Earnings call transcript Q4 2022

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Operator

Good day, and welcome to the DBV Technologies Full Year 2022 Financial Results Conference Call. [Operator Instructions] Please note this event is being recorded.

I would now like to turn the conference over to Ms. Anne Pollak, Head of Investor Relations. Please go ahead.

Anne Pollak

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

the agencies, begin, the cash timing of statements, of regarding and product interactions number ability our results we include to, regulatory runway and food regulatory not forward-looking please call to of including, today's candidates Before -- may lives our that product development our a patients of allergies. clinical limited and with but of forecast of comments note our plans, with the our improve

from assumptions uncertainties statements. suggested These forward-looking the by results cause on subject significantly to actual that that based those could risks and statements these company's are differ are to

should and not undue risks statements. reliance forward-looking these uncertainties, on place these Given you

on really the Please and results by to factors could this after refer cause SEC account circumstances call. company occur the or concerning forward-looking the French any revise reflect differ the required expectations, statements for forward-looking filings the that law, as actual risk company's for information statements update or obligation made events that publicly from this any to or company's including any disclaims Except call. to with AMF to

Medical Joining Daniel? of Officer. Daniel. Chief Tassé, Officer; I me the DBV; now over Daniel Pharis on to Officer and will today's Chief Sébastien Mohideen, Executive call are Final Robitaille, Chief call pass

Daniel Tassé

a updates. financial recent to will before afternoon. of you you moments does highlights thank results. about a through and you, joining XXXX Sébastien talk clinical to I'd on like he full call thank for walk year But the take that, In Anne, few us this few moments, all this the

with when of priority end year, the X screen modified to track that, and finalize ages the confirmed III look by first was this year, Viaskin and this quarter study pivotal protocol peanut occurs. of Last X we design patch to we our are Peanut VITESSE, patient a children of did allergy the Phase and an the on in event We top forward the our update to first diagnosis. providing to

Now patient XX-week study we modified in VITESSE, experience study with was and Viaskin of initiating ages caregiver advance years completed XX called EVOLVE, user a Peanut X the which children in of age. to XX peanut-allergic patch a

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

from also meeting Pharis weekend Peanut invite Asthma was will Allergy, speak learn update detail as well Annual that Scientific as more of all we we Meeting, all to the I on you as Academy the EVOLVE, American know presented it in Immunology Viaskin at AAAAI. what last about & that data

Pharis?

Pharis Mohideen

Daniel. Thanks,

daily designed patient the several living of experience test, X-year III our on to a an to eDiary and of tested study said, elements electronic In functionality used would adhesion information activities EVOLVE, Daniel be also EVOLVE scores. study Phase qualitative olds. collect study we X- the was on patch diary data As that user provide to in called the in

adhesion used assess of test discussed, all support data is a include analysis that plan. that adhesion As test be a into will required we stat and the the caregivers We've application. previously we by eDiary patch to patch, will in to the the have Peanut BLA of Viaskin statistical can tool potential test VITESSE modified adhesion verified capture

patch. and majority a use with patch IFU, applications. that Furthermore, supported we showed caregivers correct modified I'm Viaskin experience of detachment the Peanut application for no positive also the reported of that after edges instructions pleased parents use, of to or report listing defined the the as the EVOLVE which patch updated ease directly

a in believed to peanut-allergic treatment peanut to appeal of always have will allergy use believe Peanut that family. potential ease of profile overall profile, importance Viaskin the We in product we the continue and of

without Academy safety Let's atopic attended do presence the aged weekend important with turn and AAAAI and efficacy American meeting epicutaneous DBV now San this peanut-allergic strong conditions. children the summarize meetings Peanut with every Scientific is Meeting, Asthma posters took year in widely which most DBV of a that to as Antonio. on immunotherapy and each X Allergy, & had X among we X years the Viaskin Annual EPITOPE year. allergy at had immunology and the place year, last certain of and comorbid and to profile Immunology

safety concomitant food for a common response influenced XX%. XX% having these atopic with treatment Both conditions of was by therapy its children comorbidities either reported assessed young baseline we each in of allergy. to rate of Viaskin prevalence peanut Peanut or Specifically, allergies, dermatitis are

X The any year in result multiple other in without atopic did old. dermatitis X to allergies and groups, results appear demonstrated years severity Peanut ages Viaskin consistency for food Peanut and not change efficacy Viaskin for atopic X safety with across those dermatitis. Furthermore, with patient children in treatment to and

further benefit EPITOPE peanut the these of in children. young allergies data the Viaskin potential of that analysis validate treatment believe the for using We platform

For website. the those Publications the to who of detail you Presentations that can DBV Scientific found read of and be would in in posters like the section

the review ahead, Séb. turn I'll the point, to call to over financial Sébastien results. Go this At

Sébastien Robitaille

Pharis. you, Thank

highlights full financial XXXX. for year review briefly Let's the

which of which $XXX.X continuously maintained cost million million cash increase by mainly $XX.X were the is Net cash reflecting to XXXX. million, of in to that as compared $XX.X financing for used due year, prior measures have million the operating XXXX been decrease containment in $XXX.X XX, and since $XXX.X activities as of Cash activities December XX, in the XXXX implementation is to was XX% QX. full an in year December a equivalents compared million,

quarter and spend maximize position, the efficiency in highly rates. and from Finally, fourth benefited to U.S. in to the were of and stated our is with change which activities expenditures disciplined our in management. in cash the expectations The remain treasury the in U.S. dollar in the last our a quarter, euro line dollars exchange company's continue

turn Daniel for the will remarks. I back call closing to

Daniel Tassé

Can hear hear closing me? Thank can you, you Sébastien. In you me? --

Sébastien Robitaille

Yes.

Anne Pollak

hear can Yes, you. we

Daniel Tassé

Okay. Cool.

Sorry about that.

So I'm our continued programs. across and our in progress very with closing, financial clinical pleased discipline

Looking progress ahead III updated in a we'll Phase of to children VITESSE plans you as ages X X toddlers -- our our in X. for ages trial continue to III X keep for well -- appropriate as XXXX, development allergic Viaskin to remainder the Peanut as on potential treatment to as

there on today all you thank let's any. for us. to webcast the if want And open phone on the questions, joining the line are for operator, I

Operator

will Charles And the Instructions] from come first [Operator question with Wolleben JMP.

Jon Wolleben

type by eDiary? Wondering anaphylaxis versus XX was And patch validating any EVOLVE X requested you study on to to you or if reaction, collect the this learn other FDA. study. Anything safety Why besides data? few A here. adhesion, Wolleben from can EVOLVE Jon X X? any whether else did eDiary the data, adhesion then

Daniel Tassé

Then trial, have this a more have details. to clear, you that given when a entirely decision give were be This contemplating new was new I'll our to decision. Pharis patch. made we pivotal no, we was

label. required make We used also that a to know, would is all through the the data BLA was Jonathan, day. tool that rich eDiary obviously, capture adhesion on be the that the inform we in sure to adhesion, mark an application And of

rolled yards trial, which the came Pharis, choose own VITESSE add in to that to into tool something were was that pivotal on out to was you we when Our was make we that it tool capture data. what this me to very we want decision or VITESSE, to to out sure measure -- for prove IFU it else sort work do made a was to make not powered sort a confident the of to It's chose anything. Again, had that? to do. was us, that tool the our the to right we good expression do, is of and to we a again, anything sure or good confident intended

Pharis Mohideen

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

Daniel Tassé

please. Yes,

Pharis Mohideen

Yes.

Okay.

So to as starting was Daniel X, to this as work the the test. as far said, versus prior XX X [IFU] to designed to to X so

the you as optimize as the caregiver were in peanut- we peanut-allergic for for matter it eDiary data. X the were and X XX felt study And effective a with us always were is objective the of long same of in parent the whether nature amount could use, you being being subject, to and so course, of instructions or felt a that X generate to let's of allergic you we primary child, of we the a terms And recruitment didn't that then, efficient. of

generate to data short of wanted the period So time. a in we

So that's the for to beyond more that. XX. the X Nothing reason

to relative that just it from studies it any question, yes, other your terms of a data, always answer other we of in lot your And standpoint. and other as we Does a as collected we've that performed things, very Jon? safety normally does was consistently through safety trial seen question, other

Jon Wolleben

VITESSE you to subject study, the That's Yes. and your any could when this starting. guidance update helpful. year mentioned on you'll then running olds. have this XXX will will any update an for you you also, that Daniel, in month. be Wondering be the also get And if if X safety there's be progress In X prepared running, on remarks, up if

Daniel Tassé

Pharis have to trial meant safety the X the The answer VITESSE, year safety olds. I'll companies, on database. Yes, question was X enrich to

makes less but because the XXX mostly no be also XXX, X-month trial, challenge, faster XX-month to which trial, there's is lot a those enrollment trials be easier. you know, enrollment food As going is to obviously than

So confident the that on And completion same compete of before our of sort plateauing we the and the the or plan of lock for at to that with safety VITESSE time safety VITESSE can database towards trial not enrollment ourselves the trial. here again, trial land the your planning patients. answer the is to Does later of we're, question? as start in

Jon Wolleben

if And that's the one. Yes. then toddler update, just helpful is there. there about wondering And

Daniel Tassé

Yes. Pharis. Please,

Pharis Mohideen

the As quarter. the communicate FDA we've past, said with this we'll in Jonathan,

processes. get to probably follow terms of is feedback We'll we that from Beyond the when not application them. would comment traditional prudent in

So...

Jon Wolleben

a jump more, one-off And about be see spend Okay. how one if think in there big math pretty any quarter. but Wondering I there's might forward. off, this or to in R&D I may. moving if expenses My

Daniel Tassé

want take to is. in start-up Séb, is you color mostly VITESSE question, you the a to which R&D provide? it to cost want any jump But more in what

Sébastien Robitaille

It's you're Daniel. the of related some VITESSE. only initiate on cost will that right, to we Yes, course, fact

the some upfront So CROs. have with we

the slight of a say, will ramp-up months. I have, in our expenses few R&D last we So

Daniel Tassé

at good through, as studies. both So with actual we rolled in in Again, cushion. activities was much time. the trial no. It will communicate planned the we spend out we'll when obviously, changes, this what that frame planned financial that we the to investors complete cash in carry for If have very VITESSE that reiterate discipline, we Jonathan. safety not enough had QX All time point around the to

Operator

our question-and-answer attending our conference conclude will Thank today's today. this presentation. for session as you [Operator for well And Instructions] as call

disconnect. may You now

Daniel Tassé

Thank you, everyone.

DBV Technologies (DBVT) 2 Mar 232022 Q4 Earnings call transcript