10-QPeriod: Q1 FY2003

Merck & Co., Inc. Quarterly Report for Q1 Ended Mar 31, 2003

Filed May 13, 2003For Securities:MRK

Summary

Schering-Plough Corporation reported a significant decrease in net sales and net income for the first quarter of 2003 compared to the same period in 2002. Net sales fell by 19% to $2.1 billion, primarily driven by the loss of market exclusivity and conversion to Over-The-Counter (OTC) status for its key product, Claritin, in the United States. This decline, coupled with increased R&D spending and higher cost of sales due to manufacturing compliance efforts, led to a 71% decrease in diluted earnings per share to $0.12. The company faces substantial legal and regulatory challenges, including a consent decree with the FDA related to manufacturing practices, which will involve significant financial obligations. Additionally, ongoing investigations into pricing and marketing practices, patent litigation, and securities class-action lawsuits pose considerable risks. Despite these headwinds, Schering-Plough maintains strong liquidity with substantial cash reserves and credit facilities, and it is actively working to mitigate the impact of Claritin's loss of exclusivity through new product launches and marketing initiatives.

Key Highlights

  • 1Net sales decreased by 19% to $2.1 billion in Q1 2003 compared to Q1 2002, largely due to the loss of prescription Claritin sales in the U.S. and its switch to OTC status.
  • 2Diluted earnings per share (EPS) fell significantly by 71% to $0.12 in Q1 2003, down from $0.41 in Q1 2002, impacted by lower sales and increased R&D and manufacturing compliance costs.
  • 3The company paid $250 million of a $500 million consent decree to the FDA for manufacturing practice issues, with the remaining $250 million due in Q2 2003.
  • 4Allergy & Respiratory product sales saw a 55% decline, heavily influenced by the reduced sales of prescription Claritin ($109 million in Q1 2003 vs. $659 million in Q1 2002).
  • 5CLARINEX sales increased by $88 million due to conversion from Claritin users and international launches, but faced increased competition.
  • 6Despite the sales decline, international sales showed resilience, remaining flat excluding foreign currency fluctuations, while U.S. sales dropped 39%.
  • 7The company has substantial liquidity with $3.34 billion in cash and cash equivalents and access to significant credit facilities.

Frequently Asked Questions

The primary reason for the significant decline in net sales and earnings is the loss of market exclusivity for Claritin in the United States and its subsequent conversion to an Over-The-Counter (OTC) product. This led to a dramatic decrease in prescription Claritin sales, which heavily impacted the company's overall financial performance.

Schering-Plough is facing several significant legal and regulatory risks. These include an FDA consent decree requiring substantial payments and compliance efforts related to manufacturing practices, ongoing investigations into pricing and marketing practices by various government entities, patent litigation concerning key products, and numerous securities and class-action lawsuits. These issues could result in significant fines, penalties, and operational restrictions.

Schering-Plough maintains a strong liquidity position with $3.34 billion in cash and cash equivalents and $538 million in short-term investments as of March 31, 2003. The company also has access to substantial committed revolving credit facilities and plans to issue up to $2 billion in long-term debt securities. While domestic operations are expected to face cash flow shortfalls, the company intends to fund these through additional borrowings rather than repatriating foreign-held cash to avoid U.S. income taxes.

The outlook for the allergy and respiratory segment is mixed. While prescription Claritin sales have plummeted, sales of CLARINEX (desloratadine) have increased due to conversions from Claritin users and international expansion, though it faces intense competition. The company is also dealing with declining sales of Nasonex due to inventory adjustments and market share issues. The launch of OTC Claritin has led to significant market shifts and increased competition.