Amylin Pharmaceuticals Inc. (AMLN) filed Quarterly Report for the period ended 2009-09-30.
Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes SYMLIN injection and BYETTA injection. Amylin's research and development activities leverage the company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is located in San Diego California with over one thousand five hundred employees nationwide. Amylin Pharmaceuticals Inc. has a market cap of $1.66 billion; its shares were traded at around $11.76 with and P/S ratio of 1.9.
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BYETTA is the first and only approved medicine in a new class of compounds called glucagon-like peptide-1, or GLP-1, receptor agonists. We began selling BYETTA in the United States in June 2005. BYETTA has been approved in the United States for the treatment of patients with type 2 diabetes who have not achieved adequate glycemic control and are using metformin, a sulfonylurea and/or a thiazolidinediene, or TZD, three common oral therapies for type 2 diabetes. In October 2009, the FDA approved an expanded indication for BYETTA as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes. The FDA also approved changes to the BYETTA label to incorporate updated safety information, including pancreatitis-related safety language and an expansion of existing language regarding use of BYETTA in patients with renal impairment. In October 2008, the ADA and the European Association for the Study of Diabetes, or EASD, updated their type 2 diabetes treatment guidelines, placing the GLP-1 receptor agonist class, of which BYETTA is the only approved product, as a secondary treatment option for type 2 diabetes patients. Prescriptions declined in the second half of 2008. During that time period we committed our field resources to educating the medical community on the facts about BYETTA, pancreatitis and the product’s safety profile. We believe the decline in BYETTA prescriptions and demand for the product continued to stabilize during the quarter ended September 30, 2009. Net product sales of BYETTA were $171.1 million and $179.9 million for the three months ended September 30, 2009 and 2008, respectively, and $503.9 million and $515.9 million for the nine months ended September 30, 2009 and 2008, respectively.
SYMLIN is the first and only approved medicine in a new class of compounds called amylinomimetics. We began selling SYMLIN in the United States in April 2005. Symlin is approved in the United States for the treatment of patients with either type 1 or type 2 diabetes who are treated with mealtime insulin but who have not achieved adequate glycemic control. In early 2008, we commercially launched the SymlinPen® 120 and SymlinPen® 60 pen injector devices in the United States. These pre-filled pen-injector devices feature simple, fixed dosing to improve mealtime glucose control. Net product sales of SYMLIN were $21.8 million and $21.5 million for the three months ended September 30, 2009 and 2008, respectively, and $65.8 million and $64.5 million for the nine months ended September 30, 2009 and 2008, respectively.
Revenues under collaborative agreements for the three months ended September 30, 2009 were $18.3 million, compared to $17.0 million for the same period in 2008. Substantially all of the revenue recorded in these periods consists of amounts earned pursuant to our BYETTA collaboration agreement with Lilly. The $1.3 million increase in revenues under collaborative agreements in the current quarter compared to the same period in 2008 reflects higher cost-sharing payments from Lilly for exenatide once weekly manufacturing development expenses due to the amended cost sharing provisions contained in our collaboration agreement with Lilly mentioned above. The increase in revenues due to the increased cost-sharing ratio is partially offset by lower development expenses.
(1) Research and development expenses for our diabetes programs consist primarily of costs associated with BYETTA and exenatide once weekly which are shared by Lilly pursuant to our collaboration agreement. Cost-sharing payments received from Lilly are included in revenues under collaborative agreements. Expenditures for our diabetes development programs are generally partially offset by an increase in cost-sharing payments from Lilly. Cost-sharing payments from Lilly for BYETTA and exenatide once weekly development expenses were $17.0 million and $15.7 million for the three months ended September 30, 2009 and 2008, respectively.
The $20.8 million decrease in research and development expenses for the three months ended September 30, 2009 compared to the same period in 2008 primarily reflects decreased expenses of $10.3 million for our diabetes programs and decreased expenses of $8.1 million for our obesity development programs. The decrease in expenses for our research and development programs primarily reflects lower development expenses for exenatide once weekly and our obesity programs following the completion of our Duration-2, Duration-3 and pramlintide/leptin clinical trials, as well as efficiencies driven by our reduced cost structure. We expect research and development expenses for the remainder of 2009 to increase from current levels due to costs associated with pre-launch manufacturing activities at our Ohio manufacturing facility for the planned launch of exenatide once weekly in 2010, and the initiation of a cardiovascular outcomes study in the fourth quarter of 2009.
Revenues under collaborative agreements for the nine months ended September 30, 2009 were $44.6 million, compared to $57.2 million for the same period in 2008. Substantially all of the revenue recorded in these periods consists of amounts earned pursuant to our exenatide collaboration agreement with Lilly. The $12.6 million decrease in revenues under collaborative agreements in the current quarter compared to the same period in 2008 reflects lower cost-sharing payments from Lilly for exenatide once weekly and BYETTA due to lower development expenses for exenatide once weekly and BYETTA partially offset by an increase in Lilly’s share of the exenatide once weekly manufacturing development expenses due to the amended cost sharing provisions contained in our collaboration agreement with Lilly mentioned above.
AMLN is in the portfolios of Carl Icahn of Icahn Capital Management LP, Edward Owens of Vanguard Health Care Fund.
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