Wells Fargo Cuts Estimates & Valuation Range on Impax Laboratories (IPXL) Following Letter From FDA

June 6, 2011 12:54 PM EDT
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Price: $18.30 --0%

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Wells Fargo is maintaining its Market Perform rating on shares of Impax Laboratories (NASDAQ: IPXL), but is lowering its valuation range from $28-$29 to $25-$27.

The company received a warning letter from the FDA that highlighted issues which include sampling/testing, production record review, and investigation process for batch failures.

The firm doesn't believe that the FDA will withhold final approval of pending applications until the situation is fully resolved, while IPXL does not expect manufacturing and shipment of products already approved to be affected.

Due to the Form 483, which the company received prior, production activities in March-May 2011 slowed. As a result the firm is lowering its Q2 revenue estimate from $100.8 million to $94.7 million. It is also cutting its gross margin estimates for Q2 and Q3 from 53 percent and 51 percent to 50 percent and 49.5 percent.

The firm is also lowering its Q2 and and Q3 EPS estimates from $0.20 and $0.26 to $0.15 and $0.24. To go inline with its new quarterly results, Wells Fargo cut its FY11 EPS estimate from $1.02 to $0.96. It is maintaining its FY12 estimate of $1.19.

An analyst at Wells Fargo comments, "IPXL may have to forfeit its 180-day exclusivity on generic Doryx 150mg if it fails to receive at least a tentative approval by 6/19/2011. Given the timing of the Warning Letter, we view this as likely a foregone conclusion. IPXL emphasized that IPX066 is not affected, as it expects the drug to be manufactured at the Taiwan facility."

For more ratings news on Impax Laboratories click here and for the rating history of Impax Laboratories click here.

Shares of Impax Laboratories closed at $25.65 yesterday.


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