Biogen Idec Reports Full Year and Fourth Quarter 2008 Results
2008 Revenues Grew 29% and Exceeded $4 Billion Goal
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb 6, 2009 - Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today reported its full year and fourth quarter 2008 results.
Full Year 2008 Highlights:
“A great company is built on outstanding products, pipeline and performance – we're delivering all three for our shareholders,” said Biogen Idec CEO James C. Mullen. “In 2008, we grew revenues 29% to more than $4 billion and non-GAAP EPS 34% to $3.66. TYSABRI is well on its way to becoming a blockbuster. We've transformed the pipeline over the past two years, with 22 programs in Phase 2 trials and beyond this year.”
Fourth Quarter 2008 Highlights:
As of December 31, 2008 Biogen Idec had cash, cash equivalents and marketable securities of approximately $2.3 billion. In the fourth quarter, we recorded charges of $31 million, or $0.08 per share, in "other income, net" related to the impairment of marketable securities and strategic investments.
Revenues from AVONEX, the worldwide leading therapy for patients with relapsing forms of MS, increased 13% in the fourth quarter to $566 million. Full-year AVONEX sales increased 18% to $2.2 billion. In 2008, U.S. sales of AVONEX increased 18% to $1.3 billion and international sales increased 18% to $926 million.
Revenues for the fourth quarter and full-year 2008 included $303 million and $1.1 billion, respectively, from Biogen Idec's joint business arrangement related to RITUXAN, a treatment for certain B-cell non-Hodgkin's lymphomas (NHL) and rheumatoid arthritis (RA) that Biogen Idec co-promotes in the U.S. with Genentech, Inc. All U.S. sales of RITUXAN are recognized by Genentech, and Biogen Idec records its share of the pretax co-promotion profits. U.S. net sales of RITUXAN were $677 million in the fourth quarter (Q4 2007: $596 million) and $2.6 billion for the full year (2007: $2.3 billion), as reported by Genentech.
During the fourth quarter of 2008, Biogen Idec recognized revenue of $156 million related to TYSABRI. This amount is comprised of:
As of the end of December 2008, approximately 37,600 patients were on commercial and clinical TYSABRI therapy worldwide. To date, the safety data continues to support a favorable benefit-risk profile for TYSABRI. According to data available as of the end of December 2008:
Cumulatively, in the post-marketing setting:
Revenues from other products in the fourth quarter of 2008 were $10 million (Q4 2007: $12 million).
Table 4 provides individual product revenues.
Royalties were $29 million in the fourth quarter compared to $33 million in the fourth quarter of 2007. Royalties for the full year 2008 were $116 million as compared to $102 million in 2007.
Development Pipeline Progress
Biogen Idec made significant progress in the development of the pipeline. There are five ongoing registrational programs with novel molecules, and the Company expects this number to grow to eight by year end 2009. In total, there are 22 programs in Phase 2 or beyond in the clinical pipeline. During 2008, the Company accomplished 11 data readouts that enabled clinical development decisions and initiated three proof of concept studies. In addition, five programs started first in human trials and six programs were transitioned from research to development in 2008.
Following its strong performance in 2008, Biogen Idec outlined its 2009 financial guidance, consistent with achieving the company's 2010 financial goals:
We may incur charges or realize gains in 2009 that could cause actual results to vary from this guidance.
Conference Call and Webcast
The company's earnings conference call for the fourth quarter will be broadcast via the internet at 8:30 a.m. ET on February 6, 2009, and will be accessible through the investor relations section of Biogen Idec's homepage, http://www.biogenidec.com. Supplemental information in the form of a slide presentation will also be accessible at the same location on the internet at the time of the earnings conference call and will be available on our web site subsequently through March 15, 2009.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
This press release contains forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from that which we expect, including our continued dependence on our two principal products, AVONEX and RITUXAN, the uncertainty of success in commercializing other products including TYSABRI, the occurrence of adverse safety events with our products, competitive pressures, changes in the availability of reimbursement for our products, our dependence on collaborations over which we may not always have full control, failure to execute our growth initiatives, possible adverse impact of government regulation, problems with our manufacturing processes and our reliance on third parties, the impact of the global credit crisis, the market, interest and credit risks associated with our portfolio of marketable securities, our significant investment in a new manufacturing facility in Denmark, our ability to attract and retain qualified personnel, the risks of doing business internationally, the actions of activist shareholders, fluctuations in our operating results, our ability to protect our intellectual property rights and the cost of doing so, product liability claims, fluctuations in our effective tax rate, our level of indebtedness, environmental risks, aspects of our corporate governance and collaborations and the other risks and uncertainties that are described in Item 1.A. Risk Factors in our annual report on Form 10-K and in other reports we file with the SEC. These forward-looking statements speak only as of the date of this press release, and we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
Biogen Idec and its directors, executive officers and other members of its management and employees may be deemed to be participants in the solicitation of proxies from the stockholders of Biogen Idec in connection with the Company's 2009 annual meeting of stockholders. Information concerning the interests of participants in the solicitation of proxies will be included in any proxy statement filed by Biogen Idec in connection with the Company's 2009 annual meeting of stockholders.
In addition, Biogen Idec files annual, quarterly and special reports with the Securities and Exchange Commission (the "SEC"). The proxy statements and other reports, when available, can be obtained free of charge at the SEC's web site at www.sec.gov or from Biogen Idec at www.biogenidec.com. Biogen Idec stockholders are advised to read carefully any proxy statement filed in connection with the Company's 2009 annual meeting of stockholders when it becomes available before making any voting or investment decision. The Company's proxy statement will also be available for free by writing to Biogen Idec Inc., 14 Cambridge Center, Cambridge, MA 02142. In addition, copies of the proxy materials may be requested from our proxy solicitor, Innisfree M&A Incorporated, by toll-free telephone at (877) 750-5836 or by e-mail at firstname.lastname@example.org.
|Biogen Idec Inc.|
|December 31, 2008|
|Consolidated Statements of Income|
|(in thousands, except per share amounts)|
|Three Months Ended||Twelve Months Ended|
|December 31,||December 31,|
|Unconsolidated joint business||303,213||253,707||1,128,238||926,098|
|COST AND EXPENSES|
|Cost of sales||101,161||87,566||401,989||335,192|
|Research and development||292,767||229,292||1,072,058||925,164|
|Selling, general and administrative||230,963||193,730||925,305||776,103|
|Amortization of acquired intangible assets||90,631||70,925||332,745||257,495|
|Collaboration profit sharing||37,673||13,909||136,041||14,079|
|In-process research and development||-||35,808||25,000||84,172|
|Gain on sale of long lived assets||(9,242||)||(360||)||(9,242||)||(360||)|
|Total cost and expenses||743,953||630,870||2,883,896||2,391,845|
|Income from operations||324,960||262,430||1,213,611||779,772|
|Other income (expense), net||(34,851||)||32,631||(64,668||)||130,823|
|INCOME BEFORE INCOME TAXES||290,109||295,061||1,148,943||910,595|
|BASIC EARNINGS PER SHARE||$||0.71||$||0.68||$||2.67||$||2.02|
|DILUTED EARNINGS PER SHARE||$||0.70||$||0.67||$||2.65||$||1.99|
|WEIGHTED-AVERAGE SHARES USED IN CALCULATING:|
|BASIC EARNINGS PER SHARE||291,532||294,561||292,332||315,836|
|DILUTED EARNINGS PER SHARE||293,777||299,665||294,984||320,171|
|Biogen Idec Inc.|
Posted: February 2009
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