MANNKIND : Retranscritpion de la TC en anglais

kurchato

13 mai 2014 •08:07

Yes, thank you. We will now begin the Question-and-Answer session. (Operator Instruction) And our first call comes from Mr. Graig Suvannavejh from MLV & Company. Please go ahead.
Graig Suvannavejh - MLV & Company
Great. Good afternoon everyone and thanks for taking my questions. First, let me congratulate you on the very positive outcome that you had down the DC area. So that was great turn up for you guys.
Alfred Mann - Chairman of the Board, Chief Executive Officer
Thank you.
Graig Suvannavejh - MLV & Company
Sure. No problem. My first question just has to do with the post that event given the positive vote, can you give us a sense at all of what the nature of your interactions with FDA has been like and in particular I am curious to know if you guys have made any progress on what seems to have been the desired by the AdCom to see kind of long term follow-up in terms of particular items like diabetic ketoacidosis and potential lung cancer just given uncertainties and how you would monitor for things like that?
Alfred Mann - Chairman of the Board, Chief Executive Officer
Well, please understand that the primary task of the agency at this point in addition to making their final decision is the preparation of the license. I’m sorry, the label, the [Paramus] project which is what you are sort of referring to and also probably the phase IV study for children. And there has been interaction in between our people and the agency on events program. So it is progressing, it's still under certainly the consideration by the FDA.
Graig Suvannavejh - MLV & Company
Okay. My second question as to pick up on a comment, Al that you’ve made in your prepared remarks, you’ve mentioned something that while you can't really talk about whether it's partnership discussions or perhaps other aspects of your discussions with FDA but you had mentioned I believe that we could expect to see news in a few weeks and I don't know if you can maybe expand on that in terms of what specifically you might have been referring to.
Alfred Mann - Chairman of the Board, Chief Executive Officer
Well there are discussions going forward across the FDA has approximately what maybe eight or nine weeks to make their decision. They don't need to take eight or nine weeks. Could do it much sooner than that. Obviously it would be nice to do sooner so that we could have a more open session at the American Diabetes Association meeting in another month but the other, whether it takes four weeks or eight or nine weeks, I can answer as the partnership discussions, there are conversation going on now and those that necessarily have to wait for the NDA to be finalized. I believe that there is enough expectation of approval now which is really a question of the detail of the label and the [Paramus] program that are the only issues really outstanding at this point but one never knows what’s going to happen with the regulatory process.

kurchato

13 mai 2014 •08:08

Hakan Edstrom - President, Chief Operating Officer, Director
Graig. This is Hakan, just to make sure we are all on the same page, Alan say within a few weeks, I said coming weeks or in the weeks ahead. So that’s a little less – a little vaguer then I think you applied by your questions. I want to make sure you didn’t misunderstand.
Graig Suvannavejh - MLV & Company
Okay, that’s the exactly where I was trying to drive to see if there was something that you are trying to manage expectations appropriately in terms of news coming out on either end. And then maybe Matt, I will ask a question about current cash and I will jump back in the queue to – how are you thinking about cash right now? I think in the last call you said you felt you had enough cash through third quarter of this year and certainly we are where we are right now. So what are your latest thoughts or how should we be thinking about how you are thinking about cash right now?
Matthew Pfeffer - Corporate Vice President and Chief Financial Officer
Yes, maybe I should have elaborated on my one simple sentence into the discussion I gave. But in addition to the cash we already had on hand which could have gotten us pretty close to the revised PDUFA date but again pretty scarily close to the edge of that point, we did draw $20 million from Deerfield and it was additional straight debt to give us little more breathing room and so between that and the -- if we need to I guess we can go back to the [corpus] through our credit facility with the Mann group where we have another $30 million there. So we feel pretty comfortable. We can get us to a decision point and then see what happens.
Graig Suvannavejh - MLV & Company
Okay. Great. I have got a ton more about but I will let others ask questions. I will jump back in the queue. Thank you very much for taking my questions.
Alfred Mann - Chairman of the Board, Chief Executive Officer
Thank you.

kurchato

13 mai 2014 •08:09

Operator

(Operator Instruction) And we also have Mr. Christopher James from Brinson Patrick Securities. Please go ahead.
Christopher James - Brinson Patrick Securities
Hi. Good afternoon and thanks for taking my questions and let me also add my congratulations on the tremendous progress you have made. I understand the sensitivity around not discussing – the discussions with partnerships but could you perhaps, let us know if you are able to share some of the back and forth with the FDA regarding label and Paramus discussions with potential partners during the process or is there something that will be discussed after?
Alfred Mann - Chairman of the Board, Chief Executive Officer
Actually, we do have sharing sessions in between our regulatory people and the regulatory people of those people as we believe to be say, top potential for partnerships. So yes we are trying to address that inappropriate say collaborative manner.
Christopher James - Brinson Patrick Securities
Okay, great that’s helpful and in the past I think you said, you would be able to, from a manufacturing standpoint support commercial launch within six months of approval on partnerships. Have any of those timelines changed since the PUDFA was pushed back?
Alfred Mann - Chairman of the Board, Chief Executive Officer
No. we still are operating with, certainly the factor we will be have relative support commercial launch within six months of approval and quite honestly if approval is around July 15, we may even be a little bit faster than the six months because we cannot wait to do our validation rounds and may make the manufacturing ready for commercial operation type of upscale.

kurchato

13 mai 2014 •08:09

Christopher James - Brinson Patrick Securities
Alright. That’s helpful. And then regarding the supplement on NDA for the 9 and 12 unit cartridge, could you maybe walk us through the necessary steps for this and how much additional preparation is needed for that application?
Hakan Edstrom - President, Chief Operating Officer, Director
Yes, when it comes to the [nine unit] that is worked on very actively right now and again the assumption is that immediately upon approval of the AFREZZA, you would submit the supplemental SNDA and hopefully then get certain response within six months from that one. So that should be almost an approval in conjunction with the launch or very shortly upon launch. When it comes to the 12 units, it's a little bit more involved because the fact that we most likely will need to change a little bit of the concentration of the ingredients into that one so that’s further up in terms of the – of submission and I would say that would probably happen certainly following launch and during maybe late 2015.
Alfred Mann - Chairman of the Board, Chief Executive Officer
The difference for the nine unit is simply putting a little more powder in the cartridge whereas the as Hakan said we are adding a little more insulin onto the carrier particles for the 12 unit. How long it will take is hard to say hopefully the agency will not require much for that approval well because we really need both of those until as we can.
Christopher James - Brinson Patrick Securities
Great. That’s helpful. Thank you and good luck.
Alfred Mann - Chairman of the Board, Chief Executive Officer
Thank you.

Operator

Thank you. Our next question comes from Mr. Cory Kasimov from JPMorgan. Please go ahead.
Brittany O'Neil - JPMorgan
Hi this is actually Brittany O'Neil for Cory. Thanks for taking my questions. Just curious for your launch plans are, if you don't sign a partnership agreement this year?
Hakan Edstrom - President, Chief Operating Officer, Director
Well, we certainly doing in intends that’s our plan to launch in conjunction with the partner, I mean do we have kind of continue to plan in place where which would be appropriate for company like ours [Ph], yes we do but at this point in time, I would say we feel comfortable with all those partnership opportunities.
Alfred Mann - Chairman of the Board, Chief Executive Officer
And we have several different approaches to how we are going to do this but we don't think that we are going to get there so we are not worried. Since I am not.
Brittany O'Neil - JPMorgan
Okay. Thank you.

Operator

Thank you. And our next question comes from Graig Suvannavejh from MLV & Company. Please go ahead. Thank you very much.
Graig Suvannavejh - MLV & Company
Great. Thanks so much for the follow-up. Just two quick questions I mean one, how are you thinking about ADA right now given that less than or about a month away, how do you guys prepared for that meeting given the how important that is and without knowing what’s happening with the PDUFA?
Alfred Mann - Chairman of the Board, Chief Executive Officer
Well unfortunately, since we don't really know for certain when we are going to be approved by the FDA or we have no decision yet on the table by the agency, we are questioning whether we should have a formal operation at the ADA, they are going to be a couple of papers about AFREZZA and we have reserved a booth there whether we should spend the money unless we know we have the approval is a question before us now and we are wondering whether we should spend the money to have the booth under the circumstances.

kurchato

13 mai 2014 •08:10

Graig Suvannavejh - MLV & Company
Alright. Okay. Great. So what is if there is a default plan right now, do you have one placed around ADA activities?
Hakan Edstrom - President, Chief Operating Officer, Director
Well, not specifically but I could say that the amount of money that we would spend potentially in vain for those depending on the timing of approval. We could do a lot in terms of other information needed and some other activities in conjunction with the ADA, plus the fact we may even be in a situation where we will have a partnering opportunity there if we have both the partner and the approval in place at the time. So I think we will have to be just a little bit (inaudible) and do the best we can.
Matthew Pfeffer - Corporate Vice President and Chief Financial Officer
So, Graig, I think you can safely assume that from what we can hear so I can just kind of recap. We will all be there and there will be some presentations that we will be giving at ADA. So we all will be around. The question is just whether we have a booth on the floor or not but we will still be pretty actively involved at the ADA.
Alfred Mann - Chairman of the Board, Chief Executive Officer
We would like to have booth. The problem is that if we cannot open discussions, it's probably is worth spending the money and we can't have open discussions unless we have approval sometime and probably days if not weeks before the ADA meeting and we have no guarantee of that.
Graig Suvannavejh - MLV & Company
Sure. Just one last question if I may. Just to summarize kind of comments that you have made on this particular call. It sounds as if you guys are pretty comfortable not only on just the straight up FDA approval but also in terms of partnering opportunities and if I read in between the lines or read by your language, I think you said you weren’t worried about much. So can I just confirm that?
Alfred Mann - Chairman of the Board, Chief Executive Officer
Well, we don't see our bodies so I will go by the body language. But we are so confident of the significance of this product and there are partners out there that recognize that this is going to be a very, very significant product. So we are not really worried. It’s just a question of how we are going to launch it. There are several opportunities that we are considering.
Matthew Pfeffer - Corporate Vice President and Chief Financial Officer
Yes, great folks. Obviously nothing is going to withstand and we feel confident before but I could tell you I am sitting with only few people now and doesn’t look at all worry to me.
Graig Suvannavejh - MLV & Company
Okay. That’s great to hear. Thanks very much and good luck with the process going forward.
Alfred Mann - Chairman of the Board, Chief Executive Officer
Thank you.

Operator

At this time I am showing no further questions. I will now turn the call over to Mr. Mann for final remarks.
Alfred Mann - Chairman of the Board, Chief Executive Officer
Well, thank you all very much for joining us today. And we look forward to further and hopefully much more open communications with you during the coming weeks. Thank you all.

Operator

And thank you ladies and gentlemen. This concludes today's conference. Thank you for participation and you may now disconnect.

kurchato

13 mai 2014 •08:12

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fpelu

14 mai 2014 •10:16

Merci pour tout kuchato.
En tout cas, l'accueil est bon aujourd'hui (+3,95%).
Reste plus longtemps à attendre.