Half Year 2021 DBV Technologies SA Earnings Call
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Good afternoon, and welcome to the <unk> technologies first half 2021 financial results and business update conference call. My name is <unk>.
And I am the operator for the call at.
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 Ann Pollack head of Investor Relations and please proceed.
Thank you rice.
This afternoon TBD technologies issued a press release that outlines our financial results for the 6 months ending June 30th 2021.
It is available on 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 and regulatory development plans, our anticipated future interactions with regulatory agencies.
Financial forecast and our expectations regarding our potential patient population allergists and patient caregivers.
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.
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 on the French a enough for information concerning risk factors that could cause the company's actual results to differ materially from expectations.
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 Zhang Chief Executive Officer of D V D and Sebastian Robotize Chief Financial Officer.
It is now my pleasure to hand, the call over to Daniel.
Thank you Anne and thank you all for joining US this afternoon late afternoon and evening.
As you know Dvds highest priority is advancing bias in 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, we're making on both fronts.
Let's start with the U S.
We have selected 2 modest side by asking peanut patches or MVP patches for further development after completing chan.
Trial in healthy adult volunteers to assess your division of 5 modified patches versus the current patch.
Oh, 5 modified patches performed better than the current patch, which we referred to as CDP in channel.
And we chose the lead patches based on Champ results augmented by feedback from advisory boards with allergists as well as with patients caregivers.
The difference between the 2 selected patches is there shaped.
1 is circular and the other 1 is rectangular with rounded corners.
They are both approximately 50% larger than the current patch and total surface area, but maintained the same structure of the occlusion chamber.
Which is comprised of the phone ring the backing and the peanut protein dose of 250 microgram.
The decision to advance 1 or both patches to trials in children Ages 40, 11 will be determined by the feedback received from D. S. T E on.
Stamps, which stands for safety.
Told her ability and adhesion of the modified patches is a 6 month safety and adhesion study of MVP in children Ages, 4 to 11 with peanut allergy that day.
The FDA recommended we conduct.
We submitted the protocol for stamp to the FDA in the second quarter.
Currently awaiting feedback from the agency.
As you May remember.
With the FDA provided guidance on our regulatory path forward for by asking Peanuts in January of this year.
Do you just see agreed.
Debt a modified by asking peanut patch would not be considered a new product entity provided the occlusion chamber remains unchanged from that of the current basket patch.
And that's the occlusion chamber of M B P.
Similarly to that of the current patch.
The Fda's agreement is the foundation utilizing data from the clinical development program of the courage by skin peanut patch to support them on a site device can peanut patch.
It means we could use cease to be efficacy from 15th and importantly, preclinical data like toxicity data in animal models to support a BLA for 8 modified patch.
The FDA requested we conduct an assessment comparing the uptake of allergan or peanut protein between the patch so between CVP and MVP.
In peanut allergic children ages, 4 to 11 to confirm that.
The consistency of efficacy data between the current and modified patches.
We referred to this trial has equal.
And the acronym stands for equivalents in the uptake of Allergan.
Earlier this quarter, we initiated prequel.
A phase 1 study in healthy adult volunteers to optimize the Allergan simple collection methodologies and validate the assays, we intend to use in equal.
In parallel we continue to work closely with the FDA on how to best demonstrate the protein transport comparability.
The modified patch MTT to the reference patch.
CDP.
We have said that we will provide timeline guidance on the modified by asking peanut BLA submission once we have alignment with the FDA on the final stamp and equal protocols.
We very much look forward to provide that update as soon as possible.
I'd also like to provide an update on D. M. A review of the marketing authorization application for bias and peanuts.
It is progressing according to established EMEA processes and ongoing conversations with DMA.
We recently received the day 180 letter of outstanding issues from the domain, which is an established part of the prescribed PMA review process.
And as you know is a letter that is meant to include any remaining questions or objections at this stage in the process.
In the letter we received the EMA indicated many of their major objections and other objections from their day 120 list of questions have been answered 1 major objection remains at this time.
Now, we have an ongoing and constructive dialogue with the EMA and have additional opportunities obviously to address their questions.
As an extension of the productive nature of our relationship with DNA, we will not unilaterally bring details of our discussion into the public domain will provide further information until there is a final review decision.
We will provide risk sponsored DMA on all outstanding issues.
Based on the average length of EMA evaluation of an MAA we are.
Estimate BMA could issue a decision on potential marketing authorization price can be net late in the fourth quarter of 2021.
For the first quarter of 2022.
And now I'll turn the call over to our CFO, suggesting it would be time to review our financial results.
Sep.
Thank you Danielle and good evening to everyone on the call.
Earlier today, we issued a press release with the financial Wizards low 6 months ended June 30th 'twenty 'twenty 1.
Our cash and cash equivalents as of June 30th 1 on growth $25.5 million.
Which we continue to expect would support the Waldo issue on until the second half of 2022.
In addition, although net cash flow used in looked at in activities.
Excluding tooling has decreased by 42% between Q1.2020 in Q2.2021.
Significantly reducing our cash burn was an important goal.
From a global cost reduction plan, you said that that's true.
Im pretty sure we book of work progress.
And no I will tell on the call back to Daniel for some closing remarks.
Thank you Sebastian.
In summary, we are making good progress on advancing brascan peanuts towards potential approval in both the U S and the EU and that is our top priority.
Recently as travel restrictions have started to ease in parts of the World Representatives from Dbz attended key allergy conferences in both EU and the USA.
We have conducted a series of virtual advisory boards with tower, just in patient caregivers understand if we're out there.
The COVID-19 pandemic will introduction of FDA approved peanut oral immunotherapy changed their desire for additional peanut allergy treatments. We were encourage very encouraged to hear that allergists and patient caregivers still very much wants and need additional treatment for peanut allergy so families.
Can choose the treatment approach is right for them.
Furthermore.
The fear of net allergic reaction from an accidental ingestion has not diminished during COVID-19.
Although some families reported feeling more in control of their child's environments you range the stay at home status of Covid.
They recognize that their children will again engage in more in person schooling and other activities, where the risk from accidental peanut ingestion fields hired to them.
At <unk>, we all firmly believes that children with peanut allergy.
Their parents and loved ones as well, the allergists, who treat them all deserve multiple treatment options.
Everyone on the BD is highly committed to the potential bring baskin connect to market.
With that I would like to open the call for questions.
Later.
Thank you.
Sure.
We will now begin the question and answer session. If you have a question. Please press Star then 1 on your Touchtone phone.
If you wish to be removed from the queue. Please press the pound sign or the hash key.
If youre using a speakerphone you may need to pick up the headset first before pressing the numbers. Once again if you have a question. Please press Star then 1 on your Touchtone phone standing by for people to queue up.
Sure.
Yeah.
Okay.
Okay.
Danbury.
Most anybody.
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Sure.
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Okay. Our first question is.
From Greg Savannah day with Goldman Sachs.
Yeah.
<unk>.
Yeah, Hey.
Can you hear me okay.
We can hear you very well great how are you.
Okay.
Thanks for the update Daniel and Sebastian and it's got a few questions.
Good.
And maybe it's 3 that I can think of off the top of my head 1.
Is there any color you can provide on the update you provided on Europe and the 1 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 that.
The newly disclosed pre close 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 timelines.
And then with.
With a third question.
Okay.
Daniel we had.
I had chance to catch up and in June at our healthcare Conference and you had a view that perhaps you 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 wanted to get your thoughts on how you are feeling your day.
NAMIC 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.
Yeah, great. Thank you let me answer the question that sequence. Yeah. We are very confident that we can answer <unk> 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.
Jimmy processes, you know is is it.
Good healthy 1 with prescribe touch points between sponsored and agency at this point in time, we don't wish to comment publicly.
But the questions fall into what I would call non <unk>.
Typical interactions between sponsored agency at this point in time.
And we're quite confident that should be very confident that our product.
He is not on an approvable, but if we can show those specific questions.
When it comes to prequel.
No. That's a non factor is an important question. It's a non factor in the timeline because we needed to make sure that we have the right assays to measure as you know a micro gram quantities of peanut protein on.
On to surface. This year, we need to measure what is left on the patch we have to measure what is still on the skin and I'll see the the difference would be with whats assumed to be taken up by the languid cells.
So those methods are required just precision just not time and motion training and all of that so prequel was necessary before we start equal anyways. So we chose to start the pre COVID-19 work in parallel to our dialogue with the agency on the other elements of equal asset not save anytime that was always part of.
Our thinking so this is nothing new when it comes to.
Timeline or the rate limiting steps in any way.
And lastly.
On the exchange with the FDA is going as plan on stamps are we expect to get feedback from them in a very timely way.
As you know the agency is busy there's a lot going on right now it is a division that is responsible for managing and many other products, including obviously the whole family of vaccines for Covid.
But we're satisfied with the exchanges, we have with the FCA with their engagements and are waiting patiently.
And it should be true long before we have their return on the standard protocol.
Okay. Thanks, I'll turn it to questions Greg Yeah, Yeah. It does thank you.
Once again, if you have a question. Please press Star then 1 on you touched on phone.
Our next question is from John Walden with SMP Securities John Please begin.
Hey, just here for JMP.
Thanks for taking the questions and thanks for all the color.
I guess to the.
<unk> previous question can you discuss a little bit.
<unk> gotten feedback from FDA on the <unk> study and then how to think about the sequence of equal on staff to 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.
Important question you, Jonathan though they will be run in parallel which is why we first send the standard protocol to the agency before equal protocol.
The standard would be a 6 month study.
So obviously it will take a bit longer than 6 months to run at given obviously the logistics of running a clinical trial well equal as the study can be done by the quickie matter of a few days I've been patients essentially be under observation by the investigators here. So the rate limiting trial in time stamp, which is why we filed that 1 in there.
First place here the discussions with equal with the agency are very much on going we're exchanging ideas and approaches and prequel as part of that dialogue here because as part of the sign off on the equal protocol, we would like to have obviously full agreement on methodology given decided we're doing here is nuts.
Technically extraordinarily complex.
But notice studies is typically done as you know.
I wanted to make sure that again, we have all of our assays lined up from methodologies, well defined and DFT comfortable with them. So again, it's important to work, but it's not a rate limiting works, which is why we filed stamp force hopefully that answers your question.
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 and stamp or has that been in discussion with FDA recently 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 elements of the clinical study in food allergy to this uncomfortable for the parents with the clinician, particularly obviously for the child this new.
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 of difficulty factor.
Debt often complicates recruitment in these studies.
Got it and 1 more if I answer your question, Yes. Please yes, yes.
You mentioned the feedback on the 2 patches from advisory boards.
There was no kols can you provide any color on what they said whether 1 patch was favored over the other or any kind of feedback between the 2.
No it was the.
It was it was it was important to us for a number of reasons to do that work. So it can provide a bit more color here. What we did it first of all we assume you want the medical community and patient community to have ownership of the patches that we chose to given the fact that as I said the patches to very much weighted.
By patient patient advocates and treating physicians, but wanted to make sure that all the elements that goes more to application of the patch clarity on how we use it anything that goes what called 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 2 products. It was pretty much split 50, 50 and preferences with no big difference between number 1 and number 2 is what we choose 1 which is the other will be I think absolutely indifference to the treating community, but we thought that having their feedback was important.
Got it alright. Thanks.
Thanks again for all the color.
You're most welcome good questions, both you and Greg.
Standing by for further questions. If you have a question. Please press Star then 1.
Yeah.
It looks like Greg as a follow up so we will go to him next.
Sure.
Yes, Thanks for a company who had an extra questions.
Daniel if you could comment maybe on activities that go beyond the initial 4 to 11 indication for <unk>.
I guess bias can peanut in the modified.
On a patch formulation I guess more in particular I'm asking about earlier.
Ages are.
Or can peanuts some of your other allergy programs.
And maybe just a follow up on.
Maybe with Sebastian on the financials just on some clarification around Rev.
Revenue accounting for the necessarily collaboration in the quarter. Thanks.
Sure. Okay. Let me take the first 2 questions and then I'll have.
So that's true.
Respond to them so.
Back to your first comment here. Some day. This is the proper sequence it was around the.
The 1 to 3 year old that study has a the last patient from is it is it took place in the first quarter of this year. So last patient last visit will be in the first quarter of 2022.
And then we will be obviously underlying being in sharing the data with the community.
Regulatory agencies that once that is done but so that study is currently fully enrolled and we are in the 12 months follow up for the patients who enrolled last.
The the work on the milk patch as you know.
Is waiting.
Closure with bias in peanuts by our choice here given the fact, its the same technology and we had a number of schemes questions as the as we all know we chose to get to the right spot with the FDA on peanuts before filing or filing before having the indices to phase III.
Having discussion with the agency.
In parallel as you as you know.
The application of the milk patch to EU E.
That work was done that shops.
And.
That remains something that we're interested in pursuing also so the milk patch that you may have 2 phases to it when it comes to clinical development to go on sale to be in phase III, 1 application to the.
Prevention of milk allergies, and the other 1 to the treatment of <unk>.
Again, all of that will come once we have a clear regulatory pathway with the FDA on the peanut products.
If that has satisfactorily answered your questions I'll pass it on to Sebastian if not please.
These ask so that.
On your questions have been properly answered.
Good there would love to get some color from Sebastien.
Yes sure.
Hum.
The men on the non refundable upfront and milestone payments.
How do you feel the local nice.
Income, although the payout of the collaboration agreement.
And regarding the day, we have on the phase 2 studies with Knisley with on though.
Our collaboration.
The revision of the magic commodity revenue due to the day of the program.
Due to the recognition of negative revenue for quarter and the 6 months ended June 'twenty, you'll continue put into them.
Does it answer your question.
Thank you.
Yeah.
And I see no further questions at this time.
Speakers do you have any closing remarks before we conclude.
Yeah.
Non except thank you everybody for attending today.
And as you know, we're always available as a phone call away from any follow up or clarification.
And I wish everybody, a safe and restful rest of the summer.
Excellent. Thank you ladies and gentlemen. This concludes today's conference. Thank you for participating you may now disconnect.
Thank you.
Thank you everyone.
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