DBVT - Earnings call transcript Q4 2020

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Operator

Good afternoon, and welcome to the DBV Technologies Full Year 2020 Financial Results and Business Update Conference Call. [Operator Instructions] Please advise this call is being recorded at the company's request. At this time, I'd like to turn the call over to Anne Pollak, Head of Investor Relations. Anne, please proceed.

Anne Pollak

Thank you, operator. issued the release XX, full Technologies financial outlines XXXX. DBV for results year afternoon, a that press our This ending December the This Release in available DBV of release Technologies the website. is section Press

of clinical please agencies begin, based and with limited call a but that Before our forward-looking regarding anticipated we including, our note cause statements, on comments and our regulatory company's assumptions plans, are statements financial may forecasts. differ risks could today's These include number subject development to, suggested statements. to interactions uncertainties results not are future that those by the forward-looking actual to from that significantly these

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

Chief a This it our U.S. as are decided Officer. me shift Officer; call Sébastien context Mohideen, Robitaille, Officer; like We then to and period the provide Executive Pascal Thursday Operations this to Daniel Chief had reporting filer. for first on is scheduled Wotling, I today's last change. today. some Joining for Medical domestic to financial date on DBV Officer call Pharis would and Financial Chief originally Tassé, of DBV; Chief Technical

and financial dollars file both and now IFRS, French. will according to results U.S. U.S. both in English and GAAP our We in

both all Daniel. were additional is to is amount met. to enormous confirm now my France. U.S. external internal among and hand it work requirements the teams week can decided Daniel? take to you of one over coordinated pleasure the to imagine, in and As an We It call

Daniel Tassé

thank and this you, us thank all you joining for Anne, evening.

highest Peanut States at So Union. our European and in DBV, is both XXXX in advancing in United priority the Viaskin

children are approval XX and We both important from progress to treatment suffer who we for potential its fronts. allergy, X peanut are as ages a committed making to on

First, Day the provide the of let quarter Union began EMA European We In last Medicines for from fourth review and Peanut, me process. update Agency, application year, XXX the you validated questions EMA, an on the European or marketing review received team. the the The authorization questions Viaskin of prefiling recently we aligned our were any list about is Of the note, review with cycle, are the our for consistent efficacy adhesion impact of a or at the with not on expecting of modification. stage request conversations questions EMA. and what we patch did receive to receive side. this to

the Now on from made letter to a U.S. Food FDA, side. have the complete modifying turning in we significant Since Drug Administration, from response progress patch. August, and our the receiving

of patch their a be impact as efficacy for new the need indicated patch the adhesion and the if the FDA that The the agency's we would product reminder, requirement. modifications. concerns relates outlined a it entity As not agreed regarding met modified CRL to patch data

who peanut it with X process. on And to patches X provide patches. types X is children from technology are the has is Viaskin you Our Wotling, let's in or to modification allergy. will in multiple turn Chief Pharis more start our of over the modified and engineering; manufacturing Mohideen, call clinical of the our leading the development manufacturing platform Operations who patch engineered with whole evaluate produce suffer potential you. planning Pascal to to Officer, flexibility Technical Pascal, patch process I Chief Medical long-term obviously, to was we ages the leading, the now information to XX so mind, Officer, who regulatory,

Pascal Wotling

Thank everyone and you, the good on Daniel, call. evening to

working Then peanut foam ring to few drug would backing the the and alter the critical keep we not patch potentially months. set patch of comprised is As cell applied. adhesive mechanism of for modifying have that of on we XX-microgram that which patch could feature the the the we to adhesion. past of inner decided the diameter patch been We the alter chamber, protein unchanged. onto protein ring, parameter of perfusion we the foam which peanut of Daniel the mentioned, identified is the delivery dose that We improve

a, could: on covers example, protocol, b, the or shape for the or area the system, modify alter perfusion we adhesive the example, surface that down the the chamber; and application filter; applicator application the paper seconds. pressing for of or a dressing c, For few patch for example, increase dressing adhesive

modified or many To created prototypes tests we variables the simulate child's to the through vitro with testing scratching one ones adhesion. the rounds more development Going increased patch, this with end, to conducted we of first put in through associated new changing patch of several movements select that that and behaviors. process we several

of these conducted Second, and to protocol. changes to the vivo we the studies in potential in also application evaluate adults - impact

turn the to CMC to with potential commercial our partners external is for These children narrowed you. to patches. to X or advanced a our with clinical several X. focus eventually to into have Once my field the in testing peanut preparing now our selected, processes X Pharis identifying development patch modified scale X or the healthy for if the approved. the testing, XX to Thank of the of patches subsequently I clinical will X program X modified we patches on producing in the clinical advance modified expects selected goal trial over X ages to development modified are allergy. rounds volunteers with and batches, to patches call Over team these discuss

Pharis Mohideen

evening, Thanks, Pascal, and good everyone.

patches. clinical trials conduct expect the Viaskin We Peanut modified to X evaluate to

that just to study trial this which the one modified The We is Pascal CHAMP, in among already first mentioned. healthy one underway. for that this C-H-A-M-P. trial stands volunteers is adult of CHAMP a the of current say comparison call will and I'm the adhesion wear patches so patches, of patch is pleased modified volunteers assessed throughout at hours, the versus adhesion adhesion The trial The includes time is conditions. patch. assess real-world each the the XX patches day. for X multiple points protocol

exercise in clinical target the the will which use then the periods. X we volunteers patch or or and best, will So believe that X the population. us We bathing select perform during help patches will treatment showering data the modified when wear trials in the the

participants CHAMP of by the all completed have the expect We to end trial March.

We trials. are also planning X other

next that we ages to reminder, course we advance past a here adults patch that should in to in current demonstrate in performs a we The over the much patch. XX As the to to of January, the in the in similarly similar conducted One trial U.S. released X an chamber X the with where from agency allergen The is announced take trial trials the Viaskin recommended healthy intent protein in conduct assessed FDA is both trial how the occlusion peanut modified hours. a is We've children compare XX patch guidance somewhat on allergy. Peanut clear recommended we provided steps to that the uptake patches.

this for EQUAL, conducting So nature. We're in we a stands which new in allergen. uptake of calling trial have this trial equivalents experience of

our expect from will should a be existing to patch not data as that able use peanut product this and modified data we from program. We a the trial be should development support new treated that

safety X-month which The of patient be other calling adhesion stands population X We're tolerability trial the in expected a this and safety, and intended adhesion to study. for patches. is modified STAMP,

standard also experience course, adhesion study, we data assessing this EQUAL so recruitment. at will should require We to our Phase Neither entry practice. nor a clinical placebo-controlled STAMP collected in we trials, in all have exit, have have food or and help of parameter. pivotal previously that's double-blind, assessed facilitate and challenge of safety this III our And just

protocols the with details plans alignment, the call, as these align around I work step. time continue and on last trials, an the with update analysis statistical will stressed will lines. As our closely including to that have for we our on provide agency we Once more the we next to trials

Now, I'd over Chief our our Officer, review to to the Robitaille, like Sébastien financial call turn results. Financial to

Sébastien Robitaille

a Thank issued with you, today, Pharis, and XXXX good results. financial Earlier press evening to we release everyone the on call. our

corresponding reminder, financial in a and notice statements of to as became the EU. reported under U.S. financial you both so the by domestic filer As January GAAP a laws, are X, and applicable as and U.S. results IFRS adopted that according dollars U.S. our DBV will SEC

only. euros as foreign private We and a to have qualified according IFRS reported previously in issuer

continue we the of will to cash million, XX, and XXXX, our December cash XXX equivalents operations Our second USD which were of support as half XXXX. until believe

summary earlier today. full financial our for issued of year XXXX, And will call Thanks. I results full turn the remarks. release some now, please For Daniel back the to closing for press a see

Daniel Tassé

Thanks, Sébastien.

we the ages priority loved treat here of highly children the top With both everybody approved, towards is - operator. I open Viaskin peanut their like and for who the and allergy, is to U.S. who call summary, questions, to to and the That committed in progress in the bringing suffer and good them. if are X advancing Peanut, allergists and So approval XX in potential that, Viaskin potential making at our to Peanut EU. would XXXX, peanut ones the for parents DBV

Operator

comes And Kempen. Cogut from from first Instructions] [Operator our Alex question

Alex Cogut

patches the your the on on was European in have And making the path. Great the thinking patch is your that to progress you're as updated see Europe Since to I nicely, be also European FDA affected the progressing later relation just how of what in review FDA. on patch? process your if wondering you through European is question, on? would going application, an filing for commercialization the the latest second

Daniel Tassé

nonissue, X Okay. a it deal on it I'll how different see commercialization. clearly. with have I will some patches. Pharis you as sense on that, the we a We how then having is color provide give being after of And you

So, Pharis?

Pharis Mohideen

Yes. No.

perhaps part And between Alex, you they are the the know. X be think, and FDA. review asking you entities, European may I as of is separate difference what process regulatory the

a product a we are Europe. And the although Alex? that we in one see So as the from in answer second standpoint and one with current in any problem to moving in we're product have providing modified Does the your product modified region. region forward obviously product U.S., that regulatory question, don't a

Alex Cogut

the if additional that that guess data, I see? wouldn't you safety Yes. collecting something European regulator would are

Pharis Mohideen

validated potentially review our see process scheduled. have dossier, dossier they're the as could submitted, been They and they and it, has Alex. completing But their

think stage. this dossier the don't factors I European that review at So into

Daniel Tassé

current may, as the I being safety from also the come particular not that would European up patch add, if regulators, with concern. a Alex, I has

well-managed scale than with to a an is do It's independent our geographies the commercialization great EU happy anyway. question. able different we'll again, is cost to to U.S. are than So at equipment move that of time across be question another very a the the And regulatory But manufacture flexibility patches data of ability more different on for confident with ours, - because us, goods Maybe we're one profile with in share before be has for for manufacturing have X somewhat to has one efficiency. patch to in at questions our indication. if market concern any more obviously. built-in to them, that not is X I

ourselves. commercialization, major partner commercialize in in we to not is could a Europe. at complexity essentially We the all. find manufacturing it a to comes When issue could it commercialize So it

a in to pursue both. are position We

comfortable expertise kind desirable. obviously partnership something of are quickly is to and scale both. that's right We The with bring

ourselves. one a hand, the very it's we well product On know

open-minded that the value remain to very to we shareholders. agnostic answer best satisfy your and our somewhat So Does patients question? and maximize way for

Alex Cogut

very congrats Yes, progress. And the that's clear. on

Operator

from [Operator Goldman from The next question Instructions] Suvannavejh Graig comes Sachs.

Graig Suvannavejh

moving maybe progress the on agency now the with a a But a bit you U.S. Daniel, processes. European put on the I level Congrats clearly, CRLs the some of also you are, were then both to you maybe those X that trials? and update clearly can where any not. X sense discussions and forward see more FDA give of kind I wanted could And going how there is there. going? risk maybe between maybe with if you're of of just how forward interactions you think to that you the I if perspective you offer can provide any ask able But nature on the little or maybe interactions mean, and on are questions. are

update trials? you're with And Is there the put one updates? us trials the Just press you in different those out Or Just how to intend releases? ongoing, do you on then going maybe plan product, there. what's it with to stand-alone you the I'll respect happening really do wondering into of happening that X periodic how third, kind have would is of don't something on visibility so now outcome is the you a to communicating is quarterly back in what's absorbed on We and insight your it's competitive queue, jump intelligence product what's any on anything maybe have good happening that been competitor with telling that any that. Nestlé?

Daniel Tassé

Okay. Thanks, Graig, us those joining questions. for for tonight. Thanks

frustrating what dealing for was we attention the of then Nestlé's Let we plan eventually that an the FDA on think, review with finding collegial. the wants. obviously, what I'll to and And year, of you to tone managing which over as that, want is that's very protocols, we now the see We're a on and and to tone has to me one the patch of is have generate that being Well, to to agency. answer agency. trials, I the them. to with those so, believe anyway, the something said, patch doing tone FDA, back and in obviously lot give be by constructive. go the approval data last with Pharis, by marketplace. trials And us are very secure then matter that turn the with to we a Aimmune's with exchange consumed management on because with a in owned on modified that wants time to the been do execute but our our success a response the And to work - a bit but so We on agency of communication very the rich pandemic, the companies their planned year we'll that's his many products on being come modifying the him much the agency agency something aligned look, so, rightfully as the team CRL,

a come dynamic to So provide before more I to you I'll the color communication Pharis, more agency? on the invite on anything the to comments back make trials. Pharis want with this few us on

Pharis Mohideen

Daniel. Thanks, Yes.

clarity at by I that with the clear think, very they as we've we communication, we regulatory call, previous have described Graig, tone X were a agency. provided the pleased the as the tone the very said feel with the the path, studies. of and, provided We had

So very Daniel details protocols as become that, align the that to that appropriate bit? will obviously help those in the as for time on Does us, that the the we'll them was the feedback. as And important, said, next a communicate and with obviously. clear, receive protocols. And then be we steps around

Graig Suvannavejh

Thank does. It you.

Daniel Tassé

will the what Graig, when refiling. and start, the roughly know our on go, will would And complete, protocols, trials, the obviously, we around next have the communication that once the studies study we'll and mean we're on when to communication to for expect ready sign thus, major be off now agency we

I that's people There would with important horizon be to planning are. who where we share to patient prescribing investors, know think physicians, with us a advocates. want with are for

So we been with whole the having investors, communication a on secured. agency helpful to plan once have certainly agreements those world, the including

think I the the not yet, here. in results everybody of transparency as the far is trials, have we've but operated we're know. Patients, a to decision made way same doctors operate to serves those we want As going past,

because believe agency are them and on decision-making X you published served question to discuss we data we year used of science, clinical answer to in transparency. them our peer-reviewed have with know, best to with regulatory chose that publications adhesion, patients' we exchange in interests in by last the As that the

it So publish much that data. our been I is historically be suspect that here. what's not decision we but want That to yet, very philosophy aligned made to would

visibility to not from marketplace, a have we home there. are that we picking out business. caregivers So when What complete not any information profile we most and scale X the pandemic are it obviously, a is And is is it. driving obviously the in profiles in to here. the medical products. then is, informed. it's Peanut on of clearly provide - think reporting wouldn't though we patients, product pandemic Obviously, we're and set not are want demand is product to for the is hearing certainly Viaskin are, like color a preferential OIT, Palforzia's not on What I marketplace They're that the in practices it. patients And problematic I to that to no protocolized think have being reinforcing the Nestlé's success and big up comes OIT of how that put the product fundamentally distinct different environment. and And we believe dispense fully

Operator

comes question from Securities. JMP next the And Jon from Wolleben

Jon Wolleben

the progress. on Congrats

what FDA out? between there patch And metrics the of initial that comes scale and Just adhesion there I'm you see it one. a X Or it adhesion, data for? When you to X fact, patches, to the looking the in wondering, then is you for are looking looking the best-performing it looking consistent to uptake to present and up few modified X identify the besides you opposing some for previously, you're considered said - would of is, are there? or just And adhesive is you anything best a consistent me. is any if like boundaries on determine Or uptake? patches? kind you're on Is mentioned that

Daniel Tassé

better adheres be as it adhesion. - way as good FDA, Again, a add be finding uptake, we're can not efficacy the in will or only the We way. the to color believe, don't The to the of we're solving better be we equivalents have no, Pascal? delivery think Or obviously maybe inner When Pharis some comes consistent efficacy, agencies here. positive read as no But mentioned property us conditions. we'll what real-life looking better so given because of adhesion conceptually, Yes. protein But better in ring, the to to here. impact Obviously, on chamber The problematic. it about not that I'll adhesive we're They in any foam to the product. to slightly or better, protein fact not here. But do that looking transfer a sort adhesion would for properties. changing expect add safety that and do. for is adhesion, the expecting the affected we the concerned we're lead you the of is well other Pharis? patch that, for you Anything our effort want attentive focused will it,

Pharis Mohideen

I think that's it.

Operator

[Operator call turn back we the no questions I'll final in over currently And for have queue. the remarks. Instructions]

Daniel Tassé

your for there are just you want to, thank If more questions, all today. time no again, I

as interim, mind of that I be closure would may As we're the for said, information between this come you as to for communicate now nice we complement the a on to agreement you and you then. time we evening. the know, that Thank have wish investors. protocol, to any always happy Yes. your of all In evening, with agency available all and

Operator

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

DBV Technologies (DBVT) 12 Mar 212020 Q4 Earnings call transcript