10-QPeriod: Q3 FY2019

BIOGEN INC. Quarterly Report for Q3 Ended Sep 30, 2019

Filed October 22, 2019For Securities:BIIB

Summary

Biogen Inc. reported strong financial performance for the nine months ended September 30, 2019, with total revenues increasing by 7.8% year-over-year to $10.7 billion. Diluted earnings per share saw a significant increase of 38.5% to $23.35. This growth was driven by robust sales across key product lines, particularly SPINRAZA and biosimilars, which experienced substantial revenue increases. The company also saw positive contributions from its anti-CD20 therapeutic programs. During the period, Biogen completed the acquisition of Nightstar Therapeutics plc, expanding its pipeline in ophthalmology, and divested its Hillerød, Denmark manufacturing operations, generating significant cash. Despite these positive results, investors should note ongoing legal proceedings related to patent infringement for TECFIDERA and other products. The company also faces continued pricing pressures and competition in the biopharmaceutical industry. Management remains focused on investing in research and development and executing strategic initiatives to drive future growth, while also returning capital to shareholders through share repurchases.

Financial Statements
Beta
Revenue$3.60B
Cost of Revenue$430.00M
Gross Profit$3.17B
SG&A Expenses$554.50M
Operating Expenses$1.79B
Operating Income$1.81B
Interest Expense$45.80M
Net Income$1.55B
EPS (Basic)$8.40
EPS (Diluted)$8.39
Shares Outstanding (Basic)184.00M
Shares Outstanding (Diluted)184.20M

Key Highlights

  • 1Total revenues for the first nine months of 2019 increased by 7.8% to $10.7 billion, compared to $9.9 billion in the same period of 2018.
  • 2Diluted earnings per share (EPS) grew by 38.5% to $23.35 for the first nine months of 2019, up from $16.83 in 2018.
  • 3SPINRAZA revenues showed significant growth, increasing by 11.8% in the U.S. and 35.6% internationally for the first nine months of 2019.
  • 4Biosimilar revenues increased by 39.4% for the first nine months of 2019, driven by the launch of IMRALDI.
  • 5Acquired Nightstar Therapeutics plc in June 2019 for $847.6 million, adding gene therapy assets for inherited retinal disorders.
  • 6Completed the divestiture of Hillerød, Denmark manufacturing operations for approximately $881.9 million in cash.
  • 7The company repurchased approximately $1.6 billion of common stock in the first nine months of 2019 under its $5.0 billion share repurchase program.

Frequently Asked Questions

Biogen's primary revenue drivers were its Multiple Sclerosis (MS) products, particularly TECFIDERA, which saw a 1.4% increase in U.S. revenues, and SPINRAZA for Spinal Muscular Atrophy (SMA), which experienced an 11.8% increase in U.S. revenues. Biosimilar products also showed strong growth, with a 39.4% increase in revenues.

Biogen completed the acquisition of Nightstar Therapeutics plc, a gene therapy company, for $847.6 million, strengthening its pipeline in ophthalmology. Additionally, the company divested its Hillerød, Denmark manufacturing operations to FUJIFILM for approximately $881.9 million in cash, which helped bolster liquidity.

Biogen demonstrated strong profitability, with net income attributable to Biogen Inc. increasing to $4.45 billion for the first nine months of 2019 from $3.53 billion in the prior year. This was supported by a decrease in the effective tax rate and efficient cost management, despite increased R&D and SG&A expenses.

For TECFIDERA, Biogen anticipates continued global demand growth, with international markets expected to outperform U.S. volume declines, despite increasing competition. For SPINRAZA, growth is expected to moderate due to a lower rate of new patient starts and the dynamic of loading doses, and the company faces competition from new gene therapy products in the SMA market.