Eli Lilly and Company Tailored Therapeutics and Diagnostics

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1 Eli Lilly and Company Tailored Therapeutics and Diagnostics The views and opinions expressed herein and/or during the accompanying discussion are those of the author and do not necessarily represent the policies, viewpoints, or business of Eli Lilly and Company or its management. Robert L. Sharp Patent Counsel Eli Lilly and Company

2 Eli Lilly and Company- Fast Facts 10 th largest pharmaceudcal company in the world 38,000 employees; 7,400 employees engaged in R & D products marketed in 125 countries Mission: Make medicines that help people live longer, healthier, more acdve lives Strategy: Create value for all our stakeholders by acceleradng the flow of innovadve medicines that provide improved outcomes for individual padents. 2

3 Eli Lilly and Company- Heritage A heritage more than 135 years strong Founded in May 1876 by U.S. Civil War veteran Colonel Eli Lilly Three generadons of Lilly family leadership defined today s core values: Respect for people Integrity Thirst for excellence Colonel Lilly s priorides Manufacture high- quality products Recruit the best employees SaDsfy the customer Develop new products First research policy established in 1898 To contribute to the progress of medicine by developing new and superior agents through research. 3

4 Lilly s Strategy - Innovation Driven Lilly s fundamental strategy is predicated on innovadon The science has never been more promising and the need for new medicines never greater Lilly currently has the richest mid- to- late stage pipeline in its history, with 13 molecules currently in Phase III clinical development 13 molecules are in Phase II tesdng 22 molecules are in Phase I tesdng R&D expenditures total $5 BILLION in 2011 R&D as a percentage of workforce and sales: both 20 percent Cost of a new pharmaceudcal average cost to discover/develop a new drug = $800 to $1.2 BILLION average length of Dme from discover to padent = 10 to 4 15 years

5 Eli Lilly and Company Tailored Therapies and Diagnostics The rise of personalized medicine is one of the most important developments in health care today. Personalized medicine will change health care almost across the board... But nowhere, I would argue, are the cross-currents of change more powerful or the stakes higher than in the development, manufacture, and sale of prescription medicines. In my industry, we would be powerless to resist personalized medicine, not to say foolish. [W]e are not only on board [with personalized medicine], we re also trying in recent years to... put others on board and our business model will accommodate personalized medicine in fact, it may depend on it. John Lechleiter President and COO, Eli Lilly and Co. (now CEO and Chairman) Conference on Personalized Medicine: A Call to AcDon, Boston, November 29, 2007 Biomarker strategies in place for nearly all molecules at the earliest clinical development stage. Diagnostics to help demonstrate that a medicine is having the intended effect and will identify: The right patient, the right dose, the right time 5

6 Evolution of Lilly - FIPNet No single company, industry, agency, or even nadon will add very much to improving human health by working on its own. Rather, acceleradng the development of new medicines will depend on collaboradon, flexibility, and trust. Sidney Taurel Chairman and CEO, Eli Lilly and Co. Wharton Health Care Business Conference Speaking on Tailored TherapeuDcs, March 2008 Fully Integrated PharmaceuDcal Network (FIPNet) Access to ideas/capabilides we don't possess; "many sources, share risk, share work - Lillypedia Being a FIPNET = leveraging external competencies and collaboradon will be a primary driver 6

7 Patent Holders Pharma Cos. Research Institutions Evolving Complexity Patients Diagnostic Cos. Clinical Laboratories Payers Health Care Providers Complex, evolving science Complex, evolving, competitive industry Complex, evolving regulatory environment Complex, evolving economics Complex, evolving IP FDA Waived (Class I novel device) 510(k) or de novo (Class 2 device, market clearance) PMA (Class 3 device, Pre-Market Approval) Company ConfidenDal Copyright 2011 Eli Lilly and Company 7

8 Why we do what we do - patients Lilly researchers collaborated with sciendsts at the University of Toronto to develop a process to mass- produce insulin. The work resulted in the introducdon of the world s first commercial insulin product in 1923 by Eli Lilly and Company. Patient with diabetes before and two months after taking insulin 8