DBV Technologies SA at Morgan Stanley Global Healthcare Conference

Sep 12, 2016 AM EDT
DBV.PA - DBV Technologies SA
DBV Technologies SA at Morgan Stanley Global Healthcare Conference
Sep 12, 2016 / 06:15PM GMT 

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Corporate Participants
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   *  Pierre-Henri Benhamou
      DBV Technologies SA - Chairman, CEO
   *  David Schilansky
      DBV Technologies SA - COO
   *  Susanna Mesa
      DBV Technologies SA - SVP, Strategy

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Conference Call Participants
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   *  Matt Harrison
      Morgan Stanley - Analyst

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Questions and Answers
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 Matt Harrison,  Morgan Stanley - Analyst   [1]
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 Great. So, next up we have DBV Technologies. Just quickly, before we get started, I need to read a disclosure statement.

 Please note that all important disclosures, including personal holdings disclosures and Morgan Stanley disclosures, appear on the Morgan Stanley public website at Morganstanley.com/researchdisclosures, or you can pick up a copy at the registration desk.

 So, pleased to have with me the whole team of DBV. We've got Pierre-Henri, the CEO; David, who is the COO; and Susanna, who runs IR and strategy. So, I guess maybe just to start off, you have a unique approach to allergy treatment, so maybe you could just give us a little bit of the background on how you came to develop the Viaskin product and the history behind that.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [2]
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 Thank you. Thank you, first, to invite us. It's a pleasure to be here.

 We started this -- the Company has been founded since 2002. And we were -- I am a pediatric gastroenterologist. I am one of the founders the Company. And as a practitioner, I saw a lot of children allergic -- food allergic in my daily practice.

 And so, we looked for a treatment, a very safe approach of the treatment of food allergy. And it was clear at this moment that the cure and treatment of either immunotherapy or injection were not possible for the desensitization of the severe patients. So, we found this new concept to address the immune system by the skin in complete safety and with a very interesting profile of immune response.

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 Matt Harrison,  Morgan Stanley - Analyst   [3]
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 Perfect. So, I guess maybe a couple questions about that. I mean, so the first question is maybe you could compare and contrast OIT with your approach and what you see as the key differences there.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [4]
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 Yes. One thing is -- absolutely made consensus is the use of desensitization, which is the intake of a few amount of allergen every day in order to provoke the tolerance, is probably the best way for the desensitization, but there is a different way of administration. Injection is not possible. It's too dangerous. It can provoke some very, very severe reactions.

 Overall, immunotherapy exists for at least 20 years. And the limit of this treatment is also the safety and also probably the profile of the response, which is not long term protection when the treatment is stopped.

 And what we have found is that the immune system in the skin is very active and very tolerogenic, so we use this way of administration. And the first interest of this way of administration is the safety.

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 Matt Harrison,  Morgan Stanley - Analyst   [5]
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 Okay, perfect. And I guess as we think about the platform, I mean, this is probably a good point as we set the baseline, because I'd like to talk about Phase III studies, but maybe just briefly you could give us an overview of the Phase II data that you've generated so far and how you think that compares to some of the competitive data that exists out there.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [6]
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 First, we have several programs ongoing. The first and the main is the peanut allergy treatment, the Viaskin Peanut. Viaskin is the name of the platform. We have also Viaskin Milk, and we are in Phase IIb for the milk. And we are preparing the Viaskin Egg.

 For the Viaskin Peanut, we are now in Phase III. So, we have published different results from the older studies we have already performed, especially Phase II.

 And what is clear is, first, the treatment allows us to desensitize with complete safety. And the safety results were excellent, a very low rate of dropouts, a very high rate of compliance. The compliance rate in the different studies we have performed is superior to 95%, which is a lot, and a very good level of efficacy in the different studies.

 In the VIPES study, which was our Phase IIb, we were able to increase the level of tolerance from the patient. We do a challenge at the baseline and then after one year of treatment in order to know at what level the patient is able to react. And we were able to multiply at least by 10, sometimes much more, more than 50% of the pediatric population, and in the second year more than 80% of this population.

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 David Schilansky,  DBV Technologies SA - COO   [7]
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 And I think in the next year or so we will be releasing top line data of our five trials, which is in peanuts, two trials, the Phase III pivotal trial, but also a safety trial that I'm sure you will talk about, which is called REALISE.

 We will have the MILES trial, which is the immunotherapy for milk allergy. We also have an eosinophilic esophagitis trial going in partnership with CHOP, and we recently announced the launch of a trial in the vaccine space. So, that's all going to unfold in the next 12 to 14 months in terms of platform.

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 Susanna Mesa,  DBV Technologies SA - SVP, Strategy   [8]
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 And I'll add one more thing, Matt, I think -- in your question just on how it compares to data that's out there, I think what's clear to us is that the unmet medical need today is really to protect these patients against accidental traces that are due to cross contamination in food.

 So, when we're thinking about traces, we're thinking about amounts between 10 milligrams to 40 milligrams, maybe 100 if you're pushing it. So, at the end of the day, what you want to do in a therapy that's going to be successful commercially in this field is really find the right risk-benefit profile for a therapy that allows patients to be desensitized safely, that gets them to the protection of those accidental traces protection, but without a major side effect profile or tolerability that's going to decrease their lifestyle or that's actually going to make them feel worse than they already are feeling.

 And we feel like we've found that essential balance between safety, tolerability, and efficacy. And that's what we've packaged together into a very neat technological advantage that we've discovered at DBV, which is the Viaskin technology.

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 David Schilansky,  DBV Technologies SA - COO   [9]
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 And then this is why the compliance in our trial as well as the dropout is --.

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 Susanna Mesa,  DBV Technologies SA - SVP, Strategy   [10]
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 Exactly.

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 David Schilansky,  DBV Technologies SA - COO   [11]
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 Better than expected.

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 Matt Harrison,  Morgan Stanley - Analyst   [12]
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 Okay, perfect. So, I guess two follow ups on the Phase II. Can you talk about the theoretical benefit or how you think about the theoretical benefit of stopping treatment and patients being -- continuing to be desensitized? And if you think it's realistic, perhaps in the third year or further of when you follow these patients from Phase II, if we could get any signs of that?

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [13]
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 It's a bit early, because we have not completed the follow up part of the Phase II study. But we -- in the coming months, we will be able to give first results on the sustained effect after the discontinuation of the treatment.

 But, of course, it will be on a small amount of patients. And in the Phase III, we -- our intention is to do it in a larger population.

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 Matt Harrison,  Morgan Stanley - Analyst   [14]
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 Okay, perfect. And David, you touched on this, but you recently completed enrollment in the Phase III efficacy study for peanut. Maybe just remind us of the endpoint that you need to read out, and then how you're thinking about the timeline for when that data might be public.

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 David Schilansky,  DBV Technologies SA - COO   [15]
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 And first of all, I think we completed enrollment for the PEPITES trial, which is the pivotal Phase III, earlier than expected with more patients. So, that's a sign that -- we started acting in December. We completely in June, which is a sign that the enthusiasm around the treatment was really, really high.

 The endpoint is -- to our request has been defined with both agencies, the EMA and the FDA. And we are, according to our food challenge scale, stratifying patients according to their sensitivity at baseline.

 So, we are taking the so-called very sensitive patients that are reactive to one, three, or 10 milligrams of peanut protein at baseline. They will be considered a responder if they are able to consume at least -- if they're able to reach 300 milligrams peanut protein after 12 months. And the less sensitive patients that react to 30, 100, or 300 milligrams at baseline will be considered as a responder if they are able to reach 1,000 after a year of treatment.

 And if you apply this definition of a responder to our Phase II VIPES data, you actually get a higher difference between placebo and treatment response and a better P value, which magnify the treatment effect.

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 Matt Harrison,  Morgan Stanley - Analyst   [16]
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 And so, that data sometime in the second half of 2017?

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 David Schilansky,  DBV Technologies SA - COO   [17]
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 Absolutely.

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 Matt Harrison,  Morgan Stanley - Analyst   [18]
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 Perfect. So, I guess one other question on Phase III as we think about -- because we've spent a bunch of time talking about Phase II, any other key differences between Phase II and Phase III beyond obviously the endpoint that you're using?

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 David Schilansky,  DBV Technologies SA - COO   [19]
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 We are enrolling younger patients. Thanks to the safety of the product also generated in an NIH sponsored trial called CoFar6, we're able to lower the age of enrollment in our Phase III to four years old. We started at six years old to 11 in this Phase II, so that's another difference. Apart from that, it's very much the same, the same kind of trial.

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 Matt Harrison,  Morgan Stanley - Analyst   [20]
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 And any expectation around different -- as you get to younger and younger children, how their immune system reacts to either potentially having a more durable effect or any -- or a higher effect? I mean, any expectation around that just theoretically, obviously, because you haven't studied those patients, or would you expect them to look the same?

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [21]
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 The only thing we can say is the younger the better for the expectation of the efficacy of the treatment. So, this is something we are contemplating also in the next study we will perform in one to three year old children in the coming months.

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 Matt Harrison,  Morgan Stanley - Analyst   [22]
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 Okay, perfect. So, David, you also mentioned REALISE, which is a new study you recently announced. Maybe you could just give us the rationale for doing that study, obviously because it wasn't -- or, no, I guess it was six months, eight months after -- you'll remind me of the date, but however far after you started your first Phase III study.

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 David Schilansky,  DBV Technologies SA - COO   [23]
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 Yes. I think you know we wanted really to -- before the launch of the product to have another study that would enable us to collect real life data. So, that was really the purpose -- initial purpose of the launch of REALISE is really to have a study that enables us to leverage the patient database with quality of life questionnaires and so on.

 And also, since we were using food challenges in all of our trials, we wanted to be able to include anaphylactic patients, severely anaphylactic patients. They were excluded from all peanut allergy trials because of their food challenges.

 And we have been able to couple that in a trial that's called REALISE, which is, again, looking at the real life use of the product without any food challenge at baseline, therefore enabling us to also include anaphylactic patients, which -- they are really in need of a treatment.

 That, and our regulatory team also has been able to confirm with the FDA the number of patients in the safety database. There was no need for any filing. And in total, if you add all the studies with the 250 microgram dose that we're using with Viaskin peanut, we will have 600 patients. And we understand that is the right number to be able to file a product with the FDA.

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 Matt Harrison,  Morgan Stanley - Analyst   [24]
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 Okay, perfect. And then I guess one of the questions that I get is, if you're including severely anaphylactic patients in REALISE, doesn't that make you worried about increased risk? And so, maybe you could just talk about your confidence around including those patients in the study.

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 Susanna Mesa,  DBV Technologies SA - SVP, Strategy   [25]
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 I think one of the things that we were able to negotiate with the FDA, because that could be a risk, is that we did negotiate two different statistical analysis plans for both of those different populations. So, if there is a safety event that kind of makes us worried on that population, we'll be able to separate those two different datasets pre-stratified by the FDA.

 Now, keep in mind that we have explored the therapy in this more severe population in our Phase I. That data was published this year, and we don't see any treatment emergent adverse events that would lead us to believe that there would be a more reactive type profile for this population.

 So, from our standpoint, we feel very comfortable that, again, we've been able to create this patch that can really leverage the skin as a desensitization therapy and bypass the bloodstream. So, that's why we could treat all patient populations in peanut allergy.

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 Matt Harrison,  Morgan Stanley - Analyst   [26]
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 Okay, perfect. I guess two additional questions on peanut. First, you talked about the population four to 11 years old. What's the plan in either younger children, I think you talked about one to three, and also adolescents or adults, and how you see those developing over the next year or two?

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [27]
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 For adolescent and adults, it was a bit disappointing in the last studies. And what we think is we need to have more information on the immune system, the way the allergen is processed by the immune system in adults and adolescents, and to see how we can improve and increase the effect at this age.

 Our main option is to increase the dose, and we saw there is a clear dose effect in this treatment. But also, we are studying the size of the patch, the site of the application of the patch. And we will start studies in humans on this.

 We did some in preclinical studies in animals, but now we will do it in humans before starting the Phase III in adults and adolescents. So, it will take probably a bit more, but it will be more secure for the results.

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 Matt Harrison,  Morgan Stanley - Analyst   [28]
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 And then the very young patients?

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [29]
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 For young patients, we are ready to start.

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 David Schilansky,  DBV Technologies SA - COO   [30]
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 I think that we have always emphasized the fact that we think that our therapy is extremely well suited because it's very, very safe for pediatric use, especially in young children. And we've discussed with the agencies the start of a one, two, and three year old trial, and that we'll be able to do so in the next six to eight months.

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 Matt Harrison,  Morgan Stanley - Analyst   [31]
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 Okay, perfect. And then maybe before we switch to milk and some of the other indications, I know it's early and we're not going to start talking about commercial for a year or two, but what's your view on the market, where do you see, if you had this product available now, where the patients might initially be treated and how you think about the accessibility of those patients?

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [32]
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 Susanna, you want to answer?

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 Susanna Mesa,  DBV Technologies SA - SVP, Strategy   [33]
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 Sure. So, I think it's clear from all the market research that we've done today, which is significant, that we believe we're clearly going to be standard of care and that, because of that risk-benefit profile that we've been able to develop, there's really not going to be any major implications in terms of trying the patch even if it doesn't work.

 So, we don't see segmentations based on patient populations. We really see this as an all-comer treatment for all peanut allergy patients out there. And again, even if it doesn't work -- efficacy is not going to be 100%. For those guys that it doesn't work, we believe they will still most likely try it out for a year or two.

 What's really neat and what we've seen in our clinical data is that we do see increasing efficacy and protection with time. So, it is interesting to see that at the end of the day we'll probably see some patients that will need maybe a few more years than others.

 And ultimately, that's the way that we see the market working, not so much fragmenting by population or excluding certain patients, but maybe just in terms of duration. Some patients will wear it for longer. Some patients will wear it for less.

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 Matt Harrison,  Morgan Stanley - Analyst   [34]
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 Okay.

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 David Schilansky,  DBV Technologies SA - COO   [35]
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 And I think it's a large -- it's a very large market, and the patients are pretty well identified and they are being followed or monitored by the allergists. This is the specialist that we will be targeting when we launch the product. We will be targeting allergists.

 And therefore, this is why DBV has the reach and today the capacity to reach these physicians. There are 4,500 allergists in the US, so with a sales force of 60, 80, 100 people, we'll be able to commercialize it ourselves.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [36]
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 Our strategy is to go to the market by ourselves in the US and in the main markets, and probably to have some partnership, for example, in Asia and other countries we are not able to reach by ourselves.

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 Matt Harrison,  Morgan Stanley - Analyst   [37]
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 Okay, perfect. So, maybe we could talk about milk a little bit. Obviously, it's a different kind of allergy, a higher placebo response, it seems to be. Maybe not. So, maybe you could just comment on how we should think about that Phase II data, how you think about what the hurdle rate is to have a good therapy in milk, and just remind us sort of how much clarity you think we'll have when we get that data next year.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [38]
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 First, it's shown that there are a lot of children with cow's milk allergy, 4% to 6%, but most of them are non-IgE mediated cow's milk allergy. And these allergies have a very spontaneous improvement in the two first years of life.

 It's a bit different with the IgE mediated cow's milk allergy. And some we are targeting have a very, very high level of IgE. And in these patients, there are not much more spontaneous improvement than peanut, for example. So, we are expecting exactly the same kind of results, hopefully, than the peanut, because the allergy is not very different.

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 Matt Harrison,  Morgan Stanley - Analyst   [39]
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 Okay.

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 Susanna Mesa,  DBV Technologies SA - SVP, Strategy   [40]
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 With that said, though, I think one of the confusions, Matt, is that it's milk intolerance or something that's not as severe as peanut. And clearly this is a high unmet medical need.

 And actually, if you look at the deaths today of the -- we have 200 to 300 deaths a year of food allergy -- that are related to food allergy. And a lot of them are actually because of milk, because it's a lot harder to avoid. And it's very severe and it affects a lot of pediatric patients.

 So, from our perspective, the unmet medical need is very clear, and it's something that we're very committed to do our best effort as possible.

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 Matt Harrison,  Morgan Stanley - Analyst   [41]
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 Okay. And as part of that, I think you're using milk to look at EoE. Maybe you could just give us a little bit of background, because EoE is a bit more of a unique indication, why you're studying EoE, what the market opportunity is in EoE, and then maybe we could talk about what we might see in that data.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [42]
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 So, EoE is a severe disease. It is due to the massive infiltration of eosinophilic cells in the --.

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 David Schilansky,  DBV Technologies SA - COO   [43]
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 Esophagus.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [44]
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 In the esophagus mucosa, excuse me. And the patients having this disease are not able to eat easily. They have really a lot of trouble. So, it's very difficult because when they stop the allergen they have a relapse, but they have -- they are much better. But when they take again the allergen for a long, long time they relapse.

 So, it's really tough, and it is provoked by the contact of the allergen with the esophagus mucosa. So, it's the reason why in OIT, for example, they have so much eosinophilic esophagitis.

 And this treatment is able to treat it. We showed that in animal models, different animal models, and now we have a study with Philadelphia University, the CHOP, to show that the benefit of the treatment of eosinophilic esophagitis [trigger] forms.

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 Matt Harrison,  Morgan Stanley - Analyst   [45]
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 Just remind us, what's the incidence of EoE, and are we looking for remission in EoE? Like, what's going to be considered a good result in the study?

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [46]
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 First, it's an orphan disease, considered as an orphan disease. It's rare, but the numbers --.

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 David Schilansky,  DBV Technologies SA - COO   [47]
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 It's 250,000 patients, roughly.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [48]
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 Yes. Okay.

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 Susanna Mesa,  DBV Technologies SA - SVP, Strategy   [49]
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 It's increasing in prevalence, though.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [50]
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 And second, the benefit will be when the milk -- because the milk, in children, is the main cause of this eosinophilic esophagitis. When we will reintroduce the milk, there will be no relapse of the EoE.

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 Matt Harrison,  Morgan Stanley - Analyst   [51]
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 Okay. Okay, perfect. Maybe we could just talk about some of the other work. Obviously, there's Viaskin Egg, which is progressing, and then pertussis. Maybe just comment on the status there and what we should see next from them.

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 David Schilansky,  DBV Technologies SA - COO   [52]
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 Sure. So, as I was referring to earlier, we do have and intend to launch a food allergy product every two years. We'll be starting with peanut, then we'll go with milk, then we'll go with egg. And in the meantime, we are diversifying the platform where it makes sense, where the medical needs are.

 And we've also been investigating for I think three or four years now with University of Geneva, that's the leading center in vaccine worldwide, the use of the patch in boost vaccine of pertussis, whooping cough. The team with DBV at the center and at DBV have generated extremely good preclinical data that has been published in a reference journal called Vaccine.

 And on that basis, we decided to start a pilot trial that will be looking at safety and markers of efficacy of this -- of the use of the patch using a recombinant pertussis in 60 subjects. And we will have the results of this in H1 2017.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [53]
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 And it's really interesting. And if it works, it will be a new paradigm in the boost vaccine because it's very easy to use. There is no adjuvant in the patch, and of course no injection. It is very well tolerated too.

 And probably for young adults, as you know, the vaccination gives not the same protection than the previous one. It's an attenuated vaccine. So, at 20, half of the population are not protected anymore against whooping cough. And it's very interesting to have a very easy way to boost the patients in order to protect them on a regular basis, because every five years it will be possible to use the patch.

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 David Schilansky,  DBV Technologies SA - COO   [54]
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 So, this idea of using the device and technology in vaccines can be a platform within a platform, because you can find multiple indications and multiple patient populations for which the use of the patch, and that it's so easy to administer, would make a lot of sense.

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 Matt Harrison,  Morgan Stanley - Analyst   [55]
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 Perfect. So, maybe just one final question then, just the cash position, current runway, and what you've talked about in terms of your ability to finance yourself.

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 David Schilansky,  DBV Technologies SA - COO   [56]
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 So, we have currently EUR280 million of cash. We recently had a partnership with Nestle Health Science, also in diagnostic, which allowed us to cash in EUR10 million. And this provides us enough cash to be patient and to continue to develop both the commercial platform in the US but also the pipeline.

 And as I told you, we have five trials reading out in the next 12 to 14 months. So, obviously this cash allows us to go well beyond this date.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [57]
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 And in the diagnostic, it's another platform because we have, for the moment, the diagnostic for the cow's milk, and we are developing this with Nestle. But, it can be used in different -- and we have worked on how does my diagnostic -- for example, how is my allergy for the cow's milk.

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 Matt Harrison,  Morgan Stanley - Analyst   [58]
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 Perfect. Pierre-Henri, David, Susanna, thank you very much.

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 David Schilansky,  DBV Technologies SA - COO   [59]
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 Thank you, Matt.

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 Pierre-Henri Benhamou,  DBV Technologies SA - Chairman, CEO   [60]
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 Thank you. Thank you, Matt.




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