MannKind Corp. (NASDAQ:MNKD)
Wells Fargo Healthcare Conference Call
June 17, 2014 10:00 AM ET
Matt Pfeffer - Chief Financial Officer
Mike Faerm - Wells Fargo
Mike Faerm - Wells Fargo
Good morning. I’m Mike Faerm, Pharmaceuticals Analyst with Wells Fargo. We’re very pleased to have with us MannKind Corporation presenting for the company will be Matt Pfeffer, Chief Financial Officer. Matt?
Thank you and good morning. So, I have a shorter version and normal of our typical presentation to leave off the time for questions at the end. I will take you to the basics, most of you probably know the story of the company but I’ll try to cover the high points here. Before I start as usual I’ll caution you to check with our SEC filings for the normal cautions and so forth about the potential forward-looking statements I might make.
So, AFREZZA is the cheap product of MannKind Corporation. It’s a novel form of insulin, it happens to be inhaled which is a nice feature, but key is the kinetics of the product or the time-action profile of the product and how it works in the body. I think it's the first of a new type of insulins that we've coined the term ultra-rapid-acting insulins to differentiate them from so called rapid-acting. But the key thing is they are much more physiologic in their mechanism of action and the way they work in the body. So, I'll talk about that just for a few moments in a second here.
I'm not going to spend a lot of time on the insulin market or the diabetes epidemic is just becoming rampant in this country and worldwide, actually we're not even amongst the worst in the world, although people seem to think we are. Partly because diabetes is often associated with being overweight and we do know that we have that problem here, but still it's a growing problem worldwide and not showing any signs of getting better anytime soon. And the market as consequences is being going at a very rapid clip as well.
So, this is a huge opportunity for us and we think we have a good solution that hopefully will solve this -- may not solve, but certainly improve this problem.
Currently, there is a lot of challenges in treating with insulin, it's not very well accepted by patients, it's generally viewed as the treatment of last resort and even once they've been talked into taking or it’s been prescribed typically a third of the patients don't take it as they should, it's not convenient, there is some sick stigma associated with it if you are out in a social situation or restaurant it's just all too easy to skip now and then which leads to long term complications.
We know also that people are worried about taking insulin, it's a very potent medication, the body uses and it's the best way to control glucose, but if not used correctly it can be dangerous and people are worried about the biggest drive which is hypoglycemia so too little blood sugar. Hyperglycemia are too much, can cause a lot of problems causing microvascular damage and (inaudible) and blindness and typical complications of diabetes, but that takes years. By contrast hyperglycemia can kill you that day, I mean that it could be debilitating and potentially fatal.
So over two-thirds of patients worry a lot about hyperglycemia and doctors do as well. The most frequent reasons why patients are found in emergency rooms and doctors don't like that neither to the patients. So it’s a scary thing and as a consequence they tend to undertreat themselves as well, because they are trying to avoid hyperglycemia.
So it is probably the biggest concern over using insulin. But it does tend to have a not correct time action profile so it doesn't work the same way when it is in it’s injected form as it does in the body which causes some issues. It tends to be too slow to work and last too long. And a typical consequence of using insulin as a weight gain which obviously has some exacerbating effects on diabetes as well and obviously it’s not convenient to inject yourself and there is always going to be some stigma associated with that.
By contrast Technosphere as a powder, it’s a dry powder, it's inhaled through very simple inhalation device that you could see in this picture and it goes into the lung and in initial environment of the lung it immediately disassociates back to its natural form which is actually a liquid. So these crystals form spontaneously in a very slightly acidic environment and the manufacturing process, but these crystals are (inaudible) when they go into the lung they hit their tissues in the lung and they revert back to their natural liquid state, releasing the insulin into the bloodstream very quickly.
So this is kind of the secret sauce behind AFREZZA and why it works the way it does. And there is one thing I want you to take away for this message these curves here, which really shows the time action profile or the kinetics of AFREZZA. And you'll see by contrast that sort of reddish purplish curve is AFREZZA, it has a very, very rapid onset of action, very similar to what the human body does naturally if you are a healthy non-diabetic. And then by contrast that also goes way relatively quickly, because the whole concept here is this -- is intended to synchronize with your meal digestion. So as you start digesting your food, you want that to come into play very quickly and arrest the otherwise rapid rise in glucose in your blood stream which causes some complications. Conversely, when you are through digesting your meal, you want it to go away and you want it to fade out. And you can see that’s really exactly what does in fact happen with AFREZZA, much like if you were to chart a hypothetical curve for healthy person, it would look pretty similar to what we are showing with the AFREZZA curve here.
By contrast, the lighter bluish curve is a so called rapid acting analog, best in class injected insulins today, which take much longer to start to work; when they do, they don’t hit the same IP, and they last a very long time. So first thing you are going to do if you’re diabetic, you are going to predict when your food is going to start to be digested and plan ahead, so you’ll probably inject yourself some 15 to 30 sometimes longer minutes ahead of your meal, hope you’ve timed it well and have kind of your coffee or carbohydrates well and then try to shift that curve over a little bit to the left which will improve the situation a little bit but then you still have even if you are successful in doing that, you don’t have (inaudible) peak, so you can’t signal for example liver to stop producing glucose when you are already getting it from your food because you don’t get that same replicated first phase [instant] response and even then the curve lasts way too long.
So we kind of see far further out and we’ll see if this laser actually works. I am pushing the right button, here we go. So you see over this area when you are finished digestion, you still have a lot of insulin in your system and if that’s the case unless you are still snacking or something else, you are going to find yourself plunging towards hyperglycemia and that’s the major problem with existing insulins and the biggest problem we solve with AFREZZA.
So we would like to characterize AFREZZA as excellent control, so we are resting that rise in glucose with less risk without the risk of the late post-prandial or post-meal plunge and glucose from excess insulin even at that point. So it synchronizes better with the meal, gives you less hypoglycemia and which typically have a less weight gain too. We think the product is weight neutral. Most of our studies, we typically have shown weight loss that’s I think mostly because these people are trying very hard not to gain weight and if you take out the factor this causing it in the first place, certainly it will lose little bit and then will stabilize. So we think, certainly we can say less weight gain. And because of that form factor and ease of use, it’s just much easier to be compliant and we think patients to be much more compliant with this product in use as it (inaudible).
The patient experience obviously is very simple, it’s a palm size device; you can see it here in the palm of the hand and in use about the size of a whistle. I’m trying to be sensitive to all the people who are on the webcast as well. Breath-powered, doesn’t require cleaning, it’s gotten so inexpensive at this point that we essentially give them away, so within a month supply of these, we typically boxed in 90 cartridges per box that’s three per day for 30 days. You would find two of the inhalers packed in the box as well. So whereas you might otherwise have to clean it after a couple of weeks because you do have a powder associated with inside of those devices; at this point, you just throw it away and use a new one. So it’s very simple, very minimal training, there is almost nothing to it, it is breath-powered, so by the simple process of inhaling through device, you’re getting your dose of insulin, you don’t have to time it or synchronize it as you do with some aerosolized devices to make sure you are inhaling, so it goes in when you puff it into your mouth, it is just not cooked inside of your mouth. Makes it very simple, it’s fairly foolproof.
So I talked about less risk of hypoglycemia. This is some data from our most recent Phase 3 pivotal trial or 171 study. And you’ll see, we significantly reduced, both the incidence of severe hyperglycemia and the event rate. We have seen this pretty consistently through all of our major studies, sometimes this is more than this. It’s never been what I call less, but distinctly we have a pretty consistent hyperglycemia advantage, which I think is one of the key characteristic of the product and kind of naturally follows from the time action portfolio I showed you earlier.
FEV1 changes are changes in pulmonary function, we do see them. It’s minor; it’s not clinically significant; and it does not progress which are key things. So we think it’s more or less a reaction to the inhalation of a powder which is not typical. But you can, our measures are so good these days, you can measure it, it’s there. But we don’t see any tissue changes occurring and when you discontinue to use it, it pops right back, which tells you, you’ve not done anything permanent here, just more or less reaction to the treatment. But the key thing here is that it is not clinically significant and non-progressive.
So that’s part of the key safety summary. At this point we’re up around 6,000 patients, so 5,600 patients here for up to two years. We have had a handful or more than that but those are the longest, control study was for two years. And then AFREZZA has been very well tolerated. The only typical side effect you get is a mild throat clearing cough, this is not coughing spasm, this is usually single cough and I have experienced, this is more of you kind of like -- kind of a thing. You don’t have to do it, but it feels kind of natural to do that. But even then and if you any of you were at ADA this past weekend, when you saw the data here, you see that it drops off dramatically. It’s fairly common in about 20% plus of people in the first week. By the end of that week, 80% of those people were not experiencing cough anymore and it continues to drop after that. So as you get more accustomed to the kind of tickling sensations that comes from this inhalation, even that goes away. So, that’s the most common side effect, the rest of it are pretty typical that we talked about pulmonary function issues already.
Lung cancer is an issue that often comes up. It’s not something we’ve seen in our studies as an issue, we’re not seeing a signal, people have gotten lung cancer in the studies, but they do in the general population as well. And the rates we’ve seen have been pretty consistent with what you expect for a master group in these demographics. So there doesn’t seem to be an issue here [or huge amount] [ph] as was experienced in one prior attempt at this kind of a product.
And cardiovascular risk is a question I get asked about a lot because it has been an issue for some companies. Happily the size and duration of our studies has been such that we have a pretty clear database here and we have calculated the so called risk ratio and we have a 0.96 which is less than 1, which means I guess that would be cardio-protective, but I do not think that’s true, it’s probably just an anomaly. The bottom line is if you look at the outer balance of the confidence intervals we're still well within what the FDA [would look for] [ph] even for a post approval study, much less pre-approval. So, we're in pretty good shape on this issue.
Recap all of this, we've been through this a couple of times with the FDA but we - per our last filing in last year, we had initial PDUFA date on April 15th that was extended now to July 15th. In the interim we had an advisory committee, most of you probably know, which voted in overwhelmingly towards recommending approval of the product both in type 1 and type 2 diabetes which obviously is a major boon for us.
Slide about commercialization, needless to say, we do expect to commercialize this product with product manufactured by us out of a facility we've already built in Danbury, Connecticut. It’s not fully built out yet, there is a lot of room sitting vacant waiting for a fulfill and finish equipment being put in; what we expect to launch was about a quarter ultimate capacity, some 375 million to 400 million cartridges, that capacity increases as you added the newer machines, but we expect ultimately that that facility was designed and scaled to accommodate 12 fill and finish lines so we'll launch will 3 and we’ll install the other ones as needed but it was designed [inaudible] fairly quickly as the demand goes up. But ultimately we can do 2 billion cartridges a year out of that facility, which is pretty good number and we're quite pleased with the way that facility has turned out.
Talking further about commercialization. People ask, what is the market for this product. And this is a little harder to address, because this is, we think a very much disruptive product; it's not just simply a replacement for prandial insulins today.
So, we tend to look at the market in three major segments, the first one is probably the one that's most obvious, which is the prandial insulin users. There is 4.2 million of those patients in the U.S. today. We think a good number of those would be very happy to use AFREZZA as an alternative and as the word gets out about some of its advantages that percentage ought to increase.
But beyond that, we believe that there is an awful lot of people out there who probably ought to be on insulin and the numbers say they should be but aren't because they're very resistant; it's not something people want to do and they are probably struggling mildly with their doctors and fighting them not to do that. A good portion of those people as they start to lose that battle with their doctors will phase slowly into insulin by starting with a so called basal insulin, which is a good choice to get you started. It is only one injection and it will lower everything a bit. That said it really doesn't address the ultimate need of the patient which is their inability to deal with the prandial glucose excursions associate with a meal.
So adding a much more tolerable, easier to use and more likely to be accepted insulin such as our which is also arguably less risky, seems like a nice add on to these people, so we'll call it insulin intensification. And then beyond that, kind of so called mother lode of diabetes is the much larger group in excess of 15 million patients that have not had insulin yet. We know from a lot of surveys, a good portion of these people, most survey say roughly in the area 40% of them are not in control. So their glucose levels are much too high. That said they're trying one thing after the other and resisting mildly towards going on insulin. 500,000 of those people per year fail and also going to end up on insulin, those 500,000 would be an obvious target for our new product like this. But beyond that I hope, I really hope that we can capture a much larger percentage of that market for people who would really benefit from this insulin, if we give them a nice alternative than what they have today.
Financial summary speaks for itself. We have a fair amount of cash, [inaudible] fair amount. In addition we have some cushion if we needed from various sources. So we think we are very comfortable through approval of the product.
I do want to address one issue which is, surrounding commercialization, which is in fact the partner because that’s probably one of the most asked questions. And it’s part of the one I have the hardest time answering mostly because I am just not able to. We have said publicly we are in discussions with multiple parties, something always good to be in, but we don’t anticipate we are likely to announce a partnership before approval. So, how fast after approval? Well, that’s been a controversial question and in our recent conference appearance one of my colleagues went out a little bit on a limb and do this kind of a hypothetical number and said six to eight weeks that could be right, it could also be wrong. Could it be less? It absolutely could be less and we are hoping the people including some very well qualified bankers who have been working on this for many, many months with these same partners and working towards an agreement and are anxious to get this done, probably because we all like to get it done sooner so we can get it on the market quicker and probably because they are completely success based in their fees.
But at the end of the day we really can’t say. It’s quite likely or possible that there will -- the final partnering candidates will await for the final label and have a few things to want to hash over with us. So could it be days after approval? Yes, it could. Could it be months after? It could be that too. So I don’t want to set specific expectations, needless to say we’ll do it as quickly as we can and we think we’re pretty well equipped to do it pretty quickly after.
So summarizing and still leaving some time for questions we think this is a product clearly with blockbuster potential. Blockbuster is usually defined as anything over a billion and we can get that pretty easily with not very much of this market, actually frankly a very small percentage. And we think we have a new class of insulin therapy that addresses a very poorly met medical need in this space. We need better insulins, doctors universally agree we need them that work faster and have less risk of hypoglycemia. We think we can deliver on both those promises and we are anxious to be able to do that and that we could do it through a simple, easy to use, non-injection, and inhalation device that you can hide in the palm of your hand if you wish to, it’s just a icing on top of the cake in this regard.
So our PDUFA date is rapidly approaching, we are less than a month away at this point. We don’t know if it will take that full month, but it may very well and stay tuned and we hope for good news from FDA soon.
With that I’ll join my colleague here and answer whatever questions you might have.
Mike Faerm - Wells Fargo
Great, thanks Matt. We will open to questions. We have a mic in the room which we can get over to you if you raise your hand. We have one right here in front.
So what do you expect this product to sell for?
Well, the ultimate sales price will be determined by the commercialization partner. But I will tell you, we’ve always modeled it, and we do a lot of financial modeling you should guess, at parity with existing insulins in pen form. So we take Novolog or Humalog and pens and that’s what we use as our comparator pricing. So we’d expect to price comparably to that.
And what is your relationship with the commercializer in terms what does your company get?
Well that remains to be seen as well. The most likely scenario would be a combination of various things. Most of these kinds of arrangements are royalty based because they’re simpler, frankly but in our case, you’d likely add on some things to that. There are usually a range of milestones finding and hitting different points. And then since we’d be manufacturing the product, you would typically expect some sort of manufacturing or transfer margin on the product as well. So you get money from a lot of different sources. But that’s not the be all end all; I can tell you this at least one potential partner we are talking to that’s more of a kind of profit sharing arrangement. So, there is a lot of ways to structure them. At the end of the day, we have invested quite a -- couple of billion dollars in this product so far, so we would like to be paid handsomely for taking that risk and getting it thus far.
We think the product potential is certainly there, we just need to make sure we have the right partner who can make this a success we believe it can be.
Mike Faerm - Wells Fargo
Matt, with regard to the kind of PDUFA date on July 15th where do you stand in terms of your process with FDA? Are there still questions or information that you’re providing or are you finished and you’re just waiting?
It’s somewhere in between, there is not a lot of information per se, there is a lot of discussion. And I’ve to be a little careful how I characterize that. So, there is a lot of back and forth, virtually daily, and a lot of things to be worked out. I mean it’s pretty clear from the advisory committee, there is issues that needed to be addressed, mostly in terms of what the label looks like and what the post approval commitments would be. I mean a lot of the -- we expect there will be some restriction to label; we’ve proposed some of them; we don’t think this is a product that ought to be used like people with one disease, to state the obvious. If you have COPD, you probably shouldn’t be using a product like this. There is other groups like that as well; we proposed those and we’ll work out those kinds of restrictions and things and the usual array of safety warnings that come from the FDA.
But also in terms of post approval commitments, products like this that is kind of new innovative, you’ll almost always expect some sort of REMS program which is sort of a risk mitigation to track it for a long time to make sure there is not some complication and that all has been seen in that 6,000 or so patients that have been in the trial so far. Those trials only went out a couple of years; 10, 15 years down the road, you never know, so you watch for a long time to make sure, and then you have typically commitments to do things like pediatric studies later. These kind of products are typically only approved in adults initially, and then the FDA has you go back and do pediatric uses later, because clearly this would be a very attractive product for the pediatric market, but initially it would be only approved for adults.
Mike Faerm - Wells Fargo
And in terms of potential label restriction aside from some of the obvious ones you touched on, are there any others that could come to be that might be a little bit more concerning, for example any other populations or restrictions on total amount of use by patients or anything like that?
We don't anticipate anything like that, and there is nothing in that data that would need you to believe that would be required, but until we have it, I can’t give complete certainty.
Mike Faerm - Wells Fargo
Okay. In terms of partnering, how would you characterize the field of interested companies, sort of global, regional, people already deep in diabetes commercialization or not; how do you sort of characterize the field?
Well, it's hard because it includes examples of all of those things. I think we've generally said, our preference is to more of a global player, because it's simpler. That said, we have a lot of regional interest, and we know if we don't end up with a global player, it could be kind of fun because we could be doing other sorts of deals, and our CEO loves those sorts of deals and can barely hold him back from doing them now, and those are pretty premature.
So, we'll see. What would make a good partner? Clearly, it's somebody that has a general -- GP sales force, so it is a pretty good sized GP sales force, and that's kind of a prerequisite, at least some familiarity with products in the endocrinology space, doesn't necessarily have to be diabetes, but it would be hard for us to find somebody that meets those first two criteria that doesn't have something like that at this point. It is somewhat related.
And those are the two kind of physical characters. The third one is their desire and ability to make this a success. I keep saying I think it can be. So, obviously, we'd be looking for commitments from them to do the kind of marketing and sales efforts and so forth that we think are going to be required and dedicate the number of people and have it first in bag for those people for a good period of time to make this successful.
And then also obviously, I assume this is obvious, maybe not, we'd like them not to be conflicted. So if they have a prandial insulin in this space, they might not be the best partner candidate, for example.
Mike Faerm - Wells Fargo
Okay. And where on your list of priorities is it for MannKind to have an active role in the commercialization, and an economic arrangement that reflects that?
It’s certainly on the list, it's not at the top. We would like to have the capability, I think history has shown that companies that try to do that with the single product in this market generally do not succeed commercially, well succeed financially anyway. Even some that have looked back on as being commercial successes, people forget sometimes they actually never made any money when they were trying to sell themselves, and it's only when they have got sold to somebody else that they started becoming profitable. Because the is just that, I mean, with the number of sales people required in this space with a single product, no product in the world has ever ramped quickly enough that you don't just lose your [share] in the first couple of years.
So it's kind of tough, you need more than one. That said, we would find arrangements that we could keep our finger on the pulse of the market to some degree very attractive, and to be honest we expect that someday we will have other products, so it would be embarrassing to us if we have the products in the same market, and we could not sell our first product.
So I guess the ideal situation in our minds would be a situation whereby we could have the right, but not necessarily the obligation to co-promote, so that later on when it makes sense we could exercise that right. All that said, those kind of things are very tricky things to negotiate, and so I wouldn’t count on it. And at the end of the day, it's always you’re playing different things off against each other, and it may or may not prove to be worth it in our mindset to keep that right, but we'll have to wait and see.
Mike Faerm - Wells Fargo
Okay. We have a question here in front. Can we get the mic over there please?
Who supplies the cartridges and how well are they working?
These cartridges and the device itself for that matter, they are molded plastic, so we go to a standard medical plastics manufacturer. We own the molds, we supply the molds to them, and they do the processes. At this point, we haven’t named who the parties are. They are fairly well known. We are only using one at commercialization; we probably have to have more than one supplier. It’s never been an issue so far, this is pretty simple stuff. Designing the devices and the cartridges and so forth was very complicated, but making them is not, it’s pretty standard, easy thing to do. And if it weren’t, we wouldn’t be able to make them so cheaply, we could just give them way.
The (inaudible) stuffs the powder that goes into those cartridges. And that’s -- what we do in our facility in Danbury is to make the powder, so we take the insulin and attach it on to their Technosphere particles and put it into the cartridges. And frankly putting it into the cartridges, we are talking 2 billion cartridges a year. That really is the bottleneck in the process. So we can make the powder fairly pretty quickly, but getting it into that many cartridges and go through the shocking but probably not surprising number of tests on each little cartridge, mostly automated at that rate to make sure that the visual and weight testing and all kinds of other testing to make sure there is not a single one that flips by that’s out of [time if at all].
So it’s a really sophisticated process, it’s very -- we have had some stockholders who had the opportunity to see it. I think we gave a tour at a stockholder meeting a couple of years back before we had the facility completed to a point where you could get in (inaudible) like you do now, it is a really fascinating thing to watch.
Mike Faerm - Wells Fargo
And Matt, in terms of the commercial strategy recognizing that your partner to be would obviously have a significant say in this, it is early stage, how do you envision the targeting for this product in terms of physician audiences, the mix of specialists versus PCP or other preliminary thoughts you have at this point?
Well, I talked a little bit about that in the presentation, but you are right. The key thing I have to emphasize is ultimately it’s probably going to be up to the commercialization partner, but we have a commercialization group ourselves, and they have some ideas and we have spent more time than anybody else has thinking about this and talking to reimbursement agents and so forth, so the mix between specialists and PCPs is a little harder one to judge. I mean we know what it has been traditionally. I think one of the advantages of this product is it’s more easily and more readily used by PCPs. Typically, a general practitioner will refer someone initially going on insulin to an endocrinologist, because there is fair amount of training and expertise involved that they are just not usually equipped to deal with.
I think you might find that happening slightly less with our product because it is simpler and the training process is easier. That said, you still have to train people to use it, and finding the right dosing initially is sometimes a bit of an [arc] form and it takes a lot of judgment. So I think you’ll still see a lot of those referrals, but -- so you are always going to have to have a mix. I guess that’s part of the complication of the product.
Most of the maintenance is by PCPs, and most of the initial prescribing is by endocrinologists. So, the three groups as I talked about, I mean we’ll obviously focus immediately upon anybody using prandial or meal time insulin now as a more attractive alternative, especially amongst those that are just not being very compliant and not taking it as they should. And then associated with that would be anybody coming in new, and so you start with the people that would naturally come in, which is about 0.5 million people a year to start taking to insulin, and then you try to expand beyond that to people who ought to be taking insulin that are being resistant, and I think that’s where it starts to skyrocket.
Mike Faerm - Wells Fargo
Okay. Great. Okay. I think we will wrap up there. Thanks very much for being with us.
All right. Thanks for having me.
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