YMAB - Earnings call transcript Q2 2021 | Y-mAbs Therapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, and welcome to the Y-mAbs Therapeutics Inc.

Second Quarter 2021 Earnings Conference Call. Today's conference is being recorded.

Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Because forward-looking statements involve risks and uncertainties, they are not guarantees of future performance and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including those risk factors discussed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2020 as filed with the SEC on March 1, 2021, and in the Company's subsequently filed SEC reports. would the turn President. Company's I to conference time, Gad, Thomas Founder, this like the to over At Chairman, and go ahead, Please sir.

Thomas Gad

for much. and our very morning, earnings joining you second-quarter you for us Thank call. today Good thank everyone

continue quarter all progress of business. we pillars make notable During the XXXX, to second our of across three

our antibodies, the then First, also an leading monoclonal omburtamab.

to platform to Secondly, leptomeningeal our a XXXX. we SADA refer as platform, to Marketing metastases the rolling submission. meeting radiation. the the year. were submit a the now from strong bispecific our with the compounds for Authorization have end a We in start of and FDA developed thrilled omburtamab very after to CNS form which finally path pediatric this of patients believe, under Also Type omburtamab had with resubmission towards liquid this BLA Y-BiClone we treatment high-risk We the clear also for B initiate by of in of neuroblastoma in back We April. the June, to intend we EMA

February we know of the beginning US. demand we across are DANYELZA seeing in you started from delivering hospitals As and the

Second-quarter XX% to net as of million, $X first-quarter net $X.X compared million. were sales sales up

nation. of the quarter, roughly second XX now have we with During the DANYELZA. we across that doubled treatment the have have number centers And experience approximately gained delivered centers to

revenues and Pharmaceuticals, pilot City. guidance in as we've China of progress that. and Hong pilot not neuroblastoma not DANYELZA strong quarters, have and for from medical pleased support be on that report Boao also soon launch June, therapy have Hainan together provided provide Neuroblastoma two in DANYELZA a Hope tourism Boao our made Thanks the Mainland China. We partner that drug known expectations Boao in held on Mecca. far of could believe will the GDX Hope pleased zone our process number China, so with in approval City cyclone Kong, so, strategic the sales, to institutions. to I'm for treatment local presentation both first we we more and SciClone the with patients Although of Pharmaceuticals SciClone internal to In pleased to exceeded I'm note the to in the able be also centers

received July, You'll DANYELZA in the recall NMPA March for with trial neuroblastoma that to submitted treatment patients and high-risk in of clinical for SciClone BLA waiver in for DANYELZA and China. the refractory was relapsed a

that with in Pharma, are approved and America. Techno Latin excited marketing also dose-limiting of toxicities files this and a cancer registration to Dr. behalf the very SADA because a in from of gave of look Boston on recently submit on Techno businesses will Adium We very also Memorial in insufficient therapeutics an XX in promising of as significant and territory. expertise development employ if its dose demonstrate Nikon sale DANYELZA and as Pharma Cancer our oncology Techno Center also Pharma, commercial a Texas. known to company omburtamab The and across Sloan-Kettering and therapeutic distribution agreement with often Distribute countries will to disease exclusive [indiscernible] how technology PEGS presence to and continues a sales consequence sub-therapeutic presentation rare region. Chong

events bispecific important this we for for promising small and in cancer clear planned been lung was Phase the programs index very continue under our this need. to address uses the treatment expansions R&D our two-step nivatrotamab has also with nivatrotamab II first osteosarcoma AML potentially later potentially for last R&D therapeutic will year. CD-XX year we a study and in Pediatric as getting submitted Y-BiClone speak. ready and improve platform technology are neuroblastoma The The Pediatric of for to cell Our patients therapeutics. oncology to SADA pharmacokinetics are unique dose bispecific unmet

children the malignancies As most hematological challenging We today. the ended of second AML million quarter one remains for in with cash. $XXX.X

we the commercialization but the conjugated platforms. of our and and also DANYELZA we development. into support to sheet. advance late-stage we the Lutetium to same continued SADA have our strong At and launch potential I balance of So, believe both continue omburtamab, a nivatrotamab time, Y-BiClone technology omburtamab-DTPA, advance

excited Y-mAbs our So, which we later position elaborate Taking the consideration, are to medical very hand I'm Claus very to this at advancing unmet we call needs financial well current over continue and to achievements so. to on our we Executive activities, address with call. Officer. while expand Moller, positioned do same to Chief Thank the on our continue our will to are believe And pleased Bo that, you. pipeline is into very to our pleased commercial with very time, Dr.

Claus Moller

call. you, earnings XXXX welcome Thank and Y-mAbs Thomas, second to quarter Therapeutics

We that today. pleased are very you've join to chosen us

disease using of in DANYELZA XX% new the centers is stage, continues pipeline we and the response, We market. During the quarter and I'm you the be was toward the of launch have to very told quarter, other with across as third continued quarter, second sites ensure customer sold expect almost to - the the high-risk during to have treatment to response, approval treatment with first largest or demonstrated date but were during hard the virus for MSK partial a that approved will to the by expect or commercial to the relapsed-refractory to cancer would neuroblastoma second quarter at the pathway. therapy centers pleased in who borrowers our the accelerated country the we prior DANYELZA US. bone that stable minor FDA of ship addition patients across on the treatment first marrow advance with our this bone worked

done Treatment experience about commercial nurses had many have job outstanding and an Our medical with has now physicians their educating and organization DANYELZA affairs Centers and first DANYELZA.

and compassionate high-risk front-line complete in well. presented remission survival Clinical patients updated or in was gone DANYELZA five first GMC in SF second event-free of CRs. three-year clinical CR known XX% XX% The the overall and SF subsequent data our to in for be in June I'm understanding second as DANYELZA treatments very see consolidation for of to or also that very CR. in previously CRs. patients and presented In for rates holding three-year CR those have three-year data survival XX% Day in Two-year follow-up. first was The was for of XXXX these how survival American and the for survival seem GMC Patient at patients up. Oncology, Society XX% was at are and of survival Annual pleased Our both duration or a and R&D is neuroblastoma response use neuroblastoma of overall per poised ASCO consolidation for XXXX. the setting generally high-risk December now points latest Meeting event-free and cycles well latest from first received

Our Spain, as ongoing in progressing combination as DANYELZA are trials clinical for the refractory trials nicely. chemo patients and for neuroblastoma neuroblastoma New maintenance in in MSK treatment Barcelona, for York well first-line City all

frontline Phase ongoing. chemo We treatments II are working Phase also to osteosarcoma combination a we initiate and trial multicenter and trials for II have international both

route Type B turning on BLA neuroblastoma. omburtamab the we had leptomeningeal CNS the the metastasis for towards treatment patients of with with from meeting resubmission to omburtamab discuss to for Now, X, of another pediatric FDA the June

significant BLA that and the was is with very the therapy plus today. the and with our evaluation remaining was potential FDA US in agency end close a of in by of are prepared metastasis a to this in parallel of omburtamab final open hope * expected to landscape We rolling resubmission addition a clock very year. for the details XXX in dialog the BLA no Omburtamab to of resubmit The reach and when a days. believe We omburtamab If with approved, treatment exists form take the the strongly shortly. marketing represent to this regarding stop The for year. the European application agreement for advancement submitted of we the maintaining will application EMA aim days CNS April BLA standard

median three to by volumes study tumor that data will for the XXX-cubic appear well omburtamab of diffuse DIPG proved up presented volume and escalation cover of increased eight and the for to to historical milligri known The pontine Glioma volume infused be months compared dose to with The showed survival all or as of XX centimeters. I potentially for tolerated ASCO of four radiolabeled study Phase dose. at patients interim continue escalation and dose-escalation distribution dosing intrinsic both Iodine-XXX addition, US June to in In as group. control omburtamab dose in

year, where omburtamab our to of study are further multi-center potential expect results omburtamab. to administer significantly and II to that We share thereby improve Phase doses way paved later of The excited the treat DIPG this in efficacy. the hopefully repeated broaden for reach results have also up we these

are Desmoplastic which common MSK. FDA cancer the omburtamab the omburtamab As Small ongoing also known Cell of DTPA Phase previously has developing at in we Round have DSRCT, is cleared XXX we lutetium for study brain also as IND type and The children. II a for our treatment discussed, medulloblastoma Tumors of most primary

now medulloblastoma the study Iodine-XXX the our construct. in clinical based Phase patients trial clinical is from the treating II multi medulloblastoma international with open pediatric Our XX patients is I, experience fits and with on omburtamab for

notable EU recommended infusion and into of to to utetium the also will make Medicines treatment Medicinal clinic the medulloblastoma. to the once Agency the of giving be determine clinical maximum study European excited In the hope orphan DTPA obviously for study, tolerated Iodine-XXX and with designation DTPA profile that drug leverage prior an to called Committee again omburtamab are in June, establish this We Ommaya Orphan also has see our It XXX reservoir. known way safety in we the omburtamab in XXX, is XXX-lutetium as experience dose. to for the the COMP we for omburtamab its Products

experience BX-HX open leptomeningeal X XXX-lutetium adult positive with the and also patients BX-HX first to In in basket leverage more with XX DTPA. Iodine-XXX than cancers patients Study addition, is adult adults now positive treating or as trial prior while CNS our for brain omburtamab treated X, be hope to our screened we with known from metastasis in omburtamab

in We also our subcutaneous turning the lung study nivatrotamab's cancer Y-BiClone, to are then include patients cell administration now to thrilled small patients include with have adult bispecific we our of clinical II to antibody. Phase reach and to widen reach expanded the clinical

at separate Phase We arm in ongoing study plan two our another osteosarcoma. in to and into one neuroblastoma studies, of also expand nivatrotamab II MSK

the planned. within to we pediatric for study as We under the patients addition hope antibody as submitted quarter during six months. next Y-BiClone AML IND the during CD-XX platform planned In second bispecific in-line for the had in open an the next we bispecific to quarter, generated nine the

are we good very about know, Turning the progress. you for SADA excited to our we and technology making prospect are technology as this

are disclosed We our clinical for preparing four [ph] development.

be The first expected GDX. to is our against IND

expect we from in have quarter we our and to received year to pre-IND FDA. be IND of positive We believe fourth file the recently package feedback this what on this the

we AACR April, In GPAXX Radioimmunotherapy for colon addition GPAXX the of at end radioactivity ratio, year. XX model targeted in reported all Association had Cancer a colorectal for in the tumor is that of injection. in on for is xenograft expressed blood XX% IND uptake measure And for Pretargeted American to cancers. cancer shown, GPAXX conference XXX SADA of Research in next a hours against after

breast SADA truly cancer publicly treatment of tumors meaningful that not therapeutics the cancer. in are of includes can the in agents for prostate responses potential targets announced and the other BX-HX-SADA use believe We and to potentially about intended have excited radiolabeled improve platform. we demonstrated historically efficacy radiolabeled technology this HERX-SADA for Our

helps pipeline that of prior the At well the by by significant after being required omburtamab the - the on DANYELZA construct for. progress centers same SADA recent a than aspects, deliverables is believe are are antibody FDA an we general country have initiating DTPA we are In commercial constructs our even franchise, with to we we this and patients we had our next - predominantly much time, the Y-mAbs the build radiolabeled other that are we generation pass advancing the through better the with From our omburtamab and to we and the grow also FDA meeting promising remain development. understanding our resubmission clinic, as omburtamab clearer move more words, further already the antibodies. the to shipped some to elevates company across hope now to continue at PLD and made any deepening poised of BLA being very continued excited Omburtamab widening resubmission. a that to Looking to forward the busy and commercial-stage and business bi-specifics multiple international

this Bo quarter invite me - his for this remarks on let for financials. to share Now,

Bo Kruse

Claus. $X XX, you, of reported Thank quarter license DANYELZA ended million. June the representing We million XX, the ended million $XX XXXX, June revenues and revenues no of There revenues were net for quarter $X recorded sales of XXXX. in

$X.X sale As ended the the million the reported per or million and second basic and costs, quarter decreased XXXX. to The June quarter million that loss payments we quarter related compensation We at June selling this quarter and and operating second June XXXX. expenses a $XX.X take a million personnel XXXX. million non-cash diluted for and quarter the employee-related for a basic $XX.X XX, XXXX to look net million for license salary, million the launch diluted patients development decrease commercialization XX, general XXXX, was of quarter cost corresponds general the $XX.X Review XX, of January, of June the $XX.X MSK. know second the with $XX.X expenses to proceeds research including million where $XXX.X of the position million XX% million ended $XXX.X milestone to administrative primarily by in share for at to XXXX. a ended with compared $XX.X from ended XX, to of million and $X.XX for and increase year-end ended with net June benefits, $XX.X from expenses compared the per a closer share agreement XX, net expenses $X.XX of loss and stock-based DANYELZA. reflects the We increase administrative DANYELZA and for increase sale in acquisition of we license XXXX. we quarter the the Priority SADA to ended ended attributable reflects $XX the XX, increased which The need Voucher cash of from the Selling incurred $XX.X primarily This decrease quarter a quarter for proceeds in million a XXXX from XXXX, for in were agreements, $X.X million, June in by the our license up

$XX.X reflect in Our June cash proceeds million $XXX.X partially June the operational offering activities XX public also months million in for February net in cash by balance XXXX, ended six used raised net offset our the of XXXX. XX,

the remain Y-mAbs healthy now believe financial position. update. turn to a Thomas. financial over continue concludes And the I'll We very This to in call

Thomas Gad

for Thank you, now. Bo. the And up to This Q&A marks right you. for the end of our I'd Thank call prepared today. remarks open like

Operator

Instructions] comes America. Bank Alec [Operator go Please you. from Thank of Stranahan with The first ahead. question

Alec Stranahan

thanks Hey taking questions. our guys, for

Just DANYELZA from on a us. couple

uptake new grow you ways toxin shifting setting? in guess data And at much neuroblastoma in could your of we have would I at look my you could I question, this when to into at believe feed second got First, sort that point? mentioned chemo And point, relapsed adding versus osteosarcoma from is unit see focus do share patients market how that the this centers conference DANYELZA over then think positive treatment otherwise at fall. much a data you combo how the refractory in

great. if us update, frame extent be could that data size, should you in that'd on So, expect help sample the of and just Thanks. the we ballpark

Claus Moller

primary using have primarily previously are sites relapsed we of patients. kind treatment for been what started the are us market it too is I sufficient are MSK achieved to where using They the at lines Dinutuximab. into, Alec. tried they combination new the of on as of been numerous it and where all about using secondary patients using it's most early it refractory, - doing, taking Dinutuximab this in sites response and pretty but then clear common in think anything some and doing they share patients. Thanks, the we patients say it's develop eventually But what of is are have they've have Dinutuximab in I mean, course with which that not to seeing Well, neuroblastoma we along, chemotherapy, also that

on the that also that's treatment the of kind like typically we but are have but new you product side market. most is - happens So, - entering of when seeing a this

So, say levels and continue And see high lots growth. and additional other our I hospital physicians is have for sales, with, we professionals that teams interactions sales and to both our there our definitely can with meetings MSK. and of outside hundreds sites Also space very at of of interest. hundreds EMA and nurses, of research had

understanding a So, we to to DANYELZA use besides. see how interest in continue strong

of Your osteosarcoma presentation data. last question eventual the about

data that study all because analysis and Day patient likely will in December, I think think do - missing most we then it's still yet I recruitment the early R&D you but for one at our too it's, the seeing can be presented is it's afterwards.

that was think the I questions? answer to your

Alec Stranahan

if perfect. Yes. in. allow And another that's could Yes, one I just

Claus Moller

Sure.

Alec Stranahan

maybe year omburtamab? assuming you talk - in next? or I EU, approval Could guess Your the this early comes go-to-market later strategy about from

Thomas Gad

in XXX it calculation Yes. have It's we you this situation. but easy that would then has more likely April, months I know normal take us since clock submitted to that been seven days. stop November,

then responses to then again. submitted that questions On clock starts have have have. are and then responses clock XX additional So, review probably file. with back of EMA we And questions most will depending they in then, on their how come then this, qualified stops we responses the questions September a together stops while bunch and will when us the we the the putting to detailed the up clock XX together spending again likely of the somewhere days putting between they be if

next think day that's stop. an be would on having its So, any a And in pending of in quarter that But I we question? second situation market now called already highly ideal without we omburtamab likely the it's Europe. up clock - the said in the although handle and that that, period, sales of it's European building review means answering organization in year distribution a are XXX approval. your that can that process Was

Alec Stranahan

That's you. perfect. Thank

Claus Moller

day, Have Alec. nice a Thank you.

Operator

The ahead. next question Lebowitz comes go Morgan David with from Stanley. Please

David Lebowitz

taking much you Thank question. very for my

First is quarter rate that be has curious one my the XX% quarter, MSK run the a That's question. to, sales. just seem I'm sales. in from as from been of would to should expect there of next limit you much as say as forward that that we kind on about first contribute seems it how far contributor? to can upper MSK going It as DANYELZA hospital

Claus Moller

Yes. early mean add Absolutely, to question, continuing we I is where new we using than would them and naxitamab at we month MSK basically on from see DANYELZA centers don't with are see that MSK understand I I also than think sites joining new the are that have we to and working now, every the treated several started be where is can centers much are the of one growth going then patients. more outside bigger Omburtamab,

to the highest outside up patients six numbers think I MSK.

from growth So, will the outside definitely MSK. come

David Lebowitz

the That's the to full be to review process this in submission abbreviated ultimately or data like period helpful. a do already have would time? review leave could it has substantial the more they that What Would of the past? they the FDA given omburtamab submission respect given anticipate lot seen with And you before. the that probably of parts be six-month

Claus Moller

highly that the likely it's will But the agree before to most approve to how unlikely eight-months hope that definitely the But expect PDUFA they it be be not tend I fast most when see market of but in omburtamab likely, we it's year will the we goes review submitted, eight-month will date. I next give with think it But end - US get let's us be it also. you they traditional period. on to likely track with abbreviated. able and

David Lebowitz

you. you for Thank Thank questions. taking my

Claus Moller

Thank you, David.

Operator

from Robert Wainwright. Please HC go The ahead. question comes next Burns with

Robert Burns

on taking all the Hey, progress. guys. and Thanks questions congrats for my

if two may. I from me Just

sort I rest roughly centers this of in metrics XX the with think you thinking you actually get whether curious what still year, stated DANYELZA are by you're subsequent submission. a are FDA so, Where about you do to that then CSR, And just I DANYELZA? are number the you'll were think that just to able be that of second prescribing was we that be alignment been seeking alignment the First there's forward from any of prepared about benchmark? that I the today. curious And shipped meeting rolling my other with an what on? internal your Type of know quarter. to FDA with this question; was of going points as so, there as remarks has move to regards year-end points to centers or seeking those B if you with

Claus Moller

one, Well, to first one finish off the last the first.

the has aligned, we FDA us the and everything and is analysis have be ready update data I some are points should will we think then statistical And then discussing and doing asked to to I how we those plan. be prepare think resubmit. them analysis

it So, meeting response to that. and even can it written be but ask take a likely then and to to they would most formal have us pre-BLA

we So, understood any that us. alignment And the for we not making sure want I are think understood precisely that that. additional sure they to asked we have make FDA except what expecting

track that. with we I but So, are much - on pretty think

we I In of that biggest location first patients can the with that important a of terms penetrate think treats is rare said, about I penetrate mean, XXX more of the US And on sites as I basis - it's, neuroblastoma. the sites think into there can additional regular if sites, year. into of sites, the more these if especially I some we on in ones previously in

to a see XX in But the see I more addition have I in product. pretty and hopefully say almost to using we get, that until that. have very think that to acceleration to have would I'm a now, we think, pleased nice managed we job to bit sites can I MSK done start

dinutuximab, many need concerns many what beginning, that's doctors we in there change have definitely uptake. you a in been very some the know that but that to about are they was will it to with tried them places. as this somebody concerned it about positive also seems use not we had it's to were convince been have think That And been - United better I the we have say use than as DANYELZA. is themselves might concerned that sites DANYELZA. to them actually - it And complicated

So, I the it would positive development. think very be a continued about

Robert Burns

Awesome. Thanks for again. the clarity, Congrats, Claus.

Claus Moller

Thanks lot. a

Operator

next Joseph The with & ahead. Please comes from Cowen Company. question Thome go

Joseph Thome

and Good taking for morning. thank you questions. my

the the next If omburtamab BLA be - end DANYELZA on detailed of the submission Are the data And I the resubmitted sort you have able year of context to there modules re-submission. that Are ahead follow-up as end need submission? of then And one requested, to Type a the to at begin more then, the provide additional is well. the targeted we year. sort this bit of last rolling you complete to just additional around first next just what maybe the B? little a of after agency kind of meeting on

Claus Moller

forward hopefully we it's I from Well, that, when But having pretty based we comparable. - finalize will XXX discussed the able at analysis or a the sure And we that groups having control control to that arm are on what's meet data we make with study statistical what compare the called from green data to be it to think this that historical the a from plan and using too were backward patient upcoming to wanted the FDA now light Study meeting. report the after made XXXX was this that cohorts synthetic say said with get FDA. the on clear the analysis the early dose clinical FDA

how together with putting data So, patient control data. the are historical have on FDA based available generate set agreed about arm the also we that synthetic that the we and to

very So, actually, will FDA that's the submitted what dataset whole are has results have done we and been database we shortly. it going and building to be or on and that the

the resubmission. that's So, having far we for be everything rolling get When to, I will ready can now. when think completing it it we comes as as

I we pre-BLA take had FDA. we with think when the place that agreement will have in the

Joseph Thome

sites take in how in sort terms new dose individual they choose an of sort new you of is individual sort patients? and on to more Okay, these increase pilot to perfect. expand pattern broadly kind Do it And around information then, it DANYELZA little their can a the just of of on? give centers, then of center? more Or ordering roll initial

Claus Moller

for Yes. first have treatment What's the that's the Is the out, and patients find a happening to Monday, Friday for screened they happening then want typically is if sites. be and DANYELZA, that all treatment they put and patient they patient would presently on Wednesday they the cycle.

and for one. orders cycle, we then for also. they drug treatments. weeks does order four would have and three want then they next leaves if So, will that they those ones Nobody then, continue second see And five can start cycles it after to order first the and then, the they patient well the the then they so for product

patients receive that MSK basis. So, almost receive biweekly sites the other weekly that's and of more we are we from a orders weekly or than why most on also mean orders from a I basis treating

it's expensive how therapy. an So, do because adds I that's think also

So, you end also and them and - they buy buy and you pay spending $XX,XXX inventory. up if have six [indiscernible]. per you only expensive if of you a And six pretty then,

Joseph Thome

Yes, Great, very thank lot much. makes a you of that sense.

Claus Moller

Thanks.

Operator

comes Please The Etzer go with Securities. ahead. Darout Guggenheim next from question

Etzer Darout

my question. taking for Thanks Great.

Just for DANYELZA. me on one question

just if So, the is under as belt, on have engagement recall the sort those couple setting line with quarters your of of wondered at with conversations you front initiated a post-launch and around Thanks. sort FDA plans if have for other? of plan setting on will the Or you to the our frontline when to conversations. into dialog not, buy-in do increasing start put for and you sort if of

Claus Moller

I of expect that do to next the I've we been that year. think, saying in before beginning

the then, the this And quarter in on follow-up We study first the need frontline year, that last MSK are study. patients closed waiting naxitamab. with for we their frontline in of some

FDA So, early eventually material have supplementary what towards study, Mora necessary dataset if we think years next the Dr. when data together approval. follow-up and could data discussion the year year we have three have those wanted a of additional with on sufficient the to to I the be from we approach this end with BLA

with collect So, from a to then are together we data and study we discuss MSK agency. data with as study nice the to continuing from have dataset the the I the Dr. think Mora

Etzer Darout

Got on the it. Congrats you. progress. Thank

Claus Moller

Etzer. you, Thank

Operator

comes next go ahead. Please question David Securities. with The from Nierengarten Wedbush

David Nierengarten

my taking I a question. for have couple. Thanks

is treatment patient required a it First appeal on of things a about past the DANYELZA, and metric for to of appeal talked maybe the in or that. a for we've like part the being part center of larger less

gap expected and for signed And is year, it of be it's Thanks. if why a this up if is use patient that few to the that's or part So, for think the be quarter, the centers, - sites right into lutetium is of the in diffusion find months I'm of that and just late submitted that centers in you smaller first of trying in of part they why word the otherwise may MSK? IND selling a getting kind forward? a to And on Omburtamab; of the here was the this would you part I diffusion part while trends kind taking in qualified we DTPA curious of time prescriptions. expect into just enrollment diffusion referring time kind to so curious on strength I'm of off the - patients. then, going could point the little there? bit taken that, commented the that QX or

Claus Moller

moving the actually heavily approved in from DANYELZA. site and Danyelza then to have go treatment. also to that's to I towards because developing want patients is they in using as sites new will showing Sure. actually are But bigger treatment seeing what now to We we we it, more been what We I by that might can for want of have that that have is will product an outpatient involved open not being the have I have this an treat DANYELZA, actually themselves antibody with mean DANYELZA. some but refer to parents easier could the to Dinutuximab state patients definitely another that them move FDA. treated to past simply it be driving handle think some treat because sizes been what's with just with the think resistance

So, but been very positive very have helping Also, knowledge limited are in we day. have again, But now. that the of seeing using we I bigger and still to some until think that that learning But now up. open sites we have that's until the it's Naxitamab. every COD started

are patients get processes In actually DTPA, are omburtamab institutions. approval I the planning for I of that the to be Lutetium-XXX, start open the while studies are in of screening recruitment know has with patients now. through they But also terms taken of a the to all recruitment first know and they and both it starting patients treating

I to addition security bit for involved group time. is IND mean, it I delayed But have and do So, it's catheters treatment indwelling it - did a in happy those everybody caused also? settings radiopharmacy that complicated here take and to hospital. has little the so, think COVID-XX lutetium a the in it's by, the blaming some radiolabel with but, been the Was everything, the at I'm we but that

process going a on. of So, activities there is long

you until the because comp IND from institutions may into study the typically before you tell protocol and today, an work first do [ph], is of when they the approved patients a months get entering want the do and is that IND to you they're contract signed stone to this. you they with and contract not most not earlier. But want sign six approved it So, is simply a see the minimum

then then answered? little things IND hope that I so that you and time. take - was need it go a also explained. to So, to

David Nierengarten

curious understandable. like the arm if patient it you arm as availability; approval like it or was just again mentioned it's but that, if particular radiation I Yes, was sounds all a above. factor there the was beyond of

Claus Moller

Yes. No, patient availability an doesn't to issue. be seem

David Nierengarten

Okay, great. Thank you.

Claus Moller

Thanks, David.

Operator

next comes go Morgan. with JP Tessa ahead. The Romero question from Please

Tessa Romero

here. Hi, and for you our guys. Good taking thank morning, question

be with so third-party first And then about as such be time, what to Symphony? have are is tracking it thinking over of vendors, one expect need how around And Should accurately? latest of services on tracking kind thoughts my the these we DANYELZA your one accuracy I more. we should

Claus Moller

I think pretty that close mean close. I amazed I'm were they Well, and this they were actually

is out think did to there we on our find But about the job But there a that they good the definitely XX% way trying I think said below the they high actuals. information. collecting they having data risk precise I are based to uncertainty, are actually are some but time. were how definitely, a collecting of this

Tessa Romero

Okay.

Claus Moller

It's hard Tessa. be, but sorry, to

Tessa Romero

think No as in problem. forward of about, we've this XX% has reimbursement frontline moving move centers? - access of as formulary going Thanks, been about talked kind I I this more treatment you're has into Claus. sites is That's helpful. new And how looking? kind and seeing of discussed before kind then we've you of I it And right you're going in into or just guess my is think use next of how what the question here kind

Claus Moller

think treating we fourth-line second-line And because I outside actually and sales sales sites sales that's reimbursement would and is way grow setting more more than issues absolutely third-line more and setting. But in issues. we where seeing start would as no at sort there patients. we the MSK having of Well, expected I say of looked or many had

We haven't and seen that's with issues any positive. very been reimbursement

Tessa Romero

Okay, great. for taking our questions. Thanks

Claus Moller

much. good very a Tessa. day, you Have Thank

Operator

The ahead. with Lee Arlinda next comes Please go Canaccord. question from

Arlinda Lee

questions. my the you I Thanks guys. about as with you think XX right right do market. Hi, Can penetration proportion sites talked on in cover the that one I sites you taking your think are the line? covers? those now? do patients, and the guess how now? talk another most gaining - a larger do proportion you're later start maybe interested that just had go of And that in Can what attendant about experience is you Thanks. states this population of open What what for then,

Claus Moller

say detail, it also into it's I of more big Neuroblastoma XX% which starting site some of there I anything regular And that XX% a than the times even And of said labor to ones it for to we three in of also. study. top naxitamab over promo, I the is ask lot the had is of to there the all a on treating Well, as site is that we are patients basis. are here. the treating good to part see If whether of or formulary less to the I of I get in XX think these they the offset patients. they a in with sites the their And going difficult more XX precisely in sites there true, gets and sites that probably we also top first But sites. the planning to know treat have in Andrew to two true-- hospitals been till think is we are a smaller US is it had treating give very that XXX and shipping announced two think is which or for those to of an still initially, experience patients belonging that I patients I and for been note are use hospital. through would until lot progress treating, the making sure it bigger really sites, it's medium-sized our now, first is osteosarcoma

will little the it it sites. the takes get see spreading and out, a formulary to little we these think in a I takes time but this in smaller sites on longer bigger than So,

Arlinda Lee

Thank Great. you.

progress. Now, that It's sense. makes great

places the ex-US is provide the think pretty treatment? that do traveling market, mentioned you for I the, are think market that the this color of get timelines market? - And is? you that the additional to how market. that little China then normal a China whether been have they talk other can you what on impact On to a maybe Can you Thanks. large some bit anyone previously And about

Claus Moller

we Barcelona. Chinese Dr. have been most of patients say treated Yes. that site in Mora at I treated have the would

the to Having market think he PDUFA you that qualified market the the that said we But you to at a so, the least more And give three crisis. approved another get is XX% three something but next we a that's years, get is now our be numbers has it in not sometimes are think patients about and don't approval having be get initial estimation he will guidance government-funded also as do. sell you we that while is to expectation. the also require that in to will date but Chinese half to to two where said year XXX part US approval clear taken times about able we should treated you to get that reimbursement. Chinese reimbursement the like is last initially, would without of is I in but a of up Chinese that, is you - until But the year, in takes now and be patients our a can China Then be that it's XX% that end price could US. that I it China, an of the guess of in to first in market. not estimating as the probably than able it's go can on

most supply to be about dinutuximab to between, KOLs $XXX drop right market. we But than and end is at value sales depending estimated $XX US market was the cost means as on this where is it $XX US. value potentially the this. the excited $XX looking US of combined per see million up at a it's and and million for And we Chinese market, the United data recent could naproxen, are anywhere market in value-wise, treating US those sales with in half is more they be are looking of other year. that in that $XXX at the price of of a very DANYELZA about million you XX% definitely Therapeutics but to with reimbursement the second patient market had That same So, with that up, [indiscernible] about million from the pricing of where of per about of quarter that million can now but our

here; mix couple and million itself markets in Europe, our market into got - that and Then with turns the with is Techno US by also really ballpark interesting. in the market in and interesting to some Pharma, very hundred in out the American countries of also. covered Russia. So, we this Then Eastern if of partner, Latin be Europe, Chinese a

years. I nice in think - well in coming the placed we are for pretty growth

Arlinda Lee

much. very you Thank Great.

Claus Moller

welcome, Arlinda. You're

Operator

like the closing any turn remarks. Thomas question-and-answer Gad session. This I to concludes would over back conference for the to

Thomas Gad

today, joining forward for to have our everyone soon. great call you day. you And Thank Bye. look and to you a we you. Thank hope speaking

Operator

This conference call. concludes today's

a disconnect may lines. day. your You for pleasant have participating and you Thank

Y-mAbs Therapeutics (YMAB) 8 Aug 212021 Q2 Earnings call transcript