Amylin Pharmaceuticals announces $174.1M total revenue for first-quarter 2010

Amylin Pharmaceuticals, Inc.Apr 19 2010

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today reported financial results for the quarter ended March 31, 2010. The Company reported total revenue of $174.1 million for the quarter ended March 31, 2010, which includes net product sales of $172.3 million. Non-GAAP operating loss was $3.8 million for the quarter ended March 31, 2010, compared to $19.9 million for the same period in 2009. GAAP net loss was $38.2 million, or $0.27 per share, for the quarter ended March 31, 2010, compared to $47.0 million, or $0.34 per share, for the same period in 2009. At March 31, 2010 the Company held cash, cash equivalents and short-term investments of $598.3 million.

"With the submission of our BYDUREON response this week, we are preparing to make this revolutionary treatment option available this year to the millions of patients living with type 2 diabetes," said Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals. "We remain focused on driving revenue from our currently marketed products, BYETTA and SYMLIN, and continue to exercise financial discipline so that we remain on track to generate sustainable positive operating cash flow by year end."  

First Quarter Highlights

Highlights of Amylin's first quarter and recent activities include:

BYDUREON

• Received a complete response letter regarding the BYDUREON™ (exenatide for extended-release injectable suspension) New Drug Application (NDA) from the U.S. Food and Drug Administration (FDA), and the response to the letter will be submitted to the FDA this week
• Eli Lilly and Company submitted the marketing authorization application to the European Medicines Agency for BYDUREON
• Enrolled first patient in DURATION-6 clinical study, a head-to-head comparison of liraglutide, a GLP-1 analog, with results anticipated in the first half of 2011
• DURATION-1 manuscript published in Diabetes Care demonstrated that 52 weeks of treatment with BYDUREON produced sustained glucose control and weight loss

Obesity Program

• Announced the combination treatment of pramlintide/metreleptin will advance toward Phase 3 development

Financial Results

Net product sales of $172.3 million for the quarter ended March 31, 2010 include $149.8 million for BYETTA® (exenatide) injection and $22.5 million for SYMLIN® (pramlintide acetate) injection. This compares to net product sales of $179.3 million, consisting of $157.7 million for BYETTA and $21.6 million for SYMLIN for the same period in 2009.  Revenues under collaborative agreements were $1.9 million for the quarter ended March 31, 2010, compared to $1.1 million for the same period in 2009 and consist of the amortization of up-front fees received under the Company's collaboration agreements.

Selling, general and administrative expenses decreased to $76.7 million for the quarter ended March 31, 2010 from $87.6 million for the same period in 2009. The decrease primarily reflects lower sales force spending and the Company's reduced cost structure, partially offset by pre-launch expenses associated with BYDUREON.

Research and development expenses decreased to $41.8 million for the quarter ended March 31, 2010 from $46.7 million for the same period in 2009. The decrease primarily reflects lower development expenses for the Company's obesity programs. This reduction reflects development expense cost-sharing with Takeda Pharmaceutical Company Limited through the Company's obesity collaboration agreement and lower clinical trial expenses from trials that were completed in 2009.  

Collaborative profit sharing, which represents Lilly's share of the gross margin for BYETTA, was $67.9 million for the quarter ended March 31, 2010, compared to $73.0 million for the same period in 2009.

Non-GAAP operating loss was $3.8 million for the quarter ended March 31, 2010, compared to $19.9 million for the same period in 2009. GAAP net loss for the quarter ended March 31, 2010 was $38.2 million, or $0.27 per share, compared to $47.0 million, or $0.34 per share, for the same period in 2009.