Officials at Boston Scientific Corp. (NYSE:BSX) revealed that a snafu with the U.S. Food & Drug Administration, which led to a month-long suspension of ICD sales last spring will cost the company $300 million in lost sales over the course of 2010.
“As a result of the ship hold and product removal actions, we estimated that our U.S. defibrillator market share would decrease approximately 400 basis points exiting 2010, as compared to our market share exiting 2009, ” officials wrote in the company’s 10-Q earnings release with the federal Securities and Exchange Commission yesterday.
The estimates are actually quite a bit rosier than the company predicted at the end of the first quarter, when officials said that the self-imposed defibrillator shipments hold would cost the company some $500 million in lost sales during the course of the year. In addition, the company trimmed its impairment of goodwill charges slightly to 1.81 billion for the first half of 2010. During Q1 the company recorded a $1.85 billion impairment charge.
Despite the lightly more optimistic outlook, officials are still clearly concerned with regaining the trust of its customer base.
“We are working with our physician and patient customers to recapture lost market share,” company officials wrote. “However, our on-going net sales and profitability will likely continue to be adversely impacted as a result of the ship hold and product removal actions.”
In March, the Natick, Mass.-based medical device colossus voluntarily stopped all ICD shipments and pulled its inventory from the field after discovering that it had failed to properly notify U.S. regulators of changes to its manufacturing process and added a new parts supplier for the Cognis, Teligen and similar product lines. Sales resumed April 15.
To date, revenues in the company’s cardiac rhythm management division is down $132 million or 11 percent compared to the first half of 2009. The unit posted $1.06 billion in sales for the six month period ended on June 30, compared to $1.19 billion for the same period last year.
