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.