10-QPeriod: Q1 FY2005

ELI LILLY & Co Quarterly Report for Q1 Ended Mar 31, 2005

Filed May 5, 2005For Securities:LLY

Summary

Eli Lilly and Company reported a significant increase in net income and earnings per share for the first quarter of 2005 compared to the same period in 2004. This performance was bolstered by strong sales growth from key products like Cymbalta and Alimta, as well as an increase in international sales. The company also benefited from favorable impacts of foreign exchange rates and a one-time gain related to royalty arrangements. However, overall sales growth was tempered by reductions in U.S. wholesaler inventory levels due to restructured arrangements and decreased sales of Zyprexa. A notable change in financial reporting this quarter is the adoption of SFAS 123R, requiring the expensing of stock options, which impacted reported net income. The company also experienced a significant charge in the prior year for acquired in-process research and development, making the year-over-year net income comparison appear more favorable in the current period. Eli Lilly faces ongoing legal challenges, particularly concerning patent disputes for Zyprexa and Evista, and product liability litigation related to Zyprexa, which present material risks that could impact future financial performance.

Key Highlights

  • 1Net income increased by a substantial 84% to $736.6 million, with diluted EPS rising to $0.68 from $0.37 in the prior year's quarter.
  • 2Worldwide net sales grew by 4% to $3,497.4 million, driven by new product launches (Cymbalta, Alimta) and international market strength, though tempered by inventory adjustments and Zyprexa sales decline.
  • 3The company adopted SFAS 123R effective January 1, 2005, leading to the expensing of stock options, which reduced reported net income by $61.6 million for the quarter.
  • 4Zyprexa sales saw a 5% decrease globally, with a significant 17% decline in the U.S. due to competitive pressures and inventory reductions.
  • 5Significant legal and regulatory matters are ongoing, including patent challenges for Zyprexa and Evista, and product liability lawsuits concerning Zyprexa, which could materially impact financial results.
  • 6Cash flow from operations was strong at $804.8 million, but significant debt repayments and dividend payments reduced cash and cash equivalents.
  • 7The company is actively pursuing global launches of several new products and indications, signaling a focus on pipeline expansion and revenue diversification.

Frequently Asked Questions

The significant increase in net income is largely due to the absence of a large acquired in-process research and development (IPR&D) charge of $362.3 million that occurred in Q1 2004 related to the Applied Molecular Evolution, Inc. acquisition. Additionally, the adoption of SFAS 123R in 2005, which requires expensing stock options, had a negative impact on net income in the current quarter, making the year-over-year comparison appear more favorable.

The recently restructured arrangements with U.S. wholesalers have led to reductions in wholesaler inventory levels during the first quarter of 2005. Eli Lilly estimates this reduction cost approximately $130 million in sales for the quarter, negatively impacting reported sales growth. While these arrangements are expected to provide more competitive distribution costs and reduce speculative buying, they have caused a short-term sales decline and impacted specific product sales like Strattera and Evista.

Eli Lilly faces significant legal risks, primarily related to patent litigation for its key drugs Zyprexa and Evista, where generic manufacturers are challenging patent validity. Additionally, there are numerous product liability lawsuits concerning Zyprexa, alleging injuries related to diabetes and high blood-glucose levels, and improper promotion. There is also a civil investigation into marketing and promotional practices for Zyprexa, Prozac, and Prozac Weekly. While the company is vigorously defending these matters and currently believes they will not materially impact financial position or liquidity, an unfavorable outcome in the Zyprexa patent litigation or product liability cases could have a material adverse effect on results of operations.

The adoption of SFAS 123R (Share-Based Payment) effective January 1, 2005, requires Eli Lilly to recognize the fair value of stock-based compensation (like stock options) as an expense in its income statement. This is a change from previous accounting under APB Opinion 25, where stock options granted at fair market value were not expensed. In Q1 2005, this resulted in $108.2 million in stock-based compensation expense, reducing reported net income by $61.6 million (or $0.06 per share) compared to prior accounting methods. The company also recognized $108.2 million in stock-based compensation expense for the quarter.