Second Quarter Highlights
Highlights of Amylin’s second quarter and recent activities include:
BYDUREON
* Submitted reply to FDA Complete Response Letter for BYDUREON(TM) (exenatide injection for sustained release)
o FDA assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010
* Announced results from DURATION-4, a head-to-head study that compared BYDUREON monotherapy to Januvia(R) (sitagliptin), Actos(R) (pioglitazone HCI) or metformin. Results demonstrated that BYDUREON efficacy and tolerability profile extended to monotherapy treatment
* Presented results of an analysis of pooled safety data from three completed randomized controlled trials at the American Diabetes Association’s (ADA’s) 70th Annual Scientific Sessions that showed BYDUREON, dosed once weekly, was generally well-tolerated with a low discontinuation rate due to serious adverse events similar to pooled comparators in patients with type 2 diabetes
o Demonstrated an absence of severe hypersensitivity events in the BYDUREON and BYETTA(R) (exenatide) injection clinical programs
* Completed first patient visit in the EXSCEL (EXenatide Study of Cardiovascular Event Lowering) cardiovascular outcomes study, with results expected in 2016
BYETTA
* Presented compelling efficacy and safety data on BYETTA at the ADA’s annual meeting, including:
o No increased risk of acute pancreatitis among initiators of BYETTA compared to initiators of other antidiabetic therapies in final results from a retrospective study that included more than 260,000 patients
o BYETTA added to Lantus(R) (insulin glargine) in type 2 diabetes patients with long-standing disease resulted in glycemic control without weight gain or increased risk of hypoglycemia
o Data on improved beta-cell function indices following three years of BYETTA therapy compared to Lantus therapy
SYMLIN
* Presented data at the ADA annual meeting that demonstrated no increased risk of cardiovascular events associated with SYMLIN(R) (pramlintide acetate) injection use compared to a pooled comparator group treated with either placebo or rapid-acting insulin in an analysis of an integrated database of clinical studies
Corporate
* Appointed Christian Weyer, MD, senior vice president, Research and Development and Orville Kolterman, MD, senior vice president, chief medical officer
* Hosted Online Summit that provided perspectives from key opinion leaders on diabetes and information from topics covered at the ADA annual meeting
Quarter Ended June 30, 2010
Net product sales of $162.5 million for the quarter ended June 30, 2010 include $140.7 million for BYETTA and $21.8 million for SYMLIN. This compares to net product sales of $197.5 million, consisting of $175.1 million for BYETTA and $22.4 million for SYMLIN for the same period in 2009. Revenues under collaborative agreements were $1.9 million for the quarter ended June 30, 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 $74.2 million for the quarter ended June 30, 2010 from $92.1 million for the same period in 2009. The decrease primarily reflects lower sales force spending, the Company’s reduced cost structure and the absence of costs associated with the proxy contest in connection with the Company’s 2009 annual meeting of stockholders.
Research and development expenses decreased to $46.0 million for the quarter ended June 30, 2010 from $52.8 million for the same period in 2009. The decrease primarily reflects lower development expenses for the Company’s obesity programs, partially offset by increased expenses associated with the Company’s BYDUREON manufacturing facility. The reduction in obesity spending reflects development expense cost-sharing with Takeda Pharmaceutical Company Limited 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 $64.9 million for the quarter ended June 30, 2010, compared to $76.2 million for the same period in 2009.
Non-GAAP operating loss was $7.4 million for the quarter ended June 30, 2010, a 67% improvement compared to $22.4 million for the same period in 2009. The Company’s results for the quarter ended June 30, 2010 and 2009 include restructuring charges of $3.4 million and $11.4 million, respectively. Restructuring charges in both periods consist primarily of employee separation costs. Net loss excluding restructuring charges was $40.8 million, or $0.28 per share compared to $51.0 million or $0.36 per share for the same period in 2009. GAAP net loss was $44.2 million, or $0.31 per share, for the quarter ended June 30, 2010, compared to $62.4 million, or $0.44 per share, for the same period in 2009.
Six Months Ended June 30, 2010
Total revenues for the six months ended June 30, 2010 were $338.5 million. This includes net product sales of $334.8 million, including $290.5 million for BYETTA and $44.3 million for SYMLIN. This compares to net product sales of $376.8 million, consisting of $332.8 million for BYETTA and $44.0 million for SYMLIN for the same period in 2009.
Revenues under collaborative agreements were $3.8 million for the six months ended June 30, 2010, compared to $2.1 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 $150.9 million for the six months ended June 30, 2010 from $179.6 million for the same period in 2009. The decrease primarily reflects lower sales force spending, the Company’s reduced cost structure and the absence of costs associated with the proxy contest in connection with the Company’s 2009 annual meeting of stockholders.
Research and development expenses decreased to $87.8 million for the six months ended June 30, 2010 from $99.5 million for the same period in 2009. The decrease primarily reflects lower development expenses for the Company’s obesity programs, partially offset by increased expenses associated with the Company’s BYDUREON manufacturing facility. The reduction in obesity spending reflects development expense cost-sharing with Takeda Pharmaceutical Company Limited and lower clinical trial expenses from trials that were completed in 2009.
Collaborative profit sharing was $132.8 million for the six months ended June 30, 2010, compared to $149.2 million for the same period in 2009.
Non-GAAP operating loss was $11.2 million for the six months ended June 30, 2010, a 74% improvement compared to $42.2 million for the same period in 2009. Net loss excluding the restructuring charge was $79.0 million, or $0.55 per share. GAAP net loss for the six months ended June 30, 2010 was $82.4 million, or $0.58 per share, compared to $109.3 million, or $0.78 per share for the same period in 2009.
Conference Call
Amylin will webcast its Quarterly Update Call today at 5:00 p.m. ET/2:00 p.m. PT. Daniel M. Bradbury, Amylin’s president and chief executive officer, will lead the call. During the call, the Company plans to provide further details underlying its second quarter financial results. A slide presentation accompanying the conference call is available through the “Investors” section of Amylin’s corporate Web site at www.amylin.com.
To access the webcast, please log on to www.amylin.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. For those without access to the Internet, the live call may be accessed by phone by calling (800) 857-5738 (U.S./Canada) or (415) 228-4970 (international), participant passcode# 7487145. A replay of the call will also be available by phone beginning approximately two hours after the close of the call and can be accessed at (800) 925-2682 (U.S./Canada) or (203) 369-3958 (international).
Note Regarding Use of Non-GAAP Financial Measures
Amylin reports non-GAAP operating loss excluding non-cash items and other items such as restructuring charges, which is a non-GAAP financial measure. The Company believes that investors’ understanding of its progress towards its stated goal of generating positive non-GAAP operating results by the end of 2010 is enhanced by this disclosure. In addition, the Company refers to this non-GAAP financial information with its analysis of the Company’s financial performance. This non-GAAP financial measure should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.
About Amylin Pharmaceuticals
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) 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 headquartered in San Diego, California. Further information on Amylin Pharmaceuticals is available at www.amylin.com.
