8-KOther Events

ABBOTT LABORATORIES 8-K Report, Corporate Update (Oct 8, 2010)

Filed October 8, 2010For Securities:ABT

Summary

Abbott Laboratories has announced the voluntary withdrawal of its weight loss product, sibutramine, from the markets in the United States, Canada, and Australia. This decision follows earlier suspensions of marketing in European Union countries. The company is in discussions with other regulatory bodies globally and expects to resolve these shortly. Sibutramine generated approximately $80 million in global sales for the first nine months of 2010, with $20 million attributed to U.S. sales. Importantly for investors, Abbott has stated that this product withdrawal will not affect its previously issued earnings-per-share guidance for the third quarter or the full year of 2010. The company will record a one-time specified item in the third quarter of 2010 related to this withdrawal, the financial impact of which will be detailed when third-quarter results are released.

Key Highlights

  • 1Voluntary withdrawal of weight loss product sibutramine in the U.S., Canada, and Australia.
  • 2Company is actively engaged in discussions with regulatory authorities in other markets.
  • 3Global sibutramine sales were approximately $80 million for the first nine months of 2010.
  • 4U.S. sales of sibutramine accounted for $20 million of the total global sales in the same period.
  • 5Withdrawal will not impact Abbott's previously issued EPS guidance for Q3 or full-year 2010.
  • 6A one-time specified item will be recorded in Q3 2010 related to this action.

Frequently Asked Questions

Abbott Laboratories is voluntarily withdrawing its weight loss product sibutramine due to ongoing discussions with regulatory authorities. While the specific reasons for the discussions are not detailed in this report, such actions typically relate to safety or efficacy concerns raised by regulators.

Abbott has explicitly stated that this withdrawal will not affect its previously issued earnings-per-share guidance for the third quarter or the full year of 2010. The company will incur a one-time specified item in the third quarter of 2010, the details of which will be provided when third-quarter results are announced.

For the first nine months of 2010, global sales of sibutramine were approximately $80 million. U.S. sales contributed $20 million to this total during the same period. While not insignificant, these figures suggest the product represented a relatively small portion of Abbott's overall revenue.

Abbott has already suspended marketing of sibutramine in European Union member countries, Iceland, and Norway. They are also in ongoing discussions with regulatory authorities in other countries where the product is marketed, indicating a global approach to this withdrawal.