YMAB - Earnings call transcript Q3 2021 | Y-mAbs Therapeutics, Inc.

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Operator

00:03 Good day, and welcome to the Y-mAbs Therapeutics, Inc.’s Third Quarter twenty twenty one 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 nineteen ninety five. 0:22 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 ten K for the fiscal year ended December thirty first twenty twenty as filed with the SEC on March one twenty twenty one and in the company subsequently filed Sec reports. 00:48 At this time, I would like to turn the conference over to Thomas Gad, the Company's Founder, Chairman and President. sir. ahead, go Please

Thomas Gad

Hilary. us morning, quarter today you, you earnings and for joining for And Thank everyone, good thank call. XX:XX our third

We is and the Type of we our twenty and quarter, our as FDA our SADA the strong platform, launch. the the meeting we twenty a to notable well. BLA. one in omburtamab revenues the XX:XX September by path and pre-BLA Both the progressing with During the meeting with that three and We constituting pillars followed a made Y-BiClone platform, number held B far well a business. resubmission expectation resubmission potentially during compounds confirmed bispecific in exceeded DANYELZA as BLA of internal for essentially of DANYELZA have traded our a of treatment under which thus January, progress omburtamab, had towards centers

submitted first Tourism in Claus the significant was notable Hainan Boao, it’s that advance. relapsed Pilot review with cancer that two So, lined NMPA provide refractory IND in of The to formulation. XX:XX nivatrotamab, neuroblastoma we to with report in further Y-BiClone our for high-risk Notably, Zone. now in in cell have Pilot The up, Macau. The this important the we're XX:XX progress this accepted remains shortly. treatment [indiscernible] deliver to very made granted the the and the and it been open XX:XX clinic. lung by pediatric prescribed Zone. continue to an CDXX SADA dosing study and treat promising will DANYELZA a China, received China up small unmet able seven potentially In need. new more addition for has for patients subcutaneous DANYELZA potential platform the China our quarter, we priority treatment pleased of drug plans for as subsequently of programs for and continues that time additional to be address Medical the number initial by treatment closer Mainland bispecific Phase SciClone optimize Kong, a We're the in patients will our second medicines for been evaluation. the center to under first center strong, Hong moved AML has Moller, I'm pleased patients platform strategic SciClone to Pharmaceuticals patients with details Our many BLA and China excitement bispecific will technology XX:XX a cancers, over pediatric the also are together of DANYELZA. partner adoption and and

first file We the for quarter. our are on IND track fourth the in GDX-SADA to

more We least file cash. the XX:XX construct. the Next one IND two SADA planning third at year, ended are to million quarter in with we for fifteen

XX:XX construct So, have on the our Officer a pleased and will development. At when are And to it that, pleased Financial platforms are on with continued time, Chief position, this over Claus. with our to I'm to commercialization the very technology to strong our DANYELZA normally support our XX:XX working we Y-BiClone current the developed] we development Kruse, Lutetium we [ph]. and but And also launch nivatrotamab the into potential continue of sheet of [business advancing omburtamab-DTPA, very call. Bo on we We're and Thank omburtamab, actively believe platforms. both you. conjugated same SADA balance advance late-stage which with elaborate we later turn financial the

Claus Moller

earnings third quarter Therapeutics’ Y-mAbs calls. one to welcome and Thomas you, Thank XX:XX twenty

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

bone reflects pathway. ten strong rebates the bio FDA impact marrow to high-risk XX:XX by the We last was to percent the offset a center growth out independent the me shipment prior reflecting treatment the minor relapsed mix refractory from patients the demonstrated bone recorded of and DANYELZA disease over an partial quarter, have net for from which neuroblastoma third nine by or approved million Let is approved who sales with or a therapy on start stable DANYELZA. DANYELZA approval or response, mix a treatment both of outpatient. of accelerated in with response, Naxitamab in certain patient shift and or the quarter, in-patient

centers delivered in the the increase twenty treatment At have across DANYELZA. We are quarter, nation. experience we number of centers the particularly four had the gained that encouraged by XX:XX the of end with the

to access related net shipped expansion effort additional recently we I their across third in number are pleased We also twenty as into a the convenience still quarter in and for XX:XX gross day-out. at for to promising that is data believe patient in ship the share opinion patients are more a has the the watching as being this to be number U.S. and Some very often compared HITS included as and as is through quarter. China, very vials to gross about revenues very DANYELZA. guiding the high solid are notable of chemo Data. health XX:XX up many with the and in-patient in first and seen future continue for progressing organization, centers a to seeing the consisting ten trials also about the then is appreciate an New for to brings uses to well their reflected resistant commercial treatment third forward, as medical an immunotherapy significant Going quarter, in business have approximately nurses We percent DANYELZA This able for first this experience to the outside affairs hopes sites the opinion cycles, XX:XX for day-in available combination our revenue field we outpatient reported very Sargramostim. at omburtamab of and and together referred on MSK XX:XX PHS. naxitamab, increase of outpatient high-risk net as more and being one in subject in that held than start calculation, learn see basis. has We we centers of towards XFX, data shift DANYELZA XX:XX but which programs It other vials The treatments as with expected HITS in the in outside and new webinar one. a The increase markets. offer treatment FDA the from number see and now overall York the the line, with and DANYELZA the to look that a and subside, for second with in however and launch, percent institution formed leaders, table country. HITS MSK whom the LatAm. system neuroblastoma clinical well Spain combination have MENA, We in of of neuroblastoma ramping XX:XX the DANYELZA nonstop approval to early where Royalty the refractory of is traction physicians of during XX:XX treated ICU DANYELZA, the growth maintenance growth international being mentioned calculation Actually, started increased an our obviously more on nicely. other as outpatient job versus DANYELZA more eligible to well favor chemo which the increased medical outstanding It review trials in DANYELZA the income treatment notable new that MSK as first but from the quarter. did refers hospitals detailed with the substantial very that patients gross two and increase modest, in into words, quarter. treatment, outside ongoing to thereby continue key an the In opposed a delivered Temozolomide while net are the forty basis but public U.S. nicely. putting revenues to and line is vials significant Barcelona, significant are in or point. doctors prescribing done pleased rebates I'm sold in shift market and thereby commercial DANYELZA. as had DANYELZA first into treatment, a with freedom PHS, key humanized DANYELZA twenty of and of educating MSK the impacted given degrees the pleased Irinotecan, in non-MSK will as to of mix becoming leader in impact get second as Our

frontline We multicenter are will of II initiating combination chemo still week. trial international our next the in Phase screening and start an trial process patients from multicenter

a ongoing. detailed Type have the analysis the II the B Phase FDA provided in also feedback trial for at metastases turning to plan. Based from treatment a pediatric meeting where additional FDA from leptomeningeal statistical with patients We neuroblastoma. CNS of September, omburtamab we with XX:XX data osteosarcoma on Now, and

feedback XX:XX our we a marketing aim positioned Glioma II benefit pending submitted escalation was complete of which of prepared quarter Diffuse meeting, planned. two, way in first data study and for of I raised of twenty and the a submission evaluation need. who of the the we XX:XX responding questions our allowing have interim this and we after will to for meeting on application are with known XXX the are dose EMA twenty the as to requested are Study or a shortly US-BLA steps September parallel in for medical approved the has if next Needless was the Pontine We say, January, quarter DIPG to we back a twenty from course to for recently. believe omburtamab are FDA Furthermore, omburtamab in significant we for BLA multicenter unmet be EMA application pre-BLA in for year. to have two. major European omburtamab a to omburtamab CNS/leptomeningeal process of progressing from that is that paved Phase FDA We as currently agency. and neuroblastoma omburtamab IND pre-BLA believe positive with Preliminary very facing Phase in aligned in metastasis potentially our of the approval XX:XX filed initiate the Intrinsic in received us pleased we recently during be with patients meeting, the by first twenty resubmission believe The was April

administer up repeated doses the to study. three in omburtamab. turning to labeled We lutetium of Now, expect that to XX:XX omburtamab

ultimately XXXLu-omburtamab-DTPA its lutetium patient labeled antibody The need safety are medulloblastoma, clinical determine of include positive and XX:XX children multicenter treatment BLA to under tolerated XXXLu-omburtamab-DTPA have patients been and the BX-HX the opened has most us this cancer obviously positive from Disease adults to of XX:XX November. we priority is with for lutetium which of late eligible Our leading Rare omburtamab clinic with further XXXLu-omburtamab-DTPA this basket leptomeningeal Disease for adults designation in the type our thrilled medulloblastoma based prior for in review adult dose. for compounds is to metastasis four pay granted CNS IND our first where the see Designation indications has cancer. hope our establish BX-HX PREs. for leverage study have Iodine-XXX in adult way and started we we brain rare the to see experience now into which Pediatric patients the is Iodine-XXX the receiving common open omburtamab excited have on to Designation trial increases We for a the widen treated XX:XX Pediatric our our omburtamab to medulloblastoma, we with profile maximum The brain the the This clinical cancers first trial treatment are I/II screening makes the treated. Rare for voucher, and of potential XXX treating experience the make and addition, omburtamab of Among omburtamab. XXX Phase hope for also. program chances In primary FDA us pediatric upon with from patients now lutetium multiple to in approval development, treating reach

tumor cells. Our tumor target T Y-BiClone potentially cells. engaging arms The was binding binding arms constructs, T-cell by binding the that of new Y-BiClone format two minimal designed cells to T generation affinity may host antibodies formats Y-BiClone of bispecific T to necessary recruitment the The have contains two recruit destroy cells. for XX:XX a and for

our neuroblastoma in to of the trial II lung cancer study two clinical small nivatrotamab’s subcutaneous is expanded to plan now have in patients. MSK cell in one and We into nivatrotamab one two also recruiting and study the expand Phase at administration XX:XX patients the We Phase ongoing include arms with osteosarcoma. separate study

submitted significant interest CDXX open an bispecific within this are as SADA this Turning very our we Technology, antibody, to to the three already experienced the good platform, the study hope know, AML Y-BiClone to bispecific are clinical in generated next next have for months. We our we study. sites making We in-line on participate have for Pediatric patients and technology excited prospect from IND of this the and XX:XX you progress. to about six we multiple

positioned the that great efficacy XX:XX We the are historically the plant and has potentially announced, year. the already filing believe radiolabeled handful meaningful first can interest therapeutics SADA have We in for are SADA to of the expected partnership and significant to platform IND not December are potential SADA responses a SADA preparing in for targets demonstrated months. leverage the be tumors as And agents. this improve We technology in coming of development. it technology CDX previously is we to that seeing SADA for radiolabeled against and clinical shown

we well for. than company, pre-BLA For about franchise excited generation omburtamab, the across had as this are words, XX:XX bispecifics, same more helps with busy general the we been antibodies. made, next comments. We hoped resubmission shipped and to time, on by commercial being believe me the truly Now, this constructs, remarks radiolabeled In the constructs the patients DANYELZA of XX:XX elevates better off positioned requested. centers we even build business the has DANYELZA other financials. continued finish remain widening some clinic, a let very pipeline multiple predominantly forward to to significant are and further through At XX:XX platform. Bo stage and We antibody deepening is advancing the that commercial being progressing Y-mAbs the treatment his XX:XX invite development. the are me excited our meeting to of SADA our and we and grow move already we international the BLA quarters to Thus, country omburtamab and let progress the inside Thanks. is our share with

Bo Kruse

September million XX:XX revenue twenty. revenues DANYELZA quarter We no reported the in one. thirty, There Thank twenty for twenty you, twenty net the reported were Claus. ended nine of thirty, quarter ended September

stock of September third As and the sixty and two eight we decrease point in stock twenty. in general in fourteen quarter increased compensation ended September the one as point sharing MSK from sale three and to for hundred million and The million for related thirty, a These based to dollars take revenues. the of thirty, driven one with thirty in offering related proceeds thirty, fifteen the voucher workforce. percent primarily salary, ended clinical ended nine that also for netted the hundred the was two XX:XX note costs, one. September our in thirty, two one proceeds operational point share non-cash partially to where diluted end primarily XX:XX for thirty, net by to related six of outsourced months net thirty, XX:XX offset and loss million seven January compared thirty, This was costs. million fourteen DANYELZA expanding one raised one, balance million and reflect increase by reflects twenty million. ended the ended corresponds increase cash twenty sixty one with nine twenty twenty twenty This cash to quarter million million in eight forty personnel reported expenses of non-cash million to seven the XX:XX one. benefits including We point review by in the twenty per point a six basic February one of eight September dollars for activities of and million dollars net twenty share, quarter point DANYELZA compared twenty development one, commercialization point including dollar twenty twenty closer Our one. year XX:XX million look The loss product basic seven point We and twenty. administrative and compensation from license loss two increase per position two quarter sale quarter net used The after benefits the million expenses related expenses in and December a dollar zero point September ended one attributable twenty net thirty costs, or quarter one the hundred agreement. were our manufacturing at a net of of in zero reflected million proceeds a for six Selling, point increase seven nine salary, the per third one diluted, twenty twenty two twenty as twenty operating our million our partially to cash twenty eight twenty to the the million at twenty public six employee twenty we September point twenty two increase twenty point expenses increase by trial research from for one for personnel the for quarter quarter based the four ended September we DANYELZA. point dollar point employee primarily selling, offset expenses, twenty general million a and launch increase twenty point eleven and decrease four ended or from increases for point administrative by million in increased one

in Y-mAbs believe healthy financial position. Now, the a to turn this over remains to XX:XX I'll the financial concludes call update, and continue We now Thomas.

Thomas Gad

much, Okay. prepared Hello? today's of marks you, both. … remarks. end You hear can’t And the XX:XX like to at Hello? very This me? Thank time, I this

Operator

Thomas, hear can fine. you XX:XX I

Thomas Gad

you, the This Thank of remarks. both. marks Okay. today’s XX:XX end

Operator

hear us? you can Bo, XX:XX

Thomas Gad

you Bo, need to I think I hear Well, XX:XX can mute. operator. you

are call open This end and you So, Q much, At the remarks. prepared going I the hear for call today's Bo to Okay. questions. open us? like A. you up the and very Bo. of we marks can Thank would up for to time, this Claus

that Let's procedures, open to for the procedures your line now remind you operator the Thanks. are what submitting and can the the I ask perhaps questions.

Operator

XX:XX Bank is of Alec with [Operator Instructions] Our question Stranahan first proceed question. from your America. of Please

Alec Stranahan

XX:XX Hey our guys. Thanks questions. taking for

So, two the on from launch. me, a both just to DANYELZA trying get temperature

to more So, timing I guess many therapy the into of and there as of either over in in weighted those it from is it the speak discontinuations patient we'll the at well? that the carrying of patients end? XQ, or at fairly guess therapy And Was Operator? or started XQ spread it I beginning how treatment? guess, many completed were was I could when see patients And in possible you evenly XQ XQ? that therapy point started any, to this

Operator

and me? Thomas, Bo XX:XX us? hear you can you hear Claus, can

Thomas Gad

to problem going XX:XX try with the redial lines. a Yeah. to We're there's and

Operator

I are Hey, reopen and Okay. back. [Operator gentlemen, moment XX:XX question Instructions] the ladies queue. we while One

right. All Okay.

from Our of first of Bank Alec was question America. Stranahan

Alec Stranahan

Can Hey, me? hear XX:XX guys. you

Claus Moller

XX:XX Yeah, absolutely.

Alec Stranahan

XX:XX Perfect. Perfect.

XQ, started And have XQ therapy weighted launch. fairly timing I the XQ, of the this how guess guess in and evenly there when end? started get was I have follow-up? speak I spread sort it or mostly therapy the many point of in it or a the sort temperature trying any beginning guess on Was to just And I just patients the across DANYELZA where discontinuations? completed quarter? you more at of therapy So, could of a in that to patients the

Claus Moller

moving we of XX:XX in patient patients more more are patients, coming and Well, complete into many of cycles to secondary chemotherapy I secondary the with see patients treatment type that additional three also try also, sites, obviously, said the is they when not patients of starting typically received that treating hospital patients. as often are the As still two do or combination received of sites out retreating after new that or day the they primary on I than but patients the patients, refractory mean, out dinutuximab they MSK, we outside are capable first new of cycle and XX:XX not first But have distribution many not is but realize patients actually primary treat hours the see these see remission. DANYELZA. treatment, can later same more converting start where they a And these the as do they of these sites outpatient, than we or in-patients patients. refractory through what actually few to it details

to bit giving too early out. I think it's a start

Alec Stranahan

XX:XX Okay.

maybe that, But in guess of bolus towards the Okay. sort patients of the would the could… say spread a of of were terms you across quarter like or That I end most quarter? treatment the

Claus Moller

it the XX:XX spread evenly around was pretty throughout quarter. No, Oh, Yeah. it's…

Alec Stranahan

XX:XX And second question my then … Okay.

Claus Moller

a as little can also was maybe a It other month July summer bit things. reflecting be silent than August, September. more XX:XX

Alec Stranahan

That's I Okay. the around then DANYELZA? And I your EU China next comments playing to role any year, expanding and looking the launch do guess big see guess, geographies? have do in into for how the you you And approach market to XX:XX helpful. a the

Claus Moller

to or is second China, said, allowed expect have big approved we a that treating research Chinese going EU next quite regulatory we China commercial could expanding get XX:XX in And U.S. of So, where and with expectations. have some DANYELZA have we to Thomas programs as we the that in very And have beginning as start it. we quarter, the year patients expectations XX:XX probably China. we already late market that it's mentioned, in these just see significant are of products could for access next quarter we means approval first we be quarter during come previously Well the year. China, which that based we quite in good or a on second areas in the for EU early treat in feedback to are with Chinese interest received

need So, patients out for the of lot and treatment treatment. a it's there that available are

Alec Stranahan

Thank XX:XX you.

Operator

XX:XX question of Joseph proceed with your is Our next from Please Cowen. Thome question.

Joseph Thome

there. Difficulty] our walk new the all? just geographic online, can is bringing and or one, taking then morning Technology, what interest, you for center easing would in SADA before partner And bringing work just and have of get Thanks. a that of just like at if partner of you a questions. license through you [Technical Good [indiscernible] maybe you to a put Hi you thank of what's is us could next P first committee the individual? kind centers necessary? into XX:XX Maybe terms on be and formal kind you second point you combo through significant seeing new Do this qualify T partner approval to sort a indicated

Claus Moller

XX:XX Sure.

the staff So, sure and are reimbursement sure because to getting can somebody buying pain the any particular of hassles set-ups, the and it major is the be etcetera but treatment pharmacy I is they close XX:XX giving sites of and the it's side normally available The need not does effects. think a infusion, that to patient trained that in person the new the manage procedures on handling seeing DANYELZA And, side quick staff problems. also. and challenges make they the primarily a take it than more making education one the for is we for actual activating on staff such making

where not we have too. in actually sent size have we the any the experienced So, product

primarily education. it's So, I getting think the

with would BD like is with and MSL tech I platform. job concerned humanized which was outside technology technology could we anybody different the that think [indiscernible] where fully have are company many problem to make. there's way in great target for how and we side, with is a when rights a see to no SADA The are antibody target, use you to the SADA looking antibody On could believe taken. So, companies SADA there's make. SADA company another how no targets company that targets. problems you different no limits can what I have basically So, different for with has the technically we you a no problem. and that XX:XX our antibodies traditional many license long not fantastic we been long partnerships has against the this what team these Y-mAbs such limit XX:XX but time. are that deal that a is make they platform how many target there. can say would as have circulating limit basically that, if to can had against, these, SADA conjugate can that there's antibody we It's they to can a we do that There's about doing And when is XX:XX to to the that now another solve be particular constructs a you as a

SADA one I'm the that partnering the for who two develop wants world. And the the gets be to own partnerships SADA of think of can multiple CD-XX, constructs in So, CD-XX it's partner targets also. they Potentially can them. not spend. XX:XX generic saying GDX-SADA IND of for partners right potential their will can do a December. or whatever make regional including for do own for different constructs, construct, where our available SADA it's entire the you could course, the we then be to for the why And that each filing So, as first that's

would talking are be partners in of that. we to interested are those our that one think I

for there's multiple possibilities platform. So, SADA for the partnerships

Joseph Thome

you That’s Perfect. Thank helpful. XX:XX very very much.

Claus Moller

XX:XX Thanks, Joseph.

Operator

with XX:XX JPMorgan. [Operator Please Instructions] Our next your proceed question Tessa is question. Romero of from

Tessa Romero

so morning. Thanks Good guys. our Hey for much taking XX:XX question.

the the ex-MSK about point? DANYELZA, this sales I is have just past I guess you forty tracking portion towards as of I of came you at a about follow-up target? talked year. clarify that for how been well. the you've how first could are you activated talked in about think my what So, target And And have question increase, sites many MSK? volume outside actually but a

Claus Moller

okay. Yeah, XX:XX

of end by percent we So, sales had forty MSK. asked? by end more received during quarter is now first, has DANYELZA. I the that you what outside of twenty quarter, the than the of that said, sites the And Was four

Tessa Romero

Yes. XX:XX

I as here of that number, longer end thinking it take thinking may by Claus, to target year? sort as bit about, originally a the hit little So, thinking this able we're about you guess of anticipated be about site we're Do to you might hit think XQ than target? forty are what how you

Claus Moller

if we good sites we thing this an with that making to a sites early it think to every them twenty XX:XX three in reach we is interest XX:XX let's we quarters the are up it's think see said, I we learning effort to maybe patients. is since conferences, starting in end into to whether the as out had eight four. forty out where trying important the But early – a February like to to I a continue DANYELZA we stretch, divide you to mean up. see I the on it year. launch sites when and little but we launch on about have And are visit meet the I day new end, I say high think average but to it's seems doctors sites, forty on get at the

months this eight anticipated to what had have we actually have the we in I'm first And we year. looking very of that still seen. happens of let's see reached I So, year. at the XX:XX we see the and positive not level on are now, right think say the what rest

market the in of that's to product So, say, a I been of number at huge for for of experience and think sites. market still to quality on practical making the been a penetrate a studies you yeah, the XX:XX to of has have five doctors years positive can some it four the course, I’m a lot that this leading clinical having with and a difference and patients. course hard in lot So, product. the it, of makes takes where of existing But get has work time that into

Tessa Romero

a Yeah. just That's squeeze then quick follow-up. if could And I helpful. XX:XX

you've think results wondering thought could we those presenting December there? talked just what On frontline the I was so the II the them day, Phase potentially latest MSK what about at R&D on study, was latest is see when presented?

Claus Moller

don't last data. I XX:XX came into But in as the I Yes, said still we have the said, the February. new. we anything seen patient think haven't study

data collection. it's So,

have and at hoping December. R&D give to data update So, in available we're an day still the

Tessa Romero

Okay, Thanks for much great. so our questions. taking XX:XX

Claus Moller

you. XX:XX Thank

Operator

There at this XX:XX are time. no more questions

We now turn have will the closing reached the session, remarks. answer I end to question call Gad of for the Thomas over and and

Thomas Gad

and XX:XX for you. All in today's have right. weekend. participating a you call Bye-bye. everyone Thank Thank great

Operator

today's conference. concludes This XX:XX

participation a great and this You may you time. lines disconnect your day. Thank have your for at

Y-mAbs Therapeutics (YMAB) 5 Nov 212021 Q3 Earnings call transcript