Boston Scientific Corp.
Our number one conclusion is ... that Boston likely overreacted in pulling its products from the market and has a good chance of getting this resolved in the next week or two with the outside risk being 30 days, JPMorgan analyst Michael Weinstein wrote in a note to clients.
Boston Scientific spokesman Paul Donovan declined to provide details on when the company might resume selling the devices but said, We are working closely with the FDA to resolve the situation as soon as possible.
The company said on Monday it was halting all sales of its implantable cardioverter defibrillators and cardiac resynchronization therapy devices, stunning investors who sent its shares tumbling almost 20 percent.
Boston Scientific said it made the decision after discovering in a review that it had failed to submit required documents to the U.S. Food and Drug Administration and obtain necessary approvals for two changes it made to its manufacturing processes.
Boston Scientific said the defibrillators pose no risk to patients, and it does not recommend any devices be removed from patients. The devices, which deliver electrical pulses to help coordinate heart pumping, represent about 15 percent of the company's total sales. The action covers seven different brands of ICDs and CRT-Ds.
Bernstein analyst Derrick Sung said manufacturing process changes generally require a 30-day review by the FDA. Given Boston Scientific's conservative actions, the FDA seems unlikely to take punitive actions, Sung said.
He predicted Boston Scientific would incur market share loss of 4 percent due to a one-month sales suspension. The lost sales would shave 5 cents off the company's 2010 earnings per share, while adding 4 cents per share to rival Medtronic Inc's
Weinstein estimated St Jude stands to see a 63 percent increase in its business and Medtronic Inc a 29 percent boost, assuming Boston Scientific is off the market for 30 days.
The affected products are the Cognis, Confient, Livian, Prizm, Renewal, Teligen, and Vitality defibrillator brands.
Boston Scientific acquired the defibrillator business when it spent $27 billion to buy Guidant Corp in 2006 in a deal widely criticized for its steep price tag and that left the company saddled with debt and battling lawsuits and investigations.
The sales halt was the latest in a series of setbacks for the medical device maker, which in the past several months has announced a $1.7 billion stent patent settlement with rival Johnson & Johnson, a major restructuring and job cuts, and two deals with the U.S. Department of Justice to resolve long-running probes stemming from the Guidant acquisition.
Shares of Boston Scientific were down 14 cents, or 2 percent, at $6.95 in afternoon trading on the New York Stock Exchange.
(Reporting by Susan Kelly; Editing by Steve Orlofsky)