Q1 2008 MannKind Earnings Conference Call - Final.

Original Source: FD (FAIR DISCLOSURE) WIRE

OPERATOR: Ladies and gentlemen, thank you for standing by. Welcome to the MannKind Corporation first quarter 2008 conference call. At this time, all participants are in a listen-only mode. Later instructions will be given for the question-and-answer session. (OPERATOR INSTRUCTIONS) As a reminder, this call is being recorded today, May 5, 2008. Joining us today from MannKind are Chairman and CEO, Alfred Mann, President and COO, Hakan Edstrom, the Chief Financial Officer, Matthew Pfeffer, and Chief Scientific Officer, Peter Richardson.

I would now like to turn the call over to Mr. Matthew Pfeffer, Chief Financial Officer of MannKind Corporation. Please go ahead.

HAKAN EDSTROM, PRESIDENT, COO, MANNKIND: This is Hakan Edstrom. Good afternoon, and thank you for participating in today's call. Before we proceed further, please note that comments made during this call will include forward-looking statements within the meaning of Federal Securities laws. It is possible that the actual results could differ from these expectations, and for factors that could cause actual results to differ from expectations. Please refer to reports filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934.

Let me start by recapping our activities during the past quarter. All of our key programs are on-schedule, and are on and below budget. We are nearing the end of our pivotal Phase III trials and put in place the necessary personnel and systems, so that we can lock the databases this fall, and conduct the analysis leading to the NDA filing. We are also approaching the completion of construction phase of our manufacturing facility in Danbury.

Much of the equipment has already been installed, and our validation activities are well under way. Our target submission date for the NDA, particularly Insulin remains the end of December 2008. Although this target is still considered an aggressive goal. Our clinical operations especially Study 117, a Phase III clinical trial that will examine the effect of TI, in patients with tightly controlled fasting glucose levels. As you know out of fear of hyperglycemia, patients to-date tend to be managed at high fasting levels, so high as to invite the risk of long-term complications, and at these high levels, fasting glucose, not standard glucose, primarily controls the A1C.

Our goal in this study is to use insulin more aggressively by taking advantage of TI's superior hypoglycemia profiles and observe the effect of this aggressive insulin use on A1C levels. We also have a number of non-insulin trials under way having recently initiated a second clinical trial of our inhaled GLP-1 product, the MKC253, and a trial of the second cancer nanotherapy product, the MKC1106MT, and these other programs also appear to be outstanding opportunities. We believe that we have done everything that we have told you that we would do and even a little bit more.