|Genentech Inc (DNA)
|Genentech Inc Graph source Edgar Online Pro on April 10th, 2006
The Following data is sourced from Yahoo finance & the ANNUAL REPORT ON FORM 10-K For the Year Ended December 31, 2005 . The overview of the company was:
Genentech, Inc. engages in the discovery, development, manufacture, and commercialization of biotherapeutics for various medical needs. The company provides various products for the treatment of cancer, allergic asthma, plaque psoriasis, hormone deficiency, heart attack, blood clots in the brain and lungs, and cystic fibrosis. Its product portfolio includes Rituxan, an anti-CD20 antibody; Avastin, an anti-VEGF humanized antibody; Herceptin, a humanized anti-HER2 antibody; Tarceva, a small molecule inhibitor of the tyrosine kinase activity; Xolair, a humanized anti-IgE antibody; Nutropin and Nutropin AQ, which are growth hormone products; Activase, a tissue plasminogen activator; TNKase for the treatment of acute myocardial infarction; and Pulmozyme, an inhalation solution of deoxyribonuclease I. The company also licenses various additional products to other companies. Genentech’s products under development include Avastin for patients with relapsed, metastatic, and colorectal cancer; Herceptin to treat early-stage, HER2-positive breast cancer; and Tarceva for the treatment for nonsmall cell lung cancer; Rituxan Immunology to treat patients with rheumatoid arthritis; Rituxan Hematology/Oncology for indolent nonHodgkin’s lymphoma induction therapy; Lucentis to treat neovascular wet form age-related macular degeneration; and Xolair for pediatric asthma. The company sells its products primarily to wholesalers, specialty distributors, or directly to hospital pharmacies. It has collaborations with Novartis and Tanox, Inc.; F. Hoffmann-La Roche; Biogen Idec, Inc.; Novartis Ophthalmics; and OSI Pharmaceuticals, Inc. Genentech was founded in 1975 and is headquartered in South San Francisco, California.
We commercialize in the United States (or “U.S.”) the biotechnology products listed below.
Rituxan (rituximab) is an anti-CD20 antibody, which we commercialize with Biogen Idec Inc. (or “Biogen Idec”). It is approved for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma, including retreatment and bulky disease, and on February 10, 2006, it was approved for use in the first-line treatment of patients with diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma, in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens.
Avastin (bevacizumab) is an anti-VEGF humanized antibody approved for use in combination with intravenous 5-fluorouracil (or “5-FU”)-based chemotherapy as a treatment for patients with first-line (or previously untreated) metastatic cancer of the colon or rectum.
Herceptin (trastuzumab) is a humanized anti-HER2 antibody approved for the treatment of certain patients with metastatic breast cancer. Herceptin is approved for use as a first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy for patients with metastatic breast cancer who have tumors that overexpress the human epidermal growth factor receptor 2 (or “ HER2”) protein.
Tarceva (erlotinib), which we commercialize with OSI Pharmaceuticals, Inc. (or “OSI”), is a small molecule inhibitor of the tyrosine kinase activity of the HER1/epidermal growth factor receptor (or “EGFR”) signaling pathway. Tarceva is approved for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (or “NSCLC”) after failure of at least one prior chemotherapy regimen and in combination with gemcitabine chemotherapy for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Xolair (omalizumab) is a humanized anti-IgE antibody, which we commercialize with Novartis AG (or “Novartis”), approved for the treatment of moderate-to-severe persistent allergic asthma in adults and adolescents .
Raptiva (efalizumab) is a humanized anti-CD11a antibody approved for the treatment of chronic moderate-to-severe plaque psoriasis in adults age 18 or older who are candidates for systemic therapy or phototherapy.
Nutropin (somatropin [rDNA origin] for injection) and Nutropin AQ are growth hormone products approved for the treatment of growth hormone deficiency in children and adults, growth failure associated with chronic renal insufficiency prior to kidney transplantation, short stature associated with Turner syndrome and long-term treatment of idiopathic short stature (or “ISS”) .
Activase (alteplase, recombinant) is a tissue plasminogen activator (or “t-PA”) approved for the treatment of acute myocardial infarction (heart attack), acute ischemic stroke (blood clots in the brain) within three hours of the onset of symptoms and acute massive pulmonary embolism (blood clots in the lungs) .
TNKase (tenecteplase) is a modified form of t-PA approved for the treatment of acute myocardial infarction (heart attack) .
Cathflo Activase (alteplase, recombinant) is a t-PA approved in adult and pediatric patients for the restoration of function to central venous access devices that have become occluded due to a blood clot . Pulmozyme (dornase alfa, recombinant) is an inhalation solution of deoxyribonuclease (rhDNase) I approved for the treatment of cystic fibrosis .
See “Total Product Sales” under Results of Operations in Part II, Item 7 of this Form 10-K for a discussion of the sales of each of our products in the last three years.
Highlights of Risks Related to Our (DNA) Business
For further detail please review the 10k report in detail
1. The successful development of biotherapeutics is highly uncertain and requires significant expenditures.
2. We may be unable to obtain or maintain regulatory approvals for our products.
3. Difficulties or delays in product manufacturing or in obtaining materials from our suppliers could harm our business and/or negatively affect our financial performance.
4. We face competition.
5. Decreases in third party reimbursement rates may affect our product sales, results of operations and financial condition.
6. Protecting our proprietary rights is difficult and costly.
7. If there is an adverse outcome in our pending litigation or other legal actions our business may be harmed.
8. We may be unable to manufacture certain of our products if there is BSE contamination of our bovine source raw material.
9. We may be unable to retain skilled personnel and maintain key relationships.
10. Other factors could affect our product sales.
11. Our results of operations are affected by our royalty and contract revenues.
12. Our affiliation agreement with Roche Holdings, Inc. could adversely affect our cash position.
13. Our affiliation agreement with Roche could limit our ability to make acquisitions and could have a material negative impact on our liquidity .
14. Future sales of our Common Stock by Roche could cause the price of our Common Stock to decline.
15. Roche Holdings, Inc., our controlling stockholder, may have interests that are adverse to other stockholders.
16. Our stockholders may be unable to prevent transactions that are favorable to Roche but adverse to us.
17. Potential conflicts of interest could limit our ability to act on opportunities that are favorable to us but adverse to Roche.
18. We may incur material product liability costs.
19. Insurance coverage is increasingly more difficult and costly to obtain or maintain.
20. We are subject to environmental and other risks.
21. Fluctuations in our operating results could affect the price of our Common Stock.
22. Our integration of new information systems could disrupt our internal operations, which could harm our revenues and increase our expenses.
23. Our stock price, like that of many biotechnology companies, is volatile .
24. Our effective income tax rate may vary significantly.
25. To pay our indebtedness will require a significant amount of cash and may adversely affect our operations and financial results.
26. Accounting pronouncements may affect our future financial position and results of operations.
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