YMAB - Earnings call transcript Q3 2024 | Y-mAbs Therapeutics, Inc.

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Operator

Good morning, and welcome to Y-mAbs Therapeutics, Inc.

Third Quarter Conference Call for 2024. [Operator instructions].

As a reminder, today's conference will be recorded. I will now hand it over to Y-mAbs Head of IR, Courtney Dugan.

Courtney Dugan

good and operator, you, morning, everyone. Thank the Call. to Y-mAbs Third Conference Results Financial XXXX Quarter Welcome a release issued opened. We press before this market morning with our results press on are our The accompanying section website. IR of available and release the slides

and ended our XXXX, now turn ended be XX limited and me ended company's may statements and and CEO, thereof; and report submissions, business materially XXXX. our or Form SEC cash contains call the like statements its potential and of related thereto, distribution discussion the are Form cash clinical the other but Rossi. XX-Q Such product as on statements and anticipated results facts. XX, expectations those on quarterly Form future in and annual statements that risk the cash Litigation company's historical forward-looking XXXX, December Mike model, collaborations Securities would research from not factors, statements year September regulatory certain over XX, the involve due and forward-looking related financial the XXXX, include, marketing I XX-K quickly programs guidance Private related partnerships reimbursement to to and factors with such and XXXX quarterly to beyond June those the XX, approvals, remind and risks to, on a to our uncertainties, considered Reform implied to with our expectations Let filed including for actual and for our not preclinical of by respect quarter clinical that March and data, statements expressed and for the the previously and defined regulatory, President sufficiency trial following and runway commercialization resources to or Because that benefits and statements investment assumptions report differ filed potential studies variety you today. about are and Act current estimates the XX-Q plans, are of to report strategic in expectations quarters development for the

Michael Rossi

Thank by Courtney. I operational highlights our our I begin with from joining Vignesh Medical our third financial will progress the Rajah; Officer, Chief have Sue today me you thank Officer, sales DANYELZA and SADA us. and for or Commercial Good Pfreundschuh. Chief Financial DisAssembly Pete Chief our utilizing technology and you, morning, This radioimmunotherapy morning, clinical Smith; of Dr. key and Officer, XXXX, platform. of pretargeted quarter performance the programs PRIT radiotherapy reviewing including clinical our Self-Assembly

third Sue our global around XXXX for will guidance updates before sales review line details quarter. trials. our Vignesh in Then financial quarter and then open our performance, our clinical Pete we Q&A. provide XXXX DANYELZA our cash resources will will ongoing on provide the ISS third naxitamab reiterate the Next, full

of treatment high-risk begin anti-GDX the brand with quarter therapy is response aged the bone to and be with is the a disease older highlights marrow. the children. humanized of incomplete infants the or bone year in neuroblastoma an starting the with DANYELZA, for and common bone DANYELZA. in marrow. X in and had naxitamab, approved have most specifically most have common continues the third children and/or also FDA third who cancer the Neuroblastoma cancer children XXXX, name DANYELZA in or relapsed/refractory induction to relapsed therapy Let's for bone key for for designed

needs of the outpatient setting, While DANYELZA the designated as in an can also depending on be inpatient therapy, administered the child. specific

the this of quarter launch continued the terms we the year, carry headwinds third our around important and from we a number U.S. patients the to of existing and demand both new X% X third able commercial year. to of the since saw competition this in adoption the X-year access U.S. Despite DANYELZA. in mark the second this since increasing signals compared increase encouraging to quarter, nearing new quarter of we shows anti-GDX launch DANYELZA we of treat XXXX back This sites second We in and commercial accounts overall able DANYELZA In with added having some are patients progress reach are the in DANYELZA into progress more DANYELZA physician saw to are quarter the us to across therapy. and the of accounts

and patient advocacy care important initiatives of current to direct-to-parent option neuroblastoma awareness for an complete relapsed/refractory high-risk and treatment important goal the a remission. thoroughly drive with around understanding achieve as patient the children response of increasing to and continues efforts team in with education Our gaps DANYELZA

million down more XX% due in in decline to net on was both In product across in decrease shortly. in from $X.X the period The third the markets markets U.S. revenues hear same will recorded from You around million, the revenue $XX.X addition DANYELZA's third the a the Sue of we ex-U.S. performance ex-U.S. XXXX. our in-licensing specifics and achieved of and total revenue to U.S. our net XXXX. quarter, in in quarter quarter,

with achieved in consistent the corporate million, We XXXX. XX.X the of same net support For relatively global updates and efforts. our in months revenue that total X we quarter first the indication of expansion continued several period commercial the had year, USD

the last patent for We month. are received accepted have DANYELZA, notification extension of USXXXXXXX thrilled to

Y-mAbs Princeton, XXXX, our U.S. XXXX. X, headquarters Our agreement extended expire into quarter, Jersey. XX, February the will from June In third patent New for entered we in lease now future a

XXXX, the million, agreement of the announced from the week, for years $X which and in of completed product payments the of USD recorded in have the profit and of in XX for if we of receive commercial Under in commercialization addition the fourth milestone an Noble and half to be year. premises quarter distribution of be the the received million upfront the and to will up agreement, sharing sales XX commercial with X region. entitled agreement the Japan, this of terms exclusive expect if approved entered license are to on lease payment Japan. will we and an Earlier represents partnering to development first Japan DANYELZA region approved Pharma date. months run DANYELZA, DANYELZA, that expanding commercialized the this access Noble will Asia the we construction completion We successfully we in important and approved there. with DANYELZA and Pharma look region, an for forward if in in and to We to

named quarter third in Our Turkey patient in partner, of the Pharm, TR the program DANYELZA launched XXXX.

the look further updates how quarters. in and to forward We are very progressing is pleased providing future with launch

year. the we with American In commercial filing remain in DANYELZA to U.S. approval plan we gaps expansion in and neuroblastoma. our regulatory or addition, Argentina in partner, refractory confident Overall, for of our important marketing in Latin children trajectory the ex-U.S. fill relapsed ADM, with a to treatment DANYELZA strategy later this continued of of submit high-risk

years SADA X the Let's our or looking cancer, now safety fourth the age shift the small GDX-SADA opened quarter, above programs. our evaluating cohort melanomas. to I lung sarcomas In and with cell and trial solid is for at of neuroblastoma. XX Starting trial of with malignant a treatment tolerability Phase tumors. adult high-risk GDX-positive basket patients to include we This of

the multicenter study C while currently days demonstrate payload. B DOTA X A are the To and date, X lutetium a Part and profile A, and the total As safety which Part in, the XX Part has between the of X the in a lutetium we initial and parts. this protein intervals of reminder, to safety of sites and escalation finding dose GDX-SADA dose this have aims of optimal we structured to dose X patients single-arm efficacy the signs repeat Phase for molecule explores evaluate of to will the safety dose XXX is trial. I protein have of using Part of testing DOTA determine open dosing.

have construct blood cohorts up in protein and dosed millicuries through lutetium radioactive We X initial to with of day patients X.X payload. using of to milligram The X appears between and between per kilogram, pharmacokinetic data X X terms comparable models interval current of from are profile the patients the and and these X milligram to XXX of SADA of the completed our a days. X per profiles kilogram X of per protein and dose interval kilogram PK clearance supportive match in blood and payload milligram preclinical X

instances continue not success PK It note complete activity and what have dose-limiting of is patients a the concept events. to experienced in no encouraged no serious humans that treatment-related we that trial there scans full seen the of To we We demonstrated early by be have can to not so data SPECT-CT date, date, or these we adverse or have program. on are have seen and to Based in been ultimate of indicative toxicities, we have and bind necessarily trial both the to far. any results important tumors. of believe proof and find SADA development GDX-SADA the

objective all the protein inform from optimal B. readout timing end are from track and I we determine Part quarter of trial, A the and data administer will the A this of full We Part anticipated profile the the a which of to of present on first by is look demonstrate In radionuclide, the this in complete study year, our XXXX. A to data of safety the Part Phase will Part of to the set to

IND plan scan we images awaiting pediatric cohort show A neuroblastoma, additional I Because adults are elected trial from data we to and Part filing also in an with to open GDX-SADA data. We full include to sixth Phase a neuroblastoma. PK before our for the

in CDXX in we first of Our circulating our program the second and lymphoma, SADA are on non-Hodgkin's first T-cell is tumors. is This SADA lymphoma. focusing B-cell treatment program SADA, studying which

I Our can planned Phase here. trial, GDX-SADA you see design comparable to Phase our which follows I the

expect We have of activated end by first the first to the and selected sites and XXXX. dose sites the X patient X

in at preclinical forward In American Meeting fusion of ASH the is non-Hodgkin's a for on self-assembling data titled The abstract presentation of to CDXX addition, Diego. SADA, lymphoma radioimmune look pretargeted a Annual X, CDXX in Hematology and therapy Society X-step poster website. on December available SADA the highlighting protein bispecific San disassembling we

believe quarter manufacturing, traditional for PRE cancers and across programs are PRP updates forward. potentially both much serious in of Across and forward to administration on to PREP its potential gaps of will patients a to generation going continue look now Susan we XXXX. potential third excited development families. logistics at outcomes pass patients Smith for and very SADA advantages clinical improving a platforms, the We sales their radiopharmaceuticals. are I for range and further and potential DANYELZA our for to life DANYELZA providing advancing global with needed through SADA and to We committed of of diseases, over color on in of our provide call long-term SADA other fill quality therapies aimed to we the generation new further the

Sue Smith

Its estimate third unique were marrow. same In product seeing Thank you, Mike, administration overall the in quarter morning, carrying caregivers and in quarter and third in quarter, bone DANYELZA Despite second some good the from we're saw option $XX.X including of the XXXX, a for the to decrease with an important headwinds we into period DANYELZA pleased key progress everyone. the commercial claims. ex-U.S. launch our XXXX, neuroblastoma anti-GDX toolbox or high-risk net primarily X% an in treatment makes bone for since response representing the bone across the the DANYELZA outpatient with compared total the revenues patients and/or same Medicaid patients driven markets. and a initial DANYELZA features, in in by in relapsed/refractory the is and U.S. physician change million, commercial U.S. treatment the important of of marrow bone of alike. therapy

performance market we share accounts market the still used as and of continue competition X the its grow. ongoing the XXXX, U.S. DANYELZA's with DANYELZA in of While September addition new the on DANYELZA of anti-GDX encountered accounts of prescribed increases in X around on see We're providers continued a in estimated indicators. with in added X starting total more trial launch clinical DANYELZA steady health saw launch U.S. remains September utilization X third of now on quarter total have initial XX treatment XX, of activity, since XXXX. Since XX in key started care DANYELZA launch, XXXX, have X maintenance total patients. to patients the physician at XX, of A of months new for therapy approximately more from to XX% entrant health or excited patients. XXXX. practitioners treatment XXX to ended have or physicians XX those a we started

receive to customer continues commercial health DANYELZA sales U.S. dedicated Our ongoing on positive through care team provider feedback interactions.

of X of added XXXX. continue of quarter has which formularies adoption been addition, to bringing since XXXX, the XX to to total In September third launch hospital the hospital in XX, as we institutional DANYELZA, formularies see

Ex third WEP quarter order decrease Now an million, was quarter turning DANYELZA revenues patient to volume a had decline third of our by XX% of ex-U.S. net decrease U.S., to commercial access the product Europe, progress. were XXXX which of our XXXX. quarter driven our third primarily initial in compared from stocking The a XXXX. the program $X.X in in

The first and third Mexico, of quarter American the Latin quarter recorded Turkey led DANYELZA consecutive partner, by marked in our Pharm sales with Brazil partner, the in sales second TR our and ADM.

our more Asia, about and its last coming partner, in and launch continues up the dynamics Hong to look quarter. expect providing DANYELZA see in in the to updates region these learn use as expand further SciClone, in to DANYELZA following forward adoption We regions. In we of market Kong gearing China is additional quarters approval to over

Our year with continuing DANYELZA finishing team in DANYELZA access to across to and of is regions. strong expand to support respective as committed our quarter partners they U.S. their ex-U.S. the fourth the performance

in to trend providing of now in the to expect growth further as the to anti-GDX forward long physicians year. marrow will upward overall term. coming therapy I in to throughout to and the choice continued relapsed/refractory We pass a over updates see the sales bone look caregivers bone Vignesh. call of and confident DANYELZA and/or position the high-risk neuroblastoma both are We potential the

Vignesh Rajah

naxitamab Sue, hello, and pleased update everyone. trials. ongoing you, to a investigator-sponsored brief on provide I'm clinical our Thank

Let's start second-line Center's Phase with Sloan clinical II with Cancer Memorial evaluating in osteosarcoma. naxitamab Kettering patients trial relapsed

plans instead call, on received earnings As months. abstract BCC, full XX our we year, newly XX Phase patients there a of next the diagnosed BEAT Research MSK is not to with this team its meet analyze at patients at did event-free Childhood months standard study our this end the the in after were neuroblastoma to induction of expected back therapy high-risk second-quarter MSK neuroblastoma. Consortium, In frontline draft team medical event-free that endpoint our multicenter in steps. trial leading setting, II evaluate shared by data patients combination is our stated primary and high-risk partner, with or Cancer time based trial a meeting which results the during XX evaluating present and XX June, at naxitamab the for a from

sites As The comparison the the being ongoing. third of the XX currently is and end recruitment of a the transition an developed. treated quarter, control with protocol for BCC had external XX to amended active patients with

We therapy and that trial single-arm that to reflects care an expect standard comparative the a current patient a comparable from arm a with induction score transition trial for matched. design trial external with control selected carefully of to is population propensity

arm University of are compared care. In to is naxitamab the with breast induction for investigating NK for Phase and we of breast in demonstrate the third naxitamab the with partnering the the gemcitabine trial TGF-beta superiority trial to cancer, a trial the was Ohio cancer. response metastatic on the advanced aim initiated Patient GDX-positive XXXX. complete quarter end Ib Our patients rates of cells, in therapy recruitment at in in standard State

Mother consider the blood completed with leading and dosed in and efficacy would Upon NK design, refractory II gemcitabine of quarter with Three naxitamab date fourth to during is Poland to II before dose-limiting the As this and This Ewing the Phase needs in safety of NK a cells outcome we forward of multicenter the toxicities need cells naxitamab. be a confirmed ongoing. initiated the the trial. study was trial Institute been per is follow-up the evaluating the moving in and Phase with Child of persistence In to trial of and recruitment addition combination trial, randomized of XXXX. for patients of be the sarcoma, naxitamab. patients arm the have

patients to be is in We arm. XX that expect XXXX. total The trial in of expected a completed

a In I Center treatment to the is metastatic of in addition with discussions who Phase to MD of cancer breast indication care of current addition, naxitamab standard the of the have evaluate an objective early initiate we study are assess adult in in to program a anti-GDX of study multicenter the Cancer breast as Anderson disease. in committed to combination triple-negative the one believe for XXXX, unlock in safety quarter the rate The significant provide as expected treatment advancement cancer. this in of metastatic to clinical patients least metastatic well received future at line response prior triple-negative through anticipated studies of space of remains in potential start to cancer. II Phase which the and in working first supporting gap is will naxitamab. these We're on We triple-negative therapy and inform systemic to study, further us investigator-sponsored breast pediatric both the cancers. untapped a development The with

now to hand over Pfreundschuh. Pete call me the Let

Peter Pfreundschuh

Vignesh, morning, and you, Thank everyone. good

from due million and recorded in we by The X% Primarily XXXX, to increased of quarter decreased XX, X total XXXX, a XXXX, decline. and XXXX. earlier, international to the We respectively, by million of price third months heard million recorded quarter a quarter XX, an fourth $X.X the million third XXXX in order U.S. the during X% revenue XXXX September the and were respectively, received you XX% compared representing U.S. an unfavorable representing due and for for representing revenues and product X quarter. partially driven decrease revenues net the of months was timing X% ended $XX.X were net third third the DANYELZA decreased driven the $XX.X total September buying quarter, third million decline of $X.X DANYELZA of compared U.S. The product volume $X.X primarily mix, $XX.X was million in decline. Western million net offset issues. in cutoff was but $XX.X quarter inventory of primarily by ended from As to XXXX. XXXX product revenues the Ex revenues a to quarter the decline SciClone in the of Europe

of the X months XXXX. for net XX, the $XX licensing the $X.X the were million in ended months XX, have We ended September licensing report for flat to September XXXX. XXXX. September for not compared Our million ended did September DANYELZA XX, of did relatively X million revenue product total X X We months months revenues XXXX, revenue ended $XX.X XX,

licensing reported also of X the XXXX. XX, and $X.X million We ended revenue months for X September

to Moving operating expenses.

Our research million ended and X million months and $XX.X $XX.X same $X.X and $X.X months the administrative was months to finalized attributable for respectively, general XXXX, for million selling, XXXX, months in XX, million the XX, decreases XX, settlements and the September for X and XX, in $X.X costs, and X were impact million million net in professional quarter the to million million attributable general increase ended million September $XX.X XX, consulting ended administrative to by a X expenses a were for of million and personnel Selling, primarily XXXX. increase and million development the related to September administrative to representing a $X.X $X.X former quarter and ended The X and increase September months consulting X $X the expenses Financial Officer XX, million separation to ended primarily was selling, XXXX, $XX.X in related Chief $XX.X and compared million and periods from and and increase of of $X.X our and legal expenses ended general The compensation for XXXX. increased that expenses fees. in and $XX.X X X $X.X months XXXX. inclusive XXXX, stock-based September million September to the agreements

Financial net and consulting increase per a $X.XX for loss million in mentioned, XXXX. As compared stock-based September quarter loss ended of Chief and agreement, compensation negative basic the or $X.X $X.XX increase for and professional costs, agreement related XX, negative million Officer's million share a personnel increase of quarter the and a also or $X.X million per previously a XXXX, includes diluted inclusive our to $X separation fees. We basic million the share net ended $X.X and of diluted in $X.X consulting to XX, reported September former a

The per In basic The XXXX, $XX.X addition, for of in months net decrease by $X.X for was ended ended to by settlements share diluted loss currency diluted a $X.XX driven foreign a months months million XXXX. million $XX.X X for ended a XXXX, loss September impact. X revenues we by XX, mentioned transactions, share the was the from with for per September previously or ended net XX, of XX, net million as $X.XX and offset decreased net basic operating favorable have loss the XX, loss reported negative X and product net. and X or months primarily decreased compared a the September a the primarily expenses in the driven partially September impact net legal X increase XXXX, negative

ended we million equivalents of with to earlier, mentioned cash at of a as XXXX As cash compared million million year-end $XX.X $XX.X decrease $XX.X representing XXXX, quarter and year-to-date. third of the

a previously payments third mentioned quarter. on legal primarily million Importantly, driven strong cash by XXXX, a within outflows maintain cash the for we continue the X settlements quarter balance sheet, of in reporting to paid $X.X

reiterate the Turning year that range. total revenues expect guidance. now million, will net the full to but XXXX and in, bottom our We $XX the half be between our $XX XXXX range of guidance in full to we in come revenue year million

expect over our expenses for to range full XXXX $XXX We of year execute prior to a multiple between the will between delivery concludes strategy, positioned in with remain and a priorities the and $XX with for continue million of I full call operating sheet turn and million With anticipated the consistent to cash $XX back financial on update, our and near-term prior we the our in remain strategic million, will million which focused guidance the XXXX, milestones. This is year balance and missions investment our anticipate is guidance. support and to range the which and $XXX consistent of well we to believe of the Mike. our strong is Y-mAbs

Michael Rossi

you Thank overview, that for Pete.

let's the questions. for line open Now Operator?

Operator

[Operator Instructions].

The Markets. Capital from BMO Etzer is question Darout first from

Etzer Darout

DANYELZA the on One another on and GDX-SADA.

price/mix DANYELZA, in And this on a you dose if So to in the moving something then quarter? could what for you toxin, the bit is expect dynamic the fourth little preclinical offsets talk about you correlating forward? more quarter? to have GDX-SADA, the potential dose-limiting no And continue are And data.

If you could talk Part through maybe antibody the for key criteria the of for the sort study for of dose specifically. the selection B

Michael Rossi

Sure, pass that. first it to back much Etzer. Thank on protein. for then for question you price bring very I'll the the the and regarding Sue Sue? mix

Sue Smith

the for Thanks, Thanks Mike. question.

an the So charge out of period. for we both Medicaid-related and QX claims for took $X.X in million period approximate

decline to we even mix, And so spite due having a in net of in vials. price X% X% that saw increase revenues a in

and year-over-year the sales the X% have And up for both been so would quarter-over-quarter. with adjustment,

Michael Rossi

GDX-SADA. around second the question was the you optimal had our dose protein, the So protein on

so what So milligram per at and shortening the window. an first milligram and done the down through the we've started X have X backed X.X to is looking per escalated milligram per since kilogram we kilogram, far to at up window kilogram, that X optimized cohorts

And X data the narrowing to on we've what with the that very focus that we're we milligram so move understanding more far per to mirroring is seen us, that saw, PK into allowing for at then levels, confident the that So Part was the blood preclinical nadir. feel of we kilogram and us down. want that looking to dose B, near it

that? So Vignesh, anything to additional

Vignesh Rajah

the And course, of will to to Obviously, and build on the the all dose well of evaluate contribute optimal evaluation as dosimetry as safety to Just interval. tissues. the and normal need that. we of tumor the this in the the dose

Operator

Wang next is question Cantor. The from Watsek from Li

Li Wang Watsek

just confidence swing if as some the your guide. into you comment is of QX can the revenues level of end GDX-SADA. guess second question the factors And heading for of the we're hitting that on holidays, lower for the I

number histology. a looking at You're of

So wondering these can radiosensitivity on comment of if tumor you the types.

Michael Rossi

All you, Thank Li. right.

Pete For Pete the to fourth I'll quarter to you that. on allow guidance, pass and expand

Peter Pfreundschuh

to the of of that earnings you Li, thanks land probably as within call range the of in we range. very feel million the guidance, lower With the we for $XX We should for did regards confident that question. to half million. land part that $XX the should highlight most we

results, did did although they we the as look sales the for you highlight reported, were $XX.X land million If you quarter third Cyclone fourth in at that the quarter.

So with adjustment adjustment, numbers, then most also third the upon based would or quarter. with licensing for sales probably Noble Medicaid have Noble and the timing consensus the were where the Cyclone just the we actually landed of consensus deal, the the about the numbers

for $XX somewhere very Hopefully, between helps fourth So that the Li. the we quarter, land $XX you, to million. laid in million and a of guidance for guys lower we still out quarter, anticipate you and strong anticipate half basically the range we as

Michael Rossi

the sensitivity, second and GDX-SADA And that on question I'll your radio Li, pass Vignesh. the to around

Vignesh Rajah

you. Thank

adult So sensitivity cohort say the sarcoma, study remind osteosarcoma, It's everybody, include the too early XXXX included what small that to cancer the seen in we of terms neuroblastoma. added to indicators cancer soon in we just cell lung we've in tissue radiation. and to latest have soft melanoma, of

adult As is you well know, patients. the tumor neuroblastoma the antigen quite tumors, also as density the and include to as levels GDX in rationale expression variations heterogeneous solid within the

radiation So data get what of terms seen of we'll of on update as we've in evaluation responses, more and we in terms the here group sensitivity. dosimetry the

Operator

BofA Alec question Stranahan next from is from The Securities.

Alec Stranahan

us. from X Just

the your year, approach assets rollout here then see And making Japan, moving that your as represents additional you SADA progress there early DANYELZA. curious for your going maybe next new commercial TAM Japan and the be the with of through sort on investments you'll how to headquarters to latest incremental hear First, on deal the the in clinic. whether outline manufacturing and

Michael Rossi

Sure. Thanks, Alec.

And We're on to unique than allow a for contract philosophy hasn't SADA proteins. in themselves. have drugs able is similar to brick-and-mortar, production structure position on for with isotopes. the invest DANYELZA constructs and the use with use and we're the our SADA to changed. our isotope protein we the our in able for invest network platform, to SADA manufacturing us that rather allows manufacturing both of that contract Our caging in platform we're Which directly our and us manufacturers same current way the

doing chelators alpha as expand we're as development. rather and in invest with really that within the in again, space proprietary So then drug PET the additional work allow investing as well to than, we're looking beta manufacturing, us our

clinical Japan, that confirm will and I to X we to at limited done in small what trial the second out. rolled to patients, be think do Japan, the look we've similar that got a on point, order U.S. we've as to get in within to

we off increase expect hopefully the kick rather launch to 'XX shortly overall product, second to of early in ability 'XX. So to half the that that and

we as expect is addressable much large look the that, total a our care that, market, smaller as see at we expansion Japan significant on very not of total is it to addressable market. market a forward move we'd than health U.S., from a necessarily the market. overall, and So But but incremental

Operator

Justin from Trading. is Jones from Walsh question next The

Justin Walsh

Aanomed another I'm about I'm at specifically numbers preclinical we're EANM, what your adding the testing that approach players of that some thoughts by curious following. increasing data pretargeting thinking on to the are Roche being and already tested on groups And was approaches.

this that accomplish with think validation in you do to you're So what additional for confidence trying provides already SADA? like or

Michael Rossi

it's good a question, Yes, Justin.

it companies any around the and more to logistics off-target into the does more dose importantly, look and we shorter-lived coming isotopes. this, better see you time to get into providing validate I what is tumor, minimum maximum theory think providing it, at as more

get extremely likelihood well is people clinic. this as on get patients well. this, the the welcome more and and out to about smart go the from point more and you'll again, that more infrastructure smart of The And to what's more products to have pretargeting an into treated important the suites. as we patients leveraging So view having intellectual theranostic existing you companies more without specific to working

welcome we that So opportunity.

more which will methods a is in I variety one And is are which think time always do right. to which there's tell of there optimal, than right answer. And this.

to the then really we well on do focus move we patients practitioners. it well forward. for So what do success will the others they wish and what us And much as can allows and

Operator

Mike from Morgan is question next from Ulz The Stanley.

Unknown Analyst

Mike. for our on for taking Rohit is questions. This Thanks

to DANYELZA in mentioned something competitors you the ongoing decline think that? a And for quarter. Can on you the Medicaid clinical estimate just seasonality, to going of much back claims for on XQ I would Just how the change and sales, you contribute elaborate trials?

Michael Rossi

little volume this, Sure, potentially the about I'll we'll are Rohit. bit Thank the move And that impacting way push Medicare we what of the well bit about changes the to news we'll see looks what there. as as and backwards over little Pete guess what a Sue. very to and on you Talk much. to is like what as pass volume. the then over good talk in I a and -- it start

Peter Pfreundschuh

that sites more presence the selling question. element increase regards that the Medicaid mix good have that a to Medicaid we're the that to is sales sites. relative to With U.S. of So those continuing less the for is reality into number have in sites bit the [indiscernible] of of

And quarter the previous well we in associated an quarter, third as got that quarter coming with so as as we was both into this. into adjustment had

relative And so was about to $X.X we a quarter in that. note, the that take that there had to down push to million

overall, $XX.X million. did report So about we

this I think Su to earlier. alluded

really million, was issues, slipped thing we That With some into there shipments at the quarter million. within the fourth $XX.X specifically timing-related also was about $X.X get also quarter. into we're another was that in One that about did $XXX,XXX. not

year kind were where $XX.X compare those around of you $XX.X would And landed a somewhere ago, have actually we with million at million. so we quarter adjustments, when third

kind our of for is And saw, the actually, quarter. of kind sales did we volume so increases that have you And correlates, up. as overall

for were of there fell in timing-related some where us. that that DANYELZA is. impacted markets are, But quarter continues most again, reinforce things where it our to kind the confidence with regards So part, the to

over to So more for then I'll here. Sue pass little bit a it color

Sue Smith

in is antibodies patient number starts, from centers treating being where two with core Mike, about who coming the our that, patients prior obviously, able in U.S. or performance value responding XX% have key in you because talk notably, even Thanks, to believe, to in our coming indicators, we about of XX%-XX% us to terms And really market about a the of no longer our of still share of than high-volume indicators to of complete all physicians response question. physicians quarter-over-quarter competitive to our sales even together. attain of Pete. the our anti-GDX mix or is enabling more our number the is therapy. patients on is Thanks, Okay. majority differentiating And have heavily I grown all pretreated for are being developed Yes, if and centers And higher we volume. the patients. with look be really campaign, new at think, continues of number which

as So after large mentioned, Pete also, we're the And volume Unituxin. about. the fourth market we going timing certainly in coming from shipment that we've China that is quarter of due of how to see talked that share

Operator

question from is from [Operator Instructions] Jones The Jeff Oppenheim. next

Unknown Analyst

hear runway, Two XXXX, and around for on respect the and SADA? specifically, from looking With amongst DANYELZA Jeff. we to you you pass of detail Thank on part one included studies your there have of is and when what and first highlight which cash can runway work I'll Pete we're target indication? to and DANYELZA targets, for you, platform SADA we then at might plans, and question kind on selection how planned the cash that. more into future us, one what And in SADA. projected

Peter Pfreundschuh

question. good Yes, Jeff,

guidance. on as out kind relative for we basis net would this So part year Again, investment We've runway previous to I of where we set XXXX. of first with reiterated as well. start a quarters, or that this we communicated our what -- into that have we burn quarter cash

have noble deal, What that So $XX of cash the in slightly million issued we're is fourth things. DANYELZA. our licensing number. this the do release over of as coming coming date, mentioned earnings that things over is the quarter. above part alongside $XX investment we're to part other on We inflows this as of some we some year-to-date favorable now and $XX from guidance year million in We proceeds and million $X seeing million to that is

XX of anticipating to single XX continue somewhere more call a us for double-digit low digits mild both maybe forward $XX was flows some this XXs, what to lower investment million see So go we're of we're year. to moving to kind to views the to side cash to kind and year. In of million the that number. $XX the number number. on range as the end other over most anticipated off that I programs, And well kind would would forward, we of at DANYELZA XX. that That growth, should on then of investing track probably equation, return new in DANYELZA around get skew low it, what anticipated land the our we SADA DANYELZA view, good we in next years. every the would X of we on And be then X investment of least is

thoughts cycle you revised through kind issue So at an not of moving XX-K as of a only to guidance give we'll we we kind is around XXXX, case, but the the as this out most guys that plan as Jeff, time March, going of was new update operating investment year. forward. it thought the process our When are issue our companies in for laid also

that hopefully, you. helps So

Michael Rossi

that evaluating them Y-mAbs. a a targets that of multitude narrowing of second we're as we're question, follow-up the actually really right down the at fit what of Jeff, And part targets to doing process to now in here and

process. Pete I in plans So, what priority likely the several and are programs quarter, well bring discussed, targets to lines say year as we're you'll part And exactly of XXXX, would moving per we time forward. And going early in first invest as list in be have into and specific several see most clinic. to a targeting as the that revised we

So, but in early stay happen that that, 'XX. tuned for will

Operator

is from David next The question Wedbush Securities. from Nierengarten

David Nierengarten

of I dose there us I of was that call any escalation that and pullback, you to just tumor drove milligram. could walk on too X kind early and tumor PK? if it were push back the tell kind or don't look it seeing if types without in was level. to at giving burden? wondering want I differences Like us on Or timing data could your Was or you the you dose us know or that what just decide to drove through you

Michael Rossi

that give the detail I'll once was We'll more a release line of on Yes, you much give this. great top David, that we you question. it, but

to with to a those cover that in without out. is and need blood in time to and taking tumor radiopharmaceuticals the the we much So, talked a clear do this about the the What past. we we're pre-targeting it so putting long paint receptors

the dependent. we know So, disassembly is concentration of SADA

milligram then started the to we PK X/X based modeled We the based on model, X data the that preclinical target we when XXx looking started and had at So, higher it at milligram And than the safety we perspective, saw go X three a at the was milligrams. X/X Xx the through was But reality flexibility the at that what was preclinical. on the in that. of mouse that. the it to modeling and from brought up

it rather us which would sense higher we extend than go the to for time the to and back wait made it that level bring isotope. for So, target in

the it modeling and PK of shortening variable levels preclinical we with And do that down that as do just that to We that nothing that. it's window, that types. nothing felt we're variable now nothing data that It with with again, tumor the that back. the start had a it fine-tuning being to narrow any to at had uptake. do range changing into It and a time. back one So had of bring

any the had feel very we toxicity It enough good to that was paint enough and do the And we it else. to quickly bloodstream. that or with protein is. from really feeling about So, had nothing clear anything again, where tumor

Operator

from is question Germino Securities. Truist Nicole next The from

Nicole Germino

I on have SADA. two

a and talk and what to the little in more levels just more? bit about you are liver? accumulate can the And the one, do in drug expect first dosimetry acceptable you The kidney lutetium organs which

Michael Rossi

a Yes. Nicole, that's great question.

and the the would be kidneys think any tumor I for this, to see as bladder both off to impact well SADA understanding the that as be look as to when we we the eliminated, at far lutetium highest as the organ. expect DOTA

evaluating human. now, on those side from look to what data limits, we're know there's right are if all the have I we're clinical the The is of as you first they or bone of don't trial don't Vignesh, liver want since, and trying this second what of is far to be as discuss would below. any that that any what to your anything at And maintain like. in But kind as again, uptake part We're share marrow. looking

Vignesh Rajah

Yes.

what and you of this the of tumor thing you In just addition already said, with to dosimetry absorbed in expecting terms margins. safety tissues. shared in course, off-tumor One what we've we're dose

not results further treatment-related So safety early serious of dose-limiting or far, will through any share issues, seen no evaluation we as toxicities you indications with more get and adverse we've go, any events. soon. But we'll

Nicole Germino

Can one quick And you're you your question selection target choosing more are priorities? what your then how your targets. strategy? on for elaborate on the And target parameters

Michael Rossi

diseases. something need at total looking well unmet looking potential. commercial as ready the We're now. right at not that at part point walking Yes. are We'll through out lay to that list. receptor many We're It's we're we as disclose working of But through the as as we're strategy. this modulated

there will a putting this, we're of a into is us. significant amount be this criteria living document and for So,

clinically at looking reprioritize forward. As in targets, that be the we'll are bring commercially they positioned point we targets we clinic, time and and move move both as forward can XX X how and to into at next the

strategy So, this outline are that as entire there we'll bring several criteria, and forward. we

Operator

concludes question back comments. would over I for session. the floor This turn answer to Mike closing to Rossi the and like

Michael Rossi

joining for everyone, third and to results discuss continued progress. quarter you, Thank today Great. our us

you, throughout you of that time our with to additional forward happy positioned We unmet to have If you safer your strong a PRIT, advancing development investors while time. questions Thank believe serious meetings needs. SADA questions, the with and winter. schedule differentiated the for clinical have diseases look individual seeing and have in a We of and radio-immune to didn't and those therapeutic of answer future financial medical potentially at meetings day. point platform, we're to are many in and to upcoming at number treatment uniquely deliver get we question, therapy investor continue great the better we growth foundation a of options

Operator

concludes teleconference. This today's

You at for time. participation. Thank may your your lines this you disconnect

Y-mAbs Therapeutics (YMAB) 8 Nov 242024 Q3 Earnings call transcript