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Biogen Idec Inc. (NASDAQ: BIIB) today announced full year and fourth quarter 2012 results.
Total revenues in 2012 increased 9% to $5.5 billion year-over-year.
On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), full year 2012 GAAP diluted EPS were $5.76, an increase of 14% versus 2011. GAAP net income attributable to Biogen Idec for the year was $1.4 billion, an increase of 12% versus 2011.
Non-GAAP diluted EPS for 2012 were $6.53, an increase of 11% over 2011. Non-GAAP net income attributable to Biogen Idec for 2012 was $1.6 billion, an increase of 8% versus 2011.
As of December 31, 2012, Biogen Idec had cash, cash equivalents and marketable securities of approximately $3.7 billion.
"We recorded another solid year of revenue growth and profitability, all while advancing our late-stage pipeline and investing in upcoming product launches," said George A. Scangos, Ph.D., chief executive officer, for Biogen Idec. "We are poised to begin what we expect will be a remarkable period of growth, driven by our promising compounds including TECFIDERA and Peginterferon beta-1a for MS, and both Factor VIII and Factor IX for hemophilia. We appreciate the excitement that MS and hemophilia patients have expressed to us about these candidates, and our teams are well prepared to support the launches. We expect MS and hemophilia patients will benefit from these important new products for years to come."
Full Year 2012 Highlights:
TYSABRI® (natalizumab) revenues increased 5% year-over-year to $1.1 billion while AVONEX® (interferon beta-1a) revenues increased 8% year-over-year to $2.9 billion. RITUXAN® (rituximab) revenues from our unconsolidated joint business arrangement were $1.1 billion for the year, an increase of 14% versus prior year.
Global in-market sales of TYSABRI for the full year of 2012 were $1.6 billion, an increase of 8% over 2011. The total was comprised of $886 million in U.S. sales and $745 million in sales outside the U.S.
Based upon data available to us through the TOUCH® prescribing program and other third-party sources, as of the end of December 2012, the Company estimates that approximately 72,700 patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively approximately 112,200 patients have ever been treated with TYSABRI in the post-marketing setting.
For the full year, revenues from other products were $117 million, an increase of 67% versus 2011.
Table 4 provides individual product revenues.
Royalties in 2012 increased 6% to $169 million, versus 2011.
Corporate partner revenues for the full year of 2012 were $44 million, compared to $57 million in 2011.
Fourth Quarter 2012 Highlights:
Fourth quarter revenues increased 7% to $1.4 billion, compared to the fourth quarter of 2011. TYSABRI revenues increased 10% year-over-year to $295 million while AVONEX revenues increased 7% year-over-year to $753 million. RITUXAN revenues from our unconsolidated joint business arrangement were $281 million for the quarter, an increase of 9% over the prior year.
Global in-market sales of TYSABRI in the fourth quarter of 2012 were $433 million, an increase of 14% over the fourth quarter of 2011. The total was comprised of $243 million in U.S. sales and $190 million in sales outside the U.S.
Revenues from other products in the fourth quarter of 2012 were $26 million, compared to $24 million in the fourth quarter of 2011.
Royalties were $56 million in the fourth quarter of 2012, an increase of 7% compared to the fourth quarter of 2011.
For the fourth quarter of 2012, corporate partner revenues were $6 million, compared to $20 million in 2011.
During the quarter, we corrected our accounting for taxes on capitalized interest at our Denmark facility. The error accumulated over several prior years and increased tax expense in the quarter by $29 million. GAAP and non-GAAP net income attributable to Biogen Idec and diluted EPS include the impact of our correction. This unfavorably impacted both GAAP and non-GAAP fourth quarter 2012 diluted EPS by 12 cents.
Fourth quarter 2012 GAAP diluted EPS were $1.23, an increase of 1% over the fourth quarter of 2011. GAAP net income attributable to Biogen Idec for the quarter was $292 million, a decrease of 3% from the fourth quarter of 2011.
Non-GAAP diluted EPS for the fourth quarter of 2012 were $1.40, a decrease of 7% over the fourth quarter of 2011. Non-GAAP net income attributable to Biogen Idec for the fourth quarter of 2012 was $335 million, a decrease of 10% from the fourth quarter of 2011. Table 3 includes a reconciliation of our GAAP to non-GAAP results.
Late Stage Pipeline Updates
On January 24, 2013, Biogen Idec released the primary efficacy analysis and safety data, from its Phase 3 pivotal clinical trial, ADVANCE. Results support peginterferon beta-1a as a potential treatment dosed every two weeks or every four weeks for relapsing-remitting multiple sclerosis. Peginterferon beta-1a is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body, enabling study of a less frequent dosing schedule. Based on the top-line data from the ADVANCE clinical trial, regulatory submissions in the United States and European Union are planned for peginterferon beta-1a in mid-2013.