Full Year 2020 DBV Technologies SA Earnings Call
Good afternoon, and rockets and BBVA.
And <unk> technologies full year, 'twenty, and 'twenty financial results and business update conference call. At this time all participants are in a listen only mode. Following the formal remarks, well open up the call for your questions. Please be advised this call is being recorded and the Companys requests at this time I'd like to turn the colorant and Pollack head of Investor.
Relations and please proceed.
Thank you operator.
This afternoon D V D technologies issued a press release that outlines our financial results for the full year ending December 31, 2020. This release is available and the press release section of the D V D 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 development plans, our anticipated future interactions with regulatory agencies and our financial forecast. These forward looking statements are based on assumptions that are subject to risks and uncertainties that could.
Cause the Companys 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 a en masse 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 todays call are Daniel TASS Day, Chief Executive Officer of D V D.
Sebastian Robotize, Chief Financial Officer Officer, Pascal Bolting, Chief Technical operations Officer, and virus and all hitting Chief Medical Officer.
And we had originally scheduled this call from last Thursday, and then decided to shift it to today I would like to provide some context on the day change.
This is our first financial reporting period for D V D. As a U S. Domestic filer, we will now file our financial results and U S dollars. According to both U S GAAP and I FRS and in both English and French and as you can imagine it is an enormous amount of work coordinated among internal and external teams and both the U S and France, we decided to take one.
Additional week to confirm all requirements where net.
It is now my pleasure to hand, the call over to Daniel Daniel.
And thank you and thank you all for joining us this evening.
So 2021 and D D D. Our highest priority is advancing bias and peanuts and body.
The United States and in the European Union.
We are committed to its potential approval as a treatment for children ages four to 11.
And from peanut allergy and we are making important progress on both fronts.
First let me provide you an update on.
On the European Union side.
In the fourth quarter of last year, the European medicines agency or EMA valid.
Validated our marketing authorization application for bias Peanuts and began the review process.
We recently received the day 120 questions from Dnb review team.
The list of questions is consistent with what we were expecting to receive at this stage and the review cycle.
And are aligned to our pre filing conversations with the EMA.
Of note, we did not receive any questions about the impact of additional and efficacy or a request for patch modification.
Now turning to the U S side.
Since receiving a complete response letter from the food and drug administration and from the FDA in August we have made significant progress on modifying our patch.
As a reminder, our CRM outlined the agencies' concerns regarding the impact of patch adhesion as it relates to efficacy and indicated the need for patch modifications.
The FDA agreed that the modified patch would not be and new product entity, if we met their data requirements.
And our manufacturing process was engineered with the long term potential of the whole basket and technology platform and mine. So it has the flexibility to produce multiple types of patches.
And I will turn the call over to Pascal wouldn't link our Chief Technical operations Officer, who is leading the pack manufacturing engineering, and just Harris and bogie Dean our Chief Medical Officer, who is meeting obviously clinical development regulatory to provide you more information on the past modification process and.
And now we are planning to evaluate one or two modified patches in children ages, four to 11, who suffer from peanut allergy and.
Pascal, let's start with you.
Thank you Danielle.
And good evening to everyone on the corner.
As Daniel mentioned, we have been walking on modifying the patch for the past few months.
We decided that we would not.
And the attribution shambo, which is comprised of.
Diameter of that easy for Murray.
15, microgram dose of peanut protein.
And the backing of the full moving on to which peanut protein is price.
We said that Palmetto keeps a critical drug delivery and make an easing of the patch unchanged.
Then we indentified solid future of of the parts that we could potentially improve.
We improve adhesion.
For example.
We could.
Increase the <unk>.
Surface area or shape once that is if dressing that cobalt so present and timber.
I'll be modifies application system for it.
Example, the Paypal Cato and.
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And I would tell the parts application for the quarter.
For example.
<unk> down on south deep dressing for a few seconds.
Going through this process of changing one of more volume, but it's associated with a patch.
We created many body fight prototypes that we put through several homes of development and testing to select.
The one.
With increased debt even.
To that and we first conduct at several new and be taught that too.
Stimulate the child's movements, that's quite seen behaviors.
Second do we conducted also in vivo studies and others to evaluate the impact of esports and potential.
Potential changes.
And two the application protocol.
Although several of homes of development and testing, we subsequently narrowed its a field.
<unk> five.
<unk> modified touches.
Advanced to a quieter in healthy volunteers with a goal to.
And to paying one or two.
Eventually.
And then into clinical testing.
Testing and Chiseling ages 411, we've seen net.
LG.
One these one off towards the purchase of selected Mike.
My team expects to focus on producing the clinical batches.
And preparing our CMC processes with on Whitestone and their partners.
Potential commercial scale.
If the Apache the proof.
I will not tell us that code over to <unk> to discuss the clinical development program for the modified purchase.
Q.
Thanks, Pascal and good evening everyone.
We expect to conduct three clinical trials to evaluate the modified biased and peanuts patches.
The first trial is the one Pascal just mentioned we called this one chap.
Which stands for comparison of adhesion.
<unk> modified touches so C H and M P.
I'm pleased to say that this study is already underway.
Channel is a trial in healthy adult volunteers.
We'll assess the adhesion of five modified taxes versus the current patch.
The volunteers, where the pouches for 24 hours and the adhesion of each patch is assessed at multiple time points throughout the day.
The trial protocol includes real world conditions, so on the.
Volunteers will wear a patch when showering or building enduring exercise periods.
We believe the data will help us select the one or two modified patches that performed the best.
Which we will then use and the clinical trials and the target treatment population.
We expect all participants to have completed the trial by the end of March.
We are also planning to other trials.
As a reminder, in January we announced that the FDA provided clear guidance on the recommended next steps, we should take to advanced bias and peanuts and the U S.
The agency recommended that we conduct two trials in children and you just fortunate 11 with peanut allergies.
One trial is on Allergan uptake trial to compare the current patch two and modified patch.
And the intent here is to demonstrate that the occlusion chamber performs similarly and both patches.
We've conducted is somewhat similar trial in the past and healthy adults.
We assess how much protein is released from the patch over the course of 24 hours.
So we have experience and conducting a trial of this nature.
We're calling this new trial equal which stands for equivalents.
And uptake of Allergan.
We expect the data from this trial will support that and modified starch and should not be treated as a new product.
And that we should be able to use data from our existing peanut development program.
The other trial and the intended patient population is expected to be six months safety and adhesion study.
We're calling this one stop.
<unk> stands for safety.
Tolerability and adhesion of modified patches.
We have previously assessed adhesion and our pivotal phase III study.
So we also have experienced assessing this parameter.
And of course, we have collected 30 day and all of our clinical trials.
And that's just standard practice.
Neither stem more equal would require the double blind placebo controlled food challenge that and treat or exit.
And this should help to facilitate recruitment.
As I stressed on our last call. We will continue to work closely with the agency to align on the protocols and.
And the statistical analysis plans for these trials as our next step.
Once we have that alignment, we will provide an update with more details around the trials, including timelines.
Now I'd like to turn the call over to our Chief Financial Officer, Sebastian robots to review our financial results.
Thank you Paris, and good evening to everyone on the call.
And yesterday, we issued the press release, we though.
2020 financial Wizard.
As a reminder, as of January through did.
Did he became the U S domestic photo and.
Our pre cable assets you will.
So you will notice that they will fight on shore wisdom, and the corresponding financial statements.
We bought it.
And U S dollar and.
According to both U S GAAP and <unk>.
And by the EU.
We had previously qualified as a private insurer and.
And reported in euros, according to Ias or with somebody.
Our cash and cash equivalents as of December 31st.
2020, well 196.
<unk> built out.
And you don't see U S law.
We continue to believe we will see both the well operation until the sickle and half of 2022.
For a full summary of our financial results for full year 2020.
Please see the press release issued.
Yesterday.
And no I would tell on the call back to Daniel for some closing remarks.
Thanks Sebastian.
So in summary, we are making good progress on advancing <unk> and peanuts.
Towards potential approval from both the U S and the U.
And that is our top brand for 2021 and everybody here at <unk> is highly committed to the potential to bring Baskin peanuts, if approved to children ages 411 and.
And the peanut.
Allergy their parents and loved ones and the allergists, who treat them.
With that and I would like to open the call for questions on.
Operator.
Thank you well now begin the question and answer session.
If you have a question. Please press Star then one on your Touchtone phone.
If you wish to be removed from the queue. Please press the pound sign on and have key.
Using a speakerphone you may need to pick up the handset first before pressing the numbers. Once again if you have a question. Please press Star then one on your Touchtone phone and.
And our first question comes from Alex Kurtz from Kempen. Your line is open.
Hi, and thanks for taking my questions.
Great to see that you're making progress on the.
Patches for the FDA.
Just wondering in relation to your European application.
And how would the European filing the effect, it's usually have a updated batch going through the FDA process later on.
And as a second question also on the European Best since you're.
Review is progressing nicely and what is your latest thinking on commercialization in Europe over the batch. Thank you.
Okay.
I'll have ferrous gives you a sense of how we would deal with having two different patches.
It has been a non issue that clearly and then after that I will provide you some color on how we think the commercialization so ferris.
Yeah, No I think Alex part of what you may be asking.
Is perhaps the difference between the European review process and the FDA.
And.
There are two separate regulatory entities as you know.
Although we are providing a modified product.
And the U S.
We're obviously moving forward with the current product and Europe, and then we don't see that as any problem from a regulatory standpoint to have one product and one region and and modified product and the second and vision.
Does that answer your question Alex.
And yes, I guess.
You are collecting additional safety data.
And that's something that the European regulator would see.
They could potentially see it Alex but our Dawson and it has been submitted and they have validated the Dorset and their complete in their review process.
Process as scheduled and so I don't think that factors into the European Dossier review at this stage.
Got it okay that I would also add Alex if I may debt with the current patch and from that the European regulators and the safety has not come up that's b.
<unk> concerns so different profit different profile in the U S is there is an independent regulatory question, but it would be if the es questions for us will be happy to share data with them obviously.
And maybe another element of your question before I move to commercialization.
Very constant and our ability to manufacture two patches that are somewhat different for two geographies to be able to do that at scale with great efficiency and we will manage cost of goods is not a concern of ours again, because our manufacturing equipment has built and flexibility for app and time to have more than one pass from the market anyway.
Cross more than one indication so the complexity and manufacturing is not a major issue at all when it comes to commercialization.
And we could commercialize it ourselves so we can essentially flat on a partner to commercialize it in Europe.
We are in the position to pursue both and we're comfortable with those and the right kind of partnership to bring scale and expertise quickly somebody and so obviously desirable on young and support it we know very well ourselves.
So we remain very open minded and somewhat agnostic to the best way to satisfy patients and maximize value for our shareholders.
And then two questions.
Yes, that's very clear and.
Thank you and congrats on the progress.
Thanks, so much and thanks for calling us at Fastweb and P. M at night.
And I'll probably yeah.
And just as a reminder, and entered the queue. Please press Star then one on you touched on phone and a nice.
Question comes from Craig Savannah from Goldman Sachs. Your line is open.
Hi, good afternoon, good evening and thanks for taking my questions. Congrats also on on that forward progress on both U S and European processes.
And could you give us sense.
And of.
And how those discussions and interactions with the FDA are going on and clearly.
But to see our LS.
Maybe put.
You know.
A little bit of a risk on some level.
Between maybe you and agency or maybe not but now that you are where you are is there any any.
Date that you can provide on how you think the nature of the interactions are going clearly and moving forward with trials, but I just wanted to see if you were able to offer any kind of perspective, there and then.
Maybe if I could ask maybe two more questions just one with.
With respect to the three different trials you have ongoing how do you intend on communicating.
The outcome of those trials and it's something that you would update us and.
Periodically.
Our quarterly updates or is there and a plan to put out Standalone press releases, just wondering how youre going to.
To do that.
And then maybe third.
And maybe I'll jump back into queue is any insight on.
And what's happening with the competitor product now that it's been kind of absorbed into necessarily we don't really have any good visibility on what's happening with that practice on any anything your competitive intelligence is telling you on on what's happening there.
Okay. Thanks for those questions and thanks for joining us Tonight.
Let me give you a bit of and answer on the tone with the FCA, but then the turnover to ferrous obviously with him and his team on managing that and then I'll come back to.
Plant indication on trials and on immune products and that owned by necessarily success and marketplace.
Look last year was a frustrating year I think for many companies, giving with the FDA because the pandemic rightfully so.
A lot of management attention to the agency.
And but that being said.
We see the tone on.
This euro what has been their response to our plan to generate data on the modified patch as to secure approval eventually as being very constructive.
And we're kind of talking with the agency to be one debt is collegial.
We believe that modifying the patch is something that's a matter to the agency and in doing so we have obviously.
The rich exchange with them.
And the agency wants US review of protocols, which we want to do anyway. So that by the time, we go and execute on those trials.
We'll work on something that is very much aligned with the agency force. So I'll invite ferrous and make you a few more comments on this before I come back to communication on the trials cost anything more you won't provide us color on the dynamic with agency.
Yeah, Thanks, Daniel I think Greg.
The tone.
The communication, we were very pleased with the tone and as we've said at the previous call.
Clarity provided by the agency, we feel that they have provided very clear regulatory path as we have described with the two studies.
So that for us.
What is very important obviously.
And then as Daniel said, the next steps will be to align with.
On the protocols and the details around the protocols and as those become <unk>.
Clear, we'll obviously communicate that.
In the appropriate time as we receive that feedback.
Does that help a bit.
It does thank you.
And on communication around the trials.
Greg.
Our next major communication will be once we have the agency signed off on the protocols industrial we're ready to go we will know when the study will start when we expect the studies to complete and obviously would that would mean roughly for re filing I think that.
Planning horizon will be important for us to share with investors with.
Prescribing physicians with patient advocates or if people wanted to know where we are so we certainly plan on having a.
Helpful communication to the whole world, including investors once those agreements with the agency have been secured.
As far as the results of those trials, we have not made a decision yet, but I think we and our previous same way. We've operated in the past is transparency serves everybody here patients doctors want to know as you know our data last year that we use to discuss with the agency and exchange with them to answer the.
On the beach and we chose to have published peer reviewed publications and two of them because we believe that clinical science regulatory decision, making and patient's interests are best served by transparency. So I suspect that we want to publish that data. The decision is not made yet and it would be very much aligned to what it's been historically our philosophy.
And here.
So.
And then when it comes to power force. He is a success and the marketplace, we have no visibility to it.
Obviously, it's not that big of products and the scale of misleads business, they're not reporting on it what we're picking up from marketplace.
And he is obviously I'd like to think of.
<unk> is not a complete set of information here and I wouldn't want to provide any color of debt as you know which will be informed what we are hearing though is that the pandemic, assuming you're driving home, how the two product profiles ours bias and peanuts and and total.
Politicalize <unk> are fundamentally different products.
And the demand being put on patients caregivers and.
And and medical practices.
To dispense Oi T. Our August and he clearly problem and headaches.
In the independent <unk> environment, and we believe that he is just reinforcing the distinct and we think preferential product profile, we have for most patients.
Okay. Thank you for investors and helpful.
Yep, that's great. Thanks.
Thanks, Craig.
And our next question comes from John will it on from JMP Securities. Your line is open.
Hey, congrats on the progress and thanks for taking the questions just a few from me with him.
And you mentioned that Youre looking to identify one or two of the best performing patches.
Is there anything besides adhesion and Youre looking for and are you looking if it is in fact adhesion is it the two baskets and Hugh.
Adhesive patches are you looking for kind of opposing metrics on.
From some scale there.
And then previously you said FDA and we'd like to see a consistent uptick between the modified patch on that initial one is there any.
Boundaries on what's considered consistent uptake or is it.
And just up to you to determine and present the data that debt.
It comes out.
Yeah again on the surface at some colors here.
The consistent uptake, we believe will not be problematic, we read it as good or better because no better protein delivery, obviously can only impact efficacy and a positive way here, but given the fact that we're not changing the interchange.
And the and the.
The abuse of property of the phone ring, we don't expect that the protein transport would be affected in any way, but we will keep for equivalents with slightly better conceptually with agencies and effectiveness.
Yes.
And when it comes to adhesion know, we're looking for better adhesion the F D. A.
As you as you sort of who mentioned it is not concerned about the safety of the product.
Do you think adhesion will lead to better efficacy. So we're solving for adhesions here, obviously, it would be attentive to the other properties, but our effort is focused on finding a patch and it goes well and realized conditions.
And you want to add to that service.
And maybe Pascal.
I think that's it.
Jonathan.
And I'd answer your questions.
And Thats helpful. Thanks for the color. Thank.
Thank you.
And just as a reminder, and entered the queue. Please press Star then one on your Touchtone phone.
And were skinny back from my questions.
And we currently have no questions from the queue I will turn the call back over for final remarks.
If there are no more questions I just want to again. Thank you all for your time today.
As we have agreement and closure with the agency on the protocol, we would be happy to communicate all of that to investors and the interim as you know we're always available for any complement of inflammation.
And then may come to mind between now and then thank you all for your time this evening.
And and wish you and ICP.
Thank you ladies and gentlemen.
Today's conference call. Thank you for participating and you may now disconnect.
Okay.
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