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 2011 results.
“non-GAAP net income attributable to Biogen Idec Inc.”
Full Year 2011 Highlights:
- Total revenues in 2011 increased 7% to $5.0 billion year-over-year. TYSABRI® (natalizumab) revenues increased 20% year-over-year to $1.1 billion while AVONEX® (interferon beta-1a) revenues increased 7% year-over-year to $2.7 billion. RITUXAN® (rituximab) revenues from our unconsolidated joint business arrangement were $1.0 billion for the year, a decrease of 7% versus prior year as a result of certain royalties from individual countries expiring and a charge of approximately $50 million from an accrual relating to Genentech's arbitration with Hoechst GmbH.
- Global in-market sales of TYSABRI for the full year of 2011 were $1.5 billion, an increase of 23% over 2010. The total was comprised of $747 million in U.S. sales and $764 million in sales outside the U.S.
- On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), full year 2011 GAAP diluted EPS were $5.04, an increase of 28% versus 2010. GAAP net income attributable to Biogen Idec for the year was $1.2 billion, an increase of 23% versus 2010.
- Non-GAAP diluted EPS for 2011 were $5.90, an increase of 15% over 2010. Non-GAAP net income attributable to Biogen Idec for 2011 was $1.4 billion, an increase of approximately 10% versus 2010.
Fourth Quarter 2011 Highlights:
- Fourth quarter revenues increased 9% to $1.3 billion, compared to the fourth quarter of 2010. TYSABRI revenues increased 11% year-over-year to $269 million while AVONEX revenues increased 8% year-over-year to $703 million. RITUXAN revenues from our unconsolidated joint business arrangement were $258 million for the quarter, approximately in-line with the prior year.
- Global in-market sales of TYSABRI in the fourth quarter of 2011 were $380 million, an increase of 14% over the fourth quarter of 2010. The total was comprised of $196 million in U.S. sales and $183 million in sales outside the U.S.
- Fourth quarter 2011 GAAP diluted EPS were $1.22, an increase of 23% over the fourth quarter of 2010. GAAP net income attributable to Biogen Idec for the quarter was $300 million, an increase of 25% from the fourth quarter of 2010.
- Non-GAAP diluted EPS for the fourth quarter of 2011 were $1.51, an increase of 6% over the fourth quarter of 2010. Non-GAAP net income attributable to Biogen Idec for the fourth quarter of 2011 was $370 million, an increase of approximately 7% from the fourth quarter of 2010. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.
As of December 31, 2011, Biogen Idec had cash, cash equivalents and marketable securities of approximately $3.1 billion.
"Our success in 2011 gives us a strong position on which to build," said George A. Scangos, Ph.D., the company's chief executive officer. "In 2012 we will focus on the continued growth and leadership of our marketed products and the advancement of our strong pipeline. We will continue to work on risk stratification to unlock the value of TYSABRI and we plan to launch the AVONEX PEN in the US to support the continued growth of AVONEX. We are working to file BG-12 as quickly as possible, and are preparing for the potential launch of the product. We also anticipate phase III data later this year for our long-acting factor VIII and factor IX in hemophilia, and dexpramipexole in ALS, and are preparing for multiple filings and product launches where the data are positive. At the same time we are working to strengthen our early stage pipeline through internal research and strategic collaborations to build a foundation for growth and innovation over the long term."
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 2011, we estimate that approximately 64,400 patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively approximately 95,300 patients have ever been treated with TYSABRI in the post-marketing setting.
Other Products and Royalties
For the full year, revenues from other products were $70 million, an increase of 36% versus 2010. Revenues from other products in the fourth quarter of 2011 were $24 million, compared to $14 million in the fourth quarter of 2010.
Table 4 provides individual product revenues.
Royalties in 2011 increased 15% to $158 million, versus 2010. Royalties were $53 million in the fourth quarter of 2011, an increase of 16% compared to the fourth quarter of 2010.
Corporate partner revenues for the full year of 2011 were $57 million, compared to $32 million in 2010. For the fourth quarter of 2011, corporate partner revenues were $20 million, compared to $6 million in 2010.
2012 Financial Guidance
Biogen Idec also released its full year 2012 financial guidance. This guidance consists of the following components:
- Revenue growth is expected to be in the low to mid-single digits versus 2011.
- Cost of Sales is expected to be approximately 9% to 10% of total revenue.
- R&D is expected to be approximately 24% to 25% of total revenue.
- SG&A is expected to be approximately 22% to 23% of total revenue.
- Tax rate is expected to be approximately 24% to 26% of pretax income.
- Non-GAAP diluted EPS is expected to be between $6.10 and $6.20.
- GAAP diluted EPS is expected to be between $5.46 and $5.56.
- Capital expenditures are expected to be in the range of $230 to $250 million.
Biogen Idec may incur charges, realize gains or experience other events in 2012 that could cause actual results to vary from this guidance.
- On January 30, 2012, Biogen Idec announced Kenneth DiPietro joined Biogen Idec as Executive Vice President of Human Resources and a member of our executive management team. Mr. DiPietro joined Biogen Idec from Lenovo Group, where he served as Senior Vice President, Human Resources. He has 30 years of experience serving in a range of human resource and general management positions at companies including Microsoft Corporation, Dell Inc. and PepsiCo.
- On January 26, 2012, Biogen Idec and Elan Corporation announced a global Phase IIIb study, ASCEND, that is being conducted to evaluate the effectiveness of TYSABRI as a treatment for secondary-progressive multiple sclerosis (SPMS). According to the National Multiple Sclerosis Society, approximately half of all people initially diagnosed with relapsing-remitting multiple sclerosis (RRMS) - the most common form of multiple sclerosis (MS) - will transition to SPMS within 19 years.
- On January 20, 2012, Biogen Idec and Elan Corporation announced the U.S. Food and Drug Administration (FDA) approved a product label change for TYSABRI that will help enable individual benefit risk assessment for patients with multiple sclerosis (MS). The new label identifies anti-JCV antibody status as a risk factor for developing an infrequent but serious brain infection known as progressive multifocal leukoencephalopathy (PML). This marks the third risk factor identified to help physicians and people with MS make personalized treatment decisions when considering TYSABRI, a highly effective treatment for relapsing forms of MS.
- On January 4, 2012, Biogen Idec and Isis Pharmaceuticals announced they entered into an exclusive, worldwide option and collaboration agreement under which the companies will develop and commercialize Isis' antisense investigational drug, ISIS-SMNRx, for the treatment of spinal muscular atrophy (SMA). Biogen Idec has the option to develop and commercialize this promising compound for the most common genetic cause of infant mortality and will offer its expertise in neurology to aid in rapid development.
- On December 5, 2011, Samsung and Biogen Idec announced they entered into an agreement to invest $300 million to establish a joint venture to develop, manufacture and market biosimilars. Samsung will take a leading role in the joint venture, with Biogen Idec contributing its expertise in protein engineering and biologics manufacturing.