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Impax Laboratories Management Discusses Q2 2012 Results - Earnings Call Transcript

This morning, we announced that the FDA recently completed a preapproval inspection of Rytary and an undisclosed generic drug at our Taiwan facility and that there were no Form 483 observations. We were pleased to receive this news as we have committed significant resources to improving the operation of all of our production facilities and into strengthen our company-wide quality system. We continue to work at resolving the recent observation at the Hayward site and look forward to the FDA returning to reinspect the facility in order to close out the warning letter.

We are pleased with the transaction -- with the transition and the launch of the U.S. Zomig franchise through our brand division. Our neurology focused sales force initiated a concentrated promotional and a sampling after to the neurology target audience. We are optimistic that our efforts should continue to pay dividends.

Our generic Adderall XR sales have improved the past 3 quarters as we continue to receive supply. At this point, it is still too early to predict the impact of the recent approval of another generic Adderall XR product. We will be monitoring the market dynamics and should have a better picture in the next 2 to 3 months. But it is important to remember a few things: first of all, the royalty rate that we paid this quarter declined by 60% from the previous rate; second, the PEA [ph] can also play a significant role since every player will need the DA approve the quota for the purchase of this controlled substance; and third, we have been serving our customers for more than 2.5 years and understanding their needs.

While Zomig and the generic Adderall XR are significant contributors to our results, we are actively working to enhance our market of product portfolio and the pipeline of a pending product, both internally and through partnership. We recently announced an agreement with TOLMAR to commercialize up to 9 current approved generic topical prescription product. This agreement also included 2 additional generic topical products, of which one is a first-to-file product. We anticipate that after a brief transition period, we will begin marketing those products late in the third quarter or early fourth quarter. This transaction is expected to be accretive to our 2012 EPS and allow us to accelerate our entry into alternative dosage form area.

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