® and Synvisc® franchise ● EMA and FDA approvals granted Others for Framingham plant in Jan 2012 ● Complete return to normal supply levels of Fabrazyme® to begin in Q2 2012 Q2 2011 Q3 2011 Q4 2011 (1) Genzyme sales are consolidated since April 1, 2011 (2) Change on a constant structure basis and at constant exchange rates 8
  • 9. AgendaHighlights of key achievements to dateRare diseases and GenzymeRare diseases opportunityMultiple sclerosis opportunity 9
  • 10. Orphan Drug Market is Attractive and Offers Growth PotentialDue 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) Orphan Drug ● Several attractive market characteristics Market ● 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 10 10 (3) EvaluatePharma; internal analysis
  • 11. Unleashing the Full Potential of Genzyme within Sanofi Broaden Leverage biologics global experience scope and manufacturing expertise Escalate Develop Create existing MS R&D hub R&D franchise in Boston programs 11
  • 12. AgendaHighlights of key achievements to dateRare diseases and GenzymeRare diseases opportunityMultiple sclerosis opportunity 12
  • 13. Cerezyme® is the Foundation of the Genzyme ModelTransformative Therapy Extensive Global Reach Ensure Market Access 1983 ● Increase awareness 2011 Sales Split ● Enable access to diagnostic testing ROW U.S. 25% ● Identify and train experts 28% 2001 ● Support patient advocacy ● Partner with healthcare systems 47% EU 13
  • 14. Untapped Cerezyme® Opportunity in Gaucher Disease Large population of undiagnosed ● Focus is on supplying patients 9% of patients(1) ● Expect improving supply outlook diagnosed patients not from February 2012 forward treated ● Differentiated profile: ● 20 years of proven safety and efficacy ~7,000 ~6,400 ● Demonstrated bone benefits(2) ~4,600 ● Significant additional opportunity exists with undiagnosed patients Diagnosed Total treated CZ treated (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. 14
  • 15. Myozyme®/Lumizyme®: Only Approved Treatment for Pompe Large population of undiagnosed ● Long-term potential commercial patients(1) opportunity similar to Cerezyme® ● Documented clinical benefit across 19% of disease spectrum diagnosed patients not ● Focus is on: treated(2) ● Driving disease awareness ~2,000 ~1,600 ~1,600 ● Partnering with physicians to increase early diagnosis Diagnosed Total treated MZ/LZ treated 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 15
  • 16. Myozyme®: Our Most Successful Launch $m Sales 600 Myozyme®/Lumizyme® 550 500 450 400 Fabrazyme® 350 300 Ceredase®/Cerezyme® 250 200 Aldurazyme® 150 100 50 0 (1) 0 1 year 2 year 3 year 4 year 5 year (1) Reflects the first full fiscal year after launch 16 16
  • 17. Fabrazyme® Potential Unleashed when Supply is Restored Large population of undiagnosed ● Efficacy demonstrated at 1mg/kg patients(1) ● Regain significant market share by: 30% of ● Restoring supply diagnosed patients not ● Driving importance of dose in treated clinical outcomes ● Growing patient awareness ~6,000 ~4,200 ● Framingham plant received ~1,600 regulatory approval from FDA and EMA January 2012 Diagnosed Total treated FZ treated ● Begins the process of returning patients to full dosing levels (1) Symptomatic prevalence and diagnosed patient estimates from 2010 rare disease Market Models / Epidemiology Database. 17
  • 18. Fabrazyme® – Treating the Family Finding 1 new index patient leads, on average, to diagnosis of another 5 patients in that family 18
  • 19. Expanding Manufacturing Capacity is Key to Future Growth Sites 2011 2012e 2015e Capacity 12,000L Allston, MA 20,000L Geel, Belgium 8,000L Framingham, MA new plant 19
  • 20. Leveraging Genzyme’s Innovative Capabilities ● Strong expertise ● Unique biologics in rare diseases and platform multiple sclerosis Creation of the Genzyme R&D Center ● Integrated innovation ● Commitment to open hub in the Boston area innovation 20
  • 21. Eliglustat Clinical Data Comparable to Cerezyme® Eliglustat Phase 2 Trial Results: Mean Hb Change from Baseline Treatment Changes to 4 Years(1) % Change (g/dL) from Baseline Platelets +95% 4 100% 2 50% Hemoglobin +2.3 g/dL 0 0% Liver -28% -2 -50% Spleen -63% -4 -100% Baseline Year 1 Year 2 Year 3 Year 4 Cerezyme® Range (1) Cerezyme® Registry Data on File – Upper and Lower 95% Confidence Interval around Mean 21
  • 22. 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 December 2006 December 2009 ● Phase III trials fully recruited pre-treatment (18 years) 3 years post treatment (21 years)(2) (1) Investigational drug (2) Patient from Phase II clinical trial WORLD – World Organization of Research on Lysosomal Diseases 22
  • 23. Kynamro™: Targeting Rare Familial Hypercholesterolemias Understanding Rarity ● Four Phase III trials conducted in severe FH forms ~40,000 patients(1) ● Significant reduction in LDL-C HoFH Severe FH 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 On statins: ● Sustained reduction in apo B 60 million production decreased LDL patients and Lp(a) HeFH: 1 million patients (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 23 heFH – Heterozygous familial hypercholesterolemia
  • 24. AgendaHighlights of key achievements to dateRare diseases and GenzymeRare diseases opportunityMultiple sclerosis opportunity 24
  • 25. Global MS Market Expected to Continue to Grow MS Market Sales(1) Key FactsSclerosis Multiple about MS CAGR ● ~2.1m patients worldwide ~6% ~$15.3bn ● Prevalent in young women (~2:1 female/male ratio) ● Life expectancy 5-10 years lower $11.2bn than unaffected people 57% ● A major impact on family, social U.S. 53% and professional life ● Symptoms include fatigue, weakness, walking and balance 43% difficulties, vision problems ROW 47% 2010 2015e (1) Evaluate Pharma 25
  • 26. Emergence of a Franchise Addressing the Full Spectrum ofPatient Needs in Multiple Sclerosis RRMS(2) and RMS(3) severe/ Early MS/CIS(1) early active MS highly active Unmet need 1 Unmet need 2 Unmet need 3 Convenience Convenience Efficacy with & safety & efficacy manageable safety Aubagio™ Aubagio® Rebif® Lemtrada™ Lemtrada™ (1) CIS – Clinically Isolated Syndrome, TOPIC Phase III study presently ongoing (2) RRMS – Relapse Remitting Multiple Sclerosis (3) RMS – Relapsing Multiple Sclerosis 26 26
  • 27. A Unique Value Proposition: Superior Efficacy with Convenient Annual Dosing CARE-MS I CARE-MS II● Superior efficacy demonstrated in Phase III vs. Rebif® Patients 581 840● Manageable safety: Study Duration 2 years 2 years ● Well-characterized and consistent Patient Treatment Relapsed on across studies Population naïve prior treatment ● Effective risk management Treatment Alemtuzumab Alemtuzumab procedures in place Arms vs. IFNβ 1a vs. IFNβ 1a● FDA Fast Track designation Relapse Rate Reduction 55% 49% granted at 2 Years(1) (p<0.0001) (p<0.0001) Sustained Accumulation of Disability Reduction in 30% 42% 6 Months(1) (ns) (p=0.0084) ANN – American Academy of Neurology (1) Co-primary endpoints in CARE-MS I and CARE-MS II 27
  • 28. Aubagi A Once-Daily Oral Therapy with Comparable Efficacy to Injectable Interferon TEMSO: Reduction in Adjusted(1) ARR ● Efficacy demonstrated in TEMSO Placebo on both Relapse Rate and Disability Progression at 14mg T. 7 mg RRR: 31.2% p=0.0002 ● No superiority vs. Rebif® in RRR: 31.5% T. 14 mg TENERE but lower rate of TEAE- p=0.0005 related discontinuation 0 0,1 0,2 0,3 0,4 0,5 0,6 ● Manageable safety with up to 10 TEMSO: Reduction in Disability Progression (%) years of follow-up 30% Placebo T. 7 mg HRR: 23.7% T. 14 mg p=ns 20% HRR: 29.8% 10% p=0.0279 0% 0 12 24 36 48 60 72 84 96 108 Week (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 28
  • 29. 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™ 29 29 29