Earnings call transcript Q1 2023

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Operator

Good morning, and welcome to the Y-mAbs Therapeutics, Inc.'s Earnings Call for the First Quarter of 2023. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time.

As reminder, 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. studies, are development; to, and plans; other to to programs, commercialization future reimbursement and statements but business about current including of anticipated the and expectations of include, that and approvals, submissions; expenditure capital SADA; regarding expansion clinical and strategic and research development regulatory, territory and initiation future and the development model and preclinical of other thereof; resources; timing and or expectations requirements; sufficiency DANYELZA statements of not benefits expectations respect partnerships and and estimates beyond; revenues, statements facts. limited of our and related development our for the Such programs; our potential expenses completion guidance related regulatory not and with advancement XXXX product our and are statements distribution marketing historical cash the cash financial and collaborations for our potential performance, our to runway including

Form discussed ended with factors, risk those of report the forward-looking not on to May the SEC March the for and factors guarantees uncertainties, variety differ by quarterly of they or company's these due statements on a are forward-looking materially implied performance, results XX, may statements actual and including future XXXX, filed involve XX-Q Because year in as those from X, expressed risks XXXX.

over the and At Thomas this President. sir. time, ahead, conference the to go company's I turn to Interim Please like Gad, Founder, CEO would

Thomas Gad

joining good thank for today. us everybody. And and you morning, Thank you

our Commercial our Financial Chief Dr. Officer, Vignesh Officer, Rajah. have Kruse; the On we Officer, call Sue and Smith; Medical today, Chief Chief our Bo

you briefly quarter. by of reviewing begin highlights first the me Let with our

-- record XXXX. sales compared First of net half momentum of quarterly million, proud continued product report to of up XXXX, and XX to second in point revenue QX and $XX.X XXXX XX% we are QX foremost, from DANYELZA their

even performance treatment QX and of both to DANYELZA cash international And include new of increase $XX inventory the originally revenue to of an trends prior the the guidance to higher number prior positive initial the million expected in in which be $XX projected for from million by are quarter though guidance Product allow stocking product million range US million sales million. full the burn, at revenue underpinned than $XX addition significant year us sold to million. now we anticipated, from to accompanied million the million the $XX significantly, to our centers and internationally. revenues which increased XXXX relatively expect $XX vials year in WEP, results reduced $XX impact increase of XXXX have $XX full will on $XX This to to sales

should be more revenues potential any and well to XXXX. operations development currently into DANYELZA as XXst, as sufficient Bo of business any with development excludes of will The in we on anticipated reduction developing technology. that DANYELZA solid included commercialization January, restructuring in this our of focused a which expenses expanding our plan cash and planned as that as cash estimate operating announced March plan, our when of we combined expect of XXXX. support and plan, Reflecting XX% an XX% further for implementation XXXX, annual equivalents reduction $XX.X later. talk In omburtamab million anticipated business This a and force about

the and dose significantly resulting precisely tissues to to to -- the patients first been X have it's we Phase in thrilled trial this Phase X is open dose announce the goal trial. The to couple Lastly, determine escalation therapeutic label radiation of potential SADA dosed are to recommended increased potentially believe and interval in the dosing tumor radiation We a healthy the toxicity GDX-SADA protein of that and minimizing indices. has while isotope. of deliver technology of

at We malignant an you to. couple or cell will get update patients sarcoma melanoma, the Dr. on small back looking clearance Rajah are cancer first half-life recruiting and of pleased patients actively give to a lung and blood are which

approved of in is the DANYELZA relapse have or FDA the franchise. high-risk DANYELZA prior bone patients the to neuroblastoma demonstrated partial refractory treatment response, by and for bone for disease marrow to stable minor a response Turning who or therapies.

considerable Chief pleased our Officer, the global momentum US US and the expand where in Sue that are the efforts gaining seek outside very DANYELZA continue under to access to are of We to potentially see provide access a DANYELZA efforts on partners we Commercial are to leadership scale. commercialization Smith, making landscape, of we to to our

As US quarter successful primarily the driven the first of US in the in access quarters. XXXX, fourth starting commercial DANYELZA by by inventory I And under the of as increased XXXX sequentially number be high of million plan, the our benefit is the we a the to incremental execution sales well mentioned, increase revenues an -- of as program generated new US seeing WEP do quarter where strategy in of from first positive development net quarter. XX% -- as early at this an we outside $X.X our anticipate initial patients revenues future are of XXXX results not from as in of high

in momentum that we US both and are We confident internationally. are the gaining

growth. you. more with insights to provide Sue of the us today you, to have to pleased DANYELZA's our sources Sue. call very Over I'm on on Thank

Sue Smith

Thomas with happy today Thank talk to made. to to be and opportunity everyone. you the and progress pleased you, I'm about I'm we've morning, all the have good

us growth well believe QX marketplace. the that XXXX our We growth future plan demonstrates revenue in commercialization strategic for positions

over are benefits we the DANYELZA. physicians gaining more of Now believe more seeing launch, in and years experience two since

the effective allows center everything treatment has at to in our the terms home patient's the of them more we do, of to team transform a go that to safe convenient administration that schedule the at opportunity keeping experience the option control, First, about seized use educate a market DANYELZA, patient the disease night. of potential has and and

and in our upon identifying hub and foundational in building consistent patients, omnichannel disease our of patients of mix The highest supporting work the and our at rare approach XX. yielded number XXXX aligned new first quarter continued

focused -- their team. on Second, as and accounts team is a working very focused the

the DANYELZA territory accounts segments Thomas alignment QX, in several that centers the enhanced on We potential target focus notable for excellence. for adjusted against the new refined greatest provide to With accounts efficiency restructuring team mentioned, five laser and gained impact. including of

very center at launch, everything of their team's as to commitment of accounts of professionalism have and the DANYELZA QX focus, the since active is those team XX do. We XX am they of evidence I have alone. and we kept using adapted it in and proud the keeping patients with

upward in having customer continue resulted XX% of two support the experience, had or we which of ongoing The our cycles has customer as since more DANYELZA well, patients to support. trend administration more on provide received Third, confident team's XXXX. the led believe launch to has to in an patients number has accounts a also a we led in

By our initiatives, ensure reach as continuing can and to is DANYELZA these its as help potential mission execute on many full that possible. patients to appropriate

solid upward quarter we anti proud exiting the DANYELZA. on GDX vials the DANYELZA's in place market. now foundation and number We to we based US anti XXXX I'm we have team estimate adoption are first for XX% in sold, of encouraged to and a the market of the in and that of market the GDX market on excited share continue are share we have the see building trending

for you Back Thank you, Thomas. time. your to

Thomas Gad

Thank you, Great. Sue.

to DANYELZA to you to label As work its potentially continue on also our naxitamab know, trial for investigator expand MSK multicenter new we with sponsored osteosarcoma indications.

BCCXXX five has and In addition, activate recruiting The for actively we have diagnosed investigator sponsored. childhood X call additional are working so high-risk far. and multicenter dosed combination study therapy trial initiated we standard three the evaluates induction with with new a sites patients now for sites, study. are This newly beating patients we neuroblastoma. We study patients to naxitamab Phase in cancer sponsored

believe process early that thus the chemotherapy addition response GDX the We result anti in induction treatment of an chemotherapy survival. improved induction may overall to of in to anti GDX therapy to potential and therapy induction end add

AACR high in study Cancer triple was poster breast showed conducted in M.D. activity in at that The by and cancer is expression phase cancer may naxitamab ADCC was and April year. in showcased mediated negative presentation in to cancer, mediated GDX able Naxitamab's stem inhibit be Center associated with its targets cells tumor poor T-cell a upregulated enhancing macro poster preclinical prognosis. Anderson this Further, cytotoxicity. and breast triple-negative by growth

of University. this cells in an We start It in investigator awaiting naxitamab we gemca anticipate the in advanced will for at study naxitamab our study Phase and annual IRB December Day be State This breast Ohio recruitment this year, evaluate will We addition plan Xb patient cancer. to NK QX also is to R&D provide and an approval. of update at planned currently sponsored to year. of providing

believe to sponsored to provide trials. indications is larger potentially approach to controlled before our potentially advancing allows I shape. beginning in us environment strategy This take our proof-of-concept studies clinical our to test investigate to naxitamab establish drug and support a to adult

about possibilities opportunity going DANYELZA. forward As you the needs, can the and address pediatric additional commercial are augment we medical adult hear, very of thus excited and to unmet

now you, to to have on Vignesh. I'm very pleased Rajah also Over call Dr. today. our

Vignesh Rajah

Thomas. you, everyone. Thank Good morning,

believe platform the pretargeted our tumor continues index. that is to self-assembly, opportunities their in show targeted delivery significantly of potential pharmaceuticals to to platform. therapeutic sites now two-step promise innovative technology in is a key or portfolio radioimmunotherapy which creating SADA, SADA Turning effects, we minimal great disassembly to a off-target our increase with radio

even it company the technology, for more advancement As we potential this represents about medical become continue to and the we scientific the optimize encouraged community.

from stems our two differentiation infusion. SADA's step

rapidly first major Furthermore, needs protein ability the prior two-step tumor removes for a This radioisotope involvement possible a partners two-step on can while send to that result DOTA-caged bind the patients existing protein as followed our the potential administering infused SADA's because centers by is other before. the the protein only technology treatment pretarget of step directly in into oncologist candidate our makes method among to second injection, a that advantages. only use significantly to increased to radioisotope medical expect the infusion index therapeutic it the medicine facilitates nuclear we injection. unbound not the the seen We unique have tumor to of sitting departments to drug and clearing

may targeting by potentially treatment. point, ability open, site sarcoma including the and five in data lung sites treating early melanoma. tumors including now we a and started have of opened cell few total the cancer, this small solid assess us confirm patients ago, clinical we pharmacokinetic Such imaging tumor of Furthermore, US have at positive trial and lead enable feasibility with are a GDX UPMC, the stage the MSK At the collect an weeks imaging. to therapeutic to and

five the treated couple of and we that are or I'm next pleased PK hours in share blood the to XXX in hour first day of year interval, our human match We we initial first interval. share with will trial. you from the first data to to with initially this to data. see now started these today treating but the that intend patients using be from dosed PK X profile and preclinical later this cleared are terms have We excited patients appears XX patients cohort clearance models Phase the

with to GDX, of Beyond to refractory in need and We program against lymphoma non-Hodgkin's partnership are FDA we proud of team's continue options aim platform, lymphoma, very franchise and CDXX in year. that I'm unmet well-positioned a to be validation. SADA believe our pursuing later We to an and the this our streamlined the submitted also We're to potential SADA IND process leverage we're and relapsed SADA plan particular a progress. our building our those address explore to excited out origin. expertise, propriety T-cell non-Hodgkin's

Thank you you to all and Thomas. back

Thomas Gad

Thank you, Vignesh.

efficiently work to partnerships footprint to in regional with DANYELZA global multiple a continue We through territories. commercial support

market Pharmaceuticals we look an launch in QX sales establish planned DANYELZA know, could China DANYELZA XXXX, We SciClone forward We for the expansion that in you believe be with in and the place in took China that China. driver about greater As potentially especially for to we for a XXXX. revenue this excited important marketing regulatory Asia. approval in December, partnership in

to quarter approval the support among our first XXXX territories. subject continued covering access potential to The other LatAm, global demonstrated Central and markets partners regulatory of gaining Eastern relevant and Israel in the DANYELZA's to progress Europe

expansion other deprioritization programs. XXXX, strategic we in and with deprioritization opportunities form programs, to focus the making and DANYELZA development on-label company goal SADA including initiated a includes and focused state January, GDX value and on and vaccine continue In bispecific consider biotech CDXX revenue on DANYELZA commercial the development the the with It future program, SADA omburtamab the a and on Though of a restructuring sharper creation. platform. we our constructs, growing of are us we stage omburtamab the -- of focus of label its of early GDX the

reduction As quarter part of result we in anticipate our reduction of in DANYELZA our workforce current approximately business of into we operating for revenues expect cash in XXXX of which restructuring, the XXXX anticipated revised when based plan. business annual a the a expenses this on our implemented XXXX, will combined runway plan with and in XX% our to XX%, extend first we

support with with advance our We cash early the and believe revenues in SADA equivalents. strong efforts million revolutionary $XX.X and ended to deliver and clinical robust are continued the With pipeline, technology cash programs we to further XXXX the runway, milestones, DANYELZA stage of cash first quarter our and of well-positioned construct. continue commercialization we commercial a growing

Bo will financial Bo. this on these to Kruse, now update. elaborate you, CFO, in topics Over our

Bo Kruse

Thank everyone. you, Thomas and good morning,

$XX.X and in was first quarter an DANYELZA and primarily XXXX XX% international the net quarter had of momentum revenues fourth XXXX of increased as of revenues the an from new US the revenues. increase fourth XXXX, sequentially to are by product which in The net by quarter patients of we benefit the first increase in incremental driven million quarter of million. XXXX building $XX.X compared of

The with other we of revenues revenue $X.X quarter. for Our which not in first $X.X from program net generated an included product XXXX access the countries of of stocking our million, occur DANYELZA this program early new. the from product early expect distribution revenues to partner inventory initial order access in connection from million quarter in future do

expenses. operating to Moving

million research incremental for on to with decreased increase severance the Our our in decrease associated for million accrued outsourced of million quarter supplies an spending by $XX.X resulted of quarter impact outsourced which was and offset decreased by deprioritized decrease manufacturing stock-based out March accelerated as for in to $X expense The for programs, and R&D cost for due benefits clinical trials, period spending partially expenses primarily first XXst, the ended related charge. restructuring services, $X.X XXXX. compensation

in ended million $XX.X March compared was SG&A to for ended XXXX for primarily SG&A million related costs. $X.X inclusive compensation XXst, accelerated expenses decrease decreased three by XXst, personnel The related is months the the restructuring decrease to $XXX,XXX decreased compensation of The million months the inclusive three March an $XX.X of of costs, result related incremental expense stock-based stock-based first and to insurance personnel in costs XXXX. quarter our charge.

$XX.X first loss restructuring significant ended loss for The improvement We R&D in the primarily was XXXX, quarter XXst, and $X.X basic revenues by in per net XXst, or reported share first loss a the by driven expenses the our March increased quarter to the DANYELZA of the offset and charge. diluted quarter ended XXXX. a partially decreased net share of basic compared per March million diluted or for and million $X.XX net $X.XX XXXX of

of Thomas with first million. cash cash of XXXX we ended equivalents and $XX.X quarter the As mentioned,

$XX.X below sufficient our the pipeline Our cash our of XX% cash XXXX provides to planned prioritized support as burn programs planned. solid currently our our million currently average. position and runway XXXX operations first We quarterly believe quarter into fund was as and initiatives commercial is a financial to that

other DANYELZA to to assumptions XXXX underlying the revenues in clinical of for year BD product previous each to deliver rate assumed included XXXX strategy indications partnerships higher is this runway. As analysis potentially understand. data quarters, and assumptions the could physician XX% we new to important No and for new refined by greater expanded a this execute lead that noted in increase to or work in are DANYELZA see guidance commercial as we adoption. purpose growth and that our of hope for the We income

this are benefits purpose development us will expenses of own the point. the we behind related are advanced new our of the programs and runway and terms fact prioritized for that assumed commitments, the our This In programs this activities, pivotal assumed activities, at restructuring at have forecast regulatory be that no financial and most trials from expense, the of the point analysis. post-marketing to

have For the debt or equally borrowings. assumed not purpose offerings of the or guidance, any we the

cash earlier, XXXX. we full anticipate decreasing are protected that to are our our million in As revenues announce mentioned now million to are of $XX and million, burn to full financial year pleased very we DANYELZA updating for be Thomas we net and year $XX $XX product we to guidance, the the range XXXX to now million guidance $XX

to we disclosed, million previously $XXX $XXX expect expenses operating million. continue of As to

in remains our to our a support the milestones. execute multiple to mission, financial We and believe delivery healthy priorities, of Y-mAbs position strategic

I'll call concludes the This now back turn financial to update, and the Thomas.

Thomas Gad

you Thank Okay. much, very Bo.

time, up this operator of can this At over the the for to turn it please. remarks. prepared today's So, end marks open we to Q&A,

Operator

gentlemen, session. Ladies and begin the you. Thank [Operator will Instructions] we question-and-answer now

First comes go Alec ahead. from of Please Stranahan America. Bank at question

Unidentified Analyst

Congrats John increase. guys. for number on Good sequential sales the is DANYELZA, morning. Hey, Alec. XX% This [indiscernible] for

For XXXX, future Is top to can are example, a what at are -- China we possibility? point maybe so that we that we looking adding looking inflection meet, line. maybe at sales ex-US, for

Second SADA question on recruitment.

patients, SADA, for lung, cell recruitment you are types, patient Thanks. any and specific for be screening you when absence of for. would of Any tumor melanoma on that terms you're metrics think mutation mention, at looking small mutations you three you're did recruiting color screen I In appreciated.

Thomas Gad

you. Thank right. All

now. day to the and do half, we that launch this add launch first should here in China we that second in the year. excited about will sales, the one, any they to So happen think are ex-US yeah, our very And

think So we our that to do will sales. contribute

I that question, Vignesh. to leave second you, over the would On

Vignesh Rajah

and small that at are looking we is sarcoma. melanoma lung cancer, Yes. Thank tumors cell you. Well, the

looking we of in all who relapse types line line setting. at don't have those patient I these specific we're are at they're refractory very have specific therapy groups, second So looking for line, third these details or of markers in the but failed of the first indications, much in therapy. each

Unidentified Analyst

Thanks. Okay.

Operator

Bill next Thank you. go Genuity. Maughan comes ahead. Please question The at from Canaccord

William Maughan

morning thanks. and Good

talked So wondering you types paradigm, you'd on if to patient, the the that vials sense being I a treatment more you more looking would have happen. for lead potentially can I'm the patients DANYELZA are -- growth, dynamic commentary in was per that into enrolled. if additional that earlier you patient, per on previously of know patients treatments I you're just that just get any seeing could and about

Also I stocking, on that entirely $X.X there I'll any you after said have know in Is or that patient DANYELZA, drove And that is million demand in up stocking. a follow underlying number? that. Europe

Thomas Gad

think, can question. you I Sue, first take the

Sue Smith

are Yeah. patient Okay. bridge seeing who when a towards I think trend induction patient see has you the failed types and Thanks. Bill, they're the therapy we receiving slight therapy.

It's to -- team change. slow, solid of doing conversations on field is there the come but think from breadth I identification support plus our we're growth around a very But the bit really depth. a in training of that that it's main a a customers. those seeing So patient has with growth having foundation of working and part more with and combination

trend more things, those a the your So but number of dynamics it's some point, one slight a of patients. of yes, earlier of seeing is

Thomas Gad

you to update do give Vignesh, on want an WEP?

Vignesh Rajah

Yes.

we earlier main launched Europe program is for this that year. So this patient our

in going and patients to screening be number a center undergoing We with who one in treatment unrequested primarily, Barcelona. these of naxitamab have dissipated are are

So moment. this ongoing is at the

five we are believe treated. be three to far that are to about So there patients

William Maughan

XQ for improving know that's just trajectory. XXXX out, looking but growth Okay. Thanks. runway, I despite And DANYELZA cash you reiterated further

flow this So you at point loss at approach quarter, net cash only positivity. some a $X.X million

something do your Or do feel you spend as might horizon? cash be right you that now. the use programs could that's approach you in other that, that you balance deprioritized to on that -- So is

flow trying from Just financial to positivity of the balance growth the cash aspect R&D. versus

Thomas Gad

Thanks. Yeah.

goes course, disciplined this and at to go are development GDX. But we if and validate on on our R&D is see I of potential order strategy. in breakeven R&D, disciplined focused very So our to strategy SADA partnerships. multi the up horizon, turn are out but this at we staying on And think we obviously then and point staying point target very

William Maughan

Thank you.

Operator

question Stanley. next ahead. Ulz from Thank Please Mike you. Morgan at The comes go

Mike Ulz

taking GDX Hey, the guys. one Thanks the SADA Maybe just on program. question. for

well? cleared Is interval You mentioned it five XX dosing interval target about of XX shorten now could days, hours believe, and there hours. you're that or you for as starting Thanks. at a you've at the potentially I an and that

Thomas Gad

So, data the so interval, just XX optimal Vignesh. that, add but you be shows -- to the I'd hours let to Vignesh, I'll preclinical

Vignesh Rajah

Yes.

very our and suggests plasma that's data our data is cleared first says, much we murine by mass GDX XX be blood. XX-hour of from from I for and SADA protein majority as think serum Thomas concentrations similar the are picture the seen We're expect that virtually have human the which well. first models clearance around initial in the patient. that mark, from as of all at And the data clinical PK the SADA to similar GDX a we pretty hours a what the seeing XX hours, cleared

So that any the to lower based just we go anticipate shape the don't it on of curve. than

key protein therapeutic in of we recall SADA that unbound amount protein, elements the one the You'll of to of plasma. minimize index is maintaining the a that high ensure

be we where from allow blood PK we for a on to maximize the trade-off removed plasma just to window short tumor, the payload need that's enough think to administration. to long I the So the before almost make, ensure the completely reach half-life is enough but we narrow

will it is below short expect this your interval, question believe most we go the be terms So optimal but XX to of in interval. hours to probably answer we don't

Mike Ulz

just it. follow Got then And quick up. maybe one

the starting be test you a do dose as XX-hour or dose you at to you initially you interval As longer Thanks. need interval will escalate, escalate?

Thomas Gad

the on -- XX ahead. move -- We'll at yeah, then go --

Vignesh Rajah

ahead. go No,

Thomas Gad

We'll the remain hours. XX at

will and from the remain moment, So, on XX half-life the optimal data, clearance we've at we on hours PK this that. based at seen based

So we anticipate. don't

Mike Ulz

you. Thank it. Got

Operator

Guggenheim Securities. Please next Zhu at The you. go from Charles question Thank ahead. comes

Charles Zhu

morning a more and couple questions. SADA. the just GDX for Good thanks follow on the up taking Maybe yes. Hey,

sounds all, of First encouraged.

speeding down think been that the also enrollment guys content are how dosing we really You've administration? you regarding, much dose you. on thinking side? like sounds first how should that additional And -- the Thank in you're also, on and front. about up protein escalation But just that the the narrowing bound after we interval, remains how -- on protein but tumor how about

Thomas Gad

Vignesh, [indiscernible].

Vignesh Rajah

Yeah.

Thomas Gad

kilo, if two SADA cohort, the question three understood next same And remain cohort days. administered and cohort kilo the milligrams cohort second the kilo, are but XX correctly, kilo. cohort and subsequent that of be X.X will this one milligrams be patients. I the five increased level will first was per per -- cohort, we still we have for per the So The up next a protein kilo. And be then shortened to per the to interval level these your will for level to milligrams dose per first at now to at of on milligrams milligram first two moved and passed third now it'll X.X with final which dose that

So protein is we've we XX clearance earlier, interval. situations will all picture being seen the mimic the where a PK these in the we anticipate, the of hours pattern similar of from plasma which expect optimal SADA

question? kind of we concentration anticipate. the that's So your dosage Answer or

Charles Zhu

far, -- prepared could or when your your have on remarks line but And for the might that. so of you able guess sure data that earlier Great. I Q&A, you up. on and first dose I'm clinical based in GDX Yeah. therapeutic sight Got Thanks. earlier administer your could maybe some this of missed your not present to follow to early quick if potentially happen, into we cohort one expect for initial it. whenever just this be in is lutetium SADA? update? of one just Thanks something experience with so And it. I that earlier Got the

Thomas Gad

So get therapeutic by targeting five had tumor day so of need these would have or of not followed have a SADA therapeutic XX, course, dose, able image would dose we later in the patients to tumor but of evidence to dose, received days millicuries tumor weren't with two they shown patients, lutetium first of through DOTA. for they a later images. we And dose image, order targeting, targeting in they receive similar received protein of of days XXX on on a therapeutic that two

on been the a logical scans. would've they had imaging that if step of So evidence

Charles Zhu

Thanks questions. for taking Great. the

Thomas Gad

Okay.

Operator

Thank you.

Romero from at Morgan. question comes Next Please go ahead. JP Tessa

Tessa Romero

morning, taking so our questions. for much Good guys. Thanks

So just commercial ones two for me.

the first us through guidance you And or United metric revenues within portion follow walk States? you So versus your quick raise up. what one gave of is, here? can had And dynamic to guidance international you your most range then the to net the what updated conviction the specifically do expect one I be

Thomas Gad

want that? to you do Bo, take

Bo Kruse

Yeah. I be would happy to.

seen year. the more course, what monitoring very So We've vials increase in nice quarter the number than essentially we first even of sold what to the We, XX% US year, third sales are quarter the seeing is better last closely. is, from growth than across board. of fourth the sold we year this the quarter from last to is of the fourth which quarter

very development closely. are we this monitoring So

solid also would there's Internationally, say. I growth,

we for expect overall do this that saw increase X% had coming to the revenues sales, and of You about we XXXX, international in from XXXX.

to this from the so And sorry. --

Thomas Gad

No, go ahead, Bo.

Sorry.

Bo Kruse

So from of WEP about that an quarter the revenue. quarter fourth the year we've up seen this last year, clean when we first X% to increase

would none US So to your really $X we seventies even of to still Internationally, the nice first million a launched. and part of question, be it's expect revenues. internationals And answer of in to revenues the million. though the mid to have ramp the up countries be $X

Tessa Romero

Thanks up. quick a just That Bo. And helpful. Okay. was follow

are how her like, I dynamics hearing comments, of recent in alluded DANYELZA? your [indiscernible]? what with think any, are average around you Sue earlier to on research some market this treated patients DANYELZA on in And

Thomas Gad

Go ahead, Sue.

Sue Smith

take can that, I Tessa.

dinutuximab, with a with DANYELZA in are seeing growth there we good dynamics that predominantly doctors essentially and And market GDX the is are of is caregivers quarter-over-quarter, share. really dinutuximab cannibalizing a just terms think in So product. this slowly because I --

we're consistently and Sloan focused a adding of breadth very patients with business standpoint in is is, account on first Kettering. XX quarterly outside new Our customers from where the the

increase our from of customers saw nearly a depth half also, We significant new this last QX year a of with XXXX to standpoint, from more in patients. or QX year two

So multiple they're and patients more on. starting to now confidence they're getting have

slowly what choice. our in those of gaining confidence So I the more are GDX to market are a contributing as think

Tessa Romero

average? And how long on are Okay. patients treated

Sue Smith

number is a roughly. average to one four with about range Our of from cycles eight

Tessa Romero

Thank you.

Operator

Thank you.

comes from Please David ahead. question Wedbush go at next Nierengarten Your Securities.

David Nierengarten

one anything for on taking had SADA lymphoma. support behind in there the us that a setting? using could wondering construct the cancer point scientifically, liquid what's thanks that if was or, I the you saw Thanks. to tumor Hey, question. rationale just side this would in on or use blood was I

Thomas Gad

Go Vignesh

Vignesh Rajah

at the is that well Well, how to CDXX. known the rationale of malignancies express express fact number Yes. hematological aimed

that B-cell that So of therapies be number non-Hodgkin's show unmet T-cell know our an is more there's of on lymphoma. focus a says to need affected, the has We but her lymphoma in had lymphoma.

So multiple the expand et are at such another in expanding tumor indication development myeloma, is as has we particular CDXX want cetera. tumor to we initial But looking this expressed obviously CLL, indication. in. our this that

David Nierengarten

side it and other lymphoma is been of there's that. setting? in that things use Sorry, or it that's that, and radiation ex, to and just important I Are Is you something differentiate liquid clear, help of supports the like technology lot you've seen a that? else effects, because a about avoid mean, therapies fast to its the myelosuppression, challenges up. developing there, a follow characteristics tumors just

Thomas Gad

Yes.

differentiate from profile. said, the radioactive removing we in itself circulation because clearance the index think the it we current -- systemic we far the that allowing therefore disassembles systemic safety anticipate a think from investigational potentially rapidly we the is from CDXX its this other he is -- I therapeutic the therefore the side therapies circulation do when precisely game uptake radioisotope And aspects effects, therapeutic the this and just as and be as believe and for changer CDXX from or the serum, administer what therapies tumor could minimal or in the SADA where to payload index.

of [indiscernible] may status managing patients always in physicians, this this is ideal see this who adding think So we group. not these I the performance have the to where

David Nierengarten

Thanks.

Operator

VLK question comes S Thank you. go Please [ph] the from ahead. Sebastian . next And at

Unidentified Analyst

on you my for and thank Hi, the Congrats taking team. excellent sales questions.

on the get been actually of DANYELZA. on some insight patients you sporadically a growing that wondering was guys. treating more for basis versus market those centers has on can give first if just is a that how the question to want The breakdown consistent I numbers to maybe just treat you patients. onto I based are

Sue Smith

Sure, Sebastian.

increasing, because two accounts can with while and that you increase commensurate we in so our we've more not imagine, patients, treating patients does growth as -- vial occurring of the the the the vial are the are to So as than accounts quite place have need sales our seen number it sales.

patients treatment averaging new with what of adding average And in or essentially customers an about about any At in hub, two a who we for coverage treating. now either So active we we five given of accounts have treatment. XX are are approved XX their per look, nine. getting quarter are to we insurance range our currently time

of current And that first quarter, our patients. treating half are actively so basically accounts we the in saw

So in shipment quarter. about first new quarter in the customers, a first accounts we the XX with had receiving

sales, looking volume over of growth. because they're we're of smaller XXX% is we were But at so indication. internal predominantly obviously, an our ex-MSK -- we the we're really quite for rare numbers, grew that growth goal seeing where ex-MSK ultra And our

combination work saying in in healthy it's of account. we're doing. the over So before, the the that's I depth and the is country the like patient seeing of And patients growing growth per the number think -- well a out finding the I that was is spread team

quarter, XX XX first patients. of word you new in have patients we quarter that start MSK outside first So

Unidentified Analyst

then, it. something Got the And actually SADA, Based see so you Thank was see did not you wondering, preclinical work, you dose Okay. with mentioned on your do much. you on say cohort. targeting I can first just when that tumor on tumor targeting? expect to you

Thomas Gad

three? to -- definitely can low, X.X is be our Vignesh, milligrams one we you do we not -- I'm too but to I sure dose with three add IgG, milligram if that? want should I to obviously but be it mean, or so mean, Thanks. expect

Vignesh Rajah

low radioactivity the radioactive very also explanation when -- you question for another I we've starting to why the think It's but answer is dose. of would this expected, the either of Yes. not like the protein seen potentially SADA and easy imaging dose the

So that study XX design there millicuries if this to show who patients are increase to provision there imaging millicuries is within our XX able from of certain number a are capture. not to

at obviously this picked higher we we more it's sharp contributing up to dose to escalate anticipate this that's that certainly stage. doses, to much But this as perhaps we anticipate almost the So predictably. being not

Unidentified Analyst

Got it. you Thank much. Okay. so

Operator

point, questions. I'll you. are it back call At Thomas for the to closing there over remarks. turn seems this Gad no Thank further

Thomas Gad

day. Sue, Thank questions. you. thanks for for joining, and have Thank And great and Bo, everyone your a Vignesh you

Operator

Ladies call please and thank today. and your We ask for concludes we disconnect lines. you that this for gentlemen, participating you conference your

Y-mAbs Therapeutics (YMAB) 9 May 232023 Q1 Earnings call transcript