The FINANCIAL — Biogen Inc. on April 24 reported first quarter 2015 results, including revenues of $2.6 billion, a 20% increase compared to the first quarter of 2014. Non-GAAP diluted earnings per share (EPS) for the first quarter of 2015 were $3.82, an increase of 55% over the first quarter of 2014. Non-GAAP net income attributable to Biogen for the first quarter of 2015 was $900 million, an increase of 53% over the first quarter of 2014.
On a reported basis, GAAP diluted EPS for the first quarter of 2015 were $3.49, an increase of 73% over the first quarter of 2014. GAAP net income attributable to Biogen for the first quarter of 2015 was $823 million, an increase of 71% versus the same period in the prior year, according to Biogen.
“In the first quarter, we continued to gain share in the MS market and we believe that our MS product portfolio is well positioned to provide patients the breadth of choices that they need,” said Chief Executive Officer George A. Scangos, Ph.D. “While we saw moderating patient growth of our oral MS therapy TECFIDERA in the U.S. and Germany, the launch of PLEGRIDY continued to go well, and we have seen continued strong performance from TYSABRI. We believe that our portfolio offers patients leading choices among oral, interferon, and high-efficacy therapies, and we look forward to continued growth in our global market share.”
“Last month we presented compelling data for aducanumab (BIIB037), and we are planning to initiate Phase 3 studies later this year,” Dr. Scangos continued. “In January we reported top line results of our phase 2 study of anti-LINGO in acute optic neuritis, which we believe demonstrate this compound’s ability to remyelinate damaged neurons, and we presented detailed results of this study at AAN earlier this week. For the remainder of 2015, we look forward to continued pipeline progress, including a Phase 3 readout for TYSABRI in secondary progressive MS and Phase 2 data for both TYSABRI in acute ischemic stroke and Neublastin in neuropathic pain.”
First Quarter 2015 Performance Highlights
Total multiple sclerosis product sales were $2.1 billion compared to $1.7 billion in the same quarter last year.
TECFIDERA revenues were $825 million compared to $506 million in the same quarter last year. These results consisted of $648 million in U.S. sales and $177 million in sales outside the U.S. compared to $460 million and $46 million, respectively, in the first quarter of 2014.
TECFIDERA revenues in the first quarter of 2015 decreased 10% versus the fourth quarter of 2014. This decline was partially impacted by one fewer shipping week in the U.S. versus the prior quarter, increased discounts and allowances specific to the first quarter of 2015 and updated pricing assumptions in Germany.
Interferon revenues, including AVONEX and PLEGRIDY, were $755 million compared to $761 million in the same quarter last year. These results consisted of $518 million in U.S. sales and $236 million in sales outside the U.S. compared to $476 million and $285 million, respectively, in the first quarter of 2014.
TYSABRI revenues were $463 million compared to $441 million in the same quarter last year. These results consisted of $273 million in U.S. sales and $190 million in sales outside the U.S. compared to $234 million and $207 million, respectively, in the first quarter of 2014. TYSABRI U.S. sales include 13 shipping weeks in the first quarter of 2015 versus 12 in the first quarter of 2014.
Net revenues relating to RITUXAN and GAZYVA from our unconsolidated joint business arrangement were $331 million compared to $297 million in the same quarter last year.
ELOCTATE revenues were $54 million and ALPROLIX revenues were $43 million.
Other Financial Highlights
Revenues for FAMPYRA and FUMADERM were $34 million compared to $35 million in the same quarter last year.
Royalty revenues were $20 million compared to $38 million in the same quarter last year.
Corporate partner revenues were $32 million compared to $52 million in the same quarter last year.
Non-GAAP SG&A expense was $560 million compared to $509 million in the same quarter last year. GAAP SG&A expense was $560 million compared to $512 million in the same quarter last year.
Non-GAAP R&D expense was $461 million compared to $527 million in the same quarter last year. GAAP R&D expense was $461 million compared to $529 million in the same quarter last year.
As of March 31, 2015, Biogen had cash, cash equivalents and marketable securities totaling approximately $3.5 billion.
Neurology Highlights
In January 2015, Biogen announced positive top-line results from the Phase 2 acute optic neuritis (AON) RENEW trial in which treatment with anti-LINGO-1 showed evidence of biological repair of the visual system. Anti-LINGO-1 also demonstrated an acceptable safety profile.
In January 2015, Biogen and Google[x] Life Sciences began a partnership to explore drivers of multiple sclerosis disease progression through investigational technologies and methods, such as novel sensor platforms, advanced laboratory science, and bio-analytical tools.
In February 2015, an international consortium that includes scientists and clinicians from Columbia University Medical Center (CUMC), Biogen and HudsonAlpha Institute for Biotechnology announced the identification of a new gene that is associated with sporadic amyotrophic lateral sclerosis, or Lou Gehrig’s disease. The study was published in the online edition of Science.
In March 2015, Biogen announced data from a pre-specified interim analysis of PRIME, the Phase 1b study of aducanumab (BIIB037), in which the compound demonstrated an acceptable safety profile and positive results on radiologic and clinical measurements in patients with prodromal or mild Alzheimer’s disease.
In March 2015, the European Medicines Agency (EMA) validated the Marketing Authorisation Application (MAA) for ZINBRYTA™ for the treatment of relapsing forms of multiple sclerosis. ZINBRYTA is being jointly developed by Biogen and AbbVie.
In April 2015, Biogen initiated a Phase 3 study of TECFIDERA in secondary progressive multiple sclerosis.
This week, Biogen is presenting new clinical data supporting the Company’s marketed and investigational therapies for neurological diseases at the 67th American Academy of Neurology Annual Meeting. The 73 company-sponsored platform and poster presentations include subgroup efficacy data for TECFIDERA, long-term safety and efficacy data for PLEGRIDY, full results from the Phase 2 RENEW trial of anti-LINGO-1 in acute optic neuritis, subgroup data from the PRIME study of aducanumab in Alzheimer’s disease, and data from the Phase 3 DECIDE study of ZINBRYTA in relapsing-remitting multiple sclerosis.
Hemophilia Highlights
In January 2015, Biogen, Fondazione Telethon and Ospedale San Raffaele announced they entered into a worldwide collaboration to jointly develop gene therapies for the treatment of both hemophilia A and B. The agreement will combine San Raffaele – Telethon Institute for Gene Therapy’s extensive expertise in creating new gene therapy strategies and developing them from the bench to bedside with Biogen’s deep understanding of hematology to potentially treat the underlying causes of hemophilia A and B.
In February 2015, Biogen and Swedish Orphan Biovitrum AB announced positive top-line results of the Kids B-LONG Phase 3 clinical study that evaluated the safety, efficacy and pharmacokinetics of ALPROLIX in children under age 12 with severe hemophilia B.
In March 2015, ELOCTATE was launched in Japan, becoming the first available recombinant hemophilia A therapy in Japan that has prolonged circulation in the body.
Immunology Highlights
In February 2015, Biogen’s collaboration partner UCB announced that dapirolizumab pegol (Anti-CD40 Ligand) was well tolerated in a Phase 1b trial in systemic lupus erythematosus. The compound is expected to progress to Phase 2 in 2016.
Other Events
In January 2015, Biogen and Columbia University Medical Center formed a $30 million strategic alliance to conduct genetics discovery research on the underlying causes of disease and to identify new treatment approaches.
In January 2015, Samsung Bioepis, a joint venture (JV) between Samsung Biologics and Biogen, received EMA acceptance and validation of its MAA for its etanercept biosimilar candidate. In March 2015, the EMA also accepted and validated the MAA for the JV’s infliximab biosimilar candidate.
In February 2015, Biogen completed its acquisition of U.K.-based Convergence Pharmaceuticals. Convergence is a clinical-stage biopharmaceutical company with an innovative portfolio of ion channel-modulating product candidates for neuropathic pain including CNV1014802, a product candidate being developed for trigeminal neuralgia, a chronic orphan disease.
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