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

Good day, everyone, and welcome to the DBV Business Update Conference Call. [Operator Instructions] Please note, this call is being recorded. Now I would like to turn the conference over to Jonathan Neely, Investor Relations. Please go ahead.

Thank you. This afternoon, DBV Technologies provided a regulatory update for the Viaskin Peanut patch for children aged 4 to 7 years. 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 clinical and regulatory development plans, the design of our anticipated clinical trials, the timing and 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 is Daniel Tassé, Chief Executive Officer of DBV. I will now pass the call over to Daniel. Daniel?

Thank you, Jonathan, and thank you all for joining us today. As mentioned in our press release this afternoon, over the recent weeks, DBV has been having ongoing conversations and exchanges with the FDA regarding elements of our BLA with the intention of ensuring a complete, efficient and timely review of our upcoming Biologics License Application, the BLA for the Viaskin Peanut patch in children aged 4 through 7 years of age. These extensive detailed conversations with the FDA are the kind of exchanges a sponsor would anticipate following submission of a BLA. They have been especially valuable for a novel, unique and complex product like the Viaskin Peanut patch that requires a similarly unique and complex submission package. And to be clear, the FDA has not requested additional data. DBV and the FDA have collaborated through a series of iterative meetings, information exchanges and filings to the Viaskin Peanut IND. Through this process and based on its review, DBV received valuable actionable input from the FDA specific to the organization, mapping and formatting of existing data sets for the CMC section as well as statistical -- biostatistical elements of the BLA. To provide some context for these exchanges, as we all know, the Viaskin Peanut patch is a unique and first of its kind drug device combination, which will be reviewed and approved as a biologic and therefore, sits at the intersection of many steps of regulations. There is no analog for Viaskin Peanut. We have charted this regulatory path working closely with the FDA along the way, and we're grateful for their feedback and interaction. To give you an example, given the size and overall complexity of our submission, topics have been -- in part, been focused on ensuring the completeness of the BLA as well as identifying and mapping the location of data within the BLA to help the agency with the efficiency of their review. We are grateful for the FDA's constructive engagement at this stage of the work and believe by taking the required time to incorporate their feedback, we will strengthen our BLA submission. We plan to submit our BLA in the third quarter this year. Sorry, I skipped the page of my script here. Sorry, my apologies. The need for new treatments for children and families living with the daily burden of peanut allergies is significant, and we feel a profound responsibility to advance the Viaskin Peanut patch as thoughtfully and efficiently as possible. With this feedback in hand, I look forward to optimizing our BLA submission and moving with urgency towards our goal of bringing Viaskin Peanut patch to patients who need new treatment options. I'd be happy to talk to you more about the nature of the feedback we received from the agency and answer your questions. I'll now pass it on to the operator for the Q&A.

[Operator Instructions] Our first question today comes from Kristen Kluska of Cantor Fitzgerald.

So the things you mentioned today typically sound like the things that arise in the middle of a regulatory submission. So on one end, very good to kind of iron this out now versus have it delay things down the line. But I'm just curious why the level of conversations were so detailed at this stage before the formal submission. Is this in part based on the designations on hand you've seen? Or any color there would be really helpful.

No, absolutely. The conversations have been very rich with the agency for many months now. And when the complexity of the BLA, given the fact that, again, it has no analog became something that the agency want to make sure that their review is efficient. then the dialogue started to make sure that everything that matters to the FDA was in the BLA. And importantly, easy for them to find. You probably know that a lot of time is spent by the FDA trying to find documents in the BLA. And the idea here was to work with them to make sure all of it was structured, mapped and easy for them to find and to make sure it was complete. So you're correct. Typically, these conversations will take place post filing. We very much welcome the fact that we've had these conversations prior to filing. Did answer your question, Kristen?

Yes. And then are these factors also going to play into your BLA filing for the 1- to 3-year-olds when that occurs? And are you -- is there any other feedback or things that you can collect that are going to help with that process so that once that one is in good shape, maybe the meetings subsequently with the FDA will have already occurred as part of this 4- to 7-year-old submission?

That's an excellent question. The answer is yes. We expect that the conversation we've had right now about how to build the best BLA for the FDA to be able to review it efficiently in a timely way is going to make us a lot smarter as we put together the BLA in 1- to 3-year olds. As you can appreciate, this is -- there's nothing that looks like our product. There's no analog. So we're doing this along the way here. So dialogue with the agency on 4 to 7, obviously, will make us smarter and faster in putting the BLA together for the 1 to 3.

Next, we'll hear from Sushila Hernandez of Kempen Investment Banking.

So do you still expect that the BLA may be eligible for priority review? Or what is your latest thinking here?

Yes, we are -- we have breakthrough -- thank you, Sushila, for your question. We have breakthrough designation and thus, we are eligible for priority review. Our plan is to ask for it. And obviously, the work that we're doing right now will make that under any time frame, the review by the agency to be facilitated. So our plan is to ask for it. As you know, we get the answer at day 60 post filing.

Okay. And then in terms of time lines for incorporating the feedback from the agency, will this be a matter of days or months to finalize it? Yes, is it something that you've already been working on and just cutting it close to your own deadline?

Yes. So we are pretty rigorous with Gantt charts and planning at DBV sort of an operational focus of us. So all of this feedback from the agency has been mapped out. A lot of it can be done in parallel, obviously. We will be filing in Q3. We have a very clear plan to get it done and a clear date in mind. At this point in time, we're guiding to Q3. What I think anybody involved in filing a BLA can appreciate there's not only the changes the FDA is asking us to do, but there's a domino effect. We have to make sure that as we change something in one place in the BLA, another table or listing that essentially is connected to it will also be affected. So the element of QA/QC, if you make a change is significant. And then the e-publication of the BLA, just to go to the portal alone at the agency takes a few days given the size of the file and the need for all the proper firewalls here. So all that to say, all of that has been mapped out and can start it very closely.

Okay. And then there are no issues with the manufacturing sites that you've been contracted. It's really more about mapping out the information that you already have.

That's exactly it. The FDA has not received the BLA yet. So they want to make sure that once they do get the BLA, all the things that matter to them are there and that they can find them and find them easily along as you can imagine, there's a number of sort of sister and domino documents that come with the BLA to make sure that it's easy to access for the FDA. Does this answer your question?

From LifeSci Capital, we have Sam Slutsky.

This is Gaurav on for Sam. Just a couple for me here. So can you give color on the specific feedback the FDA wants you to incorporate in the BLA filing for 4- to 7-year olds that wasn't there prior? And then could their information request potentially change the interpretability of the clinical results?

Yes, great question. Let me start with the latter question. The answer is no, simply because the FDA has not seen the content of the BLA. So the questions we got from them and their suggestions are not reactions to data in the BLA and interpretation here. So no, the changes we're making are not meant to address observations about the content of the BLA, the interpretation of it. This is simply to make sure that all the data the FDA needs is structured in a way that's easy for them to review and easy for them to trace. So that's essentially the comments we got from them. So no, there is nothing in there that would impact -- at least they haven't reviewed the BLA. So none of the exchanges were about content or interpretability of the BLA. Is that helpful?

Okay. Yes, very helpful. And you answered my follow-up.

Happy to help.

[Operator Instructions] We'll proceed with Jon Wolleben of Citizens JMP.

A couple for me. Just wondering, without knowing the true context or set of these changes, any chance that this could get pushed to 4Q? Or is this going to be relatively easy to maneuver through?

You asked whether or not it could go into 4Q. Is that your question?

Yes. Yes.

Sorry, I think you broke up there. The answer is no. I mean, obviously, we have to do the work. You never know what surprise to come along the way here, but we have been very precise in mapping out the work we need to do, what it means and our guidance is Q3.

Okay. And then with COMFORT Toddlers, you guys have been guiding to submission in second half of the year, 6-month study, and I don't think we've heard of enrollment completing there. So any update on COMFORT Toddlers enrollment and the time lines for that BLA submission?

Yes. COMFORT Toddlers is enrolling as planned, and our guidance remains for us to file the BLA in 1 to 3 before the end of this year. And conversations with the agency on how to think about that have been ongoing.

We have no further questions at this time. Daniel, back over to you for any additional or closing comments.

Okay. Well, thank you. This concludes our call this afternoon. Again, we're very pleased with the progress we've made. We are delighted with the feedback from the agency and remain very committed, obviously, to filing the product as soon as possible as to help transform the lives of children and families who live with the daily burden of peanut allergy. Thank you so much.