2013 - Leerink Swann HC


Published on

2013 - Leerink Swann HC

  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

2013 - Leerink Swann HC

  1. 1. LEERINK SWANN HEALTHCARE CONFERENCE David Meeker, Chief Executive Officer, Genzyme New York, February 14, 2013
  2. 2. Forward Looking StatementsThis 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 includeprojections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions andexpectations with respect to future financial results, events, operations, services, product development and potential, andstatements regarding future performance. Forward-looking statements are generally identified by the words "expects","anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofis management believesthat 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 andgenerally beyond the control of Sanofi, that could cause actual results and developments to differ materially from thoseexpressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertaintiesinclude 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 toapprove any drug, device or biological application that may be filed for any such product candidates as well as theirdecisions regarding labeling and other matters that could affect the availability or commercial potential of such productcandidates, the absence of guarantee that the product candidates if approved will be commercially successful, the futureapproval and commercial success of therapeutic alternatives, the Groups ability to benefit from external growthopportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies andsubsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in thepublic filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "CautionaryStatement Regarding Forward-Looking Statements" in Sanofis annual report on Form 20-F for the year ended December31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise anyforward-looking information or statements. 2
  3. 3. AgendaSanofi highlights to dateRare diseases and GenzymeRare disease opportunityMultiple sclerosis opportunity 3
  4. 4. Sanofi Has Delivered Sales Growth for the Last Four YearsDespite the Loss of Several Mega Blockbusters Sales €34,947m €33,389m €32,367m €29,306m €27,568m +0.5% at CER(1) (2) (2) (3) 2008 2009 2010 2011 2012 (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 4
  5. 5. Sanofi Growth Platforms Have Doubled Over Four YearsWhile the Patent Cliff Enters the Rear-view Mirror Sales of Sales of Growth Platforms(1) Key Genericized Products(2) €23,548m €11,783m €7,565m €2,222m 2008 2009 2010 2011 2012 2008 2009 2010 2011 2012% of 42.7% % of 27.4% 67.4% 6.4%Total Total (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) 5
  6. 6. Sanofi Growth Platforms Grew by +9.9%(1) in 2012and Constitute Long Life Assets to Drive Future Growth 2012 growth at CER Emerging Markets(2) €11,145m +8.3% Diabetes Solutions €5,782m +16.7% Vaccines €3,897m +5.7% Consumer Healthcare €3,008m +9.9% Animal Health €2,179m +3.1% New Genzyme(3,4) €1,785m +16.9% Other Innovative Products(4,5) €611m +10.5% (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® 6
  7. 7. 2012 Was a Turning Point for Unleashingthe Full Potential of Genzyme ● Regulatory approval of Framingham plant 1 Supply ● All 2012 numbered steps for Consent Decree met Recovery ● Full supply of Cerezyme® & Fabrazyme® ● Double-digit growth of Rare Diseases franchise 2 Business ● Creation of a new Multiple Sclerosis business unit Growth ● Very encouraging U.S. launch of Aubagio® ● FDA approvals(1,2) of Aubagio® and Kynamro™ 3 Late-stage ● Filing of Lemtrada™ in EU and the U.S. Pipeline ● Positive results of two Phase III studies with eliglustat ● Significant OPEX synergies 4 Transformation ● New Research hub created in Cambridge, MA Catalyst ● Legacy business(3) enhanced through transfer to Sanofi 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 (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 7
  8. 8. AgendaSanofi highlights to dateRare diseases and GenzymeRare disease opportunityMultiple sclerosis opportunity 8
  9. 9. Orphan Drug Market is Attractive and Offers GrowthPotential 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) 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 (3) EvaluatePharma; internal analysis 9
  10. 10. Leveraging Genzyme’s Innovative Capabilities ● Strong expertise ● Unique biologics in rare disease and platform multiple sclerosis Creation of the Genzyme R&D Center ● Integrated innovation ● Commitment to open hub in the Boston area innovation 10
  11. 11. Cerezyme® is the Foundation of the Genzyme ModelTransformative Therapy Extensive Global Reach Ensure Market Access 1983 ● Increase awareness 2012 Sales Split ● Enable access to diagnostic testing ROW U.S. 26% ● Identify and train experts 40% 2001 ● Support patient advocacy ● Partner with healthcare systems 34% EU 11
  12. 12. Cerezyme® Treating Gaucher Disease for Over 20 years ● Cerezyme® maintained market share Quarterly Sales (€m) with 2012 sales up +6.0%(1) to €633m €171m in a growing market ● Patients in major markets returned to €131m normal dosing ● Gold-standard product: ● 20 years of proven safety and efficacy ● Demonstrated bone benefits(2) ● Currently treating ~5,000 patients Q4 Q4 2011 2012 (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 12
  13. 13. Fabrazyme® Delivered Very Strong Performance in 2012 ● Fabrazyme® sales almost doubled Quarterly Sales (€m) growing 96.4% to €292m in 2012 €84m ● Supply from new Framingham plant ● Shire’s withdrawal of Replagal® BLA(1) in the U.S. in early 2012 €47m ● Patients in major markets returned to normal dosing ● Regain significant market share by: ● Restoring supply ● Driving importance of dose in clinical Q4 Q4 outcomes 2011 2012 ● Currently treating ~2,000 patients (1) BLA: Biologics License Application 13
  14. 14. Fabrazyme® – Treating the Family Finding 1 new index patient leads, on average, to diagnosis of another 5 patients in that family 14
  15. 15. Myozyme®/Lumizyme®: Only Approved Treatmentfor Pompe Disease ● Myozyme® grew at a double-digit Quarterly Sales (€m) rate of +11.4 %(1) to €462m in 2012 €121m ● Long-term potential commercial opportunities similar to Cerezyme® ● Focus is on: ● Driving disease awareness ● Partnering with physicians to increase €108m early diagnosis ● Currently treating ~1,700 patients Q4 Q4 2011 2012 & (1) Growth is at constant exchange rates and at comparable perimeter - Genzyme sales were not consolidated in Q1 2011 15
  16. 16. Myozyme®: Our Most Successful Launch $m Myozyme®/ Lumizyme® 600 550 500 Fabrazyme® 450 400 Ceredase®/ 350 Cerezyme® 300 250 200 Aldurazyme® 150 100 50 0 (1) 0 1 year 2 year 3 year 4 year 5 year 6 year (1) Reflects the first full fiscal year after launch 16 16
  17. 17. Expanding Manufacturing Capacity is Key to Future Growth Sites 2011 2012 2015e Capacity 12,000L Allston, MA 20,000L Geel, Belgium 8,000L Framingham, MA new plant 17
  18. 18. Eliglustat Clinical Data Compared to Cerezyme® RegistryData 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 18
  19. 19. AgendaSanofi highlights to dateRare diseases and GenzymeRare disease opportunityMultiple sclerosis opportunity 19
  20. 20. Eliglustat(1) - A Novel Oral Therapy in Gaucher Disease Change in Spleen Volume ● Novel substrate inhibitor (% change at 9 months) ● Oral therapy +2% ● Eliminating challenges of infusions Eliglustat ● Positive results from ENGAGE, Placebo Phase III study (vs. placebo) ● Primary endpoint and all secondary endpoints met(2) ● No serious adverse events reported in 30% the primary analysis period Absolute Difference ● ENCORE Phase III study with eliglustat met its primary efficacy endpoint (vs. Cerezyme®)(3) -28% (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) 20
  21. 21. : FDA Approved to Treat HoFH(1)● 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 (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 21 heFH – Heterozygous familial hypercholesterolemia
  22. 22. AgendaSanofi highlights to dateRare diseases and GenzymeRare disease opportunityMultiple sclerosis opportunity 22
  23. 23. Global MS Market Expected to Continue to Grow ● ~2.1m multiple sclerosis patients MS Market Sales(1) worldwide(2) ● Prevalent in young women CAGR (~2:1 female/male ratio) ~6% ● A major impact on family, social and ~$16.6bn professional life ● Symptoms include fatigue, weakness, ~$12.5bn walking and balance difficulties, 57% vision problems U.S. 60% ● “ABCRE” products(3) represented >80% of the global MS market value in 2011(1) 43% ● Require frequent injections ROW 40% 2011 2016e (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 23 of EMD Serono, Inc.; Tysabri® is a registered trademark of Biogen Idec.
  24. 24. Creation of a Franchise Addressing the Full Spectrum ofPatient Needs in Multiple Sclerosis RRMS(1) and RMS(2) severe/ Early MS 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) RRMS – Relapse Remitting Multiple Sclerosis (2) RMS – Relapsing Multiple Sclerosis 24 24
  25. 25. ® Study Showed Slowing Sustained Accumulation of Disability for Six Months vs. Active Comparator(1) CARE-MS I CARE-MS II● Significant efficacy results vs Rebif® Annualized Relapse Rate ● 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) Reduction in Progression of Disability ● Autoimmune events (thyroid disorders and ITP) detected via routine monitoring and generally managed using conventional therapies● Convenient annual dosing 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 25 (4) Risk of infections higher with Lemtrada and majority were mild to moderate
  26. 26. ® A “Platform” Therapy in a Pill for Relapsing MS● Very encouraging early launch Cumulative U.S. Weekly TRx(2) 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 (1) Based on data collected at Genzymes MS One to One Patient and Provider Support Center, Sep 2012-Jan 2013 (2) IMS Weekly Total Prescriptions 26
  27. 27. 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. 27