Full Year 2021 DBV Technologies SA Earnings Call

Welcome to the D b, the full year 2021 financial results.

My name is Adrian and I'll be your operator for today's call.

This time all participants are in a listen only mode. Later, we'll conduct a question and answer session. During the question and answer session. If you have a question. Please press Star then one on your Touchtone phone. Please note. This conference is being recorded and I'll turn the call Alright, Yeah Pollack you may begin.

Thank you.

This afternoon D. B V technologies issued a press release that outlines our financial results for the 12 months ended December 31st 2021. This release is available in the press release section of the D. P. 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 and regulatory development plans, 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 improved a lot.

As 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.

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 enough 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 Daniel TASS, a chief Executive Officer of D. V D. Sebastian Robotize, Chief Financial Officer, and fires marketing Chief Medical Officer.

Daniel will provide an update on bias can peanuts, and our extended cash runway and Sebastian will review the full year 2021 financial results virus will join Sebastian and Daniel for questions at the end I will now pass the call over to Daniel.

Thank you and thank you all for joining us on the call. This afternoon.

As Ann mentioned this evening I will provide an update on two key areas of focus for D. V D. The first the clinical.

Regulatory developments of our modified Boston to my parents and the second an update on our cash management.

And our cash runway.

Now, let's turn device can peanuts.

During our last corporate update in December .

Did you know that we will initiate a pivotal phase III clinical study for a modified by SKU peanut patch in children in the intended patient population.

As we said then we still believe now this data from the pivotal trial will further strengthen the bias can peanut label, if approved and enhance its commercial potential and as such initiating this trial is our highest priority.

Now we completed the pivotal trial protocol at the end of February and prepared it for submission to put the F D. A.

To the FDA for their review now in parallel to finalizing our proposed protocol. We also have had timely and productive exchanges with the FDA. We very much appreciate everybody's willingness to engage with us during this critical stage of protocol alignment.

So we believe that incorporating any feedback from those collaborative FDA discussions on the broad strokes of the protocol will facilitate and possibly streamline the protocol review process.

We intend to submit the full protocol following that further alignment from ongoing and productive exchanges with the FDA.

And now turning to our cash management.

Through our continued financial diligence, we have extended our cash run away from the third quarter of this year into the first quarter of next year.

So first quarter of 2023.

Based on our assumptions.

We believe our cash balance and significantly reduced monthly run rate provide us with sufficient time to gain alignment with the FDA as I referred to earlier on.

And gaining alignment on final pivotal protocol.

No bias to peanuts.

Now as you know in biotech.

There is a balancing act extending cash runway is always a delicate balance between cutting expenses now and obviously our ability to preserve critical research and development, which fuels.

Enterprise value and growth later.

Soon you want to come in DVD employees, who collectively.

Aimed to do more with less and preserved our ability to thoughtfully beds, a bias can platform in the coming year.

I am looking for updating you obviously.

Our progress.

At this point, let me turn the call over to Sebastian for a review of our full year 2021 results.

Thank you Daniel.

Earlier today, we issued a press release with our 2021 times for reserves.

Cash and cash equivalents.

So two trusts 2021, well $77 3 million.

Which as stated.

The audio we believe will support the Walter issuance into the first quarter of 2023.

When we initiated our global it listen to win initiative in June 2020.

To reduce it with other words most of the cash burn by.

40% to 50% in the second half of 2021 as compared to the first half of 'twenty.

I am very pleased to report that we exceeded the logo.

Cash used in about your activities and assuming the hydro subsequent to one was 41 7 million, which represents a 54% decrease compared to the August 2020.

We continue to maximize the efficiency of course pens and the women only disciplined.

Cashman bedrooms.

And now I would turn the call back to Daniel for some closing remarks.

Yes.

Thanks Sebastian.

So again I'm very pleased by the progress we've made since we talk in late December when we announced our decision to now initiate the pivotal trial for the modified guys can do the patch.

Most importantly.

Since then we have engaged the FDA on key elements of the bias continues dossier in preparation for the new protocol submission of the protocol is written ready to go.

And we were very pleased exchanges, we're having with the FDA.

Obviously finalizing the proposed pivotal trial protocol and preparing for FDA submission was our top priority.

And I want to thank Saracen his entire team for their hard work and.

And for the position we're in right now.

I would like to also recognize.

Hence a review of our planned expenditures and financial discipline has been practically all the BD employees.

Led nicely by say best he and his team.

Employees continue to demonstrate the creativity the discipline the resilience that is needed.

To realize the full potential of Istent technology for patients.

Families.

For average shifts and treating physicians.

Now I would like to tackle one last topic before we open the line for questions.

It is not a secret that D. B V will need to raise money before we submit the modified by skin peanuts.

Hi.

The good news is that based on our current assumptions, we just shared with you.

We have sufficient time to gain foreign SBA on the protocol.

And for the pivotal <unk> trial.

Now our current stock price in our opinion does not reflect the significant potential in Nebraska and platform device can peanuts specifically.

Touch.

Exploring a number of tools to finance the company, including non dilutive financing strategies that could leverage grass and peanut significant commercial potential amongst all the other options that are worth contemplating.

A mix of financing tools done incrementally.

We're amongst the potential options that we are exploring.

Now I want to thank everyone on the phone today and the webcast for joining us.

And operator at this time, we would like to open the line for questions.

Thank you well now begin the question and answer session.

A question. Please press Star then one on you touched on Fone.

If you wish to be removed from the queue. Please press the pound sign or they ask Qi.

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They 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 our first question constant John .

11 from JMP Securities.

Hey, good afternoon, and thanks for the update and taking the questions.

It sounds like Scott Danielle it sounds like you've.

Already had some interactions with FDA on the protocol. So I was hoping you could provide a little more color on that back and forth in terms of what youre learning that they want to see in this protocol and kind of the cadence of those back and forth.

And the cadence has been very good well discussed would be a bit right now gonna called the basic broad strokes and core principle of our study as you know Jonathan we have a pretty unique patch it has no handle hubs.

And our ability to have them.

Discussion with the agency on the key elements in principle before we send them the nitty gritty of the details.

We felt was the right approach and to kind of be if he is engaged in those discussions obviously, it's hard warming to us.

Wish to provide more detail at this point in time because again.

Would be providing half of that conversation with the FDA would wish to be protective of their discussions here because what he would tell you.

That the protocol is ready to go and decide that we have not submitted it.

Is something that we're pleased with we're happy with because we're showing good progress in parallel.

Could you give us any sense of when this could be submitted and then kind of next steps between today and actually starting the study.

Yeah.

It will not be a long time the the next is correct.

Yeah.

Of course it.

Towards that.

Taking up.

We're having a hard time hearing you.

Oh, sorry, what about now.

That's good it's better.

Yes, my apologies.

So Jonathan we are ready to send to the protocol.

The interactions with the agency are taking place are frequently.

We would expect to be sitting the protocol in short order.

Again, we believe that getting to agreement on those core principles will make for a faster more expeditious and better protocol at the end of the day.

So the trade off here is the one that we're very comfortable with.

Got it makes sense and maybe one last one for me if I if I may could you give an update on the epic health program.

Yeah.

So I just want to take it.

Yes.

The Epitope study as we've said in the past is due to report out mid year.

And we're looking forward and excited to see the results of that study.

Yeah.

And have you set any internal expectations on what you'd want to see to warrant.

Moving forward in the younger one to three year olds or how should we think about a dual <unk>.

Path forward with two different.

Patches.

Well that's it if I may Saracen you can add more details.

With the current patch obviously.

Study in the intended population the second pivotal we are discussing will be in the older children.

We have another a number of options of what we do with the data as you understand Jonathan until we see the data.

Informs how we move forward.

Difficult to forecast.

At this point in time again, I'd, rather not speculate it's an important population as you know one to three year olds besides per se representing.

And it could be neology, but that with a prevalence of about 300000 kids.

But more importantly, it's also very often the age of diagnosis.

And in time also where the children are most vulnerable obviously given their.

Okay Young age.

And for them to build strategies to avoid.

External peanut consumption is much more difficult for them. So it's a very important market for us we will have the data with CBP.

And once we see it is in the past we can take but.

But I'd, rather reserve judgment until we see the data.

Most of them are excited by the potential that this study could represent.

Hmm.

Adding options for children out there, let's be clear the one to three year olds nothing is approved for that.

Yes makes sense, okay. Thanks, again for taking the questions.

Welcome Jonathan Thank you.

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One for joining this afternoon or this evening for our colleagues.

In Europe .

And as you know we're always available for comment of information. So thank you all for your attendance today.

And with sugar.

Bye bye.

Thank you ladies and gentlemen. This concludes today's conference call. Thank you for participating you may now disconnect.

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Okay.

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