-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, IZnIOJ1Fo6C7kvnlZRg5fZEKPWRzqpyF9fTU3Retba/irUfeUaGM0PswTCZ8oG/T sNK3OA8iKhYGFKeZLI0x5Q== 0001104659-07-028431.txt : 20070416 0001104659-07-028431.hdr.sgml : 20070416 20070416090143 ACCESSION NUMBER: 0001104659-07-028431 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070416 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070416 DATE AS OF CHANGE: 20070416 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AMYLIN PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000881464 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330266089 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19700 FILM NUMBER: 07767234 BUSINESS ADDRESS: STREET 1: 9360 TOWNE CENTRE DR STREET 2: SUITE 110 CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 6195522200 MAIL ADDRESS: STREET 1: 9360 TOWNE CENTRE DR STREET 2: SUITE 110 CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 a07-10571_18k.htm 8-K

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

Current Report Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  April 16, 2007

AMYLIN PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware

 

0-19700

 

33-0266089

(State or Other Jurisdiction of
Incorporation)

 

(Commission File Number)

 

(I.R.S. Employer Identification No.)

 

9360 Towne Centre Drive

San Diego, California 92121

(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code:  (858) 552-2200

Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CRF 240.13e-4(c))

 




Item 2.02.  Results of Operations and Financial Condition.

On April 16, 2007, Amylin Pharmaceuticals, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2007.  A copy of this press release is attached as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01.  Financial Statements and Exhibits.

(d)           Exhibits.

Number

 

Description

 

 

 

99.1

 

Press release issued by Amylin on April 16, 2007

 

2




SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

AMYLIN PHARMACEUTICALS, INC.

 

 

 

 

Dated:  April 16, 2007

By:

  /s/ LLOYD A. ROWLAND

 

 

 

Lloyd A. Rowland

 

 

Vice President, Governance and Compliance,

 

 

and Secretary

 

3




EXHIBIT INDEX

Number

 

Description

 

 

 

99.1

 

Press release issued by Amylin on April 16, 2007.

 

4



EX-99.1 2 a07-10571_1ex99d1.htm EX-99.1

Exhibit 99.1


Amylin Pharmaceuticals, Inc.

9360 Towne Centre Drive

San Diego, CA 92121  USA


Tel   (858) 552 2200

Fax  (858) 552 2212

www.amylin.com

 

FOR IMMEDIATE RELEASE

AMYLIN PHARMACEUTICALS REPORTS FIRST QUARTER FINANCIAL RESULTS

Net product sales increase to $162 million

San Diego, CA – April 16, 2007 – Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today reported financial results for the quarter ended March 31, 2007.  The Company reported total revenue of $172.0 million for the first quarter, including net product sales of $162.0 million.  Net loss for the quarter ended March 31, 2007 was $49.4 million, or $0.38 per share.  At March 31, 2007, the Company held cash, cash equivalents and short-term investments of approximately $634.5 million.

“This has been a quarter of strong execution in all aspects of our business,” said Daniel M. Bradbury, President and Chief Executive Officer of Amylin Pharmaceuticals.  “BYETTA and SYMLIN, our two first-in-class medicines for diabetes, continue to grow in an expanding market.  Exenatide LAR and our other pipeline programs are on track, positioning us well for future sustainable growth.”

Net product sales of $162.0 million for the first quarter include $146.5 million for BYETTA® (exenatide) injection and $15.5 million for SYMLIN® (pramlintide acetate) injection.  This compares to net product sales of $75.9 million, consisting of $68.3 million for BYETTA and $7.6 million for SYMLIN for the same period in 2006. Cost of goods sold was $15.2 million for the quarter ended March 31, 2007, compared to $9.7 million for the same period in 2006.

Revenues under collaborative agreements were $10.0 million for the quarter ended March 31, 2007, compared to $6.5 million for the same period in 2006 and consists primarily of cost-sharing payments from Eli Lilly and Company to equalize development expenses for exenatide LAR and BYETTA.

Selling, general and administrative expenses increased to $87.8 million for the quarter ended March 31, 2007, compared to $59.9 million for the same period in 2006.  The increase primarily reflects expenses associated with the recent expansion of the Company’s sales force, increased promotional expenses for BYETTA and SYMLIN and increased business infrastructure to support the Company’s growth.

Research and development expenses increased to $59.6 million for the quarter ended March 31, 2007, compared to $51.8 million for the same period in 2006.  The increase primarily reflects increased expenses for exenatide LAR and continued investment in the Company’s early stage obesity programs.

Collaborative profit sharing, which represents Lilly’s share of the gross margin for BYETTA, was $66.9 million for the quarter ended March 31, 2007, compared to $30.0 million for the same period in 2006.

1




Net loss for the quarter ended March 31, 2007 was $49.4 million, or $0.38 per share, compared to $67.9 million, or $0.61 per share, for the same period in 2006.

First quarter highlights

Highlights of Amylin’s first quarter activities include:

·            Completed transition of Daniel M. Bradbury to President and Chief Executive Officer.

·            Received U.S. Food and Drug Administration (FDA) approval for more convenient patient storage instructions for BYETTA® (exenatide) injection. BYETTA pens can now be kept at a room temperature not to exceed 77 degrees F (25 degrees C) after first use.

·            Completed enrollment in the ongoing long-term comparator study of once-weekly exenatide long-acting release (LAR) in patients with type 2 diabetes and remain on track for study results in the fourth quarter of 2007.

·            Completed enrollment in ongoing BYETTA monotherapy clinical study assessing BYETTA use as standalone therapy in type 2 diabetes, and remain on track for study results in the second half of 2007.

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, 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 supporting details underlying its first quarter financial results, and information regarding assumptions for the remainder of 2007 operations.  For those without access to the Internet, the live call may be accessed by phone by calling (866) 362-4832 (domestic) or (617) 597-5364 (international), passcode 71295475.  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 (888) 286-8010 (domestic) or (617) 801-6888 (international), passcode 81236977.

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® (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 located in San Diego, California with over 1600 employees nationwide. 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.  The Company’s 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 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 the FDA may not

2




approve the Company’s sNDAs or product candidates; 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-K.  Amylin disclaims any obligation to update these forward-looking statements.

(Financial information to follow)

3




AMYLIN PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS
 (in thousands, except per share data)
(unaudited)

 

 

Quarter Ended

 

 

 

March 31,

 

 

 

2007

 

2006

 

Revenues:

 

 

 

 

 

Net product sales

 

$

162,003

 

$

75,872

 

Revenues under collaborative agreements

 

9,975

 

6,474

 

Total revenues

 

171,978

 

82,346

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

Cost of goods sold

 

15,210

 

9,744

 

Selling, general and administrative

 

87,787

 

59,863

 

Research and development

 

59,564

 

51,774

 

Collaborative profit sharing

 

66,947

 

29,970

 

Total costs and expenses

 

229,508

 

151,351

 

Operating loss

 

(57,530

)

(69,005

)

Interest income, net

 

8,116

 

1,104

 

Net loss

 

$

(49,414

)

$

(67,901

)

 

 

 

 

 

 

Net loss per share – basic and diluted

 

$

(0.38

)

$

(0.61

)

 

 

 

 

 

 

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

 

131,054

 

111,285

 

 

4




AMYLIN PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)

 

 

March 31,

 

December 31,

 

 

 

2007

 

2006

 

Assets

 

 

 

 

 

Cash, cash equivalents and short-term investments

 

$

634,523

 

$

767,331

 

Accounts receivable, net

 

83,672

 

58,089

 

Inventories

 

65,843

 

59,299

 

Other current assets

 

26,826

 

22,098

 

Property and equipment, net

 

215,363

 

146,779

 

Other assets

 

9,428

 

6,790

 

Total assets

 

$

1,035,655

 

$

1,060,386

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities

 

$

195,111

 

$

203,887

 

Other liabilities, net of current portion

 

22,348

 

21,208

 

Convertible senior notes

 

200,000

 

200,000

 

Stockholders’ equity

 

618,196

 

635,291

 

Total liabilities and stockholders’ equity

 

$

1,035,655

 

$

1,060,386

 

 

###

CONTACT:

Mark Foletta

Senior Vice President, Finance and Chief Financial Officer

Amylin Pharmaceuticals, Inc.

+1-858-552-2200

www.amylin.com

5



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