Biogen Idec today reported first quarter 2014 results, including revenue of $2.1 billion, a 51% increase compared to the first quarter of 2013. The revenue growth year-over-year was driven by strong TECFIDERA performance and from recording 100% of TYSABRI ® revenues following our acquisition of complete rights for the asset in the second quarter of 2013. First quarter 2014 non-GAAP diluted earnings per share (EPS) were $2.47, an increase of 25% over the first quarter of 2013. Non-GAAP net income attributable to Biogen Idec for the year was $587 million, an increase of 25% over the first quarter of 2013.
On a reported basis, GAAP diluted EPS for the first quarter of 2014 were $2.02, an increase of 13% over the first quarter of 2013. GAAP net income attributable to Biogen Idec for the first quarter of 2014 was $480 million, an increase of 12% versus the same period in the prior year. (A reconciliation of GAAP to Non-GAAP quarterly financial results and 2014 guidance can be found in Table 3 at the end of this release).
Diluted GAAP and non-GAAP EPS were reduced by approximately 35 cents as a result of a $118 million R&D expense related our new Alzheimer’s disease collaboration agreement with Eisai.
“Biogen Idec started 2014 on a strong note with the approval of TECFIDERA for MS patients in Europe and ALPROLIX for hemophilia B patients in the United States and Canada,” said Chief Executive Officer George A. Scangos, Ph.D. “Following an excellent first year of sales in the U.S., TECFIDERA is off to a solid start in Germany, with plans to launch in additional countries in the coming months. Through the remainder of 2014 we anticipate regulatory decisions on new products for hemophilia and MS, and several important early-stage proof-of-concept and clinical study read-outs – and through our collaboration with Eisai we are building one of the broadest research portfolios targeting Alzheimer’s disease.”
First Quarter 2014 Performance Highlights
•AVONEX ® revenues increased 2% compared to the first quarter of 2013 to $761 million. The total was primarily comprised of $476 million in U.S. sales and approximately $285 million in sales outside the U.S.
•TYSABRI revenues increased by 41% to $441 million as a result of recording 100% of TYSABRI revenues following our acquisition of complete rights to the asset in the second quarter of 2013. Global in-market sales for TYSABRI for the first quarter of 2014 decreased 3% compared to the first quarter of 2013.
•TECFIDERA revenues were $506 million. The total was comprised of $460 million in U.S. sales and approximately $46 million in sales outside the U.S.
•RITUXAN ® and GAZYVA TM net revenues from our unconsolidated joint business arrangement were $297 million.
Other Financial Results
•Revenues for FAMPYRA ® and FUMADERM TM totaled $35 million in the first quarter of 2014, compared to $38 million in the first quarter of 2013.
•Royalty revenues totaled $38 million in the first quarter of 2014, compared to $33 million in the first quarter of 2013.
•Corporate partner revenues totaled $52 million in the first quarter of 2014 compared to $22 million in the first quarter of 2013.
•As of March 31, 2014, Biogen Idec had cash, cash equivalents and marketable securities totaling approximately $2.0 billion.
Updated 2014 Financial Guidance
Biogen Idec also increased its full year 2014 financial guidance. This guidance consists of the following components:
•Revenue growth is expected to be approximately 26% to 28%.
•R&D expense is expected to be approximately 20% to 22% of total revenue. ◦Our full year guidance for R&D expense continues to earmark approximately $200 million for new early stage business development opportunities, of which the Eisai transaction is included in this amount.
•SG&A expense is expected to be approximately 22% to 23% of total revenue.
•Non-GAAP diluted EPS is expected to be between $11.35 and $11.45.
•GAAP diluted EPS is expected to be between $9.85 and $9.95.
Biogen Idec may incur charges, realize gains or experience other events in 2014 that could cause actual results to vary from this guidance.
Multiple Sclerosis (MS) Events
•On February 3, 2014, TECFIDERA (dimethyl fumarate) was approved by the European Commission as a first-line oral treatment for people with relapsing-remitting multiple sclerosis, the most common form of multiple sclerosis.
•In March 2014, the U.S. Food and Drug Administration (FDA) extended the initial Prescription Drug User Fee Act date for its review of the Biologics License Application (BLA) for marketing approval of PLEGRIDY™, a subcutaneous peginterferon beta-1a candidate for relapsing forms of multiple sclerosis. The company now anticipates a U.S. launch of PLEGRIDY in the second half of 2014.
•On March 21, 2014, Health Canada approved ALPROLIX™ [Coagulation Factor IX (Recombinant), Fc Fusion Protein], for the control and prevention of bleeding episodes and routine prophylaxis in adults and children aged 12 and older, with hemophilia B. In Canada, ALPROLIX is the first approved long-acting hemophilia B therapy and is indicated to prevent or reduce the frequency of bleeding episodes with prophylactic infusions starting at once weekly or once every 10-14 days.
•On March 28, 2014, the FDA approved ALPROLIX. In the U.S., ALPROLIX is indicated for the control and prevention of bleeding episodes, perioperative management and routine prophylaxis in adults and children with hemophilia B. The therapy is shown to reduce bleeding episodes with prophylactic infusions starting at least a week apart or up to every 10 days.
•On April 10, 2014, Biogen Idec and Swedish Orphan Biovitrum AB released positive top-line results of the Kids A-LONG Phase 3 clinical study that evaluated the safety and efficacy of ELOCTATE™, an investigational recombinant factor VIII Fc fusion protein product candidate, in children with severe hemophilia A. ELOCTATE was generally well-tolerated and no inhibitors (neutralizing antibodies that may interfere with the activity of the therapy) were detected. Efficacy analyses showed twice-weekly prophylactic dosing with ELOCTATE maintained low bleeding rates in children.
Pipeline Development Highlights
•In January 2014, Biogen Idec entered into an exclusive worldwide collaboration and license agreement with Sangamo BioSciences focused on the development of therapeutics for hemoglobinopathies, inherited conditions that result from the abnormal structure or underproduction of hemoglobin.
•In March 2014, Biogen Idec and Eisai Co., Ltd. entered into a collaboration to develop and commercialize two of Eisai’s clinical candidates for Alzheimer’s disease, E2609 and BAN2401. The agreement also provides Eisai with an option to jointly develop and commercialize two of Biogen Idec’s candidates for AD, the anti-amyloid beta antibody BIIB037 and an anti-tau monoclonal antibody.
Corporate and Commercial Activities
•In January 2014, Biogen Idec and UCB announced that they have signed exclusive agreements granting UCB the right to commercialize Biogen Idec products in South Korea, Hong Kong, Thailand, Singapore, Malaysia and Taiwan, and to develop and commercialize Biogen Idec products in China.
•In February 2014, Biogen Idec announced that Chairman of the Board William D. (Bill) Young will retire from the Company’s Board of Directors, effective at the Company’s 2014 annual meeting of stockholders. Mr. Young has been a member of Biogen Idec’s Board of Directors since 1997 and has served as Chairman of the Board since 2010. Stelios Papadopoulos, Ph.D., a member of Biogen Idec’s Board of Directors since 2008, has been appointed to assume the role of Chairman of the Board following the end of Mr. Young’s term.
•On April 10, 2014, Biogen Idec announced the appointment of Adam M. Koppel, M.D., Ph.D., as senior vice president and chief strategy officer, effective May 15, 2014. Dr. Koppel will be responsible for leading corporate strategy and portfolio management. He will report to George Scangos, Ph.D., CEO, and will be a member of the Biogen Idec management team.