DBV Technologies SA at Jefferies Healthcare Conference

Nov 17, 2016 AM EST
DBV.PA - DBV Technologies SA
DBV Technologies SA at Jefferies Healthcare Conference
Nov 17, 2016 / 04:00PM GMT 

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Corporate Participants
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   *  Pierre-Henri Benhamou
      DBV Technologies S.A. - Co-Founder, Chairman, and CEO
   *  David Schilansky
      DBV Technologies S.A. - CFO and COO
   *  Susanna Mesa
      DBV Technologies S.A. - SVP of Corporate Strategy

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Conference Call Participants
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   *  Eun Yang

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Presentation
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 Eun Yang,    [1]
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 Good afternoon. This is Eun Yang, a biotech analyst with Jefferies. Thanks for joining us today. Our next presenting company is DBV Technologies. It's involved in food allergies; and peanut allergy product, Viaskin Peanut, is in Phase III trial.

 And presenting from DBV is Dr. Pierre-Henri Benhamou. And then we also have Susanna Mesa, Senior Vice President of Corporate Strategy. And then later on, David Schilansky, CFO, will be joining us.

 So Pierre?

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 Pierre-Henri Benhamou,  DBV Technologies S.A. - Co-Founder, Chairman, and CEO   [2]
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 Thank you. Thank you very much. It's a great pleasure to be here in this very nice conference. So I will present DBV. I will try to be short. It's very difficult for me usually, but I will try to do; and to let the major part of the meeting for the question and informal discussions.

 So, DBV, as some of you know, probably is a company involved in treatment of food allergy. And beyond food allergy, we have developed a platform using the immunologic properties of the skin. And this platform is able to address different diseases like vaccination or autoimmune diseases.

 So, what is the recent progress of the Company? As you know, we are developing a patch. And what is interesting with this patch is it's a new way and a real innovation for the treatment of food allergy. Because with this patch you can address immune cells at the surface of the skin, and progressively reeducate the immune cells in case of allergy in order to induce tolerance to the allergen.

 So, in the recent progress of the Company we have in the development of the peanuts allergy treatment we are in the middle of our Phase III. This is a pivotal Phase III. And we have completed the recruitment of this study last June. So we are absolutely on track for all the clinical trials in peanut allergy in children, and we are expecting the results of this Phase III in Q4 next year.

 We have also launched another study, very interesting for us, which its name is REALISE. It's a real-life study. This study is interesting because it's a condition of real life. As you know, in all the studies in food allergy, you are obliged to make an evaluation of the patient at the beginning. It's a challenge test. And you give to the patient increasing dose of peanut in order to see at what moment the patient will react to the allergen.

 And in this study, we are -- we have no challenge at the entry of the study, so we are able for the first time to include anaphylactic patients. It represents around 20% of the patients. And these patients were not able to be investigated by the previous studies because all the studies had the challenge at the entry, and we will be able to evaluate these patients. We did it at the -- during the Phase I, of course. And it will be interesting because the part of the patient really eager to start as soon as possible treatment. And it will be interesting at the moment of the launch of the treatment.

 And also, we are -- we have a new study starting in H1 next year concerning the very young children, 1 to 3 years old. And because, as you know, there are many, many data showing that the treatment is really crucial when it is used very, very early in life. And it's very interesting to have this kind of treatment in very, very young children.

 And also, we have recently presented the results of the three years of treatment, one during the Phase II. Patients were treated for the Phase II during one year. There was a follow-up study doing two more years. So we have now patient treated during three years. And we have published the results and we will see very, very quickly these results.

 Concerning the milk, we have just completed the recruitment phase of our Phase II study. It's a large Phase II study in North America. And we are expecting, in Q4 next year, the top line -- or beginning of 2018 -- the results of this study.

 And we have, with milk, another study concerning eosinophilic esophagitis. This study is performed in Philadelphia by CHOP, and it's a pilot study. Very interesting because esophagitis, it's an orphan disease. And it's very interesting to see if the desensitization approach by the skin is able to decrease the inflammation of the skin due to the contact of the allergen with the esophageal mucus.

 We have just announced that we are able to go in the second part of our study concerning the pertussis vaccine in Geneva. It's in collaboration with the University of Geneva. And we have a lot of research studies ongoing, preclinical studies, and we will try to accelerate all the development of the platform now.

 In the same time, DBV is growing very, very fast. And we have now a team in the US in Summit, in New Jersey, and this team is working very, very hard to prepare the launch of the product. And of course, as you know, we have a partnership with Nestle concerning the diagnostic, and this is -- this development is going very well.

 So, in summary, we have -- for peanuts we are in the middle of the Phase III. And we are expecting the top line results in the end of 2017, and the BLA for the end of 2018, and for the launch of the product in beginning 2019. For milk, we will publish the results of the Phase II study. We had the fast-track for this study also. And we have, as you know, the breakthrough designation for the peanut development. And we are working on egg, because it will be the third allergen in clinic for DBV, hopefully next year.

 Just we will pass very quickly to have time to discuss. Just to give you some -- yes, this is the result after three years of treatment, and we were very happy with this result. It's very consistent and very interesting. We give here only the results of the same cohort is 250 micrograms Viaskin. So the patient has been treated during the three years by the same treatment, and it's only children.

 But you can see there is an increase, even not a big increase, between the second and the third year. But 83% of the patients are considered as success in this treatment after three years of treatment, which is roughly almost all the patients. Because we can very easily explain the patients who didn't respond -- most of them were not able to complete [three years] of treatment.

 And the evolution of the cumulative reactive dose, which is the dose that the patient are able to take during the challenge procedure -- you can see there is a very good increase of the amount of peanuts the patients are able to take. And at the end, they are able to take 2.5 grams of peanut which is around 10 peanuts. And some were not able to take more than 10 milligrams, which is 1/25 of peanut. There is 250 milligrams of peanut protein in one peanut.

 So it's a very good progress, and of course the safety of the study is perfect. There is no SAE during this study due to the treatment, of course. And what was really a very good thing is to see that this treatment is able to really decrease the level of IgE during all the -- very consistently during all the assessment. So this is a good result for us. And it shows that this treatment is not only a very safe approach but also a very efficacious approach.

 Also just to remind you that we have also another Phase II study published by the CoFAR, which is an independent consortium for food allergy research granted by the NIH. And this treatment showed exactly the same kind of result and our study VIPES.

 So we have now four studies showing exactly the same level of response to the treatment. We have this independent study, our Phase II study, proof-of-concept study; and also the patient who were, during the first year, treated by placebo who were treated by the active treatment and who have exactly the same level of response of the active group. So we have [four time]. So we sleep relatively well on the results of the Phase III coming in next Q4.

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [3]
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 H2.

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 Pierre-Henri Benhamou,  DBV Technologies S.A. - Co-Founder, Chairman, and CEO   [4]
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 H2. Okay. So this is a very, very quick overview. And I think we can start the discussion.

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [5]
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 May be in a nutshell, the new [structure] of DBV in the next 18 months is going to be very intense. We will be disclosing top line results for our vaccine boost pertussis trial in H1 2017. We will be reporting two peanut trials -- the efficacy trial and the safety real-life trial in H2 2017. And then late 2017 or maybe H1 2018, we'll be reporting the milk trial, the Phase II trial; and the EOE trial. So that's five top line results that we'll be delivering in the next 18 months in Phase I/II or III trials.

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 Pierre-Henri Benhamou,  DBV Technologies S.A. - Co-Founder, Chairman, and CEO   [6]
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 So, open to the questions.

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Questions and Answers
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Unidentified Audience Member   [1]
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 (inaudible) anaphylactic, which I think when people think of peanut allergy, they are thinking of the patients who have a really serious reaction that could be life-threatening. And yet it's not practical to -- it hasn't been practical to study -- or, ethical, perhaps -- to study your Viaskin in those patients, at least yet. So, perhaps you could just elaborate a little on the real-life study and what it can show and its importance to the registration.

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 Pierre-Henri Benhamou,  DBV Technologies S.A. - Co-Founder, Chairman, and CEO   [2]
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 First it will anyway increase the safety data as it will be very interesting for the BLA. And, second, we will have with this study some very interesting information, especially because we are -- we have no challenge at the beginning. So, this is a way we think it's a very, very good thing for the product to be really able to be used by every kind of allergic people.

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [3]
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 There is one thing you cannot do with patients in the clinical trial, with patients that have a history of an anaphylactic reaction, is feed them with peanuts. The issue with the way our trials -- the trials in peanut allergy are built is that you do a double-blinded placebo-controlled food challenge; meaning that you give peanuts to assess the sensitivity of a peanut allergy patient.

 And therefore, we've had to exclude, by construct, the anaphylactic patients over the last few years, except in our Phase I where there was no food challenge, obviously, which was the Phase I. And we tested our patch, including with higher doses, in anaphylactic patients and there were no safety concerns.

 So in a nutshell, we are confident on the safety of our patch, even in anaphylactic patients. It's a tremendous opportunity because it represents 10% to 15% of total patients. And there is, by definition, in our trial, these patients have been stratified so we can isolate the results if need be. So we see that as an upside rather than a risk.

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Unidentified Audience Member   [4]
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 (inaudible) Quite logically. And yet, those are the ones who you can't at this point study.

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 Susanna Mesa,  DBV Technologies S.A. - SVP of Corporate Strategy   [5]
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 I think -- so the patients with a history of severe anaphylaxis are not the only anaphylactic patients. So the patients that we are studying in our Phase III trial are patients that have an objective response to a food challenge at baseline below a peanut. So basically those patients can have a reaction that includes anaphylaxis, cardiac event, below a peanut. So the patients that we study are anaphylactic in nature as soon as they are introducing to the allergen.

 There is a separate set of patients, which we believe is probably about 15% of the peanut allergic population, that has a history of severe anaphylaxis. This means that for some reason that it's not well understood today, these type of patients tend to have more anaphylaxis then than your stereotypical peanut allergic patient that still has a life-threatening reaction to peanuts.

 So that's two different types of patients that are not necessarily excluding the type of patients that we're studying today which are peanut allergic patients that have a life-threatening allergy.

 So overall, our Phase III program encompasses all patients that have a life-threatening peanut allergy, including patients that are too severe to be studied with other type of products because they have a history of severe anaphylaxis. The patients with a history of severe anaphylaxis are currently being included in REALISE because they are not exposed to the peanut protein during the food challenge, and because the product has been safe and tolerable enough.

 But, clearly, the Phase III program is studying patients that are extremely severe with anaphylaxis if they are introduced into the allergen. So I think that's the difference. It's not that the anaphylactic patients are the only ones that have anaphylaxis. It's just that it's a different type of severe patient that, for some reason, happened to have a history of severe anaphylaxis.

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [6]
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 And yes, we expect these patients to use Viaskin in the future if approved.

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 Pierre-Henri Benhamou,  DBV Technologies S.A. - Co-Founder, Chairman, and CEO   [7]
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 And it's very important to say that it's the only approach we can really treat these kind of people with. It's very helpful to have this treatment.

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Unidentified Audience Member   [8]
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 Just another one, really. Is it possible to kind of describe how it might change the life of the patient? It must -- if they've taken Viaskin for two years so they can basically have an inadvertent exposure and then manage it much without having to get (multiple speakers) or something like (multiple speakers) the difference for them from your treatment, based on your experience in the study so far.

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 Pierre-Henri Benhamou,  DBV Technologies S.A. - Co-Founder, Chairman, and CEO   [9]
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 I think it's obvious for the children. It's very difficult for parents to have a child with peanut allergy, because you can -- at any moment you can have a very, very bad reaction. So, to know that if he cannot react and he will not react with one or two peanuts, it changes really the life. This morning we had a meeting with a father of a young girl with peanut allergy, and she was able to take two peanuts. And he said it changes his life really -- her life.

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 Susanna Mesa,  DBV Technologies S.A. - SVP of Corporate Strategy   [10]
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 There's a clear unmet medical need today, and that's the need to protect those patients against the accidental exposure that may kill them. And that's exactly what we are trying to address today. And that's what we are achieving with the first year of treatment, and over 50% of the patients increasing to 80% in the second year, and 83% in the third year. So there's a clear need for what we are doing. And outside from any meaningful benefits to quality of life, it's really the regulatory need today to provide those patients with another option that is not avoidance. And that's what Viaskin does, in a very safe manner.

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [11]
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 And we do -- there was a post represented by one of the centers involved in all of our trials, CHOP, the Children's Hospital of Philadelphia, this weekend showing that the vast majority, actually 80% of the patients reintroduced peanut on a daily basis.

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 Pierre-Henri Benhamou,  DBV Technologies S.A. - Co-Founder, Chairman, and CEO   [12]
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 And they are very, very satisfied.

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [13]
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 And, yes, the quality of life has dramatically improved, absolutely.

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 Eun Yang,    [14]
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 So this is -- Viaskin Peanut is designed to protect children from accidental exposure. But once it's approved, are you going to follow those patients to see --? I read somewhere that there are like 200,000 emergency visits from peanut allergy anaphylactic reactions. So are you going to follow the patients who are going to be using Viaskin Peanut once it's approved, to see whether you can actually reduce their rate to the hospital admission or EpiPen use, or anything more practical?

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [15]
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 Susanna.

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 Susanna Mesa,  DBV Technologies S.A. - SVP of Corporate Strategy   [16]
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 It's a tricky question because at this stage, it's not something that it's being required by the payers. So I think we have -- we want to be careful on what type of data we achieve so that we don't promise something that we are not following.

 The truth is that to do a natural exposure trial, we would need probably 1,000 patients to really get a sense of whether we are reducing hospital visits, whether we are reducing EpiPen use. Now with that said, I think our trials are structured in a manner in which we have an endpoint at 12 months, which is the current endpoint for PEPITES. Following that endpoint, we do continue to monitor patients in an open-label manner for two more years; clearly to understand how the product is progressing, what any other safety events that may come.

 And so far, we see that the protection increases over time in a progressive manner. The safety and compliance continue to be extremely good. And we'll continue to do that.

 Now, the REALISE trial, though -- and that's part of the reason we introduced the REALISE program, which is the real-life study of the drug and how the physicians and patients use the product in routine clinical practice -- will enable us to start getting some quality-of-life measurements, some other type of more qualitative analyses that will help us understand how the patients use this product in daily life, and how it improves their daily life.

 But I think, at this stage, that's probably as much as we'll go for now. Clearly, we'll continue to evolve the program with Phase IV studies that will continue to give us additional guidance into the product use. But at least for now, there's no planned trials into looking into natural exposure or anything like that.

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 Eun Yang,    [17]
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 So, in Phase II, did you see the difference in terms of usage of EpiPen between Viaskin Peanut-treated patient versus placebo in Phase II?

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [18]
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 You mean in daily life? Is that what you mean?

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 Eun Yang,    [19]
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 Yes, why patients are treated for like the last three years in Phase II.

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 Pierre-Henri Benhamou,  DBV Technologies S.A. - Co-Founder, Chairman, and CEO   [20]
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 It depends what you mean during the challenge. Of course, during the challenge, it's very -- you try to provoke a reaction, so there is some use of EpiPen, of course. Due to the treatment, there is no use of EpiPen in the Phase II. And due to accidental exposure, there are -- I don't know if it's disclosed.

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 Susanna Mesa,  DBV Technologies S.A. - SVP of Corporate Strategy   [21]
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 Three cases in the Phase II in the first year, which is about 1% in the population of the actual Phase II study, which is very small compared to the actual natural exposure of patients.

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 Eun Yang,    [22]
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 So, three patients on the drug, on the patch, or placebo?

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [23]
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 Evenly spread, I would say, between the arms.

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 Susanna Mesa,  DBV Technologies S.A. - SVP of Corporate Strategy   [24]
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 Yes, exactly. We haven't given it exactly from which arm they come. But it's pretty much evenly spread across doses, ages, and placebo patients. It does include some placebo patients. It's not something that at this stage is meaningful enough for us to do retrospective analyses or anything like that because it's way below the accidental exposure on a daily basis.

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 Eun Yang,    [25]
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 I'm sure that you probably get this question a lot, because there is the oral immunotherapy versus your EPIT. So people have a different view, depending on who you talk to. So can you actually kind of elaborate, based on your discussions your experts, how they view oral immunotherapy versus cutaneous immunotherapy?

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [26]
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 Go ahead, Pierre-Henri.

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 Pierre-Henri Benhamou,  DBV Technologies S.A. - Co-Founder, Chairman, and CEO   [27]
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 No no, please.

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [28]
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 So, we -- it's the first thing to say is that it's a very large unmet medical need and it's a huge market. So there are rooms for many treatment options. The second thing is that we, at DBV, have actually created the patch just to address one absolutely key feature: safety. We think that these patients that have a constant life-threatening -- they live in a constant life-threatening zone. But their disease is not symptomatic, per se.

 So what we wanted to provide patients, caretakers, and physicians is a drug that is very, very safe, i.e., that doesn't make their life worse, and that fits in their daily practice -- for the physician, that it's easy to prescribe and monitor; and for the patient, that it's easy to live with.

 So we obviously see our product being the best in class. Because we think that for this therapy, the risk-benefit ratio needs to be very skewed on the safety; and, therefore, we provide, we think, the optimal risk-benefit ratio. Once again, it's a huge market and there is room for many different options.

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 Pierre-Henri Benhamou,  DBV Technologies S.A. - Co-Founder, Chairman, and CEO   [29]
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 Yes. And when we founded DBV, and the idea of everything about the patch was really to -- because we had -- at this moment, there was OIT that existed at this moment. And the first papers on OIT were in during the 1980s, so it's not a very new practice. And what we saw at this moment is that there were a lot of side effects with these methods, and we wanted to find another method in order to reduce the side effect. But we think nothing has changed on OIT point of view. There is many patient who are not able to take this treatment.

 And also, as it's an oral treatment, very, very few allergists choose to use it in their daily practice. Only in the big centers. So it's proof probably that it doesn't fit exactly with the practice of allergy. So this is why we think that the patch is much more convenient for daily practice.

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 Susanna Mesa,  DBV Technologies S.A. - SVP of Corporate Strategy   [30]
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 And I wanted to add one more thing to that, which is this idea -- and especially what resonates with the medical field so much -- is the fact that we've discovered probably one of the most potent ways of treating this disease. We use 250 micrograms, and we can get patients to eat over 30 peanuts after three years of treatment. 250 micrograms. The other therapies have to go to 1000 milligrams to actually even get patients to have a desensitization that's enough for accidental protection.

 So this is really just the beginning for DBV. We've found a new way of accessing the immune system that enhances the response of desensitization with the right risk-benefit profile, which we believe is absolutely key to being able to get approved.

 The FDA has placed an emphasis on safety. And being able to identify the risk-benefit profile ratio in the way that we've done where we have a treatment that works so well with basically no safety issues or tolerability issues, it's really unique in the field. And we believe it's what's going to set us apart as the standard of care.

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Unidentified Audience Member   [31]
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 I just had one other question really which is do you think the desensitization effect would continue? Does it plateau over a period of time? Could you envisage a patient, a child, just continuing to wear the Viaskin patch, and effectively for all their adult life and get more -- better able to tolerate peanuts? And is that a likely scenario? So you say oh we do have a patient were two years isn't a trial or three years, or whatever, and then stop?

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 Susanna Mesa,  DBV Technologies S.A. - SVP of Corporate Strategy   [32]
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 I think we see a couple different scenarios, to be honest. And that's what's so neat to about the patch is that we think it's a very personalized treatment that varies from patient to patient. What our data suggests is that overall there is a progressive improvement over time. So the more time that you wear the patch, the better that you get in terms of consumption; though really that accidental protection occurs within the first year of treatment.

 Now, I think what we believe the patient profile will look like is that -- you are right -- there's going to be some patients that achieve levels that will allow them to reintroduce peanut into their diet after two years, for example. We believe on average it will take three for the majority of the patients, and then they will be in a position where they'll have a few choices. One is that they can reintroduce peanut into their diet.

 We see another side of patients today that don't want to reintroduce peanut into their diet. They want to continue wearing the patch. And so far we've been able -- the reason also is we chose our extension trial for VIPES is so important is because we are able to keep that immune response, year after year, replicated. The median continues to increase and we don't see that patients are not being protected, even after three years of treatment. So that's very important, that we can continue to maintain that protection.

 There will also be another set of patients that will maybe need four or five, six years. And again, like I said at the beginning, what's really key here is understanding that this is the first step. And that this 250 micrograms dose has allowed us to really be able to get a shot at getting a product approved for these patients that are in so much need.

 But going forward, we can really think about different boosting strategies which may enhance the response in patients that are staying constant. We may think about reintroduction in combination with treatment. There's a lot of ways that we can continue to improve upon this treatment. And the 250 micrograms dose is really just the beginning. And so far, we see that we can replicate that response, year after year.

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [33]
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 I think also in desensitization, compliance is correlated with risk, meaning that if you forget your dose one day, two days, three days, in other methods you actually increase the risk because you can relapse; and then by introducing the dose again, you can actually have a reaction. What the data shows with our product and with our technology and our platform is that even if you forget actually the patch for two months in a row, which would be a big absence, you actually maintain the response. So we are not increasing the risk by a lack of compliance for whatever reason. So, it's another additional comfort that you give to patients and physicians.

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 Susanna Mesa,  DBV Technologies S.A. - SVP of Corporate Strategy   [34]
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 And I think, again, I think that's all achieved in the absence of taking the peanut through the GI system, which is so key for those patients. We're avoiding eosinophilic esophagitis. We are avoiding anaphylaxis. Were avoiding major GI issues like vomiting, diarrhea, and things that really are associated with treating the patients through the gut.

 So, from that perspective, it's something that the patient can adjust with the physician as they go. And that's exactly what we are seeing is that it's going to be very much in the physician's hand to determine how long the patch needs to be applied.

 But at least if we have some patients that decide, okay, well, I'm getting better but I don't want to reintroduce peanut -- can I stay on my patch and continue to have that protection? The answer is yes, so far, from the three years that we have with data, in the absence of consumption which is important for some patients.

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 Eun Yang,    [35]
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 (inaudible) from BLA filing and potential approval via breakthrough designation and launch timeline. But I know that the peanut allergy is a lot more prevalent in the US. But what's your strategy outside the US? Have you talked to other regulatory agencies for your steps, maybe?

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 Pierre-Henri Benhamou,  DBV Technologies S.A. - Co-Founder, Chairman, and CEO   [36]
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 Yes. We are doing the development in parallel in Europe and the US. And we have a constant relationship with EMA in the same time that we have with the FDA. So this is for the approval strategy.

 For the commercial strategy, it's true that we are starting now the European strategy for DBV. It's a bit early for us to discuss what will be the options. But, clearly, we want also to go in Europe and probably also in Asia. And so we are preparing. We are starting to prepare the launch also in Europe.

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [37]
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 And we have more time because Europe is going to -- there is no such thing as priority review. And obviously negotiating prices with local authorities takes probably a year. So we will be launching in Europe probably 18 months after the US. So, doing the homework now and seeing what we do, depending on the country, is being actually a work in progress.

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 Susanna Mesa,  DBV Technologies S.A. - SVP of Corporate Strategy   [38]
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 And I would add also just -- you didn't ask -- but I will add the fact that there are other geographies also that are of interest in the future. Clearly, today, we are focusing in the US, but Asia has a huge issue with food allergies. There are other pockets of countries that we can target in the future and continue to expand the reach of the platform.

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 Pierre-Henri Benhamou,  DBV Technologies S.A. - Co-Founder, Chairman, and CEO   [39]
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 For example, our study, the Phase III study is performing not only in Europe and North America, but also in Australia. So we are really targeting the worldwide development for all our product. And the forthcoming product, like milk and egg, will be probably much more adapted to the needs in Asia.

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 Eun Yang,    [40]
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 So, last question to you, David. The peanut allergies are really not an orphan indication. So when you looked at -- you talked about to investors, we are used to companies launching their own product. Usually in an orphan indication, it's a small biotech company.

 So what would be your response? You are targeting probably like 1 million case in the US. And can a small biotech company like DBV be able to -- can they do -- commercialize the product effectively?

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [41]
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 I think it's a very fair question. And what is so specific about peanut allergy is that the patients are being referred systematically to allergists. And allergists is a very organized, powerful community and it is a small number of physicians. So basically you get access to the very vast majority of patients by targeting allergists.

 You have 4,800 of them in the US. So, by implementing a 60, 70, 80 reps salesforce, you do target 100% of the prescriber base, and therefore have access to the patients. So it's a reasonable investment that DBV can make, thanks to the support of its shareholders.

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 Pierre-Henri Benhamou,  DBV Technologies S.A. - Co-Founder, Chairman, and CEO   [42]
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 And for the next product, like milk product, we will also address part of the pediatricians.

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 Eun Yang,    [43]
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 All right. Thanks very much.

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 David Schilansky,  DBV Technologies S.A. - CFO and COO   [44]
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 Thank you very much.

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 Pierre-Henri Benhamou,  DBV Technologies S.A. - Co-Founder, Chairman, and CEO   [45]
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 Thank you.

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 Susanna Mesa,  DBV Technologies S.A. - SVP of Corporate Strategy   [46]
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 For those on the webcast, as well.




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