Biogen Idec Inc. 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 FUMADERM™ 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
Earlier this month, Biogen Idec presented extensive new data from its multiple sclerosis portfolio at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress in Copenhagen, Denmark. More than 55 company-sponsored presentations were showcased. Highlights included:
•Interim analyses from the ENDORSE long-term extension study showing that TECFIDERA continues to offer consistent and strong efficacy combined with a favorable safety profile in a broad range of patients with relapsing-remitting multiple sclerosis in patients who had received TECFIDERA for up to six and a half years.
•New data on TYSABRI that reaffirmed the therapy’s efficacy in reducing multiple sclerosis disease activity. This effect was particularly significant in people with relapsing MS who initiated treatment when they had lower Expanded Disability Status Scale (EDSS) scores as well as in those who have been treated for more than two years.
•New clinical and MRI data from year one of the two-year, pivotal, Phase 3 ADVANCE study of PLEGRIDY TM (peginterferon beta-1a), which demonstrated a reduction in relapses, disability progression and the number of MS lesions when compared to placebo, and further supported the clinical efficacy profile of PLEGRIDY as a potential new treatment option for people with multiple sclerosis.
•On September 9, 2013, Biogen Idec announced a broad, multi-year collaboration with Isis Pharmaceuticals to leverage antisense technology to advance the treatment of neurological diseases. The agreement combines Biogen Idec’s expertise in neurology with Isis’ leadership in antisense technology to develop novel therapies to treat neurological disorders. Through this collaboration, Biogen Idec gains exclusive rights to the use of Isis’ antisense technology to develop therapies for a broad range of neurological targets. Targets discovered in this collaboration can be developed by Biogen Idec as biologic, small molecule, or antisense drugs. The agreement also provides Biogen Idec with the option to license ongoing antisense development programs against neurological targets.
•This month, Biogen Idec, along with other partners including the National Hemophilia Foundation (NHF), announced the national rollout of My Life, Our Future: Genotyping for Progress in Hemophilia, which offers genetic testing to people with hemophilia. Through genotyping, it is possible to identify the specific DNA mutation(s), or change(s), responsible for a person’s hemophilia and provide potentially useful information about bleeding severity or risk for inhibitors. The program will also work to create a central repository to enhance research to drive a better scientific understanding of the disorder.
•On September 24, 2013, Biogen Idec announced that it has been added to the prestigious Dow Jones Sustainability World Index (DJSI World) – becoming the first and only U.S. based biotech sector firm to make the list. The Company was also named to the Dow Jones Sustainability Index (DJSI) North America for the fourth consecutive year, one of only three biotech companies included.