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GENENTECH REPORTS 25% INCREASE IN SALES FOR 3RD. QTR.


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 25 percent increase in product sales driven by Genentech's oncology drugs and a 19 percent increase in earnings per share(1) for the third quarter of 2000, exclusive of the ongoing impact of the 1999 redemption of Genentech's Special Common Stock and related accounting treatment(2). As a result of the redemption-related charges, the company recorded minimal net income for the third quarter of 2000.

"During the quarter, we continued to deliver strong financial results fueled by the performance of our oncology products, Rituxan and Herceptin," 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. "This is an exciting time as we lay the groundwork for potential growth with 20 projects in our development pipeline."

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

(2) 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, second and third quarter 2000 consolidated statements of operations 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.

For the three months ended September 30, 2000:

-- Exclusive of the impact of the redemption, net income increased to $85.0 million, or 31 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 19 percent over the third quarter of 1999. Exclusive of the impact of the redemption, net income for the third quarter of 1999 was $66.9 million, or 26 cents per share.

-- Due to charges related to the redemption, the company recorded a third quarter net income of $4.5 million, or a net income per share of 2 cents. The company recorded a net loss of $62.8 million or 25 cents per share for the third quarter of 1999.

-- Revenues increased 29 percent to $445.2 million from $345.3 million in the same quarter of 1999. This revenue growth was driven primarily by sales of Rituxan(R) (Rituximab) and Herceptin(R) (Trastuzumab) and gains on the sales of marketable equity securities. Sales of marketed products increased 25 percent in the third quarter of 2000 to $334.2 million from $267.0 million in the third quarter of 1999.

On October 2, Genentech announced that it submitted for review to 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.
) a Supplemental Biologic License Application (sBLA) for Alteplase, recombinant (Activase) for use in restoring function to catheters that have become blocked, preventing the withdrawal of blood samples or infusion of vital fluids to medically ill patients. Also during the quarter, Genentech completed enrollment in two pivotal Phase III clinical trials evaluating anti-CD11a (hu1124) in patients with moderate-to-severe psoriasis. Genentech is developing anti-CD11a with XOMA, Ltd.

Product Sales

Sales of Herceptin in the third quarter of 2000 increased 52 percent to $72.6 million compared to $47.9 million in the third quarter of 1999. Since launch, an increase in penetration into the breast cancer market has contributed to a positive sales trend. During the quarter, Genentech's ex-U.S. marketing partner, Roche, received approval from the European Commission to market Herceptin for the treatment of HER2-positive 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.
 breast cancer. In collaboration with Roche, Genentech is conducting trials for the potential 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.
 treatment of early stage breast cancer in patients who overexpress the HER2 protein.

Sales of Rituxan in the third quarter of 2000 increased 62 percent to $117.9 million from $72.6 million in the third 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 
. Genentech and 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 continue to explore the use of Rituxan as a potential treatment for intermediate and high-grade non-Hodgkin's lymphoma.

During the third quarter of 2000, sales of Genentech's two cardiovascular products, Activase(R) (Alteplase, recombinant) and TNKase(R) (Tenecteplase), were $50.7 million compared to $59.2 million of Activase sales in the third quarter of 1999. This sales decrease is due to increased competition and to an overall decline in the size of the 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.
 market due to the increasing use of 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.
 as well as early intervention ear·ly intervention
n. Abbr. EI
A process of assessment and therapy provided to children, especially those younger than age 6, to facilitate normal cognitive and emotional development and to prevent developmental disability or delay.
 with other therapies in the treatment of acute myocardial infarction acute myocardial infarction (·kyōōtˑ mī·ō·karˑ·dē·  (AMI). In August, one-year follow-up data for TNKase was presented at the European Society of Cardiology The European Society of Cardiology (ESC) represents more than 50,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the impact of cardiovascular disease in Europe.  meeting demonstrating comparable efficacy to Activase with the added benefit of being the fastest thrombolytic to administer in the treatment of heart attack. In addition, in collaboration with Boehringer Ingelheim GmbH, TNKase continues to be studied in Phase II and Phase III clinical trials in combination with various anti-thrombotic agents in the potential treatment of AMI.

Sales of Genentech's 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 were $61.1 million compared to $59.9 million in the third quarter of 1999.

Sales of Pulmozyme(R) (dornase alfa dornase alfa /dor·nase al·fa/ (dor´naz al´fah) recombinant human deoxyribonuclease I (DNase I) used to reduce the viscosity of sputum in cystic fibrosis.

dor·nase al·fa
n.
) Inhalation Solution were $30.0 million in the third quarter of 2000 compared to $27.0 million in the third quarter of 1999. During the quarter, Genentech completed a Phase III clinical trial of Pulmozyme in early-stage cystic fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. . Trial results will be presented in November 2000.

Total Costs and Expenses

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

Primarily due to the increase in product sales, cost of sales, exclusive of expenses related to the redemption and push-down accounting, increased to $75.6 million in the third quarter of 2000 from $46.0 million in the third quarter of 1999. The increase in cost of sales as a percentage of sales is primarily due to product mix as well as an increase in provisions established for nonuseable inventory.

Research and development (R&D) expenses increased in the third quarter of 2000 to $113.6 million compared to $84.6 million in 1999 due primarily to an increase in expenses related to later-stage clinical trials. R&D expenses as a percentage of revenues in the third quarter of 2000 were 26 percent, compared to approximately 25 percent in the third quarter of 1999. R&D expenses as a percent of revenues are expected to continue to vary over the next several periods dependent on possible in-licensing agreements and as products progress through late-stage clinical trials.

Marketing, general and administrative (MG&A) expenses during the third quarter of 2000 were $131.7 million compared to $113.6 million in the third quarter of 1999. The increase is due primarily to the Rituxan profit-sharing expense, as well as increased sales and marketing expenses related to competitive conditions with other marketed products and the Xolair(TM) (Omalizumab) launch preparation.

Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures, and markets human pharmaceuticals for significant unmet medical needs. Fourteen of the currently approved biotechnology products stem from Genentech science. Genentech markets nine biotechnology products directly in the United States. The company has headquarters in South San Francisco, Calif., 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 Third Quarter, 2000

Genentech announced the following:

-- Submitted for review to the FDA an sBLA for Activase for use in catheter clearance.

-- Completed patient enrollment in two pivotal Phase III clinical trials evaluating anti-CD11a in patients with moderate-to-severe psoriasis. Genentech is developing anti-CD11a with XOMA, Ltd.

-- Genentech's European partner, Roche, received 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
 approval for Herceptin.

-- IDEC, Genentech's partner on Rituxan, received a "completion of review" letter from the FDA regarding the Supplemental Biologic License Application (sBLA) for Rituxan to include: retreatment with Rituxan; extended initial therapy (eight weekly infusion instead of four); and treatment of patients with bulky disease.

-- Completed a Phase III clinical trial of Pulmozyme in early-stage cystic fibrosis. Trial results will be presented in November 2000.

-- Signed agreement with UroGenesys, which provides Genentech with exclusive worldwide license to develop antibody-based therapeutics for cancer using Prostate Stem Cell Antigen (PSCA PSCA Profit Sharing/401(K) Council of America
PSCA Philippine School of Culinary Arts
PSCA Protein Sequence Comparative Analysis
PSCA Parts Stress Count Analysis (British Telecom) 
) as a target antigen.

-- Announced the appointment of Joseph McCracken to vice president, Business Development.

-- Announced the promotion of David Nagler to vice president, Human Resources.

-- In May, announced the promotion of Roy C. Hardiman to vice president, Corporate Law.

-- In May, announced the promotion of Andrew Scherer to vice president, Engineering and Facilities.

-- In October, announced a 2-for-1 stock split to be effective in the form of a stock dividend. The record date of this transaction is October 17 with distribution beginning October 24.

For more information, call 650/225-8852.
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Comment:GENENTECH REPORTS 25% INCREASE IN SALES FOR 3RD. QTR.
Publication:Biotech Financial Reports
Article Type:Brief Article
Geographic Code:1USA
Date:Nov 1, 2000
Words:1500
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