We recently reiterated our Neutral recommendation on Amylin Pharmaceuticals, Inc. (AMLN). The company reported a net loss of $0.94 per share in 2010, narrower than the Zacks Consensus Estimate of $1.26 and the year-ago loss of $1.20. Full year revenues came in at $668.8 million, down 11.8%. Despite a decline in revenues, Amylin posted better-than-expected results due to lower expenses.
We believe the company will continue controlling costs and have reduced our 2011 loss estimate by 22 cents.
Meanwhile, Amylin faced a huge setback in 2010 when it failed to gain approval for its lead pipeline candidate, Bydureon, for the second time. Amylin and its partners, Eli Lilly and Company (LLY) and Alkermes, Inc. (ALKS), were looking to get Bydureon approved for the treatment of type II diabetes.
On the fourth quarter call, Amylin announced that the US Food and Drug Administration (FDA) has approved the design for the thorough QT (tQT) study that needs to be conducted. A response to the complete response letter for Bydureon will be submitted in the second half of the year.
As far as other pipeline candidates are concerned, Amylin initiated the submission of a rolling Biologics License Application (BLA) for the use of metreleptin for the treatment of diabetes and/or hypertriglyceridemia in patients suffering from rare forms of lipodystrophy. The chemistry, manufacturing and controls (CMC) section of the BLA will be filed by year end.
The candidate enjoys fast track status and a successful regulatory process could lead to the product launch by mid 2012.
We are also positive on Amylin’s partnership agreement with Takeda Pharmaceutical for the development and commercialization of pramlintide and davalintide. This deal is a major boost for Amylin and should help the company advance its obesity program in an expeditious manner while reducing the financial and technical risk to Amylin.
Obesity is an attractive market that could be worth many billions of dollars. It is estimated that obesity affects over 400 million people worldwide. Moreover, obesity is linked to increased health risk of several medical conditions. The successful development of the obesity pipeline would help drive long-term growth at Amylin.
ALKERMES INC (ALKS): Free Stock Analysis Report
AMYLIN PHARMA (AMLN): Free Stock Analysis Report
LILLY ELI & CO (LLY): Free Stock Analysis Report
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