NuPathe's Management Presents at Stifel 2013 Healthcare Conference (Transcript)

| About: Teva Pharmaceutical (TEVA)

NuPathe Inc. (PATH) Stifel 2013 Healthcare Conference September 11, 2013 4:25 PM ET

Executives

Armando Anido - CEO and Director

Keith Goldan - CFO

Gerald McLaughlin - Chief Commercial Officer

Analysts

Annabel Samimy – Stifel, Nicolaus & Co., Inc

Annabel Samimy – Stifel, Nicolaus & Co., Inc

Good afternoon everybody and welcome to the NuPathe presentation. My name is Annabel Samimy; I’m the specialty pharmaceutical analyst here at Stifel. NuPathe has developed its pending commercialization of its branded patch for migraine, ZECUITY and also involving some other drug for central nervous disorders, although I think those are probably on hold for now. The lead product is ZECUITY for acute migraine has gained FDA approval. [Last January] has two IND stage (indiscernible) products. And with us today is Mr. Armando Anido who is the -- Anido sorry, the CEO of Nupathe. We have Keith Goldan here and Jerry McLaughlin to answer questions during the Q&A portion. So I’ll step aside and let you (indiscernible)?

Keith Goldan

Thanks a lot Annabel and good afternoon everyone. Hopefully I will be able to figure out how to turn this and change slides. Hopefully over the next 10 or 15 minutes I will give you a general overview of who NuPathe is and what we’re all about and why we believe that we have a very significant opportunity in front of us with product called ZECUITY.

I’m going to be giving you some forward-looking statements as all of the presentations do. Please go on to our website under Investor Relations and checkout our risk factors and hopefully after that you’re still interested in investing in us. We are a specialty CNS pharmaceutical company. We have the first and only FDA approved migraine patch in the United States. Migraine hits about 31 million adult migraine sufferers in the United States. And there is a significant component of migraine known as migraine related nausea that is one of the major symptoms of migraine that affects tremendously.

We are in the process of preparing to launch ZECUITY in the fourth quarter of this year and we’re also in the process of having conversations with various commercial partners to help us in broaden our reach. We do have two earlier stage CNS compounds. I’m not going to spend very much time on today. But at the end of the day, it does help to establish a pipeline to build out a long-term CNS specialty company.

Let’s talk about ZECUITY, the first and only FDA approved migraine patch. We believe its game changing and innovative and disruptive technology. It uses sumatriptan, the number one prescribed migraine medicine in the world as the main molecule that gets delivered. We had excellent patent protection. Today we have five orange book listed patents that provide protection out through 2029. And yesterday we announced that we actually have a 61 that was allowed that will hopefully be issued shortly and then be in the orange book quickly thereafter.

Migraine headache pain and migraine related nausea is really the focus of what ZECUITY can help to attack. We’ve excellent clinical data that shows rapid relief for both headache pain and nausea and a very low rate of what are known as Triptan sensations are really a -- almost have feeling of a heart attack that happens in some of the patients that take Triptan. MRN affects about half of the patients that suffer from migraine attacks on the majority of their attack. So there is a very significant product opportunity, patient opportunity and we do know that MRN has a very significant impact on healthcare utilization. And we will talk a little bit further about that.

Today there are 6,000 physicians that write about 33 million Triptan units. We think that if the specialists, the headache specialists, general neurologist really can help drive and establish ZECUITY quite well. And as I mentioned in the fourth quarter is when we’re going to be launching the product.

And it was a very easy to use, single use disposable patch. It gets supplied as you start getting the first signs of your migraine. Press the button; it works for a period of four hours. Once the product has completed, it turns itself off and you can turn it off – and you can take it off at that particular point and dispose it. To comply, it’s either in the upper arm or to the fact, so it does provide opportunities for the patient to have different slides for application. But one of the main futures is that it bypasses the GI track. So when a patient is very nauseous during their attack, the last thing they want to do is take a pill or a tablet or a spray -- nasal spray up their nose.

And as we talked about it does rapidly deliver sumatriptan and we’ll talk about some of the data. Epidemiologically 31 million adult migraine suffers in the United States. We know about half of them, 16 million of them are actually being treated and are diagnosed here in the United States and there are 8 million of them who have migraine related nausea on the majority of their attacks and that’s really the core ZECUITY market opportunity, those 8 million patients.

We know MRN causes problems for the patient. We know that even before they take a medicine that they’re less likely to respond to an oral Triptan just because they have nausea with their disease. We also know they’re causing society money, six times the number of emergency room visits, eight times the hospitalization cost versus those that don’t have nausea with their attacks. And one of the other great things about this is the guidelines are already established, we’re not trending new water at this particular point. Guidelines basically say, it recommends a non-oral treatment for those patients who suffer from migraine related nausea. I’m going to helpfully tell you why we believe ZECUITY is the best of the non-orals.

Current options that are available today don’t really meet the needs of the migraine related nausea patient. Obviously with the tablets or the melts that you have to put in the mouth when you’re nauseous, the last thing that you want to do is put anything in your mouth. We know that many patients will delay therapy which is not good form or they’ll avoid it entirely and just go into a dark room and not do anything, because they feel too nausea or they feel they’re going to throw it right back up.

In addition migraine patients also suffer from gastroparesis which is slowing down of GUT motility. And so if you actually have to take something that gets absorbed from the stomach and its not moving at the appropriate rate that it normally does. It may not actually get into the blood stream and the timeframe that you need in order to work effectively. So that’s the reason the orals and melts aren’t very effective.

Nasal spray, great idea. Spray up the nose hopefully relive the migraine attack. Unfortunately with the nasal sprays, most of it goes down the back of the throat and it tastes like rotten eggs. So at the end of the day nasal spray has never really done quite well in helping to treat that migraine related nausea patient well.

And injections fastest of all of the options that are available to patients works in 10 to 15 minutes. Unfortunately these Triptan sensations appear in 4 out of 10 patients or more. And it’s a feeling like they’re having a heart attack. It’s tightening in the chest, throat, a feeling of panic comes over them and once the patient tries one injection, likely that there are not going to try it again because of that feeling of a heart attack happening.

The result of all this is the patient switch from product to product to product looking for the solution for. We know 80% of patients will try at least two Triptan’s and we know that half of them will try three or more including a non-oral in that. So we believe there is an opportunity for us to really be able to penetrate this market quite well. We think that ZECUITY provides a solution for that because its ability to rapidly deliver sumatriptan, be able to bypass regarded at the end of the day have a very low rate of triptan sensation.

It’s a part of 5(b)(2) program that we went through, but at the end of the day we did a lot of clinical work. We had over 800 patients in our study. Its 10,000 patch applications. Our pivotal Phase 3 study comparing it to placebo was published in Headache back in October, a year-ago. And we did two additional 12 months long-term repeat use studies and one of them was already published and the other one is hopefully soon to publish, 660 patients.

The data and this is a side-by-side comparison of Imitrex, left side is the pivotal Phase 3 data for ZECUITY. You can see superior efficacy over placebo, 53% achieving headache pain relief in two hours, 84% are nausea free at that two-hour time point. And compared to the gold standard in this therapy, Imitrex 50 and 100 milligram tablets and you can see efficacy against pain relief very comparable. ZECUITY does just fine relative to Imitrex tablets. But where it wins out? And where physicians will tell you over and over again that they see it being unsurpassed is relative to nausea freedom. You can see the 84 is far above the 60% rate that Imitrex gives you and we showed statistical significance in Imitrex only in one out of four major studies today.

(Indiscernible) profiles, what you'd expect from a patch? Predominantly application site reactions that you’re going to see and here is the comparison to placebo and you can see some tingling, some pain, some itching and warmth that is very short lift. Transient and at the end of the day within a 24 hour period is for the most part gone. The key piece on terms of side-effects is the atypical sensation. You can see with ZECUITY lower than 2%, atypical sensation versus we know the injection at four out of 10 patients and the tablets are up to 15% as well.

We got a very (indiscernible) same thing clear marketing strategy that were gone; they’re take as we move forward with ZECUITY later on this year. All focus would be on 6,000 headache specialists have prescribed 33 million triptan units on an annual basis. In addition there are 44,000 additionals who prescribed 50 million triptan units. We're in the process of working with some potential partners that will help to broaden our reach to get into that incremental 34,000 or so. And so we believe, combined we’re going to get to an off a lot of them. But I’m going to hopefully show you over the next few slides how even with 6,000 you’re going to be able to get to a fairly substantial market opportunity.

The great thing is our product label has the messages we need in order to remain in and actually they’ve really compete well and be very successful with this product. It got the clinical data relief of headache pain and migraine r relate to nausea as well as a low rate off sensations.

Our strategy on pricing is to price it at parity or premium. And to be quite honest, we’re thinking that it’s probably going to be more of a premium to the current non-oral branded. We also have planning on supporting patient trial with a zero dollar Copay program for the first 12 months. So that in essence a physician will be able to give to the patient, a prescription with a sample patch in order to help them try it on and make sure they know how to use it and they wont have to make a dollar payment out of their own pocket in order to try. We are going to do that not just for the first script for any script within the first 12 months period.

And the final piece of our strategy is really around racing the market focused on migraine related nausea because the current agents haven’t really been able to address MRN and the tolerable fashion; you haven’t really talked a whole lot about it. Even though it affects more than half of the patients or about half of the patients on a regular basis. So we are going to invest and making sure that physicians and patients both require a good alternative for patients that suffer from MRN. We’ve done an extensive amount of market research in order to prepare for the launch. Of course the 800 physicians close to our little bit more than 800 patient and payrolls that represent over a 140 million lives in the United States. So our basis for believing that this product can be very successful is based on the research it’s been conducted. From a pricing standpoint, the research would indicate that. Insurance covers if 90% -- greater than 90% commercial private pay. So very little Medicare D as well as Medicaid in this whole category.

(Indiscernible) see the value in ZECUITY. They know that a poorly controlled migraine suffer actually costs them money. And they acknowledge the GI issues are a significant problem for them and finding the right product for these patients is important. We anticipate that we will not be in Tier 1. We’re not going to compete with generic oral tablets that are currently available. We’re going to be in Tier 3 and Tier 3 with a single step that is going to be just fine with us because at the end of the day what it offers us is an ability to price this product very appropriately in order to get the most value for the product. And pricing we believe it's going to be anywhere between $100 and $150 more than likely up closer to the top end of that and our research would indicate that, that would work quite well.

Most of our business based on our quantitative research would indicate that we’re going to get most of the business from patients that have been on oral therapies. So 80% plus of the patients we anticipate getting are going to come out of oral. And what's going to probably happen is that patient is going to come into the doctors office, they’re going to try them on generic oral sumatriptan. Patient is going to say to them, doc I can’t take it as early as I want -- if you want me to or I want to. And at the end of the day because I am nauseous or I am throwing up I can’t tolerate it. So what's the next alternative? We want to be the next line therapy. That next line therapy should be ZECUITY and we believe that that’s what our research would indicate that we’re going to get next line therapy.

We’ve got brand positioning that we believe is very distinct, meaningful and sustainable. We’ve got game changing disruptive technology that bypasses the GI track. It has great clinical data showing efficacy in both headache pain as well as migraine related nausea and that low incidence of Triptan sensations and we get consistent delivery regardless of whether the patient has nausea or doesn’t have nausea. So regardless of what the start out with, we’ll deliver 6.5 mg of sumatriptan through the skin over a four hour period.

To give you a sense of kind of what the market opportunity may be. What we’ve done here is basically take the 8 million migraine related nausea patients that we talked about previously. We assume that they are treating their MRN and their migraine with ZECUITY two times a month. And that’s only about half the time that they have an attack. On average these patients suffer through about three to four attacks on a monthly basis. And then we put in place $100 price per patch and a $150 price per patch. And the key take away here is that if we were to really only get about 2.5% share of that 8 million patients the product becomes over $700 million product opportunity. So it requires a very low market share of these MRN patients where ZECUITY should be the first line in order to make this several $100 million in size.

So hopefully over the last 15 minutes or so I’ve given you a sense of what NuPathe is about, particularly with securities about first and only patch, game changing technology. We got a product that is approved. We will be ready to launch in the fourth quarter. Specialist driven opportunity, long run way out, protection now through 2029 and we’re pretty excited about the long-term revenue opportunity.

So maybe what I will do now is turn it over and ask if you all have any questions that I can answer or if Anido has done. I know you do.

Annabel Samimy – Stifel, Nicolaus & Co., Inc

Definitely.

Keith Goldan

(Indiscernible).

Annabel Samimy – Stifel, Nicolaus & Co., Inc

So all right. Expect a launch for Q, with or without partner?

Keith Goldan

We are in conversations with partners as we speak and at the end of the day, its we would love to have a partner to broaden our reach and be able to get to a broader group of physicians. Don’t know for sure if that will happen for sure. But today I think that its one of those that we continue in conversations. I wish that were done by now, but its not. And we will see what happens.

Annabel Samimy – Stifel, Nicolaus & Co., Inc

So are you able to prepare? Let’s just assume that it’s not with the partner, but you’re still in discussions. Are you able to prepare for your launch right now in the same way and how it change if you had a partner? Are you still doing the same thing to normally do?

Keith Goldan

Yes. We are doing everything to prepare for the launch. As if we were doing it on or around with a partner regardless. The only thing that we have yet to pull the trigger on is the hiring of the commercial sales organization today. So we’ve got managed care lined up, we’ve got sales leader ship lined up, we’ve got marketing lined up, we’ve got the back office things that are lined up. We’ve got territories cut and it's basically a matter of, if we’re doing it on our own we’ll do it one way. If we’re doing it with a partner we’ve got it set up in a different way. And at the end of the day we’re ready to go and the final button that we’ll have to push is basically -- we’ve got recruiting firms already set up in order to allow us to get the reps up and running and these are guys that -- the recruiting firm that we’re using are some of the folks that I’ve used previously and they’re able to, you press a button and within 45 to 60 days you’ve got reps on your payroll ready environment to go.

Annabel Samimy – Stifel, Nicolaus & Co., Inc.

Are there any contingent -- well there is no contingent, it’s already approved. So are there any offers out right now that you know that we will have at least this size sales force regardless of whether we have a partner or not?

Armando Anido

Yeah, I am not going to answer that question in terms of contingent or not. But I think that we're -- we’ve got our ideas on the territories. So the territories are cut. Jerry has done a great job along with his team to kind of get it all setup. And in essence we have the recruiting firm ready to go and he’s found us people in each of every one of those territories. So, there are a group of three or four of them in each of one that we’re ready to kind of interview and ready to go. And at the end of the day once we make the final call and determine are we doing it alone, are we doing it with a partner or in some variation they’re up, we’re set to go.

Annabel Samimy – Stifel, Nicolaus & Co., Inc.

Okay. And you may or may not be able to answer those, but I am going to ask it anyway. What is the rate limiting sub for that final decision on a partner or not the partner?

Armando Anido

Yeah, at the end of the day partnerships are about to the people who love the asset as much as you do. And by loving it, it includes the economic portions of it. And I think at the end of the day we are in a couple of different discussions that can terminate quickly or can proceed quickly. And so we’re at some point here hopefully have that call made.

Annabel Samimy – Stifel, Nicolaus & Co., Inc.

Okay. And try anything special; keep on going with those partners they would earn.

Armando Anido

If you think.

Annabel Samimy – Stifel, Nicolaus & Co., Inc.

Thank you. So let me move on.

Armando Anido

Okay, all right.

Annabel Samimy – Stifel, Nicolaus & Co., Inc.

And there are (indiscernible) audience have some partner questions too, because I am just batting zero here as I always do. So you’ve been now with the company a four year. You’ve been in the migraine space before. You’ve done your due diligence; is there anything about the market that you see now as you do your due diligence with this product that you didn’t see when you started, that gets you either more excited or less excited and just give us the sense of how you see the market today?

Armando Anido

Yeah. So the market today and, one; in comparison to when I was in at Glaxo back in the late 90’s, one there were no generics at that point. We were Imitrex in the various formulations and the new competitors were just coming in. Maxalt and Pfizer’s compound and Zomig and all of them were just coming in. So it's changed a lot since then. Today we’ve got a market that after a year of looking at it further I get more excited about it. And the reason I get excited about it is that particularly for ZECUITY, with ZECUITY you have a product that we don’t want to be first one. We’re not going to compete against generic orals. We don’t want to be there. We want to be the first option after they can’t tolerate it. And manage care, the more we talk to them the more we are very happy that they are in essence not thinking of us competing with the first Tier. They’re going to put us in Tier 3 and it gives me the ability to price this thing at a fairly high rate which I’m quite happy with because I think this product deserves a good value. And at the end of the day we’re able to get the next line option, put in Tier 3 and we will get significant coverage in Tier 3 and at the end of the day be able to price it appropriately in order to make good money in a shorter time period.

Annabel Samimy – Stifel, Nicolaus & Co., Inc.

Okay. Now how about the landscape for migraine and how it's changing now? Obviously we know that – that’s fun..

Armando Anido

That’s fun.

Annabel Samimy – Stifel, Nicolaus & Co., Inc.

Let me just clear, you go horizontal,

Armando Anido

Yeah, it’s still not approved by the way.

Annabel Samimy – Stifel, Nicolaus & Co., Inc.

That’s still not improved.

Armando Anido

I got a second COO and (indiscernible) and God knows what -- who knows what's going to happen.

Annabel Samimy – Stifel, Nicolaus & Co., Inc.

Right. So they still have a clinical profile and it probably go somewhat in line with your clinical profile which is if you’re going for Triptan sale (indiscernible) respond while they can be rapid acting. They can treat nausea. So how do you position yourself which at some point in time those products will be on the market. So how are you positioning yourselves together?

Armando Anido

Yeah. I think that first and foremost I don’t think I would directly compete with DHE. I think DHE for years has been flash resort medicine in whatever formulation, whether it was nasal, injectable or whether it's orally inhaled. I think that MAP may have a nice compound or Allergan I guess at this point. It may have a nice compound that in essence maybe one of the best formulations of DHE, but at the end of the day it doesn’t really address that migraine related nausea patient very well. It's orally inhaled, so you have to put it in the mouth and many of these patients aren’t very interested in actually putting anything close to their mouth when they’re feeling nauseous or about to throw up. Second piece is, is DHE is known to cause nausea in and off itself. So that’s a big issue and if you take a look at their clinical data that’s been published you will see that at 30 minutes and at one hour it was worse than placebo, and that’s an issue for them. All right, so if you’re all of a sudden making it worse before it ultimately gets better I don’t think patients are going to go down that pathway. So I believe we’re going to compete, we’re going to get our business from the oral. If they’re going to try one oral maybe two, and then they’re going to come over to something that they need that’s non-oral and it will be I believe ZECUITY is the best of the non-orals without a doubt. It addresses it in a very tolerable fashion, and then if they don’t respond well to ZECUITY or injection or nasal, they’ll then try DHE and DHE will be in it's own little spot and I think that my guess is Levadex will become the predominant formulation in the DHE’s but it's 1% of the units today. So at the end of the day 1% of the units is 1.3 million units I’ll let them have that.

Annabel Samimy – Stifel, Nicolaus & Co., Inc.

So regardless of whether Levadex is delayed or not delayed the opportunities are completely different in your view. They’re not providing any advantage or a disadvantage?

Armando Anido

Yeah, I mean I think at the end of the day they will won't compete with us directly. I think they’re going to -- my guess is they’re going to compete and get the DHE business first. They may eventually try to get over into a broader audience. But to be quite honest because they cause nausea they’re also going to have a pregnancy category acts and if you think about the ideal patient type that is in this category it is a 30 to 50 year old female, child bearing age, why would you want to give them a product unless it's last resort. Okay, if they tried the Triptan’s and it's not working, tried several of them, tried a non-oral then go ahead and go to it. But I don’t think other than some headache specialist I don’t think primary care will ever touch DHE in whatever formulation it is whether it's oral or injectable or nasal.

Annabel Samimy – Stifel, Nicolaus & Co., Inc.

Okay. Now we’ll talk about the market for a second. So you decided that eight million nausea patients, I think at some point in a couple of your conference calls you have a 1.5 million nausea vomiting, so how are you stratifying your target audience. Who do you go to first and what really is the opportunity if the 1.5 is in the eight or there’s something between, is it -- the response of that?

Armando Anido

Yeah, the eight million are those that have nausea on the majority of their attacks. They don’t have them on a 100% of their attacks. The 1.5 million that we’ve previously listed are those that vomit every single time. So those are patients that, they’re not only nauseas but they are throwing up on every single attack, that’s 1.5 million patients, okay? We think we’re broader than just that vomiting group. We think that patients that have nausea they want to bypass the gut, they don’t want to put anything in their mouth or nose. And at the end of the day we think that we can get to that broader group and we can get to that broader group through either going after just the 6000 dots that represent 33 million Triptan units or get to a slightly broader group depending on the partnership that we would have.

Annabel Samimy – Stifel, Nicolaus & Co., Inc.

Okay. And in terms of identifying patients, it's pretty easy to identify someone who’s vomiting. How much education do you need to provide to the physician for them to ask the question, do you have nausea and vomiting to really identify that patient from a physician perspective?

Armando Anido

Well, remember that nausea is one of the symptoms, one of the classic symptoms of migraine. So physicians in their mind, headache specialists, general neurologists, general practitioners have all been taught that its headache pain, it's nausea, it's phonophobia, its photophobia. All right, so it's one of the four cardinal symptoms of migraine. So what we have to do is make sure that they now know that they have an option that’s tolerable form. All right, it's tolerable for the patient. In the past the reason nobody has really talked a lot about it is, if you got a tablet you’re not going to talk about nausea. If you’ve got an injection that causes severe pain to the chest, you’re probably not going to talk much about it, and if you’ve got a nasal spray that goes down the back of your throat and tastes miserable you’re not going to talk about it. So we believe that we’re going to, it's going to be one of those things we’ll continue to drive our medical message all about MRM. And we believe that, that will continue to drive physicians to be thinking more and more about what patient fits right with ZECUITY. Patients are going to self identify. Patients, the category – the one thing that hasn’t changed though over the past 15 years since I was in it back in Glaxo days, is that patients are always looking for a better alternative. They’re always looking it. The data would say 80% of them at least tried to and 50% are trying three or more. That’s always been the case. So always looking for something that’s going to work for them and we believe that as ZECUITY is introduced that patients are going to start seeking it out. We already get phone calls in the office. When we announced that the product had been approved we get calls from people. We get website hits from people asking us, when are you going to launch? When is it coming out? When can I get it? Because we’re all looking for something to address their migraine.

Annabel Samimy – Stifel, Nicolaus & Co., Inc.

Okay. You already had started talking about your commercial preparedness, you have (indiscernible) in place of I guess the Regional Sales Managers and I guess I want to know more is about the manufacturing and what is the status of manufacturing and do you have sufficient capacity that you want for that launch?

Armando Anido

Yeah, we have -- our manufacturing is moving along quite well. We’re ready to -- basically we’re in final -- we’re in validations at this point and we’ll be ready to start shipping product in the fourth quarter. The capacity for the first 12 month period is about 1 million units. So it does provide us with a nice ability over the first 12 months to be able to produce enough to satisfy demand. And then in about 12 to 15 months afterwards we actually are going to be going to a commercial scale manufacturing facility with new equipment and that is currently being qualified and work is being done on that at this point to the point where it will increase our capacity to over 5 million units. So I believe that between our registration batch; God Love Us, if we run out of product at our registration batch I think we’ll all be happy because the product would have done unbelievably well in its first year. And then in 12 to 15 months we’ll have the second line up and running and that line is going to provide us with 5 million units in capacity.

Annabel Samimy – Stifel, Nicolaus & Co., Inc.

Okay. We’ll we’re run out of time but does anybody have any questions from audience? No, okay. Well, thank you.

Armando Anido

Okay, great. Thanks a lot, Annabel.

Question-and-Answer Session

[No formal Q&A for this event]

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