Hi. Good morning, everyone. I'm Andrew Fein. I'm one of the biotechnology research analysts at H.C. Wainwright. It's very exciting to have the first company of the morning for us be DBV Technologies. We've followed the company for probably as long as anybody. After a number of years, we're on the precipice of greatness, I think. You know, here with us is the President CEO, Daniel Tassé. Daniel, maybe you just wanna get everyone up to speed, then we'll go into specific questions.
Yes, thanks for having me. Good morning, all. I'm Daniel, the CEO of DBV. We are a company focusing on immunology, the application of it being specifically to food allergy in pediatric populations. Our technology is rather unique, it has no analog. The idea is to use the human skin to desensitize children against their allergy, our lead product is for peanut allergy, the platform is VIASKIN. Via the skin, we desensitize. Viaskin Peanut is our lead product, we're filing our first BLA in next couple weeks, well, six weeks. Was that helpful?
Yeah. No, no. For sure. You know, maybe you can speak about, you know, it's been a while perhaps since some people have done work on the market and the commercial opportunity.
Yeah.
Where do things stand now? You know, as you've been to a couple of recent medical conferences. H eard from both physicians and parents of kids who suffer from peanut allergy, you know, we've lived through the pandemic. You know, other efforts to try and introduce therapies into the market. We are in a position where, you know, there are some options for the very severe, you know, kids. How are you guys thinking about the commercial world at this point?
Yeah, thanks. It's a very relevant question. Peanut allergy is universally seen by parents as the higher order sense of stress and concern. Peanuts are ubiquitous. They're everywhere in the food. You know, may contain traces of. You don't see may contain traces of shellfish on your packaging, but you'll see peanuts, though. Allergic responses, anaphylaxis to peanut are highly unpredictable. Your last reaction does not predict the severity of the next one, and obviously the severity and consequence are quite serious. For parents, to be able to address peanut allergy is a higher order need. They want treatment options. Right now they have OIT, essentially the homebrew version of it, since the approved product is coming off the market later on this summer.
For older kids who are multi-allergic, there is monoclonal antibodies with XOLAIR being approved, but we're seeing very little use of XOLAIR in the one to seven population that we're targeting for two reasons. The safety of chronic blockade of IgE expression has not been well-established. It's a needle and it hurts, which really does not fit very much the parental expectation here. The ease of use of our product, it takes 10 seconds every night to put the patch on, validates to the parents, "I'm doing everything I can to protect my child," against what is their highest order need. It's powerful, it's a terrible pun. We've heard in market research from parents, if you can take peanuts off the table, it would mean a lot to us. That's what we're trying to do. Does that answer your question? Is that helpful?
Yeah, uppermost so. Maybe you can, yeah, just give people a sense of the regulatory process? You know, it's been a long one. You're on, you're ready to file the BLA in the not-too-distant future.
Yeah.
Maybe you can just remind people of the process and your expectations and, you know, the requests and how they've been satisfied, and all that kind of stuff.
Yeah, the regulatory pathway has been longer than expected or needed really, in some part, in large part because the founders of the company were brilliant physicians and inventors, not drug developers. Attention to some details that matter to the FDA, this being a novel drug-device combination, has no analog, and the drug is a biological microgram amount of peanut protein for specific peanut proteins. The characterization of the product where experience was not done very well bring the FDA of a number of questions, many of which were legitimate questions.
They asked questions to which we did not have data to placate it, and solving that took a few years, complicated also by the pandemic. We're reviewed by the vaccine division at the FDA. All of that is behind us now, we have a clear regulatory pathway in children four to seven. That's the BLA going in by the end of June. In children one to three by the end of 2026. I have to tip my hat off to the FDA here that has engaged in the last few years in rich, fruitful discussion, regulators talking to the company scientists, the scientist, biostatistician, CMC expert to CMC expert. The regulatory pathway now is very clear, it took a few years to get there. That's all behind us now.
Great.
Does that answer your question?
Yeah. I mean, I guess, what aspect of the data, I guess, are you most proud of? You know, where, what aspect of the data do you think puts to bed any concerns that had previously been raised?
Yeah, the concern previously raised was around patch adhesion. Actually, the original question from the FDA was, "The patch falls off on occasion from the kids before a full day of wear. What's the consequence of that?" To which the answer was, "There is no consequence because we were hitting a primary endpoint." If you have the clinical response, the product is safe, the patch wear time should not be a driver of the regulatory framework. Again, absent data, that was important to the agency. What I'm proudest of is, again, the dialogue between our scientists and people at the FDA to recognize it's not about the patch on or off. Is the wear time adequate to drive a clinical response?
It's really a question of clinical response, because if it's sufficient, by definition, the wear time was sufficient. By turning that argument around, it's really about clinical response. Daily measurement of wear time is helpful, but you're exposing the patient's immune system to a dose of allergen every day for over a year, in fact, three, four, five years for desensitization, so any daily measurement misses the point. It's the outcome over a year that really matters. Again, hats off to my team for having engaged the discussion with the FDA constructively, and hats off to the FDA for having it also and landing on this common understanding for technology that had no analogs.
At this point, what remains to be done?
Assembling a BLA, which is, as you know, it's a big process. Again, I'm repeating, it's a drug-device combination where the technology for the device has no analogs. Again, the FDA has been extraordinarily constructive, engaging dialogue with us to make sure that everything that's important to them for the clinical dossier and for the CMC dossier was the result of a fruitful exchange with us. We know what they want, we explained to them what's feasible and what we have, and now in the process, on the tail end of that discussion of assembling the BLA and filing it.
What's left to be done is essentially putting it together and putting it together in a way that is structured that will best satisfy the agency's need. We have breakthrough designation. We will be asking for priority review, giving the agency six months, not 10 months, to review a product, again, that they've never seen before. Again, we're very thankful for the dialogue prior to the BLA filing.
I mean, many kids that have peanut allergy also suffer from other food allergies. Maybe you can speak a little bit to the polyfood allergy patients, and the role you might have there? That then segues into something that we haven't had the chance to speak about in a number of years, because of, you know, the corporate focus and the, some capital constraints. Assuming you're able to get Viaskin Peanut over the finish line. There's a pipeline here.
There is. As I said, peanut allergy is the highest order need for parents. About 50% of kids in the wild and in our clinical studies have a concomitant food allergy. Again, for parents to address and desensitize against peanut is the highest priority. That's essentially what we've seen in our clinical studies. Kids with polyallergy, asthma, atopic dermatitis, any of the other atopic conditions, it makes absolutely no difference in clinical response or in the safety profile. Our product is just as good for the child who is only suffering from a peanut allergy versus a child who would be polyallergic here. There's a pipeline. We are phase II-B ready for cow's milk allergy. That program has been discussed with the FDA and good to go.
We will probably go to the clinic early next year. As we have visibility to revenue and our cost of capital comes down, we will be quite bold with the pipeline. We also have a promising product. It's still pre-IND, but looks really good in celiac, as you and I have talked briefly about. There's discussions been engaged with the agency a few months ago to look at building a regulatory pathway for a multi-allergenic patch. Tree nuts, for example. Can we put more than one allergen on the patch?
That obviously is of greater complexity as a regulatory matter and a CMC matter. At the FDA expert panel on food allergy in late February, that question was asked, and the FDA showed a willingness to engage with industry to find or to build a regulatory pathway for a multi-allergen desensitization. That's gonna be also pretty high on our list of priorities.
Interesting. Do you think it would have to take the form of approval for peanut, approval for milk, approval for peanut plus milk, one patch?
T hat's what-
The way we typically think of, like, combo drugs.
Right now, that's the reality. The dialogue with the agency would be to find a way around that. By saying around that, we still need to show efficacy. We definitely have to show safety. There's a way to lighten the regulatory burden. There's also the reality of a polyallergenic patch where a child might not be allergic to everything in that patch. Again, I'm not speaking for the FDA here. I think the fact they're willing to have that conversation, where a kid might not be allergic to pistachios, but is to almonds, what kind of patch we build for that child, quite simply.
Still a lot of work to be done, I wanna be clear, but the fact that the agency is willing to discuss that shows that the application of our platform to build a pipeline to desensitize children, young immune systems when they're most plastic, is something we think is very promising for DBV.
What are there any post-approval-
Yeah?
What benefits does the agency then afford you as a company in terms of future approvability? Are there benefits associated with the platform after you get approved that can then, you know, benefit t he future applications?
That's a really important question. Here we're no different than any other therapeutic area with the first product, the first technology, the first of the therapeutic class had more work to do. The regulatory bar was not higher. It is an education to the agency and a dialogue to be established to make it successful. We very much believe there will be efficiencies to that as we go forward here. I think that's gonna be a way the platform pays back. The other way is gonna be also that the manufacturing technologies, everything about CMC would be so novel.
The first PAI is gonna be obviously, exactly that, the first PAI. I like to think this becomes easier with time. Again, that is I'm answering half the question here. Obviously, people at the FDA have to answer the other half of it. I like to think that there's efficiencies to be gained here that are no different that's been seen with the first monoclonal antibody and the first HMG-CoA reductase inhibitor.
I mean, some companies have spoken about platform designations.
Yeah.
You know, it's something you apply for, there benefits that come associated with it. I don't think it's that fully appreciated slash understood by the investor community yet, but it sounds like, you know, for companies like DBV, it has some tangible benefits.
It does. That discussion with the agency after we get our first product approval definitely be engaged, because there's no doubt it's actually, if you saw the machine, the machine's gonna make the milk patch the same machine that makes the peanut patch. The dimension of the patch might be different because we have to well, allow for the different physical chemical properties of different proteins. That's a conversation very much at the core of what we think is a receptive FDA to talk about that.
One question going back to the commercial side of things. I mean, one of the big differences, I think, between, you know, your potential launch and that of like OIT, for example, is, you know, the involvement of the pediatrician community. You know, your patch can be relatively easily prescribed by the average pediatrician who is the first line, of sight-
First point of call. Yeah.
First point of call. In virtually all young kids with potential, you know, food allergy. Maybe you can speak a little bit about that and how you know, engage with that, you know, enormous population and make them aware and make them comfortable and all that kind of stuff.
You're asking a really important question, Andy, 'cause there's a number of dimensions that we have to weigh. The current AAP guidelines, American Academy of Pediatrics guidelines for food allergy recommend three things: avoid the food, prescribe an epinephrine device, and refer to an allergist. That's currently the protocol. About 60% of kids with a peanut allergy age one to seven are currently seeing an allergist. Now, they might be seeing an allergist for their peanut allergy or for their asthma, but they're already seeing an allergist. What we need to do is ask ourselves, what's the best way to address the 40% still with a pediatrician? There's another dimension, which is obviously market access and price.
Allergists are used to doing prior auth, are used to obviously securing access to more complex product, which may be more expensive. Pediatricians just don't have the machinery to do that. We're gonna have to weigh that also on whether or not the access to pediatrician is optimal when it comes to maximizing the value of the franchise here. Allergists will do the skin prick test, will do a peanut-specific IgE that will not be necessary for managed care as we talk to them about market access. It's important in the documentation of the patient. That kid will be seen by the allergist a few times a year for years and years and years. We still think that directing patients to the allergist is preferable in the short term. In the mid to long term, that could change. Does that make sense?
No, very much so. I guess, you know, long term, you know, I guess as we think through the launch curve. You know, where do you kind of see the low-hanging fruit, the moderate, and the, you know, the more challenging ones to capture?
That's a really important question because we don't have a typical market we come into where there's established competitors, so displacing a competitor is important to capturing share here. Our real competitor are parents being comfortable, still very nervous, but have learned to live with read labels, vigilance, carry an EpiPen. That's sufficient. We're trying to motivate these parents to say, "Your child might do better. The familial anxiety will drop if you add VIASKIN too."
The segmentation of the market will be really in the ability to build that dialogue between allergists and parents. To find the parents who are most motivated right now to add VIASKIN to a treatment regimen. As we do the market research, this is where we see there's a segmentation, this ability to mobilize some families before other ones. That being said, there's also no outright rejection of the value proposition by families with peanut allergy. It comes down really to how we prioritize that. The segmentation will be much more around parental willingness to add something.
Have you thought about, and I'm sure you have, you know, commercial proxies? As investors and the sell side, you know, think about, you know, modeling, right? As you get closer to commercialization. You know, modeling things. You know, HAE has come up, hereditary angioedema has come up as a proxy. You know, certainly the prophylactic, you know, space within that market, as well as that's done. You know, obviously there are the, you know, the people who are extremely nervous who, you know, latch on right away because anything that can, you know, give them comfort, you know, peace of mind.
Feel good about it, yeah.
They'll jump on. We've also seen in that market, you know, patient-to-patient communication is extraordinarily powerful. You know, patients are the better advocates for products that they believe work than any company could possibly be. It has a material impact. Moreover, you know, doctors, physicians who are advocates have tremendous influence, you know, speaking to their peers about assets that have worked for them. You know, is that kind of a good proxy to think through, or what other ones might you put on people's radar screen?
Those are excellent proxies. We'll look everything also in the ADHD medication. Anything where treatment compliance reduces familial burden becomes important analogs here. As you know, Andrew, you're gonna need a basket of analogs and find the right weight to give as a function of elements of the sort of treatment paradigm here. We're hard at work on that. Our plan, obviously, as we get closer to launch is have an Investor Day on commercialization.
Our ability to share our thinking on that and help obviously the market understand how to think about update 'cause we're solving for. It's easier to forecast peak year sales. The trick is the trajectory to that. Our plan is to be quite willing to dialogue with investors and analysts on how we see the market as we get a bit closer here. We're in the process of putting the right weight on a basket. You've mentioned many of them that matter to us or other ones also. Our plan is to share that as we get closer to commercialization.
Perfect. Well, I think, we're all out of time, but if there's any final thoughts you'd like to leave people with, by all means.
No. Again, it's been a full last seven years at DBV. I wish people could walk through the office in Warren or the office in Châtillon in France and just, you know, pick up the energy. We have a product. Everybody can get their head around what it is to be a child with a peanut allergy 'cause you know someone suffers from it. I think you'll see the engagement of people at DBV that is as strong as I've seen in my career. We still have work to do, but we're entirely focused on it. I thank you for your questions today.
Thank you very much.
Thanks, everyone.