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

Welcome to the DBV Second Quarter 2026 Results and Business Update Conference Call. [Operator Instructions] 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 Pharis Mohideen, our Chief Medical Officer; and Kevin Trapp, our Chief Commercial Officer. I will now pass the call over to Daniel. Daniel?

Thank you, Jonathan, and thank you all for joining us today. 2026 is and will continue to be a pivotal year for DBV. We are working aggressively to transform the company into a commercial organization in anticipation of the potential approval of the Viaskin Peanut patch for children aged 4 through 7 by the FDA. It's certainly a tremendous amount of work to move from the clinical to commercial stage. So today, we'd like to walk you through a summary what we've accomplished toward that goal in the first half of the year. Pharis and Kevin have joined me today to help describe how we have advanced our lead program toward BLA submission, continued constructive engagement with FDA, expanded the Viaskin Peanut clinical program and strengthened the foundation required to become a commercial stage company. I'll start with the status of the BLA. As we shared 2 weeks ago, we continued to optimize our BLA submission for the Viaskin Peanut patch in children age 4 through 7 through our engagement with the FDA, which has been constructive and collaborative. These discussions have been particularly valuable for a novel first-of-its-kind product like the Viaskin Peanut patch, and let me reiterate the FDA has not requested additional data. The work underway is focused on incorporating FDA's feedback related to the organization, the mapping and formatting of existing CMC and biostatistical data sets. We believe this is the right work to do now since our objective is a timely and efficient review of the BLA for VP in 4 to 7, and we plan to submit and optimize BLA in the third quarter of 2026 to support an efficient FDA review. In addition to these conversations, our progress in the first half 2026 include important developments in our clinical program, and let me invite Pharis Mohideen, our Chief Medical Officer, to tell you a little bit more about that.

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 4 main topics: the COMFORT Toddlers, the tests, 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 age 1 to 3 years. This is an important milestone as we look to progress this program. About VITESSE, we presented new data from our Phase III 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 the test 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 treatments of food allergies and peanut allergies since they are often accompanied by other atopic conditions. The population of children we recruited in VITESSE 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 lib 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 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 III 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 Foti, 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 U.S. 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 Foti data were collected in 2022 and 2023. These 2 independent data sets collected approximately 7 years apart both point to a U.S. pediatric peanut allergy prevalence of approximately 2%. The confidence intervals further support that conclusion. Gupta reported a 95% confidence interval of 2% to 2.5%, which overlap with the estimates across each pediatric age group in the Foti paper. I'll hand over to Kevin Trapp to put this new prevalence data into a commercial context. Kevin?

Thank you, Pharis. For us, these findings are highly relevant because they reinforce that the opportunity in peanut allergy in the U.S. has not changed. This is an important point. The Foti 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 health care 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 U.S. 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 time line. Our goal in the end, 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 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.

Thank you, Kevin. I would like to emphasize Kevin's last point. The planning that we're doing and the foundation we're building reflect our belief in the potential of Viaskin Peanut patch. At the same time, we always approach these investment decisions thoughtfully in alignment with regulatory progress, commercial readiness and disciplined capital allocation. So in closing, the first half 2026 reinforced our conviction in DBV's future. We are advancing our lead program in 4- to 7-year olds towards BLA submission. We have closed recruitment for COMFORT Toddlers supplemental safety study in 1- to 3-year olds. We are expanding our Viaskin Peanut clinical program with a very important THRIVE study. We are funded into the third quarter of 2027 to support operations and commercial preparedness, including investments across our core functions required to potentially launch and support the Viaskin Peanut patch. Now we're doing all of this with a clear purpose, to help children and families living with the daily burden of peanut allergy. I will now pass it over to the operator for questions.

[Operator Instructions] And our first question comes from Yatin Suneja at Guggenheim.

So just 2 quick questions for me. First is with regard to the filing and the acceptance and the time lines around it. So what are your working assumption? Like how should we think about the acceptance time lines? 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?

No, thanks for those questions, Yatin. Let me start with the first one. So the regulatory time lines are, we will be asking for prior review given the fact that Viaskin Peanut, the platform has a breakthrough designation, thus making us eligible for priority review. As you know, that request is made formally when you file the BLA. We're working closely with the agency on the content of that BLA. That was the purpose of the update a few weeks ago here. So after we file, it's up to 60 days for the agency to accept the file for review and share whether or not the sponsor is given priority review. Right now, we're assuming 60 days. Could it be shorter, there's a possibility given how closely we're working with the agency, but the formal time lines are 60 days. We'll ask for priority review, which would be a 6-month review at that point in time. I hope that answers the first half of your question. On CMC, no, the discussions with the agency on CMC are essentially now completed. We've had all their comments. We're in the process of making the adjustments that they want here. So there is nothing that the agency has asked us to do that represents a change in any way, shape or form to the way we manufacture the product and the way we will describe that in the Module 3, the CMC section of the BLA.

Got it. One more question, if I may. Now -- like what is now the gating factor? Or what are some of the things that you need to get either an alignment or, or you have to complete it on your end? Can you just tell us before you can submit the BLA?

Yes. There are discussions ongoing, Yatin, as you know, on CMC and also on formatting, tabulation of the biostats table. So that discussion is also going on in parallel. So completing the discussions with the FDA and CMC and the same completion on biostats are the 2 gating items right now progressing in parallel.

And our next question comes from Sushila Hernandez of VLK.

I also have 2. 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 with additional suggestions on the structuring, mapping of the BLA package or in any other fronts?

Yes. Okay. So those are 2 questions, Sushila? So the short answer is yes. The dialogue with the agency is ongoing, dialogue is both talking as well as exchanging e-mails. And yes, there's been further discussion of what they want, all of which are things that we're accommodating within. Again, nothing that is being discussed right now requires incremental data or we see as being fundamentally problematic in any way. I trust that answered the 2 halves of your question?

Yes. And then just 1 more. So with the recruitment concluded of the safety study in toddlers, could you just remind us for how long you will follow these toddlers before the study is completed?

Pharis, you want to take that one? It's your baby?

So with -- yes, with the recruitment completed -- sorry, go ahead.

No, it's a 6-month safety study. Again, there's no efficacy component to it. We did the food challenge upfront to have inclusion/exclusion, but it's a 6-month treatment period.

And our next question comes from Kristen Kluska of Cantor Fitzgerald.

A couple of questions from me. First, I think most of us on the line probably have never submitted an application before. So can you help us just try to imagine what it's like to reformat things? 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.