Earnings Labs

DBV Technologies S.A. (DBVT)

Q2 2021 Earnings Call· Mon, Aug 2, 2021

$20.76

+1.81%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.
Transcript

Operator

Operator

Good afternoon, and welcome to the DBV Technologies First Half 2021 Financial Results and Business Update Conference Call. My name is Reece, and I am the operator for the call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open up the call for your questions. Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn it over to Anne Pollak, Head of Investor Relations. Anne, please proceed.

Anne Pollak

Management

Thank you, Reece. This afternoon, DBV Technologies issued a press release that outlines our financial results for the six months ending June 30, 2021. This release is available on the Press Release 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, our anticipated future interactions with the regulatory agencies, our financial forecast and our expectations regarding our potential patient population, allergists and patient caregivers. 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 today's call are Daniel Tassé, Chief Executive Officer of DBD; and Sébastien Robitaille, Chief Financial Officer. It is now my pleasure to hand the call over to Daniel. Daniel Tassé: Thank you, Anne, and thank you all for joining us in this afternoon, late afternoon and evening. As you know, DBV's highest priority is advancing Viaskin Peanut in both the United States and European Union. We are committed to pursuing its approval in both regions as a treatment for children ages 4 to 11 with peanut allergy. I'd like to highlight the important progress…

Operator

Operator

Thank you. We will now begin the question-and-answer session. [Operator Instructions] Okay. Our first question is from Graig Suvannavejh with Goldman Sachs. Graig?

Graig Suvannavejh

Analyst

Yes. Can you hear me okay? Daniel Tassé: We can hear you, Graig very well. How are you?

Graig Suvannavejh

Analyst

Okay. Thanks for the update Daniel and Sébastien, and I've got a few questions, if I could. And maybe three that I can think of off the top of my head. One, is there any color you can provide on the update you provided on Europe and the one major concern in terms of what that major concern is, or if you can't discuss what that major concern is, your comfort level and being able to adequately address that major concern? My second question is in regards to the newly disclosed PREQUAL study; at least it was new to me. Just talk a little bit more about that study and importantly, how that may or may not impact how you have been thinking about potential BLA submission time lines? And then with a third question, Daniel, we had a chance to catch up in June at our health care conference, and you had a view that perhaps you’d hear back from the FDA. And in a relatively short time, it seems that at this point in time, you have not heard yet back from FDA. And so I wanted to get your thoughts on how you are feeling your dynamic is in terms of your relationship with the FDA? And with regards to, do you feel that you have a good sense of where the agency is right now in light of the previous history with the program? Thanks. Daniel Tassé: Yes, Graig, thank you. Let me answer the question in that sequence. Yeah, we are very confident we can answer EMA's questions. So we chose not to comment on them publicly because it is an ongoing process with the regulatory agency, which we want to be respectful of. The EMA process is a good healthy one with prescribe touch…

Graig Suvannavejh

Analyst

Okay. Thanks a lot. Daniel Tassé: Did that I answer your questions, Greg, yes?

Graig Suvannavejh

Analyst

Yes, it does. Thank you.

Operator

Operator

[Operator Instructions] Our next question is from Jon Wolleben with JMP Securities. Jon, please begin.

Jon Wolleben

Analyst

Hey. Just here for JMP. Thanks for taking the question and thanks for all the color. I guess to Graig’s previous question, can you discuss a little bit if you've gotten feedback from FDA on the EQUAL study and then how to think about the sequence of EQUAL and STAMP? Do you have to finish EQUAL before STAMP, or are these going to be run in parallel. Can you just remind us of that timing? Daniel Tassé: Important question here, Jon. They will be run in parallel, which is why we first sent the STAMP protocol to the agency before the EQUAL protocol, because STAMP will be a six-month study. So, obviously, it will take a bit longer than six months to run it, given, obviously, the logistics running a clinical trial. While EQUAL is a study can be done rather quickly, in a matter of a few days, and I think patients essentially be under observation by the investigators here. So the rate-limiting trial in time is STAMP which is why we file that one in the first place here. The discussions with EQUAL with the agency are very much ongoing. We're exchanging ideas and approaches and pre-EQUAL as part of that dialogue here, because as part of the sing-off on the EQUAL protocol, we would like to have obviously full agreement and methodology, given the fact that we're doing here is not technically extraordinarily complex, but not a study that typically done, as you know. I want to make sure that again we have all of our assays lined up, methodologies well defined and the FDA comfortable with them. So, again, it's important work, but it's not a rate-limiting work, which is why we filed stamps. Hopefully, that answers your question.

Jon Wolleben

Analyst

Yes, that's helpful. And can you give any color as far as your expectations? Are you still not planning on including a double-blind food challenge in stamp, or has that been in discussion with FDA recently? Daniel Tassé: No, that is not in discussion with FDA. The FDA is not asking in either stamp or equal to measure the efficacy of the product. So there's no need for the double-blind, placebo-controlled food challenge here, which, as you know, is an intimidating element of clinical study in food allergy because it's uncomfortable for the parents for the clinicians, particularly obviously for the child. There's no need for double-blind, placebo-controlled food challenges, which is why, again, we believe that both equal and stamp will be relatively straightforward to recruit patients because you don't have that intimidation or difficulty factor that often complicates [indiscernible].

Jon Wolleben

Analyst

Got it. And one more, if I may? Daniel Tassé: Did that answer your question, yes?

Jon Wolleben

Analyst

Please, yes. You mentioned the feedback on the two patches from the advisory board, the caregivers and the KOLs. Can you provide any color on what they said, whether one patch was favored over the other, or any kind of feedback between the two? Daniel Tassé: It was important to us for a number of reasons to do that work. So if I can provide a bit more color here why we did it. First of all, we certainly want the medical community and patient community to have ownership of the patches that we choose to given the fact that, as I said, the patch is still very much awaited by patient, patient advocates and treating physicians. But I want to make sure that all the elements that goes more to application of the patch, clarity on how we use it, anything that goes – we call the softer side of treatment compliance with something we understood fully before choosing the patches here. And what we had as an outcome would be pretty -- typically, we do expect between two products. It was pretty much split 50-50 in preferences with no big difference between number one and number two is where we choose one, we choose the other, will be, I think, absolutely indifferent to the trading community, but we thought that having their feedback was important.

Jon Wolleben

Analyst

Got it. All right. Thanks again for all the color. Daniel Tassé: You're most welcome. Good questions, both you and Graig.

Operator

Operator

[Operator Instructions] Looks like Graig has a follow-up, so we will go to him next.

Graig Suvannavejh

Analyst

Thanks. Daniel, if you could comment maybe on activities that go beyond the initial four to 11 indication for, I guess, Viaskin Peanut and the modified patch formulation? I guess more in particular, I'm asking about earlier ages for Viaskin Peanut, some of your other allergy programs? And maybe just a follow-up on maybe with Sébastien on the financials, just on some clarification around the revenue accounting for the Nestle collaboration in the quarter? Thanks. Daniel Tassé: Sure. Okay. Let me take the first two questions, and then I'll have Sébastien respond to them. So back to your first comment here, some do this in a proper sequence. It was around – the one- to three-year old. That study has – the last patient first labs visit took place in the first quarter of this year. So last patient labs visit will be in the first quarter of 2022. And then we will be obviously unblinding and sharing the data with the community and regulatory agencies once that's done. But that study is currently fully enrolled, and we are in the 12-month follow-up for the patients who enrolled fast. The work on the milk patch, as you know, is waiting closure with Viaskin Peanut by our choice here, given the fact it's the same technology and we had a number of CMC questions as we all know. We chose to gets to the right spot with the FDA or in Peanut before filing or filing before having the end of Phase II, Phase III planning discussion with the agency. In parallel, as you know, the application of the milk patch to EOE is something that work was done at CHOP and that remains something that we're interested in pursuing also. So the milk patch actually may have 2 phases to it when it comes to clinical development to go in Phase IIb and Phase III, one application to the prevention of meal allergies and the other one to the treatment of EOE. Again, all of that will come once we have a clear regulatory pathway with the FDA on the peanut product. If that has satisfactorily answered your questions, I'll pass it on to Sébastien. If not, please ask so that -- you question the properly answered.

Graig Suvannavejh

Analyst

I'm good there. Would love to get some color from Sébastien. Daniel Tassé: Séb? Sébastien Robitaille: Yes, sure. Yes. So, as you may know, nonrespondent and milestone payments are deferred and recognized as operating income over the period of the collaboration agreement. And regarding delay we have on the Phase II space with Nestle with under our collaboration the revision of the Magic communal revenue due to the delay of the program has led us to the recognition of negative revenue for quarter and the 6 months ended June 2021. Do you have a question?

Graig Suvannavejh

Analyst

Yes, thank you.

Operator

Operator

And I see no further questions at this time. Speakers, do you have any closing remarks before we conclude? Daniel Tassé: No except, thank you, everybody for attending today. And as you know, Row is available as a phone call away for any follow-up or clarifications and wishing everybody a safe and restful rest of the summer.

Operator

Operator

Excellent. Thank you, ladies and gentlemen. This concludes today’s conference. Thank you for participating. You may now disconnect.