GUGGENHEIM 3RD ANNUAL HEALTHCARE INNOVATION CONFERENCE - DBV TECHNOLOGIES SA

Okay, good morning, everyone. My name is Yatin Suneja, one of the biotech analysts here at Guggenheim. Welcome to our third annual Healthcare Innovation Conference. Our first presenting company is DBV. From the company, we have two executives here. We have the Chief Executive Officer, Daniel Tesse, and we also have Chief Commercialization Officer, Kevin Trapp. Daniel and Kevin, thank you so much for your time. It's very nice. maybe, Daniel, why don't you make some opening comments? Since we have Kevin here as well, I will go into the pre-commercial launch preparation later. Why don't you make an opening comment and I'll prepare a little Q&A for you. Sure. In the business case, sorry about that. DBV Technology, company focusing on immunology, specifically the immune properties of the skin, which are quite powerful. The way we're exploiting it is through a unique patch technology, epicutaneous immunotherapy. So our platform is called ViaSkin. So that's what we do, focusing on food allergy, pediatric population, mostly as high as need. Our lead product is in peanut allergies, and we filed our first BLA in children four to seven in September. Got it, got it. So this epicutaneously immunotherapy platform, Can you just talk very briefly about it, what it is, why it is unique, and is it only for food allergy, or could you go in another area where it has broad applicability? It's not only for food allergy since we're exploiting the fact that the human skin has shown to have rather remarkable immune properties. We think about it's a barrier to things outside. The skin plays a role recognizing whether those external agents are good or bad, and with that triggers an immune response. The founders of the company found a way to work or exploit the immune properties of the skin by making sure that minuscule amount of allergen exposed to the skin, as long as the skin is intact and the allergen penetrates the first layer of the skins, and the technology is all about that, recruits an immune response to Langeren cells. Langeren cells, we have trillions of them. They recognize the antigen and through that distally, through mostly Treg mediated response, desensitize the patient. So the technology is about re-educating the immune system as to not recognize that allergen as being dangerous. So yes, it's a platform. We start with food allergy. There's applications also to arrow allergens and other forms also the immunotherapy. But right now our focus is first and foremost in food allergy, it's a really high unmet need for which there are very few treatment options got it and what type of patient population you are going after it seems like you have two strategies right kids and toddlers could you just frame for us what are these opportunities what you have seen in these two buckets of patients it's important question so you look we have the indication in toddlers children one to three indication in children age four to seven that division was a matter of regulatory choice we've made in development a few years ago. The one to seven population, if you put the two indications side by side, we're targeting because it's the intersection of three things that matter very much. The age of diagnosis is typically between the age of one and four, making one to seven the population that's most ready to be to be treated given the diagnosis. It's also the age of the parents are the most concerned so they are most mobilized to do something and lastly and importantly younger patients respond better to all forms of immunotherapy they respond particularly well to our form of immunotherapy so one to seven is sweet spot of diagnosis willingness to treat and helpful biology got it so in four to seven could you maybe tell us what you have demonstrated so far what level of efficacy you are seeing and what are or safety consideration, if any? Yeah, so we have a study, a pivotal trial that was in coordination with the agency, which walloped the primary endpoint on efficacy. Important to talk about this. These are three- to five-year treatment. That's the norm in immunotherapy. The FDA has a primary endpoint showing sufficient desensitization at one year to satisfy the regulators. But to be clear, the second or fourth year of treatment are really important. So we have an OLE in our program here. We've shown 47% efficacy on active, 14% on placebo at one year. To be clear, that efficacy is really a big jump up in the dose of allergen necessary to trigger an allergy in these kids. So the idea here is to pole vault to success. We have many patients who might not have hit the primary endpoint at one year but have a benefit, and we expect that to continue to years two, three, and four. Got it, got it. So the BLA for 4 to 7 has been filed. Yes. You took a little bit of a time to file it because there was a lot of back and forth with the FDA. So could you maybe help us understand where exactly we are on that acceptance timeline? What do you expect from, you know, after it gets accepted? What is its review timeframe? And how should we think about the FDA back and fourth? Thank you. We file on September 28th. So if you add 60 days, September 29th, I'm sorry, if you add 60 dates to that, it takes us to late November for the action date on file acceptance. The FDA has been very helpful, a very fruitful discussion that started in May, played throughout through the summer, where the FDA want to make sure that the two most complex part of any BLA, And to be clear, this is a large BLA, moreover a technology that has no analog, so we are exploiting essentially a read of the regulation for the first time, so that the CMC file and the way the biostats data was captured was structured to the way that was most satisfactory to the agency. So that's been the back and forth to land on what we believe is a BLA that not only has all the right data in it, but more importantly, structured in a way that's going to be most helpful to the FDA. I want to say one thing to be very clear. There's not a single piece of data in this discussion with the agency that we had to generate. Everything was there. How do we organize it was the point. Packaging, traceability, and architecture. A lot of documents in the BLA have the parent, grandparent, and great-grandparent structure to it. They make sure it's structured the right way. And this is a breakthrough product, so should we anticipate a priority review? We have asked for priority review. We have breakthrough designation, so that was the ask of the agency. And is there going to be an adcom, and when will that be found out if there's an adcomm or not? As you know, the adcomm decision is made during the review. In the pre-BLA minutes, the FDA shared with us they don't believe an adcoll would be necessary, with the usual caveat, subject to review. So we'll see during the preview if that changes. At this point in time, we're preparing for one out of discipline and good preparedness, but at this point of time, we're not expecting one. Got it. And then, you know, on the last quarter call, you provided incredible details on this warning letter that one of your CRO forever had received. So could you maybe remind us what was the issue? Where do we stand now? Where is the FDA enrollment in that? Thank you. And thanks for acknowledging it. We put a lot of detail out there because obviously it's something that is not as commonly diligence by investors as clinical data would be. The situation is very straightforward, to be clear. One letters happen all the time in our industry, so this is not a once-in-a-generation event here. But the situation is the following, rather typical. Observations in a different part of the facility in Amboise, which is where the product is made, Faté d'Amboise. Having to do with sterile manufacturing of a veterinary product. Had some observations at the FDA thought that the company had not dealt with the right way so that has nothing to do with our patch, but the observations when You get a warning letter are never limited to the product that was problematic They touch on the whole quality systems and quality training of the entire site So every product being made there is now touched by that one letter Very of us been very helpful very collaborative very transparent. We have good visibility to what they do with the limitation, obviously, of what is confidential about manufacturing processes for other companies we can't see, but we have visibility to the pace by which they are addressing the issues, and we're satisfied with that pace. And then the issue that was identified, obviously it was a veterinarian product. Is it more to do with the process or the quality of the product or just a little bit more? Because I think the concern that we hear from our investors is that, again, like you mentioned, that maybe Wall Street has not or not known to or not very good at, let's say, you know, knowing all the nitty-gritty about these CMC stuff. So there's always a concern that maybe something like this might linger and might not get resolved by the time your review is there. To be clear, the risk is very much there that it might not be resolved, which is why, again, we went through great detail, at least as much as was reasonable to share on the call as we have with investors this is very process like there are tons of consultants who make a living helping companies manage warning letters there's a process it's rigorous it's thoughtful and forever is using such a process so our confidence that they're doing all the right thing is high thus our confidences will be resolved prior to our pre-approval inspection is also very high and thus the the reason we share that level of detail was to to hopefully communicate to investors it's an unfortunate situation, one that happens and is manageable and managed, I think, very well. Got it. And then when generally do you expect these inspections to happen, like how, during the life of the, let's say, review, when do they happen? They typically happen, again, I'm not going to answer for DBV here because we have not provided that guidance. What is common in our industry is you invite the FDA to come visit the plant for the pre-approval sometime post the mid-cycle review, which is halfway through the cycle by definition, simply because that's when the FDA takes stock of what they should put their resource to work on in the latter half of the review, which includes inspection or telling the company, for example, you should prepare for an ad comp. We touched on that earlier on. We don't expect one. So most sponsors invite the FDA to come for the PAI post-mid-cycle reveal, which is what we've done. Got it. And we are confident this will take place after the remediation of the warning letter at Freva will have been addressed satisfactorily. Got it. Will there be an announcement to your investor or to public that this has been resolved? We would be wise to do that. We would do wise to that, yes. Got it, maybe then let's move to the toddler side and I'll come back to the commercial prep for Kevin. Where are we on the toddler site? When are you expecting to submit? What do you need to generate before you submit a BLA? Yeah, we don't need to generate much to submit the BLA in one to three. The CMSC file is very similar to the one we have in 407s, you would imagine, same manufacturing process. The pivotal sturdy epitope readout already a few years ago, comfort obviously needs to be folded into that. The discussion with the agency around the best not only timing, but process for filing it is taking place. The agency were kind enough to point out to us. They have one review team reviewing two BLAs in parallel There's a risk of a bottleneck. I'm using the word bottleneck now the agency, but that's we here so So we've agreed that we would file the BLA in one to three in a way That's most convenient for the agency to ensure an expeditious Review of one to on the back of our learnings would come in four to seven so details to come after we finalize those discussions with the agency. Got it, got it. Yeah, I think most companies would wait for the first BLA to approve because you're going to learn a lot from the first and you can incorporate in the second BLA. Including learnings for this guy on labeling and... Okay. And then with regard to the safety supplement, anything particular there that maybe the FD has an interest or is defined as an expected safety finding that is of an interest there? No, there isn't. The agency, there's no safety signal we're chasing. As you know, the safety profile of ISKIN is rather impressive. The agency wants 600 patients on active for about six months or more for the safety database. So the purpose of Comfort was to add those 480 patients, sorry, let's get the math right here, 260 patients to the 240 we had in Epitope to get to 600. We're not chasing a safety signal, so it's a study that's being done. And I guess if there's a filter of success, there's an adverse event profile that will replicate what we've already seen with our product in 1,300 patients. Got it. Sorry, 2,300 patient today. 1,000 patients. Okay. Maybe then move on the commercial side. I mean, look, this is going to be a faster review than what we expect because of the break to designation. So, Kevin, talk about how you are thinking about the commercial strategy. What about the patient population? What do you hear about Zolaire? Because that sort of is a competition to you. So just put all of that in perspective for us. Yeah, thanks, Justin. You know, commercial strategy, let me just frame out the market. I mean, 80% of kids persist for a lifetime, right? So you're thinking about that over the horizon. The 4-year-old today will be the 40-year old tomorrow. We're seeing one in five kids go to the ER for peanut allergy in this age range every year. And as Daniel said, the biology maps well. So we think we've got a target product profile that meets the needs of these families. When we look at the treatments out there, there's very few children receiving active treatment. So that's really how we think about the opportunity. That gives around 600,000 kids, according to prevalence data. We look at claims for a narrower population that has the diagnosis codes and the testing that's related to that. Split that. The four to seven comes first. Predominantly, allergists will treat this. They're the ones doing the diagnostic criteria. They'rethe ones who understand immunotherapy. So we'll focus on them with a team of about 50 to 70 specialty sales reps on talking about the product. An important lever here is the consumer, right? The parents live day-to-day with the fear of their child going to the ER that I just mentioned. And so we'll activate them with direct-to consumer efforts, focusing on more digital. These are families that are very active on social media, various blogs with advocacy groups. So we can do that without broad television in a very focused way. And then we've been discussing with payers now for a couple of months, what's the value proposition here? what's the unmet need in peanut allergy and how do we have to address that with them as we move towards a label. Got it. Maybe on the competition for a sec, in let's say one to seven patient population, how much of a Zolaire use is there right now? What are your estimates? Yeah, it's very limited. Claims data has shown around 1% of kids get Zolaure. And what we hear from allergists is kind of the long-term use of a selective immunosuppressant in young children. And what we hear from parents is, you know, children are afraid of needles, and so that can become a traumatic experience. That said, I think options are good, right? We're never going to say options aren't a good thing, but we haven't seen significant penetration in this age category. Got it. So the YSKIN product is only going after the peanut allergy, right, but the numbers that you talk about, 600,000, these are food allergy patients. So number one, could you talk about what percent have just peanut specific allergy and then as you talk to caregiver or parents what is top of their mind is it peanut or other allergies that they focus on yeah it's an important question at the 600,000 is is peanut allergy they may have concomitant foods in fact in our study 54 percent of kids had a second food allergy at least one food allergy so you know A peanut is ubiquitous in society. It's in food chain production for packaged goods. It's the ice cream scoop that may have cross contact at the ice-cream store, or the bite of a cookie at a bake sale or at a party. That's what parents worry about. It's that threshold of where the reaction happens, which is very small amounts, about a third of a peanut, is where the average accidental consumption happens. The goal with ViaSkin is to raise that threshold where they get that protection against their risk. And then, what is that percentage for peanuts? It's about 54% in your study. Is that the general number? Yeah. About a third have peanut only. Only. Right? I see. Another 40-50% have peanut plus milk or egg, which I mentioned 8 out of 10 persist with peanut. 8 out 10 resolve with milk and eggs, so those tend to go away. But what we hear from parents is, peanut's the one that's most concerning because it's a severe anaphylactic reaction that can happen, and because of the food supply having it kind of everywhere. It's the one they would like to take off the table for their child, even if they're polyallergic. Got it. But then I think a lot of people still bring up the OIT or Palforgy experience. Like what was unique about that experience, which is different than what Vyaskin offers? Yeah, I mean, a lot. I mean routes and burden. You're taking it orally and you have to go to the allergist multiple times on updosing. There's no updose with ViaSkin. So that's a burden on family life to get to the allergtist that many times. And then frankly, you know, there becomes a concern around the safety profile of the product. It needed a REMS. So all of those things are things we think we've got with the target product profile here that meets those needs that families want. But Palforzia, there's also only 100 doctors that really do OIT allergists at scale. So there was kind of a structural problem with how many allergists could actually write this we see this as something that the community allergist can do the parents aren't traveling as far as many times so this is one patch on the back first dose observation and then after that it's an at-home immunotherapy for children got it parents administer right is belforgea is a good proxy in terms of the pricing for us yeah you know pricing's not finalized we're doing a lot of work on it, Yatin. This will be based on the research. We've had plenty of discussions with payers to date and we'll continue to have more. Obviously, it's dependent on the label. Folks can look up the Palforzia price and the Zoller price. What we will do is plan for a specialty pharmacy distribution, leveraging a hub. So think about this as a specialty pediatric biologic. Make sure all of those services are there to get through a prior authorization process. And for commercial patients will think about a co-pay, but we haven't landed on the price. We're continuing to do that work. Got it. Maybe a question for Daniel, and then maybe Kevin, you can also opine on that. Can you talk about how quickly these patients feel better, what the onset is, how quickly you are able to raise this threshold so that parents are comfortable sooner rather than later? Yeah, I'll take the front end of this. I'm sure you have some thoughts on that, Kevin. We assess efficacy after 12 months of treatment, so we don't know what is a protection after three weeks or three months. We do not. So that question is one for which we don'T have clinical data. I think, Kevin, we'll reinforce to you, that's not a question that parents are asking, though. This need for validation that it works, for some parents it matters. For most of them it does not. The fact that the allergist prescribes it, And obviously, the daily application is valuing to the parents and doing everything it can to protect my child. It seems to be sufficient, but you may have picked up something else in the market. Yeah, no. I mean, look, these are parents that are already carrying epinephrine in their purse, the car, the school nurse. So they're already very vigilant in worrying about the anaphylactic reaction. You know, we hear with active treatment that that's something they want to do. And, you know, I think we had important data at Quad AI last year where we showed, you know, treating patients, 83% on the ViaSkin arm increased their eliciting dose, which confers risk reduction, where one in four that didn't treat actually went backwards in their ability to tolerate. So I think those are important things we'll communicate as we launch. But, you Know, as Daniel said, we're not going to know exactly where they are three months, six months. But that point of putting this small patch on the back every day and knowing that you have a high potential of building that threshold it's an important that we hear and obviously we do do quality of life studies after the one-year point and we've seen that relief so that's what we hear. Where are we on the commercial side once the product get approved number one how quickly you can be in the market and who is doing the manufacturing do you need another site for manufacturing and if there is a lot of demand for it. Manufacturing, I touched on, it's very vamboise. That will be, we expect to be resolved in time for the launch. So that's a non-gating factor that we're working through. And for unit launch readiness, you're getting there. Yeah, no, we are. I think supply chain being the key thing here, we would expect weeks from PDUFA. We still need to get the product from France and through U.S. distribution. We've got a 3PL third-party logistics distributor. We've selected our specialty pharmacy, so all that work is in place. We're building the patient services. element there. That's where we're focusing that in the payer lens right now. These are the investments we have to make because there's long lead time. Anything that's related to bringing the representatives on, we'll want to bring them on before approval to make sure that they're trained. But those are obviously on the regulatory milestones we have ahead. And the consumer efforts are in full throttle as well. So it'll be weeks after PDUFA to get it in supply, but we can start detailing, obviously, at PDUfa. Okay. Then maybe one final question. How is the financial health of the company um how is sort of the current runway we currently have a runway into q3 of next year that includes all the investments that must be made in commercialization um in commercial readiness including building up inventory so that's so that takes us through the launch if the breakthrough designation turns out to be priority review obviously access to more capital is something that we're always thinking about um the good news for us as we're getting closer to commercialization the number of tools we have for financing the company are numerous uh and obviously that's part of our thinking right now perfect well thank you thank you so much gentlemen thank you