Biogen Idec
Posted: Tue Nov 02, 2004 9:58 am
Some of you may find this interesting.
In talking about Antegren, and pharmas, etc., I mentioned SEC filings. So........I took a quick look at SEC filings for Biogen Idec. This is ALL public record and can be found on their website, not to mention on the Securities and Exchange Commission website.
I'm going to highlight what I found a little "surprising" in a way. Not very "diversified" are they? That's a little risky in my opinion, but who is to say?
The following are excerpts from their 10Q and 8Ks. It appears that there is a lot at stake riding on the success of Antegren.
Remember, none of this is "unusual" whatsoever, and is common practice, etc. for the most part. I just found it interesting and thought some of you might also.
Deb
********************************
Our Revenues Rely Significantly on a Limited Number of Products
Our current and future revenues depend substantially upon continued sales of our commercial products. Revenues related to sales of two of our products, AVONEX and RITUXAN, represented approximately 92% of our total revenues in the second quarter of 2004. We cannot assure you that these products will continue to be accepted in the U.S. or in any foreign markets or that sales of either of these products will not decline in the future. A number of factors may affect the rate and level of market acceptance of these products, including:
•the perception of physicians and other members of the health care community of their safety and efficacy relative to that of competing products;
•patient and physician satisfaction with these products;
•the effectiveness of our sales and marketing efforts and those of our marketing partners and licensees in the U.S., the EU and other foreign markets;
•the size of the markets for these products;
•unfavorable publicity concerning these products or similar drugs;
•the introduction, availability and acceptance of competing treatments, including therapies that we may bring to the market in the future;
•the availability and level of third-party reimbursement;
•the success of ongoing development work on these products;
•new data and adverse event information relating to any of these products;
•the continued accessibility of third parties to vial, label, and distribute these products on acceptable terms;
•the unfavorable outcome of patent litigation related to any of these products;
•the ability to manufacture commercial lots of products successfully and on a timely basis; and
•regulatory developments related to the manufacture or continued use of these products.
Given our current reliance on these products as the principal sources of our revenue, any material adverse developments with respect to the commercialization of either of these products may cause our revenue to grow at a slower than expected rate, or even decrease, in the future.
Our Long-Term Success Depends Upon the Successful Development and Commercialization of ANTEGREN and Other Products from Our Research and Development Activities and Collaborations, and Increased Acceptance of ZEVALIN and AMEVIVE.
Our long-term viability and growth will depend upon the successful development and commercialization of ANTEGREN and other products from our research and development activities and collaborations, and, to a lesser extent, increased acceptance of ZEVALIN and AMEVIVE. We continue to expand our marketing of ZEVALIN and AMEVIVE, our development and commercialization efforts related to ANTEGREN, and our development efforts related to other potential products in our pipeline. The expansion of our pipeline may include increases in spending on internal projects, the acquisition of third-party technologies or products or other types of investments. Product development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Many important factors affect our ability to successfully develop and commercialize other products, including the ability to:
•obtain and maintain necessary patents and licenses;
•demonstrate safety and efficacy of drug candidates at each stage of the clinical trial process;
•enroll patients in our clinical trials and to complete clinical trials;
•overcome technical hurdles that may arise;
•successful manufacture of products in sufficient quantities to meet demand;
•meet applicable regulatory standards;
•obtain reimbursement coverage for the products;
•receive required regulatory approvals;
•produce drug candidates in commercial quantities at reasonable costs; and
•compete successfully against other products and to market products successfully.
Success in early stage clinical trials or preclinical work does not ensure that later stage or larger scale clinical trials will be successful. Even if later stage clinical trials are successful, the risk exists that unexpected concerns may arise from additional data or analysis or that obstacles may arise or issues be identified in connection with review of clinical data with regulatory authorities or that regulatory authorities may disagree with our view of the data or require additional data or information or additional studies.
We have submitted applications for approval of ANTEGREN in the U.S. and EU as a treatment for MS. The FDA has designated ANTEGREN for Priority Review and Accelerated Approval as a treatment for MS in June 2004 and formally accepted the application for approval in July 2004. Our efforts to achieve the approvals necessary to launch ANTEGREN could be hindered if unexpected new data arises or if we encounter difficulties in our discussions with the FDA or other regulatory authorities, or if other hurdles arise.
************************************************
Our long-term growth will depend on the successful development and commercialization of new products such as ANTEGREN. Drug development involves a high degree of risk. For example, our plans to launch ANTEGREN as a treatment for MS could be negatively affected if unexpected concerns arise from additional data or analysis, if regulatory authorities require additional information or further studies, or if we were to encounter other unexpected hurdles.
For more detailed information on the risks and uncertainties associated with these forward looking statements and the Company’s other activities see the periodic reports filed by the Company with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
*******************************************
In July 2004, we and our collaboration partner, Elan Corporation, plc, entered into a license agreement with Genentech for a non-exclusive license to certain Genentech patents related to the manufacture of licensed products, including ANTEGREN. As a part of the agreement, we and Elan will each pay a $1 million license grant fee upon execution of the agreement and an additional $1 million on the first anniversary of the agreement. In addition, we and Elan may each have to pay a development milestone fee of $2.5 million, half of which would be paid upon the first marketing approval of a licensed product from the FDA and half of which would be paid on the anniversary of such approval. The agreement also requires that we and Elan pay royalties on net sales of ANTEGREN and other licensed products.
In talking about Antegren, and pharmas, etc., I mentioned SEC filings. So........I took a quick look at SEC filings for Biogen Idec. This is ALL public record and can be found on their website, not to mention on the Securities and Exchange Commission website.
I'm going to highlight what I found a little "surprising" in a way. Not very "diversified" are they? That's a little risky in my opinion, but who is to say?
The following are excerpts from their 10Q and 8Ks. It appears that there is a lot at stake riding on the success of Antegren.
Remember, none of this is "unusual" whatsoever, and is common practice, etc. for the most part. I just found it interesting and thought some of you might also.
Deb
********************************
Our Revenues Rely Significantly on a Limited Number of Products
Our current and future revenues depend substantially upon continued sales of our commercial products. Revenues related to sales of two of our products, AVONEX and RITUXAN, represented approximately 92% of our total revenues in the second quarter of 2004. We cannot assure you that these products will continue to be accepted in the U.S. or in any foreign markets or that sales of either of these products will not decline in the future. A number of factors may affect the rate and level of market acceptance of these products, including:
•the perception of physicians and other members of the health care community of their safety and efficacy relative to that of competing products;
•patient and physician satisfaction with these products;
•the effectiveness of our sales and marketing efforts and those of our marketing partners and licensees in the U.S., the EU and other foreign markets;
•the size of the markets for these products;
•unfavorable publicity concerning these products or similar drugs;
•the introduction, availability and acceptance of competing treatments, including therapies that we may bring to the market in the future;
•the availability and level of third-party reimbursement;
•the success of ongoing development work on these products;
•new data and adverse event information relating to any of these products;
•the continued accessibility of third parties to vial, label, and distribute these products on acceptable terms;
•the unfavorable outcome of patent litigation related to any of these products;
•the ability to manufacture commercial lots of products successfully and on a timely basis; and
•regulatory developments related to the manufacture or continued use of these products.
Given our current reliance on these products as the principal sources of our revenue, any material adverse developments with respect to the commercialization of either of these products may cause our revenue to grow at a slower than expected rate, or even decrease, in the future.
Our Long-Term Success Depends Upon the Successful Development and Commercialization of ANTEGREN and Other Products from Our Research and Development Activities and Collaborations, and Increased Acceptance of ZEVALIN and AMEVIVE.
Our long-term viability and growth will depend upon the successful development and commercialization of ANTEGREN and other products from our research and development activities and collaborations, and, to a lesser extent, increased acceptance of ZEVALIN and AMEVIVE. We continue to expand our marketing of ZEVALIN and AMEVIVE, our development and commercialization efforts related to ANTEGREN, and our development efforts related to other potential products in our pipeline. The expansion of our pipeline may include increases in spending on internal projects, the acquisition of third-party technologies or products or other types of investments. Product development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Many important factors affect our ability to successfully develop and commercialize other products, including the ability to:
•obtain and maintain necessary patents and licenses;
•demonstrate safety and efficacy of drug candidates at each stage of the clinical trial process;
•enroll patients in our clinical trials and to complete clinical trials;
•overcome technical hurdles that may arise;
•successful manufacture of products in sufficient quantities to meet demand;
•meet applicable regulatory standards;
•obtain reimbursement coverage for the products;
•receive required regulatory approvals;
•produce drug candidates in commercial quantities at reasonable costs; and
•compete successfully against other products and to market products successfully.
Success in early stage clinical trials or preclinical work does not ensure that later stage or larger scale clinical trials will be successful. Even if later stage clinical trials are successful, the risk exists that unexpected concerns may arise from additional data or analysis or that obstacles may arise or issues be identified in connection with review of clinical data with regulatory authorities or that regulatory authorities may disagree with our view of the data or require additional data or information or additional studies.
We have submitted applications for approval of ANTEGREN in the U.S. and EU as a treatment for MS. The FDA has designated ANTEGREN for Priority Review and Accelerated Approval as a treatment for MS in June 2004 and formally accepted the application for approval in July 2004. Our efforts to achieve the approvals necessary to launch ANTEGREN could be hindered if unexpected new data arises or if we encounter difficulties in our discussions with the FDA or other regulatory authorities, or if other hurdles arise.
************************************************
Our long-term growth will depend on the successful development and commercialization of new products such as ANTEGREN. Drug development involves a high degree of risk. For example, our plans to launch ANTEGREN as a treatment for MS could be negatively affected if unexpected concerns arise from additional data or analysis, if regulatory authorities require additional information or further studies, or if we were to encounter other unexpected hurdles.
For more detailed information on the risks and uncertainties associated with these forward looking statements and the Company’s other activities see the periodic reports filed by the Company with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
*******************************************
In July 2004, we and our collaboration partner, Elan Corporation, plc, entered into a license agreement with Genentech for a non-exclusive license to certain Genentech patents related to the manufacture of licensed products, including ANTEGREN. As a part of the agreement, we and Elan will each pay a $1 million license grant fee upon execution of the agreement and an additional $1 million on the first anniversary of the agreement. In addition, we and Elan may each have to pay a development milestone fee of $2.5 million, half of which would be paid upon the first marketing approval of a licensed product from the FDA and half of which would be paid on the anniversary of such approval. The agreement also requires that we and Elan pay royalties on net sales of ANTEGREN and other licensed products.
(That's racketeering, by the way.) They settled, but I had to laugh.
