10-KPeriod: FY2003

Merck & Co., Inc. Annual Report, Year Ended Dec 31, 2003

Filed February 26, 2004For Securities:MRK

Summary

Schering-Plough Corporation faced a challenging year in 2003, marked by a significant decline in net sales, primarily due to the loss of market exclusivity and subsequent generic competition for its leading product, CLARITIN. This led to a net loss for the year, a stark contrast to the profits reported in 2002 and 2001. The company is actively implementing a Value Enhancement Initiative (VEI) to cut costs, including workforce reductions and a substantial dividend cut, signaling a period of financial restructuring. Key drivers of the downturn include the conversion of CLARITIN to over-the-counter status, which drastically reduced its average selling price and exposed it to intense competition, and increased competition for its INTRON franchise in the hepatitis C market. Management is placing significant reliance on the joint venture with Merck & Co. for ZETIA and the ezetimibe/simvastatin combination to drive future growth. The company also faces ongoing legal and regulatory investigations, which have resulted in increased litigation reserves.

Key Highlights

  • 1Significant 18% decline in consolidated net sales to $8.3 billion in 2003, down from $10.2 billion in 2002, largely driven by a 39% decrease in the Allergy & Respiratory segment.
  • 2Reported a net loss of $92 million in 2003, a sharp reversal from a net income of $1.97 billion in 2002.
  • 3CLARITIN Rx sales plummeted by 79% to $370 million in 2003, reflecting the impact of its switch to OTC status and generic competition.
  • 4The company initiated a Value Enhancement Initiative (VEI) involving cost-cutting measures, including workforce reductions and a dividend cut from $0.17 to $0.055 per share.
  • 5Significant litigation reserves were increased by $350 million in 2003 due to ongoing investigations into sales and marketing practices.
  • 6The company is heavily investing in the cholesterol-lowering products ZETIA and the ezetimibe/simvastatin combination, developed in partnership with Merck, as a key future growth driver.
  • 7Research and development spending remained high, at 17.6% of net sales in 2003 ($1.5 billion), indicating continued investment in future product pipelines.

Frequently Asked Questions

The primary reasons are the loss of market exclusivity and subsequent generic competition for its key allergy medication, CLARITIN, which led to a drastic drop in its sales, and increased competition for its INTRON franchise in the hepatitis C market. The switch of CLARITIN to over-the-counter (OTC) status significantly reduced its average selling price.

The company has implemented a Value Enhancement Initiative (VEI) which includes cost-cutting measures such as reducing employee bonuses and merit increases, targeting a 10% reduction in payroll and related expenses (partially through a Voluntary Early Retirement Program), and installing global procurement programs. Additionally, the quarterly dividend was significantly reduced from $0.17 to $0.055 per share.

Schering-Plough is pinning its hopes for future growth and financial recovery on the cholesterol-reduction market, particularly through its joint venture with Merck for ZETIA and the ezetimibe/simvastatin combination. The company is also investing in its early-stage research pipeline and actively pursuing licensing opportunities.

The company is subject to significant ongoing investigations by U.S. Attorney's Offices concerning its sales and marketing practices, which have led to substantial increases in litigation reserves. It is also addressing issues related to Good Manufacturing Practices (cGMP) at certain manufacturing facilities, resulting in a consent decree with the FDA and associated compliance costs and potential penalties.