10-KPeriod: FY2014

REGENERON PHARMACEUTICALS, INC. Annual Report, Year Ended Dec 31, 2014

Filed February 12, 2015For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. demonstrated robust revenue growth in 2014, reaching $2,819.6 million, an increase from $2,104.7 million in 2013, primarily driven by strong performance in its EYLEA franchise. EYLEA's net product sales in the U.S. reached $1,736.4 million in 2014, with significant international sales of $1,038.5 million contributing to overall growth. The company also reported progress in its late-stage pipeline, with key clinical trial updates for PRALUENT (alirocumab) for cholesterol reduction and sarilumab for rheumatoid arthritis, alongside ongoing development for dupilumab in allergic conditions. While net income decreased to $348.1 million ($3.07 per diluted share) in 2014 from $424.4 million ($3.81 per diluted share) in 2013, this was largely attributed to the absence of a significant tax benefit recorded in 2012. Regeneron's strategic focus remains on leveraging its VelociSuite technologies for drug discovery and expanding its therapeutic reach into areas with high unmet medical needs. The company also highlighted its human genetics initiative as a key long-term growth driver.

Financial Highlights

47 data points
Beta

Revenue

$2.82B

95.4% Gross Margin

Net Income

$338.13M

12.0% Net Margin

EPS (Diluted)

$2.98

Total Assets

$3.84B

Cash & Equivalents

$648.72M

Free Cash Flow

$752.43M

Financial Statements
Beta
Revenue$2.82B
Cost of Revenue$129.03M
Gross Profit$2.69B
R&D Expenses$1.27B
SG&A Expenses$519.27M
Operating Expenses$2.00B
Operating Income$823.92M
Interest Expense$37.37M
Net Income$338.13M
EPS (Basic)$3.36
EPS (Diluted)$2.98
Shares Outstanding (Basic)100.61M
Shares Outstanding (Diluted)113.41M

Key Highlights

  • 1EYLEA continues to be the primary revenue driver, with U.S. sales reaching $1.74 billion and international sales by Bayer HealthCare exceeding $1.04 billion in 2014.
  • 2The company reported total revenues of $2.82 billion in 2014, a significant increase from $2.10 billion in 2013, showcasing strong top-line growth.
  • 3Regeneron has a substantial pipeline with 17 product candidates in clinical development, including key late-stage programs like PRALUENT (PCSK9 inhibitor) and sarilumab (IL-6R antibody).
  • 4The company initiated several Phase 3 clinical trials for dupilumab, targeting atopic dermatitis, asthma, and chronic sinusitis with nasal polyps, indicating aggressive advancement of its antibody-based pipeline.
  • 5Collaboration revenue from Sanofi and Bayer HealthCare was substantial, contributing over $1 billion to total revenues, underscoring the importance of strategic partnerships.
  • 6Research and development expenses increased significantly to $1.27 billion in 2014, reflecting ongoing investment in pipeline development and expansion of research activities, including a new human genetics initiative.
  • 7The company is subject to significant patent litigation, particularly concerning its antibody technology platforms and the PRALUENT program.

Frequently Asked Questions

Regeneron's primary revenue source is EYLEA, a treatment for retinal diseases. In 2014, EYLEA's U.S. net product sales were $1.74 billion, and international sales (marketed by Bayer HealthCare) were $1.04 billion. This strong performance was the main driver of Regeneron's total revenue of $2.82 billion in 2014.

Regeneron's growth is driven by the continued success of EYLEA and its expanding pipeline of antibody-based therapies, particularly PRALUENT for cholesterol reduction, sarilumab for rheumatoid arthritis, and dupilumab for allergic and inflammatory conditions. The company's proprietary VelociSuite technology platforms are central to its discovery and development efforts, and a new human genetics initiative is also expected to fuel future growth.

Key risks include substantial dependence on EYLEA for revenue, intense competition in the pharmaceutical market, significant ongoing regulatory obligations, potential product liability claims, risks associated with manufacturing and supply chain disruptions, and ongoing patent litigation concerning its core technologies and product candidates like PRALUENT. Collaboration agreement terminations or breaches are also a notable risk.