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FDA Approval for Santarus' Uceris

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Santarus Inc. recently announced that the US Food and Drug Administration (FDA) has granted approval to Uceris (budesonide) for the induction of remission in patients suffering from mild-to-moderate ulcerative colitis. The company plans to launch the product in Mar 2013.

In addition to announcing the approval of Uceris, management provided guidance for 2013 and said that the company should be able to meet or beat the previously announced guidance for 2012. As a reminder, the company expects 2012 revenues of about $210 million and net income of $12 million–$14 million.

Meanwhile, 2013 revenues are expected in the range of $320 million to $325 million, representing strong double-digit growth from 2012 guidance. Net income is expected in the range of $50 million to $54 million.

During 2013, research and development expenses should be in the range of $34 million to $38 million, while selling, general and administrative expenses should be approximately $131 million to $134 million. This includes $38 million to $40 million which will be incurred for sales force expansion in support of the Uceris launch and the Zegerid re-launch. All 235 sales reps will promote both Uceris and Zegerid to gastroenterologists.

Our Take

The approval of Uceris is a major positive for Santarus. The company expects peak sales of around $300 million. This is the second positive development for Santarus over the last few months. In Sep 2012, the US Court of Appeals for the Federal Circuit had reversed a part of an earlier decision issued by the US District Court for the District of Delaware regarding patent protection of Zegerid capsules and powder for oral suspension prescription products. As a result, the company will be re-launching Zegerid and is looking to stem the decline in prescription trends for the branded product.

Santarus shares were up significantly on the FDA approval of Uceris and the 2013 guidance. We expect investor focus to remain on the commercialization of Uceris and the Zegerid re-launch. We currently have a Neutral recommendation on Santarus. The stock carries a Zacks Rank #4 (Sell).

Meanwhile other pharma stocks such as AcelRx Pharmaceuticals Inc. (ACRX - Free Report) carry a Zacks Rank #2 (Buy).

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