Biogen Idec reports revenue of $1.2 billion for second quarter 2011

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

Second Quarter 2011 Highlights:

  • Second quarter revenues were $1.2 billion, flat compared to the second quarter of 2010. TYSABRI (natalizumab) revenues increased 28% year-over-year to $281 million while AVONEX® (interferon beta-1a) revenues increased 5% year-over-year to $659 million. RITUXAN® (rituximab) revenues from our unconsolidated joint business arrangement were $216 million for the quarter, down 29% versus prior year. Our share of RITUXAN revenues from our unconsolidated joint business was reduced by approximately $50 million during the second quarter of 2011 as a result of an accrual relating to an intermediate decision in Genentech, Inc.'s ongoing arbitration with Hoechst GmbH.
  • Global in-market sales of TYSABRI in the second quarter of 2011 were $389 million, an increase of 31% over the second quarter of 2010. The total was comprised of $183 million in U.S. sales and $206 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), second quarter 2011 GAAP diluted EPS were $1.18, an increase of 5% over the second quarter of 2010. GAAP net income attributable to Biogen Idec for the quarter was $288 million, a decrease of 2% from the second quarter of 2010.
  • Non-GAAP diluted EPS for the second quarter of 2011 were $1.36, an increase of 4% over the second quarter of 2010. Non-GAAP net income attributable to Biogen Idec for the second quarter of 2011 was $332 million, a decrease of approximately 3% from the second quarter of 2010. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.

As of June 30, 2011, Biogen Idec had cash, cash equivalents and marketable securities of approximately $2.5 billion.

"We are pleased with our strong second quarter performance" said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. "Our commercial and financial performance has been strong, and we have made great progress on our pipeline, which is now focused on high quality projects in areas of our expertise - neurology, immunology, and hemophilia. This quarter, we were excited by the European Commission's approval of the inclusion of JCV antibody status as an additional PML risk factor in TYSABRI labeling, as well as the conditional approval for FAMPYRA. We continue to focus on execution to insure that we achieve our ambitious goals and continue our positive momentum into the second half of this year."

Share Repurchases

During the second quarter of 2011, Biogen Idec repurchased 2.2 million shares of stock at a total cost of $191 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 June 2011, we estimate that approximately 61,500 patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively approximately 88,100 patients have ever been treated with TYSABRI in the post-marketing setting.

Other Products and Royalties

Revenues from other products in the second quarter of 2011 were $16 million, an increase of 36% over the second quarter of 2010.

Table 4 provides individual product revenues.

Royalties were $29 million in the second quarter of 2011, a decrease of 5% compared to the second quarter of 2010.

Corporate partner revenues in the second quarter of 2011 were $7 million, compared to $17 million in the second quarter of 2010.

Revised Financial Guidance

Biogen Idec also revised its 2011 financial guidance. This guidance consists of the following components:

  • Revenue growth is expected to be in the low to mid-single digits versus 2010.
  • Cost of Sales is expected to be approximately 9% to 10% of total revenue.
  • 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 pretax income.
  • GAAP diluted EPS is expected to be above $4.91.
  • Non-GAAP diluted EPS is expected to be above $5.70.
  • Capital expenditures are expected to be 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.

Recent Events

  • On July 26, 2011, Biogen Idec and Swedish Orphan Biovitrum presented data on the long-lasting recombinant factor VIII therapy at the International Society on Thrombosis and Haemostasis meeting. Results showed the potential to significantly reduce the burden of treatment for people with Hemophilia A.
  • On July 20, 2011, Biogen Idec received conditional approval in the European Union for FAMPYRA® (prolonged-release fampridine tablets) to improve walking in adults with multiple sclerosis. The novel oral therapy provides clinically meaningful improvement in daily function.
  • On July 3, 2011, Biogen Idec researchers identified a novel approach for promoting remyelination and inhibiting autoimmune activation as a potential therapeutic option for the treatment of multiple sclerosis.
  • On June 23, 2011, Biogen Idec announced that its share of RITUXAN revenues from the unconsolidated joint business will be reduced by approximately $50 million during the second quarter of 2011 as a result of an accrual relating to an intermediate decision in Genentech's ongoing arbitration with Hoechst.
  • On June 22, 2011, the European Commission approved the inclusion of Anti-JC Virus Antibody Status as a PML risk factor in TYSABRI labeling. A five year marketing authorization for TYSABRI was also renewed in the EU.
  • On June 7, 2011, Biogen Idec received approval in the European Union for AVONEX(R) PEN(TM), the first single-use intramuscular autoinjector designed to improve convenience of once-weekly AVONEX administration.
  • On June 6, 2011, Biogen Idec announced positive data from the AVONEX Dose Titration Study at the 2011 Annual Meeting of the Consortium of Multiple Sclerosis Centers. The data showed that titrating AVONEX at the initiation of treatment reduced the severity of flu-like symptoms.
  • On May 20, 2011, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use issued a positive opinion on the Marketing Authorisation Application for FAMPYRA.
  • On May 16, 2011, Biogen Idec received approval for FAMPYRA from The Australian Therapeutic Goods Administration to improve walking ability in adult patients with multiple sclerosis.
  • On May 9, 2011, Biogen Idec and Swedish Orphan Biovitrum received an opinion from the EMA agreeing to a pediatric investigational plan for the companies' long-lasting Hemophilia B therapy.
Source:

Biogen Idec Inc.

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