10-QPeriod: Q1 FY2004

ELI LILLY & Co Quarterly Report for Q1 Ended Mar 31, 2004

Filed May 7, 2004For Securities:LLY

Summary

Eli Lilly & Co. reported solid revenue growth of 17% year-over-year for the first quarter of 2004, reaching $3.38 billion. This top-line expansion was driven by strong performance across key product categories, particularly neurosciences and endocrinology, with notable contributions from Zyprexa, Gemzar, and Evista. Despite this sales increase, net income saw a slight decrease of 2% to $400.4 million ($0.37 per share) compared to the prior year. This was primarily due to a significant $362.3 million charge for acquired in-process research and development related to the Applied Molecular Evolution acquisition, which also resulted in a substantially higher effective tax rate of 34.9% compared to 17.6% in Q1 2003. The company has also been active in strategic development, completing the acquisition of Applied Molecular Evolution to bolster its biotherapeutic drug discovery capabilities. However, investors should note the ongoing significant legal challenges, including patent litigation for Zyprexa and Evista, and investigations into marketing and promotional practices. While management expressed confidence in prevailing, an unfavorable outcome could materially impact financial results. Despite these headwinds, Lilly's robust sales growth and strategic investments signal continued efforts to expand its product pipeline and market presence.

Key Highlights

  • 1Net sales increased by 17% to $3.38 billion for the first quarter of 2004, driven by strong growth in neurosciences and endocrinology segments.
  • 2A significant charge of $362.3 million for acquired in-process research and development (IPR&D) related to the Applied Molecular Evolution acquisition negatively impacted net income and earnings per share.
  • 3Net income decreased by 2% to $400.4 million ($0.37 per diluted share) compared to $407.0 million ($0.38 per diluted share) in the prior year's quarter.
  • 4The effective tax rate increased significantly to 34.9% in Q1 2004 from 17.6% in Q1 2003, largely due to the non-deductible IPR&D charge.
  • 5The company completed the acquisition of Applied Molecular Evolution (AME) for approximately $442.8 million, enhancing its capabilities in biotherapeutic drug discovery.
  • 6Key products like Zyprexa, Gemzar, and Evista showed substantial sales growth, with new product launches and pipeline developments also contributing positively.
  • 7Eli Lilly faces significant ongoing legal proceedings, including patent litigation for Zyprexa and Evista, and investigations into marketing practices, which carry potential material adverse impacts.

Frequently Asked Questions

The primary driver for the 17% increase in net sales to $3.38 billion was strong performance across key product categories, notably neurosciences and endocrinology, with significant contributions from established products like Zyprexa, Gemzar, and Evista, as well as growth from newer products.

The $362.3 million IPR&D charge resulted from the acquisition of Applied Molecular Evolution (AME). This charge pertains to the value of compounds under development that have not yet received regulatory approval. As per accounting standards, these intangible assets were written off immediately, significantly impacting net income and increasing the effective tax rate for the quarter due to its non-deductible nature.

Eli Lilly is facing significant legal risks, including patent litigation challenging the validity of patents for its key drugs Zyprexa and Evista. Additionally, the company is under investigation by the U.S. Department of Justice and the U.S. Attorney's office concerning its marketing and promotional practices for products like Prozac and Zyprexa. An unfavorable outcome in any of these matters could have a material adverse effect on the company's financial position and results of operations.

As of March 31, 2004, cash, cash equivalents, and short-term investments totaled $3.48 billion, a slight decrease from $3.71 billion at the end of 2003. Total debt increased by $426.4 million to $5.31 billion, primarily due to the issuance of commercial paper. The company expects to fund its 2004 operating needs through cash generated from operations and available cash, potentially issuing additional debt.