10-KPeriod: FY2006

Merck & Co., Inc. Annual Report, Year Ended Dec 31, 2006

Filed February 28, 2007For Securities:MRK

Summary

Merck & Co., Inc. (referred to as Schering-Plough in the filing) reported significant net sales growth in 2006, reaching $10.6 billion, an 11% increase over the previous year. This growth was largely driven by strong performance in its prescription pharmaceuticals, particularly the cholesterol franchise (VYTORIN and ZETIA) co-marketed with Merck, and key products like REMICADE, NASONEX, and TEMODAR. Net income available to common shareholders saw a substantial improvement, reaching $1.1 billion in 2006 compared to $183 million in 2005, reflecting effective management strategies and increased sales volumes. The company also highlighted ongoing investments in research and development, with a focus on new product pipelines to address unmet medical needs. However, the company acknowledged significant legal and regulatory challenges, including ongoing investigations into sales and marketing practices and past compliance issues with Good Manufacturing Practices (GMP), which led to a $435 million settlement with Massachusetts authorities. These factors, along with patent expirations and increasing pricing pressures from managed care and government entities, represent key risks to future financial performance. Despite these headwinds, Schering-Plough emphasized its commitment to rebuilding and growing the business, focusing on scientific innovation and strategic alliances.

Key Highlights

  • 1Net sales increased by 11% to $10.6 billion in 2006, driven by strong prescription pharmaceutical performance, notably the cholesterol franchise (VYTORIN and ZETIA) and products like REMICADE, NASONEX, and TEMODAR.
  • 2Net income available to common shareholders improved significantly to $1.1 billion in 2006, a substantial increase from $183 million in 2005.
  • 3The company is making significant investments in Research and Development, increasing spending to $2.2 billion in 2006 to support its product pipeline.
  • 4Schering-Plough settled a major investigation into its sales and marketing practices for $435 million, which included a criminal fine and civil settlement.
  • 5The company continues to operate under a Consent Decree with the FDA related to GMP compliance issues at certain manufacturing facilities, impacting production controls and costs.
  • 6Key products are heavily relied upon for profits and cash flows, with risks associated with patent expirations, increased competition, and potential side effects or market withdrawal.
  • 7Global operations are significant, with approximately 60% of sales generated outside the U.S., exposing the company to foreign currency exchange rate fluctuations and differing regulatory environments.

Frequently Asked Questions

Schering-Plough's financial performance in 2006 was primarily driven by strong sales growth in its prescription pharmaceuticals segment, particularly from its cholesterol franchise (VYTORIN and ZETIA) and key products such as REMICADE, NASONEX, and TEMODAR. This revenue growth, combined with strategic business initiatives, led to a significant increase in net income available to common shareholders.

Schering-Plough faces several significant legal and regulatory risks, including a $435 million settlement for investigations into sales and marketing practices, ongoing scrutiny of pricing and rebate practices, and the impact of a Consent Decree with the FDA related to Good Manufacturing Practices. Additionally, dependence on key products makes the company vulnerable to patent expirations, new competitor products, and potential safety concerns that could lead to recalls or market withdrawals.

The joint venture with Merck for VYTORIN and ZETIA is a crucial contributor to Schering-Plough's financial performance. Sales from these cholesterol-lowering drugs have grown significantly and are a major driver of the company's improved operating results and cash flow. Schering-Plough accounts for its share of the joint venture's earnings using the equity method, and a material change in the sales or market share of these products would have a substantial impact on the company's overall results.

Schering-Plough's strategy, outlined in its 'Action Agenda,' focuses on 'Building the Base' by growing the business, penetrating new markets, expanding existing products, and discovering or acquiring new ones. A core component is significant investment in scientific research and development to create therapies with medical and commercial value, aiming to meet unmet medical needs and diversify its product portfolio.