) 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.
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).
ACELRX PHARMACT (ACRX): Free Stock Analysis
SANTARUS INC (SNTS): Free Stock Analysis
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Meanwhile other pharma stocks such as
AcelRx Pharmaceuticals Inc.
) carry a Zacks Rank #2 (Buy).