Navigation Links
Amylin Pharmaceuticals Reports Third Quarter Financial Results
Date:10/21/2008

Product sales increased 14% over third quarter 2007 to $201 million

SAN DIEGO, Oct. 21 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today reported financial results for the quarter ended September 30, 2008. The Company reported total revenue of $218.4 million for the third quarter, including net product sales of $201.4 million, a 14% increase over the same period in 2007. Net loss for the quarter ended September 30, 2008 was $77.7 million, or $0.57 per share. Net loss per share, excluding an impairment loss on investments of $14.9 million, or $0.11 per share, was $0.46 per share.

"This quarter we reported strong product sales in the face of an increasingly challenging environment. Additionally we completed an exenatide once weekly product supply agreement with Lilly that strengthens our balance sheet and provides financial flexibility for the future," said Daniel M. Bradbury, president and chief executive officer of Amylin Pharmaceuticals. "We continue to manage the company towards sustainable, profitable growth by driving BYETTA and SYMLIN revenue, managing our expenses, and bringing exenatide once weekly to market."

Quarter ended September 30, 2008

Net product sales of $201.4 million for the third quarter include $179.9 million for BYETTA(R) (exenatide) injection and $21.5 million for SYMLIN(R) (pramlintide acetate) injection. This represents a 14% increase over net product sales of $177.4 million for the same period in 2007.

Revenues under collaborative agreements were $17.0 million for the quarter ended September 30, 2008, compared to $12.6 million for the same period in 2007. The increase reflects higher cost-sharing payments from Lilly for development expenses for BYETTA and exenatide once weekly.

Selling, general and administrative expenses increased to $99.7 million for the quarter ended September 30, 2008, compared to $87.7 million for the same period in 2007. The increase reflects costs associated with the Company's expanded field force, investments in market development activities for exenatide once weekly and continued investment in promotional activities for BYETTA and SYMLIN.

Research and development expenses increased to $73.5 million for the quarter ended September 30, 2008, compared to $61.5 million for the same period in 2007. The increase primarily reflects increased development expenses for exenatide once weekly and increased expenses for the Company's obesity development programs. Non-GAAP, research and development expenses net of cost sharing payments increased to $57.5 million for the quarter ended September 30, 2008 compared to $49.9 million for the same period in 2007.

Collaborative profit sharing, which represents Lilly's share of the gross margin for BYETTA, was $80.6 million for the quarter ended September 30, 2008, compared to $75.0 million for the same period in 2007.

Loss on impairment of investments was $14.9 million for the quarter ended September 30, 2008. This primarily represents recognized impairment losses on the Company's equity investments in privately held entities of $9.0 million and an impairment loss of $5.9 million associated with a corporate debt security in the Company's investment portfolio. The net book value of the Company's remaining equity investments in privately held entities was less than $5.0 million at September 30, 2008. There was no comparable expense for the quarter ended September 30, 2007.

Net loss for the quarter ended September 30, 2007 was $77.7 million, or $0.57 per share, compared to $39.8 million, or $0.30 per share, for the same period in 2007.

Third quarter highlights

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

BYETTA

-- Initiated co-promotion of BYETTA with third party Lilly primary care

sales force, increasing the sales force promoting BYETTA by 40%.

Exenatide Once Weekly

-- Executed an exenatide once weekly supply agreement with Lilly, under

which Lilly will make an initial payment of $125 million to Amylin in

the fourth quarter of 2008. In addition, Lilly extended a $165 million

line of credit to Amylin. These agreements underscore Amylin's and

Lilly's commitment to the successful commercialization of exenatide

once weekly, strengthen Amylin's balance sheet and provide

additional financial flexibility.

-- Announced publication of DURATION-1 results in The Lancet. The study

showed that continuous steady state levels of exenatide, on board 24

hours a day, seven days a week, provided durable glycemic control and

sustained weight loss.

-- Completed enrollment of DURATION-2, which compares exenatide once weekly

against a thiazolidinedione and a DDP-4 inhibitor on a background of

metformin therapy.

Obesity Program

-- Completed enrollment of a phase 2B study to evaluate different dosing

combinations of pramlintide and metreleptin. The objective of this

dose-ranging study is to support dose selection for phase 3, and to

guide the development of a delivery system for this combination regimen.

Nine months ended September 30, 2008

Total revenues for the nine months ended September 30, 2008 were $637.6 million. This includes net product sales of $580.4 million, including $515.9 million for BYETTA and $64.5 million for SYMLIN. This compares to net product sales of $506.7 million, consisting of $459.7 million for BYETTA and $47.0 million for SYMLIN for the same period in 2007.

Revenues under collaborative agreements were $57.2 million for the nine months ended September 30, 2008, compared to $52.2 million for the same period in 2007. The increase reflects higher cost-sharing payments from Lilly for development expenses for BYETTA and exenatide once weekly. Collaborative revenues for the nine months ended September 30, 2007 included $15.0 million in milestones earned upon Lilly's launch of BYETTA in the European Union.

Selling, general and administrative expenses increased to $309.0 million for the nine months ended September 30, 2008, from $268.6 million for the same period in 2007. The increase reflects costs associated with the Company's expanded field force, increased promotional activities for BYETTA and SYMLIN, investments in market development activities for exenatide once weekly and increases in business infrastructure.

Research and development expenses increased to $226.1 million for the nine months ended September 30, 2008, from $192.7 million for the same period in 2007. The increase primarily reflects increased development expenses for exenatide once weekly and continued investment in the Company's obesity programs. Non-GAAP, research and development expenses net of cost sharing payments increased to $172.1 million for the quarter ended September 30, 2008 compared to $158.7 million for the same period in 2007.

Collaborative profit sharing was $229.4 million for the nine months ended September 30, 2008, compared to $212.3 million for the same period in 2007.

Net loss was $211.3 million, or $1.54 per share for the nine months ended September 30, 2008, compared to $134.2 million, or $1.02 per share, for the same period in 2007.

Conference Call

Amylin will Webcast its Quarterly Update Conference Call today at 5:00 p.m. ET/2:00 p.m. PT. The call will be Webcast live through Amylin's corporate Web site, http://www.amylin.com, 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 provide further details underlying its third 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# 68128288. 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) 642-1687 (U.S./Canada) or (706) 645-9291 (international), Conference ID# 6812822.

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 (in thousands, unaudited):

Quarter ended Nine months ended

September 30, September 30,

2008 2007 2008 2007

GAAP research

and development

expenses $73,466 $61,457 $226,073 $192,712

Cost-sharing

payments (15,927) (11,566) (53,983) (34,013)

Non-GAAP

research and

development

expenses,

net of cost

sharing payments $57,539 $49,891 $172,090 $158,699

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 2,000 employees nationwide. Further information on Amylin Pharmaceuticals is available at http://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 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 exenatide once weekly NDA or 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)

AMYLIN PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)

Quarter ended Nine months ended

September 30, September 30,

2008 2007 2008 2007

Revenues:

Net product sales $201,364 $177,391 $580,420 $506,731

Revenues under

collaborative

agreements 16,998 12,637 57,198 52,228

Total revenues 218,362 190,028 637,618 558,959

Costs and expenses:

Cost of goods sold 23,395 13,750 70,101 43,322

Selling, general and

administrative 99,676 87,718 309,007 268,626

Research and development 73,466 61,457 226,073 192,712

Collaborative profit

sharing 80,567 75,026 229,418 212,328

Total costs and expenses 277,104 237,951 834,599 716,988

Operating loss (58,742) (47,923) (196,981) (158,029)

Interest (expense)

income, net (4,036) 8,165 590 23,834

Loss on impairment of

equity method and

available for sale

investments (14,943) - (14,943) -

Net loss $(77,721) $(39,758) $(211,334) $(134,195)

Net loss per share -

basic and diluted $(0.57) $(0.30) $(1.54) $(1.02)

Shares used in computing

net loss per share -

basic and diluted 137,389 132,805 136,799 131,884

AMYLIN PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

September 30, December 31,

2008 2007

Assets

Cash, cash equivalents and

Short-term investments $805,451 $1,130,415

Accounts receivable, net 64,130 73,579

Inventories, net 98,508 100,214

Other current assets 28,422 32,100

Property, plant and equipment, net 600,204 390,301

Other assets 35,883 47,602

Total assets $1,632,598 $1,774,211

Liabilities and stockholders' equity

Current liabilities $278,909 $287,284

Other liabilities, net of

current portion 32,661 34,109

Long-term debt, net of current

portion 876,563 900,000

Stockholders' equity 444,465 552,818

Total liabilities and

stockholders' equity $1,632,598 $1,774,211


'/>"/>
SOURCE Amylin Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Amylin Pharmaceuticals to Webcast Third Quarter Results
2. Amylin Pharmaceuticals to Present at Thomas Weisel Healthcare, BioCentury NewsMakers, and Morgan Stanley Global Healthcare Conferences
3. Amylin Pharmaceuticals and Eli Lilly Provide Context for FDA Alert for BYETTA
4. Amylin and Lilly Set Date and Time for Conference Call
5. Amylin Pharmaceuticals to Webcast Second Quarter Results
6. Amylin Pharmaceuticals to Present at Goldman Sachs Global Healthcare Conference
7. Amylin Pharmaceuticals to Present Promising Data From Diabetes and Obesity Programs at ADA 2008
8. Amylin Pharmaceuticals to Present at Annual Meeting of Stockholders
9. Amylin Pharmaceuticals to Present at FBR Capital Markets Investor Conference
10. Amylin Pharmaceuticals to Present at Baird Growth Stock Conference
11. Amylin Pharmaceuticals to Present at Bank of America Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ... June 23, 2016 , ... ... and Mold) microbial test has received AOAC Research Institute approval 061601. , “This ... introduced last year,” stated Bob Salter, Vice President of Regulatory and Industrial Affairs. ...
(Date:6/23/2016)... ... June 23, 2016 , ... STACS DNA Inc., the sample tracking ... Arkansas State Crime Laboratory, has joined STACS DNA as a Field Application Specialist. ... Jocelyn Tremblay, President and COO of STACS DNA. “In further expanding our capacity as ...
(Date:6/23/2016)... 23, 2016 On Wednesday, June 22, ... down 0.22%; the Dow Jones Industrial Average edged 0.27% lower ... 2,085.45, down 0.17%. Stock-Callers.com has initiated coverage on the following ... Therapeutics (NASDAQ: NKTR ), Aralez Pharmaceuticals Inc. (NASDAQ: ... BIND ). Learn more about these stocks by accessing ...
(Date:6/23/2016)... , June 23, 2016 ... market research report to its pharmaceuticals section with ... product details and much more. Complete ... across 151 pages, profiling 15 companies and supported ... at http://www.reportsnreports.com/reports/601420-global-cell-culture-media-industry-2016-market-research-report.html . The ...
Breaking Biology Technology:
(Date:4/28/2016)... Sweden , April 28, 2016 First ... M (139.9), up 966% compared with the first quarter of 2015 ... profit totaled SEK 589.1 M (loss: 18.8) and the operating margin ... 7.12 (loss: 0.32) Cash flow from operations was SEK ... The 2016 revenue guidance is unchanged, SEK 7,000-8,500 M. ...
(Date:4/15/2016)... -- A new partnership announced today will help life ... a fraction of the time it takes today, ... insurance policies to consumers without requiring inconvenient and ... rapid testing (A1C, Cotinine and HIV) and higi,s ... pulse, BMI, and activity data) available at local ...
(Date:3/31/2016)... , March 31, 2016   ... ("LegacyXChange" or the "Company") LegacyXChange is excited ... of its soon to be launched online site for ... https://www.youtube.com/channel/UCyTLBzmZogV1y2D6bDkBX5g ) will also provide potential shareholders a ... DNA technology to an industry that is notorious for ...
Breaking Biology News(10 mins):