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

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Nov 08, 2010
Amylin Pharmaceuticals Inc. (AMLN, Financial) filed Quarterly Report for the period ended 2010-09-30.

Amylin Pharmaceuticals Inc. has a market cap of $1.87 billion; its shares were traded at around $13.05 with and P/S ratio of 2.47. AMLN is in the portfolios of Carl Icahn of Icahn Capital Management LP, Edward Owens of Vanguard Health Care Fund, Columbia Wanger of Columbia Wanger Asset Management, Louis Moore Bacon of Moore Capital Management, LP, Louis Moore Bacon of Moore Capital Management, LP, Jim Simons of Renaissance Technologies LLC, Steven Cohen of SAC Capital Advisors.

Highlight of Business Operations:

BYETTA is the first approved medicine in a class of compounds called GLP-1 receptor agonists. In October 2009, the FDA approved an expanded indication to include BYETTA as a first-line, stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes and changes to the BYETTA label to incorporate updated safety language. Previously BYETTA was 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 (TZD), three common oral therapies for type 2 diabetes. We believe the expanded monotherapy indication and label update present new opportunities for the BYETTA brand. Net product sales of BYETTA were $132.4 million and $171.1 million for the three months ended September 30, 2010 and 2009, respectively, and $422.9 million and $503.9 million for the nine months ended September 30, 2010 and 2009, respectively.

SYMLIN is the first and only approved medicine in a class of compounds called amylinomimetics. It is approved as an adjunctive therapy to improve glycemic control in patients with either type 2 or type 1 diabetes who are treated with mealtime insulin but who have not achieved adequate glycemic control. We own 100% of the global rights to SYMLIN and are exploring partnering SYMLIN outside of the United States. Net product sales of SYMLIN were $21.6 million and $21.8 million for the three months ended September 30, 2010 and 2009, respectively, and $65.9 million and $65.8 million for the nine months ended September 30, 2010 and 2009, respectively.

At September 30, 2010, we had $537.7 million in cash, cash equivalents and short-term investments. Additionally we have availability of $165 million pursuant a loan agreement with Lilly. Although we may not generate positive operating cash flows for the next few years, we have demonstrated strong financial discipline over the last few years and we remain committed to continuing to manage our expenses in-line with expected revenues. Our goal is to continue to aggressively manage our expenses in order to maximize our available cash to maximize revenue for BYETTA and SYMLIN and support the approval and launch of BYDUREON. Additionally, we expect that our use of cash for capital expenditures will continue to be significantly lower than 2009 levels. Refer to the discussions under the headings Liquidity and Capital Resources below and Cautionary Factors That May Affect Future Results in Part I, Item 1A for further discussion regarding our anticipated future capital requirements.

Revenues under collaborative agreements for the three months ended September 30, 2010 increased to $2.1 million from $1.0 million for the same period in 2009. Revenues under collaborative agreements for the nine months ended September 30, 2010 were $5.8 million, compared to $3.2 million for the same period in 2009. Revenues under collaborative agreements consist of amortization of up-front payments received from our collaborative partners and milestone payments from our collaborative partners. For the three and nine months ended September 30, 2010, the revenues consist largely of amortization of the up-front payment we received from Takeda in late 2009 while the revenues under collaborative agreements for the same periods in 2009 consist of amortization of the up-front payment received in connection with our Lilly collaboration, for which amortization ended in 2009.

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