UPDATE 3-Boston Scientific resumes US defibrillator sales

Thu Apr 15, 2010 6:23pm EDT

* Company says FDA clears manufacturing changes

* Sees meeting full customer demand within 24 hours

* Market share loss likely - analyst

* Shares gain 6 percent (Adds analyst comments, company comment)

By Deena Beasley

LOS ANGELES, April 15 (Reuters) - Boston Scientific Corp (BSX.N) said it is resuming U.S. shipments of most of its implanted defibrillators after regulators cleared manufacturing changes, and its shares jumped more than 6 percent.

The company said it was immediately resuming distribution of Cognis and Teligen devices, which "represent virtually all of the company's defibrillator implant volume in the United States." It expects to be able to fully meet customer demand for the two devices within 24 hours.

"It's an expected outcome, but it's also the best scenario that they could have hoped for," said Spencer Nam, an analyst at Summer Street Research. "It got taken care of within 30 days."

Boston Scientific suspended sales of its implanted cardioverter defibrillators (ICDs) in March after failing to tell the U.S. Food and Drug Administration about the manufacturing changes. [ID:nN15186051]

The company is likely to lose market share due to the debacle, Nam said, since "some of their sales force may have been recruited away by the competitors," which would include St Jude Medical Inc (STJ.N) and Medtronic Inc (MDT.N).

Boston Scientific also said on Thursday that it is working closely with the FDA on getting clearances to return earlier generations of its defibrillators to the U.S. market after finding other manufacturing changes that should have been reported to the agency.

Sanford Bernstein analyst Derrick Sung said the additional process findings were "a bit unexpected" and "could raise some eyebrows within the FDA."

Analysts estimate that the devices generate about 15 percent of Boston Scientific's revenue and that the recall cost the company nearly $5 million in revenue for each day they were off the market.

Boston Scientific earlier this month hired a financial adviser to help it sell its pain management and neurovascular intervention units to raise money in the wake of the recall, according to sources familiar with the situation. [ID:nN08206319]

Company spokesman Paul Donovan declined to comment on any divestiture plans.

Nam said Boston Scientific is likely to move forward with asset sales. "They are looking for cash to pay down their debt and trying to look for another acquisition target, maybe more towards orthopedics," the Summer Street Research analyst said.

Sung also said the asset sales make sense since the flagged units would not contribute to bottom-line growth for quite a few years.

Boston Scientific said it would notify investors of the impact of the ICD hold on its financial results when it announces first quarter earnings later this month.

DEBT LOAD

Already deeply in debt because of its Guidant Corp acquisition in 2006, the company has $2.7 billion in payments due in 2011. It recently made a payment to the U.S. Department of Justice to settle charges that Guidant provided kickbacks to doctors before being acquired.

If it proceeds with the sale of its two non-core business units, analysts estimate Boston Scientific could fetch $2 billion to $2.6 billion.

In 2006, the company agreed to pay some $27 billion for Guidant, a maker of ICDs and stents, after a protracted bidding war with Johnson & Johnson (JNJ.N). Dubbed by Fortune Magazine the second worst deal ever, Boston Scientific took on a mountain of debt that has dogged the company ever since.

Soon thereafter, it had to recall some of the Guidant products and then became the subject of a DOJ investigation over their marketing. That has been settled, but the company faces another government probe over the handling of the latest recall.

The company posted $8.19 billion in revenue last year, mostly generated by sales of ICDs and cardiovascular devices like heart stents.

Shares of Boston Scientific rose 6.4 percent at $7.60 in after-hours trading. (Reporting by Deena Beasley and Lisa Richwine; Editing by Gary Hill, Bernard Orr)

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Comments (1)
Gene_S wrote:
This temporary absence from the market may not hurt as much as one might expect, because of one peculiarity of the implantable medical device market: many care providers who implant these devices deliberately split their business between — in the case of heart-assist devices — the three principal vendors, to limit the impact of any one defect or recall to one-third of their practice. So it is likely that Boston Scientific sales of these devices will recover most of that lost share over the next few months.

Apr 16, 2010 5:01pm EDT  --  Report as abuse
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