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Amylin Pharmaceuticals Reports First Quarter Financial Results

SAN DIEGO, April 21 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today reported financial results for the quarter ended March 31, 2008. The Company reported total revenue of $197.2 million for the first quarter, which includes net product sales of $178.7 million. Net loss for the quarter ended March 31, 2008 was $68.8 million, or $0.51 per share. At March 31, 2008, the Company held cash, cash equivalents and short-term investments of approximately $1,033.9 million.

"We have made steady progress in the first quarter of 2008 across near-, mid- and long-term opportunities, executing against the strategy detailed earlier this year to build Amylin's diabetes portfolio and establish our presence in the obesity field," said Daniel M. Bradbury, President and Chief Executive Officer of Amylin Pharmaceuticals. "BYETTA sales were lower than expected this quarter in part due to wholesaler buying patterns. We remain confident that we are taking the right steps to build sustainable BYETTA growth over time."

Bradbury continued, "Importantly, we achieved a significant milestone towards our efforts to submit the NDA for exenatide once weekly. We have manufactured exenatide once weekly product at commercial scale in our facility in Ohio and will begin supplying material from the facility to support ongoing and planned clinical programs by the third quarter."

Financial results

Net product sales of $178.7 million for the quarter ended March 31, 2008 include $158.5 million for BYETTA(R) (exenatide) injection and $20.2 million for SYMLIN(R) (pramlintide acetate) injection. This compares to net product sales of $162.0 million, consisting of $146.5 million for BYETTA and $15.5 million for SYMLIN for the same period in 2007.

Revenues under collaborative agreements were $18.5 million for the quarter ended March 31, 2008, which includes cost-sharing payments of $17.4 million, compared to $10.0 million, which includes cost-sharing payments of $8.9 million for the same period in 2007. The increase primarily reflects higher cost-sharing payments from Eli Lilly and Company to equalize development expenses for exenatide once weekly and BYETTA.

Selling, general and administrative expenses were $98.2 million for the quarter ended March 31, 2008, compared to $87.8 million for the same period in 2007. The increase primarily reflects promotional expenses for BYETTA, SYMLIN, exenatide once weekly market development and increases in infrastructure to support the Company's growth.

Research and development expenses increased to $77.2 million for the quarter ended March 31, 2008, compared to $59.6 million for the same period in 2007. The increase primarily reflects increased expenses for once weekly exenatide, and investment in the Company's early-stage obesity programs and drug delivery capabilities. Non-GAAP, net research and development expenses net of cost-sharing payments increased to $59.8 million for the quarter ended March 31, 2008, compared to $50.7 million for the same period in 2007.

Collaborative profit sharing, which represents Lilly's share of the gross margin for BYETTA, was $69.9 million for the quarter ended March 31, 2008, compared to $66.9 million for the same period in 2007.

Interest and other income, net decreased to $1.3 million for the quarter ended March 31, 2008, compared to $8.1 million for the same period in 2007. The decrease primarily reflects higher interest expense due to the Company's $575 million convertible debt issuance in June 2007 and the Company's $125 million term loan entered into in December 2007.

Net loss for the quarter ended March 31, 2008 was $68.8 million, or $0.51 per share, compared to $49.4 million, or $0.38 per share, for the same period in 2007.

First Quarter 2008 Highlights

Highlights of Amylin's first quarter include:


-- Submitted a supplemental New Drug Application, or sNDA, to the Food and

Drug Administration, or FDA, to seek approval for expanded use of

BYETTA as monotherapy, or stand-alone therapy, in people with type 2

diabetes who are not achieving acceptable blood sugar control.

Approval for this expanded indication is expected in the second

half of 2008.


-- Commercially launched the SymlinPen(TM) 120 and the SymlinPen(TM) 60

pen-injector devices for administering SYMLIN in the United States in

January 2008. These new pre-filled pen-injector devices feature

simple, fixed dosing to improve mealtime glucose control.

Exenatide once weekly

-- Initiated the first of three planned superiority clinical trials of

exenatide once weekly. The study compares exenatide once weekly to a

thiazolidinedione, or TZD, and a DPP-4 inhibitor in patients on

background metformin therapy. Results from this study are expected in

the first half of 2009.

-- Continued progress at the Company's exenatide once weekly manufacturing

facility in Ohio, including the manufacture of exenatide once weekly at

commercial scale. The Company plans to supply material from the

facility to support ongoing and planned clinical programs by the third

quarter of 2008

Conference Call

Amylin will webcast its Quarterly Update Conference Call today at 8:30 a.m. ET/5:30 a.m. PT. The call will be webcast live through Amylin's corporate website,, and a recording will be made available following the close of the call.

Daniel M. Bradbury, Amylin's President and Chief Executive Officer, will lead the call. During the call, the Company plans to review its first quarter financial results, and information regarding assumptions for the remainder of 2008 operations. For those without access to the Internet, the live call may be accessed by phone by calling (888) 536-6007 (U.S./Canada) or (706) 758-4632 (international), Conference ID# 43245695. A replay of the call will also be available by phone for 24 hours beginning approximately one hour after the close of the call and can be accessed at (800) 642-1687 (U.S./Canada) or (706) 645-9291 (international), Conference ID# 43245695.

Note Regarding Use of Non-GAAP Financial Measures

Amylin reports non-GAAP, research and development expenses, net of cost- sharing payments, which is a non-GAAP financial measure. The Company believes that investors' understanding of Amylin's net investment in research and development activities 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 information should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. A reconciliation of reported GAAP research and development expenses to non-GAAP research and development expenses, net of cost-sharing payments, is provided in the table that follows.

Quarter ended March 31,

2008 2007

GAAP research and development expenses $77,206 $59,564

Cost-sharing payments (17,445) (8,903)

Non-GAAP net research and development expenses,

net of cost sharing payments $59,761 $50,661

About Amylin

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(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 with over 1,900 employees nationwide. Further information on Amylin Pharmaceuticals is available at

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 or SYMLIN may be affected by competition, unexpected new data, 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 or may not replicate previous results; risks that our preclinical studies may not be predictive; risks that our NDAs for product candidates, or sNDAs for label expansion requests, such as the BYETTA monotherapy sNDA, may not be submitted timely or receive FDA approval; risks that we may not be able to complete our manufacturing facility on a timely basis; 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 or SYMLIN. 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)



(in thousands, except per share data)


Quarter ended March 31,

2008 2007


Net product sales $178,721 $162,003

Revenues under collaborative agreements 18,516 9,975

Total revenues 197,237 171,978

Costs and expenses:

Cost of goods sold 22,024 15,210

Selling, general and administrative 98,243 87,787

Research and development 77,206 59,564

Collaborative profit sharing 69,901 66,947

Total costs and expenses 267,374 229,508

Operating loss (70,137) (57,530)

Interest and other income, net 1,340 8,116

Net loss $(68,797) $(49,414)

Net loss per share - basic and diluted $(0.51) $(0.38)

Shares used in computing net loss per

share - basic and diluted 135,859 131,054



(in thousands)


March 31, December 31,

2008 2007


Cash, cash equivalents and short-term

investments $1,033,943 $1,130,415

Accounts receivable, net 65,512 73,579

Inventories, net 98,066 100,214

Other current assets 28,768 32,100

Property and equipment, net 476,990 390,301

Other assets 46,530 47,602

Total assets $1,749,809 $1,774,211

Liabilities and stockholders' equity

Current liabilities $260,136 $287,284

Other liabilities, net of current portion 36,775 34,109

Long-term debt 900,000 900,000

Stockholders' equity 552,898 552,818

Total liabilities and stockholders' equity $1,749,809 $1,774,211

SOURCE Amylin Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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