10-QPeriod: Q3 FY2015

REGENERON PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2015

Filed November 4, 2015For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. (REGN) reported a significant increase in revenue and net income for the nine months ended September 30, 2015, compared to the same period in the prior year. This growth was driven primarily by strong performance in net product sales, notably Eylea, and robust collaboration revenues from Sanofi and Bayer HealthCare. The company also announced the FDA approval of Praluent in July 2015, marking a key milestone in its cholesterol-lowering franchise, and has a strong pipeline of antibody-based candidates in various stages of clinical development across multiple therapeutic areas. Financially, Regeneron demonstrated substantial revenue growth, with total revenues reaching $3,005.7 million for the nine months ended September 30, 2015, a significant increase from $2,017.2 million in the prior year. Net income more than doubled, reaching $481.1 million, or $4.18 per diluted share, compared to $248.0 million, or $2.19 per diluted share, in the corresponding period of 2014. The company's balance sheet strengthened, with total assets growing to $5,182.9 million and stockholders' equity increasing significantly, reflecting its growing profitability and continued investment in its business. The company also continues to generate substantial operating cash flow, providing flexibility for ongoing research, development, and strategic initiatives.

Financial Highlights

46 data points
Beta

Revenue

$1.14B

94.1% Gross Margin

Net Income

$210.40M

18.5% Net Margin

EPS (Diluted)

$1.82

Total Assets

$5.18B

Cash & Equivalents

$654.59M

Free Cash Flow

$892.85M

Financial Statements
Beta
Revenue$1.14B
Cost of Revenue$67.20M
Gross Profit$1.07B
R&D Expenses$425.92M
SG&A Expenses$209.99M
Operating Expenses$745.00M
Operating Income$392.42M
Interest Expense$1.72M
Net Income$210.40M
EPS (Basic)$2.04
EPS (Diluted)$1.82
Shares Outstanding (Basic)103.35M
Shares Outstanding (Diluted)115.94M

Key Highlights

  • 1Total revenues for the first nine months of 2015 increased to $3,005.7 million from $2,017.2 million in the same period of 2014, a growth of over 48%.
  • 2Net income more than doubled to $481.1 million for the first nine months of 2015, compared to $248.0 million for the first nine months of 2014.
  • 3EYLEA net product sales in the U.S. showed strong growth, reaching $1,930.0 million for the first nine months of 2015, up from $1,218.8 million in the prior year's period.
  • 4Collaboration revenues from Sanofi and Bayer HealthCare significantly increased, contributing $1,008.9 million in the first nine months of 2015, up from $764.5 million in the comparable period of 2014.
  • 5Regeneron received FDA approval for Praluent (alirocumab) in July 2015 for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease.
  • 6The company's research and development expenses increased to $1,159.4 million for the first nine months of 2015, reflecting continued investment in its pipeline, including significant spending on dupilumab and other antibody candidates.
  • 7Regeneron ended the period with $654.6 million in cash and cash equivalents and $922.4 million in marketable securities, indicating a strong liquidity position.

Frequently Asked Questions

Regeneron's revenue growth was primarily driven by strong net product sales of EYLEA in the U.S. and increased collaboration revenues from its partners, Sanofi and Bayer HealthCare. The significant increase in collaboration revenue reflects growing R&D and commercialization activities under these partnerships, including contributions from new collaborations like the immuno-oncology initiative with Sanofi.

The FDA approval of Praluent in July 2015 is a major milestone for Regeneron, marking the launch of its second major product following EYLEA. Praluent targets PCSK9, a key protein involved in cholesterol regulation, and represents a new therapeutic option for patients with high LDL cholesterol, addressing a significant unmet medical need in cardiovascular disease. Its commercial success will be critical for the company's future growth.

Regeneron's R&D expenses increased substantially in the first nine months of 2015, reaching $1,159.4 million. This increase reflects the company's continued commitment to advancing its robust pipeline of antibody-based product candidates and Trap-based programs. Key areas of investment include dupilumab for allergic and inflammatory conditions, sarilumab for inflammatory diseases, and the ongoing development of various other antibody candidates, signaling a strong focus on innovation and pipeline expansion.

Regeneron demonstrated strong financial health, with significant increases in revenue and net income. The company ended the period with a solid liquidity position, holding $654.6 million in cash and cash equivalents and $922.4 million in marketable securities. This financial strength, coupled with substantial operating cash flow, provides the company with the resources to fund its ongoing research and development activities, potential commercial launches, and strategic investments.