Novartis AG · SIX:NOVN
Novartis — Bear Stearns Healthcare Conference 2006
29 slides from Novartis's conference presentation, Mar 1, 2006
Slide 1: Growth Platforms for a Changing Health Care Environment
Growth Platforms for a Changing Health Care Environment Ameet Nathwani Global Head Cardiovascular and Metabolism, Clinical Development and Medical Affairs Karen Huebscher Global Head Investor Relations Bear Stearns Healthcare Conference London, March 1, 2006 The following information contains certai
Slide 2: Agenda; 2005 – Another Record Year
Agenda • 2005 performance • A clear strategy • Development pipeline • Outlook 3 Bear Stearns Conference / London / March 1, 2006 2005 – Another Record Year in USD m FY 2005 FY 2004 in % USD in % LC Net sales 32 212 28 247 14 13 Operating income 6 905 6 2891 10 as % of net sales 21.4 22.3 Net income
Slide 3: Positive Margin Development in Pharma
Positive Margin Development in Pharma in % 2005 2004 29.7 29.0 21.4 22.3 14.5 15.0 8.6 7.3 Pharma- Sandoz Consumer Group ceuticals Health 5 Bear Stearns Conference / London / March 1, 2006 Pharmaceuticals Make up 63% of 2005 Net Sales and 81% of Operating Income in 2005 Net sales Operating income in
Slide 4: Pharmaceuticals – Continued Market Share Gains
Pharmaceuticals – Continued Market Share Gains Novartis Pharma market share of total health care market 4.0% 3.9% 3.8% 3.8% 3.7% 3.6% 3.4% 3.4% 3.3% 3.2% 3.0% 1 2001 2002 2003 2004 2005 1 YTD Nov Source: IMS 29 countries 7 Bear Stearns Conference / London / March 1, 2006 Key Growth Drivers Cardiovas
Slide 5: 8 of Top 10 Products Growing
8 of Top 10 Products Growing Top 10 product net sales full year 2005 in USD m2 Growth in LC vs. PY Diovan® 3 676 +19% Glivec®1 2 170 +32% Zometa® 1 224 +13% Lamisil® 1 133 -2% Lotrel® 1 075 +17% Neoral® 953 -6% Sandostatin® 896 +8% Lescol® 767 +1% Voltaren® 689 +7% Trileptal® 615 +18% 1 Gleevec® in
Slide 6: Industry Faces Challenges
Agenda • 2005 performance • A clear strategy • Development pipeline • Outlook 11 Bear Stearns Conference / London / March 1, 2006 Industry Faces Challenges • Governments and payors aggressive in managing costs − Price cuts, discounts, co-pays, formularies and other cost containment measures − Parall
Slide 7: Four Fundamental Trends Drive Growth in Health Care and Medicines
Four Fundamental Trends Drive Growth in Health Care and Medicines • Aging population with increasing health care needs • Advancing science and technology enabling new drug discovery • Economic growth of emerging countries with better health care access • Lifestyles leading to higher prevalence of ch
Slide 8: Novartis Pharma Key Strategies
Novartis Pharma Key Strategies 1 Strong pipeline / portfolio in attractive categories 2 Innovative commercial models 3 Re-engineer clinical development model 4 Business Development & Licensing excellence 5 Drive productivity 15 Bear Stearns Conference / London / March 1, 2006 Agenda • 2005 performan
Slide 9: 2005 – A Successful Year for Development
2005 – A Successful Year for Development • Good progress of key projects • Eight significant approvals, including two high priority reviews • Ten filings, including two NMEs1 • Exciting new data for Galvus®2 (vildagliptin) and Rasilez®2 (aliskiren) • 2006 pipeline attractive and robust 1 New molecul
Slide 10: Majority of Patients with Chronic Diseases Not Yet Treated Optimally
Majority of Patients with Chronic Diseases Not Yet Treated Optimally Hypertension Dyslipidemia Diabetes Prevalence, in millions1 181 315 46 % Not diagnosed1 45% 53% 39% % Diagnosed, not treated1 42% 67% 12% % Treated, not at goal2 70% 60% 63% % Treated optimally 9% 6% 19% 1 Top 7 countries, source D
Slide 11: Most Hypertensive Patients Not Receiving Adequate Combination Treatments
Most Hypertensive Patients Are Not Yet Receiving Adequate Combination Treatments to Get to Goal Average number of AHY1 drugs per patient ? 5 4 3 2 1 0 2 3 Average - Average - EU Average - US Needed for Needed for Japan 135/85 120/80 1 Anti-hypertensives 2 Average of top 5 EU countries 3 Based on IDN
Slide 12: Rasilez (aliskiren)
Rasilez® (aliskiren) 23 Bear Stearns Conference / London / March 1, 2006 The Renin Cycle Kidney Renin inhibitor • Glomerular vasoconstriction • Inflammation Angiotensinogen • Fibrosis Ang I Renin Heart • Hypertrophy Plasma • Fibrosis ACE Renin • Vasoconstriction ACEIs feedback loop Activity Vessels
Slide 13: Rasilez – Consistent Double Digit Blood Pressure Response
Rasilez® – All Data Demonstrate Consistent Double Digit Blood Pressure Response Blood pressure reduction (sitting, mmHg) with Rasilez® 300mg Placebo Rasilez® Placebo Rasilez® Placebo Rasilez® Placebo Rasilez® 0 systolic systolic systolic diastolic systolic diastolic sys diastolic systolic diastolic
Slide 14: Rasilez Demonstrates Marked Decrease in Early Morning Blood Pressure Rise
Rasilez® Demonstrates Marked Decrease in Early Morning Blood Pressure Rise Mean ambulatory SBP1 (mmHg) Rasilez® 300 mg, ITT2 population 155 150 145 140 135 Week 0 130 Week 8 125 120 115 0 2 4 6 8 10 12 14 16 18 20 22 24 Clock hour 1 Systolic blood pressure 2 Intent-to-treat Source: Data on file: Nov
Slide 15: Combination of Rasilez and HCTZ Gives Additional BP Lowering
Combination of Rasilez® and HCTZ1 Gives Additional Diastolic Blood Pressure Lowering Diastolic blood pressure reduction mmHg Rasilez® HCTZ Combination Placebo 75 150 300 mg 6.25 12.5 25 mg (1) (2) (3) 0 n=183 n=195 n=194 n=176 n=173 n=195 n=188 n=186 n=185 n=188 -7 -8 -9 * * * -10 * -11 * * * -12 -1
Slide 16: Rasilez Offers Superior Efficacy Compared to ramipril
Study 2307 – Rasilez® (aliskiren) vs. and in Combination with ramipril in Hypertensive Patients with Diabetes Randomized, double-blind, parallel group, dose escalation study in 837 patients with hypertension and diabetes Rasilez® 150 mg Rasilez® 300 mg n=282 Wash-out Placebo ramipril 5 mg ramipril 1
Slide 17: …And in Diastolic Blood Pressure
…And in Diastolic Blood Pressure Mean change in diastolic blood pressure from baseline at endpoint (week 8) mmHg ramipril Rasilez® Rasilez® / ramipril 10 mg 300 mg 300/10 0 -10.0 n = 278 -11.0 -10.7 n = 282 -11.3 -12.0 Non-inferior n = 277 -13.0 -12.8 p = 0.04 p = 0.004 Source: Study 2307 33 Bear St
Slide 18: Rasilez Shows Promise for Mono- and Combination Therapy
Rasilez® Provides Significant BP Reduction when Added to amlodipine with Reduced Incidence of Edema Mean change in blood pressure from baseline at week 6 mmHg amlodipine amlodipine Rasilez®1 150 mg 5 mg 10 mg + amlodipine 5 mg n=180 n=178 n=187 0 dia dia sys sys sys dia -4 -5 −4.8 −5.0 -6 -7 -8 −8.0
Slide 19: Extensive Hypertension Category Coverage; Plasma Renin Activity
Extensive Hypertension Category Coverage with Multiple Strong Brands with Different Mechanisms Source of Business • New patients Source of business by brand • Add-on depends on • Physician treatment • Patient not at goal on preferences diuretics / ARB • Generic / branded • Patients not at goal on CC
Slide 20: Rasilez Filings and Expected Data; Galvus (vildagliptin)
Overview of Filings, Timing of Study Starts and Expected Data for Rasilez® (aliskiren) Large outcome studies (start) Primary Long term outcome data prevention available: 2011 and beyond Post-MI1 combination Secondary therapy prevention 2005 2006 2007 2008 Filing in US Filing in EU Surrogate outcome
Slide 21: Islet Dysfunction Leads to Hyperglycemia in Type 2 Diabetes
Islet Dysfunction Leads to Hyperglycemia in Type 2 Diabetes Glucagon + HGO1 α-Cells Glucose – β-Cells first phase response glucose-dependency – Glucose Insulin uptake 1 Hepatic glucose output Adapted from Ohneda A. et al. J Clin Endocrinol Metab. 1978; 46: 504–510 and Gomis R. et al. Diabetes Res Cl
Slide 22: Nearly Half of β-Cell Function Lost by Diagnosis
Nearly Half of β-Cell Function Lost by the Time of Type 2 Diabetes Diagnosis – Window for Early Prevention? 100 Diabetes diagnosed 80 β-cell function1 (%) 60 40 Potential window for diabetes prevention? 20 0 -12 -10 -8 -6 -4 -2 0 2 4 6 Years from diagnosis 1 β-cell function measured by HOMA (Homeost
Slide 23: Galvus Is Effective as Once-A-Day Treatment
Galvus® (vildagliptin) Is Effective as Once-A-Day Treatment Change in HbA1c (%) Mean HbA1c reduction from baseline at 24 weeks (7.5%–11%) 0.0 -0.1 -0.2 -0.3 -0.3 -0.4 -0.5 -0.6 -0.7 -0.8 -0.78 -0.79 -0.9 * * -0.88 Galvus® 50 mg qd (n=104) -1.0 † Galvus® 50 mg bid (n= 90) *P=0.006; † P=0.001 vs. plac
Slide 24: Galvus Superior Gastrointestinal Tolerability to Metformin
Galvus® Has a Superior Gastrointestinal Tolerability Profile to Metformin % Patients reporting events Galvus® 100 mg (n=526) metformin 2 000 mg (n=254) 50 P < 0.001 40 30 20 10 0 Any GI Abdominal Consti- Diarrhoea Dyspepsia Flatulence Nausea Vomiting events pain pation Source: Study 2309 data on fil
Slide 25: Galvus Is a Strong Add-on Treatment to glimepiride
Galvus® (vildagliptin) Is a Strong Add-on Treatment to glimepiride Mean HbA1c (%) glim1 & Galvus® 50 mg qd (n=132) glim & Galvus® 50 mg bid (n=132) 9.0 glim & placebo (n= 144) 8.8 8.6 8.4 8.2 8.0 * * 7.8 0 -4 0 4 8 12 16 20 24 Time (weeks of treatment) 1 glimepiride 4 mg qd * P<0.001 difference vs.
Slide 26: Phase III Confirms Galvus Add-on to metformin
Phase III Confirms that Galvus® (vildagliptin) Is a Powerful Add-on Treatment to metformin Mean HbA1c (%) met1 & Galvus® 50 mg qd (n=143) met & Galvus® 50 mg bid (n=143) met & placebo (n=130) 8.6 8.4 8.2 8.0 7.8 * * * 7.6 * * * 7.4 0 -4 0 4 8 12 16 20 24 Time (weeks of treatment) 1 metformin > 1 500
Slide 27: Galvus – Data Achieves All Efficacy and Safety Goals
Galvus® (vildagliptin) – Data Achieves All Efficacy and Safety Goals • Trial data confirms attractive profile of Galvus® − Highly effective treatment of T2DM1 in mono- and combination therapy − Once-a-day therapy, can be dosed twice-a-day − Effective out to one year − Neutral on body weight − No ede
Slide 28: Overview of Filings and Expected Data for Galvus
Overview of Filings and Expected Data for Galvus® (vildagliptin) Durability Prevention Disease modification Prevention and outcome data available: 2009 and beyond T2DM Prevention of prevention CVM1 risk 2005 2006 2007 2008 2009 2010 2011 2012 Durability Combo prediabetes durability Filing in US Fili
Slide 29: Strong Newsflow Continues in 2006
Strong Newsflow Continues in 2006 Regulatory Data Submissions Decisions • Rasilez® Phase III • Rasilez® hypertension • Aclasta® Paget’s disease (US) • Galvus® Phase III • Galvus® diabetes • Co-Diovan® 320 (US) • Aclasta® Phase III1 • Exforge hypertension • Exjade® (EU) • Exforge Phase III • Telbivud