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Regeneron Reports Fourth Quarter and Full Year 2012 Financial and Operating Results
Date:2/14/2013

nited States, and share profits and losses from commercialization of EYLEA outside the United States except for Japan, where the Company receives a royalty on sales.  Regeneron maintains exclusive rights to EYLEA in the United States and is entitled to all profits from any such sales.
  • In November 2012, Bayer HealthCare received regulatory approval for EYLEA in the European Union for the treatment of patients with wet AMD.  In November 2012, Bayer HealthCare received pricing approval for EYLEA in Japan for the treatment of patients with wet AMD. 
  • Net sales recorded by Bayer HealthCare for EYLEA outside of the United States were $19 million in the fourth quarter of 2012.
  • Launches in additional countries are anticipated to continue throughout 2013 as regulatory and pricing approvals are achieved.
  • Bayer HealthCare submitted applications for marketing authorization for EYLEA in Europe in December 2012 and in Japan in January 2013 for the treatment of macular edema following CRVO.
  • ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion

  • The Company and Sanofi collaborate on the global development and commercialization of ZALTRAP, and share profits and losses from commercialization of ZALTRAP except for Japan, where the Company receives a royalty on sales.  Sales of ZALTRAP in the United States commenced in August 2012, and net sales recorded by Sanofi were $23 million in the fourth quarter and $32 million for the full year of 2012.
  • In February 2013, the European Commission (EC) granted marketing authorization in the European Union for ZALTRAP concentrate for solution for infusion in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.  
  • Marketing authorization applications for ZALTRAP are current
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  • SOURCE Regeneron Pharmaceuticals, Inc.
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