Biogen Idec first quarter revenues increase 9% to $1.2 billion

Biogen IdecApr 21 2011

Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing and commercialization of innovative therapies, today announced its first quarter 2011 results.

“We had a very solid first quarter based on the performance of our three blockbuster products”

First Quarter 2011 Highlights:

• First quarter revenues were $1.2 billion, an increase of 9% versus 2010. The increase was driven primarily by the continued growth of TYSABRI^® (natalizumab) revenues, which increased 15% to $251 million, and AVONEX^® (interferon beta-1a) revenues, which increased 8% to $642 million. RITUXAN^® (rituximab) revenues from our unconsolidated joint business arrangement were $256 million for the quarter, essentially flat versus prior year.
• Global in-market sales of TYSABRI in the first quarter of 2011 were $349 million, an increase of 20% over the first quarter of 2010. The total was comprised of $170 million in U.S. sales and $179 million in sales to markets outside the U.S.
• On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), first quarter 2011 GAAP diluted EPS were $1.20, an increase of 50% over the first quarter of 2010. GAAP net income attributable to Biogen Idec for the quarter was $294 million, an increase of 35% over the first quarter of 2010.

• Non-GAAP diluted EPS for the first quarter of 2011 were $1.43, an increase of 32% over the first quarter of 2010. Non-GAAP net income attributable to Biogen Idec for the first quarter of 2011 was $349 million, an increase of 18% over the first quarter of 2010. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.

As of March 31, 2011, Biogen Idec had cash, cash equivalents and marketable securities of approximately $2.1 billion.

"We had a very solid first quarter based on the performance of our three blockbuster products," said George A. Scangos, Ph.D., Chief Executive Officer of Biogen Idec. "We continued our transformation into a lean, aggressive and focused company, and the reinvigoration of Research and Development is well underway. We met several exciting pipeline milestones, including the positive Phase III data read-out from the DEFINE trial for BG-12, our oral MS drug candidate, and the enrollment of the first patient in our Phase III EMPOWER trial for dexpramipexole, a potential treatment for ALS. We continue to unlock TYSABRI's potential through cutting edge science and are encouraged by the CHMP's positive opinion to include anti-JC virus antibody status as an additional risk factor for PML in the TYSABRI label. With these successes, we look forward to continue to drive our core business and advance our deep late-stage pipeline."

Share Repurchases

During the first quarter of 2011, Biogen Idec repurchased 2.8 million shares of stock at a total cost of $195 million.

TYSABRI Patient Growth

Based upon data available to us through the TOUCH^® prescribing program and other third-party sources, as of the end of March 2011, we estimate that approximately 58,400 patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively approximately 83,300 patients have ever been treated with TYSABRI in the post-marketing setting.

Other Products and Royalties

Revenues from other products in the first quarter of 2011 were $13 million, the same as in the first quarter of 2010.

Table 4 provides individual product revenues.

Royalties were $26 million in the first quarter of 2011, the same as in the first quarter of 2010.

Corporate partner revenues in the first quarter of 2011 were $15 million, compared to $4 million in the first quarter of 2010.

Recent Events

• On April 19, 2011, Biogen Idec announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of AVONEX PEN™ for patients with relapsing multiple sclerosis and patients with a single demyelinating event.
• On April 19, 2011, Biogen Idec and Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) approved RITUXAN, in combination with corticosteroids, as a new medicine for adults with Wegener's Granulomatosis and Microscopic Polyangiitis.
• On April 18, 2011, Biogen Idec and Elan Corporation announced that the CHMP has adopted a positive opinion for inclusion of an additional risk factor, anti-JC virus antibody status, to the product label for TYSABRI in the European Union. The CHMP also recommended a five year renewal of the Marketing Authorization for TYSABRI.
• On April 11, 2011, Biogen Idec announced positive top-line results from DEFINE, the first of two pivotal Phase III clinical trials designed to evaluate the investigational oral compound BG-12 (dimethyl fumarate) as a monotherapy in people with relapsing-remitting multiple sclerosis. More details about BG-12 will be provided on the company's earnings conference call.
• On April 6, 2011, Biogen Idec submitted an investigational new drug application to the FDA to evaluate its anti-beta-amyloid antibody BART (BIIB037) as a potential new treatment for Alzheimer's disease. Biogen Idec licensed BART from Swiss biotech company Neurimmune in 2007.
• On March 31, 2011, Biogen Idec and Knopp Biosciences announced the enrollment of the first patient in EMPOWER, a multi-national Phase III study evaluating the efficacy, safety and pharmacokinetics of dexpramipexole in patients with amyotrophic lateral sclerosis.