MannKind's Management Presents At Cowen And Company 34th Annual Health Care Conference (Transcript)

Mar. 3.14 | About: MannKind Corporation (MNKD)

MannKind Corp. (NASDAQ:MNKD)

Cowen and Company 34th Annual Health Care Conference Transcript

March 3, 2014 3:30 PM ET

Executives

Matt Pfeffer - Chief Financial Officer

Analysts

Simos Simeonidis - Cowen and Company

Presentation

Simos Simeonidis - Cowen and Company

Hi, everyone. Thank you for joining us for the next presentation on schedule. I am Simos Simeonidis. I am one of the Biotech Analyst at Cowen. It is my pleasure to introduce the next company on our schedule MannKind, presenting for MannKind is the Chief Financial Officer, Matt Pfeffer. Following the presentation there will be a breakout from Boston University next door. Matt? So we are waiting for our audio visual person to return, let see.

Matt Pfeffer

Well, always something new is going to happen some day. I think we are having some audio visual challenges, so there is no presentation here. But I can kind of fake it. I think I have given this few times. So let’s talk a little bit about the product and where we see it going.

Oh! I can do something outside of the presentation. I understand, anybody in room go to the diabetes panel this morning? No, okay. I understand, there was some confusion that was voice in that panel about inhale (inaudible) and the variability of dosing depending on how you inhale, which surprised me.

I only heard about second and third hand, because I know we have presented data like that at prior conferences and things, where we have shown, but not only is that not true, it’s actually the converse [this year] we have shown.

They were more consistent on intra-patient basis from dose-to-dose with inhalation and injection, which surprised me when I first showed it some years ago. But I think a lot of it has to deal with it, the lung is essentially a huge surface area and so it’s difficult to [consume] things that change the way the powder is inhaled into the lung versus injection where it depends to a great extent exactly where you happen to stick the needle and sometimes these patients have scar tissue and things from multiple injections and you get some variability and it was study published and showed exactly that. It wasn’t statistically significant from an improvement standpoint, but certainly it wasn’t inferior and it was -- it did show better data.

Anyway most of you know, MannKind’s lead program has something called AFREZZA. It’s an inhale insulin program. It is currently before the FDA.

Simos Simeonidis - Cowen and Company

Slide.

Matt Pfeffer

Okay, I see, I see it popped-up on the screen now at least.

Simos Simeonidis - Cowen and Company

Yes.

Matt Pfeffer

There we go. Okay, now we have some slides. Well, of course, I almost forgot there was a slide, good you reminded me. I will be making some forward-looking statements, so obviously, I’ll refer you to our SEC filings for further information. We will in fact be filing our 10-K later today, so you can look for, I guess, I have to update because it’s still last year’s but as with the second that’s true, but not for much longer, while our this year’s 10-K or past year’s 10-K file any moment now.

So AFREZZA is in fact the first of what we consider a new class of insulin, an ultra rapid-acting insulin. We call that to differentiate from the so-called rapid-acting insulin [to say], which have a very different kinetic profile, sure they are rapid compared to the prior regular human insulins but nothing like what we are seeing with AFREZZA which is the first insulin that we think further pretty closely mimics natural human physiology in a healthy person and you will see that by some of the curve shortly.

I am not going to linger too longer on this slide. The diabetes market is huge and growing at an alarming rate world-wide and you will see some of the slides about how that’s increasing. This is a serious, one of the more serious pandemics essentially is in occurrence right now and it only showing sign of getting worse. That’s why we believe that a lot of the (inaudible) are still under reporting these numbers, but something very clear we have to do something about.

But we believe that result in what is essentially a block bluster opportunity for this product. We have done a lot of market research and consistently shown that. It is a first of kind product. Its unique pharmacokinetic profile does lead to a lot of significant advantages that we will go over shortly.

We have seen those pretty consistently in many Phase 2 trials now. Unfortunately, we have done more than we have originally expected, but at least it keeps reconfirming that information and are certainly very important clinical benefits to the patient and to the doctors.

We have shown consistent HbA1c reductions typically noninferior as the way the trials were designed, but that’s been shown multiple times now. But at the same time, when we get that noninferior results from an HbA1c standpoint, we show reductions in hypoglycemia and the amount of reduction varies from trial to trial, but its typically anywhere from half to two-thirds less hypoglycemia, which is an important advantage because consistently survey show that’s something that most concerns doctors and their patients especially.

At the same time we show less weight gain than other prandial insulins. Now people point to our recent trial in type 2 where we did not show that weight advantage, but that was a course against the placebo. So I guess you wouldn’t expect that there. But really, every time we have ever compared AFREZZA to an injected insulin and heads up study, we have shown a weight benefit. Typically we show weight loss in AFREZZA group versus weight gain in other group.

I can off the top of my head when I think of one exception to that which was the long two year safety study we did in the first few years back, where everybody in that study gained weight, even the non-diabetic, who were in their areas of control just gained weight and we have less weight gain than any of them. So we just call it weight advantage and leave it there. In our other parts we really think this is a weight neutral product.

Certainly, the inhaler is small, discrete and very easy to use. It’s something you can easily carry around your pocket and you can conceal it in palm of hand if you wish too, far crying from the last attempted and inhaled insulin.

We do think avoiding injection is a nice feature. We don’t think it’s the primary feature, it was the last time it was attempted but it is a nice thing because we think it will help with compliance which we know is a big problem with current insulin users.

At the same time, we have a pretty impressive safety database at this point. We have not seen any long-term effects from pulmonary -- I'm going to show you chart [at intervals]. We’ll show you that. Likewise we’ve not seen any signals for cancer or cardiovascular risk. Happily our cardiovascular database is large. So we have the data to show that even if you look at the upper prandial with confidence interval were well below the threshold the FDA would be looking for, not even post approval studies/much less pre-approval in cardiovascular outcomes.

So it’s good thing about having done so many patients. We have had a good database to back that up with. And cancer risk we just don’t see it, I mean, people in these age groups and having done some 6000 plus patients now, you are going to see some cancers but not beyond what you’d expect in the general population. And I think for a primary lung cancer in all those patients, I think we’ve only seen one. And I think we saw one tumor and another one but that was actually a metastasis from a different type of cancer.

So clearly there is not a signal there. So with that let me move along. Who do we target this to? Well, certainly the insulin market is quite huge and growing very, very rapidly. This is just in U.S., these numbers here where we have over 22 million patients with diabetes, almost 7 million of those take insulin today. And we add about 500,000 new insulin users every year, that would be new, I mean, in the net changes, so much small and that is frankly some of these people are dying. But that’s a good example of a market opportunity for us.

Some people feel that doctors tend to not alter their patient’s therapies unless they are having a problem of some sort, even if it’s just within their volume, their proper medication guidelines but having so many new people come in, it is more than enough to help with that problem for us. This breaks it down a little further by what type of insulin you are using.

You can see, it’s a broad range here. The only ones that wouldn’t potentially be a partner I guess, would be the type I people who are putting their insulin into a pump or people who are just taking basal. We might get a piece of that but this is really more of an add-on. This is the prandial insulin.

And that rapid-acting analog market, prandial market is large and growing. I mean, you can see it’s got 4 billion of annual sales back in 2012 which is the most recent data we have. But importantly it’s growing at over 20% per year, 22% annual growth over the last five years.

So clearly the market opportunity is huge but we know there is lot of problems with existing insulins. As much of the third, the patients do not take their insulins prescribed. It is a big bother, people don’t like to take injections depending on the circumstances they are in. They may don’t -- it’s not that you want to go do in a social situation.

And we think that clearly people are looking for a better insulin answer and frankly we think we have it. Patients are very concerned about hypoglycemia. Some things most cited as concern of theirs and I have talked to patients and that’s what they most talk to me about whether they -- when they go to sleep at night, having taken a big dose of insulin with their dinner. If they are going to wake up again or if they are going to have something happen during the night time is a big concern.

We also know that patients are, excuse me -- doctors tend to keep their patients at a pretty high fasting glucose levels, not being very aggressive with the basal insulin, really provide some safety margin against this and 74% of doctors in surveys have said they would shoot the target which means they bring it down lower if they are not so worried about hypoglycemia and trying to leave that safety advantage above that.

So clearly the limitations on the current insulin are hypoglycemia, it is a slow absorption, so it takes a long time to start working, and you do get weight gain which most of these people are trying very hard not to. The doctors are encouraging them not to but it’s really a typical side effect we start taking insulin as you do gain weight. And clearly people don’t like injections but we tend to put that in the last place here. We don’t think that’s the thing that is going to sell the product except as a side benefit to the extent, it might improve compliance.

So clearly diabetes organization say what their goal is. [It’s the] insulin that is -- has as normal glycemic profile as possible without – [ends up] with weight gain or hypoglycemia. So you see this profile -- this overlaps very nicely with where we see the clinical advantages to our product and we’ll get there in a little more detail in a moment.

So we have is new form of insulin with what we think is the ideal PK/PD profile. So it’s time of action and peaks of action or somewhere of what you see in healthy person. So it’s more physiologic. It synchronizes much better with your meals which is what healthy person does as well.

So you take a dose of AFREZZA with the start of the meal, not in advance of the meal. You don’t have to plan ahead, waiting for that half an hour to an hour for nutritional insulin to kick in. We can peak in 8 to 12 minutes which is not too dissimilar from what a healthy pancreas does, maybe a couple of minutes slower.

And as a consequence of that meal, synchronizing with your meal, you get better control but at the same time, without that long persistence after your food is digested, you are much less likely to have hypoglycemia and you also will have less weight gain as well as you’re chasing or feeding the insulin.

Certainly, it is in a new form-factor that’s much more convenient and less cumbersome and we think the key there is compliance, but patients will like it. Nobody likes injections as such. You are used to it, I’m told. But it is still not something people would want to do if they had a choice.

So what does the patient target of populations we are looking at? We tend to group them into three areas, of the kind of easy, do you understand ones or low-hanging fruit if you will of the people that are already on prandial insulin. So there is 4.2 million of them in the U.S. today that would fit into that category.

We think this is an easy group that says let’s be realistic, doctors tend not to switch their patients unless they are not doing well or having some problems. Good news or bad news depending on how you look at it is that’s a really large group of people. So, we think this is so a low-hanging fruit for AFREZZA. But beyond that, there is a lot of people that -- let’s be frank, patients don’t want to take insulin. And they are very resistant and their doctors have hard time getting them to do it.

I think there is a large subgroup of people out there that doctors would love to get an insulin and they haven’t been able to talk them into it. If they had a more attractive alternative such as AFREZZA, I hope that we will start picking up some of those. But in the minimum, people that need to intensify their insulin regimens, so let’s say they start on Lantus, which may not make intuitive sense where you start with a basal insulin for a type 2 patient given that you tend to lose prandial control first and you keep your basal control for a much longer.

That said I suspect you to see to get them to start with one dose a day versus one with each meal. And I certainly believe you can argue that will cause less hypoglycemia to start with the basal insulin or prandial. So it’s little less tricky to get them educated and using it properly. So, I suspect that’s why it’s so widely done.

But when you start moving beyond that and need more insulin, adding something like AFREZZA, seems like a natural versus having them take now suddenly move from one injection a day to four. And then we have the new insulin market. I think this is really where there is so much potential. Let’s be honest, this is going to be a little harder nut to crack. It’s harder to compete with some of these folks. I think where you will see us making in-roads here is like the people that really ought to be on insulin anyway and the doctor have never managed to convince them to do it.

I know people like that personally and some of them I talk to about their HbA1c level even which is a funny way to start a conversation. But you worry about them and you know they are high. I think we could give doctors a new tool here that might prove to be important to help the diabetes epidemic clear out this country.

So we talked about the profile, quite a lot, so here is the actual curves. You will see AFREZZA has a very rapid onset of actions. It’s almost seems vertical here, which is very much like your pancreas can do and that’s important because it does a lot of good things. The human body and healthy person, one of the reasons they have this first phase insulin response spike is the signaling mechanism to the body, to tell their liver which is where you get glucose between meals to stop secreting glucose.

So it’s lot easier to control your glucose excursions if you are not getting it from two sources but just from your meal digestion. It helps to do that much more effectively. We actually done some studies to show that we do shutdown liver very quickly, something that rapid-acting analogs have a lot of difficulty doing. But if the same token, it also goes way pretty quickly. So within a couple of hours. You can see us is essentially gone, which means by the time you finished digesting your food, we are gone too, which is what happens in healthy person.

In fact, on this spike you see here, if you were to overlay a typical insulin response curve for healthy individual, it would look very much like this. The only difference you would see and I apologize to anybody listening on the net, as you might see a little about a halfway down on the far side of the curve you might see a little hump coming out, which will vary depending on what is it is maybe even so.

The body can respond to how long it’s taking you to digest your food and what it is you ate, AFREZZA doesn’t know that obviously and can’t do that. But the good news is especially in type 2s, that capability is often present for a lot longer. So if we can replace this first phase insulin in response to spike, which is the way you typically lose as a type 2 in your earlier stages of your disease where it was replacing what’s missing.

So that’s why we say this, it really is a nice physiologic way to deliver insulin, doesn’t seem before. By contrast if you look at our typical curve for rapid acting analog, its peak is much slower and if it ever gets to the same height and also lasts way too long. So long after your food has been fully digested, it’s still lingering around potentially causing problems like hypoglycemia with a very minimum forcing you to snack or do other things that may cause weight gain.

So the upper curve is having to do with insulin concentrations, the lower curve has more to do with the activity that insulin in your blood stream which is little bit different, but the same -- are the same.

We talked a little bit about the device. It does (inaudible) favorably. We’ve done a lot of this testing both for marketing and usability and user testing perspectives. It’s very simple. It’s easy to use. It’s disposable with this case. I’ll call it semi-disposable, because we expect you’ll use it for two weeks. And then at a point where you might otherwise have to clean it, we’d say don’t bother with it, just throw it away. We’ll give you two in every month’s supply. The prices come down so far that it’s easier to stew that than rather than add a complication having to clean it for the patient or frankly for the approval purposes.

So no cleaning is required. It is breath powered. It is sort of like a whistle as you can see in this picture, except instead pulling you inhale. So it’s very much like that which is an advantage for any of you who have ever used it, for example an asthma inhaler or spinning aerosolized inhaler or try to (inaudible) use it which is my own personal experience.

I am getting into -- synchronize that properly and yet be inhaling when you push that button. Otherwise, it tends to get coated inside your mouth with something like this by definition. It doesn’t come out of cartridge until you are already inhaling and it works very well.

We know the compliance of the cartridge has been about half a second. That said, your inhalation obviously is still longer than that because you need to get out of cartridge but into the deep lung. So I don’t remember the exact timing and the instruction in the current anticipated package insert, but it says inhale for few seconds.

And pretty much it doesn’t matter, so very much how hard or softly you inhale within wide limits. So it’s a very forgiving device and we’ve (inaudible) testing for every conceivable situation you can imagine dropping off the table or stepping on it, during when you’re laying down, standing on your head, whatever you do, it works pretty much in a full proof manner.

So it’s very easy to use also. I’ve seen some, actually some videos of this which is quite fascinating up to and including handing it to a patient with no instruction at all to see if they can figure it out and generally to see if they can probably do. So sure we expect to show some training and certainly some instruction sheets, but this is going to be much easier thing to do than trying to teach people how to get themselves an injection for the first time.

Clearly out of the marketplace, there are people looking for a better alternative to existing insulins. These are some surveys that have been done in the past at the ADA meetings. Most doctors clearly say we need a better alternative, we need something that works faster than the current rapid-acting analogs, but on the same token, I think this second plot is not quite so relevant anymore, and we used to have a lot of questions about this. There [isn’t] really any demand for this, especially given the Exubera experience. Unfortunately, we stopped doing these questions after 2010, but clearly the trend was in the right direction, and at that point, (inaudible) this is an ADA, so it’s a self-selected, small subgroup of people who are in the field, but at that point even in 2010 after all of the noise of Exubera, 95% of the doctors who were surveyed and came by this particular booth said they would consider using this if it were approved.

And our own market analysis backs that up too, and we’ve done an awful lot of it. So where are we? We’ve obviously been down this vertical a couple times before. We are on our now third submission, so second resubmission. In the last one, they did give us some specific guidance having to do with the change of the device used to inhale this insulin, and we went back and met with them a few times to make sure we are on the same page as far as the protocols of these clinical trials, because frankly we thought the risk there was not -- that the trials will not work, but that we would do trials that didn’t exactly meet the FDA’s requirements.

So we met with them multiple times and did those trials where they were successful. I will show you the date in a moment, but the bottom line is we believe it does meet the requirements of the questions that were asked in the last Complete Response letter, so we have demonstrated efficacy in two studies using the new device and also had in one of those studies a direct comparison between the old device and the new device.

The FDA asked for that comparison only for safety purposes. They didn’t ask for an efficacy comparison. We didn’t do it. We obviously have that data. It’s confusing people, we didn’t release it immediately because it wasn’t part of the endpoint of the study. So we didn’t consider it part of top line, but it came out the same, and it sort of surprised to no one, we had already shown bioequivalence.

The key thing here was that we showed a bridge to the very extensive safety database we have with the old inhaler. So they wanted to see the pulmonary function, differences between two devices, and you will see in a moment those curves just nicely overlay.

Where are we now? We did resubmit last October. We have an April 15th PDUFA date, so we are less than 45 days away, and we have now an Advisory Committee which has since been confirmed as being April 1st. That’s now been published and you can see that up on FDA’s website.

I am not going to read you these quotes, but those of you who are online can see them, and if you guys want to read them, you can find them online after this meeting, but these are actually quotes from Complete Response Letter and the end of review meeting and talking about what it is they were looking for and how we ended up where we did.

So the two trials, I am just going to go over these very quickly. Most of you have seen this. The first trial is the 171 study in Type 1 diabetes. This was different in that it was a three-arm study, so this was a one we put the old so-called MedTone device in the study to do a direct safety comparison between that and new so-called Dreamboat device. I am not just stopping using Dreamboat, but it’s been so many years we have been saying that it will never be known as Dreamboat, by the way that was just an internal development name and sometimes these names leak out into the public and you later regret it. You will see it interchange when they call it the Gen2 device, a lot of our literature, so maybe I should just get more used to saying that.

In any event, it was simple study with four-week running period for basal optimization and then randomizing any of these three groups with a four-week follow-up. So, it was essentially a six-month study, six months here being defined as 24 weeks.

And what do we see? We did achieve our primary endpoint of non-inferiority, which was really the most important thing obviously in the study, so we did that since this was an insulin substitution study, you wouldn’t expect somebody that had no change to have a drop, but you do get [steady] effects, so you see a pretty substantial drop in Hb1Ac in the insulin aspart group even though they really had no change during the study, and we show (inaudible) as well not quite as large but within the balance of non-inferiority is established by the FDA which is the primary endpoint of the study.

People ask why weren’t you at least as good or numerically as good or better, and I usually attributed to the other thing that we saw in study which was less hypoglycemia. It would be hard for us to argue for anybody that hypoglycemia is a good thing. However, it does tend to lower your Hb1Ac. So, if you can stop having those plunges leading to hypoglycemia, you will not quite get as good an Hb1Ac but you still might end up with better glucose control. That said, Hb1Ac is the accepted endpoint for these kinds of study, so that's what we are using.

But I said we have significantly less hypoglycemia. We tend to find that in all [majors] hypoglycemia; mild, moderate, and severe. Severe is more rare, however, so while we did have certainly what I’ll call a -- I can’t use the word significant, a pretty dissent reduction in severe hypoglycemia, it wasn’t statistically significant, although it was numerically significant, how about that.

But this has been consistently seen in really all of our studies, and you can go back to the published Phase IIIs that we did. I think we put them in last 2008 or 2009 or so, where it was an excruciating detail. Here, we are mostly just showing the topline results.

So, I will talk about the FEV1 change. This again, you can see this is well in the two-year data, where this was actually a little easier to see what’s going on here. I think in some ways, this is a little bit misleading because it makes it look like it is (inaudible), but the key thing is that the starting point there, it was the same obviously because that's where we did the randomization and the first measurement where those two lines are, so they diverged by that much at that point.

The next point, they were more or less consistent. In this chart, it looks like it is a little bit less, but maybe we had those bars, there is a little bit of variability, so it’s the same. I mean if you look to the (inaudible) study, you will see that it did the same thing exactly. It diverged essentially instantly, and then they ran parallel for essentially the whole two years until they came off study, (inaudible) and then at the end we do another major one after they have been off for a while, you see it could come back to the same.

Here, it actually shows AFREZZA group as being a little bit different, but that's in the balance of normal variability. The key thing here is this demonstrates we are not causing any long term tissue damages, this is just we believe just a reaction to the inhalation of the powder which is not unusual.

So, clearly it’s non-inferior, we demonstrated advantages in hypoglycemia and weight, and we did it in a bridge which is another primary end point to the safety data base that we had prior. We also did a type 2 study. This was very different, and we did it in insulin naïve patients. They have not been on insulin before, essentially metformin failures.

Here, we are comparing ourselves to a placebo. So, you stayed on whatever orals you are on, pretty much this metformin, you’re allowed (inaudible) such common use, but this is way early in the treatment paradigm for type IIs, and our goal here obviously was superiority.

We did achieve that. Obviously, we did better than what we saw pretty marked steady effects here having to do with how we design the trial and the amount of education we are giving these patients, and a whole lot of public comes for the monitoring of their glucose levels and so forth. We achieved the primary end point of superiority on a very significant way in this trial, which is what we are trying to accomplish. So, bottom line is both the trials met their primary end points and an array of secondary ones.

Safety summary I talked about little before. At this point, we’ve got a huge database of patients, and we have not seen any significant safety signals. It is well tolerated. You often see a cough, but it’s a very mild typically one cough, that typically goes away after about a week or so depending on the patient.

It’s an odd sensation inhaling a powder like this. So we get a little bit of a tickling sensation. We’re not talking about coughing spasm, we are talking of usually a single cough. We do see a measurable but not clinically significant difference in FEV1 or pulmonary function, but it’s like I said its small, it’s not clinically significant. It doesn’t progress and we stop taking it and resolves. So we know we are not causing any permanent changes, just we believe are reaction with the inhalation of our powder.

We do see cancer, we just see in any group of the size and (inaudible) age range, but it’s not outside of the balance where you would expect in any group within the general population in this area. And again we have no increase in cardiovascular risk, as major (inaudible) risk factor ratios, we actually show 0.96 relative risk which we imply might actually show slight benefit, but that's a little silly.

We don’t believe it has cardiovascular benefit. That would be the point estimate. The key thing is the range and the upper end of the range does not hit the 1.3 bound or it might be close to where the FDA in their published guidance is expecting to [start ]thinking about our post approval study, much less than pre-approval study.

Production capability, we are quite proud of the facility we’ve built in the Danbury, Connecticut. We expect to have three of the scaled probe lines in operation at the time of launch with about -- up to 375 million cartridges per year capability, ultimately with the whole facility build out. And we are talking about with just filling the rooms with equipment. The rooms for the most part just sitting there, waiting for that, we can get up to 2 billion cartridges per year.

Financial summary, we did finish the year with $70.8 million at the end of the year, lot of ins and outs here though, so we kept just a few of them. Remember, we did repay in cash, $115 million convert in December that was converted to get a very high price, and obviously we’re not close to it. So we did end up paying that back in cash.

We do still have $30 million available under our line of credit from Mann Group. Remember that was originally a $350 million line, but we’ve converted and we’ve paid back in the interim. So we have $30 million available. We are just going to keep in that as a little safety margin. I don’t expect to need it or I hope not to have it drawn it, but it’s nice to have it there.

We do have $40 million that we anticipate coming in upon approval from the Deerfield Group under the facility financing we’ve already done with them. We’ve got now three tranches of $40 million each. We have one more final tranche of $40 million that we hope will come at approval. You will remember they had the ability to convert one of those four tranches into equity at essentially market based on trailing (inaudible) formula. We announced in the call that they hadn’t exactly full done that, so the amount outstanding today at Deerfield has gone to $80 million of the $120 million and that all was done pretty painlessly.

We still have a pretty healthy cash burn though. I have been saying $10 million to $12 million is approximately pretty much as long as I can remember. It will prove to be true. I think we’re in a 10-point something per month all of last year, and you might think it’s going to go down with the completion of the Phase III clinical trials, and I wish that were the case.

But the good news, bad news is, yes, those expenses do go away but we are ramping up seriously towards commercialization. So you’ll see a lot of those cost being replaced by cost for expansion and building up the capabilities in our Danbury manufacturing facility, because we do expect to manufacture this product, and we want to make sure we have plenty of it.

So summing up, we do think AFREZZA is a first of kind new product that’s something surely needed in diabetes, a new class of insulin. The first really physiologic insulin that works not too dissimilarly to what a healthy person’s insulin secretion works in his kinetic profile.

It clearly has blockbuster potential. This is a huge, huge growing rapidly population, both in the U.S. and worldwide. While we intend to address only the U.S. market initially, I think there is applicability for this product in many other jurisdictions. Pricing will be a challenge in some of them, because we know they don’t spend a lot for insulin in some of those jurisdictions. But that said, there are many parts of the world, they have even much worse problem with diabetes than we have in the U.S.

Many of us think of this as a U.S. problem because we associate it with diabetes and lifestyle, but we’re actually not even in the top 10 for problems of diabetes in U.S. I hope that’s not a group we’ll ever crack into, but there are some areas in the world, particularly in the mid-east and some other places where this is shockingly a large problem and you would be amazed of the percentage of population suffering from it.

And it is clearly a very poorly met medical need. The fact that the leading cause of things like blindness and loss of limbs and so forth in this country are classic side effects of diabetes not being well treated, and diabetes is still the leading cause of those things.

So we’re not doing a very good job treating this, and it’s hard to place the blame on any one particular place, but clearly new tools would be desirable and we think this offers a very important one. It is as I said, the first of what we believe is a new class of insulin and ultra-rapid-acting insulin mimicking the human physiology in a very nice way which offers much better glycemic control, at the same time without increasing but in fact reducing some of the complications of insulin used, say amongst those hypoglycemia and weight.

The fact that it’s delivered through a discrete and easy-to-use inhaler is icing on a cake in our minds. We think this may in the end have important clinical advantages from improved efficacy -- or excuse me improved compliance, but that (inaudible) be seen. We have seen evidence of that in early trials, but we haven’t -- there is no way to test for that in clinical trials, but I believe that will be the case.

So stay tuned. We have some really important milestones coming up in the near term. In just couple of weeks, we’ll have the ADCOM panel. For those of who don’t know, that is streamed live, and so you can all listen to it if you wish too. Everybody on this -- listening to me on the web or it’s open to the public and gets such pretty interesting attendance there. It’s going to be very exciting, I believe.

And then we have the PDUFA date, April 15th, probably the most common question I get about that is will the FDA be able to meet that date given the short time between that and the ADCOM, and obviously the answer is we don’t know. It’s clear that they’re working very hard and trying to stick to that date, but I suspect it is largely dependent on what happens with the ADCOM. So stay tuned for that and we will see.

With that, I welcome you -- thank you for attending the presentation today. Stay tuned, it’s going to be an exciting next couple of months for Mannkind. Thank you very much.

Question-and-Answer Session

[No Q&A for this event]

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