YMAB - Earnings call transcript Q4 2024 | Y-mAbs Therapeutics, Inc.

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Operator

Good morning, and welcome to Y-mAbs Therapeutics, Inc.'s Earnings Conference Call for the Fourth Quarter and Full Year 2024. [Operator Instructions] As a reminder, today's conference will be recorded. I would now like to hand the call over to Y-mAbs' Head of IR, Courtney Dugan.

Courtney Dugan

Thank you, operator, and good morning, everyone. Welcome to the Y-mAbs Fourth Quarter and Full Year 2024 Financial Results Conference Call. We issued a press release with our results this morning before the market open. accompanying website. available and section the release our of press slides on are IR The

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

GAAP of President cost A measure of and include call sold, is will IR goods in at on non is non-GAAP the a measure discussion our today's and release description financial Officer, -GAAP Mike Rossi. turn over our Chief like closest which to the to of slide press section and reconciliation financial presentation addition, expenses, now included financial a the operating to excluding today's measure. would website the this available Executive ir.ymabs.com. I In

Michael Rossi

Thank our January; for Chief Head, Head, DANYELZA our you the thank morning, Radiopharmaceutical you, joined in and Natalie I reviewing recently Business us. begin Pfreundschuh. This by me Unit today with Tucker; across Doug Unit Financial Officer, from Courtney. Good I Gentilcore, us morning, our have quarter fourth key XXXX. highlights who and Business year business and joining Pete will full our

our details first the and Pete full and GDX update and the of before provide and around our on data will Doug on forward. XXXX sales will then cash year I moving Natalie this guidance our recent Next, updates resources fourth DANYELZA SADA quarter strategy our around will and overview pretargeted second Phase global quarter our planned PRIT provide radiopharmaceutical XXXX line year review performance full provide SADA an quarter anticipated open platform expectations we year. our our performance, Q&A. financial for Then reiterate for

did total what full anti-GDX the of of range across our We steady of USD revenue, the set year revenues to million there we kept has in between our XX%. guidance U.S. stated license between business net and achievements Let's the and million million. $XX within we in importantly, looking is our and product is a of more I'm key XXXX, market And share begin of what which in be XX% at and achieved team done. revenues work XXXX. out inclusive of do, achieved our to proud XX.X DANYELZA XXXX. $XX DANYELZA for by

expanded growth strong. ex-U.S. naxitamab demand partnerships with continued. successfully face for to competition continue trials remains We and headwinds from DANYELZA We several including through patients, and vial

A endpoints Part anticipated of and PRIT sharing quarter a have highlighted. SADA achieved data our forward the trial biomarkers platform, readout by radiopharmaceutical GDX-SADA more previously look data the a of I from Phase proof platform to our of include concept which our that at with number will in we as second complete we XXXX. preliminary Looking trial, demonstrated We year,

SADA cash activated cash trial, annual total support working I first trial continue are current in Regarding our ended our patient. a to XXXX, guidance. Phase X million CDXX to-date year, sites USD and anticipate have our XXXX. stated for cash XX.X in equivalents, standpoint, our we million $XX.X below From cash we our into the which plans financial and cash investment equivalents that reflects dose to We with and will actively XXXX

was announced Let's unit, to strategic XXXX, DANYELZA. new realignment, expect to business effort to through and a day the our world since tremendous founded from our decision mission distinct recently manage will company January leadership further our and this improve around potential quickly undertaken of in business other development radiopharmaceutical operate New better establish strategic align job we lives X Princeton, cancer the to capital we by based to of strategy. Through Jersey. and is as company's majority efficiencies therapies U.S. business done XX, DANYELZA. team priorities. With capabilities, maximize This then important targets DANYELZA to right with Gad. The an accelerate patients here accelerate positively execution, our impacting the our On now of has bring the The Y-mAbs in our of expand since realignment executed the Radiopharmaceuticals in which SADA changes as anti-GDX leading countless possible. our clinical Thomas therapy, and senior recently X PRIT anniversary and April our now novel and platform business. program will is mark our XX-year high-value was turn our we announced units, This

organization achievements member our coordinate In XXXX addition, we thankful team commercial adjustment dedication potential each of PRIT opportunities potential growth therapies for bringing new at the a the focus patients. committed to and outcomes platform our I'm of to through important advancement to team's implementing of aimed DANYELZA's process in to are advancing mission the clinical market. Again, anti-GDX from new improving of development of generation and the the We to in staunchly therapies remain quality U.S. patients call pass long-term color a proud roles of on on for moving of sales team the the the the some quarter further of will families. I to within now and to DANYELZA's efficiently provide of the fourth over Gentilcore to for and more Denmark our life to small Doug XXXX. their

Doug Gentilcore

strategic Artemis, Thank morning, pediatric joined on rare predominantly Pharmaceuticals. the disease you, the and in radiopharmaceuticals and as in in experience January DANYELZA XX and of I and Prior of good focused joining then space. Y-mAbs, by was Exelixis Commercial years our everyone. Y-mAbs CEO I I've which Head business biotech, unit. as to of Chief Mike, acquired served operations commercial Officer

thrilled Although that I've across I'm been is commitment unmatched. and the unit. our at be only DANYELZA for of level X Y-mAbs team business passion leading I've months, seen to a

As new supporting trials marrow, the and differentiated the with our bone current further believe is and/or on potential investigator benefits. therapy proven indications. high-risk U.S. our a and bone increase utilization opportunity We only approved anti-GDX relapsed/refractory therapy market we DANYELZA while clinical their DANYELZA for into penetrate to indication in to advance even physician sponsors an neuroblastoma have

at the commercial highlights of look take Let's a in fourth quarter some XXXX.

order fourth product year and the revenue of DANYELZA are guidance total of total of $XX.X We revenues pleased million million, our revenues China. achieved net million. an favorable were product XXXX, of to in driven international full compared net to impact same XXXX, markets, in a In $XX.X the representing quarter stocking $XX.X inventory by increase have the period X% strong primarily including DANYELZA

we saw from performance U.S. a the sponsored of in activity, indicators. in new key maintenance competition well therapy both trial continued ongoing encountered third-party as the entrant we increases for market While launch as clinical still

XXXX. DANYELZA's December the of ordered have market remained anti-GDX estimated initial XX U.S. total accounts accounts at in XX%. with XX% a the added XX, XXXX, As total launch of share between has and around XXXX, DANYELZA U.S. since steady XX its of in

activity, hospital provider bringing XXXX. The since team In XX, to DANYELZA team allow meaningful to Along as the to we team will we the of is focus the focus the unit the trials are institutional sites interactions, dedicated hospital new DANYELZA. what on for the with trajectory as customer will this DANYELZA, to and will produce of of continued will ongoing as of develop efforts thought structure on leaders, year, rightful to advocacy a promotion and seen the commercial relationships will KOLs strong promotional receive typical positioning and saw new health was formularies through which on Our the DANYELZA of December medical care and added feedback education, XX to coming same time, of advocates. as off XXXX prioritize solely further with would business in the key these we DANYELZA. with XXXX, data start-up which DANYELZA. At critical we amongst and continues realigned continuing future build adoption fruits kick upward that X total team new online number the site ISS The formularies We've newly well launch of already initial product. in year. impactful positive deem

sales product decrease Turkey partner Western our of in XX% to sales our DANYELZA's in revenues and driven XXXX. quarter product outside sales DANYELZA an our fourth of the the net highest named America, was increase Latin both Asia XXXX XXXX Brazil in of by turn the offset was consecutive $X.X increased of Western our quarter INPHARMUS. American The in increase launch U.S. net patient by fourth our led net partially Ex-U.S., DANYELZA And patient Eastern compared in a in in Mexico, the let's in partner, program DANYELZA's revenues Western of fourth Europe. The commercial international Latin our and were third Asia, quarter which Now progress named Adium. program million, quarter marked to with particularly Asia in product and by

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

in the sales and of will team in working quarter terrific energized from are with related this we an the to is to DANYELZA call bone neuroblastoma benefited now to to global DANYELZA reach the relapsed/refractory and/or China. I'm our relabeling critical new potential high-risk patients pass Natalie. order stocking Our and in with its advancing goals in into committed for beyond. marrow, further and advance bone expanding the to and excited inventory XXXX therapy be DANYELZA indications. I

Natalie Tucker

and in Doug, held Vice to appointed being Development where our Novartis' you, everyone. as Radioligand of I of hello, global in I'll and President and at what business Chief I of CEO programs May Head of XXXX and innovative of second before roles pretargeted the Business Staff strategies this theranostic of joined Thank our Y-mAbs to on the our to companies. the experience I'm expect as Radiopharmaceuticals biotech business year. My of Previously, in extensive unit pharmaceutical Therapy excited focus and consultancy, this leadership includes I to and advancement Director of background for commercial pipeline and specialized and platform recap served pharmaceutical operational update earlier Planning quarter SADA-PRIT lead Head execution programs. Today, the Business provide clinical launch Strategy and a with year. radiopharmaceuticals. strategy for our unit current experience a for Guidehouse, Executive

and Let's Phase GDX-SADA Trial start overview with XXXX. on a X our trial, update brief

adult and X melanomas objective doses X X.X, tolerability Part first explored Trial to to As small safety and with pretargeting days. mgs the we the solid interval in neuroblastoma. In kilogram a cancer, of patients reminder, and X tumors, sarcomas, lung of X primary a in malignant XXXX of of including A, per protein GDX-SADA is cell variable evaluate

in models data current of of patients these total lutetium. patients, seen XX SADA both The profiles are Of GDX of XX, with the and with X of X had were payload. from and [ initial and February a SADA study of patients profile dosed dosed protein diagnostic to the the pharmacokinetics match appears XXX phase our milliliters open As protein interval terms patients positive patients the PK and X therapeutic preclinical up dose the between of days. to clearance supportive expression and blood and lutetium the blood receive comparable XX X ] the we've of sites for eligible those to

is platform, serious To We continue far. been to instances so seen achieved Based dose-limiting date, and on seen PK no we've treatment-related encouraged we've no and the activity thus any PRIT have there be we've far, SPECT/CT scans of SADA toxicities what we events. validity with believe SADA and our and of adverse the of these tolerated the bind indicative well ultimate demonstrating target to data patients. It can trial are that the part results to or that an or the program. important ongoing still development are not GDX-SADA note full of and both tumors of necessarily by is trial success early

As data you present year, XXXX a in the January, set including update more A quarter Part from we scanned from expect our second PK additional saw to images in and this of Trial of data. complete

initiatives date. to of quarter have update. SADA I non-Hodgkin's focusing trial B a activated Our expect to of been recruitment on plan Two those to first lymphoma, sites third Phase the the impact second accelerate platform, and PRIT those activated We've our of is treatment the We lymphoma. see and in X months. CDXX-SADA, activities X sites with sites T-cell selected the since coming in for

second from this what let's we quarter the Now, to of in our pipeline update year. turn expect

data In platform programs that A optimization more further addition complete from forward. to our the XXXX, of going present a will additional programs data clinical advancements Trial current and Part expect new set to of inform we

In addition, we present plan and pipeline PRIT to expansion timeline. road our map

a state based target for such less unmet known on tumors OS considerations XX%, to included, conducted and that targets and greater and next high-value sensitivity. potential target targets. annual X in incidents, We work that down characterized of XX has are evaluating indication X,XXX characteristics of half than need team Key a targets. with narrowed XXXX, size the radiation database to X,XXX disease selection selection over the have year of than second started between XX fully Our as

we at tumor attributes tissue looked expression healthy expression. as Secondly, such location, cellular and target-specific

of these high-risk forced we this risk of lastly, targets, we ranked that theranostic Business targets, beyond leading unit the our development archetypes these oncology. develop potential high-reward experts. changing approach development. be update. our radiopharmaceutical mix providing industry to work targets. In and look during quarter believe potential pipeline a targets of alongside to We Radiopharmaceutical Lastly, excited second for continuing to and a targets details quarter fantastic second targets, well-validated diversify unveiling PRIT with year, targeted game this plans the in is known future proof-of-concept team more We platform will novel, pre believe a our anticipate we to high-value across I'm around forward space new the

Now let me hand Pete. to the call over

Peter Pfreundschuh

good and everyone. morning, Thank you, Natalie,

sales for for compared million to increase. fourth increase fourth XXXX, in named This in offset XX% the in DANYELZA offset in XXXX $X.X representing increase million quarter unfavorable fourth fourth offset by by Western total XXXX revenues DANYELZA months revenues you $X.X revenues million international program $XX.X due decrease by was the XX, $XX.X X% of net compared primarily in quarter in product driven America. earlier, an international XXXX, a to was were we partially December a sales driven and heard December U.S. million revenues ended Western decrease increase net a XXXX. Ex-U.S., total Latin patient X XX, decline. for DANYELZA and months that and product a and net X% As the DANYELZA product in product XX% in recorded net $XX.X product and the quarter quarter representing volume This The representing were in primarily $XX.X revenues by decline the in was Eastern was respectively, of XXXX, U.S. in revenues. U.S. XXXX, The to a an in revenues the of million net Asia an partially increase million Asia and primarily was was price which respectively, X ended increase mix, Europe. product by net a launch XXXX XXXX.

revenue $X.X revenue XXXX, net $X.X for full licensing ended XX, year recorded the licensing $XX.X DANYELZA we December the December XXXX, and flat product year XX, December XXXX were for the million months ended the of December and year reported not Nobelpharma, XXXX ended total revenues of quarter XXXX. Research and XXXX. licensing for and recorded ended million have compared million $XX.X did and to revenues XX, in XX, XX, of revenue respectively. net $XX.X ended X XXXX. We product development relatively the from for the for of were expenses of X for million Our $X revenue December XXXX, XX, months We million December million we year million licensing ended ended December XX, the $XX.X

and or ended Our to and research from to XX, expenses former million related December was $X.X costs impact in of in our $X.X XX, with XXXX, December XX, licensing SADA million ended and XX, were for to and the and $XX primarily SG&A development executives of fourth $X.X million as compensation $X.X personnel reported the XXXX. million XXXX, million increase XX, compensation. We year $X.XX milestone the XXXX. business year per XXXX, increase agreement includes diluted expenses in costs $X.X costs, periods share a stock-based $X licensing development XXXX, our increase increase to decrease related to basic XX, negative December administrative million for year or and of million ended for XX, was a associated related for stock-based of months XXXX, compensation per million the year attributable related settlements and expenses quarter The diluted was the negative The million separation ended million $X.XX The the XX, also million ended the general X associated for primarily representing agreements with primarily XXXX. to and December share SG&A ended the costs legal personnel basic net and the charge the attributable realignment. The $X.X a increased ended million year consulting and compared increase and $XX.X million XXXX. Selling a of of XX, personnel a in December to decrease $X.X the $XX.X stock-based to and net to loss for $X.X for with ended quarter a million ended $X.X XXXX. a and recognition December in in restructuring December attributable in quarter to compared acquisition same $X.X million of during loss inclusive December December $XX.X net year research respectively,

$XX.X as ended December XX, partially of net XXXX. The a loss December for XX, for diluted by we have ended million and $X.XX year net basic in offset to year a compared million share year reported primarily share of the loss addition, an foreign $XX.X currency quarter the In and XXXX, in impact for per XXXX, expenses $X.XX net or and basic XX, revenues. ended transactions, driven increase increase an increase negative per in operating negative the loss or net product from unfavorable was by an December and diluted

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

a fourth the cash million continue quarter XXXX. $X.X outflows to for we Importantly, strong reporting balance sheet, maintain

Turning now to our full year XXXX guidance.

We in and our net million range XXXX $XX are to million. be of year between announcing a full total anticipated revenue $XX

with the anticipated million total and net between $XXX for full year sold. cost of including Y-mAbs which historically, to be has total of XXXX. expenses, our reminder, $XXX a million cost Consistent goods, As include expenses, operating provided operating that expected is approach, goods

to between Excluding million and XXXX. million be cost our operating is $XXX sold, goods for of $XXX full expenses year expected the net total

million. full and We between to cash range the for in XXXX investments expect be of $XX $XX total million annual year

million. net XXXX we first which between and for also quarter of range will a addition, million $XX our are announcing be In $XX guidance total revenue,

fair back business of is guidance the and This across we strategy, concludes now positioned priorities strong noted a the focused prepared to over amount Y-mAbs of that we strategic ahead. update, on call our consensus company is and balance numbers believe XXXX, a a and numbers. The With guidance execute the multiple there year to variation turn we our I sheet Mike. the providing committed delivery to realistic. is in guidance As estimates support well our anticipated for in mission milestones financial are to and unit will

Michael Rossi

Pete. Thank you overview, for that

Let's open for now the line questions. Operator?

Operator

Our Bank from Instructions] America. comes Stranahan with first of Alec question [Operator

Alec Stranahan

other just start some a the seasonal should most we full there could and part all the given trajectory updates to factors flat ups account the roughly here. year? XQ Appreciate guidance, or year we as Maybe DANYELZA, be year maybe for the the about on for and revenue throughout or be XXXX downs first thinking impacts

Michael Rossi

the for thanks question. Alec,

market atXXXX, of look supporting put and plans we growth. little to through the a within over penetration the and well going expand guidance for Pete additional some opportunities other 'XX trials as for in to for relapsed/refractory product. But we're ramping the to it I'll up neuroblastoma It's some take also As here. high-risk place looking our the accelerate quarter as on bit we've our clinical turn looking to

Peter Pfreundschuh

question. the appreciate Alec, Yes.

to year just first the So, year [Indiscernible] We this out guidance that remind QX off, of upon realistic and everybody that of kind be of did revised want based the to guidance put those beginning last credible. provide at numbers numbers unaudited we hit our for preliminary we in actually XXXX.

make Street full like parcel that numbers sure stocking guide as of seen quarter we've to that and some in past to as to I U.S. our seasonality both partners. alluded of year as part that with to those for the is the XXXX the some think for the out of some really you putting we So year numbers regards ex to effects us effects this first well and

full that. for very year So, guidance later admit numbers we be were to year. don't first year full want I again, range. to think the for is that I'll wide to the this we quite the But note, reset clear, the

first which think We're we're it out feel full on year revenue the next to range range so million the equation. Obviously, separately, good months pretty guys as guidance it stick in midpoint quarter that model then, $XX think we guys, update. And $XX a about million a going guidance on we the of is number the should about within the that quarter. is quarter, basis. future was that you company And think that. this laid for provide the results the into quarter, you out of kind you I stick for of way year So we're first intent range already as and to move we already forward side our seeing that X the as that quarters, to to the about within

So, the the year we're with for instance, narrow earnings you at second as will to we'll quarter to and move first we regards call, through And the the then quarter. provide guidance range full also we year. update number, the going

So, hopefully, as company Alec. march the that's for achievable you down the will that very kind guys it to to of helpful are move Hopefully, for as also numbers year. helps, and through us that analysts, we allow

Alec Stranahan

maybe SADA helpful. thinking update. one very And that's just the one, upcoming No, quick Yes. about

you're think selection concentration the most a perspective? important dose which readout, upcoming measuring As tissue the in from tumor will tissues outside do you be

Michael Rossi

itself, looking you we kidney. time as this, at potentially radiopharmaceuticals, aside and the where the would X you're look it any think remain, concentrate one being tumor at I Alec, at from look Hey areas

renal an products look that could be of be that would So as limiting. at the you dose something potentially elimination area

that you what would if area have be And another Bone you in increased for marrow would additional you is second hepatic see liver. The marrow bone then look at concentrations. elimination, uptake. so finally,

what that, move you where the gland one goes. product with agents, and market places that's liver looking PSMA that how of radiotherapy body. of the too, on you thing labs acute just it see the think salivary to renal really all much the these of at in things, lacrimal see determine external start you if is because additional I big of you an keys you impacts doses having I to Same big or actually outside And relatively the at as but injury small look today, But that? So with uptake. into if PET beam that chronic. effects has you're systemic out the emitting of one there's are the through the the this, at different see actually compared if at you enzymes you'd can impact think radiopharmaceuticals, either elimination, any look see not passing is to

seeing are injury -- you it really it's from So just versus concentration?

Operator

question next Morgan from Mike comes with Our Stanley. Ulz

Michael Ulz

Maybe guidance sort just question, particularly of on OpEx. another

$XXX year. to million this million guiding $XXX You're to

as wondering Just R&D the years, forward how ramp and move you start as program, you should can into And of SG&A. then if evolving the between the about give SADA we R&D us there? sort to think breakdown we outer

Michael Rossi

Yes, Mike, I it. appreciate

As we a of for will we turn bringing I'll also into about be additional to look in breakdowns. the think at over our this, as there targets it as But look runway, our for our in. at of that's investment, things. planning some Pete couple cash and we

coming out was on XXX So that's there'll completion, our a of be commitment. as some costs coming study to DANYELZA which our post-marketing

little bring bit optimized been in We -- we're treating I Phase in and a our how done we also targets the differently our that have additional also that targets preclinical on we've coming into R&D from it But a has SADA phase system, into past. perspective.

the Pete spend actual second actually how the bring these is we sharing our quarter on we it But So, process send decrease be and many can that I'll for to what over into clinic targets cost in we'll to and to targets get forward. breakdown. how -- plan

Peter Pfreundschuh

question. Sure. Thanks, Mike. Mike, good

So, guidance clarify, of just cost OpEx goods. $XXX to is $XXX without the million number to million our

OpEx to detail breakdown specific $XXX of breakdown cost that more cost goods that, the like Just for would sold. $XXX million provide think XXXX the provided $XXX including goods, that is $XXX million. Coming the number on everybody for think guidance a past, Again, cost million I about the the of in we've of Mike, about way including to historically today's said and reported. without kind on line, of back a as SG&A as of million we our we reminder, cost of to call as a as the goods, reminder don't company, is

and was number overall as $XX other that as was that in remember, But in one-time there settlements our some things, that a well kind some million, number about about number, legal to of number. $XX was So of million. of as part related there million charges disclosed of $X

XXXX. I those take we anticipate not minus presume, some then one-time that's million, rest the in So, base. is $XX bit, the And of kind grow the of a items reoccurring base but a R&D. will million That little don't a would $X lot.

I model kind Mike. it that of your suggest as you Hopefully, you would way that's helps, about think So, numbers. the

Operator

Our from with Jeff Jones question comes next Oppenheimer.

Jeffrey Jones

the how you investigator-sponsored looking the you you're shift bit As could investment about beyond speak spend we forward, revenue XXXX we studies and are to can about think R&D a guidance? over away at making and that look how impacting from time in say, little DANYELZA the DANYELZA, in thinking

Michael Rossi

I question. the Jeff, Yes, appreciate

trials, things I as trial, the the DANYELZA, some the we completing think we with look as invest post-marketing one investigator-sponsored which support additional look those, at DANYELZA to cost competition continue lead we so as on with within indications, and penetration at XXX our our short-term in associated the we'll continuing that. to commitment. create highest to increased It When patients. would R&D are segment is currently does well for of

expanded open a to that, better opportunity move as way will term have tailwind. long for additional some the at it up registration look GDX. indications diagnostic developing again provide We're better potential select to we on for also trials think I select, However, a forward with to will and the product. And

we actually of the opportunity in know And we look registration we trial. select to get one ISS to more in So, with to at able potential some get investment for into it us things like GDX being as closer as gives both that, as well additional osteosarcoma the patient the GDX. trials, are challenges

Jeffrey Jones

follow-up Appreciate on that, Mike. one just And program. CDXX the

the have sites open but still trial to first those that patient. been enroll noted working for while, you're a You

there color that SADA is any that on might -- if the else? program target or related challenges something Just and that how study to the enrolling the or

Michael Rossi

Yes. is No, these while it since. third up the them that. of sites and I taken to say -- segment appreciate rest a we It's a is It patients. and and to difficult enroll We had up X running. brought in running get then on X very quarter I'll

or trial either much biggest they that's but they think weren't been healthy qualification challenge. the very was for because stage. qualify enough. didn't I it identified So, the our patients, end through process, We've

SADA, a challenge. more very non-Hodgkin's segment difficult So, have that the refractory and the it been to patients related to unrelated is

Operator

with Our Germino next Nicole Truist. question comes from

Nicole Germino

Just a study. the on question quick bridging

And to C? what B expectations bridge advancing Part So timelines Part of us does B? the can push remind the again Part for and the to B are and out XXXX you start

Michael Rossi

Sure, Nicole. that. it what I to appreciate could kind the are the question. turn timelines of bit to I'm to study a speak the why, and going little is, for bridging Natalie, over what who

Natalie Tucker

Thanks, Mike, thanks, and Nicole.

and 'XX. kicking the think So, currently will A And just back work because molecule Part quite especially and a to we really that's Part number just B, ongoing. it the we testing in the study XXXX off patients, to be enrolling of compared fewer we we're regarding of early quick, bridging optimization anticipate that are study the that

will all phase. be reporting So, B we go in all, data will a our relatively bridge with on be in it we into us into the targeting to QX going and escalation that our dose B readout to strategy back quick what But QX bring the plans plan Part forward. full believe in Part back

Nicole Germino

also question, then part and the expectations timelines Great. remind you second can of us B the that C? Part on about and And for

Natalie Tucker

anticipated is relative mean, XX were I XX Part B patients Part -- consented A. that to the XX for Yes. the

we'd mean, anticipate a be will So, including the -- with let's timeline bit PET on have having roughly we quite directed go just that, patient I bit fact that a selection. to quite the quicker, and expect we quicker,

to relatively on FDA will Part the But be we data be on Part quick. little go And So, will to the detailed to bit back timelines. timeline we we once compared then see Part a more A. we B A, -- relatively announce B and in will in C, terms Part the Part of quick

Operator

next Our comes from question Cantor Li Watsek Fitzgerald. with

Li Wang Watsek

guess I Part main I'm step patients, received dose to for Lutetium? whether for therapeutic curious just And X GDX-SADA, than from the for the select protein GDX-positive the these the more dose patients X the of A. you

Michael Rossi

that patients a uptake showed that So, receive level per follow-up of Li. did was therapeutic and appreciate dose, it, the those protocol. X All

patients an protein currently move to around optimal part is trial. that be received amount we in narrow is confident of uptake we down it that as dose information doing that only we're dose work we So, limited the advancing the showed able to when the we'll but of the itself, therapeutic. into in think -- those what protein we evaluated those diagnostic significant as feel the It forward

Li Wang Watsek

of also a I you looking number at, And be Okay. guess, mentioned that you'll targets. different SADA

So, given it just strategy BD realistic them? your them, for might curious of be to develop not what of be, I guess, might all some

Michael Rossi

question. a that's No, good Yes.

with think the that over or down therapy So, platform. the top and XX at optimal we targets targets, narrowed we XX these X,XXX be would them radioimmune looked started to we we as for

So, with franchise fall in to outside X that, those commercialization X areas identified in interested be those of we those would ourselves. Several we targets which franchises. of bringing targets also

would they our be an partner the more would the view, ideal ones franchises to be to that we efficiency would targets So, keep in-house. targets with we're point looking within out-license, or forward while from of bring

bring partner a So, strategy we're well. focused update. target the also that their wanted our of part opportunity, opportunities. There's to be our quarter willing partnership, that have us within be open and if would BD as franchises, discussion commercialization be will our we external to to will for potential But to and an second forward

Operator

Our next with from Bill Clear Maughan comes question Street.

William Maughan

the or that competitive and guidance DANYELZA discuss you to and in competitive references should like for updated evolving of increasingly to at be XXXX context DANYELZA looking growth? at looks an Could of looking of well, long-term competitive we dynamic sort kind dynamic So, that -- what DANYELZA. bring how help life an

Michael Rossi

absolutely. Sure,

products are come patients, other well one things competitive this, compete So for of we right? the at there that ultimately, for overall which areas in therapies. patients, several and at look as you the have the as market we to clinical look That that trials. As is is competition is

dynamics invest, that experience to to to; how it our you falls leverage and to bring some we're is for confident in move trials and A, the share clinical continue the into do goal to out penetration. But and to in increasing overall product. Doug, the competitive and sure on to market Doug very add plan we're we color possible, those make that? as many market want to as So a gaining really patients the product. But forward has

Doug Gentilcore

the transient, trial groundwork news that we're that meaning study doses, is in Yes. The for the a what's term in come the to but impact Most near good beyond competing laying for and of from those is above going future. doses starts some with really market plenty the and as and ISS, whole. also feedback the from patients, extremely mentioned, market we're XXXX but for competing of market to investigators early lead move, already for new happen and that patient positive there's seeing in the a as Mike standpoint,

Michael Rossi

only bone outpatient at expand for a and opportunity as Bill, go parents with experience outpatient forward, DANYELZA the of are well option for And treated. outpatient being as And parents. increase we we bone in as lot the and the children marrow involvement opportunity for option the look that gives indication increase at institutions to to the and us having

Operator

next comes Walsh with Justin from Our question JonesTrading.

Justin Walsh

for clinically would of there moving Now and ultimately commercially forward what level CDXX and great you in be viable. need see useful would discuss that patients with the could to need you're benefit it the to if clinic prove unmet the asset SADA,

Michael Rossi

was knowledge internal the the the the an forward made of say forward to Yes, years market. of work the on to target to that a Justin, that some I'll bring CDXX, in antibody it. had with members decision team based past bring done with ago few Coming I CDXX appreciate the

an very unmet it's need space. in For us, again, is competitive a non-Hodgkin's. there But

N second X. bringing of in to opportunity the an with was forward of selecting this tumor to part validating get quickly, able CDXX team do. Patient a which we a but circulating can more versus a into target just difficult, is rather solid clinic at that to was much validate looking also So, tumor get an

targets, of to we -- develops on tell will forward data Time as how the as be seeing. it, we're team, our these much the that we QX will some and could are. what and to So on up start this give targets or different comparing the to effort look that but long how X Natalie update

Operator

comes next with from Wainwright. Robert H.C. Our question Burns

Robert Burns

look to forward the coming XQ. Really update in

market approval could And if that I could around second just COGS Obviously, sales? may. be of one, significantly color neuroblastoma, the -- late a especially higher me, you dynamics the around guess provide Just the around the potentially the DFMO this question X in how COGS. is were quarter. XXXX DANYELZA questions FDA in from and I impacting with little more the granular first then

So just color some around that.

Michael Rossi

Yes.

therapy coming an a out with therapy. an at to it's of try on market, inhibitors begins how to patients start they'll for the the a to inhibitors, with to know be DFMO. inhibitor tend limiting patient need there's I'll So into the entrant they'll be very aggressive you When to look that Once because, advance, a long we back more to them. always solution. again, But opportunity temporary go new

to need child For come possible. us, it's be order back as to to in can begin that, response treated. always a as anti-GDX long positive an But come therapy they'll as maintain off to of when the patients

And we a to there's think that'll a of the but little in some that. additional parents. are flows helping is patients, hope from prevent move of And disease forward, return there's options there's options for and the again, recurring. From an as a that perspective, goods headwind I for -- that So, of you bit equilibrium. options complete what's the patient maintaining ebbs cost best to an response

in, So, there'll in different as points costs we look batch be time. come at that at product bringing in

low-volume, batches, product. of of So additional over an a certain it's drives a color fluctuations. doing what what whether those goods high-value But of to see Pete for little is SADA. I as is you'll we're it's can a on bit goods cost cost increase this or turn DANYELZA a number whether it

market, to as we're partners. you'll similar So stock-ins getting Pete? buy-ins us in our from ex-U.S. in see see you will from the

Peter Pfreundschuh

Yes, Mike, it's spot on.

that component in the The kind COGS quite obviously strong, also is So, That's other fourth with addition to take some that quarter you component. But the of elements and can drives was stock-ins of what numbers. ex-U.S. continued write-offs. inventory in look fourth results that. a a did component that, have and quarter, we then at associated

really -- in of of there past. but So haven't that. had of kind that the write-offs We component a a was history minor

some into factor helps. hopefully, of numbers, things but those all course, of that those So,

Robert Burns

certainly does. Yes, it

Operator

Our with Dolliver comes Capital Markets. Kemp question from next Brookline

Brian Kemp Dolliver

we've dynamics with that's at the looks DFMO? the WACC because from X with they've main is the it carry speak guidance back Also, become range, can And regard mix like seen So then in you Unituxin, increases very with going in aggressive to your first to the competitor, least quarters WACC. the any in patients change regard in recycling payer through, last particularly also there half? that to to with

Michael Rossi

Yes, Kemp, and I appreciate it.

few things. a Just

overall population the start our we this, looking and models at availability, we look build patient As accordingly. at we

in. that on another therapy, be those may factor cycling of and So, off those we with

be the time to a as We on also that would resident product. therapy. And little that looks more speak we speak products -- we what our don't can well we to a and done payer like We the have they Pete the competitive therapy overall. can let bit I'll and they but what to really competitive really speak see how as our on factor versus we'd WACC do, what in mix

Peter Pfreundschuh

Kemp. Yes.

a pricing is X% from first and this we So perspective, perspective, a year. took this off, WACC price increase data, public

I'm I'll details that. much on get leave to not increase. to into competitors just at a going it take price that. higher Our tend

what of You a price look because relative our the into as increases, that was obviously, and thorough numbers those obviously includes analysis very well Medicaid what are. do that as XXXB is We question, there's take a all a well payer to your to where can non-Medicaid, is our those price other as payer at and which as go those out implication I folds base think as mix, elements. mix component with non-XXXB,

overstep situation of increases, the then a on equation. givebacks price with an third-party increases that end up at where in the external do we make look provider just and service further price other we when sure that so, And have side don't we work we to

Medicaid sales kind of X.X we've as has X I terms of think in with regards through kind the mix, more quarters, the institutions towards years, of moved to X to the mix move years. continued last

we this As with regards we've migrated move gross has margin stabilization had business. But in that of overall course, forward. the see we probably some as at impact of that to juncture, kind most to direction,

think increase, you So at we're we kind that But did had this we of in we stabilization most in should point probably forward last -- see number. quarter, we that last quarter have had over an as 'XX, a we know. where as slight in increase I move quarter, peak

So, helps, hopefully, fronts. on that Kemp, both

Brian Kemp Dolliver

that's Yes, relates engage more a to just great. COG efforts your to little behind sites. And if second that. detail My question could give with you

Michael Rossi

Kemp, it. I appreciate Yes,

So, when brought the market through we look to at COG. this, the we know product competitive was

it's DANYELZA taken a taken it's COG lot little So, -- a effort penetrate forward. the of benefits well, bring bit sites of to those and

both at as scheduled We multiple across giving COG they ongoing sites as look as option kick well have trials, clinical DANYELZA leading as to an some off sites. with

focused as So, for the provide top option. that XX and us, well outpatient on as still we're to XX increase to penetration sites penetrate to continue

working leaders very the we're key opinion closely So, with there.

relationships very within as known company continue a on well focused COG experience those good we sites. have build and GDX, as the as are to and build We

Operator

further There are to for I at call time. back this Rossi remarks. will closing Mike hand the questions now no

Michael Rossi

well and quarter is Thank our to and positioned and readout and Thank you for Radiopharmaceutical Radiopharmaceutical Business planned DANYELZA quarter. full and across look believe units have forward continued strategic GDX-SADA you, Pipeline thank great in during achieve further 'XX us a data Update We XXXX to Phase our I Y-mAbs execute and We providing progress. beyond. priorities day. updates and results Part second fourth A discuss all, operator, joining to for our year today you, everyone, strong and our

Operator

Thank program. you This conclude participation. for your does the

now disconnect. may You

Y-mAbs Therapeutics (YMAB) 4 Mar 252024 Q4 Earnings call transcript