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Weather-induced FDA delay hits Staar Surgical’s bottom line

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Weather-induced FDA delay hits Staar Surgical's bottom line

California-based STAAR Surgical (NSDQ:STAA) swung hard to a 1st-quarter loss after storm-related regulatory delays cost the company its bottom line.

Staar went from a 1¢ per diluted share profit during this time last year to a 4¢ loss. Excluding special charges, its earnings would have amounted to a profit of 4¢ per share, beating Wall Street’s estimates.

The FDA in February postponed an Advisory Panel meeting slated to review Staar’s Toric ICL intraocular implant, costing the medical device maker double what it had expected to pay in regulatory costs.

"Our expenses related to the FDA Panel Advisory meeting were expected to be higher during the quarter as a result of the postponement of the February 14th panel meeting due to weather and the re-scheduling to March 14th," president & CEO Barry Caldwell said in prepared remarks. "These costs associated with the Advisory meeting were nearly double our original forecast and led to the GAAP net loss for the quarter."

Staar has since had its day with the FDA, during which the agency’s advisors recommended approval for the Toric ICL, but the delay cost the company $1 million.

In total Staar Surgical reported losses of $1.4 million, or 4¢ per share, on sales of $20.2 million during the 3 months ended April 4. That compared with profits of $471 million, or 1¢ per share, on sales of $18 million during the same period last year. Total FDA panel expenses came to about $1.4 million for the quarter, according to a financial report.

STAA shares dropped hard in yesterday’s trading following release of the financial news. Shares closed at $17.01, down 9.3% on the day.

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