Printer Friendly
The Free Library
19,607,050 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

GENENTECH REPORTS 21% INCREASE IN 1ST QTR PRODUCT SALES.


Genentech, Inc. (NYSE NYSE

See: New York Stock Exchange
:DNA DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
), South San Francisco South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , has announced a 21 percent increase in product sales and a 27 percent increase in earnings per share for the first quarter of 2000, exclusive of the impact of charges associated with the redemption of Genentech's Special Common Stock and related accounting treatment, and a legal settlement in the first quarter of 1999. As a result of the redemption-related charges, the company recorded a net loss for the first quarter of 2000.

For the three months ended March 31, 2000:

-- Net income increased to $74.7 million, or 28 cents per share Cents per share

The amount of a mutual fund's dividend or capital gains distributions that a shareholder will receive for each share owned.
, an increase in earnings per share of 27 percent over the first quarter of 1999, exclusive of the impact of the redemption in the first quarter of 2000 and the impact of a special charge for a legal settlement of $50 million in the first quarter of 1999.

-- Due to charges related to the redemption, the company recorded a first quarter net loss of $25.9 million, or a net loss per share of 10 cents, as compared to net income of $14.4 million, or 5 cents per share, in the first quarter of 1999. The company recorded net income of $58.5 million or 22 cents per share for the first quarter of 1999, exclusive of the impact of a special charge for a legal settlement.

All earnings (loss) per share data and number of shares reflect the stock split effective November 2, 1999.

The accounting treatment under 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).
) requires Genentech to establish a new accounting basis for the company's assets and liabilities. This accounting treatment is the result of Roche's exercise of its option to redeem Genentech's Special Common Stock in June 1999. The company's new accounting basis is based on the cost of Roche's 1990 through 1997 purchases of Genentech shares and the redemption of Genentech's Special Common Stock on June 30, 1999. Roche's cost of acquiring Genentech is "pushed down" to Genentech and reflected on Genentech's financial statements beginning June 30, 1999. The effect of push-down accounting on Genentech's first quarter 2000 consolidated statement of operations See Income statement.  include recurring charges for the amortization of goodwill and other intangibles, and costs related to the sale of inventory that was written up at the redemption.

-- Revenues increased 20 percent to $385.7 million from $322.3 million in the same quarter of 1999. This revenue growth was driven primarily by sales of Herceptin(R) (Trastuzumab) and Rituxan(R) (Rituximab) and gains on the sale of certain marketable equity securities.

"We begin the year with progress on all fronts -- solid sales performances from our marketed biooncology products, positive advances with the products in our pipeline and strategic headway with our business alliances," said Arthur D. Levinson Arthur D. Levinson (born March 31, 1950 in Seattle, Washington, United States) is President and Chief Executive Officer of Genentech. He has held these positions since July 1995, and was named chairman of the board of directors in 1999. , Ph.D., Genentech's chairman and chief executive officer. "Herceptin and Rituxan have once again achieved record sales this quarter. In addition, Genentech announced positive Phase III results for anti-IgE and we have also enhanced our cardiovascular portfolio of pipeline products with the addition of tezosentan and the initiation of the combination trials for TNKase."

During the quarter, Genentech, with partners Novartis Pharma AG and Tanox, Inc., presented positive Phase III results for anti-IgE, a recombinant humanized monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing  to IgE, in asthma at the annual meeting of the American Academy of Allergy, Asthma and Immunology in March. Treatment with anti-IgE may reduce the number of asthma exacerbations while reducing the need for steroids and rescue medication in children and adults. The companies plan to file for regulatory approval in the United States and in Europe by second quarter 2000.

Genentech also continued its positive momentum in the focus on cardiovascular medicine by announcing plans to collaborate with other major pharmaceutical manufacturers to test the new, single-bolus thrombolytic thrombolytic /throm·bo·lyt·ic/ (throm?bo-lit´ik) dissolving or splitting up a thrombus, or an agent that so acts.

thrombolytic

1. dissolving or splitting up a thrombus.

2. an agent that dissolves or splits up a thrombus.
, TNKase(TM) (Tenecteplase), in combination with various leading anti-thrombotic agents in the treatment of acute myocardial infarction acute myocardial infarction (·kyōōtˑ mī·ō·karˑ·dē·  or heart attack. The company also signed a licensing agreement with Actelion, Ltd. for the development and co-promotion of tezosentan, which is being developed for the potential treatment of acute heart failure.

Product Sales

Sales of marketed products increased 21 percent in the first quarter of 2000 to $283.2 million from $234.1 million in the first quarter of 1999.

Sales of Herceptin in the first quarter of 2000 were $68.7 million compared to $39.9 million in the first quarter of 1999. Since launch, an increase of physician acceptance of Herceptin has contributed to a positive sales trend and successful penetration into the breast cancer market. Genentech has begun one and is preparing a second 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 Herceptin in adjuvant therapy Adjuvant therapy
A treatment done when there is no evidence of residual cancer in order to aid the primary treatment. Adjuvant treatments for endometrial cancer are radiation therapy, chemotherapy, and hormone therapy.
 for breast cancer and has begun Phase II clinical trials in 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.
.

Sales of Rituxan in the first quarter of 2000 increased 49 percent to $85.1 million from $57.1 million in the first quarter of 1999. This sales increase is due primarily to increased market penetration for the treatment of non-Hodgkin's lymphoma non-Hodg·kin's lymphoma
n.
Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells.


Non-Hodgkin's lymphoma 
. With partners IDEC IDEC Instituto Brasileiro de Defesa do Consumidor (Portugese: Brazilian Consumer Protection Agency)
IDEC Information Design & End-User Computing
IDEC Interior Design Educators Council, Inc.
 Pharmaceuticals Corporation and Roche, Genentech continues to explore other uses of Rituxan as a single agent as well as in combination with other traditional therapies through clinical trials. A Genentech/IDEC Phase III clinical trial of Rituxan in intermediate- and high-grade non-Hodgkin's lymphoma that is intended to extend product labeling was initiated in the fourth quarter of 1999.

Sales of Activase(R) (Alteplase, recombinant) during the first quarter of 2000 were $47.5 million compared to $52.0 million in the first quarter of 1999. Sales of Activase decreased due to a decline in the overall size of the acute myocardial infarction market due to mechanical reperfusion re·per·fu·sion
n.
The restoration of blood flow to an organ or tissue that has had its blood supply cut off, as after a heart attack.
 and continued competition. This decrease was partially offset by an increase in sales relating to the drug's increased use in peripheral blood peripheral blood Cardiology Blood circulating in the system/body  vessel occlusions.

Sales of Genentech's three growth hormone growth hormone or somatotropin (sōmăt'ətrō`pən), glycoprotein hormone released by the anterior pituitary gland that is necessary for normal skeletal growth in humans (see protein).  products, Protropin(R) (somatrem for injection), Nutropin(R) (somatropin (rDNA origin) for injection) and Nutropin AQ(R) (somatropin (rDNA origin) injection), were $55.1 million compared to $56.2 million in the first quarter of 1999.

In December 1999, Genentech announced Nutropin Depot(TM) (somatropin (rDNA origin) for injectable suspension) -- the first long-acting dosage form of recombinant growth hormone -- received approval from 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.
) for pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 growth hormone deficiency growth hormone deficiency Hypopituitarism Endocrinology A condition which affects 1:4000 children; ♂:♀, 3-4:1 Etiology 70% of GHD is idiopathic and attributed to a prenatal insult, possibly due to hypothalamic dysfunction, given that GHD children  after being granted a six-month priority review. Genentech expects to launch Nutropin Depot by mid-2000.

Sales of Pulmozyme(R) (dornase alfa) Inhalation Solution decreased to $26.8 million in the first quarter of 2000 compared to $28.2 million in the first quarter of 1999 primarily due to fluctuations in timing of orders and the impact of recording a provision against sales related to a packaging defect.

Total Costs and Expenses

Costs and expenses increased in the first quarter of 2000 as compared to the first quarter of 1999.

Research and development (R&D) expenses increased in the first quarter of 2000 to $111.4 million compared to $90.7 million in 1999. The increase is primarily due to an in-license agreement with Actelion that included an upfront fee of $15 million in February 2000. R&D expenses as a percentage of revenues in the first quarter of 2000 were 29 percent, compared to approximately 28 percent in the first quarter of 1999. R&D expenses as a percent of revenues are expected to vary over the next several periods dependent on possible in-licensing agreements and as products progress through late-stage clinical trials.

Primarily due to the increase in product sales, cost of sales, exclusive of expenses related to the redemption and push down accounting, increased to $62.9 million in the first quarter of 2000 from $45.7 million in the first quarter of 1999.

Marketing, general and administrative (MG&A) expenses increased during the first quarter of 2000 to $101.9 million compared to $97.2 million in the first quarter of 1999 due to an increase in marketing and selling expenses in support of Genentech's oncology products, including the Rituxan profit-sharing expense. This increase is partially offset by a decrease in general and administrative expenses related to royalties and write down of investments.

Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures, and markets human pharmaceuticals for significant unmet medical needs. Thirteen of the currently approved biotechnology products stem from Genentech science. Genentech markets seven biotechnology products directly in the United States. The company has headquarters in South San Francisco, California South San Francisco is a city in San Mateo County, California, United States, located on the San Francisco Peninsula in the San Francisco Bay Area. The population was 60,552 at the 2000 census. , and is traded on the New York Stock Exchange New York Stock Exchange (NYSE)

World's largest marketplace for securities. The exchange began as an informal meeting of 24 men in 1792 on what is now Wall Street in New York City.
 under the symbol DNA.

Genentech Business and Product Development Events in the First Quarter, 2000

Genentech Recently Announced the Following:

-- With Novartis Pharma AG and Tanox, Inc., presented positive Phase III results for anti-IgE in asthma at the annual meeting of the American Academy of Allergy, Asthma and Immunology in March. Positive Phase III results of anti-IgE treatment for seasonal allergic rhinitis seasonal allergic rhinitis,
n See hay fever.

seasonal allergic rhinitis Allergic rhinitis in which Sx wax and wane as a function of environmental pollen. See Allergic rhinitis.
 were announced in 1999. The companies plan to file for regulatory approval in the United States and in Europe by second quarter 2000.

-- Announced plans to collaborate with other major pharmaceutical manufacturers to test the new, single-bolus thrombolytic -- TNKase -- in combination with various leading anti-thrombotic agents in treatment of acute myocardial infarction or heart attack.

-- Signed licensing agreement with Actelion, Ltd. for the development and co-promotion of tezosentan in the United States for the potential treatment of acute heart failure.

-- Began first of two Phase III clinical trials of Herceptin in adjuvant therapy for breast cancer.

-- With Aradigm Corporation, announced the start of a U.S. Phase IIa clinical trial of Genentech's Pulmozyme (dornase alfa inhalation solution) using Aradigm's proprietary AERx pulmonary delivery system.

-- Millennium Pharmaceuticals, Inc. announced the initiation of a Phase II clinical trial of LDP-02 for Crohn's disease. Genentech is collaborating with Millennium in the development of the antibody and holds exclusive worldwide commercialization rights.

-- XOMA Ltd. announced the initiation of a Phase I/II clinical study of anti-CD11a in the prevention of kidney transplant rejection. Genentech is collaborating with XOMA to develop the antibody.

-- Announced the public offering by Roche of 17.3 million Genentech shares in March and the January Roche offering of a zero-coupon debt instrument exchangeable for shares of Genentech common stock owned by Roche.

-- In early April, announced the purchase of a cell culture manufacturing facility in Porrino, Spain, from Glaxo Wellcome Biofarma S.A. The facility has been established as a wholly owned subsidiary Wholly Owned Subsidiary

A subsidiary whose parent company owns 100% of its common stock.

Notes:
In other words, the parent company owns the company outright and there are no minority owners.
 company, "Genentech Espana S.L.," and will supplement Genentech's existing bulk cell culture production capacity.

-- Filed a motion with the Federal Circuit Court of Appeals in Washington DC seeking an expedited appeal and reinstatement of an injunction granted in 1995 that has prevented Bio-Technology General Corporation from selling its human growth hormone human growth hormone (HGH): see growth hormone.  product in the United States. The motion is in response to a decision by a U.S. Federal District Court in New York finding one of Genentech's human growth hormone patents invalid following a week-long jury trial.

-- Issued a drug notification regarding a defect in the packaging of its cystic fibrosis drug, Pulmozyme.

For more information, visit http://www.gene.com or call 650/225-1034.
COPYRIGHT 2000 Worldwide Videotex
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2000 Gale, Cengage Learning. All rights reserved.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Comment:GENENTECH REPORTS 21% INCREASE IN 1ST QTR PRODUCT SALES.
Publication:Biotech Financial Reports
Article Type:Brief Article
Geographic Code:1USA
Date:May 1, 2000
Words:1842
Previous Article:BIOMARIN REPORTS 1999 YEAR-END NET LOSS.
Next Article:NEORX REPORTS NET LOSS OF $2.4 MILLION FOR 1ST QTR 2000.
Topics:



Related Articles
Hourly Rates Inch Up in 3rd Quarter.
GENENTECH REPORTS 33% INCREASE IN PRODUCT SALES FOR 2ND QTR.
EARNINGS.
IN BRIEF.
IN BRIEF.
CAUSE FOR CELEBRATION IN THE MAGIC KINGDOM: DISNEY AMUSEMENT PARKS POWER QUARTERLY PROFITS.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles