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Lilly Reports First-Quarter 2013 Results
Date:4/24/2013

e company's business. The company's 2013 financial guidance is also being provided on both a reported and a non-GAAP basis.

"Lilly delivered solid financial results in the first quarter of 2013 despite numerous headwinds, as growth in several key products and regions offset the post-patent decline in Zyprexa, a weaker Japanese yen and a slowdown in parts of our animal health business," said John C. Lechleiter, Ph.D., Lilly's chairman, president and chief executive officer. "We also continued to maintain strict expense controls this quarter. Most importantly, we have remained focused on advancing our late-stage pipeline, and are pleased to announce that we have received Fast Track designation from the FDA and have initiated a rolling submission for ramucirumab. Together with the recent submission of empagliflozin, these are the first two of what could be up to five U.S. regulatory submissions this year."

Key Events Over the Last Three Months

  • The company and its partner, Boehringer Ingelheim, submitted a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin to the U.S. Food and Drug Administration (FDA) for the treatment of type 2 diabetes mellitus in adults. In addition, the European Medicines Agency accepted for review a marketing authorization application for empagliflozin.
  • The company received Fast Track designation from the FDA and initiated a rolling submission for ramucirumab as monotherapy treatment in second-line gastric cancer.
  • The company announced that the primary endpoints related to reduction in HbA1c were met in the Phase 3 AWARD-2 and AWARD-4 studies for dulaglutide, an investigational GLP-1 receptor agonist being studied as a once-weekly treatment for type 2 diabetes.
  • The Phase III rheumatoid arthritis (RA) program for tabalumab was discontinued due to lack of efficacy. The decision was not based on safety concerns. The tabalumab Phase II
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  • SOURCE Eli Lilly and Company
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