Genentech's Year-End Results Show Growth Plan on Track: Earnings Increase Nine Percent on Revenues Exceeding $1 Billion.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. , Calif.--(BW HealthWire)--Jan. 22, 1997-- -- Four 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. approvals in 1997, and nine late-stage development products entering 1998 demonstrate strength of company's Long Range Plan -- Genentech, Inc. (NYSE NYSE See: New York Stock Exchange :GNE GNE Gateway Network Element (data communications) GNE Game Neverending (MMORPG) GNE Gross National Expenditure GNE Game Networking Engine GNE Graphical Network Editor (Nortel) ) announced today that earnings for 1997 increased nine percent to $129.0 million, or $1.02 per share(a), from $118.3 million in 1996, or 95 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. (a). This increase reflects increased revenues partially offset by increased marketing, general and administrative expenses. Earnings for the fourth quarter of 1997 increased to $41.5 million, or 33 cents per share(a), from $7.5 million, or 6 cents per share(a), in the fourth quarter of 1996. This quarter-to-quarter earnings increase primarily reflects increased revenues. Revenues for 1997 increased 5 percent to $1,016.7 million from $968.7 million in 1996. This growth came from all revenue areas, but primarily from royalties and from contract and other revenues. Revenues for the fourth quarter of 1997 increased 20 percent to $277.0 million from $230.3 million in the fourth quarter of 1996, primarily due to an increase in contract and other revenues. Genentech's royalties in 1997 were $241.1 million compared to $214.7 million in 1996. This increase primarily reflects increased sales by licensees. Contract and other revenues in 1997 were $121.6 million compared to $107.0 million in 1996. The increase in contract and other revenues for the quarter and on a full-year basis is largely due to strategic alliances formed with Sumitomo Pharmaceuticals Co., Ltd., and Pharmacia & Upjohn, Inc. "1997 was a successful year for Genentech on many levels, validating the corporate strategy for growth that we implemented in 1995," 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 president and chief executive officer. "Our financial results were consistent with our plan to begin to see a modest earnings increase in 1997, and we made substantial progress with our pipeline and our strategic relationships. We also implemented a new Long Range Plan to meet our objectives and give us, as we move into the 21st century, the potential for a strong bottom line, strong prospects for future growth and a strong late-stage pipeline." Genentech received four regulatory approvals from the U.S. Food and Drug Administration in 1997. One was for a new product, Rituxan(TM) (Rituximab), which Genentech launched with its partner 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 for the treatment of patients with relapsed or refractory low-grade or follicular fol·lic·u·lar adj. 1. Relating to, having, or resembling a follicle or follicles. 2. Affecting or growing out of a follicle or follicles. , CD20-positive B-cell non-Hodgkins lymphoma. The others were for new indications of certain 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. Genentech also announced favorable preliminary Phase III results and began preparing regulatory filings for another new oncology product, Herceptin(TM) (trastuzumab) anti-HER2 antibody, and started or began planning, either alone or with partners, Phase III trials for five potential products. With ongoing trials and an additional Phase III product in-licensed during 1997, Genentech now has nine products or potential products in late-stage clinical development (entering Phase III or beyond). Genentech expects to submit regulatory filings on Herceptin in the second quarter of 1998. Genentech also moved two potential new products into initial clinical testing in 1997. Marketed Products Product sales for 1997 increased slightly to $584.9 million from $582.8 million in 1996. Sales from Rituxan and increased sales of Genentech's growth hormone products and 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. , recombinant) Inhalation Solution offset the decline in Activase(R)(Alteplase, recombinant) sales. In 1997, Genentech launched a new BioOncology initiative that includes the marketed product Rituxan as well as the oncology products that Genentech has under clinical development. Genentech and IDEC launched Rituxan on December 16, 1997, and recorded initial sales of $5.5 million for 1997. While Genentech is encouraged by these sales figures, not enough time has passed for these figures to be indicative of future sales, and the figures may reflect pent up demand for the product. With a new competitive thrombolytic agent thrombolytic agent Clot-dissolving drug, thrombolytic An agent–eg, tPA, streptokinase, that effects thrombolysis and restores vascular patency–eg, in managing acute MIs. See Thrombolytic therapy, tPA. on the market and a decline in the overall size of the thrombolytic therapy Thrombolytic Therapy Definition Thrombolytic therapy is the use of drugs that dissolve blood clots. Purpose When a blood clot forms in a blood vessel, it may cut off or severely reduce blood flow to parts of the body that are served by market as some heart attack patients receive 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. rather than thrombolytic therapy and from two large ongoing clinical studies, Activase sales decreased to $260.7 million in 1997 from $284.1 million in 1996. Activase's market share in the fourth quarter of 1997 was approximately 71 percent compared to approximately 76 percent in the third quarter of 1997 and approximately 80 percent in the fourth quarter of 1996. Sales of growth hormone products Protropin(R) (somatrem for injection), Nutropin(R) (somatropin (rDNA origin) for injection) and Nutropin AQ(R) (somatropin (rDNA origin) injection) increased slightly to $223.6 million in 1997 from $218.2 million in 1996. Sales of Pulmozyme were $91.6 million in 1997 compared to $76.0 million in 1996. This increase resulted primarily from increased penetration in patients with mild and moderate 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. as well as from variation in customer ordering patterns. Marketing, General and Administrative Expenses MG&A expenses for 1997 were $269.9 million compared to $240.1 million in 1996. The increased expenses were primarily in support of marketing and sales for Genentech's launch of its new BioOncology initiative; for its launch of a new indication, 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 in adults, for Nutropin and Nutropin AQ; and for its efforts to defend Activase against new competition. In addition, there was an increase in general and administrative expenses due to royalty expense. R&D Expenses Research and development expenses for 1997 were $470.9 million compared to $471.1 million in 1996. R&D expenses as a percentage of revenues in 1997 were 46 percent, compared to approximately 49 percent in 1996. "This initial decrease in R&D expenses as a percent of revenues," said Levinson, "is in line with our continuing efforts to bring increasing revenues to the bottom line through disciplined spending in all areas of the company." Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures, and markets human pharmaceuticals for significant unmet medical needs. Eleven of the currently marketed biotechnology products stem from Genentech science. Genentech markets or promotes eight biotechnology products 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. and Pacific Exchange under the symbol GNE. -0- (a) All earnings-per-share amounts in the text of this news release represent diluted earnings per share diluted earnings per share An earnings measure calculated by dividing net income less preferred stock dividends for a period by the average number of shares of common stock that would be outstanding if all convertible securities were converted into shares of as defined under Statement of Financial Accounting Standards No. 128, "Earnings per Share." -0- GENENTECH BUSINESS AND PRODUCT DEVELOPMENT PROGRESS IN 1997 In 1997 Genentech made significant progress with the products in its pipeline, including several stemming from business collaborations. During the year: -- Along with partner IDEC Pharmaceuticals Corporation, Genentech received approval for Rituxan for the treatment of patients with relapsed or refractory low-grade or follicular, CD20-positive B-cell non-Hodgkins lymphoma. -- Genentech received approval for Nutropin and Nutropin AQ for the treatment of growth hormone deficiency in adults. -- Genentech received approval for Nutropin AQ for the treatment of short stature associated with Turner Syndrome Turner syndrome Chromosomal disorder (from the presence of only one sex chromosome, X, in all or some of the body's cells) that causes abnormal sexual development in females. . -- Genentech announced favorable preliminary Phase III trial results and began preparing regulatory filings for Herceptin for the treatment of breast cancer. -- Genentech began a Phase III trial of nerve growth factor nerve growth factor n. Abbr. NGF A protein that stimulates the growth of sympathetic and sensory nerve cells. Nerve growth factor in diabetic patients with sensory peripheral neuropathy Peripheral Neuropathy Definition The term peripheral neuropathy encompasses a wide range of disorders in which the nerves outside of the brain and spinal cord—peripheral nerves—have been damaged. . -- With partner Boehringer Ingelheim International GmbH (BI), Genentech began a Phase III trial for TNK TNK Tank TNK Tenecteplase TNK Tomorrow Never Knows (Beatles song) TNK Tanak TnK Tenshi Na Konamaiki (anime) TNK Tyumenskaya Neftyanaya Kompaniya (Tyumen Oil Company, Russia) t-PA for acute myocardial infarction. -- BI completed enrollment in its ECASS ECASS Cardiology An international, double blinded, randomized trial–European Cooperative Acute Stroke Study which evaluated effects of thrombolytics in Pts with stroke. See Thrombolytic therapy, tPA. II stroke study, which is investigating using Activase for acute ischemic stroke within the first six hours of symptom onset (Activase is currently approved for acute ischemic stroke within the first three hours of symptom onset). -- Genentech began a Phase III Early Intervention Trial with Pulmozyme in young cystic fibrosis patients with preserved lung function. -- With partner Alkermes, Inc., Genentech began pivotal Phase III trials of ProLease(R) sustained-release human growth hormone human growth hormone (HGH): see growth hormone. (hGH). -- Genentech agreed to provide Sumitomo Pharmaceuticals Co., Ltd., exclusive rights to develop, import and distribute in Japan Nutropin AQ and ProLease sustained release growth hormone. -- Genentech agreed with Alteon, Inc. for continued development and future marketing in the United States of Pimagedine, currently in Phase III trials to treat kidney disease in diabetic patients. -- With partners Novartis Pharma AG and Tanox Biosystems, Inc., Genentech began planning a Phase III trial of an anti-IgE antibody for the treatment of allergic asthma. -- Roche began Phase III clinical trials of Sibrafiban, an oral IIb/IIIa antagonist for acute coronary syndrome acute coronary syndrome n. A sudden, severe coronary event that mimics a heart attack, such as unstable angina. acute coronary syndrome . In 1997, Roche assumed development of Sibrafiban on its own. Genentech will provide clinical and scientific input for the program and may subsequently opt-in and join development at any time up to the New Drug Application filing for the first indication. -- Roche began Phase II clinical trials of the anti-CD18 antibody for the treatment of shock and burns, and Genentech began planning Phase II clinical trials of this antibody for the treatment of acute myocardial infarction acute myocardial infarction ( Phase I safety trials of vascular endothelial growth factor Vascular endothelial growth factor (VEGF) is an important signaling protein involved in both vasculogenesis (the de novo formation of the embryonic circulatory system) and angiogenesis (the growth of blood vessels from pre-existing vasculature). (VEGF VEGF vascular endothelial growth factor. ) in patients with coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. . -- Genentech completed one and initiated a second of two planned Phase I safety trials of Genentech's anti-VEGF antibody in patients with refractory cancer. -- Genentech agreed with LeukoSite Inc. to develop and commercialize LeukoSite's LDP-02, a humanized monoclonal antibody for the treatment of inflammatory bowel diseases. LDP-02 is expected to enter human clinical trials in 1998. -- In exchange for development costs, fees and, upon marketing, royalties, Genentech agreed to provide to Pharmacia & Upjohn (P&U) exclusive worldwide rights for thrombopoietin (TPO (Twisted Pair Only) Refers to the use of twisted pair wire when other options are available. For example, a TPO suffix at the end of 3com Ethernet adapter model numbers indicates the card has only an RJ45 connector. ), which is in Phase II trials for potential use in treating patients with complications of cancer chemotherapy. P&U and Genentech will jointly develop TPO. -- Genentech discontinued IGF-I IGF-I see somatomedin C. IGF-I Insulin-like growth factor I, somatomedin-C A polypeptide hormone structurally similar to proinsulin, synthesized in the liver and fibroblasts, giving fibroblasts a paracrine function; serum levels correlate with development effort in Type I and Type II diabetes Type II diabetes Type II diabetes is the most common form of diabetes and usually appears in middle aged adults. It is often associated with obesity and may be delayed or controlled with diet and exercise. Mentioned in: Diabetic Ketoacidosis , based on the scope and extended time frame of the clinical program required to address potential concerns about diabetic retinopathy. -- With partner Scios, Inc., Genentech discontinued development of Auriculin after an interim analysis of data from an ongoing Phase III study in oliguric acute renal failure acute renal failure Acute kidney failure Nephrology An abrupt decline in renal function, triggered by various processes–eg, sepsis, shock, trauma, kidney stones, drug toxicity-aspirin, lithium, substances of abuse, toxins, iodinated radiocontrast. suggested a low probability of a positive outcome. -- Genentech returned to IDEC Genentech's U.S. marketing rights for IDEC-Y2B8, a radioimmunotherapy under investigation for the treatment of relapsed or refractory non-Hodgkin's B-cell lymphoma. -0-
Genentech, Inc.
Condensed Consolidated Income Statements
(In thousands, except per share amounts)
(unaudited)
Three Months Year
Ended Dec 31 Ended Dec 31
1997 1996 1997 1996
Revenues:
Product sales $143,352 $139,724 $ 584,889 $ 582,829
Royalties 60,789 54,156 241,112 214,702
Contract and other 54,134 19,046 121,587 107,037
Interest 18,778 17,399 69,160 64,110
Total revenues 277,053 230,325 1,016,748 968,678
Costs and expenses:
Cost of sales 22,719 26,659 102,536 104,527
Research and
development 119,144 128,135 470,923 471,143
Marketing, general and
administrative 79,348 65,170 269,852 240,063
Interest 1,196 1,024 3,642 5,010
Total costs and
expenses 222,407 220,988 846,953 820,743
Income before taxes 54,646 9,337 169,795 147,935
Income tax provision 13,117 1,867 40,751 29,587
Net income $ 41,529 $ 7,470 $ 129,044 $ 118,348
Net income per share(1):
Basic $ 0.33 $ 0.06 $ 1.05 $ 0.98
Diluted $ 0.33 $ 0.06 $ 1.02 $ 0.95
Weighted average number of
shares used in computing
per share computations:
Basic 123,974 121,354 123,042 120,623
Diluted 127,230 124,562 126,397 124,197
Selected financial data
(unaudited):
Cash and short-term investments $ 833,322 $ 623,164
Accounts receivable 189,245 197,612
Inventories 116,026 91,943
Long-term marketable securities 453,189 535,916
Property, plant and equipment, net 683,304 586,167
Other long-term assets 177,201 149,205
Total assets 2,507,612 2,226,372
Total current liabilities 289,557 249,951
Long-term debt 150,000 150,000
Total liabilities 476,387 425,313
Total stockholders' equity 2,031,225 1,801,059
(1) All Net Income per share amounts were calculated in accordance
with Statement of Financial Accounting Standards No. 128.
CONTACT: Genentech, Inc. Laura Leber, 650/225-5759 (media contact) Susan Bentley, 650/225-1034 (investor contact) http://www.gene.com |
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