The FINANCIAL -- Biogen Inc. on October 24 reported third quarter 2017 financial results, including:
Total revenues of $3.1 billion, a 4% increase versus the prior year or a 13% increase excluding hemophilia revenues.
Multiple sclerosis (MS) revenues, including approximately $65 million in royalties on the sales of OCREVUS, were $2.3 billion, demonstrating the resilience of Biogen’s core MS business.
Revenue growth was driven by the launch of SPINRAZA, which contributed $271 million in global revenues.
GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. of $1.2 billion and $5.79, respectively.
Non-GAAP net income and diluted EPS attributable to Biogen Inc. of $1.3 billion and $6.31, respectively.
“In the third quarter, we executed well against our strategic priorities,” said Michel Vounatsos, Biogen’s Chief Executive Officer. “Our multiple sclerosis portfolio demonstrated resilience in an increasingly competitive market, and we’re encouraged by the strength of SPINRAZA’s global launch. We had a solid third quarter, and over the balance of the year we anticipate seasonal pressure as well as increased spending as we invest behind our strategic priorities.”
“We believe that our new agreements with Eisai and Neurimmune will improve our long-term economics of aducanumab. We are pleased by Eisai’s decision to exercise their option on aducanumab, demonstrating their confidence in the asset. The region-based profit split with Eisai is designed to leverage each company’s respective geographic strengths and infrastructures.”
Vounatsos continued, “We made important progress advancing our pipeline, including initiating new trials in Alzheimer’s disease and epilepsy and completing enrollment of studies in stroke and Parkinson’s disease. In the next 12 months, we expect data readouts from multiple programs across our core and emerging growth areas.”
In the third quarter of 2017, TECFIDERA revenues comprised $836 million in sales in the U.S. and $233 million in sales outside the U.S.
In the third quarter of 2016, U.S. TECFIDERA revenues benefited by approximately $40 million to $50 million due to inventory build in the channel, affecting the year over year comparison.
Inventory levels in the third quarter of 2017 for TECFIDERA in the U.S. were relatively flat versus the second quarter of 2017.
In the third quarter of 2017, SPINRAZA revenues comprised $198 million in sales in the U.S. and $73 million in sales outside the U.S. Inventory levels for SPINRAZA in the U.S. were relatively flat versus the second quarter of 2017, as compared to a $30 million increase in the second quarter of 2017. Outside the U.S., SPINRAZA revenues were primarily from Germany and Turkey, according to Biogen.
R&D expense in the third quarter of 2016 included a $75 million payment to Ionis Pharmaceuticals in connection with Biogen’s exercise of its opt-in right to develop and commercialize nusinersen globally.
R&D expense in the second quarter of 2017 included $360 million related to the exclusive license agreement with Bristol-Myers Squibb for BIIB092 (formerly known as BMS-986168).
Other Financial Highlights
As of September 30, 2017, Biogen had cash, cash equivalents, and marketable securities totaling approximately $6.6 billion, with approximately two thirds of this outside the U.S., and approximately $6.5 billion in notes payable and other financing arrangements.
For the third quarter of 2017, the Company’s weighted average diluted shares were approximately 212 million.
Collaboration Agreement Updates
In October 2017, Biogen announced that it renegotiated its agreement with its collaboration partner Eisai Co., Ltd. related to aducanumab, the Company’s investigational treatment for early Alzheimer’s disease (AD). Biogen will now receive 55 percent of potential aducanumab profits in the U.S., 68.5 percent of profits in Europe, and 20 percent of profits in Japan. This agreement leverages Biogen’s strong presence in the U.S. and Europe, and Eisai’s distinct advantage in Asian markets. In connection with this agreement, Eisai exercised its option to jointly develop and commercialize aducanumab.
In October 2017, Biogen also restructured its agreement with Neurimmune related to aducanumab. Biogen agreed to make a one-time payment in exchange for a reduction in Neurimmune’s royalty rate on potential sales of aducanumab.
This week Biogen is presenting more than 80 oral and poster presentations at the seventh Joint Meeting of the European Committee for Treatment and Research in MS and Americas Committee for Treatment and Research in MS (ECTRIMS-ACTRIMS, October 25 - 28, 2017). These presentations include updates on real-world data generation initiatives, including MS PATHS, which leverages technology in routine care to produce real-time data, and the Big MS Data Network, intended to provide pooled registry data from more than 140,000 people living with MS. Biogen is also presenting data supporting the Phase 2 investigational molecule opicinumab (anti-LINGO-1) as a potential therapy to repair damage to the central nervous system caused by MS.
In October 2017, Biogen’s collaboration partner Ionis Pharmaceuticals announced the initiation of a Phase 1/2a clinical study of IONIS-MAPTRx in patients with mild AD. IONIS-MAPTRx is an antisense drug designed to selectively reduce the production of microtubule-associated protein tau (MAPT), or tau protein, in the brain. Biogen has an option to develop and commercialize IONIS-MAPTRx.
In October 2017, Biogen initiated the Phase 2b clinical trial AFFINITY, designed to evaluate opicinumab as an investigational add-on therapy in people with relapsing MS.
In October 2017, Biogen initiated the Phase 2 OPUS study evaluating the efficacy, safety, and tolerability of natalizumab in drug-resistant focal epilepsy.
In October 2017, Biogen presented new data at the 22nd International Congress of the World Muscle Society demonstrating that earlier initiation of treatment with SPINRAZA may improve motor function outcomes in infants and children with spinal muscular atrophy (SMA). Results demonstrated the favorable efficacy and safety profile of SPINRAZA.
In October 2017, Biogen reported that BG00011 (STX-100) achieved proof of biology in a Phase 2a study in patients with idiopathic pulmonary fibrosis. The Company plans to initiate a Phase 2b study for BG00011 in 2018.
In September 2017, Biogen opened a new manufacturing facility in Research Triangle Park, North Carolina dedicated to the production of antisense oligonucleotide therapies (ASOs). This facility gives Biogen the capability to manufacture ASO drugs like SPINRAZA for the first time and will also support a clinical pipeline of additional ASOs.
In August 2017, Biogen completed enrollment in the Phase 2b ACTION2 study evaluating the effects of natalizumab versus placebo on clinical measures of functional independence and activities of daily living in acute ischemic stroke patients. Data from this study is expected in early 2018.
In August 2017, Biogen announced results from a recently conducted analysis of the long-term extension (LTE) of its ongoing Phase 1b study of aducanumab. The updated analyses include data from the placebo-controlled period and LTE for patients treated with aducanumab up to 24 months in the titration cohort and up to 36 months in the fixed-dose cohorts. The results are consistent with previously reported analyses from this ongoing Phase 1b study and support the design of the ongoing Phase 3 studies of aducanumab for early AD.
In August 2017, the European Commission granted a marketing authorization for IMRALDI (also known as SB5), an adalimumab biosimilar referencing HUMIRA. IMRALDI was developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen, and will be commercialized by Biogen in the European Union. With this approval, Biogen became the first company with approved biosimilars in Europe for the three most prescribed anti-TNF biologic treatments.
In July 2017, Biogen completed enrollment in the Phase 1 study of BIIB054, an anti-alpha synuclein antibody, in both healthy volunteers and patients with early Parkinson’s disease.
In September 2017, Biogen appointed Camille Lee as Senior Vice President, Alzheimer’s Therapeutic Area. Ms. Lee is responsible for the design and execution of commercial strategy for the Company’s late-stage AD assets and works in partnership with Biogen’s Research & Development function in overseeing Biogen’s entire Alzheimer’s portfolio. Ms. Lee previously served as Senior Vice President, Diabetes & Obesity Marketing at Novo Nordisk.
In September 2017, Biogen appointed Dr. Sanjay Jariwala as Senior Vice President, Worldwide Medical. Dr. Jariwala is responsible for leading and driving Biogen’s Worldwide Medical strategy working closely with the Company’s Global Therapeutic Operations and Research and Development leadership teams. Dr. Jariwala joined Biogen from AstraZeneca Pharmaceuticals, where he held the roles of Vice President, Head of Strategy and Vice President of Infection, Neuroscience, Autoimmunity and Anti-thrombotics, Global Medical Affairs.
In July 2017, Biogen appointed Anabella Villalobos, Ph.D., as Senior Vice President, Biotherapeutic & Medicinal Sciences (BTMS). Dr. Villalobos leads Biogen’s BTMS organization in the delivery of high-quality, differentiated molecules to the clinic. Dr. Villalobos joined Biogen from Pfizer Worldwide Research and Development where she most recently served as Vice President and Head of Medicinal Synthesis Technologies.