Eli Lilly and Co LLY
Q1 2013 Earnings Call Transcript

Transcript Call Date 04/24/2013

Operator: Ladies and gentlemen, thank you for standing by and welcome to the Q1 Earnings Call 2013. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session with instructions given at that time. As a reminder, today's conference is being recorded.

I would now like to turn the conference over to our host, Vice President of Investor Relations, Phil Johnson. Please go ahead.

Philip Johnson - VP, IR: Good morning. Thank you for joining us for Eli Lilly and Company's first quarter 2013 earnings conference call. I'm Phil Johnson, Vice President of Investor Relations. Joining me today are our Chairman and CEO, John Lechleiter; our Chief Financial Officer, Derica Rice; our President of Lilly Research Laboratories, Dr. Jan Lundberg; our President of Elanco Animal Health, Jeff Simmons; and Ilissa Rassner and Travis Coy from Investor Relations.

During this conference call, we anticipate making projections and forward-looking statements based on our current expectations. Our actual results could differ materially due to a number of factors, including those listed on Slide 3 and those outlined in our latest Forms 10-K and 10-Q filed with the Securities and Exchange Commission. The information we provide about our products and pipeline is for the benefit of the investment community. It is not intended to be promotional and is not sufficient for prescribing decisions.

We're pleased with our performance in the first quarter of 2013, of growth in key products and regions, replaced lost revenue and earnings due to Zyprexa's patent exploration. Lilly employees remain focused on advancing the pipeline and on increasing productivity, while delivering results to put us on track to meet our 2013 financial guidance and to meet or exceed our mid-term financial minimum goals.

Let's start with a quick review of events that have taken place since our last earnings call. From a regulatory perspective the first two items I'd like to highlight were achieved in collaboration with Boehringer Ingelheim. We received approval in Japan for Trazenta as add-on therapy insulin and we submitted the SGLT2 inhibitor, empagliflozin for both the U.S. Food and Drug Administration and the Europe Medicines Agency, for a review as a treatment for type 2 diabetes.

We also submitted insulin lispro U-200 in the U.S. for type 1 and type 2 diabetes patients and we're pleased to announce that after consultation with the FDA we received fast track designation and have initiated a rolling BLA submission for ramucirumab as monotherapy treatment for second-line gastric cancer. The first module was recently submitted, and we anticipate that the final module will be submitted before the end of the year. Based on the overall efficacy and safety data from the REGARD trial, we believe that ramucirumab has a promising treatment profile in this difficult to treat patient population and we look forward to completing the rolling submission.

In clinical news, for dulaglutide, our investigation of GLP-1 receptor agonist being studied at a once-weekly treatment for type 2 diabetes, we announced that the primary endpoints related to reduction in HbA1c were met in the Phase III AWARD-2 and AWARD-4 studies.

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