TYSABRI drives Biogen Idec's first-quarter revenues of $1.1 billion

Apr 20 2010

Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its first quarter 2010 results.

“We have several efforts underway that have the potential to drive long-term TYSABRI adoption, including the JC virus assay and SURPASS comparative study, our pipeline has great prospects with six programs in registrational trials, and we have solid financial fundamentals with strong cash flow.”

First Quarter 2010 Highlights:

• First quarter revenues were $1.1 billion, an increase of 7% over the first quarter of 2009, driven primarily by the continued growth of TYSABRI (natalizumab) revenues, which increased 32% to $219 million in the quarter, and AVONEX^® (interferon beta-1a) revenues, which increased 7% to $593 million. RITUXAN^® (rituximab) revenues decreased 9% to $255 million.
• Global in-market net sales of TYSABRI in the first quarter of 2010 were $292 million, an increase of 28% over the first quarter of 2009, of which $135 million were in the U.S. and $157 million were in rest of world markets.
• First quarter 2010 GAAP diluted EPS were $0.80, a decrease of 5% over the first quarter of 2009. GAAP net income attributable to Biogen Idec for the quarter was $217 million, a decrease of 11% over the first quarter of 2009.
• First quarter 2010 non-GAAP diluted EPS were $1.08, an increase of 3% over the first quarter of 2009. Non-GAAP net income attributable to Biogen Idec for the quarter was $296 million, a decrease of 3% over the first quarter of 2009. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.

First quarter GAAP and non-GAAP results include a $14 million charge resulting from the impairment of our investment in AVEO Pharmaceuticals following its initial public offering in March of this year. First quarter results were also impacted by a $13 million charge due to the recently approved Patient Protection and Affordable Care Act. This is the result of expanded 340(B) pricing and increased Medicaid rebates mandated by this legislation.

As of March 31, 2010 Biogen Idec had cash, cash equivalents and marketable securities of approximately $2.2 billion.

"We continue to execute on our strategy and actively position Biogen Idec for future growth," said James C. Mullen, Biogen Idec's President and CEO. "We have several efforts underway that have the potential to drive long-term TYSABRI adoption, including the JC virus assay and SURPASS comparative study, our pipeline has great prospects with six programs in registrational trials, and we have solid financial fundamentals with strong cash flow."

TYSABRI Patient Growth

Based upon data available to us through the TOUCH^® prescribing program and other third-party sources, Biogen Idec estimates that as of the end of March 2010 approximately 50,300 patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively approximately 67,700 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 2010 were $13 million, the same as in the first quarter of 2009.

Table 4 provides individual product revenues.

Royalties were $26 million in the first quarter of 2010 compared to $24 million in the first quarter of 2009.

Share Repurchase Programs

During the first quarter of 2010, Biogen Idec completed the $1 billion share repurchase program announced during the fourth quarter of 2009. The Company repurchased and retired 10.5 million shares at a total cost of $577.6 million during the quarter.

In April 2010, the Board of Directors authorized an additional $1.5 billion share repurchase program with the objective of returning excess cash to shareholders. The shares repurchased under this authorization will be retired. The authorization is open-ended and we expect that repurchases will be made over a longer period than our recently completed $1 billion share repurchase program.

Recent Events

• Biogen Idec presented 38 company-sponsored platform and poster presentations during the American Academy of Neurology's (AAN) 62nd Annual Meeting in Toronto, April 10 - 17, 2010. The AAN Annual Meeting is the world's largest gathering of neurologists. These presentations included data on five compounds that are marketed or currently in development by Biogen Idec and its partners for the treatment of multiple sclerosis (MS), including two approved therapies for MS, TYSABRI and AVONEX, and three promising compounds in the late stages of development: BG-12 (dimethyl fumarate), PEGylated interferon beta-1a and daclizumab.
• On April 1, 2010, Roche announced that Genentech, Inc., a member of the Roche Group, had submitted in collaboration with Biogen Idec a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) to extend the current label for RITUXAN in non-Hodgkin's lymphoma to include maintenance treatment for previously untreated patients with advanced follicular lymphoma.
• On March 24, 2010, Biogen Idec and Elan Corporation, plc announced enrollment of the first patient in a global Phase 3b, randomized, rater-blinded, active-controlled study designed to evaluate switching to TYSABRI from Copaxone^® (glatiramer acetate) or Rebif^® (interferon beta-1a) in patients with relapsing remitting MS (RRMS). The study, called SURPASS, is expected to enroll 1,800 patients in 27 countries and provide direct comparative data of different treatment options for RRMS patients who experience breakthrough disease activity.
• On March 22, 2010, Biogen Idec announced that Dr. Eric K. Rowinsky and Dr. Stephen A. Sherwin had been appointed to its Board of Directors pursuant to an agreement with Carl C. Icahn and certain funds affiliated with Mr. Icahn.
  
  Under the terms of the agreement, the Icahn Group agreed to vote its shares at the 2010 Annual Meeting for Biogen Idec's director nominees, who will include current directors Nancy L. Leaming and Brian S. Posner as well as Drs. Rowinsky and Sherwin.

• On March 8, 2010, Roche and Biogen Idec announced their decision to suspend ocrelizumab treatment of patients in the rheumatoid arthritis program. The decision follows the recommendation of the independent Ocrelizumab RA & Lupus Data and Safety Monitoring Board based on their assessment of the studies in RA (SCRIPT, FEATURE, FILM and STAGE) and lupus (BELONG and BEGIN).
• In March, 2010, Biogen Idec and Elan began enrolling patients in two clinical studies, STRATIFY 1 and 2, to evaluate the potential clinical utility of a blood test that is designed to detect antibodies to the JC virus. These studies are intended to define the prevalence of serum JC virus antibody in patients with relapsing MS receiving or considering treatment with TYSABRI and to evaluate the potential to stratify patients into lower or higher risk for developing PML based on antibody status.
• On February 18, 2010, Genentech and Biogen Idec announced that the FDA approved RITUXAN in combination with fludarabine and cyclophosphamide for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia.
• On February 18, 2010, Biogen Idec and Swedish Orphan Biovitrum announced that they restructured the collaboration agreement for the companies' long-acting, recombinant Factor VIII Fc fusion protein (rFVIIIFc) in hemophilia A patients and the recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients.
  
  Under the amended agreement, Biogen Idec will assume full development responsibilities and costs, as well as manufacturing rights for the rFVIIIFc and rFIXFc programs. Biogen Idec also gains marketing responsibility for the rest-of-world territories that had previously been shared between the two companies, in addition to its existing commercial rights in North America. Swedish Orphan Biovitrum will retain commercial rights in Europe, Russia, Turkey and the Middle East. The cross-royalty rate has been reduced for both companies. The royalty rates could be further adjusted when Biogen Idec's increased costs are reimbursed.

• In January 2010, we initiated patient enrollment in a registrational study for long-acting recombinant Factor IX in hemophilia B, known as B-LONG. The initiation of this study resulted in the achievement of a milestone, obligating us to pay $40.0 million to the former shareholders of Syntonix. We recorded this payment as acquired in-process research and development expense during the first quarter of 2010.

SOURCE Biogen Idec

www.biogenidec.com