EX-99.1 2 d245091dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

FOR IMMEDIATE RELEASE

AMYLIN PHARMACEUTICALS REPORTS THIRD QUARTER FINANCIAL RESULTS

Non-GAAP Operating Income of $13 Million

Amylin Well Positioned for Anticipated Launch of BYDUREONTM in Early 2012

San Diego, CA – October 19, 2011 – Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today reported financial results for the quarter ended September 30, 2011.

 

   

Total revenue was $175.0 million, which included net product sales of $155.1 million and a $15.0 million milestone payment from Eli Lilly and Company in connection with the launch of BYDUREON in the European Union

 

   

Non-GAAP operating income was $13.0 million, compared to a non-GAAP operating loss of $16.1 million for the same period in 2010

 

   

GAAP net loss was $13.2 million, or $0.09 per share, compared to $50.7 million, or $0.35 per share, for the same period in 2010

 

   

Cash, cash equivalents, short-term investments and restricted cash totaled $460.8 million at the end of the quarter

“We continue to advance our goal of bringing the first ever once-weekly diabetes therapy to patients in the U.S. We are closely monitoring BYDUREON launches across Europe and will apply insights from those launches to our U.S. planning for this important therapy,” said Daniel M. Bradbury, president and chief executive officer of Amylin Pharmaceuticals. “Additionally, we look forward to the FDA’s anticipated decision on an expanded label for BYETTA for use with insulin glargine. We believe this complementary approach to glycemic control will be a smart partnership that could result in an important new treatment option for patients. We continue our focus on fiscal discipline as we execute against our strategic objectives through the end of the year, and plan for the pivotal year ahead.”

Highlights of Amylin’s Third Quarter and Recent Activities

BYDUREON

 

   

Submitted a reply to a complete response letter by the U.S. Food and Drug Administration (FDA) regarding BYDUREON™ (exenatide extended-release for injectable suspension), which included results from a thorough QT study that showed exenatide, at and above therapeutic levels, did not prolong the corrected QT interval in healthy individuals

 

   

Announced that the FDA assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012 for BYDUREON

 

   

Presented compelling efficacy and safety data at the European Association for the Study of Diabetes (EASD) Annual Meeting from the DURATION-3 and -4 trials. The studies demonstrated that patients treated with BYDUREON experienced significant improvements in select cardiovascular risk factors, including improvements in composite endpoints related to body weight, abnormal blood pressure and abnormal lipid levels, in comparison to patients who received commonly prescribed diabetes treatments


Obesity Program

 

   

Announced the discontinuation of the pramlintide/metreleptin development program for obesity. The joint decision between Amylin and Takeda Pharmaceuticals Limited was based on a commercial reassessment of the pramlintide/metreleption program. The companies continue to evaluate other assets as potential candidates for the treatment of obesity and related indications under the terms of their existing collaboration agreement

Quarter Ended September 30, 2011

Net product sales of $155.1 million for the quarter ended September 30, 2011 include $128.1 million for BYETTA® (exenatide) injection and $27.0 million for SYMLIN® (pramlintide acetate) injection. This compares to net product sales of $154.0 million, consisting of $132.4 million for BYETTA and $21.6 million for SYMLIN for the same period in 2010. Revenues under collaborative agreements were $19.9 million for the quarter ended September 30, 2011, and included a $15.0 million milestone payment from Lilly in connection with the launch of BYDUREON in the European Union in July, compared to $2.1 million for the same period in 2010.

Selling, general and administrative expenses decreased to $63.1 million for the quarter ended September 30, 2011 from $70.0 million for the same period in 2010. The decrease primarily reflects lower expenses associated with BYDUREON pre-launch activities and a reduced cost structure associated with the Company’s efforts to drive efficiencies in the business.

Research and development expenses decreased to $46.6 million for the quarter ended September 30, 2011 from $51.2 million for the same period in 2010. The decrease reflects reduced spending for BYDUREON pre-launch inventory manufacturing, partially offset by increased spending on our metreleptin development program.

Collaborative profit sharing, which represents Lilly’s share of the gross margin for BYETTA, was $59.0 million for the quarter ended September 30, 2011, compared to $61.2 million for the same period in 2010.

Non-GAAP operating income was $13.0 million for the quarter ended September 30, 2011 compared to a non-GAAP operating loss of $16.1 million for the same period in 2010. Net loss excluding restructuring charges was $10.7 million, or $0.07 per share, for the quarter ended September 30, 2011, an improvement of 76% compared to $44.7 million, or $0.31 per share, for the same period in 2010. GAAP net loss was $13.2 million, or $0.09 per share, for the quarter ended September 30, 2011, compared to a GAAP net loss of $50.7 million, or $0.35 per share, for the same period in 2010.

Nine Months Ended September 30, 2011

Total revenues for the nine months ended September 30, 2011 were $485.7 million. This includes net product sales of $460.7 million, including $385.1 million for BYETTA and $75.6 million for SYMLIN. This compares to net product sales of $488.8 million, consisting of $422.9 million for BYETTA and $65.9 million for SYMLIN for the same period in 2010.

Revenues under collaborative agreements were $25.0 million for the nine months ended September 30, 2011, and included a $15.0 million milestone payment from Lilly in connection with the launch of BYDUREON in the European Union in July, compared to $5.8 million for the same period in 2010.


Selling, general and administrative expenses decreased to $192.9 million for the nine months ended September 30, 2011 from $214.3 million for the same period in 2010. The 10% decrease primarily reflects decreased expenses associated with BYDUREON pre-launch activities, and reduced business infrastructure spending resulting from continued efforts to drive efficiencies in the business.

Research and development expenses decreased to $133.5 million for the nine months ended September 30, 2011 from $145.6 million for the same period in 2010. The 8.3% decrease reflects reduced spending for BYDUREON pre-launch inventory manufacturing and our efforts to manage our expenses, partially offset by increased spending on our BYDUREON cardiovascular outcomes study (EXSCEL) and metreleptin development program.

Collaborative profit sharing was $179.5 million for the nine months ended September 30, 2011, compared to $194.1 million for the same period in 2010.

Non-GAAP operating income was $8.0 million for the nine months ended September 30, 2011 compared to a non-GAAP operating loss of $27.3 million for the same period in 2010. Net loss excluding restructuring charges was $76.4 million, or $0.53 per share, for the nine months ended September 30, 2011, a 38% improvement compared to $123.7 million, or $0.86 per share, for the nine months ended September 30, 2010. GAAP net loss for the nine months ended September 30, 2011 was $81.9 million, or $0.56 per share, compared to GAAP net loss of $133.1 million, or $0.93 per share for the same period in 2010.

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 third quarter financial results. A slide presentation accompanying the conference call is available through the “Investors” section of Amylin’s corporate website 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 number 7156306. 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 (866) 415-3327 (U.S./Canada) or (203) 369-0696 (international).

Note Regarding Use of Non-GAAP Financial Measures

Amylin reports non-GAAP operating income or 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 sustainable positive non-GAAP operating results 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® (pramlintide


acetate) injection and BYETTA® (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, and has a commercial manufacturing facility in Ohio. Further information on Amylin Pharmaceuticals is available at www.amylin.com.

This press release contains forward-looking statements about Amylin, which involve risks and uncertainties. Our actual results could differ materially from those discussed herein due to a number of risks and uncertainties, including risks that BYETTA, SYMLIN or BYDUREON, and the revenues or royalties generated from these products, may be affected by competition, unexpected new data, safety and technical issues, or manufacturing and supply issues; risks that our financial results may fluctuate significantly from period to period and may not meet market expectations; risks that any financial guidance we provide may not be accurate; risks that our clinical trials will not be completed when planned, may not replicate previous results, may not be predictive of real world use or may not achieve desired end-points; risks that the CMC section of the metreleptin BLA may not be submitted in a timely fashion or that the BLA will not receive regulatory approval; risks that our preclinical studies or the data analyses mentioned in this press release may not be predictive; risks that our NDAs for product candidates, such as the BYDUREON NDA, or sNDAs for label expansion requests, may not be submitted timely or receive FDA approval; risks that the information we provide in our response to the FDA’s BYDUREON complete response letter may not satisfy the FDA; risks that the FDA may request additional information prior to approving BYDUREON; risks that the launch of BYDUREON, if approved, will be delayed; risks that our expense reductions will not be as large as we expect; and other risks inherent in the drug development and commercialization process. Commercial and government reimbursement and pricing decisions and the pace of market acceptance may also affect the potential for BYETTA, SYMLIN or BYDUREON. These and additional risks and uncertainties are described more fully in the Company’s recently filed Form 10-Q. Amylin disclaims any obligation to update these forward-looking statements.

(Financial information to follow)


AMYLIN PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)

 

    

Quarter ended

September 30,

    Nine months ended
September 30,
 
     2011     2010     2011     2010  

Revenues:

        

Net product sales

   $ 155,075      $ 154,026      $ 460,703      $ 488,798   

Revenues under collaborative agreements

     19,889        2,075        25,040        5,825   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     174,964        156,101        485,743        494,623   

Costs and expenses:

        

Cost of goods sold

     11,671        12,680        36,058        47,644   

Selling, general and administrative

     63,059        70,019        192,901        214,331   

Research and development

     46,560        51,155        133,544        145,574   

Collaborative profit sharing

     58,959        61,249        179,462        194,056   

Restructuring

     2,499        6,028        5,483        9,452   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total costs and expenses

     182,748        201,131        547,448        611,057   

Operating loss

     (7,784     (45,030     (61,705     (116,434

Interest and other income, net

     (5,412     (5,702     (20,223     (16,697
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (13,196   $ (50,732   $ (81,928   $ (133,131
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share – basic and diluted

   $ (0.09   $ (0.35   $ (0.56   $ (0.93
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used in computing net loss per share – basic and diluted

     145,987        143,763        145,545        143,354   
  

 

 

   

 

 

   

 

 

   

 

 

 

A reconciliation of reported GAAP operating net loss to non-GAAP operating income (loss) excluding non-cash items is provided in the table that follows (in thousands, unaudited):

 

    

Quarter ended

September 30,

    Nine months ended
September 30,
 
     2011     2010     2011     2010  

GAAP operating loss

   $ (7,784   $ (45,030   $ (61,705   $ (116,434

Stock-based compensation

     7,409        7,030        23,277        27,234   

Other non-cash compensation

     4,333        4,021        12,914        15,631   

Depreciation and amortization

     11,602        13,712        36,866        42,443   

Amortization of deferred revenue

and other credits

     (5,039     (1,875     (8,789     (5,625

Restructuring

     2,499        6,028        5,483        9,452   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP operating income (loss)

   $ 13,020      $ (16,114   $ 8,046      $ (27,299
  

 

 

   

 

 

   

 

 

   

 

 

 


AMYLIN PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

     September 30,
2011
     December 31,
2010
 

Assets

     

Cash, cash equivalents and short-term investments

   $ 445,826       $ 442,663   

Restricted cash

     15,000         15,000   

Accounts receivable, net

     50,853         54,645   

Inventories, net

     107,345         118,629   

Other current assets

     39,978         45,458   

Property and equipment, net

     825,205         811,745   

Other assets

     32,385         43,289   
  

 

 

    

 

 

 

Total assets

   $ 1,516,592       $ 1,531,429   
  

 

 

    

 

 

 

Liabilities and stockholders’ equity

     

Current liabilities

     242,285         401,595   

Other liabilities, net of current portion

     307,867         317,654   

Long-term debt

     653,964         468,697   

Stockholders’ equity

     312,476         343,483   
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 1,516,592       $ 1,531,429   
  

 

 

    

 

 

 

CONTACTS:

Financial:

Michael York

Senior Director, Investor Relations

Amylin Pharmaceuticals, Inc.

(858) 458-8602

michael.york@amylin.com

Media:

Anne Erickson

Senior Director, Corporate Affairs

Amylin Pharmaceuticals, Inc.

(858) 754-4443

anne.erickson@amylin.com