Immunology

Biogen Idec Inc. (NASDAQ:BIIB) today reported third quarter 2013 total revenues of $1.8 billion, an increase of 32% over the third quarter of 2012. Non-GAAP diluted EPS for the third quarter of 2013 were $2.35, an increase of 23% over the third quarter of 2012. Non-GAAP net income attributable to Biogen Idec for the third quarter of 2013 was $561 million, an increase of 23% versus the third quarter of 2012.

GAAP diluted EPS for the third quarter of 2013 were $2.05, an increase of 23% over the third quarter of 2012. GAAP net income for the third quarter of 2013 was $488 million, an increase of 22% over the third quarter of 2012. A reconciliation of our GAAP to Non-GAAP financial results can be found in Table 3 at the end of this release.

Revenue gains were driven by TECFIDERA (dimethyl fumarate) with TECFIDERA revenues totaling $286 million during the third quarter of 2013. According to IMS, TECFIDERA is now the leading oral MS therapy in the United States after only six months on the market. AVONEX^® (interferon beta-1a) revenues decreased slightly versus the third quarter of 2012 to $733 million, while TYSABRI^® (natalizumab) revenue increased by 46% as a result of Biogen Idec recording 100 percent of TYSABRI revenues following the Company's acquisition of full rights for the therapy from Elan in the second quarter of 2013. Global in-market sales for TYSABRI for the quarter were flat as compared to the third quarter of 2012.

"We believe the continued growth of TECFIDERA is a testament to its value to patients and physicians and we are pleased with how it has complemented our robust portfolio of MS therapies," said Chief Executive Officer George A. Scangos.

"Our continuing commitment to innovation also has resulted in exciting new data that show advances in many of our approved and investigational therapies as we continue to enhance options for MS patients now and in the future.

"Looking ahead, we believe we are entering an exciting period in our company's evolution as we anticipate bringing patients significant advances for the treatment of Hemophilia A and B, continue to take measures to strengthen our pipeline with new therapies to treat unmet medical needs, and further our efforts to transform our approach to early-stage research. I believe our organization is prepared to meet all of these new challenges and opportunities," Scangos added.

Performance of our Therapies in Detail

• TECFIDERA revenues were $286 million during the third quarter, consisting of $284 million in U.S. sales and $2 million in sales in Canada. The Company estimates that approximately $12 million of U.S. TECFIDERA revenues in the third quarter represent incremental inventory in the channel. As a result, revenue generated in the U.S. from underlying patient demand was approximately $272 million in the third quarter. As of the end of the third quarter, we estimate U.S. inventory in the channel was in the 4 to 5 week range or approximately $92 million. TECFIDERA currently is approved in the United States, Canada and Australia. The Company continues to work to make TECFIDERA regulatory data protection clearer to all parties prior to approval from the European Medicines Agency (EMA).
• AVONEX third quarter revenues decreased slightly over the same period in the prior year to $733 million. The total was comprised of $457 million in U.S. sales and $277 million in sales outside the U.S.
• TYSABRI revenues, adjusted for the impact of hedging, increased 46% year-over-year to $401 million due to our recording 100 percent of TYSABRI revenues following our acquisition of full rights in TYSABRI from Elan in the second quarter of 2013. Global in-market sales of TYSABRI in the third quarter of 2013 totaled $403 million, remaining flat when compared to TYSABRI global in-market sales in the third quarter of 2012. The total in-market sales were comprised of $232 million in U.S. sales and $171 million in sales outside the U.S.
• RITUXAN^® (rituximab) revenues from our unconsolidated joint business arrangement were $303 million for the quarter, an increase of 5% compared to the third quarter of 2012.

Other Financial Highlights

• Revenues for FAMPYRA^® and FUMADERMâ„¢ totaled $33 million in the third quarter of 2013, compared to $28 million in the third quarter of 2012.
• Royalty revenues totaled $54 million in the third quarter of 2013, compared to $47 million in the third quarter of 2012.
• Corporate partner revenues totaled $17 million in the third quarter of 2013, compared to $12 million in the third quarter of 2012.
• As of September 30, 2013, Biogen Idec had cash, cash equivalents and marketable securities totaling approximately $1.0 billion.
• During the third quarter of 2013, Biogen Idec repurchased 1.7 million shares of stock at a total cost of approximately $360 million.

2013 Financial Guidance

Biogen Idec increased its full year 2013 financial guidance. This guidance consists of the following components:

• Revenue growth is expected to be approximately 23% to 25%.
• Cost of Sales is expected to be approximately 12% to 14% of total revenue.
• R&D expense is expected to be approximately 21% to 23% of total revenue.
• SG&A expense is expected to be approximately 24% to 26% of total revenue.
• Tax expense is expected to be approximately 24% to 25% of pretax income.
• Non-GAAP diluted EPS is expected to be between $8.65 and $8.85.
• GAAP diluted EPS is expected to be between $7.50 and $7.70.
• Capital expenditures are expected to be in the range of $250 to $270 million.

Biogen Idec may incur charges, realize gains or experience other events in 2013 that could cause actual results to vary from this guidance.

New Data and Analyses Across Biogen Idec's MS Franchise