10-QPeriod: Q1 FY2011

BRISTOL MYERS SQUIBB CO Quarterly Report for Q1 Ended Mar 31, 2011

Filed April 28, 2011For Securities:BMYCELG-RIBMYMP

Summary

Bristol-Myers Squibb Company (BMY) reported its first quarter results for 2011, demonstrating revenue growth driven by key products like PLAVIX*, BARACLUDE, and SPRYCEL. Net sales increased by 4% to $5.01 billion, with net earnings attributable to the company rising significantly by 33% to $986 million, or $0.57 per diluted share. This growth was partially boosted by favorable comparisons to the prior year which included higher restructuring and impairment charges. The company also highlighted progress in its pipeline, including the FDA approval of YERVOY for melanoma treatment and positive developments for ELIQUIS* and NULOJIX*. Despite the positive top-line and bottom-line performance, investors should note potential headwinds. The company continues to manage the impact of U.S. healthcare reform, including a new annual pharmaceutical company fee, and faces ongoing legal proceedings, particularly concerning PLAVIX* patent challenges and potential generic competition. Furthermore, the company received a warning letter from the FDA regarding its Manati manufacturing facility, which poses a risk to future product approvals. Investors should also be aware of the upcoming loss of exclusivity for PLAVIX* in the U.S. in May 2012, which is expected to significantly impact future revenues and profitability.

Financial Statements
Beta

Key Highlights

  • 1Net sales increased 4% to $5.01 billion for the first quarter of 2011, compared to $4.81 billion in the prior year.
  • 2Net earnings attributable to Bristol-Myers Squibb Company rose 33% to $986 million, or $0.57 per diluted share, compared to $743 million, or $0.43 per diluted share, in Q1 2010.
  • 3The company received FDA approval for YERVOY (ipilimumab) for the treatment of melanoma.
  • 4Pipeline development showed progress, with positive opinions for ELIQUIS* in Europe and a pending NDA submission in the U.S., and a positive opinion for NULOJIX* in Europe.
  • 5PLAVIX* net sales grew 6% to $1.76 billion, but its U.S. market exclusivity is now scheduled to expire in May 2012.
  • 6The company is addressing a warning letter from the FDA concerning its Manati, Puerto Rico manufacturing facility.
  • 7Cash flow from operations increased to $481 million, and the company maintained a strong net cash position of $4.45 billion.

Frequently Asked Questions

Revenue growth was primarily driven by key products such as PLAVIX*, BARACLUDE, SPRYCEL, and ORENCIA. Favorable foreign exchange rates also contributed to the increase in international sales.

While PLAVIX* continues to be a strong performer, its U.S. market exclusivity is set to expire on May 17, 2012. The company anticipates a rapid and material decline in PLAVIX* net sales and net income following this patent expiration, and is actively managing its business to build a strong foundation for the future.

Yes, key risks include ongoing legal proceedings related to patent challenges for PLAVIX* and other products, potential generic competition, and the FDA warning letter regarding the Manati manufacturing facility, which could impact future product approvals. Additionally, U.S. healthcare reform legislation is expected to have an ongoing financial impact.

The company made significant progress in R&D, notably achieving FDA approval for YERVOY. Pipeline advancements were also seen with ELIQUIS* and NULOJIX*. Research and development expenses increased due to upfront and milestone payments related to product licensing.