10-QPeriod: Q3 FY2016

BIOGEN INC. Quarterly Report for Q3 Ended Sep 30, 2016

Filed October 26, 2016For Securities:BIIB

Summary

Biogen Inc. reported solid financial results for the nine months ended September 30, 2016, with total revenues of $8.58 billion, an increase of 8.2% year-over-year. Diluted earnings per share attributable to Biogen Inc. reached $13.92, a notable increase from $11.57 in the prior year period. The company's strong performance was driven by robust sales growth in key products like TECFIDERA, TYSABRI, ELOCTATE, and ALPROLIX, alongside contributions from newly launched biosimilars BENEPALI and FLIXABI. Significant strategic developments during the period include the announced intention to spin off the hemophilia business into a new company, Bioverativ Inc., expected in early 2017. The company also made progress on key pipeline candidates, including nusinersen for spinal muscular atrophy (SMA) which met its primary endpoint in a Phase 3 trial and for which an NDA was filed. In addition, ZINBRYTA received regulatory approvals for multiple sclerosis in the U.S. and EU. The company ended the period with a strong liquidity position, with total cash, cash equivalents, and marketable securities of approximately $7.41 billion.

Financial Statements
Beta
Revenue$2.96B
Cost of Revenue$416.90M
Gross Profit$2.54B
SG&A Expenses$462.70M
Operating Expenses$1.53B
Operating Income$1.43B
Interest Expense$66.00M
Net Income$1.03B
EPS (Basic)$4.72
EPS (Diluted)$4.71
Shares Outstanding (Basic)218.90M
Shares Outstanding (Diluted)219.40M

Key Highlights

  • 1Total revenues for the nine months ended September 30, 2016, increased by 8.2% to $8.58 billion compared to the prior year.
  • 2Diluted earnings per share (EPS) attributable to Biogen Inc. grew to $13.92 for the nine months ended September 30, 2016, up from $11.57 in the same period last year.
  • 3Product revenues increased by 8.5% to $7.32 billion for the nine months ended September 30, 2016, driven by strong performance in Multiple Sclerosis (MS) therapies, notably TECFIDERA and TYSABRI, and hemophilia products ELOCTATE and ALPROLIX.
  • 4The company announced plans to spin off its hemophilia business into an independent company, Bioverativ Inc., expected to be completed in early 2017.
  • 5Key pipeline developments include nusinersen meeting its primary endpoint in a Phase 3 trial for infantile-onset SMA, leading to an NDA filing and EMA MAA submission.
  • 6ZINBRYTA, a new MS therapy, received FDA and EMA approval and began sales in the third quarter of 2016.
  • 7The company ended the period with a healthy balance sheet, reporting $7.41 billion in cash, cash equivalents, and marketable securities, while total borrowings remained relatively stable.

Frequently Asked Questions

For the nine months ended September 30, 2016, Biogen reported total revenues of $8.58 billion, an increase of 8.2% compared to the same period in 2015. Net income attributable to Biogen Inc. was $3.05 billion, resulting in diluted earnings per share of $13.92, up from $11.57 in the prior year.

Revenue growth was primarily driven by strong sales of TECFIDERA, TYSABRI, ELOCTATE, and ALPROLIX. Additionally, revenues from newly launched biosimilars, BENEPALI and FLIXABI, in the EU contributed to the overall increase.

Biogen announced its intention to spin off its hemophilia business into a new publicly traded company named Bioverativ Inc., expected to be completed in early 2017. The company also made significant progress in its pipeline, with nusinersen meeting its primary endpoint in a key Phase 3 trial and ZINBRYTA receiving regulatory approvals.

Biogen maintains a strong financial position, with total cash, cash equivalents, and marketable securities amounting to approximately $7.41 billion as of September 30, 2016. Net cash provided by operating activities for the nine months was $2.95 billion. Total borrowings remained stable at around $6.53 billion.