|The Biogen IDEC (BIIB)
|Biogen IDEC Graph source Edgar Online Pro on April 18th, 2006
The Following data is sourced from the ANNUAL REPORT ON FORM 10-K For the Year Ended December 31, 2005 . The overview of the company was:
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, we transform scientific discoveries into advances in human healthcare. We currently have five products:
AVONEX ® (interferon beta-1a). AVONEX is approved for the treatment of relapsing forms of multiple sclerosis, or MS, and is the most prescribed therapeutic product in MS worldwide. Globally over 130,000 patients have chosen AVONEX as their treatment of choice. In 2005, sales of AVONEX generated worldwide revenues of $1.5 billion as compared to worldwide sales of $1.4 billion in 2004.
RITUXAN ® (rituximab). RITUXAN is approved worldwide for the treatment of relapsed or refractory low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphomas, or B-cell NHLs. In February 2006, RITUXAN was approved by the U.S. Food and Drug Administration, or FDA, to treat previously untreated patients with diffuse, large B-cell NHL in combination with anthracycline-based chemotherapy regimens. In addition, in February 2006, the FDA approved the supplemental Biologics License Application, or sBLA, for use of RITUXAN, in combination with methotrexate, for reducing signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis, or RA, who have had an inadequate response to one or more TNF antagonist therapies. We market RITUXAN in the U.S. in collaboration with Genentech, Inc., or Genentech. All U.S. sales of RITUXAN are recognized by Genentech and we record our share of the pretax copromotion profits on a quarterly basis. In 2005, RITUXAN generated U.S. net sales of $1.8 billion of which we recorded $513.8 million as our share of copromotion profits as compared to U.S. net sales of $1.6 billion in 2004 of which we recorded $457.0 million as our share of copromotion profits. F. Hoffmann-La Roche Ltd., or Roche, sells rituximab outside the U.S., except in Japan where it co-markets RITUXAN in collaboration with Zenyaku Kogyo Co. Ltd., or Zenyaku. We received royalties through Genentech on sales of rituximab outside of the U.S. of $147.5 million in 2005 as compared to $121.0 million in 2004. We are working with Genentech and Roche on the development of RITUXAN in additional oncology and other indications. RITUXAN is the trade name for the compound rituximab in the U.S., Canada and Japan. MabThera is the tradename for rituximab in the EU. In this Form 10-K, we refer to rituximab, RITUXAN, and MabThera collectively as RITUXAN, except where we have otherwise indicated.
TYSABRI ® (natalizumab). TYSABRI was approved by the FDA in November 2004 to treat relapsing forms of MS to reduce the frequency of clinical relapses. In February 2005, in consultation with the FDA, we and Elan Corporation plc, or Elan, voluntarily suspended the marketing and commercial distribution of TYSABRI, and we informed physicians that they should suspend dosing of TYSABRI until further notification. In addition, we suspended dosing in clinical studies of TYSABRI in MS, Crohn’s disease and RA. These decisions were based on reports of cases of progressive multifocal leukoencephalopathy, or PML, a rare and frequently fatal, demyelinating disease of the central nervous system in patients treated with TYSABRI in clinical studies. We and Elan conducted a safety evaluation of patients treated with TYSABRI in MS, Crohn’s disease and RA clinical studies. The safety evaluation included the review of any reports of potential PML in MS patients receiving TYSABRI in the commercial setting. In October 2005, we completed the safety evaluation and found no new confirmed cases of PML. Three confirmed cases of PML were previously reported, two of which were fatal. In September 2005, we submitted an sBLA for TYSABRI to the FDA for the treatment of MS. The sBLA includes: final two-year data from the Phase 3 AFFIRM monotherapy trial and SENTINEL combination trial with AVONEX in MS; the integrated safety assessment of patients treated with TYSABRI in clinical trials; and a revised label and a risk minimization action plan. We and Elan have also submitted a similar data package to the European Medicines Agency, or EMEA. This information was supplied as part of the ongoing EMEA review process, which was initiated in the summer of 2004 with the filing for approval of TYSABRI as a treatment for MS. In November 2005, we were granted Priority Review status for the sBLA, which will result in action by the FDA approximately six months from the submission date, which is in March 2006. In January 2006, we and Elan announced that we had received notification from the FDA that the Peripheral and Central Nervous System Drugs Advisory Committee would review TYSABRI for the treatment of MS on March 7, 2006. In February 2006, we and Elan announced that the FDA informed the companies that the FDA removed the hold on clinical trial dosing of TYSABRI. We and Elan expect to begin an open-label, multi-center safety extension study of TYSABRI monotherapy in the U.S. and internationally in the first quarter of 2006. We plan to work with regulatory authorities to determine the future commercial availability of TYSABRI. See “Item 1A — Risk Factors — Safety Issues with TYSABRI Could Significantly Affect our Growth.” .
ZEVALIN ® (ibritumomab tiuxetan). The ZEVALIN therapeutic regimen, which features ZEVALIN, is a radioimmunotherapy that is approved for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell NHL, including patients with RITUXAN relapsed or refractory NHL. In 2005, sales of ZEVALIN in the U.S. generated revenues of $19.4 million as compared to revenues of $18.7 million in 2004. ZEVALIN is approved in the EU for the treatment of adult patients with CD20¡ follicular B-cell NHL who are refractory to or have relapsed following RITUXAN therapy. We sell ZEVALIN to Schering AG for distribution in the EU, and receive royalty revenues from Schering AG on sales of ZEVALIN in the EU. Rest of world product sales for ZEVALIN in 2005 were $1.4 million as compared to $4.3 million in 2004. The $4.3 million of rest of world product sales in 2004 relates to ZEVALIN sold to Schering AG in 2003 and 2004, recognition of which had been deferred when the selling price was fixed and determinable.
AMEVIVE ® (alefacept). AMEVIVE is approved in the U.S. and other countries for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. In 2005, sales of AMEVIVE generated worldwide revenues of $48.5 million as compared to sales of $43.0 million in 2004. We are seeking to divest AMEVIVE as part of a comprehensive strategic plan which is discussed below.
We also receive royalty revenues on sales by our licensees of a number of products covered under patents that we control. In addition, we have a pipeline of research and development products in our core therapeutic areas and in other areas of interest.
We devote significant resources to research and development programs. In connection with the strategic plan discussed below, we intend to commit significant additional capital to external research and development opportunities. We intend to focus our internal and external research and development efforts on finding novel therapeutics in areas of high unmet medical need and finding therapeutics in our focus areas of oncology, neurobiology and immunology. Our current efforts include our collaboration with Elan on the development of TYSABRI as a potential treatment for Crohn’s disease; our work with Genentech and Roche on the development of RITUXAN in additional oncology indications, RA and MS; our collaboration with Fumapharm AG, or Fumapharm, on development of an oral therapy as a potential treatment for psoriasis and MS; and our collaboration with PDL BioPharma, Inc., or PDL, on development of three Phase 2 antibody products in a variety of indications.
Comprehensive Strategic Plan. In September 2005, we began implementing a comprehensive strategic plan designed to position us for long-term growth. The plan builds on the continuing strength of AVONEX and RITUXAN and other expected near-term developments. The plan has three principal elements: reducing operating expenses and enhancing economic flexibility by recalibrating our asset base, geographic site missions, staffing levels and business processes; committing significant additional capital to external business development and research opportunities; and changing our organizational culture to enhance innovation and support the first two elements of the plan. In conjunction with the plan, we consolidated or eliminated certain internal management layers and staff functions, resulting in the reduction of our workforce by approximately 17%, or approximately 650 positions worldwide. These adjustments took place across Company functions, departments and sites, and have been substantially implemented. In February 2006, we sold our NICO clinical manufacturing facility in Oceanside, California to Genentech. In addition, we are seeking to divest several non-core assets, including AMEVIVE and certain real property in Oceanside, California. Our AMEVIVE assets held for sale include $8.0 million related to intangible assets, net, and $5.4 million for property, plant and equipment, net. In addition, our AMEVIVE inventory balance at December 31, 2005 was $49.8 million, of which $24.8 million related to the historical manufacturing costs and $25.0 million related to the increase in fair market value of inventory acquired at the merger, as described below.
On November 12, 2003, Bridges Merger Corporation, a wholly owned subsidiary of IDEC Pharmaceuticals Corporation, was merged with and into Biogen, Inc. with Biogen, Inc. continuing as the surviving corporation and a wholly owned subsidiary of IDEC Pharmaceuticals Corporation. At the same time, IDEC Pharmaceuticals Corporation changed its name to Biogen Idec Inc. The merger and name change were made under an Agreement and Plan of Merger dated as of June 20, 2003. As a result of the merger, each issued and outstanding share of Biogen, Inc. common stock was converted into the right to receive 1.15 shares of Biogen Idec common stock. Our stock trades on the Nasdaq National Market under the symbol “BIIB.” The results of Biogen, Inc.’s operations from November 13, 2003, the day after the effective date of the merger, to December 31, 2003 have been included in the 2003 consolidated financial statements filed in this Annual Report on Form 10-K.
High lights of Risks Related to Our (BIIB) Business
For further detail please review the 10k report in detail
1. Our Revenues Rely Significantly on a Limited Number of Products.
2. Safety Issues with TYSABRI Could Significantly Affect our Growth.
3. Our Long-Term Success Depends Upon the Successful Development and Commercialization of Other Products from Our Research and Development Activities and External Growth Opportunities.
4. Competition in Our Industry and in the Markets for Our Products is Intense.
5. We are Subject to Risks Related to the Products that We Manufacture.
6. We Rely to a Large Extent on Third Parties in the Manufacturing of Our Products.
7. The Manufacture of Our Products is Subject to Government Regulation.
8. Royalty Revenues Contribute to Our Overall Profitability and Are Not Within Our Control.
9. Our Operating Results Are Subject to Significant Fluctuations.
10. Our Sales Depend on Payment and Reimbursement from Third Party Payors, and a Reduction in Payment Rate or Reimbursement Could Result in Decreased Use or Sales of Our Products.
11. We May Be Unable to Adequately Protect or Enforce Our Intellectual Property Rights or Secure Rights to Third Party Patents.
12. Legislative or Regulatory Changes Could Harm Our Business.
13. Failure to Comply with Government Regulations Regarding Our Products Could Harm Our Business.
14. Some of Our Activities may Subject Us to Risks under Federal and State Laws Prohibiting “Kickbacks” and False or Fraudulent Claims.
15. Failure to Prevail in Litigation or Satisfactorily Resolve a Third Party Investigation Could Harm Our Business.
16. Our Business Involves Environmental Risks.
17. We Rely Upon Key Personnel.
18. Future Transactions May Harm Our Business or the Market Price of Our Stock.
19. We are Subject to Market Risk.
20. Our Financial Position, Results of Operations and Cash Flows can be Affected by Fluctuations in Foreign Currency Exchange Rates.
21. We are Exposed to Risk of Interest Rate Fluctuations.
22. Volatility of Our Stock Price.
23. We Have Adopted Several Anti-takeover Measures As Well As Other Measures to Protect Certain Members of Our Management Which May Discourage or Prevent a Third Party From Acquiring Us.
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