Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its full year and fourth quarter 2010 results.
“non-GAAP net income attributable to Biogen Idec Inc.”
Full Year 2010 Highlights:
- Total revenues in 2010 were $4.7 billion, an increase of 8% versus 2009. The increase was driven primarily by the continued growth of TYSABRI® (natalizumab) revenues, which increased 16% to $900 million, and AVONEX® (interferon beta-1a) revenues, which increased 8% to $2.5 billion. RITUXAN® (rituximab) revenues from our unconsolidated joint business arrangement decreased 2% to $1.1 billion for the year due to the expiration of royalties on sales outside the United States.
- Global in-market 2010 TYSABRI net sales were $1.2 billion, an increase of 16% over 2009. The total was comprised of $593 million in U.S. sales and $637 million in sales to rest of world markets.
- On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), full-year 2010 diluted earnings per share (EPS) were $3.94, an increase of 18% over 2009. GAAP net income attributable to Biogen Idec for 2010 was $1.0 billion, an increase of 4% over 2009.
- Non-GAAP diluted EPS for 2010 were $5.15, an increase of 25% over 2009. Non-GAAP net income attributable to Biogen Idec for 2010 was $1.3 billion, an increase of 10% over 2009. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.
"Our solid 2010 performance reflects the strength of our core business," said George A. Scangos, Ph.D., Chief Executive Officer, Biogen Idec. "In addition to driving AVONEX and TYSABRI revenue growth, we also substantially reduced our cost base, focused the company, and recruited top talent. We will continue the company's transformation in 2011, and we're looking forward to several key pipeline milestones in the coming months."
Fourth Quarter 2010 Highlights:
- Fourth quarter revenues were $1.2 billion, an increase of 8% over the fourth quarter of 2009, driven primarily by the continued growth of TYSABRI revenues, which increased 12% to $242 million in the quarter, and AVONEX revenues, which increased 10% to $654 million. RITUXAN revenues were $258 million, an increase of 1%.
- Global in-market net sales of TYSABRI in the fourth quarter of 2010 were $333 million, an increase of 12% over the fourth quarter of 2009, of which $162 million were in the U.S. and $171 million were in rest of world markets.
- Fourth quarter 2010 GAAP diluted EPS were $0.99, a decrease of 7% over the fourth quarter of 2009. GAAP net income attributable to Biogen Idec for the quarter was $240 million, a decrease of 21% from the fourth quarter of 2009.
- Fourth quarter 2010 non-GAAP diluted EPS were $1.42, an increase of 18% over the fourth quarter of 2009. Non-GAAP net income attributable to Biogen Idec for the quarter was flat, totaling $347 million. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.
As of December 31, 2010 Biogen Idec had cash, cash equivalents and marketable securities of approximately $2.0 billion.
During 2010, Biogen Idec repurchased 40.3 million shares of stock at a total cost of $2.1 billion. Two share repurchase authorizations accounted for the activity as follows:
- In October 2009 the Board authorized a $1.0 billion share repurchase program. During 2010 Biogen Idec purchased and retired 10.5 million shares for a total of $578 million under this authorization, completing the program.
- In April 2010 the Board authorized a $1.5 billion share repurchase program. Biogen Idec purchased and retired 29.8 million shares for a total of $1.5 billion under this authorization.
TYSABRI Patient Growth
Based upon data available to us through the TOUCH® prescribing program and other third-party sources as of the end of December 2010, we estimate that approximately 56,600 patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively approximately 78,800 patients have ever been treated with TYSABRI in the post-marketing setting.
Other Products and Royalties
Revenues from other products in the fourth quarter of 2010 were $14 million, as compared to $14 million in the fourth quarter of 2009. Revenues from other products for the full year of 2010 were $51 million as compared to $54 million in 2009.
Table 4 provides individual product revenues.
Royalties were $45 million in the fourth quarter of 2010 compared to $41 million in the fourth quarter of 2009. Royalties for the full year 2010 were $137 million as compared to $124 million in 2009.
Biogen Idec also outlined its 2011 financial guidance. This guidance excludes any significant business development activities and consists of the following components:
- Revenue growth is expected to be between flat and low single digit versus 2010.
- R&D is expected to be approximately 22% to 24% of total revenue.
- SG&A is expected to be approximately 20% to 21% of total revenue.
- Tax rate is expected to be approximately 26% to 28% of total revenue.
- GAAP diluted EPS is expected to be above $4.82.
- Non-GAAP diluted EPS is expected to be above $5.70.
- We expect capital expenditures in the range of $200 to $220 million.
Biogen Idec may incur charges, realize gains or experience other events in 2011 that could cause actual results to vary from this guidance.
- On January 28, 2011, Genentech, a member of the Roche Group, and Biogen Idec announced the U.S. Food and Drug Administration (FDA) approved RITUXAN as a maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with RITUXAN plus chemotherapy (induction treatment).
- On January 21, 2011, Biogen Idec announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a negative opinion recommending against approval of FAMPYRA® (prolonged-release fampridine 10 mg tablets) to improve walking ability in adult patients with multiple sclerosis in the European Union. Biogen Idec intends to appeal this opinion and request a re-examination of the decision by the CHMP.
- On January 5, 2011, Biogen Idec announced that Douglas E. Williams, Ph.D., had been named Executive Vice President, Research and Development (R&D), and Steven H. Holtzman had been named Executive Vice President, Corporate Development.
- On December 22, 2010, Biogen Idec and Elan Corporation, plc announced that the companies had submitted a supplemental Biologics License Application to the FDA and a Type II Variation to the EMA to request review and approval to update the respective TYSABRI Prescribing Information and Summary of Product Characteristics. The companies are proposing updated product labeling to include anti-JC virus antibody status as one potential factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML), a serious brain infection, in the TYSABRI-treated population.
- On December 20, 2010, Biogen Idec and Neurimmune Holding AG announced that Biogen Idec acquired the world-wide rights to three pre-clinical immunotherapy programs. The three programs are focused on the discovery and development of novel human antibodies that address three central nervous system targets: alpha-synuclein, tau and TDP-43. These targets are believed to be relevant for the treatment and prevention of a wide variety of neurodegenerative diseases, including Parkinson's disease, Alzheimer's disease and amyotrophic lateral sclerosis.
- On December 10, 2010, Biogen Idec and Swedish Orphan Biovitrum announced that the first patient had been dosed with the companies' long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc) in a global registrational clinical trial. The study, called A-LONG, is an open-label, multicenter, Phase 2/3 study designed to evaluate the safety, pharmacokinetics and efficacy of rFVIIIFc in previously-treated hemophilia A patients.
- On November 3, 2010, Biogen Idec announced a number of strategic, operational and organizational changes. The goals of these actions are to increase focus and efficiency and leverage the company's strengths to provide a solid framework for growth.
- Strategically, Biogen Idec will focus on neurology and leverage its strengths in biologics R&D and manufacturing to pursue select, high-impact biological therapies. The company is terminating its efforts in cardiovascular medicine and seeking to spin out or outlicense its oncology assets.
- Operationally, the company is consolidating its sites. The company's site in San Diego is being closed, and the company's sites in eastern Massachusetts are being consolidated.
- Organizationally, Biogen Idec is in the process of reducing its headcount by approximately 13%. In addition, the company implemented a strong program management system to improve decision making and execution, and it reorganized business development, venture development and corporate strategy into a new Corporate Development Group.
- Financially, as a result of these actions, the company expects to realize annual savings of approximately $300 million.
- On November 3, 2010, Biogen Idec and Cardiokine, Inc. announced that they had agreed to dissolve their collaboration on lixivaptan.