Early Access

10-KPeriod: FY2015

REGENERON PHARMACEUTICALS, INC. Annual Report, Year Ended Dec 31, 2015

Filed February 11, 2016For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. (REGN) reported strong financial performance in 2015, driven primarily by significant growth in its lead product, EYLEA. EYLEA demonstrated robust sales growth of 54% year-over-year, solidifying its position as the market-leading anti-VEGF therapy in the U.S. The company also achieved key regulatory milestones, including U.S. and European approval for Praluent (alirocumab) for LDL cholesterol reduction, marking a significant entry into the cardiovascular market. The company's pipeline advanced with positive Phase 3 data for sarilumab in rheumatoid arthritis and progressed dupilumab in atopic dermatitis and asthma, indicating strong future growth potential. Regeneron's commitment to innovation is further evidenced by its advanced genomics initiatives and strategic collaborations. Financially, the company saw substantial increases in both total revenues and net income, reflecting its successful commercialization efforts and ongoing pipeline development. Investors should note the continued reliance on EYLEA for a substantial portion of revenue, alongside the significant potential of Praluent and its robust pipeline. The company's strong financial results and strategic partnerships position it well for future growth, though ongoing regulatory and competitive landscapes remain key factors to monitor.

Financial Statements
Beta
Revenue$4.10B
Cost of Revenue$241.70M
Gross Profit$3.86B
R&D Expenses$1.62B
SG&A Expenses$838.53M
Operating Expenses$2.85B
Operating Income$1.25B
Interest Expense$14.24M
Net Income$636.06M
EPS (Basic)$6.17
EPS (Diluted)$5.52
Shares Outstanding (Basic)103.06M
Shares Outstanding (Diluted)115.23M

Key Highlights

  • 1EYLEA® (aflibercept) Injection delivered 54% net sales growth in 2015, becoming the market-leading branded anti-VEGF therapy in the U.S.
  • 2Praluent® (alirocumab) Injection received regulatory approval in the U.S. and Europe for LDL cholesterol reduction and has been launched in key markets.
  • 3Positive Phase 3 data for sarilumab in rheumatoid arthritis was reported, with a regulatory application submitted to the FDA.
  • 4Significant progress was made with dupilumab, including positive Phase 2b data in asthma and completion of Phase 3 enrollment for atopic dermatitis.
  • 5Two antibody candidates, REGN2222 for RSV prevention and fasinumab for osteoarthritis pain, advanced to Phase 3 studies.
  • 6Regeneron expanded its R&D collaborations with Mitsubishi Tanabe Pharma and Sanofi (immuno-oncology).
  • 7The company's genomics initiative advanced significantly, with the capacity to sequence 100,000 exomes annually.

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