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Amgen's Third Quarter 2007 Adjusted Earnings Per Share Increased 4 Percent to $1.08.


Third Quarter 2007 Revenue Remained Unchanged at $3.6 Billion; Anemia Franchise Product Sales Decreased 16 Percent

Third Quarter 2007 GAAP GAAP

See: Generally Accepted Accounting Principles


GAAP

See generally accepted accounting principles (GAAP).
 Earnings Per Share of $0.18 Reflect $1.0 Billion in Charges Primarily Related to the Write-Off of In-Process R&D from the Alantos and Ilypsa Acquisitions and Restructuring Activities

THOUSAND OAKS, Calif. -- Amgen (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:AMGN) reported adjusted earnings per share (EPS (Encapsulated PostScript) A PostScript file format used to transfer a graphic image between applications and platforms. EPS files contain PostScript code as well as an optional preview image in TIFF, WMF, PICT or EPSI, the latter being an ASCII-only format. ), excluding stock option expense and certain other expenses, of $1.08 for the third quarter of 2007, an increase of 4 percent compared to $1.04 for the third quarter of 2006. Adjusted net income, excluding stock option expense and certain other expenses, decreased 4 percent to $1,181 million in the third quarter of 2007 compared to $1,224 million in the third quarter of 2006. Stock option expense on a per share basis totaled 2 cents and 3 cents for the third quarter of 2007 and 2006, respectively.

Total revenue remained unchanged during the third quarter of 2007 at $3.6 billion versus the third quarter of 2006.

Adjusted EPS and adjusted net income for the third quarter 2007 and 2006 exclude stock option expense, certain expenses related to acquisitions, restructuring charges and certain other items. These expenses and other items are itemized on the attached reconciliation tables. Adjusted EPS including the impact of stock option expense are also itemized on the attached reconciliation tables.

On a reported basis and calculated in accordance with U.S. Generally Accepted Accounting Principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records.

Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting
 (GAAP), Amgen's GAAP EPS were $0.18 and GAAP net income was $201 million for the third quarter of 2007. These amounts are down from the prior year GAAP EPS of $0.94 and GAAP net income of $1.1 billion. GAAP reported results for the third quarter of 2007 were negatively impacted by the write-off of $590 million of acquired in-process research and development related to the acquisitions of Alantos and Ilypsa; $293 million of charges principally related to asset impairment, accelerated depreciation Accelerated Depreciation

Any method of depreciation used for accounting or income tax purposes that allows greater deductions in the earlier years of the life of an asset.

Notes:
The straight-line depreciation method spreads the cost evenly over the life of an asset.
, staff separation costs and accruals for losses on leased facilities in connection with the previously announced restructuring plan; and the write-off of $90 million of inventory principally due to the changing regulatory and reimbursement environments.

As a result of the regulatory and reimbursement changes to Erythropoiesis erythropoiesis /eryth·ro·poi·e·sis/ (-poi-e´sis) the formation of erythrocytes.erythropoiet´ic

e·ryth·ro·poi·e·sis
n.
The formation or production of red blood cells.
 Stimulating Agent (ESA 1. (architecture) ESA - Enterprise Systems Architecture.
2. (body) ESA - European Space Agency.
) products and their impact on the Company's operations, in particular Aranesp([R]) (darbepoetin alfa darbepoetin alfa

Aranesp

Pharmacologic class: Recombinant human erythropoietin

Therapeutic class: Hematopoietic

Pregnancy risk category C

FDA Boxed Warning

), on Aug. 15, 2007, Amgen announced plans to restructure worldwide operations in order to improve its cost structure while continuing to make significant innovative research and development investments and build the framework for future growth. In connection with this restructuring plan, the Company expects to incur approximately $775 million to $850 million in total restructuring charges (as compared to the prior estimate of $600 million to $700 million). The increase in the total estimated restructuring charges is primarily the result of additional rationalization of manufacturing facilities, including the indefinite postponement of planned manufacturing operations in Ireland and the closure of a clinical manufacturing facility in Thousand Oaks. Through Sept. 30, 2007, Amgen has incurred $582 million of restructuring charges and anticipates that the remaining estimated charges will be incurred in the fourth quarter of 2007 and, to a lesser degree, in 2008.

"Sales of our ESA products were adversely affected by regulatory and reimbursement changes," said Kevin Sharer, chairman & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "We are making good progress in implementing a global restructuring plan to rationalize our cost structure and improve cash flow, while continuing to invest in the future."

Product Sales Performance

During the third quarter, total product sales increased 1 percent to $3,524 million from $3,503 million in the third quarter of 2006. Sales in the U.S. totaled $2,809 million, a decline of 2 percent versus $2,864 million in the third quarter of 2006. International sales increased 12 percent to $715 million versus $639 million in the third quarter of 2006. Changes in foreign exchange positively impacted third quarter 2007 international sales by $46 million. Excluding the impact of foreign exchange, total product sales decreased 1 percent and international product sales increased 5 percent.

Worldwide sales of Aranesp decreased 23 percent to $818 million in the third quarter of 2007 versus $1,067 million in the third quarter of 2006. This was principally driven by a decline in U.S. demand. U.S. Aranesp sales were $460 million versus $720 million in the third quarter of the prior year, a decrease of 36 percent. This was due to a decline in demand primarily reflecting reaction to regulatory and reimbursement developments throughout the year, including the National Coverage Determination (NCD NCD - Network Computing Devices ) issued by the Center for Medicare & Medicaid Services (CMS (1) See content management system and color management system.

(2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system.
) on July 30. To a lesser extent, this also reflects a decline in segment share versus the third quarter of the prior year. International Aranesp sales increased 3 percent to $358 million versus $347 million in the third quarter of 2006, due to changes in foreign exchange which positively impacted third quarter 2007 sales by approximately $24 million. In Europe, growth was negatively impacted by dosing conservatism in the oncology segment and price pressure across the ESA class. Excluding the impact of foreign exchange, worldwide Aranesp sales decreased 26 percent and international sales decreased 4 percent.

Sales of EPOGEN([R]) (Epoetin alfa e·po·e·tin al·fa
n.
A recombinant preparation of human erythropoietin used to treat some forms of anemia.


epoetin alfa

Epogen, Eprex (CA) (UK), Procrit

Pharmacologic class:
) decreased 5 percent to $602 million in the third quarter of 2007 versus $633 million in the third quarter of 2006. This was primarily driven by a decline in dose / utilization and increased discounts versus the third quarter of the prior year, partially offset by patient population growth of 3 percent. The decline in dose / utilization reflects reaction to regulatory and reimbursement developments throughout the year, including final KDOQI KDOQI Kidney Disease Outcomes Quality Initiative (National Kidney Foundation) [TM] guidelines, revised labeling and the pending EMP EMP
abbr.
electromagnetic pulse
 update.

Combined worldwide sales of Neulasta([R]) (pegfilgrastim) and NEUPOGEN([R]) (Filgrastim), increased 10 percent to $1,100 million in the third quarter of 2007 versus $998 million in the third quarter of 2006. Combined sales of Neulasta and NEUPOGEN in the U.S. were $830 million in the third quarter of 2007 versus $772 million in the third quarter of 2006, an increase of 8 percent primarily driven by favorable wholesaler inventory changes. Combined international sales increased 19 percent to $270 million in the third quarter of 2007 versus $226 million for the same quarter in the prior year, reflecting both increased conversion to Neulasta versus the third quarter of the prior year and changes in foreign exchange which positively impacted third quarter 2007 combined international sales by $18 million. Excluding the impact of foreign exchange, combined worldwide sales increased 8 percent and international product sales increased 12 percent.

Sales of Enbrel([R]) (etanercept) increased 16 percent in the third quarter of 2007 to $821 million versus $705 million during the same period in 2006 driven by an increase in demand due to increases in both patients and net sales Net Sales

The amount a seller receives from the buyer after costs associated with the sale are deducted.

Notes:
This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight
 price. Sales growth continued in both rheumatology rheumatology /rheu·ma·tol·o·gy/ (-tol´ah-je) the branch of medicine dealing with rheumatic disorders, their causes, pathology, diagnosis, treatment, etc.

rheu·ma·tol·o·gy
n.
 and dermatology, driven by segment growth that was partially offset by slight share declines versus the third quarter of the prior year. ENBREL continues to maintain a leading position in both segments.

Worldwide sales of Sensipar([R]) (cinacalcet HCl) increased 47 percent to $122 million in the third quarter of 2007 versus $83 million in the third quarter of 2006. This growth was principally driven by demand.

Vectibix(TM) (panitumumab) sales for the third quarter were $41 million as compared to $45 million in the second quarter of 2007. This decrease was primarily driven by reaction to unfavorable Panitumumab Advanced Colorectal Cancer colorectal cancer

Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat.
 Evaluation (PACCE PACCE Professional Association for Construction Computing Excellence LLC ) study results released late in the first quarter of 2007.

Operating Expense Operating Expense

The essential things that a company must purchase in order to maintain business.

Notes:
For example, the payment of employees wages are an operating expense.

Also known as OPEX.
 Analysis on an Adjusted Basis:

Cost of sales increased 21 percent to $585 million in the third quarter of 2007 versus $485 million in the third quarter of 2006. This increase was primarily driven by product mix, due to higher sales of ENBREL, which is more costly to manufacture, as well as certain other items. These include an excess capacity charge at the Company's manufacturing facility in Puerto Rico and the write-off of excess inventory primarily related to certain new product presentations. Excess capacity charges are expected to continue to occur through 2008. Cost of sales margin throughout this period is expected to be similar to the third quarter of 2007 due to excess capacity charges and product mix.

Research & Development (R&D) expenses decreased 16 percent to $699 million in the third quarter of 2007 versus $835 million in the third quarter of 2006. R&D expenses were lower primarily due to optimization of ongoing trials, lower in-licensing expenses primarily due to two deals in the third quarter of 2006 and the benefit derived from licensing denosumab in Japan to Daiichi Sankyo. R&D expenses are expected to increase in the fourth quarter versus the third quarter. For the full year, R&D expenses are expected to be below 2006 levels.

Selling, general and administrative (SG&A) expenses increased 3 percent to $804 million in the third quarter of 2007 versus $782 million in the third quarter of 2006. The increase was principally due to higher legal costs associated with ongoing litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 and higher Wyeth profit share expenses due to ENBREL sales growth partially offset by lower promotion and advertising spending on marketed products. SG&A expense growth was essentially flat year-over-year excluding higher Wyeth profit share expenses. As in the past, SG&A expenses are expected to increase in the fourth quarter versus the third quarter, though not as much as in 2006.

During the third quarter of 2007, adjusted EPS grew 4 percent while revenue remained unchanged. Adjusted EPS leverage of 4 percentage points for the third quarter was principally driven by fewer shares used in the computation of adjusted diluted EPS partially offset by higher interest expense.

Average diluted shares for adjusted EPS in the third quarter of 2007 were 1,089 million versus 1,174 million in the third quarter of 2006.

Capital expenditures for the third quarter of 2007 were approximately $306 million versus $376 million in the third quarter of 2006. Capital expenditures for the full year 2007 are expected to be approximately $1.4 billion versus $1.2 billion in the full year 2006. Worldwide cash and marketable securities Marketable Securities

Very liquid securities that can be converted into cash quickly at a reasonable price.

Notes:
Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has
 were $6.0 billion and debt was $11.3 billion at the end of the third quarter of 2007.

The Company reaffirmed its 2007 adjusted EPS guidance range of $4.13 to $4.23 excluding stock option expense and certain other expenses.

Third Quarter Product and Pipeline Update

The Company provided updates on selected late-stage clinical programs including Aranesp, Vectibix, ENBREL, romiplostim (formerly known as AMG AMG All Music Guide (music website)
AMG All Media Guide (group of media websites)
AMG All Movie Guide (Movie website)
AMG Arzneimittelgesetz (German Law) 
 531) and denosumab.

Aranesp: The Company provided an update on its discussions with regulatory agencies regarding product labeling revisions to its ESA products. The Company is working closely with the Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) to complete revisions to its U.S. labels based on both the Oncologics Drugs Advisory Committee (ODAC ODAC Old Dominion Athletic Conference
ODAC Oracle Data Access Components
ODAC Oil Depletion Analysis Centre
ODAC Oncologic Drugs Advisory Committee
ODAC Open Democracy Advice Centre
ODAC Open Document Architecture Consortium
ODAC Old Dominion Aquatic Club
) and Cardiovascular and Renal Drugs Advisory Committee (CRDAC) recommendations. As previously announced the European Medicines Agency's (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) Committee for Medicinal Products for Human Use “CHMP” redirects here. For French language Canadian radio station, see CHMP-FM.

CPMP, Committee for Proprietary Medicinal Products, now CHMP Committee for Medicinal Products for Human Use
 (CHMP CHMP Committee for Medicinal Products for Human Use
CHMP Cultural Heritage Management Plan
CHMP Centrale Humanitaire Médico-Pharmaceutique
CHMP Certified Hazardous Materials Practitioner (Institute of Hazardous Materials Managers) 
) has communicated a proposal for amending prescribing information for ESAs in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the

European Community
 (E.U.), including Aranesp. The proposed amendments are expected to be finalized by the end of the year.

Vectibix: The Company previously announced that the CHMP issued a positive opinion recommending Vectibix for conditional approval in the E.U. for patients with refractory metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.

Mentioned in: Coagulation Disorders


metastatic

pertaining to or of the nature of a metastasis.
 colorectal cancer (mCRC) with non-mutated (wild-type) KRAS KRAS Knowledge Representation for Autonomous Systems  genes. The Company will continue to integrate KRAS and other biomarker analyses into its ongoing clinical program studying Vectibix in earlier lines of mCRC therapy in combination with chemotherapy, as well as in other tumor types. As a result, the protocols of the Phase 3 studies of Vectibix in the treatment of 1st and 2nd line colorectal cancer are being amended. As part of these modifications, the Company plans to increase enrollment in both studies which will extend the completion of these studies versus previously planned timelines. These study changes are expected to allow the Company to assess the utility of Vectibix in patients with and without mutant KRAS-bearing tumors.

The Company also announced that they and the FDA have adopted changes to the U.S. prescribing information for Vectibix based on the results of the PACCE trial. The update is intended to highlight to clinicians the greater risk seen when Vectibix is combined with Avastin([R]) and the specific chemotherapy used in the PACCE trial to treat patients with 1st line mCRC. Vectibix is not indicated for the 1st line treatment of mCRC and the new safety information applies to an unapproved un·ap·proved  
adj.
Not approved or sanctioned: an unapproved vaccine; an unapproved protest march. 
 use of Vectibix.

ENBREL: The Company and Wyeth Pharmaceuticals, a division of Wyeth, have submitted a supplemental Biologics License Application (sBLA) to the FDA for the use of ENBREL in treating pediatric patients with chronic moderate to severe plaque psoriasis who have tried another therapy. If approved by the FDA, ENBREL is expected to be the first biologic, as well as the first systemic medication, indicated to treat this disease in pediatric patients.

Romiplostim (AMG 531): The Company has filed for FDA approval of romiplostim for the treatment of thrombocytopenia Thrombocytopenia Definition

Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets.
 in adult patients with chronic immune (idiopathic) thrombocytopenic purpura thrombocytopenic purpura
n.
See idiopathic thrombocytopenic purpura.
 (ITP ITP - Intent to Package ) and expects to file in the E.U., Canada and Australia by the end of 2007. Romiplostim successfully met all key endpoints in its pivotal Phase 3 studies and data from both studies as well as a long-term extension study will be presented at the American Society of Hematology (ASH) later this year.

Denosumab: Denosumab is still on target for review of the entire Postmenopausal post·men·o·paus·al
adj.
Of or occurring in the time following menopause.


postmenopausal Change of life Gynecology adjective Referring to the time in ♀ when menstrual periods stop for ≥ 1 yr
 Osteoporosis (PMO PMO Prime Minister's Office
PMO Premier Oil Plc (stock symbol)
PMO Pasteurized Milk Ordinance (USA Milk Industry)
PMO Provost Marshal's Office
PMO Postmenopausal Osteoporosis
) data set in the second half of 2008. The Company disclosed that its Phase 2 PMO study in Japan met its primary and secondary endpoints.

For more product information or the full prescribing information, please refer to the Amgen Web site at www.amgen.com.

As previously announced, the Company has posted in the Investors section of the Company's Web site (www.amgen.com/investors) a slide presentation related to its third quarter financial results conference call, scheduled for 2 p.m. Pacific Time today. The conference call will be broadcast over the Internet and can also be found on Amgen's Web site at the above web address.

Forward-Looking Statements

This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended Dec. 31, 2006, and in our periodic reports on Form 10-Q Form 10-Q

See 10-Q.
 and Form 8-K Form 8-K

The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock.


Form 8-K

See 8-K.
. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. The Company's results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments (domestic or foreign) involving current and future products, sales growth of recently launched products, competition from other products (domestic or foreign) and difficulties or delays in manufacturing our products. In addition, sales of our products are affected by reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and health care cost containment cost containment,
n the features of a dental benefits program or of the administration of the program designed to reduce or eliminate certain charges to the plan.
 as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects Side effects

Effects of a proposed project on other parts of the firm.
 or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers.

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease Kidney Disease Definition

Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease.
, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
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COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved.

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Publication:Business Wire
Article Type:Financial report
Date:Oct 24, 2007
Words:2938
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