10-KPeriod: FY2012

REGENERON PHARMACEUTICALS, INC. Annual Report, Year Ended Dec 31, 2012

Filed February 15, 2013For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. (REGN) reported a significant financial turnaround in 2012, achieving profitability with a net income of $750.3 million, a stark contrast to the net loss of $221.8 million in 2011. This profitability was largely driven by the strong performance of its lead product, EYLEA, which generated $837.9 million in U.S. net sales in 2012, following its launch in late 2011. The company also benefited from a substantial income tax benefit of $335.8 million due to the release of its deferred tax asset valuation allowance, and milestone payments from its collaboration partners, Sanofi and Bayer HealthCare. The company's pipeline remains robust, with 13 product candidates in clinical development, primarily monoclonal antibodies. Key collaborations with Sanofi and Bayer HealthCare are crucial for its ongoing research and commercialization efforts, particularly for EYLEA outside the U.S. and for ZALTRAP. Despite the positive financial results, Regeneron faces ongoing risks related to competition, regulatory approvals for new indications and products, and the potential for adverse outcomes in ongoing patent litigations, notably with Genentech.

Financial Statements
Beta
Revenue$1.38B
Cost of Revenue$83.93M
Gross Profit$1.29B
R&D Expenses$625.55M
SG&A Expenses$210.75M
Operating Expenses$920.76M
Operating Income$457.71M
Interest Expense$45.30M
Net Income$750.27M
EPS (Basic)$7.92
EPS (Diluted)$6.75
Shares Outstanding (Basic)94.69M
Shares Outstanding (Diluted)115.38M

Key Highlights

  • 1Regeneron achieved profitability in 2012 with a net income of $750.3 million, a significant improvement from a net loss of $221.8 million in 2011.
  • 2EYLEA, launched in late 2011, generated substantial net sales of $837.9 million in the U.S. during 2012, becoming a key revenue driver.
  • 3The company recorded a significant income tax benefit of $335.8 million in 2012 due to the release of its deferred tax asset valuation allowance.
  • 4Regeneron continues to advance a robust pipeline with 13 product candidates in clinical development, many of which are monoclonal antibodies.
  • 5Key collaborations with Sanofi (for ZALTRAP and antibodies) and Bayer HealthCare (for EYLEA) are central to the company's development and commercialization strategies.
  • 6The company faces significant competition in its key markets, particularly in ophthalmology with products like Lucentis and off-label use of Avastin.
  • 7Ongoing patent litigation with Genentech regarding VEGF Trap technology presents a notable risk, impacting both financial resources and potential market exclusivity.

Frequently Asked Questions

The primary driver for Regeneron's return to profitability in 2012 was the strong commercial performance of EYLEA, its ophthalmic drug, which generated significant net sales in the U.S. post-launch. Additionally, a substantial income tax benefit related to deferred tax assets and milestone payments from collaborators contributed significantly to the net income.

The collaborations with Sanofi and Bayer HealthCare are critically important. Sanofi is a key partner for the development and commercialization of ZALTRAP and a broad range of monoclonal antibodies, providing substantial funding for research and development. Bayer HealthCare is Regeneron's partner for the global development and commercialization of EYLEA outside the United States. These partnerships are vital for advancing the pipeline and generating future revenues.

Key risks include intense competition in its product markets, particularly for EYLEA, from established players and off-label uses of other drugs. The company also faces regulatory risks related to obtaining approvals for new indications and products, as well as potential negative outcomes from ongoing patent litigations, notably with Genentech, which could impact market exclusivity and incur significant costs.

Regeneron has a robust pipeline with 13 product candidates in clinical development, primarily focused on monoclonal antibodies discovered using its proprietary VelociSuite technologies. Key areas of development include oncology, ophthalmology, and inflammatory diseases. EYLEA is also being investigated for additional indications like diabetic macular edema (DME).