Amgen's Second Quarter 2006 Adjusted Earnings Per Share, Excluding Stock Option Expense, Increased 19 Percent to $1.05; GAAP Earnings Per Share of 1 Cent Reflects $1.1 Billion One-Time Write-Off of In-Process R&D Related to Abgenix Acquisition.THOUSAND OAKS Thousand Oaks, residential city (1990 pop. 104,352), Ventura co., S Calif., in a farm area; inc. 1964. Avocados, citrus, vegetables, strawberries, and nursery products are grown. , Calif. -- Full Year Adjusted 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. Guidance Excluding Stock Option Expense Raised 15 Cents to $3.75 - $3.85; Revenues Grow 14 Percent to $3.6 Billion; International Sales up 18 Percent Excluding FX Impact 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), excluding stock option expense and certain other expenses, of $1.05 for the second quarter of 2006, an increase of 19 percent compared to 88 cents during the second quarter of 2005. Adjusted net income, excluding stock option expense and certain other expenses, increased 12 percent to $1.24 billion compared to $1.10 billion in the second quarter of 2005. Stock option expense on a per share basis totaled 4 cents in the second quarter of 2006 compared to 5 cents in the second quarter of 2005. Adjusted EPS including stock option expense was $1.01 for the second quarter of 2006, an increase of 22 percent compared to 83 cents in the second quarter of 2005. Total revenue increased 14 percent during the second quarter of 2006 to $3.60 billion from $3.17 billion in the second quarter of 2005. Adjusted EPS and adjusted net income for the three months ended June 30, 2006 and 2005 exclude certain expenses related to the acquisitions of Immunex, Tularik, and Abgenix, stock option expense, and certain other expenses. Adjusted EPS, including the impact of stock option expense, is itemized on the reconciliation tables below. On a reported basis and calculated in accordance Accordance is Bible Study Software for Macintosh developed by OakTree Software, Inc.[] As well as a standalone program, it is the base software packaged by Zondervan in their Bible Study suites for Macintosh. 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 GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). ), Amgen's EPS was 1 cent in the second quarter of 2006, down from 82 cents in the same quarter last year, substantially due to the write-off Write-Off A reduction in the value of an asset or earnings by the amount of an expense or loss. Companies are able to write off certain expenses that are required to run the business, or have been incurred in the operation of the business and detract from retained revenues. of acquired in-process research and development of $1.1 billion related to the acquisition of Abgenix which closed on April 1, 2006. Net income was $14 million in the second quarter of 2006 versus $1.0 billion in the second quarter of 2005. Effective January 1, 2006, Amgen began recording expense associated with employee stock options in accordance with the Statement of Financial Accounting Standards No. 123R. As a result, reported GAAP results for the second quarter of 2006 were negatively impacted by $63 million on a pre-tax basis. "I am pleased with our excellent financial performance in both the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and internationally," said Kevin Sharer, Chairman and Chief Executive Officer. "Execution of our important clinical programs continued at an aggressive pace, and we took meaningful actions to defend our intellectual property. Today we raised our adjusted EPS guidance for the year despite a significant increase in R&D investment. This reflects our confidence in our ongoing business performance." Product Sales Performance During the second quarter, total product sales increased 14 percent to $3.49 billion from $3.07 billion in the second quarter of 2005. Sales in the United States totaled $2.86 billion, an increase of 13 percent versus $2.53 billion for the second quarter of 2005. International sales increased 17 percent to $630 million versus $540 million for the second quarter of 2005. Excluding the impact of foreign exchange, total product sales increased 14 percent and international product sales increased 18 percent. Worldwide sales of Aranesp(R) (darbepoetin alfa darbepoetin alfa Aranesp Pharmacologic class: Recombinant human erythropoietin Therapeutic class: Hematopoietic Pregnancy risk category C FDA Boxed Warning) increased 26 percent to $1,055 million in the second quarter of 2006 versus $837 million during the second quarter of 2005. This growth was driven by demand. U.S. Aranesp sales increased 33 percent to $713 million versus $536 million in the prior year, driven by both segment growth and continued overall share gains. International Aranesp sales increased 14 percent to $342 million versus $301 million in the second quarter of 2005.Sales of EPOGEN E·po·gen A trademark for the drug epoetin alfa. epoetin alfa Epogen, Eprex (CA) (UK), Procrit Pharmacologic class: Recombinant human erythropoietin Therapeutic class: (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: ) declined 5 percent to $613 million in the second quarter of 2006 versus the second quarter of 2005, due to unfavorable wholesaler inventory changes and increased use of Aranesp in the hospital setting. Amgen believes that conversion to Aranesp in the hospital setting has stabilized sta·bi·lize v. sta·bi·lized, sta·bi·liz·ing, sta·bi·liz·es v.tr. 1. To make stable or steadfast. 2. as of the middle of this year. On June 30, 2006, the Company instituted a 1 percent price increase for EPOGEN. Underlying demand in free standing dialysis dialysis (dīăl`ĭsĭs), in chemistry, transfer of solute (dissolved solids) across a semipermeable membrane. Strictly speaking, dialysis refers only to the transfer of the solute; transfer of the solvent is called osmosis. clinics remained consistent with annual patient population growth of 3-4 percent. Combined worldwide sales of Neulasta(R) (pegfilgrastim pegfilgrastim Neulasta Pharmacologic class: Granulocytic colony stimulating factor Therapeutic class: Hematopoietic drug Pregnancy risk category C Action) and NEUPOGEN Neupogen® Filgrastim Oncology An agent used to ↓ neutrophil recovery time and duration of fever after chemotherapy for AML. See Acute myelogenous leukemia. (R) (Filgrastim filgrastim /fil·gras·tim/ (fil-gras´tim) a human granulocyte colony-stimulating factor produced by recombinant technology; used to enhance neutrophil function, stimulating hematopoiesis and decreasing neutropenia. ), increased 12 percent to $1,005 million in the second quarter of 2006 versus $899 million for the second quarter of 2005, driven by increased demand for Neulasta including the impact of a 2 percent U.S. price increase in April. Combined sales of Neulasta and NEUPOGEN in the United States were $785 million in the second quarter of 2006 versus $698 million in the second quarter of 2005, an increase of 12 percent. U.S. Neulasta sales continue to benefit from a label extension based on new clinical data demonstrating the value of first cycle use in moderate risk chemotherapy regimens Chemotherapy regimens are often identified with acronyms, identifying the agents used in combination. Unfortunately, the letters used are not consistent across regimens, and in some cases (for example, "BEACOPP") the same letter is used to represent two different treatments. . Combined international sales increased 9 percent to $220 million in the second quarter of 2006 versus $201 million for the same quarter in the prior year.North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. sales of Enbrel En·brel A trademark for the drug etanercept. etanercept Enbrel Pharmacologic class: Immunomodulator Therapeutic class: Antiarthritic Pregnancy risk category B (R) (etanercept etanercept /eta·ner·cept/ (e-tan´er-sept) a soluble tumor necrosis factor receptor that inactivates tumor necrosis factor, used in the treatment of rheumatoid arthritis. e·tan·er·cept n. ) increased 13 percent in the second quarter to $724 million versus $639 million during the same period in 2005, driven by underlying demand including the impact of a 4.9 percent U.S. price increase in May. Sales growth was impacted by slower than expected Dermatology dermatology (dûrmətŏl`əjē), branch of medicine concerned with diagnosis and treatment of diseases and disorders of the skin. segment growth and increased competitive pressure. ENBREL maintained its leading position in both the 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 the Dermatology segments. In June, the U.S. 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. ) approved our new Sureclick(TM) autoinjector for ENBREL which will greatly improve the ease of administration. This is a valuable enhancement for many patients, especially those with limited hand mobility or needle phobia phobia: see neurosis. phobia Extreme and irrational fear of a particular object, class of objects, or situation. A phobia is classified as a type of anxiety disorder (a neurosis), since anxiety is its chief symptom. . Worldwide sales of Sensipar(R) (cinacalcet HCl) increased 119 percent to $79 million in the second quarter of 2006 versus $36 million during the second quarter of 2005. This growth was also driven by demand including the impact of a 4.9 percent U.S. price increase in April. 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 decreased 7 percent to $492 million in the second quarter of 2006 versus $530 million in the second quarter of 2005, primarily driven by lower royalty expenses and to a lesser extent, production efficiencies. Royalty expenses were lower than the prior year driven by the expiration EXPIRATION. Cessation; end. As, the expiration of, a lease, of a contract, or statute. 2. In general, the expiration of a contract puts an end to all the engagements of the parties, except to those which arise from the non- fulfillment of obligations created of certain contractual royalty obligations on Neulasta and NEUPOGEN sales and the acquisition of certain royalty rights on sales of ENBREL and EU Neulasta and NEUPOGEN sales. For the remainder of 2006, Amgen expects cost of sales as a percent of sales to remain lower than 2005. Research and development (R&D) expenses increased 29 percent to $729 million in the second quarter versus $564 million in the second quarter of 2005. The second quarter increase was primarily due to higher staff levels and increased funding necessary to support clinical trials for our late-stage programs, including clinical material and manufacturing costs. Second quarter 2006 expenses fully reflect the impact of the Abgenix acquisition. The Company expects R&D expense growth rates Growth Rates The compounded annualized rate of growth of a company's revenues, earnings, dividends, or other figures. Notes: Remember, historically high growth rates don't always mean a high rate of growth looking into the future. to accelerate in the remainder of the year reflecting a full six months of the seven mega-trials (involving 200 or more sites) started in the first half of the year and additional mega-trials expected to start in the second half. Selling, general and administrative (SG&A) expenses increased 24 percent to $799 million in the second quarter versus $646 million in the second quarter of 2005, reflecting higher staff and additional infrastructure costs to support the growing organization, in particular our Global Enterprise Resource Planning See ERP. (application, business) Enterprise Resource Planning - (ERP) Any software system designed to support and automate the business processes of medium and large businesses. (ERP (Enterprise Resource Planning) An integrated information system that serves all departments within an enterprise. Evolving out of the manufacturing industry, ERP implies the use of packaged software rather than proprietary software written by or for one customer. ) program; 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 related to ENBREL sales. The Company expects moderation of the SG&A expense growth rate in the last half of the year. During the second quarter of 2006, adjusted EPS growth of 19 percent exceeded revenue growth of 14 percent by 5 percentage points. Earnings leverage was principally driven by fewer shares used in the computation Computation is a general term for any type of information processing that can be represented mathematically. This includes phenomena ranging from simple calculations to human thinking. of adjusted diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. EPS compared to the second quarter of 2005 and higher interest income. Amgen continues to expect its 2006 full year adjusted tax rate to be lower than in 2005 due to increased manufacturing in Puerto Rico Puerto Rico (pwār`tō rē`kō), island (2005 est. pop. 3,917,000), 3,508 sq mi (9,086 sq km), West Indies, c.1,000 mi (1,610 km) SE of Miami, Fla. and potential tax settlements. During the quarter, Amgen repurchased 13 million shares at a total cost $876 million, with year to date repurchases totaling 59.7 million shares at a total cost of $4.2 billion. In December 2005, Amgen's Board of Directors authorized au·thor·ize tr.v. au·thor·ized, au·thor·iz·ing, au·thor·iz·es 1. To grant authority or power to. 2. To give permission for; sanction: a new stock repurchase Stock repurchase A firm's repurchase of outstanding shares of its common stock. program of $5.0 billion. The Company currently has $2.3 billion remaining under its stock repurchase program. Average diluted shares for adjusted EPS were 1,181 million versus 1,250 million in the second quarter of 2005, reflecting the Company's aggressive share repurchases Share Repurchase A program by which a company buys back its own shares from the marketplace, reducing the number of outstanding shares. This is usually an indication that the company's management thinks the shares are undervalued. . Capital expenditures for the second quarter of 2006 were approximately $233 million versus $205 million in the second quarter of 2005 as the Company continued its manufacturing capacity and site expansions in Puerto Rico and other locations, and the ERP program and investments in the ERP program. 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 $5.0 billion at the end of the second quarter of 2006. The Company now expects 2006 adjusted EPS in the range of $3.75 to $3.85, excluding stock option expense and certain other expenses, up from the prior range of $3.60 to $3.70, based upon a favorable fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. product mix and lower cost of sales due to production efficiencies and reduced royalty obligations. The Company is also narrowing its revenue guidance range to $14.0 billion to $14.3 billion, from the previous range of $13.9 billion to $14.4 billion. Second Quarter Product and Pipeline Highlights The Company also highlighted research and development matters, including recent regulatory news, updates on selected late-stage clinical programs (Aranesp, Sensipar, panitumumab, denosumab, 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 AMG 706) and an early-stage pipeline update. AMG 706: Interim data from the Phase 2 study in gastrointestinal stromal tumors gastrointestinal stromal tumor GIST Surgical pathology A nonmucosal GI tumor most common in the stomach Clinical Benign–leiomyoma or malignant–leiomyosarcoma, determined histologically by ↑ mitotic activity and bizarre cells, findings seen in (GIST) became available during the second quarter and will be presented in the fourth quarter of this year. The Company's review of the data indicates evidence of clinical activity. Based on the preliminary assessment, median follow-up at the time of analysis was only ten months and at that point median survival had not been reached. The final overall analysis is still pending. The Company reported that it expects that the data will be included in any regulatory filing but that it cannot stand alone. Additionally, the Company announced that cholecystitis Cholecystitis Definition Cholecystitis refers to a painful inflammation of the gallbladder's wall. The disorder can occur a single time (acute), or can recur multiple times (chronic). and enlargement enlargement, n an increase in size. enlargement, Dilantin, n.pr See hyperplasia, gingival, Dilantin. enlargement, idiopathic, n of the gall bladder gall bladder, small pear-shaped sac that stores and concentrates bile. It is connected to the liver (which produces the bile) by the hepatic duct. When food containing fat reaches the small intestine, the hormone cholecystokinin is produced by cells in the intestinal have been observed in patients who have received AMG 706. Cholecystitis is inflammation inflammation, reaction of the body to injury or to infectious, allergic, or chemical irritation. The symptoms are redness, swelling, heat, and pain resulting from dilation of the blood vessels in the affected part with loss of plasma and leucocytes (white blood of the gall bladder and is commonly due to a gallstone gallstone: see gall bladder. gallstone Mass of crystallized substances that forms in the gallbladder. The most common type occurs when the liver secretes bile with too much cholesterol to stay in solution. that cannot pass through the neck, or cystic duct cystic duct n. The duct that leads from the gallbladder and joins the hepatic duct to form the common bile duct. , of the gall bladder. To date, approximately two to three percent of patients treated with AMG 706 alone or in combination with various other anti-cancer regimens have developed cholecystitis and these events have been managed with standard clinical practice. Ongoing studies are expected to continue, subject to protocol amendments. The Phase 3 studies in first-line breast cancer and first-line non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. (two of the planned eleven mega-trials) which were expected to start in the fourth quarter have been delayed. Denosumab: Three Phase 3 studies in oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. targeting skeletal-related events (Prostate Cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. , Breast Cancer and Solid Tumors) commenced during the second quarter. In addition, the head-to-head study versus alendronate alendronate /alen·dro·nate/ (ah-len´dro-nat) a bisphosphonate calcium-regulating agent used in the form of the sodium salt to inhibit the resorption of bone in the treatment of osteitis deformans, osteoporosis, and hypercalcemia related began enrolling as planned this quarter. In rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. (RA), data from a Phase 2 study measuring the impact of denosumab on bone erosions in RA has been submitted to the American College American College is the name of:
The Company also disclosed preliminary results from the latest review of its ongoing Phase 2 post-menopausal osteoporosis osteoporosis (ŏs'tēō'pərō`sĭs), disorder in which the normal replenishment of old bone tissue is severely disrupted, resulting in weakened bones and increased risk of fracture; osteopenia (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 ) dose-finding study remains on schedule and will complete in 2007. The Company has been able to review the three year data results from the study. The results are as expected and in-line with one-year and two-year results. The Company observed a continued increase in bone mineral density bone mineral density n. See bone density. bone mineral density A measurement of bone mass, expressed as the amount of mineral–in grams divided by the area scanned in cm2. See Bone densitometry. among patients who continued to receive denosumab and the safety profile remained consistent with previous data. The Company also noted that bone turnover increased and bone mineral density declined in patients for whom denosumab treatment was discontinued dis·con·tin·ue v. dis·con·tin·ued, dis·con·tin·u·ing, dis·con·tin·ues v.tr. 1. To stop doing or providing (something); end or abandon: , indicating that the denosumab effect was reversible reversible, adj capable of going through a series of changes in either direction, forward or backward (e.g., reversible chemical reaction). reversible hydrocolloid, n See hydrocolloid, reversible. . The Company is continuing to follow those patients who have discontinued treatment to document the extent of the decline in bone mineral density. Vectibix(TM) (panitumumab): In March, the Company completed the Biologic License Application (BLA BLA abbr. Bachelor of Liberal Arts ) submission with the FDA for Vectibix in 3rd line 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 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. (CRC (Cyclical Redundancy Checking) An error checking technique used to ensure the accuracy of transmitting digital data. The transmitted messages are divided into predetermined lengths which, used as dividends, are divided by a fixed divisor. ). This rolling BLA submission was initiated last December. The potential indication is for the treatment of metastatic colorectal cancer in patients who have failed prior chemotherapy chemotherapy (kē'mōthĕr`əpē), treatment of disease with chemicals or drugs. One chemotherapeutic approach is the development of selectively toxic substances, i.e. , including oxaliplatin- and irinotecan-containing regimens. The FDA has granted fast track status to Vectibix for this indication. In June, the FDA granted Priority Review of this BLA. The Company disclosed that their interactions to date with the FDA have been positive, the PDUFA PDUFA Prescription Drug User Fee Act of 1992 (USA) date is September 28th and they expect to obtain approval in the United States later this year with launch of Vectibix by year end. Additionally, outside the United States, marketing applications have been submitted to the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.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. ) and Health Canada Health Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health. Health Canada's goal is to improve Canadian life by improving Canadian longevity, lifestyle and use of public healthcare. in April, and Australia and Switzerland in May. The Company continues to enroll patients in its PACCE PACCE Professional Association for Construction Computing Excellence LLC study, a non-registration-enabling trial evaluating Vectibix in first-line treatment A first-line treatment or first-line therapy is a medical therapy recommended for the initial treatment of a disease, sign or symptom, usually on the basis of empirical evidence for its efficacy. of metastatic colorectal cancer. Patients are randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. to treatment with Avastin plus chemotherapy with or without Vectibix. The primary endpoint of this study is Progression Free Survival (PFS PFS, n post facilitation stretch; therapeutic approach utilized during proprioceptive neuromuscular facilitation in which the patient begins the stretch midway between the fully relaxed and fully stretched position and uses maximum level of effort to ), with secondary endpoints of Response Rate (RR), Overall Survival(OS) and Safety. To date the Company has enrolled over 900 of the target of 1,000 patients and expects enrollment to be completed by the end of the third quarter. As reported previously, the Company expects an initial analysis of response rate data, based on local assessment, to be available during the Company's 2006 year-end earnings Web cast in January 2007. Additionally, PFS data, the primary endpoint in this study, are expected to be available in second quarter 2007. Enrollment in the Phase 3 study in second line metastatic colorectal cancer began in the second quarter and enrollment in the Phase 3 study in first line metastatic colorectal cancer is expected to begin within the next few weeks. Phase 3 studies in CRC Adjuvant adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant) 1. assisting or aiding. 2. a substance that aids another, such as an auxiliary remedy. 3. , first line locally advanced Squamous Cell Cancer Squamous cell cancer A form of skin cancer that usually originates in sun-damaged areas or pre-existing lesions; at first local and superficial, it may later spread to other areas of the body. Mentioned in: Cryotherapy of the Head and Neck (SCCHN SCCHN Squamous Cell Cancer of the Head and Neck ) and first line Recurrent recurrent /re·cur·rent/ (re-kur´ent) [L. recurrens returning] 1. running back, or toward the source. 2. returning after remissions. re·cur·rent adj. 1. or Metastatic Squamous squamous /squa·mous/ (skwah´mus) scaly or platelike. squa·mous or squa·mose adj. 1. Covered with or formed of scales; scaly. 2. SCCHN have been slightly delayed from the timelines This article or section contains self-references. For other uses of "Timeline", see Timeline (disambiguation). The following is an index of timelines found on Wikipedia. previously disclosed. First line locally advanced SCCHN and first line Recurrent or Metastatic SCCHN have been delayed by one and two quarters, respectively, in order to respond to changes in the competitive marketplace in the head and neck setting. The CRC Adjuvant study, the Company's co-operative study with the National Surgical Adjuvant Breast and Bowel bowel: see intestine. Project (NSABP NSABP National Surgical Adjuvant Breast Project Oncology A series of ongoing multicenter clinical trials evaluating the effects of various therapies, including RT, surgery and chemotherapy–eg, tamoxifen and 5-FU, in treating advanced breast or colorectal CAs ) group, has been delayed by a quarter as the Company works with the NSABP group on specific features of the trial design. AMG 531: Enrollment in both Phase 3 studies in immune thrombocytopenic purpura immune thrombocytopenic purpura n. See idiopathic thrombocytopenic purpura. immune thrombocytopenic purpura Idiopathic thrombocytopenic purpura, see there (ITP ITP - Intent to Package ) has been completed and are expected to conclude in late 2006 with database locks expected by early 2007. The Company has previously received fast track designation from the FDA. Aranesp: Enrollment in the Phase 3 RED-HF(TM) (Reduction of Events with Darbepoetin alfa in Heart Failure) Trial began in the second quarter. The RED-HF trial is a randomized, double-blind, placebo-controlled, multicenter and multinational study to evaluate the effect of treatment of anemia anemia (ənē`mēə), condition in which the concentration of hemoglobin in the circulating blood is below normal. Such a condition is caused by a deficient number of erythrocytes (red blood cells), an abnormally low level of hemoglobin with Aranesp on morbidity and mortality Morbidity and Mortality can refer to:
1. pertaining to or of the nature of a symptom. 2. indicative (of a particular disease or disorder). 3. heart failure. Enrollment continues in the Company's TREAT (Trial to Reduce Cardiovascular cardiovascular /car·dio·vas·cu·lar/ (-vas´ku-ler) pertaining to the heart and blood vessels. car·di·o·vas·cu·lar adj. Abbr. Events with Aranesp(R) Therapy) trial, the first randomized controlled trial A randomized controlled trial (RCT) is a scientific procedure most commonly used in testing medicines or medical procedures. RCTs are considered the most reliable form of scientific evidence because it eliminates all forms of spurious causality. specifically designed to determine whether treating anemia reduces cardiovascular events in individuals with chronic kidney disease Chronic kidney disease (CKD), also know as chronic renal disease, is a progressive loss of renal function over a period of months or years through five stages. Each stage is a progression through an abnormally low and progressively worse glomerular filtration rate, which is (CKD See count-key-data. ) and Type 2 diabetes type 2 diabetes n. See diabetes mellitus. . To date, over 2,250 patients have been enrolled towards the target of 4,000 patients and it is expected that enrollment will continue beyond year end. To this point, the rate of event occurrences is on track to achieve the planned timelines. Additionally, enrollment was completed in the Phase 3 anemia of cancer study for which the primary endpoint is to evaluate the effect of Aranesp for treatment of anemia in cancer patients that are not undergoing chemotherapy. Results are expected to be available in the first half of 2007 with a full presentation at the American Society of Hematology hematology Branch of medicine concerned with the nature, function, and diseases of the blood. It covers the cellular and serum composition of blood, the coagulation process, blood-cell formation, hemoglobin synthesis, and disorders of all these. (ASH) in late 2007. Sensipar: Data from the Phase 3 study for use in secondary hyperparathyroidism secondary hyperparathyroidism Endocrinology ↑ Parathyroid activity with overproduction of PTH due to parathyroid hyperplasia in response to an extraparathyroid defect that results in ↓ Ca2+ Etiology Rickets, vitamin D deficiency, chronic renal failure of chronic renal insufficiency renal insufficiency A defect in renal ability to 'clear' waste products, a sign of inadequate glomerular filtration (stage 3 and 4 CKD) will be available by the end of this year. Additionally, the Phase 3 trial E.V.O.L.V.E. (EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events) has been initiated. The E.V.O.L.V.E. Trial is the largest international, prospective clinical outcomes study to determine whether Sensipar(R)/Mimpara(R) (cinacalcet HCl) can effectively reduce the risk of mortality and morbidity morbidity /mor·bid·i·ty/ (mor-bid´it-e) 1. a diseased condition or state. 2. the incidence or prevalence of a disease or of all diseases in a population. mor·bid·i·ty n. in patients with stage five chronic kidney disease (CKD) undergoing maintenance dialysis. The trial is expected to enroll 3,800 patients and enrollment is expected to begin later this year. Early-Stage Pipeline Update: The Company announced that it continues to make progress advancing its early-stage pipeline. Since the start of 2006, five new molecules, two in oncology solid tumors, two for diabetes and one for idiopathic pulmonary fibrosis idiopathic pulmonary fibrosis Idiopathic interstitial fibrosis of lung Pulmonology An idiopathic condition characterized by scarring and fibrosis of alveolar septae more common in middle-aged men, possibly related to collagen vascular disease, with positive have been advanced into clinical development. Additionally, two new molecules, one for diabetes and one for pain, have entered the clinic for introduction into humans. During this period, three early-stage programs have been terminated. 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 Investor section of the Company's Web site (www.amgen.com/investors) a slide presentation related to its second quarter financial results conference call, scheduled for 2 p.m. Pacific Daylight 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 forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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 December 31, 2005, 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, sales growth of recently launched products, difficulties or delays in manufacturing our products, and regulatory developments (domestic or foreign) involving current and future products and manufacturing facilities. In addition, sales of our products are affected by reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. policies imposed by second party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare 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 possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government 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 Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities . We, or others could identify 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. 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. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated in·val·i·date tr.v. in·val·i·dat·ed, in·val·i·dat·ing, in·val·i·dates To make invalid; nullify. in·val or circumvented by our competitors. 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 therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. . 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 broad and deep 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. EDITOR'S NOTE Editor's Note (foaled in 1993 in Kentucky) is an American thoroughbred Stallion racehorse. He was sired by 1992 U.S. Champion 2 YO Colt Forty Niner, who in turn was a son of Champion sire Mr. Prospector and out of the mare, Beware Of The Cat. Trained by D. : An electronic version of this news release may be accessed via our Web site at www.amgen.com. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Media section of the Web site. Appendix I
Amgen Inc.
Condensed Consolidated Statements of Operations and
Reconciliation of GAAP Earnings to "Adjusted" Earnings -- Excluding
Stock Option Expense
(In millions, except per share data)
(Unaudited)
Three Months Ended
June 30, 2006
----------------------------------
"Adjusted",
Excluding
Stock
Option
GAAP Adjustments Expense
----------------------------------
Revenues:
Product sales $3,491 $ - $3,491
Other revenues 113 - 113
------ ------- ------
Total revenues 3,604 - 3,604
Operating expenses:
Cost of sales (excludes
amortization of acquired
intangible assets presented
below) 493 (1)(1) 492
Research and development 788 (28)(1) 729
(16)(2)
(12)(3)
(3)(4)
Selling, general and
administrative 840 (34)(1) 799
(7)(3)
Write-off of acquired in-process
R&D 1,101 (1,101)(5) -
Amortization of intangible assets 87 (87)(6) -
Legal settlements - - -
------ ------- ------
Total operating expenses 3,309 (1,289) 2,020
Operating income 295 1,289 1,584
Interest and other income
(expense), net 21 - 21
------ ------- ------
Income before income taxes 316 1,289 1,605
Provision for income taxes 302 68 (10) 370
------ ------- ------
Net income $ 14 $ 1,221 $1,235
====== ======= ======
Earnings per share:
Basic $ 0.01 $ 1.05
Diluted (11) $ 0.01 $ 1.05 (12)
Shares used in calculation of
earnings per share:
Basic 1,173 1,173
Diluted (11) 1,185 1,181
Three Months Ended
June 30, 2005
----------------------------------
"Adjusted",
Excluding
Stock
Option
GAAP Adjustments Expense
----------------------------------
Revenues:
Product sales $3,072 $ - $3,072
Other revenues 100 - 100
------ ----- ------
Total revenues 3,172 - 3,172
Operating expenses:
Cost of sales (excludes
amortization of acquired
intangible assets presented
below) 530 - 530
Research and development 567 (3)(4) 564
Selling, general and
administrative 646 - 646
Write-off of acquired in-process
R&D - - -
Amortization of intangible assets 87 (87)(6) -
Legal settlements 49 (49)(7) -
------ ----- ------
Total operating expenses 1,879 (139) 1,740
Operating income 1,293 139 1,432
Interest and other income
(expense), net 6 (20)(8) (14)
------ ----- ------
Income before income taxes 1,299 119 1,418
Provision for income taxes 270 44 (10) 314
------ ----- ------
Net income $1,029 $ 75 $1,104
====== ===== ======
Earnings per share:
Basic $ 0.83 $ 0.90
Diluted (11) $ 0.82 $ 0.88 (12)
Shares used in calculation of
earnings per share:
Basic 1,233 1,233
Diluted (11) 1,250 1,250
(1)-(12) See explanatory notes on following pages.
Amgen Inc.
Condensed Consolidated Statements of Operations and
Reconciliation of GAAP Earnings to "Adjusted" Earnings -- Excluding
Stock Option Expense
(In millions, except per share data)
(Unaudited)
Six Months Ended
June 30, 2006
----------------------------------
"Adjusted",
Excluding
Stock
Option
GAAP Adjustments Expense
----------------------------------
Revenues:
Product sales $6,618 $ - $6,618
Other revenues 203 - 203
------ ------- ------
Total revenues 6,821 - 6,821
Operating expenses:
Cost of sales (excludes
amortization of acquired
intangible assets presented
below) 1,045 (1)(1) 1,044
Research and development 1,443 (57)(1) 1,353
(16)(2)
(12)(3)
(5)(4)
Selling, general and
administrative 1,529 (71)(1) 1,451
(7)(3)
Write-off of acquired in-process
R&D 1,101 (1,101)(5) -
Amortization of intangible assets 174 (174)(6) -
Legal settlements - - -
------ ------- ------
Total operating expenses 5,292 (1,444) 3,848
Operating income 1,529 1,444 2,973
Interest and other income
(expense), net 101 - 101
------- ---------- --------
Income before income taxes 1,630 1,444 3,074
Provision for income taxes 615 123 (10) 738
------ ------- ------
Net income $1,015 $ 1,321 $2,336
====== ======= ======
Earnings per share:
Basic $ 0.85 $ 1.97
Diluted (11) $ 0.84 $ 1.95 (12)
Shares used in calculation of
earnings per share:
Basic 1,188 1,188
Diluted (11) 1,202 1,198
Six Months Ended
June 30, 2005
----------------------------------
"Adjusted",
Excluding
Stock
Option
GAAP Adjustments Expense
----------------------------------
Revenues:
Product sales $5,807 $ - $5,807
Other revenues 198 - 198
------ ----- ------
Total revenues 6,005 - 6,005
Operating expenses:
Cost of sales (excludes
amortization of acquired
intangible assets presented
below) 1,019 - 1,019
Research and development 1,091 (6)(4) 1,085
Selling, general and
administrative 1,223 - 1,223
Write-off of acquired in-process
R&D - - -
Amortization of intangible assets 174 (174)(6) -
Legal settlements 49 (49)(7) -
------ ----- ------
Total operating expenses 3,556 (229) 3,327
Operating income 2,449 229 2,678
Interest and other income
(expense), net (4) (20)(8) (4)
20 (9)
------- ----- -------
Income before income taxes 2,445 229 2,674
Provision for income taxes 562 84 (10) 646
------ ----- ------
Net income $1,883 $ 145 $2,028
====== ===== ======
Earnings per share:
Basic $ 1.52 $ 1.63
Diluted (11) $ 1.49 $ 1.60 (12)
Shares used in calculation of
earnings per share:
Basic 1,241 1,241
Diluted (11) 1,270 1,270
(1)-(12) See explanatory notes on following pages.
Amgen Inc.
Notes to Reconciliation of GAAP Earnings to "Adjusted" Earnings --
Excluding Stock Option Expense
(In millions, except per share data)
(Unaudited)
(1) To exclude the impact of stock option expense in accordance with
Statement of Financial Accounting Standards ("SFAS") No. 123R.
Effective January 1, 2006, Amgen adopted SFAS No. 123R and
elected not to apply this new accounting standard to its prior
years' financial statements. Prior to such date, Amgen disclosed
in the notes to its financial statements what the related expense
and impact to earnings per share (EPS) would have been (i.e., on
a pro forma basis) had it elected to expense the fair value of
employee stock options in accordance with SFAS No. 123. For the
three and six months ended June 30, 2005, the total pro forma
pre-tax expense for all employee stock options in accordance with
SFAS No. 123 was $66 million and $137 million, respectively,
resulting in dilution to GAAP EPS of 5 cents and 11 cents per
share, respectively, on a pro forma basis.
(2) To exclude the ongoing, non-cash amortization of the intangible
asset, XenoMouse(R) technology, acquired with the Abgenix, Inc.
("Abgenix") acquisition. The annual non-cash charge for 2006 is
currently estimated to be approximately $48 million, pre-tax.
(3) To exclude the incremental compensation provided to certain
Abgenix employees associated with their retention. Substantially
all related amounts have been incurred.
(4) To exclude the incremental compensation provided to certain
Tularik Inc. ("Tularik") employees associated with their
retention. The total estimated remaining costs of such
incremental compensation is approximately $7 million, pre-tax.
(5) To exclude the non-cash expense associated with writing off the
acquired in-process research and development related to the
Abgenix acquisition.
(6) To exclude the ongoing, non-cash amortization of acquired
intangible assets, primarily ENBREL, related to the Immunex
Corporation ("Immunex") acquisition. The annual non-cash charge
for 2006 is currently estimated to be approximately $347 million,
pre-tax.
(7) To exclude the impact of legal settlements incurred, net of
amounts previously accrued, primarily related to settling a
patent legal proceeding.
(8) To exclude the net gain realized on the termination of a
manufacturing agreement with Genentech, Inc. ("Genentech")
for the production of ENBREL at Genentech's manufacturing
facility in South San Francisco.
(9) To exclude the pro rata portion of the debt issuance costs that
were immediately charged to interest expense as a result
of certain holders of the convertible notes due in 2032
exercising their March 1, 2005 put option and the related
convertible notes being repaid in cash.
(10) To reflect the tax effect of the above adjustments, except for
the non-tax write-off of the acquired in-process research and
development related to the Abgenix acquisition. (see (5) above).
(11) The following table presents the computations for GAAP and
"Adjusted" diluted earnings per share, excluding stock option
expense, computed under the treasury stock and the "if-converted"
methods:
Three Months Ended Three Months Ended
June 30, 2006 June 30, 2005
---------------------- -------------------
"Adjusted",
"Adjusted", Excluding
Excluding Stock
Stock Option Option
GAAP Expense GAAP Expense
---------------------- -------------------
Income (Numerator):
Net income for basic EPS $ 14 $ 1,235 $1,029 $ 1,104
Adjustment for interest
expense on convertible
notes, net of tax (A) - - 1 1
------ --------- ------ ----------
Net income for diluted
EPS, after assumed
conversion of
convertible notes $ 14 $ 1,235 $1,030 $ 1,105
====== ========= ====== ==========
Shares (Denominator):
Weighted-average shares
for basic EPS 1,173 1,173 1,233 1,233
Effect of dilutive
securities 12 8 (B) 9 9
Effect of convertible
notes, after assumed
conversion (A) - - 8 8
------ --------- ------ ----------
Weighted-average shares
for diluted EPS 1,185 1,181 1,250 1,250
====== ========= ====== ==========
Diluted earnings per share $ 0.01 $ 1.05 $ 0.82 $ 0.88
====== ========= ====== ==========
Six Months Ended Six Months Ended
June 30, 2006 June 30, 2005
---------------------- -------------------
GAAP "Adjusted" GAAP "Adjusted"
------------------ -------------------
Income (Numerator):
Net income for basic EPS $1,015 $ 2,336 $1,883 $ 2,028
Adjustment for interest
expense on convertible
notes, net of tax (A) - - 6 6
------ --------- ------ ----------
Net income for diluted
EPS, after assumed
conversion of
convertible notes $1,015 $ 2,336 $1,889 $ 2,034
====== ========= ====== ==========
Shares (Denominator):
Weighted-average shares
for basic EPS 1,188 1,188 1,241 1,241
Effect of dilutive
securities 14 10 (B) 10 10
Effect of convertible
notes, after assumed
conversion (A) - - 19 19
------ --------- ------ ----------
Weighted-average shares
for diluted EPS 1,202 1,198 1,270 1,270
====== ========= ====== ==========
Diluted earnings per share $ 0.84 $ 1.95 $ 1.49 $ 1.60
====== ========= ====== ==========
(A) On May 6, 2005 and August 17, 2005, in connection with an exchange
offer, we modified the terms of substantially all of our
convertible notes due in 2032. As a result, if converted, these
convertible notes would be settled in 1) cash equal to the lesser
of their accreted value at the conversion date or the conversion
value, as defined, and 2) shares of common stock, if any, to the
extent the conversion value exceeds the accreted value.
Accordingly, the convertible notes due in 2032 do not impact
diluted earnings per share under the "if-converted" method but
rather, they impact diluted earnings per share under the treasury
stock method, and only to the extent that the conversion value
exceeds the accreted value during any reporting period, requiring
such difference, if any, to be potentially settled in shares of
common stock.
(B) Dilutive securities used to compute "Adjusted" diluted earnings
per share for the three and six months ended June 30, 2006 were
computed exclusive of the methodology used to determine dilutive
securities under SFAS No. 123R.
(12) "Adjusted" diluted earnings per share including the impact of
stock option expense for the three and six months ended June 30,
2006 and 2005 is as follows:
Three Months Ended Six Months Ended
June 30, June 30,
------------------ -----------------
2006 2005 2006 2005
-------- ------ ------- ------
"Adjusted" EPS, excluding
stock option expense $ 1.05 $ 0.88 $ 1.95 $ 1.60
Impact of stock option expense (0.04) (0.05) (0.08) (0.11)
------- ------ ------ ------
"Adjusted" EPS, including
stock option expense $ 1.01 $ 0.83 $ 1.87 $ 1.49
======= ====== ====== ======
Amgen Inc.
Product Sales Detail by Product and Geographic Region
(In millions)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
------------------ ----------------
2006 2005 2006 2005
--------- ------ ------- ------
Aranesp(R) - U.S. $ 713 $ 536 $1,309 $ 983
Aranesp(R) - International 342 301 639 577
EPOGEN(R) - U.S. 613 647 1,217 1,230
Neulasta(R) - U.S. 579 490 1,076 906
NEUPOGEN(R) - U.S. 206 208 397 390
Neulasta(R) - International 122 97 233 182
NEUPOGEN(R) - International 98 104 195 216
Enbrel(R) - U.S. 685 614 1,314 1,184
Enbrel(R) - International 39 25 68 47
Sensipar(R) - U.S. 57 28 102 52
Sensipar(R) - International 22 8 38 11
Other product sales - U.S. 8 9 17 18
Other product sales -
International 7 5 13 11
--------- ------ ------- ------
Total product sales $ 3,491 $3,072 $6,618 $5,807
========= ====== ======= ======
U.S. $ 2,861 $2,532 $5,432 $4,763
International (1) 630 540 1,186 1,044
--------- ------ ------- ------
Total product sales (1) $ 3,491 $3,072 $6,618 $5,807
========= ====== ======= ======
(1) For the second quarter of 2006, the change in foreign exchange
rates from the second quarter of 2005 negatively impacted product
sales by $9 million. Excluding this impact, total product sales
would have increased 14% and international product sales would
have increased 18% over the prior year amounts.
Amgen Inc.
Condensed Consolidated Balance Sheets -- GAAP
(In millions)
(Unaudited)
June 30, December 31,
2006 2005
----------- ------------
Assets
Current assets:
Cash and marketable securities $ 4,970 $ 5,255
Trade receivables, net 2,018 1,769
Inventories 1,520 1,258
Other current assets 995 953
------- --------
Total current assets 9,503 9,235
Property, plant, and equipment, net 5,438 5,038
Intangible assets, net 3,965 3,742
Goodwill 11,210 10,495
Other assets 1,172 787
------- --------
Total assets $31,288 $ 29,297
======= ========
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $ 4,145 $ 3,595
Convertible notes 1,768 (1) -
------- --------
Total current liabilities 5,913 3,595
Deferred tax liabilities 1,064 1,163
Convertible notes 5,000 (2) 1,759 (1)
Other long-term debt 2,232 2,198
Other non-current liabilities 240 131
Stockholders' equity 16,839 20,451
------- --------
Total liabilities and stockholders'
equity $31,288 $ 29,297
======= ========
Shares outstanding 1,170 1,224
(1) Holders of our outstanding convertible notes due in 2032 may
require the Company to purchase all or a portion of the notes on
specific dates as early as March 1, 2007 at the original issuance
price plus accrued original issue discount through the purchase
date. Accordingly, as of June 30, 2006, these convertible notes
have been classified as current liabilities.
Holders of these notes also had the right to require the Company
to purchase all or a portion of the notes on March 1, 2006.
However, because the holders of substantially all of the then
outstanding convertible notes did not require us to repurchase
such notes on this date, these convertible notes were classified
as non-current liabilities at December 31, 2005.
(2) In February 2006 we issued $2.5 billion of convertible notes due
in 2011 and $2.5 billion of convertible notes due in 2013.
Amgen Inc.
Reconciliation of "Adjusted" Earnings Per Share Guidance to GAAP
Earnings Per Share Guidance for the Year Ended December 31, 2006
2006
--------------
"Adjusted" earnings per share guidance -- excluding
stock option expense $3.75 - $3.85
Known adjustments to arrive at GAAP earnings:
Amortization of acquired intangible assets --
Primarily ENBREL (1) (0.18)
Tularik merger-related incremental compensation (2) (0.01)
Stock option expense (3) (0.12 - 0.14)
Write-off of Abgenix acquired in-process R&D (4) (0.92)
Amortization of acquired intangible assets,
XenoMouse(R) technology (5) (0.02)
Abgenix merger-related incremental compensation (6) (0.01)
--------------
GAAP earnings per share guidance $2.47 - $2.59
--------------
(1) To exclude the ongoing, non-cash amortization of acquired
intangible assets, primarily ENBREL, related to the Immunex
acquisition. The total 2006 annual non-cash charge is currently
estimated to be approximately $347 million, pre-tax.
(2) To exclude the incremental compensation provided to certain
Tularik employees associated with their retention.
(3) To exclude the estimated stock option expense associated with
Amgen's adoption of SFAS No. 123R on January 1, 2006.
(4) To exclude a one-time expense associated with writing off acquired
in-process research and development incurred with the acquisition
of Abgenix on April 1, 2006.
(5) To exclude the ongoing, non-cash amortization of the intangible
asset, XenoMouse(R) technology, acquired with the Abgenix
acquisition. The annual non-cash charge for 2006 is currently
estimated to be approximately $48 million, pre-tax.
(6) To exclude the incremental compensation provided to certain
Abgenix employees associated with their retention.
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