8-KOther EventsExhibits & Filings

BOSTON SCIENTIFIC CORP 8-K Report, Corporate Update (Nov 23, 2011)

Filed November 23, 2011For Securities:BSX

Summary

Boston Scientific Corporation (BSX) announced on November 22, 2011, that it received U.S. Food and Drug Administration (FDA) approval for its PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System. This marks the U.S. market launch of their next-generation drug-eluting stent technology, with immediate marketing plans underway. While this approval is a positive development for the company's product pipeline, investors should be aware of an expected pre-tax charge of approximately $40 million ($35 million after-tax) in the fourth quarter of 2011. This charge, primarily due to inventory reserves stemming from the early approval and launch timing, was not factored into the company's previous financial guidance and is expected to impact gross margins.

Key Highlights

  • 1FDA approval received for the next-generation PROMUS Element™ Plus Everolimus-Eluting Coronary Stent System.
  • 2The company plans to commence U.S. marketing of the new stent system immediately.
  • 3An approximate $40 million pre-tax charge ($35 million after-tax) is expected in Q4 2011.
  • 4The charge is primarily related to inventory reserves due to early approval and launch timing.
  • 5This charge was not included in the company's prior financial guidance for Q4 2011.
  • 6The approval signifies a key advancement in Boston Scientific's drug-eluting stent technology.

Frequently Asked Questions

The FDA approval of the PROMUS Element™ Plus represents the launch of Boston Scientific's next-generation drug-eluting stent technology in the U.S. market, indicating progress in their cardiovascular product portfolio.

The company expects to record a pre-tax charge of approximately $40 million ($35 million after-tax) in the fourth quarter of 2011. This is primarily due to inventory reserves related to the timing of the approval and launch, which will negatively impact gross margins and was not part of previous financial guidance.

The charge is expected to be recorded during the fourth quarter of 2011.

The filing states that this charge was not included in the company's previously issued financial guidance for the fourth quarter, implying that guidance may need to be revisited or that the market will need to adjust expectations accordingly.