DBV Technologies (DBVT) 4 Mar 222021 Q4 Earnings call transcript

Welcome to the DBV Full Year 2021 Financial Results. My name is Adrian [ph] and I will be the operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct question and answer session. [Operator Instructions] Please note this conference is being recorded. call Anne the turn I'll over Pollak. to And you may begin. Anne,

December issued This for release ended of release the afternoon, Release you. website. the a available the XXXX. on is DBV months DBV results Thank section financial Technologies press Press This our that XX Technologies XX, outlines

of that timing any including, interactions that allergies. the These and to limited comments candidates the our clinical cause Before note results may actual our our could to a assumptions significantly not approved today's we food lives are statements forecast begin, to of subject based on the number those the cash but statements. include development company's of and improve these our plans, regulatory agencies, runway the regulatory differ call with ability suggested product by forward-looking that please of to with results forward-looking uncertainties of from and statements, of patients regarding are is risks and

for Except this forward-looking Given statements. Please you reflect these made that the results forward-looking after any the the risk filings account company's including AMF information on to SEC disclaims expectations, from events differ materially concerning by occur on company's as should undue this with reliance cause or for that risks call. to law, obligation publicly or statements factors forward-looking update not to any statements the call. refer to required circumstances these French place could any company and the or revise and actual uncertainties,

to for Sébastien will over at XXXX the pass Chief question Sébastien Peanut Financial update of Officer extended the Daniel Officer; are and and financial will provide Viaskin Chief an on results. cash Robitaille, today's our Medical the call year DBV; I Daniel call Executive me end. Chief Pharis Joining Officer. Tassé, Daniel. and Pharis Mohideen, now will join will runway full on and Sébastien Daniel review

joining for this us all you thank and Anne, afternoon. call on you, Thank the

Anne for on provide I this an of areas focus mentioned DBV. evening update As will two key

the and the second of cash clinical modified in The our Viaskin our regulatory our runway. first, development being on management cash update Peanut patch

with start Peanut. let's Now Viaskin

During our Peanut a a will the in last children we Phase announced initiate for pivotal DBV study intended in modified patient that X clinical update patch corporate December, Viaskin in population.

we will as said our Viaskin and further trial now Peanut we highest enhances As if and from several then trial this approved still the initiating strengthen is data the priority. believe commercial label, its this potential such,

of and Now submission we completed end February the for their prepared review. to the the it FDA pivotal at for trial protocol

in us with timely protocol, Now, exchanges parallel productive also had during stage FDA's we willingness critical this to We to with much of finalizing protocol proposed the very alignment. our FDA. have the appreciate and engage

cash runway cash financial Through our the those broad quarter year we productive feedback the the now from process. protocol with and that into submit incorporating further the the to And So discussions ongoing of management. have from protocol of and following protocol will FDA. facilitate on strokes from this review full our next first any that We turning to alignment the third we believe the of continued diligence, FDA collaborative quarter our possibly streamline year. extended exchanges intend

Viaskin with with Peanut. and reduced referred on earlier I gain delayed. our XXXX significantly of protocol quarter rate for alignment and first run balance to our alignment the on monthly sufficient So Based final as time FDA believe we us on cash pivotal assumptions, gaining provide to

aim can development this less DBV forward preserve obviously I growth to let on enterprise results. in to research with progress. want thoughtfully you later. collectively advance our in commend ability critical Extending our you, full updating know Now, me and balancing now, Sébastien the and At there's which always is runway a I'm as And more between cash cutting expenses obviously, preserve to looking you biotech, our a fills balance Viaskin XXXX assume point, to do fuels Seb? over act. delicate year value employees who for coming their of review ability turn year. platform to call for to the and

half to decrease XX% by all the our burn aim compared Earlier half first of of second a where am the XXXX. earlier, of $XX.X global a Thank exceeded report second restructuring we and to When I today, our goals. to reduce $XX.X activities of that XXXX. which half [ph] you as barriers represents cash we XXXX. stated Daniel. which compared we alterations initiated XXXX, in XXXX press in used XX% the equivalents we XX, to The XXXX we our the we release very with in half support results. million, XX% XXXX, as cash are cash first issued into in quarter monthly of our operating Cash average initiatives June million, financial believe December was XXXX of to the first pleased

continue back We I some our our Daniel and now to to management. disciplined remain in highly for will remarks. closing of the maximize turn spend cash efficiency the call

Thanks Sébastien.

we the submission demonstrate protocol also go FDA. continue with their employees, full the the of Obviously having the Viaskin financial priority protocol dossier very DBV to to our I'm Pharis hard written, we're entire creativity, for again, realize with practiced families, since of in key the employees thank pivotal the the then, treating patients, Most Sébastien patch. and the late are all decision our element FDA submission. to was have pleased I to finalizing work modified to and for the is when potential and for to physicians. in would pleased like by now. we've recognize preparing the Peanut is expenditures his extensive preparation, top December, proposed on Viaskin trial discipline engaged for So last plan we we're ready very made by we the trial now has for team we exchanges in progress FDA The and Peanut the and new pivotal since technology for the talked importantly, review Viaskin announced initiate that to protocol and and our position the resilience DBV by discipline, allergists and I and his led want been right the needed to nicely team. the

for would like DBV submit based Peanut before trial. you, gain I modified the before to Now, open money good that pivotal A with on BLA. our line have topic we news that fund their sufficient the no mVP assumptions raise secret we time FDA just questions. one It on need we Viaskin protocol to shared tackle is we is to current last for [ph] will the

of stock Now the not platform price Peanut opinion specifically. the significant Viaskin reflect does our current potential and Viaskin in our

options such, potential of Peanut As other amongst are Viaskin options number are all contemplating. leverage of significant the finance exploring. are a incrementally A to the tools amongst company, exploring could done we mix financing that commercial that worth non-dilutive including strategies that potential financing tools

to Now, operator, to thank everyone line on call at like want for us. for questions. we I the would And time, webcast the today this open and joining

you. Thank

from session. We Jon will And [Operator Instructions] comes question the now question first answer and Securities. Wolleben begin from JMP our

Daniel. update on the sounds with and It like Hey FDA and good questions. for interactions the protocol. like thanks taking the sounds had you've It afternoon some already

forth terms want a provide what that learning see of more hoping little on in color the back was protocol, I that you of So in back you're and to cadence forth? of could this those kind and they and

what I now is been We'll with the discuss has call principle very good. broad right basic FDA cadence The our core strokes study. and of the

that don't details, heartwarming In before unique and pretty gritty wish the analogs the a of the on that no have happy showing conversation we the elements. send and the ready obviously, have fact but because to we discussion parallel. And point have this fact only I tell half of be it, was patch we protective key FDA's would Jonathan, that is the to this something us. the approach the know, the protocol I with, agency not discussions, rich can submitted that progress engaged to ability be you we nitty to of provide our As has in more to with we're the to would we're is that FDA we're in providing with, thought at you is go. that detail because pleased time, them within here, discussion in the that those right again, I us principle, wish

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

Yes. It next step The step, next will The time. of course, be towards… towards. on not

you you. having breaking hard a Daniel up. are hearing time We're

Sorry. What now? about

good. That's

better? it Is

Yes.

apologies. My

the sending or is we expeditious better getting faster agency So we the of protocol interaction frequently. But are on the We principles order. would to the short make agreement the Jonathan, will to protocol, believe at send those expected a be protocol end for see this day. taking place core in that to and again, ready with

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

you Got if on it. the one an maybe Can sense. Makes give last may. program? And for I update one EPITOPE me,

it? Pharis, do you want to take

Yes.

study said to And is that past and we've results the to see due study. as of So excited the year. forward looking EPITOPE the we're report in mid out

different dual want with olds, about And we the on and set patches? towards or one, year any should have to you how the a what see you three internal forward forward expectations younger moving two think path

details. more obviously, EPITOPE if be second With done we're may patch, The will current discussing study with you the add pivotal is intended older can children. the that I and the population, the said, Pharis, in

number importantly, se given the It's per we with data about more much and population, our to this consumption also how is But build diagnosis, the to about of is year representing time difficult for speculate. Viaskin where three old strategies until that to very also an is are peanut understand [Indiscernible] more the again, an most rather of we I'd time their Obviously, have see data, not ability of options, of young At avoid do vulnerable. forecast. we them them. for to XXX,XXX important it's We age you epidemiology children -- forward kids. as one as move point decides the and and difficult prevalence age, know, what the often informs,

it's So us. important very for a market

data. reserve out the But with the on can could represent is we there. path will CDP. options study tell. until in have a children we this see it excited And once data adding rather potential the we're We by But extremely that for see I'd judgment we

that. clear three for is that olds, nothing to year be Let's approved one

Yes, makes sense.

Okay, questions. thanks taking again for the

you. Welcome, Thank Jonathan.

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information. Okay. for you colleagues comment this know, And evening for want joining always or Again, I afternoon as this to Europe. you everyone available we're our thank in for

attendance evening. your for all today and you great thank wish So you Bye-bye.