Amylin Pharmaceuticals Inc. Reports Operating Results (10-Q)

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Aug 08, 2011
Amylin Pharmaceuticals Inc. (AMLN, Financial) filed Quarterly Report for the period ended 2011-06-30.

Amylin Pharmaceuticals Inc. has a market cap of $1.55 billion; its shares were traded at around $10.18 with and P/S ratio of 2.31.

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BYETTA is the first approved medicine in a class of compounds called (GLP-1) receptor agonists. It is approved as a first-line, stand-alone medication, or monotherapy, along with diet and exercise to improve glycemic control in adults with type 2 diabetes. BYETTA is also approved as an adjunctive therapy to improve glycemic control in patients with type 2 diabetes who have not achieved adequate glycemic control by using metformin, a sulfonylurea and/or a thiazolidinediene, or TZD, three common oral therapies for type 2 diabetes. In December 2010 we submitted a supplemental NDA, or sNDA, to the FDA for expanded use of BYETTA as an add-on to basal insulin and expect a response from the FDA in 2011. The type 2 diabetes treatment guidelines of the American Diabetes Association, or ADA, the European Association for the Study of Diabetes, or EASD, and the American Association of Clinical Endocrinologists, or AACE, include the GLP-1 receptor agonist class, which includes BYETTA, as a secondary treatment option for type 2 diabetes patients. Net product sales of BYETTA were $129.0 million and $140.7 million for the three months ended June 30, 2011 and 2010, respectively, and $257.0 million and $290.5 million for the six months ended June 30, 2011 and 2010, respectively.

SYMLIN is the first and only approved medicine in a class of compounds called amylinomimetics. We began selling SYMLIN in the United States in April 2005 as an adjunctive therapy to mealtime insulin to treat diabetes. Other than insulin and insulin analogues, SYMLIN is the first FDA-approved medication addressing glucose control for patients with type 1 diabetes since the discovery of insulin over 80 years ago. We own 100% of the global rights to SYMLIN which had net product sales of $25.8 million and $21.8 million for the three months ended June 30, 2011 and 2010, respectively, and $48.6 million and $44.3 million for the six months ended June 30, 2011 and 2010, respectively.

Revenues under collaborative agreements for the three months ended June 30, 2011 increased to $3.3 million from $1.9 million for the same period in 2010. Revenues under collaborative agreements for the six months ended June 30, 2011 increased to $5.2 million compared to $3.8 million for the same period in 2010. For both the three and six months ended June 30, 2011 the revenues consist of amortization of the up-front payment we received from Takeda in late 2009 and royalty revenues earned from sales of Byetta outside the United States. For the three and six months ended June 30, 2010 the revenues consist of only the amortization of the up-front payment we received from Takeda. At the end of the first quarter of 2011, the cumulative gross margin threshold for sales of exenatide outside the United States was achieved, and we recorded royalties of $1.4 million in the second quarter of 2011. The royalties are based on the gross profits of exenatide sales outside the United States and are tiered.

For the year ended December 31, 2011 we expect to recognize $7.5 million of collaborative revenue in connection with the ratable amortization of the up-front payment we received from Takeda. We expect to earn a $15 million milestone from Lilly upon the launch of BYDUREON in the United Kingdom in July 2011, which will be recorded as revenues under collaborative agreements in the third quarter or 2011. We expect the total amount of royalty revenues earned in 2011 will be less than $5 million.

Collaborative profit sharing was $60.7 million and $64.9 million for the three months ended June 30, 2011 and 2010, respectively, and $120.5 million and $132.8 million for the six months ended June 30, 2011 and 2010, respectively, and consists of Lillys 50% share of the gross margin for BYETTA in the United States.

During the three months ended June 30, 2011 we recorded restructuring charges of $0.1 million. During the six months ended June 30, 2011 we reduced our workforce by approximately 25 employees and recorded restructuring charges of $3.0 million. The restructuring charges recorded during the three months ended June 30, 2011 consist primarily of asset disposal costs and the restructuring charges recorded during the six months ended June 30, 2011 consist primarily of employee separation costs and asset impairment charges. During both the three and six months ended June 30, 2010 we recorded restructuring charges of $3.4 million that consisted solely of employee separation costs. We are continuing to assess our facility requirements for our San Diego campus and may record additional facilities-related charges over the next several quarters, but cannot quantify the amount at this time.

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