DBVT - Earnings call transcript Q2 2021

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Operator

Good afternoon, and welcome to the DBV Technologies First Half 2021 Financial Results and Business Update Conference Call. My name is Reece, and I am the operator for the call. 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. like Investor it Relations. I'd Pollak, to time, of Head this to over turn Anne At Anne, proceed. please

Anne Pollak

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

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

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

over to Daniel Officer. call to is DBD; Sébastien Financial and call the It today's of are pleasure Robitaille, my on Tassé, Chief Daniel. me Officer Executive Joining now Chief hand

Daniel Tassé

in you late all you, and afternoon, Thank this afternoon and for joining evening. thank us Anne,

and both Viaskin highest know, you United States Union. priority DBV's As Peanut European advancing in is the

like a both are are ages for important highlight children to to peanut its as regions treatment pursuing fronts. we making approval X committed on XX allergy. to both with the I'd in We progress

the start with Let's U.S.

results assess of patches better versus Peanut current we current the CHAMP, Viaskin patch, and agency. modified the allergy study patches with as advisory protocol two of feedback based we XX% STAMP FDA Modified and to in to patch for adhesion chamber, the healthy the of peanut ages FDA and maintain STAMP. a current the advance They is micrograms. decision conduct. six-month XX second development well mVP rectangular in lead stands of occlusion selected FDA or total CHAMP, dose is from We to the corners. we approximately performed to have further will patch. is to surface modified on Tolerability between after completing as two and the caregivers. in Patches, in ages are in from patches and by adhesion MVP comprised the The selected five both cVP with other the the same protein which structure four children Safety, with ring, for patches the chose referred patches the but submitted STAMP, backing to that awaiting the allergists, by than is feedback we shape. on children circular, patches the foam the We received or one be The the trial which their from volunteers determined both the are peanut CHAMP Adhesion a for in four rounded modified patient is augmented safety recommended the of trials boards currently of feedback area, quarter, the XX than we XXX as to and five patches All which the difference One with larger adult one

this the that we validate to we of continue acronym foundation, The program we so methodologies cVP. patches. the Uptake and between of the the forward for the considered patch. in unchanged volunteers Peanut mVP between stands similarly the In patches, assays confirm path FDA entity initiated the remember, Viaskin sample parallel, XX not that modified protein a of Viaskin occlusion to closely FDA's ages on may provided preclinical peanut FDA peanut in efficacy in clinical could data work to the intend current an data the consistency agreed modified new performs Viaskin that would comparing year, Phase with chamber Peanut animal to patch, in how adult four protein the agreement current a utilizing of Phase transport to assessment, comparability and the uptake of toxicity the from data cVP from of collection a modified We a from or the that It to provided for the the use between means be to demonstrate quarter, the data ALlergen. to EQuivalence agency and like X guidance Earlier study modified allergen children reference importantly, conduct and and mVP we Viaskin we the on EQUAL, patch. patch, the requested the the mVP the regulatory trial this to to study for chamber support optimize allergic as patch you efficacy best a use patch current PREQUAL, APLA is support the this and healthy EQUAL. current FDA to allergen occlusion in of refer Viaskin remains product As Peanut in January the of models patch. with The III the modified Peanut development patch Peanut of

letter stage of an or is know, prescribed received include of outstanding remaining at from EMA the you EMA at line and a that much Marketing guidance on the meant in as answered. questions questions this objection EQUAL the to once letter with been Day and conversations protocols. list their final provide from the process. of We submission, the objections the ongoing Application many STAMP review Authorization Day any have Viaskin EMA, according time indicated have said forward the is EMA. the review, letter issues with on the very I'd as to Peanut. which we Viaskin soon time. BLA FDA EMA We to of We provide received, major established is possible. update to the as modified other that XXX major Peanut process. part And have the One an providing It objections remains will look update XXX also like alignment this EMA we is In for recently processes we and established on the objections progressing their

obviously, Now, ongoing to EMA their we dialogue have additional address and with an have opportunities, questions. and constructive

until As or the review of discussion information an provide relationship further productive public we EMA, decision. is with bring nature a of the into our will final domain not extension of our details there unilaterally

Based our first of turn average evaluation our and authorization on And Sébastien We price to to an a of response financial XXXX all the estimate review of MAA, Séb? results. will could EMA provide EMA call now, issue we to on the quarter on or marketing potential issues. the decision the XXXX. length EMA of outstanding its CFO, contentiously over fourth I'll Robitaille, the in quarter

Sébastien Robitaille

June call. today, results financial Thank release XXXX. ended press Earlier we with for issued you, our six a Daniel, and on everyone months good the the XX, evening to

cash our XX to million, as Our $XXX.X support half were cash and continue equivalents which until the expect of second June we will XXXX. operations of

was our by important to turn XX% an has of will now decreased our And pleased report used our I operating I'm activities, in plan for net And between last reducing cash flow and remarks. restructuring, XXXX excluding addition, global some call In cash to closing Significantly reduction QX initiated the burn cost XXXX. progress. Daniel back our QX year. goal

Daniel Tassé

towards U.S.A. good of In Thank DBV the EU, you, and in top U.S. potential making to the are advancing world, summary, Sébastien. parts restrictions approval that in the allergy EU and travel in both representatives both and our key progress the conferences ease priority. Peanut have attended started Recently, in we as is from Viaskin

that a of hear additional immunotherapy families can changed COVID. We were still so encouraged, peanut patient allergy very fear very peanut We the choose of caregivers peanut for have from to and series additional or caregivers COVID-XX how treatments and diminished virtual much allergy, the allergists is approach advisory with during FDA-approved understand allergists for if want right to an encouraged reaction the has that accidental and desire Furthermore, not treatments. treatment pandemic oral introduction the need of the conducted peanut boards ingestion patient allergic them. or for

schooling their allergy, higher for Peanut Viaskin recognize will ones, and phases believe peanut treat that of to of to of like open some families their With loved with potential to children who child’s parents accidental again at the to highly the environment as deserve in market. DBV more activities I call Everyone treatment them, bring them. multiple engage that ingestion we reported in-person is COVID, options. in that, At feels more the during all allergists of firmly would where all the control as questions. and committed children well DBV, peanut their they risk feeling other their stay-at-home Although, Operator?

Operator

you. Thank

will Okay. the [Operator Instructions] begin now We question-and-answer session.

Our first Graig Sachs. with Goldman Graig? from Suvannavejh question is

Graig Suvannavejh

hear okay? Can you Yes. me

Daniel Tassé

hear are very you? can you, Graig We well. How

Graig Suvannavejh

the three a provide can't one is, and there if and you top adequately concern the your My can least the major the on was I is concern One, to I I you new it can being disclosed color update you is concern or to regards on update any think question off head. in of newly me. provided discuss few that got And for of Okay. Thanks PREQUAL that and Daniel what could. to terms able maybe Sébastien, major major and major the second concern? in that I've questions, at what comfort Europe of my address if level study; is, that

this in conference, back have in a had health care that not perhaps little FDA that up heard you to lines? submission question, and then catch June time, a a or you yet at view third you’d short may that you that from about have how BLA not bit potential about a importantly, in study with thinking point how and FDA. may impact talk had back we more the at a It time from time. hear been And Daniel, Just and seems relatively chance our

And Thanks. the in of light thoughts your your with And right agency you the so the your is that how with the feel sense now in you do previous you to, get history with a where FDA? on good program? are regards relationship dynamic feeling of I of wanted to terms is have

Daniel Tassé

you. thank Graig, Yes,

Let Yeah, questions. we can answer the we confident me answer very are question that sequence. EMA's in

which agency, So want it is is we regulatory them EMA because ongoing we chose prescribe know agency. The healthy publicly respectful with not to you process process sponsor and with points comment as a on touch to be good an one the between of.

time, don't questions. quite confident actually, patch. between fall So product to right I that the know questions two at It's left that's at in point have we very as here. approvable, assays pre-EQUAL. publicly. And that can typical measure comes But important agency needed and the protein you peanut to wish the the we're line, an in because to is would time it is comment We the this time. surfaces but if It's interactions need point into, When non-factor call, what quantities confident question. measure not make this answer our specific we on what -- to we're sponsor non-factor. on a only a sure of we to in microgram No, those we

And by is up skin. to the measure have We the to assumed be the obviously, on would what what's taken be Langerhans difference cells. still

just are those So that. motion, all not required, and just and training methods precision, of time

So anyways. start before was necessary we pre-EQUAL EQUAL

chose the to That time. we thinking. always to of the agency on element Yes. other with not in start parallel the pre-EQUAL So part save any was to EQUAL dialogue as work our our of

stand. or any comes with line in way. is lastly, rate-limiting as FDA to there's time or new So the steps when nothing exchange going And the planned it

We a very get from them in feedback timely expect to way.

have whole There's know, agency is vaccines a you family lot on going of for responsible is engagement exchanges It COVID, As many satisfied busy. should And with but the on waiting long their the too have patiently. we are a the division other managing now. is obviously, for we're before products, it the standard with FDA, the with that right including, protocol. return be and their we

Graig Suvannavejh

a Thanks Okay. lot.

Daniel Tassé

Did Greg, your yes? that questions, I answer

Graig Suvannavejh

it Thank Yes, you. does.

Operator

Instructions] JMP [Operator next is Wolleben Our begin. question please Securities. Jon with from Jon,

Jon Wolleben

Hey.

you before sequence I feedback color. to on that all of about Just remind are and from EQUAL you how finish question, Can to for for have discuss the you've Graig’s here to STAMP? these gotten us can in Thanks previous Do be the you JMP. a little just question guess if study thanks the or FDA taking think to then going for parallel. EQUAL EQUAL and run and the of timing? bit STAMP,

Daniel Tassé

will Jon. STAMP before They is why we the to because question study. here, the will run be STAMP parallel, Important six-month a in first protocol protocol, the EQUAL be agency sent which

will take to run it obviously, bit than a the a obviously, longer logistics clinical six months it, running So, given, trial.

While EQUAL few in the patients quickly, days, think study rather investigators essentially I matter here. can under a be a observation is be done and of a by

ideas agency would the the one exchanging part of typically of again very make doing sure on is obviously methodology, time all we the part lined dialogue that as which not as So methodologies well like the assays approaches first defined that want you study rate-limiting our comfortable in The as pre-EQUAL FDA here place ongoing. I is trial in up, done, much full them. and of the the a to that with file protocol, agreement know. EQUAL sing-off have we We're and but with fact and why have that here, with that here. not extraordinarily given to discussions and STAMP are the complex, we're EQUAL because is we technically

So, filed again, important that is but work, question. why your which Hopefully, rate-limiting a it's not we answers it's stamps. work,

Jon Wolleben

in far you any can a on as in color been challenge or still including And discussion recently? expectations? your you Are as give food planning helpful. has not FDA stamp, that's with that double-blind Yes,

Daniel Tassé

in not in measure or equal is stamp asking efficacy No, the of that not discussion to FDA. is with FDA The product. either the

allergy for is clinical challenges, as it's no because for that So recruit the placebo-controlled factor to uncomfortable or will you the straightforward study believe There's we because no the need that placebo-controlled of [indiscernible]. often stamp and that challenge again, complicates know, child. particularly double-blind, for obviously food food food parents for intimidating here, there's is element relatively intimidation have why, both equal need an clinicians, which for which, double-blind, in don't be difficulty patients you the

Jon Wolleben

And if it. Got one may? more, I

Daniel Tassé

Did your answer question, that yes?

Jon Wolleben

Please, yes.

and any of the over two one feedback on two? what patch the the KOLs. or mentioned from the on they You feedback other, Can patches you provide between the whether favored the board, advisory kind the color caregivers said, any was

Daniel Tassé

It was to to important of number us for reasons a do that work.

provide So it. more we color a if I bit can here why did

certainly between And pretty XX-XX having big patches we and outcome goes community two choosing advocates was more the treatment how important. of had absolutely number patient, and one side will to the one, still treating anything make But expect all the an we that typically, we clarity physicians. with sure fully we in given the goes on use all, no that medical between we their patient think, the is split patches and to by of I it, we before difference compliance that but of softer patch, that ownership I choose to where call that, elements do community, choose what – -- community much the be, two First want pretty much thought application here. said, would we the patch something trading I fact we feedback very as the indifferent number that awaited choose have to as be other, want is preferences It the products. to patient we was with the of we understood

Jon Wolleben

Thanks the again right. color. All for it. all Got

Daniel Tassé

Good you both and Graig. most You're questions, welcome.

Operator

follow-up, him Graig go like next. Looks has to will a [Operator so we Instructions]

Graig Suvannavejh

Sébastien you comment if I in maybe and for, XX formulation? activities earlier on Thanks. beyond on the go about on Peanut initial the Nestle on Viaskin Daniel, guess, four to that could Peanut, a Thanks. for quarter? guess indication I'm other asking the particular, in maybe I your patch ages more accounting follow-up modified the just the some allergy with revenue clarification collaboration Viaskin for some programs? just And maybe around the financials, of

Daniel Tassé

Sure.

Okay.

the questions, then take me to Sébastien two Let I'll respond them. have first and

some to quarter a first – last the your the place took the comment do to in visit has patient around sequence. of here, three-year this back – So first It proper one- That old. this labs in first study year. was

the work done. as the So had in the last of spot that the patient XXXX. enrolled, III work that's labs community to filing The agencies also. In in closure Peanut visit here, and is once a agency. at the We of be planning will gets quarter know, by of And XX-month the unblinding that and we patch having interested the waiting with before all will done something fact Phase choice chose you and with CMC technology with the you was the data the as something it's we who the same is of or parallel, II, CHOP that regulatory pursuing know. we number questions follow-up remains Peanut patients EOE then with given as FDA end application are milk discussion that fully currently fast. is to we before first filing know, obviously Phase sharing study the and in But our enrolled we're the in on to milk patch, or the be right Viaskin and for

Phase of If III, clinical X to the when and development phases to other to to prevention on it you So go application the it question -- to clear questions, all your If Sébastien. that a it the of please one have ask the milk the in I'll that so allergies Phase product. IIb has EOE. not, have regulatory answered. on pathway the meal one we once patch the come properly actually answered peanut comes may pass will Again, treatment FDA and that satisfactorily to of with

Graig Suvannavejh

love there. to from I'm some Sébastien. color get good Would

Daniel Tassé

Séb?

Sébastien Robitaille

Yes, sure. Yes.

may of on and as the Phase So, period over you And recognized of have the our has II for the ended the know, recognition the Do negative revenue milestone we regarding collaboration agreement. due Nestle are the have and nonrespondent led deferred collaboration to to us payments space under as operating and income with the with Magic delay program June XXXX. question? revision revenue X you months of of quarter the delay the a communal

Graig Suvannavejh

thank Yes, you.

Operator

no have before we do this at remarks And conclude? you any I further time. see closing Speakers, questions

Daniel Tassé

except, everybody know, summer. is available restful you, thank you follow-up and clarifications away as rest the And of today. No any for for attending everybody as safe phone Row and a a or call wishing

Operator

ladies concludes Thank you you, gentlemen. conference. Thank and Excellent. today’s participating. This for

You may disconnect. now

DBV Technologies (DBVT) 2 Aug 212021 Q2 Earnings call transcript