Morning, everyone. So before we begin, we are required to make certain disclosures and public appearances about Goldman Sachs' relationships with companies that we discuss. The disclosures relate to their investment banking relationships, compensation received, or 1% or more ownership. We are prepared to read aloud disclosures for any issuer upon request. However, these disclosures are available in our most recent reports, available to you as clients on our firm portals. With that, thank you, everyone, for joining. Good morning. My name is Rajan Sharma. I'm part of the healthcare research team here at Goldman Sachs in Europe. I'm pleased to have Daniel Tassé with us this morning, CEO of DBV. Daniel, thank you for joining us. Good morning, Rajan. Thanks for having me. I guess maybe to start, for those perhaps less familiar with the company, could you maybe just give us a high-level introduction of DBV Technologies and the areas that you're working in? Yeah, happy to do so. DBV is an immunology company focusing essentially on food allergies in children. The company was founded by two pediatric gastroenterologists who figured out, you know, 15 or 20 years ago that the human skin actually is a pretty powerful immune organ, can be used to tolerize against allergens. And with that came a platform known as epicutaneous immunotherapy. Our form of it, which is the only one that's being developed, is called viaskin. It's a patch worn on the back of the child, scapula. The scapula is important because this is where the highest concentration of the Langerhans cells we're trying to recruit to essentially induce this tolerization against the allergen. The patch has a minuscule microgram amounts of peanut protein against a backing, and the patch is applied, it creates a condensation chamber, where the humidity of the skin is sufficient to solubilize the protein, have it drop onto the epidermis, where this recruitment Langerhans cells then mobilizes Tregs, and with that, essentially, the desensitization to the allergen wherever the exposure may take place. This desensitization takes place over time, and as we'll talk about later on, I assume, has shown pretty impressive clinical results. Yeah. So. I guess just on that piece, and I hope you don't mind me saying, it's been kind of a, a bit of a mixed development history that you've had with viaskin Peanut. Could you just maybe walk us through the history and, and where you are today? Yeah, quite simply, and it's a very fair way to put it. We're currently pursuing 2 BLAs in parallel, one in children 1 to 3 in toddlers, one in children 4 to 7. The The checkered development history is the result of our original application in children 4 to 11, received a complete response letter from the FDA. This was in August of 2020. 2020. Some background is important here. Our product is reviewed by the vaccine division at the FDA. Although we're not a vaccine, there is, in the model of intervention, we're trying to induce a measured immune response as to protect the child against something that might happen in the future. Here, being accidental consumption of peanuts, since our lead product is peanut. In 2020, the division was obviously quite busy and has been for the bulk of the last four years with the COVID pandemic. So anyways, we got a CRL in August 2020. The company had not done a good job, to be honest, of characterizing the patch adhesion experience. How important was the length of wear to clinical response? So that was our bad. That's what I explained to the agency. That was the previous management team, I need to mention that. And with that came a CRL, where the agency asked us to redesign the patch so that it would adhere better to the skin, which we've done. So that has contributed to that checkered history, and was also checkered and a touch slower than we all hoped, because, until last month, when the vaccine division finally declared they had caught up to the COVID essentially backlog, the review of our dose has always been rather slow. So is that helpful in answering your question? That's helpful. Yeah. Yeah. And then you talked about kind of the two settings. So you have the 1-3-year-olds and the 4-7-year-olds. Could you maybe just talk about how the strategy is defined in each of those? Absolutely. So first of all, for us and for investors, there's an element of sort of hedging by having two separate BLAs as opposed to a BLA and a supplemental BLA. We made the acceleration or slippage of one or the other to not be essentially a factor here in value creation, so the two are independent track. Pretty much tracking nose to nose when it comes to filability, with probably program in 1-3 being slightly ahead here. So viaskin Peanut in toddlers 1-3 is with one patch, the original patch, and in 4-7 is with the modified patch the agency asked us to pursue. When it comes to the clinical program, efficacy in 1-3 has been shown in a study called EPITOPE that unblinded about 2 years ago, was published last May in the New England Journal of Medicine. Let's be clear, this was a big deal, this study, and showed significant clinical response, and we'll discuss again later on, if you wish, continued improvement through the second year. So efficacy has been shown. The FDA wants us to do a supplemental safety study, not because we're chasing a safety signal. There's been really no safety signal seen in our program ever. The agency wishes to have 600 patients on active per PREA guideline, which we're fine to do, and thus the supplemental safety study, which will be called COMFORT Toddlers, is currently being discussed with the agency to be finalized, initiated. So the completion of that study is what is rate limiting to us deposing a dossier in 1-3. In 4-7, the efficacy trial is ongoing, recruiting nicely. We should have last patient first visit next quarter, in Q3 of this year. It's a 12-month study. We expect to have top-line results in Q3 of 2025. The agency also wants 600 patients on active, so there'd be a supplemental safety study called COMFORT Children here, and that study will start a bit later on this year. Since it's a shorter study, always easier to recruit, we can drive both of them in parallel as to when, with data readout on both of them around the same time. Okay. Okay. Is that helpful? Yeah. A lot of information. My apologies for that. No, that's, that's helpful. And then just on the, the safety piece that's running in parallel- Yeah -with VITESSE, where are you in terms of kind of timing on that? Because previously, you didn't want VITESSE to compete with the safety trial and vice versa, right? Correct, yeah. So our plan is to start that COMFORT Children study sometime in the second half of this year. Okay. Since VITESSE is a 12-month study, the safety study is a 6-month study, we can start the safety study later, with two studies coming at the same time. Over recruitment for safety studies is always easier in food allergy. For those of you that are familiar with food allergy, the way efficacy is assessed is through a protocol that can be very demanding for parents and for families. The children are giving escalating doses every 20-30 minutes of peanut protein until they're sick, and that becomes essentially what is known as the eliciting dose. So that's very stressful for families. The kids don't like it, obviously, and they do that all over again after 12 months to see the number of step changes to assess efficacy. Safety studies don't have a food challenge. They're thus a lot easier to recruit. So our plan is to start COMFORT Children later on this year, and we expect both data sets to read out in the second half of 2025 and current BLA. Okay, and COMFORT Children, you're fully aligned with the agency on that? We're still in discussion with COMFORT- Okay ... with the agency on COMFORT Children, but since we're in discussion with COMFORT- Yeah Toddlers, a lot of the key elements we want to finalize with agency will play out through that discussion also. So we see COMFORT Children as not being... agreement with the agency on COMFORT Children is not rate limiting in our ability to start that trial. Yeah. Okay. I guess just on those two points, because- Yeah COMFORT's obviously a key focus in terms of having the alignment there and getting that. Yes What are your latest... I mean, where is the discussion with the agency? Are there specific pieces of the trial or the protocol that you need to agree on? The short answer is no. But this study is extraordinarily complex to run. As you can imagine, our product is a drug device combination that has absolutely no analog at the agency. Yeah. Thus, we want to make sure that we're absolutely aligned with the agency on every element that is essential for the review. To put it differently, we want to make sure that once we start any of the two COMFORT studies, there's only clinical risk to be assessed, i.e., what are the odds we're going to fail a safety study with viaskin, which is very slim. So the product has shown a rather impressive safety profile to date, but we don't want any review issues. For those who are familiar with DBV, when we initiated VITESSE in the fall of 2022, we thought we had full alignment with the agency. We went over the partial clinical hold because of some misunderstandings. Want to make sure this does not happen again. So we're in active discussion with the agency on COMFORT Toddlers. All the key elements have been agreed: size, placebo to active ratio, inclusion criteria. All of that has been agreed, but defined details, I want to make sure are completely buttoned down and completely agree with the agency before we start the trial. So given that complex regulatory history- Yeah you've defined here, we're leaving the market, patients, and obviously investors, with simply assessing what is the clinical risk of us. Yeah not succeeding in a safety trial, which I think is a much fairer bet than going into this with any element that has not been buttoned down. Okay, cool. And I guess- Is that helpful, Nathaniel? That makes sense. Yeah. I guess COMFORT Toddlers, COMFORT Children, how confident are you that once you're aligned on COMFORT Toddlers, then that is also kind of a level of confidence on being aligned for COMFORT Children? Very high, 'cause the minutiae of the protocol- Yeah which is where we want to make sure there's no misunderstanding. Yeah are essentially the same between the two studies. Right. And the agency has communicated to us that how we approach one study is the way they want us to approach the other one here. So the discussion on COMFORT Toddlers are very much determining what will be the key elements, the like key elements in COMFORT Children. Okay. And then just on the agency itself, and you kind of talked earlier about how there were some constraints from a resource perspective or- Yeah Change of focus during the 2020, as we'd expect. To what extent has that been resolved now, or do you feel...? Because, I mean, you know, you could make the argument that the length of time it's taken to align on the study designs is quite potentially a cause for concern. So what would be helpful to understand is how much of that is actually kind of misalignment or getting the trial aligned versus resourcing at the agency? The bulk of it is resourcing at the agency. Dr. David Kaslow, who's the new head, director of the Office of Vaccines Research and Review, our regulator, publicly on April thirtieth, said that it's official, that division has finally caught up to the backlog with the, with sponsors. They should come back to have actually meetings. As you know, with OVR, the bulk of the exchanges between sponsors, DBV and other sponsors, and that division has been through what we call written response only. And as you know, that's not as efficient as scientist to scientist, biostatistician to biostatistician, sitting together and working things through. So, but that was only announced a month ago- Yeah that the backlog was behind us. We've seen parallel and engagement when it comes to our product around toddlers that is at a pace that finally satisfies me. Okay. And I, I know it's kind of a difficult question for you to answer, but what are your expectations in terms of timing here? Yeah. What's the base case that you're working to internally? Thank you. In children, it's better determined because what's really limiting here is the study we test. Yeah. So we expect to have all data we need to support a BLA in the second half of 2025. Assembling a BLA takes a couple, three months. It will be a 10-month review, so you can guide to essentially where this leads us. The path for 1 to 3 essentially parallels that. We had expected to start the study in the first quarter of this year. It should start, obviously, we believe, in the next few months, although until we've come to agreement, I don't wish to guide to that. It's a 6-month study, not a 12-month study. Recruitment, we expect, will take 8 or 9 months, so leading us again to roughly the same timeframe as we have in the children BLA when it comes to filing. So that's the way I would sort of guide is too strong a word, but indicate what is essentially the timeframe here. Yeah. Okay. Is that helpful, those two questions? Yeah, that makes sense. And then I guess just in terms of thinking about the efficacy piece, I mean, we're focused on the safety to date. What gives you the confidence there that this is... And we'll talk about kind of competitive landscape a- Yeah A bit later, but just, you know, this has been a market that we've tried to address in the past. Yeah. What gives you confidence that viaskin Peanut is the product to do that from an efficacy perspective? Well, it's data, quite simply. In toddlers, the study that was published in the New England Journal of Medicine, the study known as EPITOPE, we've shown 67% efficacy as the primary endpoint at one year of treatment. Placebo was 33.5%. And besides having a minuscule p-value, what matters to this division is a delta to lower bound the confidence interval. That leap has to be 15%. We hit 22.4%. So the study was highly significant statistically. So efficacy, that was very strong, compares to the top line efficacy rates we've seen with Palforzia. Yeah. We've even seen with Xolair, although Xolair, the 67%, was only for peanuts only, not for all three allergen. That was only 47%. So it's very much in the ballpark of what the market has seen as- Yeah the important numbers. I would argue, even more importantly, we have had no discontinuation because of treatment-emergent adverse events in either year 1 or year 2, the open-label extension, and this is something that's important to remember here. An outcome in treating food allergy requires treatment compliance, and you'll not achieve treatment compliance if there are adverse events- Yeah - or the protocol for using the product daily is burdensome to the family. Our product is not. We had no limitations to daily living in any of our studies, so put the patch on and go be a kid and play. So we believe that this is a particularly attractive treatment option. The efficacy is where the headspace of the market is. The adverse event profile is clearly superior, and that should lead to the outcomes that parents want to see, which is, a treatment that's easy to use day after day after day after day. I will also add, that, EAACI, the European Academy of, Allergy and Clinical Immunology, was last week in, Europe. and for those who might have seen, but EAACI has updated their guidelines for the treatment of peanut allergy, and those guidelines state that, EPIT, is suggested to be used with a high level of evidence, commensurate with the level of evidence that exists for OIT, which has had a number of studies, once available. So we're actually very pleased to see their progress, not quite approved yet in Europe, is on the EAACI guidelines with a level of evidence that is comparable to what we have with OIT, which has been around for over a hundred years, as you know. and I think it's a testament to the work that's been done by the team, in building what is a really very robust data set, with our product. I think adds to this, you know, pattern of evidence accumulating that this is an important treatment. Okay. And- Is that helpful? It is, but I have a few follow-ups as well. Please. So in terms of just kind of the competitive dynamics that you touched upon, Xolair and Palforzia. Maybe if we take Palforzia first, what do you think is kind of the key differentiation for viaskin Peanut if, you know, if and when that comes to market? It's ease of use. Okay ... and ease of treatment compliance. Oral immunotherapy has been around for a long time. It's a very important, very helpful tool to be offered to families, assuming the family can make it work for them. There's good evidence that's been made public that showed that PALFORZIA, so protocolized oral immunotherapy, was being offered by allergists to the great majority of families who had a child that was diagnosed with a peanut allergy. But 80% of families refuse to go on therapy because, one, the concern about adverse events. As you know, the risk of anaphylaxis on treatment is significant, which is why there's a risk evaluation mitigation strategy plan that parents have to opt in to get the product. The fact that it's very burdensome. For 3 hours a day, your child has to be at rest, which for a lot of families, is just difficult to do. So the product was being offered, parents declined it. Also, the good people who launched Palforzia did a good job when it comes to managed care access and reimbursement. The product was a very solid formulary position, good access, majority of lives in the U.S. at a price. I thought they did a very nice job of it. So again, the product is offered, the product is reimbursed, the product is just not used because there's just something burdensome about it. The fundamental difference between viaskin Peanut and Palforzia is this ease of use. It takes 20 seconds to put the patch on your child's back. Market research shows that it's actually something that parents appreciate greatly because it's a warm, loving gesture. There's a protocol to it that helps parents on a daily basis reinforce that they're doing everything they can to protect their child by putting the patch at bedtime or in the morning before they go to school or after bath. And that is essentially what is fundamentally different between our product and oral immunotherapy. It's important not simply as a daily thing. It doesn't take three hours from my day. If you want an outcome with chronic therapy- Yeah. You need treatment compliance, and our product leads to that. There's very low discontinuation, as you know. Okay. And then Xolair, so obviously, the market reacted pretty negatively to the news- Yeah ... earlier this year. I remember you and I had spoken. You weren't overly concerned about the competitive risk there. Could you maybe just characterize why? Yeah. Well, it's an injection that is meant to block the IgE cascade in young children. Our market would be children 1-7. We don't hear from allergists that they will use a monthly or bi-monthly injection, which normally there's a fear of needle, but the pain. Most importantly, monoclonal antibodies are important treatment options, but they're not disease-modifying. And in young children, disease-modifying treatment would seem to be preferred, including oral immunotherapy. So blocking IgE in a developing immune system is something that will be done only in rather exceptional cases. So we're happy that Xolair is approved because there's a dialogue that you could imagine needs to take place between the parents, the child, the physician around lifestyle, what it means, burden, ability to comply with treatment needs to take place. The more options are available to animate that dialogue, the better off the market is, the better off parents are. Although in this case, Xolair is not an alternative to the patient be using our product. It enriches the marketplace where parents are crying for treatment options. Okay, that's helpful. And then just whilst we're talking about kind of commercial, what do you think is the commercial opportunity to provide viaskin Peanut? Is this kind of a $500 million product? Is it a billion? Is it two? Is it three? I'll describe what we see the epidemiology and how it's actionable, and a few guide to PALFORZIA's price. I'm not announcing a price today, but they did a good job of getting good market access at around $1,000 a month in the US, as you know, a bit more than that. We think the market is really, really important. Epidemiology to sort of start off with, there's about 100,000 children in the US per year, strip of one year of age, that will be diagnosed with a peanut allergy. So we estimate that there are 290,000 children, age one to three, 380,000 children, age four to seven. Those are our two BLAs. So close to 700,000 children with a peanut allergy. Take any reasonable penetration of that market against any analog- Yeah ... for a breakthrough therapy, at a look at PALFORZIA's price is, and you get to a product that we are pretty confident is gonna be very significant in sales. The commercialization also is not a difficult commercialization model, since most of the children are treated by food allergists. In the U.S., there's about 4,500 of them. They will probably treat between 70%-80% of those children. So there's also the ability to concentrate our commercial effort on an audience we know very, very well. Very well. We've known them for a long time, that we think adds up to commercial opportunity that is quite significant, relatively easily actionable, with a product that to most families, will be very easy to fold into, their daily living. Okay. On the pricing piece, you obviously have- Yeah two patches, so in- Yeah ... in each population. How do you think about pricing of each of those? Is it- is there any reason it could be different? ... Yeah, there are reasons why it could be different. Let's start with what they have that are similar. The efficacy, safety profile, ease of use is the same. So that would argue for pricing that is in the same ballpark. And again, with all the proper caveats here, I'm not announcing a price. As you know, pricing is finalized in the last few weeks before you launch, 'cause the label, the words and label are really, really important, which we don't have at this point in time. If there is a difference, Rajan, it's an important one to imagine, and one that very much excites the allergy community and patient advocacy groups, is the fundamental disease-modifying potential in toddlers. There's reasons, look at EPITOPE signature, to see that an intervention in children 6 months, 12 months, 18 months could be disease modifying, again, to be verified. We do have, at year 2, as you know, the first year of open label extension in toddlers has shown that 56% of children could make it right through the food challenge, which is 12-14 peanuts worth. That is not an accidental peanut consumption at that point in time. Made it right through the food challenge without having the, the symptoms that would bring the, the establishment of eliciting dose here. And there's certainly a lot of energy within the allergy community to look at what would be that very important, you know, 2- or 3-year study starting in children at high risk. So imagine the LEAP patients, essentially, when the LEAP trial was done a few years ago, but instead of using immunotherapy, you would have the patch. The immunotherapy is, you know, compliance was very difficult. The patch every day we believe would be much smaller. We're not there yet. That would be a post-approval study, obviously, but if that could be shown, obviously we would then show a dramatic difference in benefit, which is why we're keeping the question of finalizing price be very much open, and as it should be, should be driven by clinical data. Okay, and then- Is that helpful? That is helpful. And then on commercial strategy- Yep. How do you think about that? You know, is the base case, again, that you will market and commercialize this product alone, or are you open to partnerships? We're always open to partnership. Our default position, after much thought in the US, is we will commercialize it ourselves. For the reasons I mentioned earlier on, the allergy community, we've been ready to launch this product for a long time, to put it honestly. So we've built really a superb relationship with the allergy community. We've also done a lot of market research to understand the psychographics of families, the segmentation of what families want. That is important to understand also, we think it's rather sophisticated. And with the relatively small audience to be essentially targeted, we believe it makes good sense for us to do it ourselves. Moreover, there is no established large company that has built a franchise in this space that would argue for a trade-off between they get a piece of the pie in exchange for acceleration- Yeah ... to peak market penetration. So we believe in the U.S., we would be best served by doing it ourselves, but obviously, we would be silly not to listen to alternatives. In Europe, we are now looking at instead of a partnership model there, because every market in Europe has a very different structure when it comes to how care is given and who prescribes treatments for food allergy. And that sort of Balkanized market reality may argue instead to find the right partner in different markets. But again, that's something that we're assessing at this point in time. Okay, perfect. Maybe just switching gears a little bit to kind of strategy. Sure. Recently, you've appointed a Chief Regulatory Officer. We have. to the management team. Could you maybe just kind of discuss, firstly, I guess, why now is the right time for that? And secondly, why you felt that there was a need for that addition to the team? Yeah. Let me start about why he was the right person. Dr. Bob Petrusko has been in the industry for 40 years, has had 35 products approved. We believe one in every division at the FDA, both CDER and CBER, a man of extraordinary experience. Bob is also very much involved at the policy level. He is a chair or co-chair of the Alliance for Regenerative Medicine, so he's somebody who just understands the FDA and the EMA very well. As somebody also I've known for a long time, we... This dates us, but we got together, both of us, 30 years ago. Those of you with sinusitis or children with otitis media. And he just brings a significant consulting with us since the fall of last year, and then decided to join us these discussions with the agency. Moreover, ability for regulatory will get as we get closer to launch here, so it just made sense, essentially, to bring Bob on board. Value creation for our company will come first through alignment with the agency and then with product approval. To bring his expertise on board just made sense. Okay. He's a good guy, too. We're into the last five minutes, and I know- Yeah We're tight for time, so I just wanted to talk about cash. Yeah. Could you remind us you are in terms of current liquidity? We have $101.5 million at the end of last quarter. We have guided this would take us to the end of this year. The fact is that we essentially, since we have not started those studies, obviously we're not burning cash as per guidance, so we have some cushion there. We will need capital to finalize the VITESSE study and to finalize the two BLAs. Our plan is to come back to the market, obviously, once we have a complete alignment with the agency on regulatory pathway. That has been the overhang on DBV for way too long, and we've made the choice, and I remain steadfast in that choice. Let's get to full agreement with the agency, share that with complete transparency, with the market, with investors. We believe that's going to be providing quite a bit of support and uplift to the stock. We're also going to be very smart about financing the company in bites and in steps, obviously, to minimize dilution. Our top investors have stayed very loyal to the company, very much committed to the company. I want to be very respectful of that as we look at raising capital over the next, six months or so. Okay. And in terms of the options that you have in order to kind of raise capital, how... You know, what do you have available, and how are you ranking those in terms of preference? Well, equity is always easiest, obviously. Yeah. But here we have to be attentive, obviously, to our current investors. We have an ATM available. We could raise equity directly. A partnership in Europe remains a way. We can also look at financing the company. And, in the forms of equity financing, also, as I said, we're looking at ways of doing it so that the step-by-step evolution or raises is again sensitive to the needs of investors. Staying debt, again, to share my... We have alignment with the agency. My confidence that our product is going to perform in the clinic, and with that perform commercially, is very high. But at this point in time, that would be, I think, improved thing to do. Okay. And maybe when, you know, if you go to the market to raise capital, but you need a clinical readout to kind of raise on the back of that? Or, you know, we recently do kind of pipe to that data. How do you each of those options? We talk to investors, is clarity of alignment on COMFORT Toddlers is the key catalyst. So financing around that is something obviously we would be thinking about. Last patient first visit in Q3 of this year, which means we're 12 months away from data readout and 12 + a few months away from a BLA in 2 and 4-7 is another catalyst. We'll have year 2, the open label extension, year 3 of treatment in toddlers in the fall. That becomes important also. We'll have the data readout of VITESSE in Q3 of next year. So between now and 15 months out, we have 1 regulatory event readouts or clinical milestones, I should say, that we think could be important in anchoring a financing. Okay, and then- Two questions. That makes sense. And then very quickly, in the last minute, there are other things in the pipeline. You know- Yeah. You've kind of investigated viaskin Milk in the past. Right now, should we assume that the total focus is just on viaskin Peanut? That is correct. We want to be good stewards of our shareholders' money, so viaskin Peanut is getting all of our attention. Milk, we're ready to go into EoE and cow's milk allergy in phase 2b studies. Those protocols have been discussed and agreed with the agencies. We're good, good to go on that front also. And soon be talking also about our program in celiac, preclinical. That seems to be also very, very promising. So there's more to come, but all of that will be mobilized once our cost of capital comes down on the back of this regulatory certainty, which we owe the marketplace. Okay, perfect. I think we're pretty much right at time. Superb. So that was a well-timed answer. Thank you very much. Thank you, Daniel. Enjoyed the discussion very much. Thank you, everybody, for joining us today. Thank you. Thank you.