10-QPeriod: Q2 FY2003

Merck & Co., Inc. Quarterly Report for Q2 Ended Jun 30, 2003

Filed July 31, 2003For Securities:MRK

Summary

Schering-Plough Corporation reported a significant decline in net sales and net income for the second quarter and first six months of 2003 compared to the prior year. This was primarily driven by the loss of market exclusivity and conversion of CLARITIN from prescription to over-the-counter (OTC) status in the United States. While international sales showed growth, the overall financial performance was negatively impacted by these factors and ongoing challenges related to manufacturing compliance and significant legal and regulatory investigations. The company is actively managing these challenges, including strategic partnerships like the one with Merck for ZETIA and simvastatin combination therapy. However, the substantial decline in revenue and profitability, coupled with increased R&D spending and the ongoing consent decree payments, indicates a period of considerable transition and risk for the company. Investors should closely monitor the resolution of legal matters and the success of new product launches in mitigating the impact of CLARITIN's declining prescription sales.

Key Highlights

  • 1Net sales for the three months ended June 30, 2003, decreased by 17% to $2.3 billion compared to the prior year, driven by a 24% volume decline.
  • 2Net income for the three months ended June 30, 2003, plummeted by 71% to $182 million ($0.12 EPS) from $633 million ($0.43 EPS) in the same period last year.
  • 3The global prescription CLARITIN sales significantly declined by 86% in the second quarter of 2003 due to its loss of market exclusivity and conversion to OTC status.
  • 4Global R&D spending increased by 10% in the quarter and 11% year-to-date, reflecting continued investment in drug development, including clinical trials for ZETIA.
  • 5The company paid the second installment of $250 million towards the $500 million consent decree with the FDA, impacting cash flow from operations.
  • 6Significant ongoing legal and regulatory investigations are a material concern, with the company increasing litigation reserves by $150 million in February 2003 to cover potential liabilities.
  • 7Credit ratings were negatively impacted, with Moody's lowering the outlook to 'negative' and S&P placing ratings on CreditWatch with negative implications, later downgrading ratings.

Frequently Asked Questions

The primary reason for the substantial decrease in net sales and net income is the loss of market exclusivity and the subsequent conversion of CLARITIN, a major revenue driver, from a prescription drug to an over-the-counter (OTC) product in the United States. This led to a dramatic decline in prescription sales.

Schering-Plough launched OTC CLARITIN in December 2002 and also markets CLARINEX (desloratadine) for prescription use. However, the transition to OTC has resulted in a rapid and material decline in overall revenue. The company faces additional private-label competition for OTC CLARITIN as its exclusivity period expires. The company's ability to capture and maintain market share for CLARINEX is also impacted by the presence of generic OTC loratadine products.

Schering-Plough faces several significant risks and uncertainties, including ongoing legal and regulatory investigations (with increased litigation reserves), the resolution of a consent decree with the FDA related to manufacturing practices, intense competition in the pharmaceutical market, potential generic competition for key products like REBETOL, and the uncertain outcomes of patent disputes. Credit rating agencies have also expressed concerns, leading to rating downgrades and negative outlooks.

As of June 30, 2003, the company had $3.6 billion in cash and cash equivalents. However, cash flow from operations has declined significantly, partly due to the CLARITIN sales impact and a $250 million consent decree payment in the second quarter. The company anticipates that operating cash flow may not be sufficient to cover working capital, capital expenditures, and dividends in the near term, and intends to fund domestic needs through borrowings and access to capital markets. Foreign-held cash is not expected to be repatriated due to potential tax implications.