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

Hello, can you hear me on?

Go on. You are live now.

Seems we're live.

Are we live, okay? Well, Daniel, good afternoon. How are you?

Good. How are you, Graig?

I'm well.

Thanks for hosting us.

Welcome to your second Goldman Sachs Global Healthcare Conference. It's nice to see you again. I wish it was under different circumstances, but great to see you.

Likewise.

Maybe before we go directly into our fireside chat, maybe we can start off with -- you having joined the company in -- I think it was November 2018, and we find ourselves in summer 2020. And maybe just start with a few words on like, DBV, your company, but then, where was it when you joined? Where is the company now? And where do you want it to be in 3 to 5 years?

I appreciate that. Well, yes, joined about 18 months ago, as you know, late November of 2018. I joined the company for, I think, the 2 reasons somebody should wish to join a biotech company. One, the core science is very promising. The idea of using the human skin as an immune organ, which is rather a novel idea. There was very little publication on that topic 15 years ago. Now there's a lot more. So this, this whole approach to helping patients unmet needs is rather novel. So the technology is promising, and there's a lot of applications besides our first product in peanut. And secondly, the commercial potential of these products is huge. And the markets are with some complexity on top of it, being a marketing guy by training, you always like markets or some complexity where there's no analog, that makes sort of go make your way on your own. So 18 months later, those 2 elements are still very much there. The technology is very promising. The market potential is huge. DBV at that point in time was going through a transition that's quite common from many biotech companies. We move on from the scientific founder to somebody who looks more like me or a lot of people who have more of a commercial and at-scale background. And that's been pretty much my effort for the last 18 months is to build up the organizational depth, commercial capability, clinical development capability to fully exploit the 2 elements I just talked about.

Okay. Great. And so when people think about peanut allergies, obviously, they, at least in the western world, see lots of children with peanut allergies, but maybe can you put into context for us what the potential market opportunity is like? Maybe the numbers of patients, and how tractable is that market opportunity for a company like DBV?

Yes. The opportunity is significant. The unmet medical need is huge for parents who have a child who suffers from food allergy. It changes family dynamics. It becomes a key element of what essentially is the day-to-day of those lives. So besides being important for each family, there's 850,000 such children in the country between the ages of 4 and 11, which is the market that we are targeting for initial indication with Viaskin Peanut. And although in our market research, a number of families are happy with the 2 fundamental elements are already there: vigilance, lead labels, talk to the waiting staff, talk to the neighbors when there's a sleepover to make sure that the child is not exposed to peanut. That's one element. The other one is always have an EpiPen or epinephrine injection handy. Some families are happy with that, but the great majority of families in our market research would love to be able to add a third element to it. We often refer to it as sort of the same approach we have with driving. Your -- pay attention to the rules of the road and you put on your safety belt. If you buy a car that on top of it have airbags, you would do that. So if there's a contact, there's an accident, they deploy and they protect you. That's sort of the psychology that we're tapping into with our product.

Okay. Great. And then your lead candidate, Viaskin Peanut, very interesting products. Maybe for those who don't know the DBV story well enough, maybe if you could remind us the product profile in terms of what you've seen in terms of the safety and the efficacy? And I guess, basically, what are the key product attributes that you think make this an ideal product for those with peanut allergies?

Yes. We have to recognize it's a -- it requires a chronic treatment. So there's 3 elements that makes for the product to give you the outcome, because we don't want efficacy, we don't want safety, we want outcomes. And that comes from an efficacious product, that is safe, obviously, and encourages compliance and treatment that drives the outcomes that you want. And I think our product achieves that quite nicely. It's a different approach immunotherapy than what is used by many allergists, which is more of a brute force approach by using either SCIT, SLIT or oral immunotherapy. We are slowly over time, recalibrating the patient's immune system and its ability to deal or recognize peanut as an antigen. And that efficacy has been shown to be very good at 12 a month. It keeps on improving through years 2 and 3. And the reason we got to 3 years of data is for the other 2 reasons that matter, the product is very safe. And on top of it, because it is an easy gesture, you put the patch on the back of your child on a daily routine, that's easy enough to do to get high compliance and with that the outcomes that you want. So we like the profile of our product because we hit all 3 elements that adds up to good outcome. Yes. That make sense?

Yes. Yes. So the product is currently under review at the FDA. You resubmitted last year and recently announced that there was an update, and there were some -- maybe some additional questions that were asked by the FDA during the review process. Obviously, this is all happening during COVID-19 as well. So maybe can you just recap kind of where the situation is right now? If there are -- there were questions that were asked that maybe or you can share with our audience and kind of what has been done from the DBV side of things and kind of where we see things going forward?

Yes, I'd be happy to. So yes, we filed in August of last year. File was accepted for review in October. Our action date is August 5. On the 13th of March, the agency contacted us to inform us that the AdCom was suspended. And without more explanation, we reached out to them the following business day, which was Monday, the 16th. We got on the phone with the agency. And they shared with us, and it was just a verbal conversation that they had questions at the intersection of adhesion of the patch and efficacy, without being more specific. It was in the middle of the COVID crisis, we still are in the middle of it. And as you know, our product is reviewed by the division of vaccines and related product at the FDA. So it's fair to assume that there's a lot of work taking place right now at the agency, a lot of calories being burned on COVID regulatory pathway. So we made a decision to send the FDA a clinical summary. Was sent to the agency on the 9th of April. It was a 34 page document in total, including appendices, including every table and chart. That explains, and I'll be happy to add some details, if you wish, that patch adhesion is not correlated to efficacy in a great majority of patients, that there are good reasons when it comes to modality of action to explain that. We're also in the process of publishing that data for the first of the 2 publications. So there's a lot of data in that dossier. You’ve seen there’s 2 publication. One was published actually today a few hours ago online and in asthma and allergy proceedings; and the other half of that, we publish, hopefully within a few weeks in the same journal, so...

So I think it caught the market by surprise that the FDA had some questions around patch adhesion. Maybe if you could provide your perspective on were they not prepared? Didn't they have data around patch adhesion? And maybe as a follow-up to that, I know you mentioned that you had submitted additional data. Maybe if you could describe what some of that data, were that -- they had already seen?

Yes, happy to. The adhesion data was part of our pre-BLA package. It actually represented a good section of our pre-BLA package sent to the agency back in early 2018. At that time, the agency did not express that they wanted the company to dive deeper into this adhesion data. So then it was not a featured element of our BLA. The data is always attached in every last blood pressure taken on patient is part of the data set that you send to the agency, but a narrative explain how adhesion may or may not interact with efficacy, was not something that was an element of our BLA. So that's what we provided in -- on April 9. And it's rather straightforward. What we have shown in a epicutaneous pharmacodynamic study in healthy volunteers, young adults between the age of 18 and 25, is that the peanut protein payload, 85% of it is delivered within 12 hours of the patch being applied to the patient's skin. So we looked essentially at every script of 4 hours, actually 2 hours in the early going, how quickly the protein is taken off the patch and thus, assumed to be in the patient's epidermis, in the epicutaneous tissues. And we see that at 12 hours, 85% of the protein has been delivered, and you're approaching the lower boundary of quantification methods at that point in time. And at 16 hours, you're below our ability to quantify, you're down to the trace elements. So 12 to 16 hours seems to be more than sufficient to deliver the protein to the patient's skin. So we've done afterwards that we actually validated that observation, which was a mechanistic one, with a clinical data we have from a pivotal trial. And we looked at, since we have daily diary of the patient's patch experience every day, every patient for all 365 days of the study, it was possible to calculate what was the average daily exposure of every patient over that year. And we looked at whether or not there was any difference at 10, 12, 14, 16, 18, 20 hours of wear in clinical response. And it pretty much validated what the mechanistic data showed is, as long the patients wear the patch for more than 10 hours, they see a significant clinical response. And 16 hours or more makes no difference. That seems to be the sweet spot of response here. So the data we saw into piece validated the fact that we have a daily patch, but not because it needs to be worn for 24 hours. We have a daily patch because it's the best way to integrate the therapy to the patient's daily routine, about 12 to 16 hours of wear is sufficient to get a clinical response. And that's the data was published this morning by AP in a peer review journal.

Okay. So I guess for investors, what does this all mean in terms of kind of where the process is? Obviously, I think investors have been looking forward to kind of this product getting across the finish line. Is there anything you can say about the regulatory processes right now? Or maybe when do you anticipate that you might be in a position to update the market on where Viaskin Peanut is?

The agency received data on April 9. They said it would require some time to review it. And we assume it would be even a longer time period, given the fact that COVID is obviously a huge factor for their workload here. We know that the data has been reviewed by the agency. We know it's being discussed internally. We have not had a formal return from the agency yet on our adhesion data. And as a citizen and as a father and as a son of elderly parents, I understand, I want the agency to crack the code on the right a way to vaccine the population on COVID here. So obviously, we're being insistent in trying to get response from the agency, but without being overly aggressive, obviously, given the fact that, the pandemic is a unique situation that hasn't been seen in living memory. So we're patiently awaiting for the Agency's return. The moment we have response from the agency, obviously, if it is substantive, we would communicate it to the market. We lost you Graig. You're on mute.

So I guess we'll just have to wait until the exam [ time to ], but in the meantime, there is another product that is available for allergy patients -- peanut allergy patients, it's approved earlier this year. And maybe it's a good point in our conversation just to do, perhaps, a little compare and contrast on how your product is -- what the differences may be and perhaps, in addition to going through the different product attributes, where might your product be positioned for a certain type of patient and/or caregiver versus the other approved product?

Yes. The other product was approved back in January. The only feedback we have to provide is the one that they have provided and the fact that COVID has been impacting their uptake. We think it is terribly disappointing. The unmet need is real. Peanut allergy is something that consumes the life of more than 1 million families in this country, 850,000, I said in the age range that we're looking at. And if an alternative is offered or available but cannot be accessed because of access to the physician is limited in a COVID times, I mean it's very unfortunate. As we've shared, you and I, Graig, we don't need [ immune ] to fail for us to be successful nor vice versa for 2 reasons: One, it's a huge market to displace for both. But more importantly, you've touched on it. What families want, what families need, what they're willing to invest in one therapy versus the other is fundamentally different. One product is more attractive for one family, the other one may be more attractive to the other family. And as we do our market research, we like our product profile as being one that we think, fits into the busy lifestyle of many families much more easily than our competitor's product. But that being said, as I said, there's a -- as a marketer by training, it's really the most interesting market dynamic I've seen. We look at the psychology of caregivers, of parents and obviously, how the 2 of them need to interconnect to turn into a prescription for a given patient. It's a dynamic I've never seen before, where the 2 products might be competing in the same market. They're not really competitive when it comes to the unmet needs of the consumer itself, which, again, is a great position for us to be in and for our competitor to be in. Does that make sense?

It does make sense. So...

The other thing also, I missed -- if I may, Graig, I'm sorry to cut you off, but in this post-COVID world, where the practice of medicine will be affected, at least for a while, by COVID, by some kind of risk avoidance by parents, trying to avoid doctors' offices for some, the change in practice patterns, we do like the profile of our product, as obviously, my clinician, my team exchanges with patient advocacy groups. That's something that certainly make clear is that, they want both products out there, they want alternatives. And the profile of our product is pretty elegant one, particularly elegant one in a post-COVID world.

Well as you are awaiting, word from the FDA, clearly, the company has been preparing for success, preparing for eventual commercialization. Maybe let's talk a little bit about DBV's precommercial activities, its level of preparedness, what are some of those key plans and strategies and tactics that you think are necessary to engage in or execute on the successful launch of the product?

Yes. The -- those have been consuming a lot of our attention. As you know also, Graig, the preparation for launch is done in strips. Now as you get closer and closer to launch, the level of activity goes up significantly. The level of investments required to ensure successful launch also is important. And the thing we do not want to do is, in any way, cheat the success of the product, since momentum at launch is quite important here. So we've been doing everything we expect us to do. We're talking to payers about the fact that there's going to be a new product coming or hopefully coming to the market soon. How would they see that? We've been talking, obviously, keeping relationship with investigators and with opinion leaders, who are medical affairs group, again all that done, absolutely, within the laws of the land. And we're doing a lot of market research, again, to understand what I call the psychographics, the psychology of parents and caregivers and make that work here. So we're ready to go. As you know, a lot of things get finalized once you get the label because that allows you to finalize all sales aids and positioning statement, everything else. But the team is ready to quickly move to commercialization on approval. Then one thing we do want to understand well, though, and we're going to be smart about it, is the way care is given, may have changed quite a bit in this market, given COVID, the pandemic. There's been a dislocation of how health care services are being delivered. Our physicians' practices may have changed also. So all those things we have to keep in mind as we fine-tune our launch of the product here, so that everything we do is nicely aligned to a market dynamic that may have evolved from where we understood it to be prior to the pandemic.

If we can just touch upon maybe some -- I realize that you don't have a product approval yet in hand. You don't have a label just yet. But in terms of some of the market research that you have done and your level of engagement with payers as well as physicians. Is there anything you can give us that's a little bit granular in terms of what the perception is of the product, whether it's favorable or what are some of the things that you need to do to make sure payers and/or physicians are convinced of the value proposition of Viaskin Peanut?

Yes. The market, both payers and physicians are very receptive to the product profile as they know it today. Because obviously, it's been -- there's been many publication, much discussion about it. Payers understand that this is a high unmet need, one that is important to satisfy here. And as long as the players in this market behave in a way that is responsible to them when it comes to pricing, that there is a receptiveness in making sure that these products are covered in a reasonable way, in a relatively timely way. So we don't perceive that access to the market would be particularly problematic. We have to be patient, obviously, because these things take time to play out here. But we're not seeing any major resistance, when it comes to payers of the product profile. When it comes to clinicians, it's fascinating to see to what extent the mechanism of action matters a lot to them. So that this is a different way to treat. And most of our clients understand OIT, SCIT, SLIT and SCIT, SLIT is OIT but delivered differently. And this recruiting of Langerhans cells and essentially, T-reg modification, the T regulatory cells modification matters a lot, not because the doctors will be explaining that to the parents, but it's part of managing what would be the patient experience, wear this patch on a daily basis, simple routine and over time, we hope to be able to help protect your child against accidental peanut consumption here. And that ability to remind parents and physicians of what this product is supposed to be, becomes quite important. We will do, obviously, all the handholding and all the patients sort of support that is required in launching new product, although, again, given the nature of our product, that is not a screaming demand because the use of the product is relatively straightforward. Is that helpful?

That is helpful. Maybe just more granularly, we have a product again, a competitor product that's on the market. Could you just remind us how it's priced? And how are you thinking about the value proposition and pricing, market access reimbursement for your products?

Yes. I believe our competitor has announced a list price of $800-and-something per month. That's -- I could be wrong about that. It's for them to argue. We believe that payers and parents need to look at the economics in a very full way. One product requires a lot more visit to the doctor's office than ours does. The number of times a parent has to pull out their wallet and pay a co-pay becomes important also. There's a lot more of them with one product than the other. All of that goes to, as you know, the very, very difficult and delicate balance between list price, net price, out-of-pocket price to the parents, but that drives a lot of the compliance here. And all of that is very difficult to finalize until you get very close to launch and mostly, you have your label in hand here. So we're in no position to be able to comment on how we feel about pricing vis-à-vis our competitor. The point is, the dynamic is fundamentally different. And our pricing to the marketplace will be very sensitive to all those dynamics.

Okay. And admittedly, your competitor has launched in a COVID-19 world and even with that said, I'm wondering, if there's anything that you have seen from a competitive intelligence perspective in terms of what might be lessons learned that can be instructive for you or perhaps pitfalls to avoid? Or does your commercialization strategy, as you have it mapped out right now, is that really unchanged based on what you're seeing thus far, based on a competitor launch?

Yes, it's unchanged. It's unchanged, and we did not expect we would need to change it. Again, coming back to -- that the 2 product profiles are quite distinct. The first-to-market in any market, in this case, it's our competitor's responsibility, has a stewardship role, that's important here, to educate and develop the market. And to be straight down the middle of the fairway, when it comes to what the disease is and what are the ways to manage it here. So that, obviously, we have no way to observe how that's going because there's been little activity because of COVID here. But if there's anything we would be vigilant to, is not to the competitive profile of the product and adoption out there. The fact is that we both have a role to play and make sure that we build up a market here, where patients understand there are options. The options are a good thing. And that what we wish is for hundreds of thousands of families in the U.S. now to not have to live with peanut allergies quite the same way, whether they use our product or their product.

I think you touched upon it before, but I think it's worth revisiting again. But irrespective of whether COVID-19 remains with us for some time or if it is in fact receding albeit, slowly or not, but just in terms of your product profile versus your competitor's, it seems as if that yours naturally lends itself as a product that would be easier for a caregiver or a patient to get access to. And maybe if you can walk us through, why that is the case? And I just think it's important just to compare and contrast again, just the ease of access to your product versus perhaps, the other.

Yes. And I'll use the opportunity maybe to look back to the data which is published, which goes answering the questions of the agency. Our product's a patch, right? So that's obviously different than a tablet, it's obviously different than an injector or an asthma inhaler. And we certainly have to explain to our customers how to use that patch and how it's not all that difficult. And we will encourage families to go into a routine that's right for them. For some families, it may very well be that the right time to put the patch on is just before dinner or right after bath time or right before bedtime or in the morning before their child goes to school, depending on again what works well for that family. So that's an element that is obviously important. And in our discussion with customers and through market research, I do not appreciate to what extent that -- it's a rather beautiful gesture, if you think about it. I'm speaking like a dad here, okay? A rather beautiful gesture to put a patch at the back of your child once a day. It's caring, it's warm, and in the psychology of parents, it's very important. It's very nourishing to them that, I'm doing that thing on top of vigilance and carrying an EpiPen. And doing that one thing on top that hopefully can add another layer of protection for my child. So that's an important element of our product offering. And well, you don't need to be in the doctor's office to learn to do that. That can be done through telemedicine. That can be done -- it's a product that's quite adaptable and does not require sort of the bedside power coaching. In our clinical studies, patients were to stay in a doctor's office for 2 hours after the first application as a matter of being vigilant here. But as we saw, and the data should obviously guide, what the label will show is, nothing happened to these children, these 2 hours here. So although we were vigilant in the context of a clinical study, it really should not inform clinical practice because none of the patient experienced any adverse event that were of concern in those 2 hours here. So -- and given the fact that, again, the patch is to be worn ideally for 24 hours, it makes a routine to be easier, but to achieve 12 or 16 hours is more than sufficient to get the clinical payback. That's something else that parents can think about, if that becomes important consideration for them, is when is it they want to put the patch on to get the outcome that they may wish, if that dimension becomes important to them in their home and their family. I don't know if that answers your question or not but...

It does. And I think another element, I think, is important for our audience is that, the other product that is approved requires serial admittance to an actual [ admissions ] office which...

Yes, yes, every 2 weeks for many, many hours. But -- and again, I'd rather talk about my product than talk about what may be different about my competitor's product here. But there's no doubt that goes into, we believe, is a profile that's very attractive because it's a lot easier to fold that into the patient's daily life here than they need to go to the doctor's office for hours at a time, they'll begin to wait for the better part of 6 months, if you can get there in 6 months, very often the dose escalation takes longer because, life gets in the way here. But that being said, that may be something that's perfectly acceptable for some families, and it's wonderful that the choice is out there. But I think patients will be very well served by having 2 options out there, not just one.

Okay. Maybe my last question on Viaskin Peanut is, obviously, we look forward to the approval. A lot of investors when they gauge a product launch, revenue is obviously the easiest thing to gauge. But are there other key metrics you think that are important that also provide a lens on how successful or how well you're tracking on a launch? And maybe a follow-up to that is, is there a view that you have on whether you will be providing some sort of color around other launch metrics, besides just revenue?

That's an important question, Graig. We have not come to closure a decision on that. But like any chronic therapy, you want to pay attention to uptake of new prescriptions, but obviously, persistence of the product use over how many years here, using the key variables with our product, whether or not, we would help investors by providing that granularity or not, is a decision we have not made yet, but one that's rather important given the nature of our product. And again, as we say, the fact that, since compliance should be facilitated, given the ease of use. That dimension becomes quite important as we think about the sales potential of the product.

Okay. And actually, a last question before moving on to things beyond Viaskin Peanut, I do want to highlight that there was just a EAACI, and there were some objects that were presented in reference, a publication that just came out today. So perhaps, can you just kind of update us on the important takeaways from these presentations?

Yes. We had data because we should talk about biology and [ mix ] of action, a lot of it, very clever biologists who work for us in [ Montrouge ] in France, were presenting data again, that added to our understanding our insights around epicutaneous immunotherapy. There was some interesting data published also here in milk allergies, paralleling the important work done by Remington and Baumert to look at risk reduction, relative risk reduction of therapy, given the fact that we can really quantify and model the risk of accidental peanut consumption from packaged food. That work has been done, published, showing that the sweet spot is from less than 100-milligram eliciting dose to more than 300, protects kids against 95% to 99% of accidental peanut consumption accidents. Similar work has been done by Baumert and Remington to look at food prepared in restaurants and now they publish like work for milk allergies. And again, showing that there's a lot of benefit that comes from simply a few-fold increases eliciting dose, which, again, makes sense, given what we know about the pathophysiology and supportive again to our approach we would have with a patch for milk in due time. And the clinical Viaskin Peanut presentation, I think is the most important one is a work that shows that, we have had regular, very consistent fold increases in clinical response. So besides hitting the primary endpoint as defined in the clinical study, the fact that whether kids had very low eliciting doses or high eliciting doses, pretty consistently, we've seen fold increases in their eliciting dose at month 12, again, reinforces, we believe that there's a nice therapeutic effect of our product across all types of patients. And all these fold increases in the spirit of what Baumert and Remington showed, all those fold increases are protective. So in other words, you can fold sure the primary endpoint in the study and still protect the child. And I think it's important it's not lost on caregivers here.

Okay. Well, clearly, the focus for the company right now is Viaskin Peanut. You have a technology platform that lends itself to other food allergies. So let's transition talking about what could be next for the company? Clearly, I think Viaskin Peanut is an important trigger as to kind of what happens next. But maybe if you can spend a few moments just kind of describing how DBV is thinking about what's next beyond Viaskin Peanut?

Yes. The -- after Viaskin Peanut in the U.S. we'll be filing Viaskin Peanut in Europe towards the end of the year. That remains very much our plan. Viaskin Milk is ready for the end of Phase II discussions with the FDA, where we believe it's a very important, very promising product. We chose to postpone the discussion with the FDA, given that it's the same platform we're using for Viaskin Peanut, which is very novel. Let's learn what the agency, how they think about the platform to Viaskin Peanut review process, before we go and discuss with them the Phase III program for Viaskin Milk. And then there's a lot of work going on, not just with eggs, but with tree nuts, which are a huge unmet medical need that the team is working on. And hopefully, later on this year, sometime next year, we can start talking also about other application of our technology outside of food allergies, but I think it's very promising. We're doing some interesting work. It's too early to talk about it now. But certainly, I hope that 3 years from now, to build on your basic question, we will have Viaskin Peanut launched, approved launch, generating significant revenues, allowing us to intelligently but aggressively invest in further developing a pipeline that is fundamentally attractive because there's so many other applications besides peanut allergies.

And maybe just a follow-up on the platform and your interest in going to other food allergies. Like how seamless is it to use the technology to go from, say, peanuts to milk to tree nuts. What needs to be done? And I realize it may be, complicated answer. But from a high level, the scalability of the platform?

It's a very important question, Graig. It is -- the 2 elements that are the trickiest. We have a platform, the obvious one is you need clinical data. So Viaskin Milk will have different data than Viaskin Peanut. So that's a given. Given the fact that we use electrospray as the means to apply the peanut protein. So since we charge the protein with electricity, to dry up the protein and on top of it, provide some electrostatic binding on the patch. That's sort of the -- that's the magic of our patch here, then the trick for our physical chemists and protein experts, is how much can you charge a milk protein to get the same effect here. So there's a lot of tweaking, but don't underestimate the complexity. But that's the scalability, essentially. That's the tricky part. And we're getting pretty good at it because we've been doing it for quite a few years.

Okay. Great. We've got maybe less than 2 minutes to go in our fireside chat. And maybe at this point, financing, where your cash levels are? You're about to undertake a launch. So how do you think about your current cash position and your options to kind of finance ...

We ended Q1 with EUR 262 million as our cash reserves. If we were in full launch mode, we've already said that this would take us into Q1 of next year, given the fact that there's a lot of scripts of aggressive investment that need to take place to support the launch. And then obviously, on the back of an approval, we would have to look at all source of forms of financing that -- I'm not announcing a financing here, but that's self-evident. And we obviously have a few levers that we can pull to extend the cash runway, if that's necessary, given the COVID environment.

Okay. And then maybe very last question is over the next 6, 12 months, what are the key things you want investors to look out for from DBV?

Yes. With the approval of our product in the U.S., obviously, is the biggest catalyst of value. The filing in Europe is also not insignificant. There's a lot of patients to be helped in Europe. And hopefully, a year from now, greater clarity on our milk product as we're taking it to the agency.

Okay. Great. Well, Daniel, thank you again very much for your participation.

Most welcome.

In our conference. So hopefully, we'll be in touch in person next year. But best on success, and thank you again.

Thank you. Thanks for your time today. And thanks, everyone.