Full Year 2022 Dbv Technologies SA Earnings Call

Speaker 1: I.

Speaker 1: I the.

Speaker 1: But's many to for.

Speaker 2: Good day and welcome to the DBV Technologies full year 2022 Financial Results Conference call. All participants will be in a listen-only mode. Should you need assistance, please signal conference specialists by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions.

Speaker 2: To ask a question, you may press star then one on your touch tone phone. And 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 Ms. Anne Pollock, data investor relations. Please go ahead. ——

Speaker 3: Thank you. This afternoon, DBV Technologies issued a press release that outlines our financial results for the 12 months ended December 31, 2022. This press release is available in the press release section of the DBV Technologies website. Before we begin, please note that

Speaker 3: 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 timing and results of interactions with regulatory agencies, our forecast of our cash runway, and the ability of our product candidates to improve the lives of patients with food allergies.

Speaker 3: 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.

Speaker 3: 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.

Speaker 3: including any forward-looking statements made on this call.

Speaker 3: 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.

Speaker 3: Joining me on today's call are Daniel Tasse, Chief Executive Officer of DBV, Sebastian Rogatay, Chief Financial Officer, and Faris Mohadeen, Chief Medical Officer.

Speaker 3: I will now pass the call over to Daniel. Daniel?

Speaker 4: And thank you and thank you all for joining us on this call this afternoon.

Speaker 4: In a few moments, Sebastien will walk through the highlights.

Speaker 4: of the full year 2022 financial results.

But before he does that, I'd like to take a few moments to talk about recent clinical updates.

Last year, our top priority was to finalize the design and protocol of VTES.

the phase 3 pivotal study of the modified by skin peanut patch in children ages 4 to 7 with a confirmed peanut allergy diagnosis.

We did that and we are on track.

to screen our first patient by the end of the first quarter this year, and we look forward to providing an update when this event occurs.

our first patient by the end of the first quarter this year, and we look forward to providing an update when this event occurs. Now in advance of initiating the test,

We completed a study called EVOLVE.

a study called EVOLVE which was a 12 week

caregiver in patient user experience study with the modified bias can peanut patch in 50 people allergic children ages 4 to 11 years of age

Now, our objective with Evolve was pretty straightforward. It was to optimize the eDiary tool that families will use in VITES to best capture patch adhesion and patch experience data.

I will invite Ferris.

Just speak in more detail about EVOLVE, what we learned from it, as well as also update you all on Viacin-Pina data that was presented last weekend at the American Academy of Allergy, Asthma, Immunology Annual Scientific Meeting, the meeting that we all know as Quad AI. Faris?...

Thanks, Danielle. As Danielle said, EVOLVE was a user experience study designed to provide qualitative data on several study elements that would also be used in the test of Phase III studies in four- to seven-year-olds. For more information, visit www.evolve.com

In EVOLVE, we tested the functionality of an electronic patient diary called the E-Diary.

to collect information on activities of daily living and patch adhesion scores.

As we have previously discussed, the test will assess patch adhesion of the modified bias ginklinate patch, and we will include a statistical test of adhesion in the test that's analysis how that should collapse.

Evolve verified that the eDiary tool can be used by caregivers to capture the adhesion data in the test.

I'm also pleased to report that Evolve showed that the updated instructions for use, the IFU, supported correct patch application.

which we defined as no lifting of the patch edges or detachment directly after application.

Furthermore, the majority of parents and caregivers reported a positive ease of use experience with the modified bias skin peanut patch. We have always believed in the importance of ease of use in a potential peanut allergy treatment profile.

And we continue to believe that the overall product profile of via skin peanuts will appeal to peanut allergy families. Let's turn now to the American Academy of Allergy, asthma and Immunology Annual Scientific Meeting which took place last weekend in San Antonio.

Quad AI is among the most important and widely attended meetings on allergy and immunology each year. And VDZ had a strong presence this year as we do every year.

DDD had two epitope posters at the meeting that summarized the efficacy and safety profile of epicutaneous immunotherapy with biostim peanuts in peanut allergic children aged 1 to 3 years with and without starting comorbid atopic condition.

Specifically, we assess a treatment response or safety of biopinoptherapy with influence by either baseline atopic dermatitis or concomitant food allergy. Both of these conditions are common comorbidities in young children with peanut allergies.

each having a reported prevalence rate of 60 to 17%.

The results demonstrated consistency in bioskin peanut safety and efficacy across multiple patient groups.

those with and without other food allergies, and atopic dermatitis.

Furthermore, treatment with VioSkin peanut for one year did not appear to result in a change in atopic dermatitis severity for children ages one to three years old. We believe that these episode data analyses further validate the potential benefit of using the VioSkin platform for the treatment of peanut allergy in young children.

For those of you who would like to read the posters in detail, they can be found in the scientific publications and presentations section of the DVD website.

At this point, I'll turn the call over to Sebastian to review the financial results.

Thank you, Ferris. Let's briefly review financial highlights for the full year 2022.

Cash and cash equivalents were $209.2 million as of this on the other side of the trust.

2022 compared to 77.3 million dollars as of 31st 2021.

which is an increase by 131.9 million dollars, many due to 194.1 million dollars in 5-inch activity in Q2.

Net cash used in operating activities for the full year was $81.8 million, which is a decrease of 24% compared to prior year.

reflecting the cost containment measures that have been continuously maintained since their implementation in 2020. Finally in the last quarter our treasury

benefited from a change in the euro to the US dollar-out of trains. The company's activities and expenditures in the fourth quarter were in line with expectations and continue to maximize the efficiency of our spend and with an highly disciplined in our cash management. I will turn the call back to Daniel for closing remarks.

Thank you Sebastian. In closing.

Can you hear me? Can you hear me? Yeah, we can hear you.

I'll be back.

So in closing, I'm very pleased with our continued financial discipline.

and progress across our clinical programs.

So, can you head to the remainder of 2023? We will continue to keep you updated as appropriate on our VTS3 face-retroprog left in children ages 47, as well as our development plans for biasing peanut as a potential treatment for pinotrgic toddlers ages 1 to 3.

I want to thank you all on the phone today on the webcast for joining us and operator. Let's open the line for questions that are already.

Yes, sir. We will now begin the question and answer session. To ask a question, you may press star than one on your touch tone phone. If you're using a speaker phone, please pick up your handset before pressing the keys. And to withdraw your question, please press star than two. And at this time, we'll pause momentarily to assemble our roster. And be first.

4-11 versus 4-7, and then did you collect any other data with the patch, keys, and an Asian site reaction, Xanaflax, that's for any safety data, anything else you can learn from the evolved state of the sense, validating the E-diary.

The, I'll have Paris give you more details. Didn't it be clear now this was entirely our decision. This decision was made when we were contemplating 20 new pivotal trial. Given the fact we have a new patch, we also know Jonathan that now adhesion on application is a marker but he did obviously through the day.

And that we could be using eDiary tools to make sure that we captured all the rich data was required to inform the DLA and the label. So a decision was made on our own to sort of...

The expression to me was sort of, world the yaya is out.

to make sure that when we rolled out that tool in VITAF at PIVotal Trial, we were very confident it was the right tool for us, which is what this was intended to do. Again, it was not powered to prove or measure anything. It's something we choose to do, or chose to do, again, to make sure that we came into VITAF confident that we had a good IFU and a good tool to capture the data.

If there's anything else you want to add to that.

No, let's correct, but I can answer the other questions if you would like Daniel.

but I can answer the other questions if you would like, Daniel. Yes, please.

Yeah, okay, so hang on, how you're doing? So, as far as the 4-11 versus 4-7, so as Daniel said, this was designed to work the Yaya's out prior to starting the test. And so, with the nature of the objective of the study, being let's...

optimized that you diary and the instructions for use. It didn't matter whether you were 4 to 7 or you were 4 to 11. As long as you were a peanut allergy subject, we felt that in a caregiver parent of a peanut allergy.

child, we felt that we could generate the same amount of data and then of course recruitment for us is always...

in terms of being effective and efficient. So we wanted to generate the data in a short bit of time. So that's the reason for the 4 to 11. Nothing more beyond that.

And in terms of the other questions, yes, we collected safety data, a lot of other things, just as we normally would through any other trial. And it performed, as it always does, very consistently relative to other studies that we've seen from a safety standpoint.

Does that answer your question, John ?

Yep, that's helpful. In the prepared remarks, Daniel, you mentioned that the TESTS will be up and running this month. Wondering if you can get an update on this 275 subject safety study, you'll also be running if there's any guidance for when that will be starting. Then also, if you have any update on your progress in the one of the three roles.

Yeah, I'll have a fair sense of the question on one to three year olds. The safety trial companies, VTS, were as meant to enrich the safety database. As you know, the six month trials, both the 12 month trial enrollment is going to be faster because 275 obviously is less than 600.

In the test, as to not compete with ourselves for patients, and we're, again, planning and confident that we can land the completion of the safety trial at the same time or before the database lock of the test trial.

compete with ourselves for patients. And we're, again, planning and confident that we can land the completion of the safety trial at the same time or before the database lock of the Vitez trial. Does that answer your question?

Yes, and then that's helpful there. Just wondering about the Toddler update if there's one.

So as we said in the past, Jonathan, I will communicate with the FDA this quarter. Beyond that, it's probably not prudent to comment in terms of when we would get feedback from them. I will follow the traditional application processes. I think in one more if I may. Thank you.

Yes, so my math might be off, but I see a pretty big jump in R&D, this quarter, what I think if there's any one-off expenses in there, or how to think about spend moving forward.

Seb, do you want to take the jumping R&D question, which in a startup cost to detest is mostly what it is, but any more colour you want to provide?

Yes, of course, you are right, and it's really related to the fact that we have initiated some cost on details. And so we have some upfront with the CRO, so we have, I will say, a slight drop-up of our R&D expenses in the last few months. And so we have, I will say, a slight drop-up of our R&D expenses in the last few months.

No, it will not carry through. We will not carry through Jonathan. Again we reiterate that we have enough cash to complete the test in the safety trial with the cushion. If that changes obviously we can make that investors at this point in time. We will not carry through.

all around good financial discipline, the actual spend as an activities plan.

Q4 was very much what we had planned when we rolled out the...

the time frame for both studies.

Thank you. Again, if you have a question, please press star, then one. What is my vision?

And this will conclude our question and answer session as well as our conference call for today. Thank you for attending today's presentation. You may now disconnect.

And this will conclude our question and answer session as well as our conference call for today. Thank you for attending today's presentation. You may now disconnect. Thank you everyone.

St F, the St F F D Ion.

I.

Hi. Hi. Hi. Hi. Hi. Hi. Hi.

.....