MannKind Earnings Call INSIGHTS: Trial Update, Re-file NDA

On Tuesday, MannKind Corporation (NASDAQ:MNKD) reported its second quarter earnings and discussed the following topics in its earnings conference call. Take a look.

Trial Update

Seamus Fernandez – Leerink Swann: Just to clarify on a thing what Hakan said in 2Q, are we expecting to see the data or did you say that’s the time when you expect to complete enrollment?

Hakan S. Edstrom – President and COO: We expect to complete enrollment next month.

Seamus Fernandez – Leerink Swann: So, in 2Q, you expect to have

Hakan S. Edstrom – President and COO: 2013?

Seamus Fernandez – Leerink Swann: Yes.

Hakan S. Edstrom – President and COO: Yes.

Seamus Fernandez – Leerink Swann: Then Hakan you also spoke about the – you walk us through the numbers you had the screen randomizing and what you think will finish the trial. Can you update us – actually, first of all, do you think now you have a pretty decent handle on the ratio of patients screen versus the ones will be treated? Can you disclose how many people have been treated so far in each trial?

Alfred E. Mann – Chairman and CEO: 15 patients have already completed the trial.

Seamus Fernandez – Leerink Swann: You said 15% or 15 patients?

Alfred E. Mann – Chairman and CEO: 15 patients have completed the trial. But we’re on course as Hakan said, we have 86% of the 171 trial already completed and ready and they’re not all fully enrolled yet, but they will be shortly and the balance will be done in the next few weeks.

Seamus Fernandez – Leerink Swann: Al, the 15 number you said it’s for 171, correct?

Alfred E. Mann – Chairman and CEO: Yes, that’s right. The 175 started later and it’s a faster trail, it won’t take it long.

Seamus Fernandez – Leerink Swann: Then just to clarify again the average starting HbA1c, it was 8.5 for 171, was it the same for 175?

Alfred E. Mann – Chairman and CEO: Yes, that’s right. It’s close to 175, which is I pointed out in my remarks, highly defines early stage type 2, but we will separately evaluate those in the lower part of the A1c range, so that we can show what I believe will be as enormous opportunity to be able to control people in early stage without all of the issues with alternative therapies, and frankly, in a way which will produce excellent control with virtually no risk of hypos, but of course, we have to wait till we do not before we can make any claims.

Seamus Fernandez – Leerink Swann: A final question and then I’ll jump back in the queue, your current thinking about European submission, are you going to wait for potentially a partner to do this or are you in discussions with EMA right now?

Hakan S. Edstrom – President and COO: We are not in discussions with EMA so to speak, however, as we are preparing the documents for the EMA submission. We certainly are keeping EMA submission in mind whether if we sign on the partner early enough certainly we would utilize their resources for application for the European submission as well.

Re-file NDA

Matthew Lowe – JPMorgan: Hi, it’s actually Matt Lowe in for Cory today. Just a quick question as most of my questions were answered, but in terms of when you think you might be able to re-file the NDA, was that 3Q, 2013, did I catch that correctly?

Hakan S. Edstrom – President and COO: Yes. That’s correct.