0001104659-09-029097.txt : 20090504 0001104659-09-029097.hdr.sgml : 20090504 20090504171533 ACCESSION NUMBER: 0001104659-09-029097 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090504 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Cost Associated with Exit or Disposal Activities ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090504 DATE AS OF CHANGE: 20090504 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: 09794384 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 a09-12548_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): May 4, 2009

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 1.01. Entry into a Material Definitive Agreement.

On May 4, 2009, Amylin Pharmaceuticals, Inc. and Eli Lilly and Company entered into a cost allocation agreement, or the Cost Allocation Agreement, which amends the exenatide development and commercialization cost-sharing provisions contained in the companies’ Collaboration Agreement, dated September 19, 2002, as amended, and Exenatide Once Weekly Supply Agreement, dated October 16, 2008, or the Agreements.

Under the terms of the Cost Allocation Agreement, the following changes will be applied with respect to the cost-sharing provisions of the Agreements retroactively as of January 1, 2009:

· Lilly will be responsible for 53% of shared exenatide global development and commercialization expenses that generate utility both in the United States and outside the United States, including global manufacturing development expenses. Amylin will be responsible for 47% of these expenses;

· Lilly will assume 100% of all exenatide development and commercialization expenses that generate utility predominantly outside the United States. Under the previous cost-sharing arrangement, Amylin was responsible for 20% of some of these expenses; and

· The royalty structure for exenatide revenues generated outside the United States has been modified to reflect Lilly’s revised expense burden, with a reduction in Lilly’s royalty payments to Amylin.

The companies will continue to equally share all exenatide development and commercialization expenses that generate utility predominately in the United States. Amylin and Lilly are parties to a number of other agreements that have been entered into in connection with their development and commercialization of exenatide.

The above description of the Cost Allocation Agreement is a summary and is qualified in its entirety by the terms of the agreement which will be filed on Amylin’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009.

Item 2.05. Costs Associated with Exit or Disposal Activities.

On May 4, 2009, Amylin announced a new approach to sales within the diabetes market. Amylin’s existing primary care and specialty sales forces will merge into a single organization which will reduce the total number of Amylin sales representatives by approximately 35%, or 200 employees, resulting in an annualized benefit of approximately $45 million to GAAP operating results in 2010 and a partial year benefit of approximately $20 million in 2009. A copy of Amylin’s press release announcing the sales force restructuring is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

Amylin expects to incur charges under the corporate restructuring during the second quarter, including an estimated restructuring charge of $13 to $15 million, of which approximately $11 to $13 million will result in future cash expenditures, consisting primarily of one-time severance and other employee-related costs.

Item 8.01 Other Events.

The information included in Item 2.05 of this Current Report on Form 8-K is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d)	Exhibits.

	Number	Description

	99.1	Press release issued by Amylin on May 4, 2009

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: May 4, 2009	By:	/s/ LLOYD A. ROWLAND
		Lloyd A. Rowland
		Vice President, Governance and Compliance, and Corporate Secretary

EXHIBIT INDEX

Number		Description

99.1		Press release issued by Amylin on May 4, 2009.

EX-99.1 2 a09-12548_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	Investors:	Michael York
		858-458-8602
		michael.york@amylin.com

	Media:	Alice Izzo
		858-642-7272
		alice.izzo@amylin.com

AMYLIN PHARMACEUTICALS ANNOUNCES A NEW SALES APPROACH

TO BETTER TARGET THE DIABETES MARKET

Changes will result in a 35% sales force reduction and approximately $45 million annual GAAP operating results benefit

SAN DIEGO, May 4, 2009 — Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced a new approach to sales within the diabetes market. Amylin’s existing primary care and specialty sales forces will merge into a single organization that brings a specialty approach to endocrinologists and diabetes-focused primary care physicians. The changes are expected to be implemented in the next several weeks and will reduce the total number of Amylin sales representatives by approximately 35 percent, or 200 employees, and will result in an annualized benefit of approximately $45 million to GAAP operating results in 2010.

The new sales approach is part of Amylin’s continuing efforts to improve the efficiency and effectiveness of exenatide alliance operations with partner Eli Lilly and Company, and to maximize the value of the Company’s current and future portfolio of first-in-class diabetes products. The changes to Amylin’s field sales organization will be coordinated and aligned with the continuing exenatide sales efforts of Lilly. Amylin’s resulting field sales organization will include approximately 325 sales representatives focused on endocrinologists and other physicians that treat significant numbers of diabetes patients. Lilly will continue their efforts within the endocrinology and larger primary care prescriber market to support BYETTA® (exenatide) injection. Overall, these changes will better position the companies for the anticipated launch of exenatide once weekly.

“This new, more focused approach to sales optimizes Amylin’s sales organization for our portfolio today and in the future, and will enable us to improve the quality of our interactions with core prescribers through more efficient and frequent interactions. These changes build on Amylin’s scientific strength, and leverage Lilly’s expertise and reach with primary care prescribers, so that we are well positioned to address the information needs of the complex diabetes market,” said Daniel M. Bradbury, president and chief executive officer at Amylin Pharmaceuticals. “Today’s actions are in line with our stated goal of achieving positive operating cash flow by the end of 2010, while continuing to position the company to increase sales of BYETTA and SYMLIN and bring exenatide once weekly to market as quickly as possible.”

Mr. Bradbury continued, “We appreciate the significant contributions of field sales employees who will be affected by today’s announcement and are grateful for their efforts and dedication to Amylin’s mission.”

The sales force changes will result in an annualized benefit of approximately $45 million in GAAP operating results in 2010, and a partial year benefit of approximately $20 million in 2009, which includes reductions in field sales staff and expenses, partially offset by additional cost-sharing for Lilly’s primary care sales efforts. As a result of these expense reductions, which are primarily cash expenses, the Company estimates that total GAAP operating expenses for 2009 will now be at the lower end of the previously stated guidance range of $600 million to $625 million, and GAAP operating loss will also be at the lower end of the previously stated guidance range of $175 million to $200 million. This guidance for GAAP operating loss excludes a restructuring charge, estimated to be approximately $13 to $15 million, which the Company will record in the second quarter, consisting of primarily severance and other employee-related costs.

About Amylin Pharmaceuticals

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 headquartered in San Diego, California. Further information on Amylin Pharmaceuticals is available at http://www.amylin.com.

This press release contains forward-looking statements about Amylin. Actual results could differ materially from those discussed or implied in this press release due to a number of risks and uncertainties, including the risk that BYETTA, SYMLIN and/or exenatide once weekly and the revenues generated from BYETTA and/or SYMLIN may be affected by competition; unexpected new data; safety and technical issues; clinical trials not confirming previous results; pre-clinical trials not predicting future results; New Drug Applications and label expansion requests not being submitted in a timely manner or receiving regulatory approval; the sales force changes not producing the operating loss benefits we expect; financial guidance we provide may not be accurate; the restructured operations for exenatide and the new sales approach mentioned in this press release not producing the results we expect; or manufacturing and supply issues. The potential for BYETTA, SYMLIN and/or exenatide once weekly may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the commercialization of pharmaceutical products. These and additional risks and uncertainties are described more fully in Amylin’s most recent SEC filings including their Annual Report on Form 10-K. Amylin undertakes no duty to update these forward-looking statements.

###

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For Immediate Release

Investors:

Michael York

alice.izzo@amylin.com