DBV Technologies S.A. Q2 FY2024 Earnings Call

Welcome to the DBV Second Quarter Financial Results and Business Update Conference Call. All participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.

Thank you. This afternoon, DBV Technologies issued a press release that outlines our financial results for the three and six months ended June 30, 2024. This press release 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 clinical and regulatory development plans, the design of our anticipated clinical trials, the timing and results of interactions with regulatory agencies, our forecast of our cash runway, 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 Dr. Daniel Tassé, Chief Executive Officer of DBV; Dr. Pharis Mohideen, DBV’s Chief Medical Officer; and Virginie Boucinha, our Chief Financial Officer. I will now pass the call over to Daniel.

Thank you Katie, and thank you everyone for joining our call this evening to review DBV's second quarter and first half 2024 financial results. For those of you who may be less familiar with our business, DBV is developing Viaskin, an investigational proprietary technology platform with broad potential applications in immunotherapy, including food allergy. Viaskin is based on epicutaneous immunotherapy, which we refer to as EPIT, and it is our method of delivering biologically active compounds to the immune system through intact skin to progressively induce immune tolerance. Our most advanced candidate is Viaskin Peanut, which we are developing for peanut allergic children, ages one through seven, where there exists a significant unmet medical need in the U.S. and around the world and, critically, is an age group where the immune system is particularly malleable. It is also where there is the most risk to these children from accidental exposure to peanut. Moreover, 75% to 80% of children with a peanut allergy will not outgrow their peanut allergy over their lifetime. And today we are pleased to provide updates on our two Viaskin Peanut development programs, one in children aged four to seven years of age using the modified larger circular patch, and one in toddlers age one to three using the original square patch. As you know, we plan on filing two separate biological license applications or BLAs, one for each age group. There are three key highlights we wish to share with you today. First, regarding the program in children four to seven years old, we are running the VITESSE Phase 3 pivotal trial of the modified Viaskin Peanut patch in that population. Results from this trial, together with the COMFORT Children supplemental safety study, will form the basis of a BLA for this age group. Since the middle of last year, we have seen very good momentum enrolling the VITESSE trial patients, and we are unchanged in our expectation that the final subject will be screened by the end of the third quarter of this year. Turning to our other program in toddlers aged one to three years, we announced successful results from the Phase 3 efficacy study, or pivotal study known as EPITOPE, which clearly met its primary endpoint and was published in the New England Journal of Medicine last year. Also recall that the FDA requested that we conduct a supplemental safety study, which we call COMFORT Toddlers, to increase the number of subjects on treatment in the one to three-year-old safety database in support of that BLA. We submitted the COMFORT Toddlers protocol to the FDA in November of last year, and the agency responded in March. Since then, we have been engaged in ongoing dialogue with the FDA regarding the COMFORT Toddlers supplemental safety study, focusing mainly on patch wear time experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patch wear time. We recognize the importance of that question, and we believe the right answer resides in the result of our existing trial, EPITOPE. In an effort to seek alignment with FDA, we recently submitted to the agency a draft labeling proposal, with comprehensive supportive data and analyses informed by the EPITOPE pivotal data, focused on user experience during the first 90 days of treatment, to address agency's queries about patch wear time. The agency asked us for more details and analysis about that proposal, which we provided to FDA on June 28th. While we are awaiting a response from FDA on this labeling proposal, we continue to advance study preparation activities to initiate the study once we have protocol alignment. Finally, the third update is the result of continued cost-saving measures, extending our cash runway into Q1 of 2025. I will let Virginie, our CFO, give more details on that shortly. At this point, I would like to turn the call over to our Chief Medical Officer, Dr. Pharis Mohideen, for a more detailed update on our clinical programs.

Thank you, Daniel. First, let's start with the tests. If you recall, this is a 600-patient study in 4 to 7-year-olds with peanut allergy using the modified Viaskin Peanut patch. We have 86 sites across the U.S., Canada, Europe, UK, and Australia. The study is assessing the efficacy and safety of Viaskin Peanut over the course of 12 months of treatment. I'm really pleased with the progress that we have made. The test has been a company-wide priority, and it's taken a coordinated effort within DBV to get to this point. For example, our medical affairs team is small in numbers, but they are incredibly diligent and never fail to engage our multiple stakeholders at medical conferences. Our investigators and their staff have done a fantastic job, and we really appreciate the support we have received from the patient advocacy groups and the academic societies. I must also thank our study participants, the parents, caregivers, and subjects for their tremendous contributions. As we said in the press release, we anticipate closing recruitment by the end of the third quarter of this year. We estimate that top-line results would follow approximately 12 months after the last patient is screened. We will certainly provide more detailed updates along the way. Let’s move now to the status of the COMFORT Toddlers supplemental safety study protocol. The FDA asked us to do a supplemental safety study in the one to three-year-old patient population to enhance the EPITOPE safety database in this age group. Following a Type C protocol meeting, we submitted the Toddlers safety protocol to the FDA in November of 2023. The agency responded with comments in March of this year. Since then, DBV and FDA have been engaged in ongoing dialogue, focusing largely on patch wear time experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patch wear time. On June 28, DBV submitted a proposed draft labeling approach with comprehensive supportive data and analyses intended to address the agency’s concerns related to patch wear time experience. We are now waiting for the FDA’s feedback on this labeling proposal. The agency’s questions we believe are best answered with the data from our pivotal trial, EPITOPE. We are still in discussion with the agency and awaiting feedback, but I can give you an overview of the concept. Based on our analysis of the EPITOPE data, we have identified two groups within the Viaskin Peanut treatment arm: label in and label out subjects. The baseline immunological characteristics of the label in and label out subjects, such as peanut-specific IgE, Skin Prick Test, and eliciting dose, are similar. There is clearly a difference in the sensitivity to the locally applied peanut allergen that drives differences in patch wear time experience, which we refer to as differences in immune physiology in the press release. Within the first 90 days on treatment, it is possible to identify and separate subjects into those that are very likely to have a robust efficacy response relative to those who are less likely to have a robust efficacy response. All of this can be done with just the patch wear time experience during the first 90 days on treatment. Subjects that are likely to have a robust efficacy response are called label in. The proposed prescribing information, the label, would recommend that these subjects continue Viaskin Peanut treatment. Alternatively, subjects that are less likely to have a robust efficacy response are called label out, and the proposed prescribing information would recommend a shared decision-making process between the healthcare provider and the parent or caregiver to determine if treatment should be discontinued. In other words, for subjects identified as label out, the proposed label indicates that clinical efficacy is less likely, and discontinuation of treatment should be discussed. If Viaskin Peanut is approved, we believe this labeling proposal would give prescribers a pragmatic, data-driven way to discuss and provide guidance on patch wear time experience to parents and caregivers.

Thank you very much, Pharis. We will now briefly review financial highlights for the first semester of 2024. There are two key highlights I would like to elaborate on: our cash run rate and our P&L, particularly operating expenses. We closed H1 with €66.2 million of cash on hand, and our cash runway now takes us into the first quarter of 2025, an extension from prior communication where our cash runway was sufficient to fund operations until the end of 2024. This extension is due to cost-saving measures we have implemented and that we will continue to drive. Cash used in operations totaled $70 million in the first semester, largely for ongoing clinical trials, CMC, and regulatory activities. It is important to note that H1 cash consumption includes $24 million of non-recurring costs, such as comfort study startup costs and supply chain activities. Our operating income amounts to $2.6 million for the semester, now exclusively composed of the research tax credit following the termination of the collaboration agreement with Nestle Health Sciences. Operating expenses totaled $65 million, a 28% increase from last year, driven by Viaskin Peanut clinical and CMC activities. Again, a third of it comprised non-recurring expenses, leading to a net loss of $60.5 million for the semester. We continue to maximize the efficiency of our spending and remain highly disciplined in our cash management. That concludes the financial overview, and I'll turn the call back to Daniel for closing remarks.

Merci, Virginie. Before bringing the call to your questions, I would like to recap our anticipated milestones for the remainder of 2024, which is a critical year for DBV. By the end of the third quarter, we anticipate completing enrollment in our ongoing VITESSE Phase 3 efficacy trial in children aged four to seven years, and we will communicate once that's done. Secondly, we believe that DBV's proposed labeling approach is a pragmatic solution backed by robust analyses and data from EPITOPE. Importantly, on April 29, the Office of Vaccine Research and Review, known as OVRR, stated that non-COVID related backlogs for products such as ours are now behind them, and the agency would have more bandwidth for interaction with sponsors. We are seeing that firsthand in our interactions with the agency in the last few months, both for CMC questions as well as clinical-related questions. We are encouraged by that. Later this year, we anticipate having the year three results from our ongoing open-label extension EPITOPE, our successful Phase 3 trial in toddlers. Recall that we observed further significant improvements across all efficacy parameters in desensitization year two. We look forward to sharing with you later this year the year three results and the publication of the year two results in a medical journal. I want to thank everyone on the phone and webcast for joining us today. I will now ask Pharis and Virginie to join me for the Q&A.

At this time, we will conduct the question-and-answer session. And our first question will come from Jon Wolleben with Citizens JMP.

Hey, good afternoon. Thanks for the update and taking the questions. Maybe just one quick clarification on the label-in, label-out, and then I have some follow-ups on that. When you say patch wear time experience, do you mean how long the kids are wearing the patch or the experience they have while wearing the patch or an interplay between those two concepts?

Yes, important question Jonathan, thanks for asking. No it’s the former. It’s the fact that some kids wear the patch easily 24 hours a day. Other kids vary more from one day to the other. So that patch wear time experience measured in hours of wear varies in some patients, and that’s the data that is rich to identify patients who will be the best responders in a nutshell. Pharis, is that a good way to put it?

Yes, that’s a good way, Daniel. The other way I like to think about it, Jonathan, is it’s kind of like a holistic experience, right? So not just is the patch there or not, like an adhesion type of assessment, but it’s the day-to-day variability in the wear time. It’s the individual sensitivity, tolerability, itching, and the overall experience they have while wearing it. There may be some lifestyle components that are a little harder to tease out, but it’s not just one element. And as Daniel said, you can look at average daily wear time, but that doesn’t always tell you the story in terms of day-to-day variability. So I like to think of it as a more holistic experience with the product. Does that help to kind of fill in some of the gaps there?

Yes. Well, does that make it harder to quantify them, though, than a simple number of hours worn?

No, not necessarily. We just – it’s kind of the opposite. We have a lot of data, and we can look at a lot of different parameters. With all of that data, you can get a pretty good sense of the type of experience the patient’s having. Obviously, we can't talk to the patients, right? But there's so much data that we collect in our trials that you can get a pretty good characteristic of these patients, and there's really quite a clear differentiation between those who are labeled and labeled out based on this whole accumulated dataset that we have on them.

Got it. Okay. You guys said there's an association between a robust clinical efficacy response. I'm wondering if you could put some parameters around what you define as a robust response, and then what percentage of the EPITOPE patients were label and label out based on this criteria?

Do you want to take it or want me to take it?

Yes. I can take it. Yes. At this point, because we're still in dialogue with the FDA, it's probably not the best idea to throw out specific numbers and details, but we know this data set really well, and those numbers are robust in terms of what you've seen in the past from the EPITOPE results. It is a pretty good separation between those labeled in versus labeled out. I know that's kind of vague, but at this point, until we have final agreement with the FDA and have wrestled this down, it's probably not the right time to discuss it. As we move forward, we will present all of this in a public fashion.

Fair enough.

There's a reference point I would add here, Jonathan. We have a 67% overall response rate, so obviously, the label in subjects would have a better response rate than that. By definition, it's a traditional enrichment strategy here. The quantification will come down to the agreement we reach with the agency, and once we have that, the details will be shared at that point in time.

Got it. And one last one for me, an update on COMFORT Children. You guys don't have any expectations for feedback timing there, it seems. Wondering, do you think that any progress with COMFORT Toddlers would help with COMFORT Children, or are there different issues and feedback from the FDA there?

Yes, I'll take that one, Ferris. The two are intertwined. The ability to get to the right protocol design for COMFORT Toddlers was an element of COMFORT Children. We wanted to solve for toddlers first before addressing children next year as the next step in our discussions with the agency.

Got it. Okay. Thanks again for taking the questions.

Thank you. That concludes our call for this afternoon. Again, we are pleased with our progress in the first half of the year. We look forward to achieving the additional value-creating milestones that I described this year and next. As always, we will keep you posted on our progress, and I wish you all a very good evening.

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