DBV Technologies SA at Barclays Global Healthcare Conference

Mar 16, 2016 AM EDT
DBV.PA - DBV Technologies SA
DBV Technologies SA at Barclays Global Healthcare Conference
Mar 16, 2016 / 06:35PM GMT 

==============================
Corporate Participants
==============================
   *  Charles Ruban
      DBV Technologies SA - Chief Commercial Officer

==============================
Conference Call Participants
==============================
   *  Geoff Meacham
      Barclays - Analyst

==============================
Presentation
------------------------------
 Geoff Meacham,  Barclays - Analyst   [1]
------------------------------
 Afternoon. Welcome to the second day of the Barclays Global Healthcare Conference. My name's Geoff Meacham. I'm the senior biopharma analyst.

 Today we have DBV Technologies. Charles Ruban is the Chief Commercial Officer, and also Susanna is in the audience. She's not speaking. Thank you.

------------------------------
 Charles Ruban,  DBV Technologies SA - Chief Commercial Officer   [2]
------------------------------
 Thank you, Geoff. So, I'm not Susanna Mesa, but I'm with Susanna Mesa only for professional purposes, obviously (laughter).

 So, I'm really happy and really thank you for inviting us to present on this Barclays' conference. Really -- the first slide is obviously our disclaimer. The second, we want to talk a little bit about DBV today.

 So, DBV at a glance is -- what you should take home is that we are the creator of a very innovative approach to treat food allergy and to develop immunotherapy through the skin. And this method is called epicutaneous immunotherapy.

 It's a very novel pathway, activating the skin. It offers a potential noninvasive and well-tolerated treatment. And it's extremely suited for pediatric patients.

 Our ambition today is really to become the leader in food allergy, to treat all patients in food allergy. So, we are talking about a platform. We are extremely advanced in terms of clinical development. So, we have positive data coming from a Phase II trial.

 We have a lead product candidate in peanut allergy, which is the most prevalent allergy, as you know, and is a significant unmet medical need. And we have additional products coming in in the pipeline such as milk, such as egg, and milk is already in Phase II.

 As far as the peanut development is concerned, we have a breakthrough therapy status. We have Phase IIb data that read out positively. We have an extremely good safety and efficacy profile, and we are moving -- we are already in Phase III. And we are the most advanced company in the field.

 You will understand later that actually beyond the field of food allergy we also have additional applications to treat other immunological disease. And obviously, the ambition of DBV is not only to become the food allergy leader, but also to do that by ourselves and to actually deploy our effort not only in development, but also, as far as the commercial operation is concerned in different zones, to start with the US, Europe, and Asia.

 This is basically our pipeline. As I told you, peanut is extremely advanced. Then there is the milk product. On the milk, you will see that we have a different set of applications for this product, not only to desensitize patients but also to treat a very severe disease which is called eosinophilic esophagitis. And we have the egg product coming in.

 A very quick snapshot on food allergy globally. It's a very significant unmet need. The prevalence is increasing drastically. One child out of 13 is today suffering from a food allergy. The main allergies are peanuts, milk, and egg.

 Today those patients don't have a solution, so basically avoidance is the rule. There are lots of visits to the ER. Every three minutes an allergic reaction leads a patient to the ER. And basically those patients react to traces of peanut, of milk, of egg in the food.

 Obviously, this is not a solution for those patients. There is no therapy available. And those patients who actually are given an EpiPen, they are not satisfied with that. Their quality of life is extremely poor, and they are looking for a solution, immunotherapy solutions that are actually safe and convenient.

 This is why, basically taking into account those patients' needs, we have developed this novel approach. This approach is based on activating the immune capacity of the skin.

 So, in the skin you have a network, a dense network of very specific cells which are called Langerhans cells. So, by exposing those cells -- by exposing the allergen to the skin, we actually were able to activate these Langerhans cells and still avoiding the allergen to go into the bloodstream, thus avoiding any kind of systemic reaction.

 So, you see on this experiment -- and the one that is magnified is actually a Langerhans cell that has been able to capture an allergen. That has been traced and marked with a fluorescent marker.

 And you see that this allergen basically is appearing in the epidermis, in the very superficial layer of the skin. Then once -- the dendritic cell has gone back to the dermis and traffics to the lymph nodes in order to activate the immune system and to generate a tolerogenic response.

 This is the patch. So, the patch is a very simple and elegant product. It's also a very high tech product. Part of the technology comes from the semiconductor industry.

 We have been able to load a very small and very tiny quantity of allergens that actually are still extremely potent at the surface of this patch through a technique which is called electrospray. So, it comes from the semiconductor industry.

 Once the patch is applied on the skin, it creates a condensation chamber between the skin and the surface of the patch, enabling the perspiration to hydrate totally this chamber and to solubilize the extract. It basically creates spaces within the epidermis cells, allowing the solubilized extract to be in contact with the allergen and to be able to initiate, by constant pressure, the desensitization process.

 And again, we still keep this protection of the skin barrier. So, you apply the patch on intact skin. This is actually very important, to apply the patch on intact skin so as to prevent any systemic reaction.

 Patient friendliness has been really at the forefront of our thinking when we thought about the patch. It's a very simple product. A Viaskin is applied once a day for 24 hours. It's a single dose product. It's applied by the patient himself or the mother, the chief mother officer, as we call her.

 It is extremely safe. It's well tolerated. It is meant for different kinds of patients, adults, children. But, I just really want to [insist] on the children because you can treat very, very young children with this patch, obviously.

 It is fully developed by DBV, fully patented, and we have the rights on this -- all rights on this product. It's meant to be a prescription product.

 This is the clinical development of the peanut development. So, you see it's the most -- it's the biggest clinical development ever conducted in food allergy. It's basically composed of two parts. The blue ones are the ones that are totally monitored and controlled by DBV. It is a development plan that actually meets the requirements of FDA and EMA.

 Phase I, Phase II has been conducted. We are now in Phase III with 330 patients. We have had the breakthrough therapy status from FDA on this development plan. But, we also enjoyed having the chance to have very nice academic collaboration to start with this Arachild study, which is very much the first proof of concept of this product performed in France.

 And very recently we had during the last AAAAI meeting, that is to say last week, the outcome of the CoFAR 6 trial, which is a consortium of food allergy research. It's an NIH sponsored trial that actually read out positively, confirming again and again that the product was efficacious and safe.

 This is the design of the Phase II study. So, the very specificity of our development is that actually we do perform food challenges in our trial. That is to say we include patients who are peanut allergic. They have positive skin prick tests. They have positive IgE.

 But, we check the level of reactivity of those patients by exposing them to peanut through a very, I would say, cumbersome, complex procedure that has to be controlled and performed in the settings that are very -- where we can guarantee the full safety of the patient.

 So, the idea is to expose the patient to a gradual increase of peanut, starting from one milligram of peanut, waiting for 30 minutes to see if there is any reaction, and then moving to three milligrams, then to 10, to 30. So, the rules for conducting the food challenge are actually extremely precise. And the product that we use to perform this food challenge has also been specifically developed by DBV and for DBV.

 We are performing those food challenges at different points in time at baseline to include the patients, that is to say patients we would be including in our trial if he reacts to a dose that is 300 milligrams of peanut protein or below. 300 milligrams peanut protein is one peanut. So, some of the patients that you will see later are reacting to tiny traces of peanut and some of them are actually reacting to a dose which is equivalent to one peanut.

 And they are challenged again at the end of the first year with the same -- exactly the same procedure to see to what extent their threshold has been able to increase, showing a desensitization process going on.

 It's a three year treatment, as you see on this chart. All the patients after one year are switched to the highest dose, the 250 microgram dose. And they are being followed for two additional years.

 So, today in this trial we have obviously the one year data, but also we have the two year data. What is important to us is to count the number of responders. What we call the responder in that kind of trial is the patient who is able to multiply by 10 his initial reactive dose.

 So, for instance, if he reacts at 10 milligrams, he has to jump to 100 milligrams, or if he reached the threshold of 1,000 milligrams peanut protein, which is four peanuts, which is actually extremely significant for those patients, because I forgot to say that the key need for those patients is to be protected against accidental exposure to peanut. Those patients globally don't want to eat peanuts. They just want to be protected in case of an accident. And then we also look at other endpoints such as changes of IgE and IgG4.

 This is the distribution of the reactive dose at baseline of those patients. So, what is the typical peanut allergic patient? So, a typical peanut allergic patient is a patient that, for children, reacted at the dose of 30 milligrams, or a 10th of a peanut. He would have an objective reaction at this dose. He has usually asthma, eczema, allergic rhinitis, is poly-allergic.

 And by construction, this trial has been stratified into two populations, six to 11 and 12 and above, so as to be able to analyze those subpopulations after the end of the trial.

 First and foremost, and this is exactly why we have designed this approach, the compliance. So, the compliance of this product within the trial is absolutely exceptional. We are talking about more than 96% compliance all in all. The patients do wear the patch every day, and we do monitor that on a daily basis.

 The drop out is extremely limited. So, less than 1% of the patients basically drop out due to the patch. And it's actually very important, because we are talking about a very long exposure. And to be efficient and safe, the product has to be applied on a continuous basis.

 Safety wise, so what do you see from the safety? So, the patch really holds its promise, being a very safe product. That is to say there is no SAE related to the patch. There is no epinephrine injection, which is the rescue treatment of that kind of disease, attached to the patch application.

 There are only two withdrawals in the study due to local effects of the patch, which is dermatitis which was a bit severe, and which led the patient to drop out from the trial. The most frequent related AE are local cutaneous reaction at the site of application of the patch, and they tend to fade when we treat the patient longer.

 The primary endpoint of this trial was met overall in the overall population, displaying a 50% response rate in the 250 microgram dose versus a 25% response from placebo. And more interestingly, we saw really that the -- in the population of six to 11 years old, that's where we had the greater magnitude of efficacy.

 And as you see, in this patient population we have a very significant increase of cumulative reactive dose, that is to say the dose the patients are able to ingest during the food challenge. You see that in the placebo, for instance, the median value and the mean value is very limited. And we have a very strong dose effect leading the 250 microgram patients to have an increase of cumulative reactive dose of more than 1,000 milligrams in mean and 400 milligrams in median, which is actually extremely significant.

 Together with dose changes, we have significant changes in immunomarkers. We are looking at IgE. This is what you have on the left side of the slide. So, IgE basically marked the level of sensitization of those patients. And as expected, they are supposed to increase at baseline and to go down to baseline value at least after one year, whereas the IgG4, which showed basically the desensitization process going on swiftly, are actually dose dependent.

 So, you see a very significant increase of IgG4 up to a level of seven milligrams per liter, which represents a 19.4 increase, which is actually extremely significant if you think about the very tiny dose that we apply with the patch. It's only 250 micrograms of peanut protein that is the daily exposure.

 OLFUS-VIPES results; so basically you remember that all those patients have been switched to 250 micrograms, placebo, 50, 100 and 250 micrograms switched. A significant proportion of those patients have been enrolled in the study. And the rollover rate is even greater in children.

 Again, the safety profile of this drug has been confirmed in the second part of the trial. No drug related use of epinephrine, no SAE related to the Viaskin Peanut, and the compliance remains the same at a very high level, 96%.

 Being treated an additional year for those patients with 250 micrograms provides an additional benefit. You see that are jumping from more than 50% response rate in year one to 80% response rate in year two, showing that actually the desensitization process continues to move on, as also shown in the change of cumulative reactive dose.

 So, now we have patients -- the change from baseline of cumulative reactive dose reaches almost two grams after two years. And even the median increase is extremely significant. It's more than one -- it's around 1.5 milligrams -- 1.5 grams, I'm sorry, in median. So, this shows really a strong effect of the drug and a strong value in treating an additional year -- with an additional year in those patients.

 In six to 11, again, those patients treating initially with placebo who have been switching to the active display the same response rate as the ones that have been treated one year only with the 50 microgram, really confirming again the effect of the drug. We are able to repeat the efficacy level that we have found in first year.

 As far as the IgE and IgG4s are concerned, you see now that actually this prolonged the effect of the drug. It's translated into a change of the immunological markers, and especially IgE on the left-hand side of the slide that you see. Now we have the IgE levels going down below the baseline value, 40% below the baseline value, showing that actually the effect of this drug is [pursuing] in year two, whereas the IgG4 are still maintaining their very, very high level.

 Interestingly, we had the chance to all attend a very, very important congress which is called the AAAAI last week in Los Angeles. And the CoFAR data were actually published and revealed, unveiled last week.

 This study, again controlled by NIH, included 75 patients, 25 patients per arm, placebo, 100 micrograms and 250 micrograms. Primary endpoint is a little bit similar to the one we have, the 10X or five gram, whereas we have the 10X or one gram in our trial. So, it's a little bit stringent here in this population.

 The age range is four to 25 years old. And the data where actually extremely positive, really totally confirming what we have seen with the VIPES data, showing first that actually the primary endpoint was met in this trial, which was a trial that was not controlled at all by DBV, really performed by NIH as a black box, I would say.

 So, we have a 48% response rate in the trial in the active arm, whereas we have a 12% response rate in placebo. And we have a concentration of the therapeutic effect in the children's population. Again, we see that the 250 microgram works extremely well in the four to 11 years old, reaching 61% response rate, whereas the placebo rate is even lower than that.

 First and foremost, we have been able to confirm the safety of this drug and the high compliance. So, no SAE, no epinephrine use during the treatment, 96% compliance, the primary endpoint is met, as I said, and a significant age/treatment interaction. As I told you, the drug works better in children than in adolescents and adults.

 I don't show the IgG4 increase, but actually you basically have the same kind of pattern as to what I showed in VIPES, an increase of IgG4 that is actually significant and which marks the treatment effect.

 To conclude on Viaskin Peanut, I think it's important to say that we have extensively studied this drug. I mean, more than 450 patients have been randomized in five clinical trials. We have conducted hundreds and hundreds of food challenges. The efficacy has been confirmed. The safety has been really demonstrated over a lot of -- over multiple clinical trials.

 All Phase II's conducted with this product have read out positively. They all have met their primary endpoints. And again, the convenience of this drug is really demonstrated again and again. We have very high compliance rates. The elegance, the simplicity of this patch is really demonstrated. This single dose application is really something that will make a difference, definitely. It is very well suited to treat children.

 And I must say that the next step for DBV now is to move into Phase III, obviously. So, we have already launched our Phase II trial. I'll be happy to provide you with the design in four to 11 year olds, which is the one that you see now on the screen.

 So, basically we are replicating what we have seen in Phase II. So, this Phase III is focusing on patients four to 11 years old with a 250 microgram dose, which has been really demonstrated as to be the relevant dose. The endpoint is a little bit more stringent than the one we have in Phase II. It has been discussed, obviously, with FDA, and it's ongoing.

 So, we have initiated the recruitment of this trial in December. The recruitment is going extremely well. The patient motivation is just amazing. We expect to have recruited our trial by -- all the patients of our trial in Q3 this year, and the motivation of the center is obviously extremely significant.

 All the designs and presenting here obviously have been discussed extensively with FDA during end of Phase II meeting in May last year. I must say too that actually this is not the only piece of Phase III development that we have for the peanut development, because we will be soon conducting a Phase III in one to three years old.

 So, that's going to be following the trial, because we obviously -- we understand that this patient population is at risk too and can benefit very significantly from the patch. And also, it's the request from regulatory agency, especially in the frame of the pediatric investigation plan from EMA and from pediatric study plan for FDA to study a very young patient population.

 So, those patients will be treated, one to three years old, with the patch. Really it makes even more sense to treat those kind of patients with a patch. And obviously, adolescents and adults will be also -- we will perform clinical development on adolescents and adults with a higher dose of the patch. So, that's to really guarantee an optimal efficacy.

 I will skip this one. So, just two words on the milk trial which is really also ongoing. So, milk, again it's the platform as a whole, because here we are talking about desensitizing patients to milk allergy with a clinical trial that is actually the same features as the one you have for peanut.

 We have already been able to demonstrate the safety of this drug, and we are now enrolling lots of patients in our Phase II, which will read out exactly the same as for the Phase III, in Q3 2017.

 Two to 17 year old patients are actually included. And I must say that we also have additional applications for this patch. We are extremely active on eosinophilic esophagitis, especially since this EoE is usually, for 70% of the cases, treated with [doing without] milk.

 We have a trial ongoing with one of the best centers in the world, which is the center of Jonathan Spergel at Children's Hospital of Philadelphia to treat EoE with the patch. We have very significant preclinical data showing very great hope for that.

 And we have a bunch of other applications, celiac disease, EoE as I said, hemophilia A, diabetes. And if you look at the number of posters that we basically had at the scientific congress, AAAAI, you will see that there are great opportunities here for a patch treatment.

 Very dense news flow; again, our very successful AAAAI congress for DBV will be presented at the [JACI]. The next clinical trials' data will be available in Q3 normally for all this year three. You will have the sustained responsiveness data available H1 2017. And in 2017, obviously we'll have seen some data on the peanut and the milk trial.

 I forgot to mention that we also have a development in pertussis vaccine, the first proof of concept that we are about to initiate this year. And we hope to have those data at the end of the year. But, this is being studied as a boost vaccine.

 Well, in a nutshell, we are a very solid company. We have -- at the end of last year, have a significant cash position with more than $320 million at the end of the year. We have long term investors. We are preparing the commercial build up of the company, gearing up extremely significantly here in the US and I am personally in charge of this. And we are delivering significant shareholder value, and I think we have -- as you see the names here, we have very long term investors that actually are helping us extremely significantly.

 Thank you for your attention. And I am happy to take any questions.

------------------------------
Unidentified Participant   [3]
------------------------------
 Breakout.

------------------------------
 Charles Ruban,  DBV Technologies SA - Chief Commercial Officer   [4]
------------------------------
 Breakout. There are no questions? Okay.




------------------------------
Definitions
------------------------------
PRELIMINARY TRANSCRIPT: "Preliminary Transcript" indicates that the 
Transcript has been published in near real-time by an experienced 
professional transcriber.  While the Preliminary Transcript is highly 
accurate, it has not been edited to ensure the entire transcription 
represents a verbatim report of the call.

EDITED TRANSCRIPT: "Edited Transcript" indicates that a team of professional 
editors have listened to the event a second time to confirm that the 
content of the call has been transcribed accurately and in full.

------------------------------
Disclaimer
------------------------------
Thomson Reuters reserves the right to make changes to documents, content, or other 
information on this web site without obligation to notify any person of 
such changes.

In the conference calls upon which Event Transcripts are based, companies 
may make projections or other forward-looking statements regarding a variety 
of items. Such forward-looking statements are based upon current 
expectations and involve risks and uncertainties. Actual results may differ 
materially from those stated in any forward-looking statement based on a 
number of important factors and risks, which are more specifically 
identified in the companies' most recent SEC filings. Although the companies 
may indicate and believe that the assumptions underlying the forward-looking 
statements are reasonable, any of the assumptions could prove inaccurate or 
incorrect and, therefore, there can be no assurance that the results 
contemplated in the forward-looking statements will be realized.

THE INFORMATION CONTAINED IN EVENT TRANSCRIPTS IS A TEXTUAL REPRESENTATION
OF THE APPLICABLE COMPANY'S CONFERENCE CALL AND WHILE EFFORTS ARE MADE TO
PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS,
OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE CONFERENCE CALLS.
IN NO WAY DOES THOMSON REUTERS OR THE APPLICABLE COMPANY ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER
DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN
ANY EVENT TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S
CONFERENCE CALL ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE
MAKING ANY INVESTMENT OR OTHER DECISIONS.
------------------------------
Copyright 2018 Thomson Reuters. All Rights Reserved.
------------------------------