The FINANCIAL — Biogen Inc. on Aptil 25 reported first quarter 2017 financial results, including:
Total revenues of $2.8 billion, a 3% increase versus the prior year and an 8% increase excluding hemophilia revenues.
TYSABRI revenue grew 14% versus the prior year. Outside the U.S., TYSABRI revenues benefited by approximately $45 million due to reaching an agreement with the Price and Reimbursement Committee of the Italian National Medicines Agency (AIFA) related to TYSABRI sales in prior periods.
Versus Q4 2016, Biogen estimates TECFIDERA U.S. revenues were negatively impacted by approximately $50 million to $60 million due to lower inventory levels in the channel.
Worldwide SPINRAZA revenues were $47 million.
GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. of $748 million and $3.46, respectively.
GAAP net income and diluted EPS were negatively impacted by $263 million and $1.22, net of tax, respectively, related to the settlement and license agreement with Forward Pharma including consideration of the U.S. Patent and Trademark Office (USPTO) ruling in favor of Biogen in the interference proceeding, according to Biogen.
Non-GAAP net income and diluted EPS attributable to Biogen Inc. of $1.1 billion and $5.20, respectively.
“I am very pleased with the results of the first quarter. We saw continued stability in our MS business, executed a strong launch of SPINRAZA, grew market share for our biosimilars business across Europe, and reinforced the intellectual property for TECFIDERA,” said Chief Executive Officer Michel Vounatsos. “Furthermore, we continued to build our neurology pipeline with the anticipated addition of our new Phase 2-ready anti-tau antibody.”
“We are encouraged by the progress we made launching SPINRAZA in the U.S., and, following the positive CHMP opinion, we are ramping up pre-launch activities in Europe. The value this therapy provides to patients is compelling, and we are working to accelerate patient access globally,” Vounatsos continued. “Overall, I believe we’re building positive momentum at the company, and I look forward to leading Biogen into a new and exciting era.”
Biogen also recorded GAAP-only pre-tax charges in Q1 2017 of $354 million related to the settlement and license agreement with Forward Pharma including consideration of the USPTO ruling in favor of Biogen in the interference proceeding. These charges are included in amortization of acquired intangible assets and exceed the amounts anticipated in Biogen’s previously announced 2017 full year GAAP financial guidance related to this agreement.
Other Financial Highlights
As of March 31, 2017, Biogen had cash, cash equivalents and marketable securities totaling approximately $5.7 billion, and approximately $6.5 billion in notes payable and other financing arrangements.
For the first quarter of 2017, the Company’s weighted average diluted shares were approximately 216 million. The Company ended the quarter with approximately 214 million basic shares outstanding.
During the first quarter of 2017, Biogen repurchased approximately 2 million shares of the Company’s common stock for a total value of $584 million. Since the end of the quarter, the Company has repurchased an additional approximately 2 million shares for a total value of $543 million.
Business Development Highlights
In April 2017, Biogen announced an agreement with Bristol-Myers Squibb to exclusively license BMS-986168, an experimental medicine with potential in Alzheimer’s disease and progressive supranuclear palsy (PSP), a rare condition that affects movement, speech, vision, and cognitive function. Biogen plans to initiate Phase 2 studies for BMS-986168 in both of these indications. Biogen anticipates making an upfront payment of $300 million to Bristol-Myers Squibb in the second quarter of 2017 as well as a near-term $60 million milestone payment to the former stockholders of iPierian, Inc. upon initiation of a Phase 2 trial for BMS-986168. These amounts exceed the estimated $100 million in business development expense assumed in Biogen’s previously announced 2017 full year financial guidance. This agreement is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States, and is expected to close in the second quarter of 2017.
Other Recent Events
At the 69th annual meeting of the American Academy of Neurology (AAN) being held in Boston from April 22 to April 28, 2017, Biogen is presenting data from its portfolio of treatments and investigational therapies for people with serious neurological and neurodegenerative diseases. Platform and poster presentations include new real-world evidence supporting TECFIDERA and TYSABRI, underscoring the importance of early and appropriate treatment for multiple sclerosis (MS); new data demonstrating the clinically meaningful efficacy and favorable benefit-risk profile of SPINRAZA for spinal muscular atrophy; and previously presented results from the Phase 1b studies of aducanumab, an investigational treatment for early Alzheimer’s disease.
In April 2017, Biogen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the granting of a marketing authorization in the European Union (EU) for SPINRAZA (nusinersen) to treat patients with spinal muscular atrophy. The CHMP reviewed SPINRAZA under an accelerated assessment procedure, which is a regulatory mechanism to facilitate earlier access to patients for medicines that fulfill unmet medical needs. SPINRAZA is the first treatment for spinal muscular atrophy to be recommended by the CHMP for approval in the EU.
In March 2017, the USPTO ruled against the Coalition for Affordable Drugs V LLC, an entity associated with a hedge fund, in the inter partes review of Biogen’s U.S. Patent No. 8,399,514 (the ‘514 patent). The ‘514 patent includes claims covering the treatment of MS with 480 mg of dimethyl fumarate as provided for in Biogen’s TECFIDERA label.
In March 2017, the USPTO ruled against Forward Pharma in the interference proceeding between Forward Pharma’s pending U.S. Patent Application No. 11/576,871 and the ‘514 patent.
In March 2017, Biogen presented data from its Alzheimer’s and Parkinson’s disease programs at the 13th International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™) in Vienna, Austria. The Biogen presentations included data from research of Alzheimer’s and Parkinson’s disease biomarkers; the investigational treatment for Alzheimer’s disease, aducanumab; and the investigational treatment for Parkinson’s disease, BIIB054.
In March 2017, Roche announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11 to 0) that the benefit-risk of rituximab/hyaluronidase for subcutaneous (under the skin) injection was favorable for the treatment of certain blood cancers. This new co-formulation includes the same monoclonal antibody as intravenous RITUXAN® (rituximab) and hyaluronidase, a molecule that helps to deliver medicine under the skin. The FDA is expected to make a decision on approval by June 26, 2017. Roche and Biogen collaborate on RITUXAN in the U.S.
In March 2017, Biogen appointed Anirvan Ghosh, Ph.D. as Senior Vice President, Research and Early Development (RED). Dr. Ghosh will lead Biogen’s RED organization in the discovery and development of drug candidates from idea through proof of concept.
In February 2017, Biogen announced the completion of the separation of its global hemophilia business. The new company, known as Bioverativ, is an independent, publicly traded global biotechnology company focused on hemophilia and other rare blood disorders. Bioverativ trades under the symbol “BIVV” on the NASDAQ Global Select Market.
In January 2017, Siemens Healthineers and Biogen announced plans to jointly develop magnetic resonance imaging (MRI) applications with the intent of quantifying key markers of MS disease activity and progression.
In January 2017, Biogen initiated a Phase 1 trial of an anti-tau monoclonal antibody, BIIB076, in healthy volunteers and participants with Alzheimer’s disease. BIIB076 was derived from Neurimmune’s reverse translational medicine platform.