DBV Technologies Q2 2026 Earnings Call | Commercial Viaskin Regulatory Timelines Outlined

Welcome to the DBV second quarter 2026 results and business update conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Jonathan Neely, investor relations. Please go ahead, sir.

Thank you. Good afternoon. DBV Technologies reported financial results for the second quarter and half year of 2026. This update is available in the press releases section of the DBV Technologies website. Before we begin, please note that today's call may include a number of forward-looking statements, including but not limited to comments regarding our forecast of estimated cash runway, clinical and regulatory development plans, the design and conduct of our clinical trials, the timing and the results of interactions with regulatory agencies, and the ability of any of our product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements are based on assumptions that are subject to risks and uncertainties that could cause the company's actual results to differ significantly from those suggested by these statements. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Please refer to the company's filings with the SEC and the French AMF for information concerning risk factors that could cause the company's actual results to differ materially from expectations, including any forward-looking statements made on this call. Except as required by law, the company disclaims any obligation to publicly update or revise any forward-looking statements to account for or reflect events or circumstances that occur after this call. Joining me on the call today are Daniel Tassé, our chief executive officer, as well as Ferris Mogaded, our chief medical officer, and Kevin Trap, our chief commercial officer. I will now pass the call over to Daniel.

Thank you, Daniel. While much of our team is laser focused on BLA preparation and submission, we are also working hard to continue to build our scientific platform. So today, I will share an update on four main topics: the COMFORT toddler study, the EPITOPE study, THRIVE, and whether or not the prevalence of peanut allergy has changed over the last 10 years. First, let me start with COMFORT toddlers. I'm pleased to say that in the second quarter, we closed the recruitment for COMFORT toddlers, a supplemental safety study evaluating the Viaskin peanut patch in toddlers aged 1 to 3 years. This is an important milestone as we look to progress this program. About the EPITOPE study, we presented new data from our phase 3 study in 4 to 7 year olds at the American Academy of Allergy, Asthma, and Immunology annual meeting earlier this year. This data included additional efficacy assessments demonstrating consistency of the treatment effects regardless of baseline eliciting dose and across multiple statistical subgroups. And last month at the European Academy of Allergy and Clinical Immunology Congress, we presented EPITOPE data showing that subjects with asthma, eczema, and/or other food allergies, common comorbid conditions for our study population, had no difference in the Viaskin treatment effect. This is an important dimension of the treatment of food allergies and peanut allergies since they are often accompanied by other atopic conditions. The population of children we recruited in EPITOPE is very typical of the overall peanut allergy population seen in allergists' offices. This data reinforces our confidence in the potential role that the Viaskin peanut patch may play both for allergists who are navigating the everyday complexities of the food allergy population and for families who are looking for a practical treatment that fits into their everyday lives. Also at EAACI, the design elements for THRIVE were presented by Dr. Kirsten Perrett, who is the co-lead investigator along with Professor Gideon Lack. THRIVE is assessing the efficacy and safety of the Viaskin peanut patch in achieving ad libitum consumption of dietary peanut in infants with peanut allergy aged 6 through 12 months following 3 to 4 years of treatment with the Viaskin peanut patch. We are pleased to have shared that the first subject was enrolled in this first-of-its-kind study last month at Dr. Doug Mack's site in Canada. We believe this study is nicely aligned with earlier introduction of allergens into the diet and consequently more patients being identified with a food allergy at an earlier age. Given the positive results of the phase 3 EPITOPE study in 1 to 3 year olds which was published in the New England Journal of Medicine in 2023, we believe that the THRIVE study has the potential to be a landmark study. We pay very close attention to the ever-evolving food allergy treatment landscape, and a question that we frequently get is whether the prevalence of peanut allergy has changed. I'd like to take a minute to discuss an important recent publication that informs discussions of the prevalence of IgE-mediated food allergy across children and adults. Dr. Alessandro Fiocchi, a leading allergist, and colleagues conducted a standardized survey-based study of peanut allergy prevalence in children using a methodological approach deemed by the FDA as sufficient to produce evidence of high to medium strength. In the United States, the study reported a 2% prevalence of peanut allergy in children. That estimate is broadly consistent with prior US literature, including the approximate 2.2% prevalence rate previously reported by Dr. Ruchi Gupta and colleagues in 2018. Importantly, the Gupta data were collected in 2015 and 2016, while the Fiocchi data were collected in 2022 and 2023. These two independent data sets collected approximately 7 years apart both point to a US pediatric peanut allergy prevalence of approximately 2%. The confidence intervals further support that conclusion. Each group reported a 95% confidence interval of 2% to 2.5% which overlap with the estimates across each pediatric age group in the Fiocchi paper. I'll hand over to Kevin Trap to put this new prevalence data into a commercial context.

Thank you, Ferris. For us, these findings are highly relevant because they reinforce that the opportunity in peanut allergy in the US has not changed. This is an important point. The Fiocchi data reinforces that peanut allergy remains a persistent population-level issue. Despite early introduction, the peanut allergy patient population remains largely consistent. Peanut allergy also remains one of the most common food allergies in children, and it still creates a daily burden for patients, families, and healthcare systems. That is why our work matters and why as we move toward BLA submission, we're planning now for what it takes to bring Viaskin Peanut Patch to the market at scale if approved. For commercial, that means focusing on building the infrastructure a successful US launch requires. We are investing across market access, patient services, brand readiness, field force planning, and launch operations. We have built the launch model around cross-functional execution. Commercial is working closely with medical affairs, our regulatory team, pharmacovigilance, quality, supply, and manufacturing so that the launch planning is connected to the evidence, our safety systems, product supply, and the regulatory timeline. Our goal in the end is to ensure a prescriber and patient experience that supports their needs and fits into their daily routines. It looks simple on the front end, but is so complex on the back end. We're also spending real time with the food allergy community, including caregivers, advocates, physicians, and payers to understand where the greatest barriers exist and how DBV can support adoption of the peanut patch. In short, we're doing the work now to drive both a successful launch and the long-term growth of Viaskin Peanut Patch. As part of that longer-term planning, we're taking a close look at company operations that would be required to support potential peak demand for the Viaskin peanut patch if approved. So, we're reviewing what the future would look like for our manufacturing capacity, supply chain readiness, and related capital requirements. We believe the opportunity is significant and that the patch has the potential to transform treatment in a large market with significant unmet need. Our planning must reflect that potential. Daniel, I'll pass it back to you.

If you would like to ask a question, please press star one on your telephone keypad now. You'll be placed into the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you would like to ask a question, please press star one on your phone now. And our first question comes from Yatin Suna at Guggenheim.

Hey guys, thank you for taking my question and thank you for all the details. Very helpful. So just two quick questions for me. First is with regard to the filing and the acceptance and the timelines around it. So what are your working assumptions? How should we think about the acceptance timelines? Will this be a standard review or a priority review? And then with regard to the CMC readiness and commercial supply, are there any implications from the FDA feedback, any changes in manufacturing dossier, or anything you sort of have to do from a launch perspective?

Got it. One more question if I may. Now, what is now the gating factor or what are some of the things that you need to sort of get an alignment on or have to complete on your end before you can submit the BLA? Thank you.

Thank you very much.

And our next question comes from Susilla Hernandez of VLK.

Yes, thank you for taking my questions. I also have two. So do I understand correctly that you have engaged with the FDA since the last conference call that you organized? And if so, have they provided additional suggestions on the structuring or mapping of the BLA package or on any other front?

Yes, thank you. And then just one more. So with the recruitment completed of the safety study in toddlers, could you just remind us for how long you will follow these toddlers before the study is completed?

Okay, that's clear. Thank you.

And our next question comes from Kristen Kluster of Canaccord Fitzgerald.

And thanks so much for the updates. A couple questions for me. First, I think most of us on the line probably never submitted an application before. So can you help us just try to imagine what it's like to reformat things? You know, why isn't it as simple as just copy and pasting in other areas? Sorry for the basic question, but I think it will help since we don't have this experience.

Yeah, thank you so much for that additional color. And then on COMFORT toddlers, are you still planning to file that later this year or how should we be thinking about that based on the time to collect the safety data?

Okay. Thank you so much.

And our next question comes from John Williban of Citizens Capital.

Hey, thanks for taking the question. A couple on commercial for me. Do you guys have any sense of the average price of Xolair in 1 to 7 year olds and what pricing band you guys have been testing with payers?

Yeah, sure. As you know, Xolair is IgE and weight-based, so it'll vary across that age range. We've seen prices from around $10,000 into the $30,000s, depending on that. We've tested a range of prices. We're not going to finalize anything yet. We've got payer discussions that'll be upcoming here in the next month, advisory boards, but the research is being done, and as we get tighter on this and closer to launch, we'll give you some more ranges.

Okay. And then when we think about commercial, do you have a sense in your research what proportion of 1 to 7 year olds with peanut allergy would seek some form of therapy, and then digging into that, who would be a likely candidate for Viaskin peanut versus who would not be?

Yeah, sure. We've done a lot of both parent research and allergist research, and I would say that we always see very significant demand as we talk to parents. And we know it's not one market. So as we continue to look through segmentation and who will activate first, we think there are a number of things in our framework: from those that have just been diagnosed or just had a reaction, those that have already sought out immunotherapy but perhaps didn't continue with it for either the burden of frequency of visits or the tolerability, and then there's a group that maybe get farther out in their avoidance and EpiPen and they may need more education and they'll be later down the path. So we've got our framework done. We're doing a lot of work on kind of segmentation and prioritization. And again, I think we'll have more to say on that in the second half of the year if we're talking about a commercial day at some point. So, is that helpful?

It'll be more helpful around the commercial day, but I appreciate you guys taking the question.

Canaccord is wonderful. Thanks, John.

As a reminder, if you would like to ask a question, please press star one on your telephone keypad. And our next question comes from Sam Slitzky of LifeSci Capital.

Hey, good evening. Appreciate the question. Just in terms of the THRIVE study, could you remind us what the ultimate goal of that is? Are you expecting to eventually get a label change with it, whether it's age groups or just the language around treatment in general? Just kind of what's the end goal of that study hopefully?

So this is a phase 2 study. It's really almost more of a proof of concept study, Sam. So the objective, and this is sort of trampolining off of the 1 to 3 year old success that we saw in EPITOPE at that age group. So we're going a little bit younger. As you know, younger patients tend to have a more responsive immune system. And the ultimate goal is to see if these patients can get to the point where they can consume peanut ad libitum. And we have a very broad definition because one size doesn't fit all in this patient population. At this point, we're running the study. It's not really intended to be a registration study. It's a single arm study. We've not talked to agencies about what this data set could do. We just started recruitment as I mentioned. It's in its early stages, but for us conceptually, it's a natural study to do given the data that we presented with desensitization and sustained unresponsiveness and with the introduction of food allergens earlier. This population absolutely does exist, right? This early stage, Sam, again, right now we're going to run the study and see where we end up. If we choose to dialogue with the agencies in the future, we'll have those conversations, but for now it's open sides, recruit, and see what the study shows.

Okay. Thanks. Is that helpful then? Yeah.

Yep.

Thank you.

And this concludes our question and answer session. I would like to turn the conference back over to Daniel Tassé for any closing remarks.

This concludes today's conference call. Thank you for attending.