10-QPeriod: Q2 FY2019

BIOGEN INC. Quarterly Report for Q2 Ended Jun 30, 2019

Filed July 24, 2019For Securities:BIIB

Summary

Biogen Inc. reported a strong second quarter of 2019, with total revenues increasing by 7.8% year-over-year to $3.62 billion. This growth was driven by solid performance in its core Multiple Sclerosis (MS) franchise, particularly TECFIDERA, which saw a 5.3% increase in U.S. revenues, and continued strong growth from SPINRAZA for Spinal Muscular Atrophy (SMA), up 12.0% in U.S. revenues. The company also reported significant increases in biosimilar revenues (up 45.4%) and revenues from anti-CD20 therapeutic programs (up 17.5%). Net income attributable to Biogen Inc. surged by 72.5% to $1.49 billion, leading to a substantial increase in diluted earnings per share (EPS) to $7.85, up 87.8% from the prior year. This profitability was boosted by a notable decrease in total costs and expenses, primarily due to a significant reduction in R&D spending compared to the prior year, which included substantial charges related to a collaboration with Ionis Pharmaceuticals. Additionally, a lower effective tax rate contributed favorably to net income. Financially, Biogen maintained a strong liquidity position with approximately $4.3 billion in cash, cash equivalents, and marketable securities. The company continued its commitment to shareholder returns, repurchasing approximately $910 million of its common stock under its new $5.0 billion repurchase program during the quarter, in addition to completing its prior $3.5 billion repurchase program. Biogen also completed the acquisition of Nightstar Therapeutics plc for $847.6 million, strengthening its pipeline in ophthalmology with gene therapy assets.

Financial Statements
Beta
Revenue$3.62B
Cost of Revenue$476.30M
Gross Profit$3.14B
SG&A Expenses$587.60M
Operating Expenses$1.66B
Operating Income$1.96B
Interest Expense$47.70M
Net Income$1.49B
EPS (Basic)$7.85
EPS (Diluted)$7.85
Shares Outstanding (Basic)190.30M
Shares Outstanding (Diluted)190.40M

Key Highlights

  • 1Total revenues grew 7.8% to $3.62 billion, driven by strong product sales and collaboration revenues.
  • 2Net income increased significantly by 72.5% to $1.49 billion, with diluted EPS rising 87.8% to $7.85.
  • 3Product revenues saw a 4.5% increase to $2.88 billion, with TECFIDERA and SPINRAZA showing solid growth.
  • 4Acquisition of Nightstar Therapeutics plc for $847.6 million closed on June 7, 2019, adding gene therapy assets in ophthalmology.
  • 5The company repurchased approximately $910 million of its common stock in Q2 2019 under its new $5.0 billion share repurchase program.
  • 6Research and development expenses decreased by 50.6% due to a strong prior year comparable period that included significant charges related to an Ionis Pharmaceuticals agreement.
  • 7Proposed divestiture of Hillerød, Denmark manufacturing operations expected to close in Q3 2019, with an estimated loss on sale recognized in the quarter.

Frequently Asked Questions

Biogen's revenue growth was primarily driven by its Multiple Sclerosis (MS) products, particularly TECFIDERA, and SPINRAZA for Spinal Muscular Atrophy (SMA). Additionally, biosimilar revenues and revenues from anti-CD20 therapeutic programs (like RITUXAN and GAZYVA) showed substantial growth. Contract manufacturing revenues also contributed positively to 'Other revenues'.

Profitability saw a significant improvement. Net income attributable to Biogen Inc. increased by 72.5% to $1.49 billion, and diluted earnings per share (EPS) rose by 87.8% to $7.85. This was driven by revenue growth, a substantial reduction in R&D expenses, and a lower effective tax rate.

Biogen completed the acquisition of Nightstar Therapeutics plc for $847.6 million, expanding its pipeline into gene therapy for inherited retinal disorders. The company also continued its share repurchase program, buying back approximately $910 million of its common stock. A proposed divestiture of its Hillerød, Denmark manufacturing operations is expected to close in the third quarter of 2019.

The company acquired Nightstar Therapeutics plc with two mid-to late-stage clinical assets (BIIB111 and BIIB112) for inherited retinal disorders. Separately, Biogen and Eisai announced the discontinuation of the Phase 3 trials for aducanumab, an Alzheimer's disease candidate, while continuing to analyze the data. The New Drug Application for diroximel fumarate (BIIB098) for RMS was accepted for review by the FDA.