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10-QPeriod: Q3 FY2011

REGENERON PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2011

Filed October 27, 2011For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. (REGN) reported a net loss of $62.4 million for the third quarter of 2011, an increase from the $33.9 million net loss in the same period of 2010. This wider loss was primarily driven by higher selling, general, and administrative expenses, and increased research and development spending. Total revenues remained relatively flat year-over-year, at $102.8 million for Q3 2011 compared to $106.0 million for Q3 2010, with collaboration revenues from Sanofi and Bayer HealthCare forming the largest portion. The company's cash and marketable securities position stood at $511.7 million at the end of the third quarter of 2011, bolstered by a recent $400 million convertible senior notes offering. Key developments during the period include progress in the clinical development and regulatory pathways for EYLEATM (aflibercept injection) for wet Age-Related Macular Degeneration (AMD), with a BLA submission and Priority Review status from the FDA, though the review target date was extended. ZALTRAP® (aflibercept) also showed positive Phase 3 results for metastatic colorectal cancer, with planned regulatory submissions. The company continues to invest heavily in its extensive pipeline of antibody-based candidates, particularly in collaboration with Sanofi. The substantial increase in operating expenses, especially in SG&A and R&D, reflects significant investments in commercialization preparations for EYLEATM and ongoing pipeline advancement.

Financial Statements
Beta

Key Highlights

  • 1Net loss widened to $62.4 million in Q3 2011 from $33.9 million in Q3 2010, primarily due to increased operating expenses.
  • 2Total revenues for Q3 2011 were $102.8 million, a slight decrease from $106.0 million in Q3 2010, with collaboration revenue being the largest contributor.
  • 3EYLEATM (aflibercept injection) for wet AMD received Priority Review from the FDA, with a BLA submission completed; however, the FDA extended its review target date to November 18, 2011.
  • 4ZALTRAP® (aflibercept) demonstrated positive Phase 3 results for metastatic colorectal cancer (mCRC) and is slated for regulatory submissions by year-end 2011.
  • 5ARCALYST® net product sales were $5.5 million in Q3 2011, compared to $4.9 million in Q3 2010.
  • 6Cash and marketable securities totaled $511.7 million as of September 30, 2011.
  • 7The company completed a $400 million offering of convertible senior notes in October 2011 to fund general corporate purposes and operations.

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