Mentor ( MNT) said first-quarter earnings beat Wall Street's estimates and came in ahead of last year's performance. However, the company declined to provide additional information on its progress in dealing with the Food and Drug Administration for approving the company's silicone gel implant. CEO Joshua Levine said Monday he was "highly optimistic and strongly convinced" that
Mentor will meet all of the conditions set by the agency last week. The Santa, Barbara, Calif., medical products company earned $22.5 million, or 47 cents a share, on revenue of $135.3 million in the latest quarter. The EPS would have been 6 cents higher, but the company has adopted new accounting rules that require it to recognize the dilution related to convertible subordinated notes. The consensus of analysts polled by Thomson First Call predicted a first-quarter profit of $20.5 million, or 43 cents a share, on revenue of $134.6 million for the three months ended June 30. For the same period last year, Mentor earned $17.7 million, or 37 cents a share, on revenue of $122.4 million. The company also reaffirmed its fiscal year earnings prediction of $1.60 to $1.65, adding that final results should be on the "high end" of that range. The Thomson First Call estimate is $1.62.
In addition to implants, Mentor makes cosmetic medical products and urology products. The implants account for nearly half the company's sales, and they could account for much more depending on the FDA. Mentor said its full-year EPS prediction excludes the possibility of FDA approval for these implants. The agency has prohibited widespread use of such devices since 1992, saying companies had failed to provide adequate tests showing the implants' long-term safety. Silicone implants are available in foreign markets, and there are rare circumstances, such as reconstructive surgery after a mastectomy, in which the FDA allows them to be used. Companies are allowed to sell saline (saltwater-filled) implants in the U.S. for cosmetic purposes. In April, an FDA advisory panel approved Mentor's application for widespread use of silicone gel implants with several restrictions. Last week, the FDA gave conditional approval for the implants. Levine said last week that the conditions set by the FDA are "generally consistent" with the recommendations of the advisory panel, which voted 7-2 to support the Mentor application. The panel recommended to the FDA that Mentor's silicone gel implants should only be sold to board-certified plastic surgeons who complete special training and provided to patients who sign documents showing they understand that the implants could rupture. On Monday, Levine declined to provide details of Mentor's discussions with the FDA. He told analysts during a telephone conference call that it would be "imprudent" to speculate on a timetable for meeting the agency's conditions. If Mentor brings its silicone gel implant to the broader U.S. market, the company will have a big advantage over rival Inamed ( IMDC). The same advisory panel that voted for Mentor's implant voted 5-4 against Inamed's silicone product. Inamed is revising its application in an effort to convince the FDA to change its mind. Mentor's financial results were issued after markets had closed. In regular trading, the stock gained $1.45, or 3%, to $50.46.