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

Welcome to the DBV Technologies Update Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Jonathan Neely. Please go ahead, sir.

Thank you, operator. This afternoon, DBV Technologies issued a press release announcing positive top line results from its Phase III VITESSE clinical trial of the VIASKIN Peanut patch in children aged 4 to 7 years old. This press release is available in the Press Releases section of the DBV Technologies website. Before we begin, please note that today's call may include a number of forward-looking statements, including, but not limited to, comments regarding the therapeutic potential of VIASKIN Peanut and EPIT, our clinical and regulatory development plans, the design of our anticipated clinical trials, the timing and results of interactions with regulatory agencies, plans and expectations with respect to the submission of BLAs to FDA, expectations around the BLA's potential eligibility for priority review, anticipated support for the BLA submission, the exercise by investors of certain warrants issued as part of the financing announced on March 27, 2025, and the anticipated use of proceeds. Our forecast of our cash runway and the ability of any of our product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements are based on assumptions that are subject to risks and uncertainties that could cause the company's actual results to differ significantly from those suggested by these statements. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Please refer to the company's filings with the SEC and the French AMF for information concerning risk factors that could cause the company's actual results to differ materially from expectations, including any forward-looking statements made on this call. Except as required by law, the company disclaims any obligation to publicly update or revise any forward-looking statements to account for or reflect events or circumstances that occur after this call. Joining me on the call today are Daniel Tassé, DBV's Chief Executive Officer; and Dr. Pharis Mohideen, Chief Medical Officer. Also joining today's call is Chief Financial Officer, Virginie Boucinha; and Kevin Trapp, our Chief Commercial Officer. I will now pass the call over to Daniel. Daniel?

Thank you, Jonathan, and thank you all for joining us this afternoon for this very exciting development, positive top line results from our pivotal Phase III VITESSE clinical trial of the VIASKIN Peanut patch in children 4 to 7 years old. I will begin with a few remarks before turning the call over to Pharis Mohideen, our Chief Medical Officer, to dive into the results in more detail. We will then wrap up and happily take your questions. To repeat, I'm absolutely thrilled to announce positive top line results from our Phase III VITESSE trial. This is a transformative moment for DBV Technologies and most importantly, represents tremendous hope for the nearly 400,000 children in this age group living with peanut allergy in the United States. Let me highlight the key takeaways from today's announcement. Most importantly, we met our primary endpoint. The lower bound of the 95% confidence interval was 24.5%, substantially exceeding the FDA's prespecified threshold of 15%. Additionally, 46.6% of subjects treated with the VIASKIN Peanut patch met response criteria at 12 months, and that compared with 14.8% of subjects in the placebo arm. The treatment effect of 31.8% was highly statistically significant, the miniscule p-value well below 0.00001. Additionally, the data suggests the VIASKIN Peanut patch was safe and well tolerated with safety results that were consistent with the safety profile we've observed in the VIASKIN Peanut clinical program to date, which, as you know, is considerable. These results bring us closer to providing a much-needed treatment option for children with peanut allergy to their families, if approved. And we look forward to submitting a BLA as planned in the first half of 2026 with a potential priority review given our Breakthrough designation. Before moving on, let me briefly address our financial position. In March of this year, we completed a financing of up to EUR 284.5 million. This included EUR 116.3 million received upfront with a potential additional aggregate of up to EUR 168.2 million in gross proceeds to receive, but the financing rate it warrants are all exercised. Recall that the terms of the financing provided the exercise period of these warrants is accelerated upon the announcement of positive VITESSE top line results. And thus, as a result of today's announcement, the warrants are exercisable through January 15, 2026, which is 30 days following today's announcement. Assuming all warrants are exercised, we believe that DBV will be sufficiently funded through the expected BLA submission for VIASKIN Peanut patch in 4- to 7-year-olds and through commercial launch, if approved. And with that overview, I'll turn the call over to Pharis to discuss the detailed clinical results. Pharis?

Thank you, Daniel, and good afternoon, everyone. Today, we will present top line data. As you're aware, we will review and analyze the full data set as a standard practice and look forward to presenting the full results at upcoming medical meetings as well as publication in a peer-reviewed medical journal. Now for the results. Let's start with the primary endpoint. The results are compelling. As Daniel mentioned, 46.6% of subjects treated with VIASKIN Peanut met the responder criteria at 12 months compared to 14.8% of subjects in the placebo arm. Critically, the lower bound of the 95% confidence interval was 24.5%, well exceeding the FDA's prespecified threshold of 15%, meeting the primary endpoint and giving us a clear regulatory path to BLA submission in the first half of next year. The treatment difference of 31.8 percentage points is highly statistically significant with an exceedingly small p-value. This treatment effect is consistent with the treatment effect observed in our Phase III EPITOPE study of VIASKIN Peanut in 1- to 3-year olds, which was 33.4%. So it's reassuring to see the consistency of the VIASKIN Peanut treatment effect across the 1- to 7-year-old age range. As you'll recall, VITESSE was originally designed to enroll 600 subjects. However, due to tremendous interest from families and investigators, we exceeded our target by enrolling 654 subjects. This makes VITESSE the largest immunotherapy clinical trial ever conducted in food allergy. Now let me provide a brief reminder of the study design. VITESSE was designed to target a younger, more sensitive patient population of children aged 4 to 7 years with an entry eliciting dose for the food challenge of 100 milligrams. As we've seen in our prior clinical trials, these are the patients with a very high unmet medical need and who have experienced robust treatment effects with VIASKIN Peanut. The responder definition was designed to capture clinically meaningful increases in desensitization that would reduce the risk of an allergic reaction from accidental peanut consumption. Recall that we changed our responder criteria relative to our previous studies to align with a younger, more sensitive target patient population. A treatment responder was defined as a subject with a baseline eliciting dose of less than or equal to 30 milligrams, reaching greater than or equal to 300 milligrams at month 12; or a subject with a baseline eliciting dose of 100 milligrams, reaching greater than or equal to 600 milligrams at month 12 as measured by double-blind, placebo-controlled food challenge. The month 12 responder rates for the 1- to 30-milligram baseline eliciting dose stratum and the 100-milligram baseline eliciting dose stratum performed as expected based on our statistical projections from the 4- to 7-year-old subjects in our PEPITES 4- to 11-year-old study, and both beat the 15% lower bound of the 95% confidence interval. The levels of desensitization we saw are highly clinically relevant. Studies of accidental peanut exposures show that the median amount consumed is 125 milligrams. So the results we are achieving with VIASKIN Peanut in the study are well above what children might typically encounter in real-world accidental exposures. As mentioned, I'm very pleased to report that VIASKIN Peanut was well tolerated by participants in this trial, and the safety results were consistent with the safety profile of VIASKIN Peanut that we've observed in our prior clinical studies, which now encompasses over 1,600 patients and more than 1.1 million patch applications. The most common treatment-emergent adverse events observed during the VITESSE study were mild to moderate local skin reactions at the patch application site. Discontinuations due to treatment-emergent adverse events were low at 3.2% in the treatment arm compared to 0.5% in the placebo arm. Notably, there were no reports of treatment-related serious adverse events. And treatment-related anaphylaxis was low at 0.5% for just 2 subjects. Neither case of anaphylaxis resulted in treatment discontinuations. Overall, study compliance was high at 96.2% and consistent with what we have observed in other Phase III VIASKIN Peanut studies. Adhesion data were collected throughout the study using a more robust collection methodology relative to previous studies. The data from this exploratory assessment were in line with the company's expectations. Before I conclude, I would like to thank the patients and their families who participated in this study. Without them, none of this would have been possible. I also need to thank the study centers. This was a very large study, and our centers really came through for us in recruitment and high-quality execution of the study protocol. To everyone who contributed to the study, thank you for your support and participation. Now I'd like to turn the call back over to Daniel. Daniel?

Thank you, Pharis. Before moving on, there is one final point I'd like to make. Rates of enrollment in the VITESSE open-label extension were in line with previous VIASKIN Phase III studies. This is important because based on those previous studies, we anticipate the response rate to increase over time, consistent with other forms of allergy immunotherapy. We're currently evaluating the long-term efficacy and safety in the VITESSE open-label extension study, and we look forward to presenting those results in the future. Now today's positive VITESSE top line results paved the way for BLA submission for the 4- to 7-year-old age group, which is anticipated in the first half 2026, follow a potential U.S. launch subject to FDA approval. Now for our other clinical indication in toddlers ages 1 to 3, we have positive Phase III data already published in the New England Journal of Medicine, and we're currently conducting the COMFORT Toddlers supplemental safety study to support a BLA submission, which is anticipated in the second half of 2026 under an accelerated approval pathway. Together, these 2 products, if approved, could address approximately 670,000 children ages 1 to 7 with peanut allergy in the United States, representing a substantial commercial opportunity and more importantly, a chance to meaningfully improve the lives of children and families living with this condition. Now to wrap things up and before opening up to questions, please let me summarize our key takeaways for today. First, VITESSE met its primary endpoint with highly statistically significant results, giving us a clear path to BLA submission as planned in the first half of next year with the potential for priority review. Second, the clinical meaningfulness of these results is clear with a favorable safety profile consistent with previous clinical trials. VIASKIN Peanut has the potential to be a treatment solution for the nearly 400,000 children ages 4 to 7 living with peanut allergies, if approved. And lastly, today's announcement of the positive VITESSE top line results triggers an acceleration of the exercise period of warrants issued as part of our March financing. Recall that we received EUR 116.3 million upfront. We have the potential to receive up to an additional -- sorry, EUR 168.2 million if all warrants are exercised as a result of today's positive VITESSE results. Needless to say, we are very excited to end the year with this positive announcement as we enter 2026. We continue to execute on key activities, including completing both BLA submissions, preparing inventory and advancing toward potential commercialization launch in 4- to 7-year olds. I will now turn it over and to happily answer your questions. Operator?

[Operator Instructions] And our first question will come from Sam Slutsky with LifeSci Capital.

Congrats on the awesome update.

Thank you.

I guess on the approval process, what has to be done between now and BLA filing? Also, any recent conversations with the FDA that are notable, just given some of the personnel changes they've had at the agency? And then as you think about what an FDA label could look like, assuming approval, what's kind of your expectations there?

I'll be happy to take a part of that and have Pharis answer what the labeling might be, which again, is a bit of a premature question because we actually don't know. But no, the next steps are for us to file the BLA in the first half of this year. There's a lot of work to be done internally, obviously, in assembling the BLA. The dialogue with the FDA continues, continues to be fruitful. The key people we've been interacting with are still at the agency, which I think is important. And there is nothing gating our ability to file that the FDA owes us. It's up to us to do the work and file in a timely way. As far as the label goes, Pharis, you might want to talk about the REMS and sort of claim structure? The absence of REMS claim structure.

Yes. So Sam, as far as the label, I think it's going to be very traditional. Obviously, we have to have those discussions with the FDA. And what I mean by that is the efficacy is really clear cut. We're well above the 15%. There's nothing controversial there. The safety, as we've described, is entirely consistent with what we've seen in the past. And we will obviously use some of our legacy data in the BLA. We've talked about would the FDA or other regulatory bodies want to put some sort of a REMS on this. And as we've talked about internally and externally, we can't think of what you would REMS -- I don't know if that's a real word, but because, again, put the patch on and you go about your daily living, and there's no real criteria that we could add to a label that would improve the use of the product from a safety standpoint. And to be clear, as we've said before, the FDA has not identified a safety signal to date. We don't expect them to see one. So I think the label from my viewpoint right now, again, a little premature, but I think it will be very traditional efficacy safety as it's so clear cut.

Got it. Okay. And just jumping over to actually the 1- to 3-year-old safety study real quick. Just any update there as it relates to where that's at on enrollment and kind of time lines, et cetera?

Pharis, do you want to take that one?

Sure. Yes. So we're tracking exactly as scheduled. As you know, we have to go through each of the different regions and their regulatory bodies that's tracking as planned. For the sites that have already opened and are recruiting, they're doing well. So we're really pleased with the progress that we're making on the 1- to 3-year-old front.

And our next question will come from Jon Wolleben with Citizens.

Congrats on the data. Long time coming.

Thank you.

Got a couple on data and then a couple on the opportunity. Hoping you could provide a little context on the clinical relevance of the primary endpoint. And then if you could provide any details on kind of ending cumulative eliciting or reactive dose that you saw for VIASKIN Peanut.

So Pharis, why don't you take the clinical relevance as a clinical regulatory matter, then I'll have maybe Kevin add some comments on the commercial front.

Yes, sure. As far as the primary endpoint, Jonathan, yes, it's absolutely highly clinically relevant. What we have to remember is the first year efficacy is an FDA statistical endpoint, right? And we clearly passed that. And as we've discussed in the past, allergen immunotherapy is a 3- to 5-year endeavor, right? And so this is where shared decision-making comes in for families and the allergists making these longer-term decisions. And we believe that we check sort of the 3 major boxes of efficacy, safety, ease of use. And as we've said in the past, and as you've seen, we have long-term 3-year data where year 2 is better than year 1, year 3 is better than year 2. So we're really happy with where we are as far as the clinical relevance and where this fits into the treatment paradigm. And your second question was related to the cumulative reactive dose, is that correct?

Cumulative reactive dose, yes.

Yes. So again, this is top line data limited to the top line output as is normally the case when you do top line for a study. Obviously, we're going to get the full tables and listings, and we'll be presenting a lot more as we go through the full data set in the coming weeks to 2 months, and we'll present at congresses as well as published in a peer-reviewed journal. Does that answer your question, Jonathan, just to be clear?

Yes, as much as you can say. And then Daniel, you mentioned the 690,000 patients. Wondering if you could talk a little bit about further segmentation into what proportion have multiple food allergies. Where do you think VIASKIN Peanut could fit in now that Xolair is also available in children 1 year and older for multiple food allergies. Like how do you think about the addressable population for VIASKIN Peanut?

Yes. Let me kick that off, and I'll hand over to either Pharis or Kevin to add here. So there's only us as the best option, we believe, for desensitization, which is what parents want. Many of the kids we see in our studies, I don't know what the results are in this study, but historically, it's been 60%, 65% of our children were multi-allergic. That being said, we have no problem recruiting patients, although we're only offering a solution for peanut. And the reason for that, and I'm sure Kevin can add to what he picks up in market research, is peanut is the big risk. Peanuts are ubiquitous. The reaction is unpredictable. They can be quite violent and quite serious, and parents are perfectly happy to deal with peanut first and manage the rest of their kids allergies with vigilance and carrying an EpiPen. The use of an IgE blocker in a population 1 to 7 is something that we don't see happening right now because the safety of blocking IgE production in the immune system in a chronic way has not been established. Moreover, needles and pain is an issue also in that population. So we like where we are. We think we're a product that is going to be, by far, the preferred choice when it comes to desensitizing kids. Anything you want to add about that, Kevin?

Yes. No, I think you said it. I mean there's no desensitizing multi-allergen FDA-approved treatment. So the desensitization factor here is important. And as Daniel said, we've done a number of studies in market research where parents are very concerned about peanut. And if we can just take that away, it's just a big relief. And that's really what we'll focus on. I think it was a bit of a surprise in the market research that even kids on, who have multiple allergies, wanted to really take care of peanut. So that's what we'll focus on. We're certainly doing more work on segmentation, Jon, and we'll continue to look at that as we've got the profile here out of the test, which we're very excited about.

And we'll move next to Yatin Suneja with Guggenheim.

Congratulations. Very good results.

Thank you.

Just a couple for me. So the data look pretty much in line to what you have generated in Toddlers if you look at the younger patients. So the question is, have you looked at the breakdown between 4 to 5 versus 6 to 7 years old in this study? And again, in that context, look, if the data continue to look pretty similar across 1 to 7, can you just talk about the TPP? I assume like the TPP for the toddler should be similar to the 4 to 7 as well, just put that in context?

Yes. Before Pharis adds here, yes, to make a key observation, the treatment effect was 31.8% in active in placebo and 4 to 7. It was 33.4% in 1 to 3. So that's pretty telling. And we're pretty pleased to see if that's rather remarkable the treatment effect is the same across 1 to 7 in the clinical study. So Pharis, anything you want to add about the data cuts of -- by age group, data that we have, and we'll be sharing later on?

Yes. So Yatin, we will definitely look at a lot of different parameters along those lines. Right now, we are focusing just on top line results. And I think the key point here is what Daniel said, the treatment effect across the 1- to 7-year-old age range is just remarkably consistent. And it really is unbelievably consistent from that standpoint. So we can look forward to seeing more data cuts in the future. But right now, we're just focused on top line.

One more question if I may. One more question, if I may. Can you just talk about the duration of treatment? What is your expectations of resolution or kids growing out of allergy or your ability to sensitize them? And how should we think about that as we sort of model it? And then if you can comment anything on the pricing, given that this data continue to look pretty solid, like how should we -- or what is your research suggesting?

So Pharis, maybe what you're hearing from treating physicians about duration of treatment and then Kevin, what you're picking up in talking to the families?

Yes. So what we hear is that all allergen immunotherapies tend to be 3 to 5 years duration of treatment, and VIASKIN Peanut would definitely fall into that category. Longer durations of treatment, you tend to have better efficacy response. In terms of resolution, there is sustained unresponsiveness data that we've generated in the past that is highly suggestive that there could be resolution. But obviously, that's not the primary endpoint of this study. We do have a 3-year open-label extension that Daniel mentioned, and that will give us a lot of insight into longer-term effects of VIASKIN Peanut. And we don't have resolution data coming right now at year 1, obviously. But we, like I said, do have some generated data in the past.

Kevin, anything to add?

Yes, I would just want to add -- I'd just add, I mean, I think this is a product where parents want to see it through the desensitization. I think given the 3 elements we've talked about of efficacy, the safety profile of this and the ease of use, it's something that does fit into their daily routines. And as Pharis said, we've seen high retention into the open-label extension. So they do see it as allergy immunotherapies have been for decades, a 3- to 5-year treatment. They know what they're signing up for, and it fits into their life to be able to take peanut off the table, if you will. I mean what happens after that 3-year period in terms of introducing food or continuing with the product, I think that's up to an individual family. But the profile that's emerged here is very good. And I'll bridge to the pricing question, Yatin, is we're doing the work. I think that's always subject to final label. So we've got to wait a little bit on that. And -- but we're out talking to payers now, and we've heard nothing but this is a category that they're not managing a lot. And I think we feel good that the product profile that comes out here will be consistent with what we've seen in other food allergy data points that are in the market. Does that answer your question?

Yes, very good.

[Operator Instructions] And we'll move to Kristen Kluska with Cantor.

Congrats on the data and great day for the peanut allergy community. Long time coming for them. So given that you enrolled a more sensitive group at baseline, curious how you're thinking about the percent of patients that will ultimately benefit recognizing that what is meaningful for each of them are going to differ based on where they start in a real-world setting, factoring the fact that patients will also likely be on the product for over 12 months as well.

So Pharis, why don't give a clinical perspective on this and maybe, Kevin, a commercial one?

Yes. So we targeted the younger, more sensitive patients because we felt there was the highest unmet medical need. But this is definitely generalizable to the larger 4- to 7-year-old indication. Remember, we did have a higher threshold of 300 milligrams in our other studies. And as you said, it's individualized to each family's needs and once from a therapy. And that's where the shared decision-making process comes into play, right? And what we've heard from our sites and investigators is for families that want to know, okay, how much can my son or daughter tolerate? They can do what's called an open clinical food challenge where maybe you don't push them to near anaphylactic reactions, but you just see, hey, can they consume half a peanut, 1 peanut, 2 peanuts. And so it's very generalizable. And again, we work very closely with our allergists, and that's our prescribing base as we move forward. So we're very comfortable that this data is very much generalizable to the overall 4- to 7-year-old peanut population.

Yes. I'd just add commercial, Kristen. Let me just add commercially. I mean you're not going to typically do the food challenge at entry. You're going to find out through skin test and that they're allergic. So as Pharis said earlier, 125 milligrams is that threshold where typically the median where allergic reactions happen. So we're able to take them up to 300 or 600 milligram in 2 endpoints, which are significant fold increases, certainly in the ultrasensitive, the 1 milligram to 30 milligram cohort. But those that are at 100 milligram are still under that threshold, and we're able to take them up to 600 milligram. So you're not going to necessarily know those in clinical practice, but you know your child have an allergy that's either going to the ER has been diagnosed at the allergists. And I think these are very meaningful clinical results at year 1 that will typically get better in years 2 through 5.

Okay. And I recognize you might not have the answer to this question yet, but one other thing we've discussed at length is part of this product potential is that if patients do have allergic reactions to peanuts, potentially the VIASKIN could make the reaction a little bit less severe. So I'm curious if you looked at the allergic reactions that did occur from the ED testing in the VIASKIN group relative to placebo and if there were any differences, albeit all the patients were having reactions at that point, but if the levels or complexities behind them showed any differences.

Yes. I can take that one.

Yes, Pharis can answer that. Before you answer Pharis, but yes, Kristen, you make an important point where not only does ED go up, so that's protective because the dose that triggers allergic reaction goes up. But yes, we did publish that the severity of those symptoms when you do consume peanuts tends to be quite a bit less also. So there's 2 elements here of protection. I gather, Pharis, we picked that up -- we've collated the data in the study also.

Yes, that's correct. As Daniel said, in the 1- to 3-year-old data set that we published, we did see a decrease in the severity of the reactions, and we also observed that in the other study that we did in 4- to 11-year olds. We have assessed that not for the top line results. But as I said, as we move forward, analyzing the full data set, we'll definitely look at that and present as is appropriate at upcoming medical conferences and/or in peer-reviewed journals. And obviously, the expectation is that we'd see similar decreases in severity during the food challenge.

And we'll hear next from Andrew Fein with H.C. Wainwright.

This is [ Abbie ] on for Andrew. Congratulations on the readout. So my question is, while the study met its primary endpoint, we have heard from physicians that they were hoping for kind of a responder rate closer to 50% in the treatment group. Can you talk about how you expect allergists to contextualize this result clinically and whether there are specific subgroups or secondary analyses that you think will be most important in reinforcing the confidence in real-world use?

So Pharis, why don't you take it from a clinical perspective and Kevin, commercial?

Yes, sure. So [ Abbie ], remember, year 1 efficacy is an FDA statistical endpoint, and we clearly passed that, right? And allergen immunotherapy, not just VIASKIN Peanut, but allergen immunotherapy in general is at least a 3- to 5-year treatment period. And so shared decision-making between the allergists and the family really comes into play here for a longer-term therapy. And what allergists and families are looking for products that are efficacious, safe and really easy to use, so they can stay on it for 3 to 5 years. And we believe VIASKIN Peanut has achieved those outcomes. And as we've talked about our longer-term data in the 1- to 11-year-old age range, we know that year 2 is better than year 1, year 3 is better than year 2. So we just have to be sure we take the longer-term big picture view of this. Obviously, there will be a lot of secondary and exploratory and even [ post-hoc cuts ] of different efficacy parameters. And based on our extensive data from previous studies, we know that there are a lot of other clinically meaningful endpoints that don't get exactly captured in just the primary endpoint. If you look at things like what percentage of patients had an eliciting dose that increased, right. If you live at 1 milligram, 3 milligrams, and you get to 100, 1/3 of a peanut kernel, that's absolutely clinically meaningful and can change lives, but it doesn't get captured as a regulatory type endpoint, right? So we'll have a lot of that data coming out in the near future. And Kevin, is there anything you want to add to that?

Yes. No, thanks for the question. I think it's an important one. I think these 3 elements we keep talking about, to me, VIASKIN checks all 3 boxes, and it addresses a significant unmet need the way other pediatric food allergy treatments don't. And we know this from the market research we've conducted with hundreds of parents and allergists. And it suggests it fits nicely within their practice routines where there's no need for multiple office visits. And it easily fits in for their current appointments for asthma or eczema that are already scheduled. So it is that shared decision-making. And I think it's important that this is a product that meets the needs of a lot of families, and we're looking forward to, if approved, getting the communications out around this. Thanks for the question. Does that answer?

Yes. That's great. And then just one more, if I can. Just a clarifying question on the warrants. So I know you guys said on the call that the warrants exercise has not been triggered by this data. So -- but you said that it funds the 4 to 7 BLA and into launch and commercialization if approved. Does this also cover the 1 to 3 BLA and -- moving towards commercialization? Or would there need to be additional capital for the toddler age group?

Thanks for the question, [ Abbie ]. Well, for now, obviously, we want to make sure that the warrants are exercised. I think the economics make a lot of sense for them to be exercised, get that in. And that is sufficient for us to do the big, how should I say, bullish and full of energy launch that we want to have in 4- to 7-year-olds. Other capital needs will be addressed in due time. But right now, our focus is 4 to 7 and exercising those warrants.

And next, we'll hear from Sushila Hernandez with Kempen.

Congrats on the results. So on both [indiscernible] how do you foresee both [indiscernible] at some point? And then a question on the patient compliance. Great to see this high level of patient compliance. Could you elaborate on the steps taken to increase the patient experience with the patch?

You broke up on the first half of your question, Sushila, be kind enough to repeat it? We got the second half on treatment compliance, but we missed the first half.

Yes. So with the patch in both -- for both children and toddlers, how do you see the patch being used? Will patients switch at some point?

Pharis?

Yes. So if I understood the question correctly, so it's the age of initiation. So 4 to 7, you would stay on that product. 1 to 3, you can stay on that product. You don't necessarily have to switch when you become 4 or 5 if you were initiated when you were age 1 or 2. Does that answer your question? I wasn't sure that I heard the question correctly, sorry.

Yes, yes. That answers my question. And on patient compliance, could you just give the steps taken to increase the patient experience with the patch?

Yes. So the compliance rates are extraordinarily high, 96.2%. That's consistent with what we've seen in other studies. So compliance is really not an issue or challenge at all for these patients. Improving the patient experience, I'm not sure what we would do in that sense because, again, we have no restrictions in our clinical trials. Patients put the patch on any time of day they want, morning, afternoon, evening, and they just get into a routine. There are no restrictions as far as the patient needs to sit still or anything like that. Obviously, they avoid peanut while they're on the product. So from our standpoint, the product is very easy to use. And I think our longer-term enrollments in the 3-year to 5-year studies that we've done really are a testament that it's easy to use. It's pragmatic. The safety profile you've seen is very well tolerated. So we believe that it checks all 3 of those boxes, as Kevin said, efficacy, safety, practicality, ease of use.

And we have no further questions at this time. I'd like to turn the conference back to Daniel Tassé for any additional or closing remarks.

I want to thank everybody for joining us and again, congratulate the team at DBV who has worked so hard. This was a very large study. And without sites and patients participating, obviously, we would not have these good results to share with you today. So I thank you all for attending today. And as always, we're always available for extending conversation in other forms if you wish to do so. I wish everybody a great evening and happy holidays [ if we not talk ]. Bye-bye.

And this concludes today's conference call. Thank you for attending.