10-QPeriod: Q1 FY2004

GILEAD SCIENCES, INC. Quarterly Report for Q1 Ended Mar 31, 2004

Filed May 5, 2004For Securities:GILD

Summary

Gilead Sciences, Inc. (GILD) reported strong financial performance for the first quarter of 2004, primarily driven by significant growth in its key HIV drug, Viread. Total revenues more than doubled year-over-year, reaching $309.1 million, with product sales showing a robust 77% increase to $276.6 million. Viread sales surged by 80% to $193.1 million, now constituting a dominant 70% of total product sales and solidifying its position as the most prescribed antiretroviral in its class. This growth translated into a substantial increase in operating income and a nearly fourfold rise in cash flow from operations, reaching $98.2 million. The company also saw notable contributions from Hepsera, with sales up 226%, and the newly launched Emtriva. While AmBisome sales experienced a slight volume increase, projected full-year sales are expected to be lower due to anticipated competition. Gilead's strategic focus on anti-infectives, coupled with its product pipeline and ongoing R&D investments, positions it for continued growth, although the company acknowledges potential risks related to competition, regulatory processes, and market access.

Key Highlights

  • 1Total revenues reached $309.1 million for Q1 2004, a significant increase from $165.1 million in Q1 2003.
  • 2Product sales grew by 77% to $276.6 million, largely driven by an 80% increase in Viread sales to $193.1 million.
  • 3Viread's market share has grown, becoming the most widely prescribed antiretroviral in its drug class.
  • 4Cash flow from operations increased by 369% year-over-year to $98.2 million.
  • 5Hepsera sales showed substantial growth, increasing 226% year-over-year.
  • 6The company submitted marketing approval applications for a co-formulation of Viread and Emtriva in the U.S. and European Union.
  • 7Research and Development expenses increased 30% to $53.7 million, reflecting investments in pipeline development, particularly the Viread/Emtriva co-formulation.

Frequently Asked Questions

The primary driver of Gilead's revenue growth is the strong performance of its HIV drug, Viread. Sales of Viread increased by 80% year-over-year, becoming the dominant product in the company's portfolio and the leading drug in its therapeutic class.

While AmBisome sales saw a modest increase in the first quarter, the company expects full-year 2004 sales to be lower than 2003 due to anticipated increased competition.

Gilead faces several risks, including dependence on key products like Viread and AmBisome, potential emergence of new safety issues, regulatory hurdles, manufacturing dependencies on third parties, risks associated with collaborative relationships, and pricing and reimbursement pressures in global markets. Competition from larger pharmaceutical companies is also a significant concern.

Gilead has successfully co-formulated Viread and Emtriva into a single pill and has submitted marketing approval applications in the U.S. and European Union in March 2004. The company expects this co-formulation to be a key growth driver for its HIV franchise.