Amylin Pharmaceuticals: Creating Value as a Leader in the Treatment of Diabetes
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1 Amylin Pharmaceuticals: Creating Value as a Leader in the Treatment of Diabetes Daniel M. Bradbury President & Chief Executive Officer JPMorgan Healthcare Conference January 12, 2009 Safe Harbor Statement This presentation contains forward-looking statements about Amylin. Our actual results could differ materially from those discussed due to a number of factors, including: BYETTA and/or SYMLIN may be affected by competition, safety or other issues; clinical trials not being completed in a timely manner or achieving the intended clinical endpoints; NDAs or sndas not being submitted in a timely manner or receiving regulatory approval; expense reductions not being as large as we expect; our label update not being finalized in a timely manner; or manufacturing and supply issues. The pace of market acceptance and rate of patient adherence may also affect the potential for BYETTA and/or SYMLIN. These and other risks and uncertainties are described more fully in Amylin s most recently filed Form 10-Q. Amylin disclaims any obligation to update these forward-looking statements. 2
2 Value Creation in 2009 BYETTA Gain monotherapy approval Finalize label updates Return the product to growth EXENATIDE ONCE WEEKLY Position for launch Submit NDA Execute clinical strategy SYMLIN Continue growth OBESITY Complete Phase 2 studies Finalize development and funding strategy OPERATING RESULTS Reduce expenses and improve operating results Achieve positive cash flow by the end of Risk-Advantaged Value Creation Strategy DISEASES ASSETS GOAL RESULTS Diabetes Obesity Peptide and Protein Mimics of Human Hormones First-in-class Medicines Improve Patient and Health Outcomes Increased Shareholder Value 4
3 WITH A NEW DIAGNOSIS EVERY 21 SECONDS, DIABETES IS THE FASTEST GROWING DISEASE IN AMERICA AND THE FIFTH DEADLIEST. American Diabetes Association 5 Weight Control Linked to Growing Diabetes, Obesity, and Heart Disease Epidemics >80% of people with type 2 diabetes are overweight Obesity increases the risk of CV disease 44% in people with type 2 diabetes Cardiovascular death accounts for at least 75% of all deaths among people with diabetes Type 2 Diabetes Obese/ Overweight CV Disease Sources: Centers for Disease Control and Prevention (CDC); American Diabetes Association (ADA), Swedish National Diabetes Register (6 year follow up; ~65,000 patients-years; ~1,900 events) 6
4 Weight Control Linked to Growing Diabetes, Obesity, and Heart Disease Epidemics >80% of people with type 2 diabetes are overweight Obesity increases the risk of CV disease 44% in people with type 2 diabetes Cardiovascular death accounts for at least 75% of all deaths among people with diabetes Increase in Risk vs. Normal Weight In Type 2 Diabetes Patients Event CHD CVD Death Overweight +27% +24% +16% Obese +49% +44% +71% Sources: Centers for Disease Control and Prevention (CDC); American Diabetes Association (ADA), Swedish National Diabetes Register (6 year follow up; ~65,000 patients-years; ~1,900 events) 7 The Market is Shifting Treatments Beyond Glucose Control are Increasingly Valued LANDMARK TRIALS EXPERT ENDORSEMENT INCREASED RECOGNITION OF UNMET NEEDS TREATMENTS BEYOND GLUCOSE CONTROL UKPDS 10-Year Follow-up ACCORD ADVANCE ADA/EASD Consensus Algorithm ADA 2008 Banting Lecture Glycemic control Weight control Hypoglycemia Adherence VADT 7
5 $700 $600 $500 $400 $300 $200 $100 $ LTM Net Sales ($MM) LTM = Last Twelve Months ended 3Q08 BYETTA: Powerful Glycemic Control with Weight Loss First and only FDA-approved GLP-1 agonist Rxs declined following FDA safety posting and stabilized at end of 4Q08 Monotherapy indication and updated labeling anticipated in 1Q09 ~4 years on the market >1MM patients and large safety database Collaboration with Eli Lilly 9 BYETTA: Poised for Renewed Growth SUSTAINABILITY INNOVATION First and only daily GLP-1 Powerful glycemic control with weight loss Lower hypoglycemia risk Improved CV risk factors Established safety profile MOMENTUM Gain monotherapy approval Leverage ADA/EASD guidelines Capitalize on market shifts Enhance field force execution Patient and HCP education and support Reinforce broad managed care access BYETTA is the only daily GLP-1 agonist currently available 10
6 The Inconvenient Truth: Not all GLP-1 Agonists are Created Equal METABOLISM Exenatide is a natural molecule with no chemical modification Exenatide metabolism is known, has no metabolic byproduct cleared intact through the kidney EXPERIENCE Only exenatide has been on the market nearly 4 years >1MM patients ~85% tier 2 managed care access 11 The Inconvenient Truth: Not all GLP-1 Agonists are Created Equal BYETTA is the first and only GLP-1 available, and sets the bar for daily GLP-1s 12
7 WHEN THE ONCE-A-WEEK EXENATIDE FORMULATION BECOMES AVAILABLE THIS NEW STRATEGY MIGHT SUBSTANTIALLY CHANGE THE MANAGEMENT OF TYPE 2 DIABETES. Scheen AJ. Lancet 2008;372: Exenatide Once Weekly: Opportunity to Transform Diabetes Therapy Provides continuous therapeutic levels of exenatide, in a once-weekly dose, resulting in: 2% A1C reduction 9.5-lb Weight loss Powerful A1C reductions 74% of patients achieving endpoint A1C 7% Weight loss Improved CV risk factors No increased risk of hypoglycemia when used with metformin or a TZD Improved tolerability profile 14
8 Exenatide Once Weekly NDA Submission Pathway Established FDA feedback: DURATION-1 sufficient for NDA DURATION-1 extension appropriate to demonstrate manufacturing comparability results in 1Q09 Meta-analysis on entire exenatide safety database to evaluate CV risk NDA submission by end of 1H09 15 Positioning Exenatide Once Weekly for Market Dominance Comparator Design Background Subjects Results DURATION-2 Sitagliptin or pioglitazone Double blind, Metformin Q09 DURATION-3 Insulin glargine Open label, Metformin +/- SFU Q09 DURATION-4 Metformin, sitagliptin or pioglitazone Double blind, Drug naïve CV Outcomes Standard of care Double blind, Drug naïve mono and combo failures 12,000+ Interim: 2012 Final:
9 Positioning Exenatide Once Weekly for Market Dominance Comparator Design Background Subjects Results DURATION-2 Sitagliptin or pioglitazone Double blind, Metformin Q09 DURATION-3 Insulin glargine Open label, Metformin +/- SFU Q09 DURATION-4 Metformin, sitagliptin or pioglitazone Double blind, Drug naïve CV Outcomes Standard of care Double blind, Drug naïve mono and combo failures 12,000+ Interim: 2012 Final: Exenatide Once Weekly: Transforming Diabetes Therapy First once weekly diabetes therapy ever Transformational efficacy supported by BYETTA safety profile FDA path established for regulatory submission Manufacturing facility operational ready to go Clinical plan for market dominance Unique value proposition to patients, physicians and payors 18
10 $90 $80 $70 $60 $50 $40 $30 $20 $10 $ LTM Net Sales ($MM) SYMLIN: Steady Growth Addresses key unmet needs of insulin therapy Glucose fluctuations reduced Glucose control improved Weight loss Amylin owns 100% of economics ~4 years on the market Used by >100,000 patients with type 1 or type 2 diabetes LTM = Last Twelve Months ended 3Q08 19 SYMLIN: Enables Patients to Fine Tune their Glucose and Weight Control MOMENTUM FOCUS Targeted physicians Patient selection Patient expectations INNOVATION SymlinPen launched January 2008 Innovation = convenience Continued patient support and physician education Improved persistence A Pen and a Partner The SYMLIN Support Program SM 20
11 OBESE PEOPLE DESERVE ACCESS TO SAFE AND EFFECTIVE MEDICATIONS PHYSICIANS ARE EAGER TO HAVE ADDITIONAL TOOLS TO HELP THEIR PATIENTS. Caroline Apovian, The Obesity Society 21 Opportunity to Transform Therapies in Obesity Amylin/Leptin analogs 12.7% weight loss over 24 weeks Phase 2B dose-ranging results 3Q09 Davalintide (AC2307), 2nd generation amylin analog Phase 2 results 4Q09 Potential for enhanced efficacy and less frequent dosing 22
12 Value Creation Opportunities in Q 2Q 3Q 4Q BYETTA Monotherapy & Label Revision DURATION-1 Extension Comparability Results DURATION-2 Results DURATION-3 Results Submit Exenatide Once Weekly NDA Initiate Exenatide Once Weekly CV Outcomes Study Pramlintide/Metreleptin Phase 2B Results Davalintide (AC2307) Phase 2 Results Finalize Obesity Development and Funding Strategy 23 Value Creation in 2009 BYETTA Gain monotherapy approval Finalize label updates Return the product to growth EXENATIDE ONCE WEEKLY Position for launch Submit NDA Execute clinical strategy SYMLIN Continue growth OBESITY Complete Phase 2 studies Finalize development and funding strategy OPERATING RESULTS Reduce expenses and improve operating results Achieve positive cash flow by the end of
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