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【技术产业】Allergan公司重获FDA植入许可
Allergan, Mentor Up on FDA Implant OK
NEW YORK — Shares of Allergan Inc. and Mentor Corp. jumped Monday after the Food and Drug Administration allowed the sale of silicone gel-filled breast implants late Friday after a 14-year ban on the products for use in cosmetic procedures.
Allergan shares gained $7.33, or 6.5 percent, to $119.84 in afternoon trading on the New York Stock Exchange at three times their average trading volume. Shares reached a new high of $120.20 earlier in the session, after having traded between $92.57 and $117.99 over the past 52 weeks.
Mentor surged $4.43, or 9.3 percent, to $52.01 on the NYSE at more than seven times their average volume. Shares have traded between $37.25 and $56.65 over the past 52 weeks.
Late Friday, both companies received approval to sell silicone gel-filled breast implants for reconstruction in women of all ages and cosmetic augmentation in women ages 22 and older. The silicone-gel filled implants were pulled from the market in 1992 for cosmetic use after thousands of women claimed the implants were responsible for health problems.
The approval comes about a year later than first anticipated, about 14 months after the FDA issued "approvable letters" to Mentor and Inamed, the company which was later acquired by Allergan.
The agency requires the companies continue monitoring women given the implants and to conduct large postmarket approval studies that follow about 40,000 women each for 10 years.
Late in October, Canadian regulators allowed silicone-gel implants back on the market for cosmetic uses after a similar ban.
Following the FDA's decision, Bank of America analyst David W. Maris, who rates Allergan a "Buy," raised his breast implant sales forecast for 2007 to $350 million from $306 million, and lifted his earnings per share outlook to $4.43 from $4.33. Analysts surveyed by Thomson Financial estimate 2007 earnings per share of $4.31.
"It is not simply the approval, but the long duration asset that the breast implant business represents, which makes this news so significant as a value driver," Maris said in a note. The analyst speculated that the approval would move Allergan shares up by at least $5 to $10 on the news.
Morgan Stanley analyst Louise A. Chen maintained her "Overweight" rating and price target of $125 for Allergan, noting that many investors thought the approval would get dragged out into 2007. Chen also noted that FDA conditions for approval will not increase research and development spending as much as anticipated.
In his note on Mentor, SunTrust Robinson analyst Jonathan Block estimated the approval has the potential to boost Mentor's U.S. cosmetic revenue by more than $1 billion over the next 10 years, while only increasing research and development costs by $35 million to $40 million over the period.
Block, who rates Mentor a "Buy," predicts that more than half the company's implant sales will be silicone-gel by the end of 2007. As a result, the analyst increased his 2007 revenue estimate to $382 million from $328 million, and upped his earnings per share guidance to $1.68 from $1.34.
Analysts forecast an earnings per share consensus of $1.44 for fiscal 2007.
CIBC analyst Amit Hazan, who rates Mentor a "Sector Performer," was a bit more conservative, estimating that silicone implants could make up 25 percent of the market by the end of 2007 and 36 percent by the close of 2008, but did not rule out a greater than 50 percent penetration of the market by that time.
Silicone gel implants are expected to cost about double that of saline-filled implants, resulting in a higher margin product. The implants are considered to look and feel more lifelike than their saline-filled counterparts. [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-05-06 17:11
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