Amylin Pharmaceuticals Inc. (AMLN, Financial) filed Quarterly Report for the period ended 2009-06-30.
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 $2.11 billion; its shares were traded at around $14.98 with and P/S ratio of 2.5.
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 $22.4 million and $22.8 million for the three months ended June 30, 2009 and 2008, respectively, and $44.0 million and $43.1 million for the six months ended June 30, 2009 and 2008, respectively.
In future periods, we expect that revenues under collaborative agreements will consist of ongoing cost-sharing payments from Lilly for sharing of development costs, possible future milestone payments, $0.9 million of remaining amortization of the $30 million portion of the up-front payment received from Lilly upon signing of our collaboration agreement in 2002 and, following the commercial launch of exenatide once weekly, the amortization of a portion of the $125 million cash payment received in connection with the exenatide once weekly supply agreement discussed above. Future cost-sharing revenue recorded will be dependent on the timing, extent and relative proportion of total development costs for the exenatide once weekly and BYETTA development programs incurred by us and by Lilly. The receipt and recognition as revenue of future milestone payments is subject to the achievement of performance requirements underlying such milestone payments.
Interest and other expense consists primarily of interest expense resulting from our long-term debt obligations. Interest expense in the three months ended June 30, 2009 consists of interest on our $775 million par value of outstanding convertible senior notes and our $109.4 million of outstanding long-term note payable, the amortization of associated debt issuance costs and recognized gains and losses associated with recording economic hedge transactions at fair value. Interest and other expense was $4.9 million and $5.5 million for the three months ended June 30, 2009 and 2008, respectively. The decrease in interest and other expense for the three months ended June 30, 2009 primarily reflects an increase in capitalized interest associated with our Ohio manufacturing facility and an increase in recognized gains associated with economic hedge transactions, partially offset by increased non-cash interest expense from the amortization of the debt discount on our 2007 Notes discussed in Note 2 to the accompanying financial statements.
Revenues under collaborative agreements for the six months ended June 30, 2009 were $26.2 million, compared to $40.2 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 $14.0 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.
In future periods, we expect that revenues under collaborative agreements will consist of ongoing cost-sharing payments from Lilly for sharing of development costs, possible future milestone payments, $0.9 million of remaining amortization of the $30 million portion of the up-front payment received from Lilly upon signing of our collaboration agreement in 2002 and, following the commercial launch of exenatide once weekly, the amortization of a portion of the $125 million cash payment received in connection with the exenatide once weekly supply agreement discussed above. Future cost-sharing revenue recorded will be dependent on the timing, extent and relative proportion of total development costs for the exenatide once weekly and BYETTA development programs incurred by us and by Lilly. The receipt and recognition as revenue of future milestone payments is subject to the achievement of performance requirements underlying such milestone payments.
Read the The complete ReportAMLN is in the portfolios of Carl Icahn of Icahn Capital Management LP, Edward Owens of Vanguard Health Care Fund.
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 $2.11 billion; its shares were traded at around $14.98 with and P/S ratio of 2.5.
Highlight of Business Operations:
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 is 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 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. In August 2008, the Food and Drug Administration, or FDA, updated a prior alert for BYETTA referencing pancreatitis. We are currently in discussions with the FDA regarding potential updates to the BYETTA label regarding pancreatitis and other matters. 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 products safety profile. We believe the decline in BYETTA prescriptions and demand for the product continued to stabilize during the quarter ended June 30, 2009. Net product sales of BYETTA were $175.1 million and $177.5 million for the three months ended June 30, 2009 and 2008, respectively, and $332.8 million and $336.0 million for the six months ended June 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 $22.4 million and $22.8 million for the three months ended June 30, 2009 and 2008, respectively, and $44.0 million and $43.1 million for the six months ended June 30, 2009 and 2008, respectively.
In future periods, we expect that revenues under collaborative agreements will consist of ongoing cost-sharing payments from Lilly for sharing of development costs, possible future milestone payments, $0.9 million of remaining amortization of the $30 million portion of the up-front payment received from Lilly upon signing of our collaboration agreement in 2002 and, following the commercial launch of exenatide once weekly, the amortization of a portion of the $125 million cash payment received in connection with the exenatide once weekly supply agreement discussed above. Future cost-sharing revenue recorded will be dependent on the timing, extent and relative proportion of total development costs for the exenatide once weekly and BYETTA development programs incurred by us and by Lilly. The receipt and recognition as revenue of future milestone payments is subject to the achievement of performance requirements underlying such milestone payments.
Interest and other expense consists primarily of interest expense resulting from our long-term debt obligations. Interest expense in the three months ended June 30, 2009 consists of interest on our $775 million par value of outstanding convertible senior notes and our $109.4 million of outstanding long-term note payable, the amortization of associated debt issuance costs and recognized gains and losses associated with recording economic hedge transactions at fair value. Interest and other expense was $4.9 million and $5.5 million for the three months ended June 30, 2009 and 2008, respectively. The decrease in interest and other expense for the three months ended June 30, 2009 primarily reflects an increase in capitalized interest associated with our Ohio manufacturing facility and an increase in recognized gains associated with economic hedge transactions, partially offset by increased non-cash interest expense from the amortization of the debt discount on our 2007 Notes discussed in Note 2 to the accompanying financial statements.
Revenues under collaborative agreements for the six months ended June 30, 2009 were $26.2 million, compared to $40.2 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 $14.0 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.
In future periods, we expect that revenues under collaborative agreements will consist of ongoing cost-sharing payments from Lilly for sharing of development costs, possible future milestone payments, $0.9 million of remaining amortization of the $30 million portion of the up-front payment received from Lilly upon signing of our collaboration agreement in 2002 and, following the commercial launch of exenatide once weekly, the amortization of a portion of the $125 million cash payment received in connection with the exenatide once weekly supply agreement discussed above. Future cost-sharing revenue recorded will be dependent on the timing, extent and relative proportion of total development costs for the exenatide once weekly and BYETTA development programs incurred by us and by Lilly. The receipt and recognition as revenue of future milestone payments is subject to the achievement of performance requirements underlying such milestone payments.
Read the The complete ReportAMLN is in the portfolios of Carl Icahn of Icahn Capital Management LP, Edward Owens of Vanguard Health Care Fund.
