DBV Technologies S.A. (DBV) Earnings Call Transcript & Summary

Okay. Good morning, everyone. Welcome to the 8:50 a.m. session of the 42nd Annual Goldman Sachs Global Healthcare Conference. My name is Graig Suvannavejh, and I cover both U.S. and European biopharma names here at Goldman Sachs. It's my pleasure to be hosting DBV Technologies in a fireside chat this morning. And with that, let me welcome CEO, Daniel Tassé. Daniel, it's good to see you, again, and hope everything is well?

Thank you, Graig. Thank you. Yes, everything is wonderful. And thanks for having me this morning.

Okay. Great. I think maybe just to start off with, it's always good to reset. And just for those who perhaps are newer to the DBV story or perhaps revisiting it after some time, maybe let's start with you telling us a little bit more about the company, and what you consider your core technologies or key areas of core expertise is?

Yes, Graig, thanks for asking. So DBV Technology is a company that was founded about 15 years ago by 2 pediatric gastroenterologists, who had the brilliant idea, and that's really the core of our -- of DBV, is to recognize that the human skin is actually an immune organ and can be used to desensitize against allergens. And as -- and the application of that would be to many areas of immunology. But as pediatric gastroenterologists in their practice, they saw a lot of the symptoms of food allergies. And they've decided to redeploy the technology towards food allergy as our first generation of product and peanuts, specifically, as being our lead product. The technology is known as Viaskin, sort of intuitive name, by which you -- we put a minute amount, microgram amount of allergen on the child's back, and through that, manage to recruit a rather complex and well understood now immune response that brings these kids to be protected against that allergen. So that's our core technology.

Okay. Great. And certainly, peanut allergies is, at least, here in the United States, and perhaps parts of Western Europe as well seems to be -- well, I've got a son who's got peanut allergy. So certainly, I'm very well aware of the need, and perhaps the unmet medical need. So maybe can you just talk about maybe the broader peanut allergy market? And with that in mind, how you think Viaskin Peanut maybe uniquely addresses that market?

Yes. It's an important question. Let's start with the epidemiology because that's the core element of, obviously, what we wish to do to help families and children suffer from the peanut allergies. In the U.S., about 1.1 million kids between the ages of 1 and 11 suffer from peanut allergies. So it's a cohort of incidence yearly about 100,000 kids, so that's huge. And about 1.1 million would be the epidemiology. And I'm describing 1- to 11-year-olds because that's the time where the diagnosis is often made between the age of 1 and 5, and where, obviously, these children not having built some of the reflex they have an adult to better learn to manage the risk of the allergy are most at risk. So that's the epidemiology. In Europe, the incidence rate is about the same, not recognized quite as much. And we estimate that in the 5 largest markets in Europe, we're looking at about 400,000 or 500,000 kids who suffer from peanut allergy. So there's a significant market there also. But there's more to the epidemiology, and you would know, Graig, since that you have a child who suffers from food allergy, there's a family anxiety. There is a way that food allergies start consuming so much of family life. The anxieties before child goes to camp, in case there's accidental contact with peanuts. The difficulty with sleepover. Some obviously have the difficulties in managing the lunchroom at school. So what we wish to do is not only, obviously, reduce the risk of the serious consequence of accidental peanut consumption, that's the medical value proposition, but there's a huge one when it comes to family quality of life and anxiety reduction to know that this technology, which is very elegant, it's a patch applied to the child's back. I can describe that in more detail in a minute. That patch applied to the child's back every day becomes a routine that hopefully adds to what we know the parents do. They're hypervigilant to, obviously, peanuts in the environment, peanuts in the diet, one. They usually carry an EpiPen with them just in case they've accidental contact, that remains. But can we add essentially a third element of safety here by reducing the risk of having serious consequences to accidental peanut consumption is what really Viaskin is meant to do. Our data has shown efficacy as measured, as you know, by the ability to increase the eliciting dose. So how much peanut does it take for the child to react. As you also know, the alternatives, since times immemorial for over 100 years now to treat children who suffer from forms of allergies, is slow escalation of the allergen until they develop some kind of resistance to it. But besides being very uncomfortable, as a means of treatment and extraordinarily onerous on -- in time, they're also associated with quite a bit of accidental anaphylaxis. There's side effects of using that strategy. Ours exploits a completely different biology, the immune response as driven by Treg cells and Langerhans cells in the skin. And in doing so, we've also seen besides the efficacy, a safety profile that we believe is much more agreeable to families where the risk of complication during treatment are very few. And all of that adds up to good compliance. It's difficult to get kids who suffer from chronic diseases or conditions to comply with therapy. The beauty of our technology is that the daily gesture of applying the patch on the child's back is easy to do. It's a routine that's easy to integrate to family life and does not come with any other forms of limitation. The kid can stay active, you can play soccer, you can take showers, you can swim. And in doing so, you don't have the limitations that are important to get those outcomes. So that's Viaskin for you, if that was helpful.

Of course, it was helpful. I think there are elements of the patch itself that I do want to ask further questions about. But with that said, for those who perhaps know the DBV story well, knows it as a company that, if I can be very blunt, has had a history of some fits and starts, especially in terms of the regulatory process. I think it's probably helpful just to maybe rewind a couple of years back, just to remind us kind of the history, especially from a U.S. regulatory perspective, where we've been with Viaskin Peanut?

So you're right. There has been fits and starts to our technology. The reasons for that are in part rooted into the origin of the company. Our founders were men of great energy, superb clinician scientists who had this brilliant idea to find a way to use the skin testing to get immune response. There's an element of lack of expertise in drug development and taking drugs through the difficult rigorous process of getting it approved. And we've had a few setbacks along the way. That being said, if I may speak for myself, I'd rather be CEO of a company that has great technology, and you can always work through the fits and starts, and we're in the process of doing that as opposed to having a need to do a product with a straightforward regulatory pathway. But I want to be sensitive to give to our investors, and certainly, to patients who'd been waiting a long time for this technology to be available and be happy to provide you an update on where we are with the FDA and where we are with the EMA in bringing this technology to children. So as you know, in August of last year, the company received a complete response letter from the FDA for Viaskin Peanut, our first product. There were a number of CMC questions, and I would call them mechanical questions that are really important to address with the agency that we did not think were particularly complex, these things that we can answer. The agency, first and foremost, expressed that they had questions, and I'll quote, at the intersection of the patch's adhesion to the skin and efficacy. And the agency asked us to redesign the patch so that it would have better adhesive properties, and through that, better satisfy their needs. We had to make a decision at DBV at the time because fundamentally, we believe the agency is wrong. This product is approvable and can help patients as it is. But that being said, if the regulator has asked you to redesign the product, you'd have to give that a lot of weight. And we've decided that we would redesign the patch. And in large part because our ability to do that was quite significant, given the fact that Viaskin is meant to be a platform, and after peanut would come other allergens, milk, tree nut, egg, the manufacturing process and the engineering process allowed us to modify the patch as a function of what would be the needs of the next allergens. So we've decided that we would modify the patch as to provide better adhesion. And if I can go back to maybe describing for people who are listening today, our patch is made essentially of 2 components to it. The engine of the patch where the allergen is being delivered to the skin of the patient is not being changed. So it's a condensation chamber where there are literally 250 micrograms of peanut protein every patch. So that's 1:1,000 of the protein content of the peanuts, and that through stabilization, and essentially, absorption of what would be water vapor coming from the child's skin, allows that allergen to be solubilized and absorb it to the patient's skin into the epicutaneous tissues where it stimulates the immune response. That is not changing. So the motor is not changing. Around that patch is -- around that condensation chamber is the adhesive element of the patch around that surrounds it. And that is something we're in the process of changing right now. We have quite a bit of latitude around the type of adhesive, shape, size of that, what we call, the overlay as to provide a patch that adheres better. And we've committed to the agency, we would do that. In January of this year, the agency got back to us after we put forward a remediation plan for the complete response letter. And we've agreed to 2 studies that would be required to bridge essentially the data that exists with our current patch to what we call the modified Viaskin Peanut, mVP. And those 2 studies are met, one, to show that the protein transport into the skin is the same between the modified patch and the current patch. That study is known as EQUAL. It stands for equivalence in allergen uptake. And that study is one of some complexity technically because we have to measure minute amounts of protein on the skin on the patch over time, but to show that the protein absorption properties of the modified patch and the current patch are the same and they are since we have not changed what makes it work in the first place. So that's the first protocol we have to do. It will allow us to bridge the efficacy of the current Viaskin Peanut to the modified one. And the second study is to show the improvement in adhesion. That study is known as STAMP. It stands for safety, tolerability and adhesion of the modified patch, S-T-A-M-P. And that's to adhere. We've agreed with the agency, what they want to see when it comes to adhesion, at what point in time. And right now, we're in the process of exchanging protocols with the agency to get their support and their sign off before we start. The last thing I will add since my answer has been a bit long here is that for both EQUAL and STAMP, our plan is to have full alignment with the agency and sign off from them on a protocol and a statistical analysis plan. So that as we go and perform these 2 studies, we have the execution risk of studies here, which we all accept, but no risk of regulatory lack of clarity between DBV and the agency.

Okay. Thank you for that explanation of kind of where things are right now. I think just as a follow-up, you got the feedback from the FDA, and the course of the company in terms of what to do next was to test a wide number of alternative routes. Just walk us through like what types of routes you kind of worked around? How many prototypes did you actually end up developing? And I believe you've taken 2 modified patches forward? What are the characteristics of those final two? How do those make the final cuts, so to speak?

Yes. Well, yes, so the winners are DNH of the 20-some-odd prototypes that we tested in the clinic. But thanks for asking that question, Graig, because there's been a lot of work invested here by the engineering and manufacturing team at DBV. We started with close to 80 designs of how we could modify the patch. As I said, we could look at the concentration of adhesive, size of the overlay and shape of the overlay. We've done a lot of laptop experimentation to see, essentially, which of these factors contributed most to adhesion. Surprisingly, shape plays a big role. As you probably know, Graig, the current patch is square, with 4 corners. And kids move. So those are 4 corners that may get caught in the child's clothing or may get caught against the chairs they sit down, and probably, somewhat increase the risk of the patch lifting. So we looked at all those dimensions with 80 prototypes or so, decided to test more than 30 on the laptop. We took 12 to the clinic, actually, to test on human volunteers -- so on human skin. And we chose patients, who -- some of them had atopic dermatitis, who have inflamed skin a little bit closer to what you may see in the peanut allergic patients. Since as you know, dermatitis is seen in about 50% to 60% of children, but it was in healthy volunteers, to be clear. And there, we had then gone through a rigorous day of moving around, exercising, doing jump and jacks, taking showers, mimicking what would be a day [indiscernible] DNH prototypes are not to be the winners, and we'll take that to the clinic. We may not need to when discussion with the agency whether or not to bring 2 to EQUAL and STAMP is best or only one of them. We have a favorite by a nudge versus the second one. But sometimes, there is strength in numbers and the good hedging strategy in taking 2 forward here. So the team has done a rather remarkable job, and we've learned a lot about to stick better on the back of an active child.

Okay. So if the -- it sounds like the goal is to be able to get to an alignment with the FDA in terms of the trial protocols, the statistical analysis plan. Can you provide some guidance on when you expect to be in a position to communicate that you have indeed either met with the FDA and/or already have some sort of an agreement in place?

Yes. Our plan is once we have that agreement to come back to the market, investors who want to know, patients and patient parents who want to know, patient efficacy groups who want to know, certainly investigators and opinion leaders would want to know. Once we have agreement with the agency, and what I define as agreement is there's a sign off on the protocol and have sign off on the SAP of that data. The stamped protocol has been sent to the agency already. So we expect a return from them over the next few weeks or so. We may not come to agreement on the first part of discussion. We need to be practical here. And the EQUAL protocols and discussions have been engaged between the company and the FDA on EQUAL protocol, but we have not submitted the protocol quite yet. That also will be coming in the next few weeks.

Okay.

To give a bit more color to your question, if I may. It's typically about 60 days for the agency to get back to you with comments on protocols. It may take longer than that. It might take a little bit less time. We may make 2 rounds of discussion. So we expect that some time later around this year, we'll be able to come back to all of the stakeholders, and at that point in time, say this is when we expect our first patient in, the last patient out; from that, when we expect to refile the product to provide that time line that could be projected to refiling the product at that point in time.

Okay. And while I don't want to pin you down to a time line or more specific time line, do you anticipate that this would be some time in the second half of this year? Or could this be even a 2022 type of event?

The clarity with the agency, we expect to be in the second half of this year, yes. The -- cutting a deal with the FDA, I don't like the term, but illustrates what we have to do, agreement on protocol, an agreement on how we will process the data. We expect to have them in the second half of this year.

Okay. Very well.

Again, we control have that conversation to be clear. The other is up to the agency, but they've been very, very responsive.

Of course. I want to go back to the comment that you have to modify patches that you feel very comfortable with, and you've got one that may be slightly preferred versus the other, although you feel very confident in both. If the FDA were to say, we want you to test both of them versus just one, given that -- and we can revisit where you were financially speaking towards the back end of this chat. But how would that, if at all, if you had to test two versus one, how does that impact clinical trial costs? It shouldn't be thought of as a doubling -- necessarily does it?

Yes. It would not be. It would -- the study, obviously, would be costlier. It will not impact our cash position significantly in our ability to -- we have cash right now into the second half of 2022. So the reason for that is typically the doubling of a study in size often translates to study that is much longer to complete. The beauty of both EQUAL and STAMP is that neither of them requires a food challenge. The reason why enrolling patients in trials for food allergy is so long is besides the fact that the endpoint is usually 1 year of treatment to measure efficacy because the nature of the evaluation is a bit barbaric, as you know. The poor child is fed over 2 consecutive days either escalating doses of placebo, or in the other day, escalating doses of the allergen until the child exhibits serious symptoms of food allergy. It makes recruitment to be very difficult. Neither STAMP nor EQUAL require a food challenge, which is significant. It -- by the way, it was part of the acknowledgment by the agency that modified VP was not a new product. It was just simply an improvement on the old product, and thus, no need to redo the food challenges. That was significant in the agreement we've achieved with the agency back in January. So yes, it might take a little bit longer time and it might be a bit more costly, but not significantly. So since -- because we expect these studies will enroll pretty quickly given the absence of giving them a food challenge.

Okay. And maybe for context, if we think about, let's fast forward, towards the second half of this year, and you're able to announce that you have an agreement in place with the FDA, and you're ready to go with EQUAL and STAMP, are these studies that would happen and initiate concurrently? Can you give us a sense of how long from start to finish these studies takes -- they importantly don't involve the food challenges for perspective?

Yes. It's an important question. I should have mentioned that. The longest pull in that tent should be STAMP. The agencies is asking us to look at adhesion over 6 months. So -- and that's a reasonable request on their part. So STAMP would be a 6-month trial. EQUAL is a study that can be done over a few weeks. We look -- need to look at patch adhesion for a few days. As you know, there's an escalation over the first 2 weeks of patch wear. So we have to respect that. But EQUAL is a study that would take only a few weeks to run while STAMP would be a few months, would be 6 months. Add to that, the usual time to ramp up locking down the database and analyzing the data. These are not studies that will take a lot of time to run. But from first patient in to last patient, now we're pretty confident both of them could be done in about a year or so, with again STAMP being the one that will consume the most time. And that's the reason why we send the STAMP protocol to the agency before the EQUAL protocol. They're both important. But if we can solve for STAMP, it would be best all for time line. That makes sense? Yes.

It does. And maybe one last set of questions around STAMP and EQUAL realizing that you don't have an agreement in place just yet, but in terms of approximate sizing of how many patients is required in each of these studies, are we talking about 50 patients in EQUAL and 500 patients in STAMP? Or is there a way to think about sizing, relatively speaking?

Well, relatively speaking, you're touching. We're not in a position right now to comment on the size of the studies because, again, the SAP is part of what we have discussed with the agency. There's no doubt that STAMP would need to be a more robust study to measure adhesion that would be pre-agreed at time point with the agency. While EQUAL is more of a mechanistical study here of great technical complexity, but relatively straightforward conceptually here. So STAMP will be the largest of the 2 studies. And again, the one -- whether or not it's 5:1, 8:1, 10:1 in order of magnitude, I'm not in a position to comment on that right now. But your directional thinking, Graig, is correct.

Okay. Well, we're all eager to see whenever that update comes.

So am I.

With that in mind, I think it's important to remind investors that you have submitted Viaskin Peanut for approval in Europe. And so maybe you can talk about based on where you sit, importantly, getting into a perspective from the European health regulatory agency side, do you have any sense of initially if their thinking is very similar to the U.S. side? Is there a different approach? And with a view that perhaps whether it's the MHRA or the EMA without really knowing well from a therapeutic area consistency perspective, how they shake out on things, can you provide us a view of whether some of the hiccups you've seen on the U.S. side may or may not translate to the European side? Just trying to get a sense of how Europeans are thinking about this product?

Yes. It's an important question, Graig. We submitted to the EMA in the fall of last year. The file was accepted for review. In October, we got the day 120 questions as expected in Q1. Those have been tackled, answered, and answers sent back to the agency. So the next key regulatory time point here will be day 180, which will come later on this summer. The -- so that's where we are in the process. To answer the core of your question, the dialogue with the European agency has been fundamentally different. First of all, the process with EMA allows for much more exchange in a formal way than the FDA process. And also made for the fact that when -- by the time we file the dossier with the European agency that was after we received the CRL in August of last year. So the adhesion question that the agency had did not evolve in parallel to the European dossier, that was known, and we made that very clear to the European agency when we filed that the agency had questions about the adhesion of what we call cVP, the current Viaskin Peanut, which is what we filed in Europe. At the day 120, there were no questions on adhesion coming from the European agency. So they seemed to be at this point in time unconcerned about the adhesion properties of the patch, which again, to us, was only so surprised, as I mentioned, we believe that the cVP is a product that can help patients right now. And we're in the process right now of answering the questions we got from them, which we call more typical questions as we get around endpoints, adverse events, analysis of first 6 months versus last 6 months, the usual bread and butter of the total regulatory review.

Okay. And 2 follow-up questions just on Europe, actually maybe 3. First, the approval process is certainly different and reimbursement process is different in Europe. So on an anticipation that in a -- perhaps a bullish scenario that you do, in fact, get approval, what does it look like in terms of times to actual revenue and kind of launch time lines from a commercialization perspective? And I guess the follow-up is like what is happening or how is DBV preparing in terms of what are those precommercialization activities, which your infrastructure looks like?

Yes. Very important questions. I'm not sure I agree that approval in Europe is the bullish scenario. But that being said, for me, to handicap the odds of approval, obviously, is not something that I wish to do, but we feel good about our European dossier. You're correct. Besides a regulatory pathway in Europe that is well-defined and provides for timely interaction between the sponsor and the agency, there are like processes with key payers in Europe, the French, the Germans and the British, obviously, being the most important one since they have the heaviest weight reputationally across Europe, and also with the processes are well defined. And they are 3 of the 5 largest markets in Europe, obviously. That work has always been going on in parallel. That's driven dose -- HTA dose -- health economic dossier are prosecuted by DBV's team. It's our data. We know it well. We did the health economic comparisons. It's something we master very well. Our team has done a nice job of that. And as you know, we went through a significant downsizing last year, but keeping the commercial moxie was obviously a key element of the reorganization here. So that continues in parallel to secure the right market access or the right price through NICE in the U.K., GBA in Germany and the French Authorities, and that's going to be done by us. And that's -- as I said, that's going hand-in-hand with the regulatory dossier because you want to be in a position where soon after approval, you've secured market access, you've secured a decent price and are positioned to launch at that point in time. Your question around commercial infrastructure in Europe. Right now, we have all of the strategic marketing, market research expertise, health economic expertise that we need to be able to do the work I've just described. The decision to launch ourselves or launch with a partner is one that we keep on examining. We certainly are more than willing to do it ourselves and capable of doing ourselves. What we need to understand though, in Europe, and it's fundamentally different than the market construct in the U.S. In the U.S., there are 4,500 physicians, allergists who treat about 80% of children with peanut allergies. So it's possible to deploy quite a bit of muscle to what is a relatively well understood and small target audience. Physicians who treat food allergies in Europe from one country to the other is very different. It could be pediatrician, it could be internalist, it could be allergist, it's often a mix, to use, some needs a bit of a cliche. The market sometimes is more like 6-inch deep and 1 mile wide. And thus, the trade-off in finding the right partner versus doing it ourselves is a key element of our analysis here. We're receptive to both. Obviously, we're in dialogue with potential partners all the time. But the important work is approval and securing the right price. That's been driven by us. Does it answer your question, Graig?

It does. I do want to talk about the other peanut allergy product, just briefly, just because it is a market that already has, at least in the U.S., an approved product. That is a product that's marketed by Nestlé, it's called Palforzia. And I know given our past conversations, you are perhaps loathed to provide too much of an opinion on another product. But qualitatively, can you provide a perspective of kind of what you think is happening with the launch of Palforzia? And how does that inform either positively or negatively, how you're thinking about launching Viaskin Peanut in the U.S.?

Yes. The -- it's an interesting market dynamic here because as we've discussed during the past, this is not a zero-sum game market as is often the case and why the competitive spirits become important, and where CEOs have to be careful with their confidence here as you've touched on. But here, there is a large unmet need, over 1 million children suffering from peanut allergies. With 2 treatment modalities, oral immunotherapy in a protocolized way, Palforzia. So a sophisticated, programmatic way to do what has been done by some food allergists for many years now. For our product, which, as I said, explores a completely different biology, and we like to think for parents who have a child with some food allergy to have 2 options beat to one, especially the two of them are radically different because it taps into that other element I was touching on. We're not just treating the risk of accidental peanut consumption, we're also trying to reduce family anxiety. And you've seen one child, you've seen one child. You've seen one family, you've seen one family. And what we have learned through the Palforzia's launch, which, unfortunately, for them, took place during the pandemic, with a product that requires 2 visits a month for 6 to 9 months just to get to maintenance therapy. With allergists' offices being shut down or working in -- with reduced time, treating food allergies was not a priority. So Palforzia's launch, we believe, has been very much handicapped by, one, the pandemic; and two, an element of their product profile, that, to some families, will be problematic. They just don't have the time to invest in it. That being said, if families are willing to invest their time, Palforzia is a product that has been approved and has a profile, and certainly, would be very attractive for many of them. So pivoting to Viaskin Peanut, what we see here is a second product will be welcomed by the marketplace that's quite clear. But on top of it, being a different approach, that does not require up-dosing every 2 weeks. In fact, many physicians have told us that they would be comfortable prescribing it through telemedicine. Something we did not expect because we did not plan the launch of our product in the pandemic either turns out to be very attractive and reinforces elements of our product we believe are important. Parents want protection, parents want family anxiety to go down, that means confident in the outcome. And outcome is not just efficacy and safety, it's efficacy, safety and compliance to treatment. And our patch provides that.

Okay. We've got maybe 3, 4 minutes left. I do want to get through a couple of last questions. My first has to do with any updated thoughts on how you might price Viaskin Peanut relative to what we know for the price of Palforzia?

Yes. Palforzia was launched at $890 a month. So that's about $11,000 a year. That's a price that was roughly in what we were testing for market research sake. That being said, as you know, Graig, prices are finalized in our industry once you have label in hand because that matters a lot in claim and claim structure here. So at this point in time where we see Palforzia as an element, a reference point in our pricing the product, but that's not the whole question. As I said, compliance and outcomes matters a lot here.

Okay. Great. I'd be remiss if I didn't ask you about the pipeline. I mean I know most investors are focused very much on the outcome and what's happening with Viaskin Peanut. But as you alluded to in the very beginning of our talk, you have a core technology. So if you could spend maybe a brief few words on kind of what are the next programs that you might want to advance?

Yes, we'd sum that up in 2 buckets. There's the other applications in food allergy where the milk allergy is the one that's in Phase II, already going to Phase III. Milk also -- Viaskin Milk, may have application treating EoE. So Viaskin Milk may essentially have 2 applications here, allergies per se and EoE. That probably will be our next program, we're going to spend some time on. And then all the preclinical work on application technology to other food allergies and other areas of immunology outside of the food allergy continues. We've been very protective of that. We're working hard at it. The fact that we don't talk about is not because we're not working at it. But as you said, until we get Viaskin Peanut on a clear path, investors, I don't think I want to be hearing too much about what else we're working on. But I want to assure you that we are working on other things.

Okay. Great. And then I would say the last questions are a bit more housekeeping in nature. I will ask you, I think you did allude to the fact of your cash runway goes into 2022 second half, I believe, is what you mentioned?

Correct.

Could you just remind us where exactly you stand with respect to cash? And then we've probably talked about this as well in terms of next catalysts. It seems like the update some time in the next, hopefully, few months or so or second half on the regulatory update here in the U.S., but anything else that we should look to in terms of catalysts as well?

We finished Q1 with $152.5 million. We now report in dollars as opposed to euros since we're now IFRS in the U.S. We use our cash burn by about half with the downsizing I described earlier on so that we can focus on what matters here and not be distracted. And the key catalysts, I believe, is there's two of them. Clarity from EMA, which will play out towards the end of this year; and agreement with the agency on EQUAL and STAMP, where we've made a commitment to come back to investors in the larger community with an update once we have it.

Right. And if you can indulge maybe in one last question, which is kind of if you look perhaps 5 years down the line from now, where would you like to see DBV 5 years from now?

5 years from now, we'll be generating significant cash from Viaskin Peanut, which we will deploy because it's the cheapest way to fund a pipeline and a good use of capital into a pipeline that we think is very promising. We'll have probably closed another product in food allergy, maybe even a second product in the market. And we'll have a pipeline of applications outside food allergies that we'd be celebrating.

Okay. Excellent. Well, that was a great vision that you've left us with. And with that, Daniel, I want to thank you for your participating in our health care conference. And I want to thank everyone for joining on this webcast as well. So thank you all and have a good rest of your day.

Thanks, everyone, and be safe. Graig, thank you.

Thank you.