The FINANCIAL -- Biogen Idec Inc. (NASDAQ: BIIB), one of the global biotechnology leaders in the discovery, development, manufacturing, and commercialization of innovative therapies, on February 9 announced its full year and fourth quarter 2009 results.
Full Year 2009 Highlights:
• Total revenues in 2009 were $4.4 billion, an increase of 7% versus 2008. The increase was driven primarily by the continued growth of TYSABRI(R) (natalizumab) revenues, which increased 32% to $776 million, and AVONEX(R) (interferon beta-1a) revenues, which increased 5% to $2.3 billion. RITUXAN(R) (rituximab) revenues from our unconsolidated joint business arrangement decreased 3% to $1.1 billion for the year due to the expiration of royalties on sales outside the United States.
• Global in-market 2009 TYSABRI net sales were $1.1 billion, an increase of 30% over 2008. The total was comprised of $509 million in U.S. sales and $551 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 2009 diluted earnings per share (EPS) were $3.35, an increase of 26% over 2008. GAAP net income attributable to Biogen Idec for 2009 was $1.0 billion, an increase of 24% over 2008.
• Non-GAAP diluted EPS for 2009 were $4.12, an increase of 13% over 2008. Non-GAAP net income attributable to Biogen Idec for 2009 was $1.2 billion, an increase of 11% over 2008. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.
"Biogen Idec delivered strong financial and operational performance in 2009. We recorded our sixth consecutive year of double-digit EPS growth, TYSABRI became Biogen Idec's third blockbuster product and we advanced two programs into registrational trials," said James C. Mullen, Biogen Idec's President and CEO. "We are confident that our continued focus on our products, robust pipeline and disciplined use of cash will fuel future earnings growth and drive value for Biogen Idec shareholders."
Fourth Quarter 2009 Highlights:
• Fourth quarter revenues were $1.1 billion, an increase of 5% over the fourth quarter of 2008, driven primarily by the continued growth of TYSABRI revenues, which increased 39% to $216 million in the quarter, and AVONEX revenues, which increased 5% to $596 million. RITUXAN revenues decreased 15% to $257 million.
• Global in-market net sales of TYSABRI in the fourth quarter of 2009 were $296 million, an increase of 37% over the fourth quarter of 2008, of which $137 million were in the U.S. and $159 million were in rest of world markets.
• Fourth quarter 2009 GAAP diluted EPS were $1.06, an increase of 51% over the fourth quarter of 2008. GAAP net income attributable to Biogen Idec for the quarter was $306 million, an increase of 48% over the fourth quarter of 2008.
• Fourth quarter 2009 non-GAAP diluted EPS were $1.20, an increase of 29% over the fourth quarter of 2008. Non-GAAP net income attributable to Biogen Idec for the quarter was $345 million, an increase of 26% over the fourth quarter of 2008.A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.
As of December 31, 2009 Biogen Idec had cash, cash equivalents and marketable securities of approximately $2.5 billion.
Share Repurchases
During the fourth quarter of 2009, Biogen Idec repurchased 14.8 million shares of stock at a total cost of $694 million. Two share repurchase authorizations accounted for the activity as follows:
• Biogen Idec repurchased the 6.0 million shares remaining from its 2006 share repurchase authorization at a cost of $271 million. The 2006 share repurchase program was used principally for share stabilization.
• In October 2009 the Board authorized a $1 billion share repurchase program; Biogen Idec purchased 8.8 million shares for a total of $422 million under this authorization. These shares have been retired.
During the first quarter of 2010 to February 5, 2010, we purchased an additional 5.4 million shares for a total of $289 million under the October 2009 share repurchase authorization. There is $288 million remaining under this program.
TYSABRI Patient Growth
Based upon data available to us through the TOUCH(R) prescribing program and other third-party sources as of the end of December 2009, we estimate that approximately 48,800 patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively approximately 64,600 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 2009 were $14 million, as compared to $10 million in the fourth quarter of 2008. Revenues from other products for the full year of 2009 were $54 million as compared to $49 million in 2008.
Table 4 provides individual product revenues.
Royalties were $41 million in the fourth quarter of 2009 compared to $29 million in the fourth quarter of 2008. Royalties for the full year 2009 were $124 million as compared to $116 million in 2008.
Financial Guidance
Biogen Idec also outlined its 2010 financial guidance. This guidance excludes any significant business development activities and consists of the following components:
• Revenue growth in 2010 is expected to be in the mid single digits.
• Core operating expense growth is expected to be in the low single digits.
• R&D is expected to be approximately 24% to 27% of total revenue.
• SG&A is expected to be approximately 20% to 22% of total revenue.
• GAAP EPS is expected to be above $3.71.
• Non-GAAP diluted EPS is expected to be above $4.55.
• We expect capital expenditures in the range of $170 to $200 million.
Biogen Idec may incur charges, realize gains or experience other events in 2010 that could cause actual results to vary from this guidance.
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