10-KPeriod: FY2006

BRISTOL MYERS SQUIBB CO Annual Report, Year Ended Dec 31, 2006

Filed February 26, 2007For Securities:BMYCELG-RIBMYMP

Summary

Bristol-Myers Squibb Company (BMY) reported a challenging year in 2006, with net sales decreasing by 7% to $17.9 billion, primarily impacted by the "at-risk" launch of generic clopidogrel bisulfate, which significantly affected PLAVIX® sales, and the loss of exclusivity for PRAVACHOL. Despite these headwinds, the company made progress on its long-term strategy by launching several key products, including ORENCIA and SPRYCEL, and seeing robust growth in other brands like ABILIFY®, REYATAZ, and ERBITUX®. The company is strategically investing in its future, particularly in the growing biologics market with plans for a new manufacturing facility. However, ongoing patent litigation, especially concerning PLAVIX®, and other legal matters represent significant ongoing risks that could materially impact future financial performance and liquidity.

Key Highlights

  • 1Net sales for 2006 decreased by 7% to $17.9 billion, impacted by generic competition for PLAVIX® and loss of exclusivity for PRAVACHOL.
  • 2The "at-risk" launch of generic clopidogrel bisulfate by Apotex in August 2006 had an estimated adverse impact of $1.2 billion to $1.4 billion on PLAVIX® sales in 2006.
  • 3Despite overall sales decline, key growth drivers like ABILIFY® (+41%), REYATAZ (+34%), ERBITUX® (+58%), and the SUSTIVA Franchise (+16%) showed strong performance.
  • 4The company launched new products in 2006, including ORENCIA, SPRYCEL, and ATRIPLA® (in partnership with Gilead), which are expected to be significant contributors to future growth.
  • 5Research and development investment increased by 12% to $3.1 billion in 2006, reflecting a continued focus on pipeline development and unmet medical needs.
  • 6The company is making significant capital investments, including approximately $750 million for a new biologics manufacturing facility, to support its strategic shift towards specialty products.
  • 7Significant legal risks persist, particularly the ongoing patent litigation for PLAVIX® and a DOJ criminal investigation into a proposed settlement, which could materially impact financial condition and liquidity.

Frequently Asked Questions

The primary reason for the decline in net sales was the "at-risk" launch of a generic version of PLAVIX® by Apotex in August 2006, which significantly impacted PLAVIX® sales. Additionally, the loss of market exclusivity for PRAVACHOL in the U.S. and some European markets contributed to the sales decline.

The company identifies PLAVIX®, ABILIFY®, AVAPRO®/AVALIDE®, REYATAZ, the SUSTIVA Franchise, ERBITUX®, ORENCIA, BARACLUDE, and SPRYCEL as key growth drivers. These products, along with new specialty products and biologics, are expected to drive future revenue and earnings.

The company faces significant legal risks, most notably the ongoing patent litigation concerning PLAVIX® with Apotex and other generic competitors, which could lead to renewed or additional generic competition. Additionally, a Department of Justice criminal investigation into a proposed settlement of the PLAVIX® patent litigation, along with other pending litigations and investigations related to pricing, sales practices, and product liability, could materially impact the company's financial condition, results of operations, and liquidity.

The company is making substantial investments to increase its internal capacity for biologics manufacturing. This includes approving approximately $750 million for a new biologics manufacturing facility in Devens, Massachusetts, with construction set to begin in early 2007, and expanding its facility in Syracuse, New York. The company is also utilizing third-party manufacturers to support increased production capacity for biologics.