Eli Lilly provides financial guidance for 2010

Dec 10 2009

• Company remains focused on speeding innovation to patients and delivering greater value to customers.

• Five strategic business units prepared to maximize growth opportunities in multiple therapeutic areas and geographies.
• Lilly advances ranking to ninth in worldwide pharmaceutical sales; fastest growing top 10 pharma company in the U.S., major Europe and globally.
• R&D pipeline boasts more than 60 molecules in clinical development, including 25 in Phases II and III.
• Company expects 10 Phase III molecules in 2011, plans to launch 2 new medicines per year beginning in 2013.
• Continued strong cash flow expected to fund R&D investment and business development transactions, while at least maintaining the current dividend.
• 2010 EPS guidance set at $4.65 to $4.85, excluding the potential impact of health care reform in the U.S.
• Longer-term guidance reconfirmed at low double-digit compound annual EPS growth between 2007 and 2011

At its annual meeting today with the investment community, Eli Lilly and Company (NYSE: LLY) highlighted how its innovation-based strategy will enable it to better serve patients and compete effectively in a challenging health care environment. The company also detailed the progress being made in its labs and across its five new business units on an expanding pipeline of innovative molecules and marketed medicines, and provided investors with the company's financial guidance for 2010.

"In 2009, Lilly has once again exhibited strong performance in a tough environment, and we've continued with a series of actions aimed at speeding innovation to patients and delivering greater value to our customers," said John C. Lechleiter, Ph.D., Lilly's president and chief executive officer. "Through these actions and more, we are transforming Lilly to compete and to win in an ever more demanding and challenging environment. We see a divergence of strategies among our peers to deal with these challenges, including the wave of consolidation this year. Many companies are seeking to lower risk by reducing their focus on innovative medicines. This is not our path. Our strategy is to create value by accelerating the flow of innovative new medicines that provide improved outcomes for individual patients. We aim to discover, develop, or acquire innovative new therapies - medicines that make a real difference for patients and deliver clear value for payers."

Steven M. Paul, M.D., executive vice president, science and technology and president of Lilly Research Laboratories, reinforced the company's commitment to innovation. "I believe that there's never been a more compelling case for innovative medicines. Our strategy is dependent upon our pipeline of potential medicines. I am encouraged by the fact that today we have the strongest pipeline in our history. We currently have more than 60 new molecules in clinical development, including 25 in Phases II and III, targeting unmet medical needs in areas such as Alzheimer's disease, cancer and diabetes, among others. We are excited by both the quantity and the quality of these molecules, and their potential to improve patient's lives."

Paul expanded on the efforts being made in Lilly's research and development organization. "By ramping up our efforts in discovery research, we have nearly doubled the number of new molecules moving into the clinic each and every year. As a result, we have tripled the number of potential new medicines in our clinical pipeline since 2004. Through the acquisition of ImClone and other actions, we have increased our portfolio of biotechnology-based molecules, which now represents over one-third of our clinical-stage pipeline. We are also applying creative approaches to every point in the R&D chain to develop more medicines more quickly at lower cost. Initiatives such as our phenotypic drug discovery program (PD2), numerous risk-sharing collaborations, the early-stage work of our virtual Chorus team and our new Development Center of Excellence will further accelerate development, and increasingly tailor molecules for those patients most likely to benefit from them. Through these efforts, we expect to have at least 10 molecules in Phase III clinical development by the end of 2011 and plan to launch two new medicines per year beginning in 2013 and to sustain a steady flow of innovation thereafter."

Derica Rice, Lilly senior vice president and chief financial officer, provided commentary on the company's current financial performance and forward-looking expectations. "Lilly is completing another year of strong operating performance, delivering solid earnings growth resulting from volume-based sales growth, improving gross margins and tightening control of operating expenses. Looking ahead to 2010, we expect to once again deliver good sales and earnings growth, excluding the potential impact of health care reform legislation in the U.S. We also expect to generate solid cash flow in the coming years to fund continued investment in research and development, as well as to fund our dividend and anticipated business development activity. We continue to expect to deliver low double-digit compound annual earnings-per-share growth between 2007 and 2011. We are taking the steps necessary to prepare our operations for the upcoming challenges of patent expiries. We are committed to becoming leaner, more focused, more customer-oriented and more competitive."

Based on IMS Health data, for the 12 months ending June 2009, Lilly has moved into the ninth spot among the top 10 companies ranked by worldwide pharmaceutical sales. Among these top 10 companies, Lilly was the fastest growing globally and the fastest growing in the United States and major Europe; the fourth-fastest growing in the pharmerging markets; and the sixth-fastest growing in Japan.

The company recently refocused its operations around five business units to create a clear line of sight to the customer. The five business units cover oncology, diabetes, established markets, emerging markets and animal health. The following sections highlight each of these five business units, including the performance of key marketed products and updates on the status of select late-stage and mid-stage pipeline molecules.