Amgen announces 27 percent increase in earnings per share.THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Oct. 19, 1995--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) Thursday announced that its earnings per share for the third quarter ending Sept. 30 increased by 27 percent, to 52 cents from 41 cents for the same quarter a year ago. Net income was up 28 percent, to $145 million from $114 million for the same quarter a year ago, and revenues increased 16 percent to $493 million from $426 million. Earnings per share increased by 25 percent for the nine-month period ending Sept. 30, to $1.40 from $1.12 for the same period a year ago. Net income also increased by 25 percent for the nine-month period, to $392 million from $315 million, and revenues were up 18 percent, to $1.426 billion from $1.205 billion. To develop its expanding product pipeline, Amgen increased its investment in research and development to a total of 23 percent of sales, an increase of 29 percent over the same quarter a year ago, to $106 million from $82 million. For the third quarter, 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: ) increased 23 percent, to $230 million from $187 million for the same quarter a year ago. Worldwide sales of NEUPOGEN (R) (Filgrastim) increased by 7 percent, to $230 million from $215 million. U.S. NEUPOGEN sales increased to $164 million from $160 million, while international NEUPOGEN sales increased to $67 million from $55 million for the same quarter a year ago. These results have been influenced by extensive wholesaler purchasing just before the July 4 holiday which created an artificially high inventory level at the end of the second quarter, suppressing the increase in domestic third-quarter sales of NEUPOGEN (R). While domestic NEUPOGEN growth has been slowing over the past several years, underlying demand in the third quarter remained essentially the same as that in the second quarter. "For some time, health care providers have been encountering increasing cost reduction pressure because of managed care and guidelines, and these pressures are intensifying. We continue to invest heavily in defining both NEUPOGEN's benefits in oncology as well as its future role in a variety of new clinical settings and market opportunities, including HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. and other infectious diseases," said Gordon Binder, chairman and chief executive officer. PRODUCT DEVELOPMENT Several significant product development events also occurred during the quarter. These include a preliminary analysis of results of a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of NEUPOGEN in Community Acquired Pneumonia (CAP). The 756-patient study of NEUPOGEN with antibiotics compared with antibiotic therapy alone in patients with moderate pneumonia did not meet its primary endpoint of time to resolution of morbidity (TRM). It did, however, demonstrate a statistically significant benefit in patients receiving NEUPOGEN in eliminating chest X-ray chest x-ray, n an examination of the chest using x-rays. Routinely performed in patients complaining of chest pain to rule out respiratory or heart disease. chest X-ray Chest film, see there signs of pneumonia. The trial also demonstrated that in those patients receiving NEUPOGEN, there were statistically significant clinical benefits relating to two serious complications of pneumonia: reducing the incidence of end organ end organ n. The encapsulated termination of a sensory nerve. end organ, n the expanded termination of a nerve fiber in muscle, skin, mucous membrane, or other structure. failures and reducing the incidence of Adult Respiratory Distress Syndrome Adult Respiratory Distress Syndrome Definition Adult respiratory distress syndrome (ARDS), also called acute respiratory distress syndrome, is a type of lung (pulmonary) failure that may result from any disease that causes large amounts of fluid to (ARDS Ards District (pop., 2001: 73,244), Northern Ireland. Formerly part of County Down, Ards was established as a district in 1973. Much of its land is devoted to crops and pasture. Newtownards, settled c. 1608 by Scots, is its administrative seat and manufacturing centre. ). ARDS is a respiratory emergency in which the patient has respiratory insufficiency or failure. This trial did not show significant benefit in other secondary endpoints. In a recent, small Phase I/II study in patients with severe pneumonia, patients taking NEUPOGEN in combination with antibiotics demonstrated a mortality benefit over those taking antibiotics alone. Consistent with the results of this trial and numerous preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. , a subset of patients in the Phase III trial with more severe pneumonia also demonstrated a mortality benefit, although there was no mortality difference for all patients. Amgen said it will initiate a Phase III clinical trial this winter to confirm mortality benefit in patients with severe pneumonia and to more clearly delineate the benefits of NEUPOGEN in this seriously ill patient population, which, in this country alone, may number more than 150,000. In addition, Amgen said that the FDA's Biological Response Modifiers biological response modifiers, n.pl substances such as phytochemicals and fibers that modulate mech-anisms related to the development of disease, such as hormonal changes, immune function, inflammatory activity, oxidative stress, and home-ostasis. Advisory Committee has scheduled a November 13 meeting at which the agency will review Amgen's request to expand the package insert package insert Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific for NEUPOGEN to include mobilization of peripheral blood progenitor cells (PBPC PBPC Peripheral Blood Progenitor Cell PBPC Palm Beach Photographic Centre (Delray Beach, FL) PBPC Pneumatic Back-Up Pressure Control PBPC Pseudo-Random Binary Phased-Code ). In comparison with autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. bone marrow, PBPC is believed to provide more rapid neutrophil neutrophil /neu·tro·phil/ (noo´tro-fil) 1. a granular leukocyte having a nucleus with three to five lobes connected by threads of chromatin, and cytoplasm containing very fine granules; cf. heterophil. 2. and platelet recovery following myeloablative or myelosuppressive chemotherapy. The Company also has filed for regulatory approval in Europe to include the use of NEUPOGEN (R) in treating neutropenia Neutropenia Definition Neutropenia is an abnormally low level of neutrophils in the blood. Neutrophils are white blood cells (WBCs) produced in the bone marrow that ingest bacteria. due to myelosuppressive medications in patients with HIV infection. In developments relating to two late-stage pipeline products, Amgen announced that it has begun Phase III trials of Brain- Derived Neurotrophic Factor (BDNF BDNF Brain-Derived Neurotrophic Factor BDNF Beaverhead-Deerlodge National Forest (Montana) ) in Amyotrophic Lateral Sclerosis amyotrophic lateral sclerosis (ALS) (ā'mīətrōf`ik, sklĭrō`sĭs) or motor neuron disease, (ALS Als (äls), Ger. Alsen, island, 121 sq mi (313 sq km), Sønderjylland co., S Denmark, in the Lille Bælt, separated from the mainland by the narrow Alensund. ) and of Stem Cell Factor stem cell factor n. A cytokine that promotes the differentiation and growth of hematopoietic stem cells into other types of cells. (SCF SCF Service Canadien des Forêts (Canadian Forest Service) SCF Stem Cell Factor SCF Scientific Committee on Food (European Commission) SCF Service Canadien de la Faune ) in combination with NEUPOGEN for mobilizing progenitor cells in the treatment of cancer. Amgen also said it will file a Product License Application (PLA (Programmable Logic Array) A type of programmable logic chip (PLD) that contained arrays of programmable AND and OR gates. PLAs are no longer used. See PLD. (language, music) Pla - A high-level music programming language, written in SAIL. ) for INFERGEN (R) to treat chronic hepatitis C. Amgen is a global biotechnology company that discovers, develops, manufactures and markets human therapeutics based on advanced cellular and molecular biology. -0-
AMGEN INC.
Condensed Consolidated Statements of Operations
(In millions, except per-share data)
(Unaudited)
Three months ended Nine months ended
Sept. 30, Sept. 30,
1995 1994 1995 1994
Revenues:
Product sales $460.6 $401.7 $1,334.4 $1,136.0
Corporate partner revenues 23.8 16.9 65.1 49.7
Royalty income 8.9 7.7 26.9 19.3
Total revenues 493.3 426.3 1,426.4 1,205.0
Operating expenses: Cost of sales 64.1 59.1 207.1 176.8 Research and development 105.5 81.7 327.7 235.6 Marketing and selling 69.1 61.9 197.8 174.7 General and administrative 37.6 31.9 106.8 90.4 Loss of affiliates, net 15.2 9.8 41.2 25.6 Total operating expenses 291.5 244.4 880.6 703.1 Operating income 201.8 181.9 545.8 501.9 Other income/(expense): Interest and other income 15.4 6.8 46.7 16.0 Interest expense, net (3.6) (3.3) (11.2) (8.7) Total other income/(expense) 11.8 3.5 35.5 7.3 Income before income taxes 213.6 185.4 581.3 509.2 Provision for income taxes 67.8 71.4 189.2 194.3 Net income $145.8 $114.0 $ 392.1 $ 314.9 Earnings per share: Primary earnings per share $ 0.52 $ 0.41 $ 1.40 $ 1.12 Fully diluted earnings per share $ 0.51 $ 0.41 $ 1.38 $ 1.12 Shares used in calculation of: Primary earnings per share 281.8 278.5 280.2 280.0 Fully diluted earnings per share 283.2 279.1 283.8 281.9 -0-
AMGEN INC.
Condensed Consolidated Balance Sheets
(In millions)
(Unaudited)
Sept. 30, Dec. 31,
1995 1994
ASSETS
Current assets:
Cash and marketable securities $ 991.7 $ 696.7
Trade receivables 205.3 194.7
Inventories 85.8 98.0
Deferred tax assets, net 70.2 70.2
Other current assets 67.0 56.0
Total current assets 1,420.0 1,115.6
Property, plant and equipment, net 707.9 665.3
Other non-current assets 220.3 213.2
Total assets $2,348.2 $1,994.1
LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities $ 596.2 $ 536.4 Long-term debt 177.2 183.4 Stockholders' equity 1,574.8 1,274.3 Total liabilities and stockholders' equity $2,348.2 $1,994.1 Shares outstanding 266.0 264.7 CONTACT: Amgen, Thousand Oaks David Kaye, 805/447-6692 (media) Sarah H. Crampton, 805/447-1659 (investors) |
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