10-QPeriod: Q2 FY2004

ELI LILLY & Co Quarterly Report for Q2 Ended Jun 30, 2004

Filed August 5, 2004For Securities:LLY

Summary

Eli Lilly and Company reported a decrease in net income for both the second quarter and the first half of 2004 compared to the prior year. This decline was primarily driven by increased costs of goods sold and research and development expenses, which outpaced sales growth, and also impacted by significant asset impairment charges and acquired in-process research and development (IPR&D) costs related to the Applied Molecular Evolution (AME) acquisition. Despite the year-over-year dip in net income, the company experienced robust sales growth of 15% and 16% for the second quarter and first half of 2004, respectively, fueled by strong performance in key products like Zyprexa, Strattera, and Evista, with notable international expansion contributing significantly. Investors should be aware of the ongoing legal challenges, particularly the patent litigation surrounding Zyprexa and Evista, which could materially impact financial results if unfavorable outcomes occur. Additionally, the company is facing investigations into its marketing and promotional practices, which also carry potential financial and legal ramifications. Despite these headwinds, Lilly is actively managing its product pipeline with several new launches and seeking regulatory approvals for new indications, aiming to drive future growth.

Key Highlights

  • 1Net income for the second quarter of 2004 was $656.9 million, a 5% decrease from $692.2 million in the prior year's quarter, with diluted EPS at $0.60 versus $0.64.
  • 2First-half 2004 net income was $1.057 billion, a 4% decrease from $1.099 billion in the prior year's period, with diluted EPS at $0.97 versus $1.02.
  • 3Worldwide net sales increased by 15% to $3.56 billion for the second quarter and by 16% to $6.93 billion for the first half of 2004, driven by strong performance in key products like Zyprexa and Strattera.
  • 4The company recorded asset impairment charges of $108.9 million in Q2 2004 and a significant charge of $362.3 million for acquired in-process R&D from the Applied Molecular Evolution acquisition.
  • 5Several significant legal proceedings are ongoing, including patent litigation for Zyprexa and Evista, and investigations into marketing and promotional practices, which carry potential material adverse impacts.
  • 6Lilly is actively pursuing new product launches and indications, including Alimta, Cialis, Forteo, Strattera, Symbyax, and Cymbalta, indicating a focus on pipeline development and market expansion.

Frequently Asked Questions

The decrease in net income is primarily attributed to increased costs of goods sold and research and development expenses that grew at a faster rate than sales. Additionally, significant one-time charges, including $108.9 million in asset impairment charges in the second quarter of 2004 and $362.3 million for acquired in-process R&D from the Applied Molecular Evolution acquisition in the first quarter, also impacted profitability.

The company is facing patent litigation from several generic manufacturers challenging the validity of its U.S. compound patent for Zyprexa, which expires in 2011. A trial court ruling is expected in the summer of 2004. While Lilly believes its patents are valid and expects to prevail, an unfavorable outcome could lead to the launch of generic versions prior to the patent's expiration, which the company states would have a 'material adverse impact' on its consolidated results of operations, liquidity, and financial position.

For the full year 2004, Lilly anticipates low double-digit sales growth. While earnings per share for 2004 are projected to be between $2.39 and $2.44 (excluding future unusual items), this includes the impact of the aforementioned IPR&D and asset impairment charges. The company expects continued strong international sales growth for Zyprexa, but anticipates a decline in U.S. Zyprexa sales in the second half of 2004 compared to the prior year. R&D expenses are expected to grow in the mid-teens, while marketing and administrative expenses are projected to grow in the single digits.

The company completed the acquisition of Applied Molecular Evolution, Inc. (AME) for approximately $442.8 million, aimed at enhancing its biotherapeutic drug discovery capabilities. This acquisition resulted in a significant charge for acquired in-process R&D. The report also highlights the global rollout of seven important products/indications, including Alimta, Cialis, Forteo, Strattera, Symbyax, Zyprexa IntraMuscular, and Zyprexa for bipolar maintenance, and notes positive regulatory developments for other key products.