GENENTECH REPORTS 1996 FIRST QUARTER RESULTS; Though revenues increased, earnings decreased as Genentech invested aggressively in future potential products.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.--(BUSINESS WIRE)--April 16, 1996-- 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 the first quarter of 1996 declined 12 percent to $38.2 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. , from $43.4 million, or 36 cents per share, in the first quarter of 1995. Reported revenues increased 2 percent to $242.9 million from $239.0 million in the same quarter of 1995. This revenue change reflects increases in contract revenues and royalties offset by reductions in sales, due primarily to Roche Holdings Inc.'s assumption of Canadian sales of Genentech products and European 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 in the fourth quarter of 1995. "Our results for the first quarter of 1996 show growth in U.S. sales of our two leading product lines, Activase and 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). , and a growth in royalty and contract revenues stemming from our revised relationship with our majority stockholder, Roche," said Genentech President and Chief Executive Officer Dr. 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. . "Also during the quarter we launched a new growth hormone product; filed for regulatory approval to market a new indication for Activase; began clinical trials for a new indication for DNase, the active ingredient An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. in Pulmozyme; and entered one new business development agreement and expanded another." Increased Royalties and Decreased MG&A Expenses as Roche Assumes ex-U.S. Sales In November 1995, Genentech began receiving royalties rather than recording sales on all European sales of Pulmozyme as Roche assumed responsibility for those sales per Genentech's new 1995 arrangement with Roche. In December 1995, Roche similarly assumed responsibility for Canadian sales of all Genentech products. These changes have led to a reduction in reported product sales compared to the first quarter of 1995, but also to increased royalty revenues and decreased marketing, general and administrative expenses. On a pro forma As a matter of form or for the sake of form. Used to describe accounting, financial, and other statements or conclusions based upon assumed or anticipated facts. The phrase pro forma basis that considers the new arrangement with Roche, product sales increased 3 percent to $152.3 million from $148.3 million. Reported total product sales were $152.3 million in the first quarter of 1996 compared to $162.1 million in the first quarter of 1995. Royalties in the first quarter of 1996 increased to $52.9 million from $47.1 million in the first quarter of 1995. MG&A expenses in the first quarter of 1996 decreased to $52.0 million from $64.3 million in the first quarter of 1995. Marketed Products On a pro forma basis, sales of Activase(R) (Alteplase, recombinant), a tissue-plasminogen activator (t-PA), increased to $76.6 million in the first quarter of 1996 from $75.9 million in the first quarter of 1995, with a $3.8 million bulk shipment of t-PA to licensees in Japan included in the first quarter of 1995. This increase follows Food and Drug Administration clearance in April 1995 for Genentech to promote an accelerated infusion of Activase and its mortality benefits, after which Genentech's U.S. 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 share jumped from approximately 70 to 75 percent. Reported total sales of Activase during the first quarter of 1996 decreased to $76.6 million from $78.2 million in the first quarter of 1995. On a pro forma basis, sales of Pulmozyme increased 6 percent to $18.9 million in the first quarter of 1996 from $17.8 million in the first quarter of 1995, with the increase driven primarily by sales of Pulmozyme to Roche for ex-U.S. sales. Principally due to Roche's assumption of ex-U.S. sales, reported total sales of Pulmozyme decreased to $18.9 million from $28.5 million in the first quarter of 1995. Sixty percent of U.S. 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. patients over age five currently receive Pulmozyme. On a pro forma basis, sales of Genentech's two growth hormone products Protropin(R) (somatrem for injection) and Nutropin(R) (somatropin (rDNA origin) for injection) increased 4 percent to $56.0 million in the first quarter of 1996 from $53.7 million in the first quarter of 1995. Reported total growth hormone sales increased to $56.0 million from $54.4 million in the first quarter of 1995. This increase occurred even with the assumption of responsibility for Canadian sales of growth hormone by Roche and with the introduction in late 1995 of a competitive growth hormone product. These results support our comprehensive plan to defend our leadership position in this market. During the quarter, Genentech launched the first liquid version of growth hormone, Nutropin AQ(TM) (somatropin (rDNA origin) injection) and an injection device, GenJect(TM) , representing two potentially important competitive advantages. Genentech continues to defend its patent position against potential new growth hormone competition. In June and August of 1995, respectively, a district court in New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of granted preliminary injunctions preventing Bio-Technology General and its affiliates (BTG BTG BIT (Built-In Test) Target Generator BTG Bridging the Gap BTG British Technology Group BtG Betreuungsgesetz (Germany) BTG Biomass Technology Group BV BTG Begbies Traynor Group ) and Novo Nordisk Wikipedia is not the place for advertisement or self-advertising. Novo Nordisk (, NYSE: NVO) manufactures and markets pharmaceutical products and services. Founded in Denmark in 1923, the company has since become a world leader in diabetes care with the broadest A/S and its affiliates (Novo) from marketing their human growth hormone human growth hormone (HGH): see growth hormone. products in the United States. Subsequent to those decisions, both companies appealed the decisions against them to the Federal Court of Appeals for the Federal Circuit. In February, 1996, that appeals court overruled the preliminary injunction against Novo, but in April 1996 it upheld the preliminary injunction against BTG prohibiting sales of its growth hormone product. Genentech has since sought a rehearing rehearing n. conducting a hearing again based on the motion of one of the parties to a lawsuit, petition or criminal prosecution, usually by the court or agency which originally heard the matter. on the overturn of Novo's preliminary injunction, and it has sought a second preliminary injunction against Novo on another patent not previously considered. Neither product is currently on the market, though a third product from Pharmacia & Upjohn Inc. has been on the market since December, 1995. Contract Revenues Contract and other revenues in the first quarter of 1996 increased to $22.1 million from $16.2 million in the first quarter of 1995. This increase resulted primarily from $17.1 million from Roche for its exercise of its option (per Genentech's 1995 arrangement with Roche) to codevelop the IDEC-C2B8 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 for non-Hodgkin's B-cell lymphoma outside of the United States. This is made up of a one-time option fee, including pre-opt-in development costs and Asian rights of $13.1 million, with the balance related to development activity since Roche chose to opt in. On a quarter-to-quarter basis, this amount from Roche was partially offset by a $4.0 million gain in the first quarter of 1995 on sales of biotechnology securities and normal quarter-to-quarter variation in contract revenues. Genentech is codeveloping the IDEC-C2B8 antibody, currently in Phase III clinical trials, for the same indication in the United States with 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. Research and Development Expenses and Progress Research and development expenses in the first quarter of 1996 were $115.6 million compared to $94.9 million in the first quarter of 1995. This increase was related to production of product and other expenses for clinical trials for Genentech's HER2 monoclonal antibody (in pivotal Phase III trials for the treatment of breast cancer) and for GenentechUs various cardiovascular products under development, including trials related to Activase for the treatment of ischemic stroke (currently awaiting regulatory approval) and GenentechUs second-generation t-PA, 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) (currently in Phase II clinical trials). The increase also stems from an up-front $5 million payment to Washington University to license worldwide rights to human neurturin, a homologue homologue /ho·mo·logue/ (hom´ah-log) 1. any homologous organ or part. 2. in chemistry, one of a series of compounds distinguished by addition of a CH2 group in successive members. of glial glial /gli·al/ (gli´'l) of or pertaining to the neuroglia. glial of or pertaining to glia or neuroglia. glial limitans a dense network of glial processes at the pia mater. cell-derived neurotrophic factor neurotrophic factor A generic term for any of a family of substances with roles in maintenance and survival of neurons–eg, secretory proteins, nerve growth factors–see there, brain-derived growth factor, neurotrophin-3 (GDNF GDNF Glial-cell Line-Derived, Neurotrophic Factor GDNF Gesinnungsgemeinschaft der Neue Front (German) ) in preclinical research that might be useful for the treatment of neurodegenerative disorders. For the quarter, Genentech invested 48 percent of revenues into R&D. "For the short term we plan to continue to invest close to half of our revenues back into R&D so we can realize the full potential of our strong product pipeline," said Dr. Levinson. "Over time, though we will continue to increase R&D investment in dollar terms as our revenues increase, we expect a decrease in this spending as a percentage of revenues as we bring more revenues to the bottom line. We anticipate spending about 25 to 30 percent of our revenues on R&D by the turn of the century." Genentech's aggressive investment in R&D was coupled with significant progress in product development during the quarter. Besides launching Nutropin AQ, Genentech: - Submitted a product license application for Activase in acute ischemic stroke, or brain attack, within three hours of system onset. - Began clinical trials of DNase, the active ingredient in Pulmozyme, for the treatment of lupus nephritis lupus nephritis n. Glomerulonephritis that occurs with systemic lupus erythematosus and is characterized by hematuria progressing to renal failure. , kidney damage kidney damage Kidney injury Nephrology A structural or functional compromise in renal function due to external–eg, athletic, occupational, or other trauma, resulting in bruising or hemorrhage, which can be profuse and life threatening Etiology Vascular resulting from an inflammatory connective tissue disease connective tissue disease Autoimmune disease, collagen-vascular disease Any of the diseases affecting connective tissues, with an autoimmune component, and immunologic/inflammatory defects Clinical Arthritis, connective tissue defects, endocarditis, myositis, . - Identified for development 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. ) for the treatment of ischemia; began preparing to file an investigational new drug application by year end. Also, during the quarter, Roche indicated that it will not exercise its option (per Genentech's 1995 arrangement with Roche) to develop and commercialize outside of the United States Genentech's anti-HER2 antibody for the treatment of breast cancer. Genentech is actively seeking another partner for ex-U.S. development of this product. Business Development During the quarter, besides entering into a business development agreement with Washington University as described above, Genentech: - Expanded its collaborative agreement with IDEC to include the clinical development and commercialization of its IDEC-Y2B8 antibody, currently in Phase I clinical trials, as a potential complementary treatment for non-Hodgkin's B-cell lymphoma. - Invested in Genenvax, Inc., which was created to continue the development and commercialization of gp120, Genentech's potential vaccine for the prevention of HIV-1 infection, and agreed to provide Genenvax with exclusive rights to gp120. Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. Ten of the currently marketed biotechnology products stem from Genentech science, five of which Genentech markets directly in the United States. Genentech is headquartered 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 and Pacific Stock Exchanges under the symbol GNE. Genentech's world wide web address is http://www.gene.com. -0-
GENENTECH, INC.
CONDENSED CONSOLIDATED INCOME STATEMENTS
(In thousands, except per share amounts)
Three Months
Ended March 31
1996 1995
Revenues: Product sales $ 152,337 $ 162,067 Royalties 52,893 47,149 Contract and other 22,100 16,222 Interest 15,554 13,529 Total revenues 242,884 238,967 Costs and expenses: Cost of sales 25,879 26,750 Research and development 115,633 94,959 Marketing, general and administrative 52,042 64,323 Interest 1,559 1,871 Total costs and expenses 195,113 187,903 Income before taxes 47,771 51,064 Income tax provision 9,554 7,660 Net income $ 38,217 $ 43,404 Net income per share $ .31 $ .36
Weighted average
number of
shares used
in computing
per share
amounts 123,360 120,493
Selected financial data: Cash and short-term investments $ 761,149 $ 722,374 Accounts receivable 174,865 166,143 Inventories 88,853 94,300 Long-term marketable securities 386,664 219,975 Property, plant and equipment, net 514,461 482,117 Other long-term assets 100,146 88,551 Total assets 2,065,668 1,806,846 Total current liabilities 224,377 205,802 Long-term debt 150,000 175,140 Total liabilities 400,356 404,600 Total stockholders' equity 1,665,312 1,402,246 CONTACT: Genentech, Inc. Laura Leber, 415/225-5759 (Media Contact) Lisa Brock, 415/225-1034 (Investor Contact) |
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