YMAB - Earnings call transcript Q1 2022 | Y-mAbs Therapeutics, Inc.

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Operator

Good day, and welcome to the Y-mAbs Therapeutics, Inc.’s Earnings Conference Call for the First Quarter of 2022. Today’s conference is being recorded.

Let me quickly remind you that the following discussion contains certain forward-looking -- certain statements that are considered forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Because forward-looking statements involve risks and uncertainties, they are not guarantees of future performance and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including those risk factors discussed in the company’s annual report on the Form 10-K for the fiscal year ended December 31, 2021, as filed with the SEC on March 1, 2022. At this time, I would now like to turn the conference over to Thomas Gad, the Company’s Founder, Interim CEO and President.

Thomas Gad

you. Thank and joining everybody, today. you thank morning, us for Good accomplishments briefly first I’m to our in very pleased review the quarter. BLA the We saw on of as notably progress with XXXX in the promised. resubmission a great our start key to for QX, omburtamab excellent programs, a presented net for We April. at the AACR X% DANYELZA with platform increase SADA the in of technology sequential the and in had revenues advancement data recently

transformative year We for expect yet XXXX to another be Y-mAbs.

position has Executive by we leadership I’m Executive the as in announced on and our assumed Commercial for role I’ve Medical his last as wish Officer. down As search best considerable while and Dr. Kruse, his Interim all Bo Officer; future and CEO, Chief Lisby, him the Smith, grateful And Chief Chief Møller The Vignesh under stepped the joined made Officer. our Claus call are is company Officer; his Steen CFO; Officer. contributions new our endeavors. Sue his for our Chief the Scientific Rajah, today, Chief from week, progress ongoing we

who the from marrow of of with bone neuroblastoma or here who relapsed/refractory therapy. All patients first commercial in stable is demonstrated our product not accelerated bone disease truly DANYELZA relapses to and the was response launched Y-mAbs proud or or XX treatment prior FDA’s approval high-risk months in children respond us ago who a are after for to the previous bone the partial neuroblastoma have multiple experienced marrow to treatment. DANYELZA -- bone have of at or to offer did high-risk

And She Go year, already we’ll implemented to over call on U.S. Sue and positive hand DANYELZA at disease the has approach. now very her Officer, her. ahead, today, our Sue. and several to I’m the pleased it leveraging Commercial have Sue the joins experience Chief changes markets. Smith, to to start of other in us the is Our highlight and differentiate rare who

Sue Smith

the talk to today Good some place to and processes the to opportunity our opportunities of with you, Thomas. new growth into to you pleased and morning. all to I’m barriers about entry. mitigate put Thank drive to strategies be have and happy also new

quarter, developed based market relying This supporting includes road further from focus map the learnings journey. efforts and academic our community institutions. full patient not first post-launch valuable just at experience, on pediatric key patients the hospitals and a During our all among the we’ve neuroblastoma identifying on to

plan consists Our X [ph]. of commercial perks

we engagement. opinion team been First, focus existing with support, than having management we’re and education. our network leaders experience patients, growing help our to of half accounts key inclusion are enriching We’ve maintaining and now with our business. multiple formulary growing account peer-to-peer the With also more of

aligned I have commercial the and data active us using drive patients is allows journey. success. new incentive all these to we’re claims worked with I’ve first and The road operationalize the now to to leadership the DANYELZA activities levers compensation team we patients goals, those create Second, to And in team And real-time a recognition funnel. their improve earlier mentioned. team understand identify based very we and recognition use customers relevant goals. commercial including filling and map time. targeting with where of our in team for and the with with and leads account journey. they us appropriate goals aligning provide with our the managers This on are This engage customers awards third, to are allows for to clear strategic their have

DANYELZA forward X% early first $XX.X increase from previous approach quarter, working Our net as of recorded the show a the quarter. we sales million refined appears to for

have gained year. nation, Sloan DANYELZA increase Approximately end up sold XX that increase the by only the vials U.S. last by now with administered or XX% treatment across the treatment of centers is XX in of to of number Memorial experience encouraged centers compared having the also Kettering quarters. with outside outside We’re XX% the sold the of notable centers since DANYELZA in a This approximately MSK. XX% sold in vials prior are the now were MSK of of

the on to We getting at continue the and focused we’ve market in the recently are increase pleased point. launch field about traction XX%. our sales be headcount very made the we’re Accordingly, decision DANYELZA to this by with

gained X market have consecutive understanding the a growth. patterns. reported We of of quarters now we penetration fundamental have believe we And

into of the very we between And team for be rapid XX adoption. currently infusion, DANYELZA’s the continues fewer the above by drive benefits The A launch, million. hospitalization And a to and $XX.X its revenue we’re available encouraged first $XX is other including options, notch an setting. in outpatient now over days product expect full total XXXX to and expectations. million quarter revenues year our internal year

focused squarely expanded are are continuing expediting development in on And We adoption. DANYELZA’s its indications. we

clinicians’ underscored we So are DANYELZA, feedback. opportunity the long-term to summarize, optimistic by for about as

accelerated And additional to site activation. broaden training we Our further on ahead, continued education focus looking medical adoption. remains conduct plan to

Thomas Gad

you, Thank Sue.

ongoing Going discussions this DANYELZA opportunity. on, very also introducing focused on have DANYELZA, into to larger we’re indications started adult partnership and on address

as the are DANYELZA as GDX a needs DANYELZA well-defined focused capturing while on very we focus larger hear, going continued As unmet adult opportunity growing drug, the excited as target. of we about forward. medical Staying top-line remains possibilities on provides a additional indications commercial very revenues, pediatric you can

Moving on to omburtamab.

treatment for of are thrilled of with the We recent metastases for resubmission our neuroblastoma. BLA omburtamab CNS/leptomeningeal the

FDA recall, path the which our March our might we ultimately achieved. January confirmed we towards and meeting year BLA with of pre-BLA this resubmission, you in had As the

you. neuroblastoma will high-risk patients is for be given rate, therapies the future any significantly metastases. commercial our well approved developing fact to infrastructure data in us addressing enable survival that that commercial And fit hopeful view this additional improvements meaningful will this data our that We indication, FDA-approved time. investments. We medical there sharing major existing omburtamab are important if infrastructure omburtamab overall approved, with to forward matured CNS into We in the without unmet to the no leverage has and for look further believe which in DANYELZA an with need of near

into indication target. important pediatric expressed believe will that expansion significant and unmet drug with within also we opportunities omburtamab diseases, an a mature larger rare needs is label Additionally, over BX-HX present several a widely opportunity as medical

by As the pediatric to we from receive omburtamab Priority are has agency approved. disease granted the Review a designation been is a FDA, if omburtamab eligible Voucher rare

net year. $XXX received from XX% DANYELZA’s MSK, for previously our PRV of we and that million subsequently the further cash agreement to with securing received rate. proceeds from first PRV that extend PRV. sale, Under XX% the licensing potentially run net of to generated sale receive entitled the recall, last solid And the you the proceeds omburtamab approval sold our company non-dilutive will cash of a they MSK is the a PRV As for generated contribution

SADA. Moving on to

SADA multiple our platform SADA promise portfolio potential tumors. a show Y-mAbs to the is precisely to radiopharmaceuticals, great that key in in which target continues Turning technology, the for pre-targeted unlocking

construct, for become community. tumors first GDX-SADA represents about for the optimize to As we the The technology, company medical continue we’ve GDX-positive SADA scientific the filed and solid was a it even encouraged for last advancement more IND the our year.

third year. IND patients during the great expect made fourth on the to or first and treat the of have We quarter this progress

on for strategy medical our in unmet the to validating focused on pediatric is treating lung portfolio. focus GDX-SADA, well-known adults on need in rare of tumors. We here X-pronged we larger Annual this a are while construct indications, GDX-SADA year. strategy while at cancer, disease work pediatric a building preclinical our presented out-license AACR data pediatric Meeting indications, April large We cell GDX-positive our here, small we indication our Remember,

monomer that demonstrated anti-tumor effects activity over that stronger of seems start state. persistent affinity tissue the poster vivo shown preclinical have significantly models with in lasting is the uptake treatment. As state to SADA of compared Data further confirmed in increase domain XXX and tetrameric anti-tumor tumor in after the binding to and have days a the

leverage platform the the SADA explore We are coming in positioned months. options well to partnership to

fitting We address on pediatric needs, several addressing unmet also both are our strategy. large medical into working targets indications that while partnership

have in excited targets. could X proven SADA these potentially safely by the enhance as targets targets evident platform, construct further demonstrated index, optimize of based in therapeutic that of Phase repurpose agents. Also been responses already a historically pre-targeted about SADA by humans significantly on meaningful its have potential are not failed attributes potentially PK of that ability pharmaceuticals the therapeutic tumors the in of and the rate potential of to to We SADA SADA unlocking technology. truly terms key making

unmet this believe CDXX our AML potentially remains Y-BiClone treatment important And address malignancies challenging The pediatric need moving most Now is AML hematological promising we clear. for to the has as medical platform. -- an on the pediatric children. bispecific can for been for this one of IND

We over to first dose expect the summer. the patients

have focus We bispecific a to GDX-SADA DANYELZA the monotherapy financial to GDX addressing into program, as the potential efficiently as small our GDX-positive our the runway. well and potential we our capital other adult utilize solid to being to nivatrotamab, our tumors. clinic large as on want as GDX-CDX will enable This deprioritized extend of realize both going commercial lung full financial more us future disclosed indications cell cancer and

Pharmaceuticals for DANYELZA partnership omburtamab As Greater you know, a we SciClone and have China. with in

about excited place the and which approval milestone. DANYELZA a take late potential especially near-term regulatory will to summer We this trigger are China, in expected

to have DANYELZA’s in in for China market this in uptick revenue to be see sales. and zone pilot an expect important an We the driver continued Asia treated patients

the our to partnerships global and DANYELZA track a in We And to focused pipeline our quarter SADA cash ended pipeline, commercial on of LatAm, omburtamab programs, strong as as Eastern external you and can we we We support and clinical see, additional the many more Central constructs. With pipeline and leveraging and covering by deliver commercial be continue order well Israel. launch if value potential we cash. to with milestones, robust on as internal have and by able And work a will footprint. $XXX.X the approved, of Europe belt runway the partnerships. including our making prioritizing by are sure advance unlock have execution early-stage in through DANYELZA commercialization to the tightened continued omburtamab, near-term million have technology

Chief our in with position, current Kruse, you. pleased on will very are a minute. our which Officer, Thank financial Bo Financial We elaborate

me to turn now over Let it Bo.

Bo Kruse

net to XX% of the corresponds the first year-on-year reported fourth of We $X.X quarter quarter We DANYELZA ‘XX. product Thomas. were increase X% net million experienced a revenues the vials revenue for DANYELZA growth of $XX.X which of product for the the first you, compared XXXX reported of sales from quarter year, a this delivered. first million Thank to when

million million by XXXX increase March quarter quarter $X.XX The or outsourced XXXX. sale the March income operating per expenses $XX.X clinical basic million net March DANYELZA employee-related for quarter increase which $XX.X and expenses $XX.X ‘XX proceeds $XX.X including offset first of for was XXXX, a expenses sharing of to quarter the XXXX. as the increased or $XX ‘XX diluted expenses as net costs ended of offset $X.XX per ended per of of growing in for XX, million XX, and DANYELZA’s per the the earnings increased XX, XX, at As March reflects $X.X sale increase XX% cash million revenues. decrease the XXXX development by by $XXX.X with from as non-cash to ended the loss in $XXX.X for was for we end Priority MSK quarter an $XX.X the operating look compared from XXXX for with of basic from in DANYELZA, for The expenses. $X.X driven million SG&A activities the for the to the first quarter increase license million of $X.X and commercialization or compared net net employee-related net in to agreement. XX, quarter quarter take of our that a primarily We our research position the ended million $XX used commercial year XX, share a XXXX. or million in closer a of reflects by expenses. stock-based ended costs, reported The the XX, XXXX. cash of the of launch the March SG&A to Review The We gain XXXX related quarter in well ended include million included the quarter the after we’ll Voucher million diluted March benefits ended at March million a decrease favorable partially XX, a impact operational salary, share ended costs, and by compensation March in decreased note quarter $XX.X from trial first ‘XX, share partially increased the the and manufacturing ended income $X.XX million

Now based Thomas which to in reprioritization of of on for our cash mid terms estimate we understand. to important to our that is mentioned, are the ‘XX. assumptions operations of current currently sufficient the guidance financial this pipeline runway programs, the million various The EURXXX.X underlying position cover

So we let approval assumptions PRV, to me potential for upon sell took proceeds just net which -- be not we the approach of any on could on received and omburtamab. explain the approval that conservative a the include did anticipated of

are also income and for the modestly revenues Potential are not are In assumed analysis new to or year of revenues addition, approval the purpose this no included of BT-related sources runway. DANYELZA upon omburtamab only increase of the each included. partnerships new

clear, Just and to expanded an hope in indications execute could to refined adoption. years physician come we different commercial and growth greater lead for to continue entirely be deliver clinical see as our that to data DANYELZA the strategy to rate we

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

expenses million this priorities. position public to $XXX to do $XXX million Y-mAbs debt or borrowings financial No operating for to last week, execute $XX are total a $XX As XXXX. guidance. expecting its disclosed strategic in or we in cash release burn and million a on of of press We our in million believe are healthy remain offerings included equity

to and now back Now turn Thomas. this the financial concludes I’ll update, the call

Thomas Gad

questions. today’s This up the open end Bo. the line At Thank time, this marks you, Thank remarks. for of to like prepared I’d you.

Operator

question The from have first Instructions] [Operator Alec Stranahan from America. of is we Bank

Alec Stranahan

Two both commercial. from us,

X% $XX.X DANYELZA, That’s plus on quarter-over-quarter. First million XQ. in

the continue in there choice balance of I treatment limiting you are into maybe. trajectory for guidance your Can X% of volumes, inflection to maybe of the shift? keeping from just prior think at of outside points What the this you you sequentially linear you thinking And question And went year? it’s on a strategy for how then talk to we from through approach? plus academic your a then XQ. driving saw uptake was sort expand if this later range, our SG&A the Sue centers, here sort do are And considerations some second midpoint look check? as that omburtamab. in follow-up, And to or plan while

sort sales mentioned of describe in approved, terms of the what what added that for force launch submission of just for Assuming it the no the would FDA built already gets synergies you launch. sort DANYELZA? the accepts be Thomas, you would involved efforts? you and you’ve Can there’s in need really that the

Thomas Gad

take omburtamab. and I’ll Sue let to then first question on I’ll go the

Sue Smith

about in X%. with and So In per the see inflection think that hit by order million, quarter, about the average we we’ve averaging of DANYELZA, the will of I a the more trajectory $XX been terms year. patients in XX fourth we fairly second month estimate an need half of linear to

engaging very terms what have So the the very to transplant marrow in And earlier journey, speaking instance, bone the is the doctor. in is that for compliantly with a understanding accounts, of we team leading really, multi-disciplinary patient in clear a engaged The essentially talking is identification. to plan teams. with patient currently

from to time XX to appropriate months it’s rare disease identification patient patient. can a sometimes that for when take X And

of when we’re So I they’re filling the is why go root think fruits we’ll that their see currently I -- the as efforts towards -- we say by And that’s -- through taking funnel, what we year. mean. the

and So growth. I justifiable more that linear a as see

we our of going imperative in maintain academic is to terms I centers. -- think of are the grow in the and outside first --

in knowing, to proposition our current of So to that at COVID, be we and get home looking and of of progress value seen abandoning an And actually there. the interest some during to more home. closer that closer setting. have certainly treatment made good But treatment aligns of we terms we’re by dynamics, really outpatient parents well have market the focus with

So by have before. identifying where now in be through setting, we which the turning the know patient claims, community didn’t we a could up

specifically, patient. that’s there if time and go an discriminate So their and appropriate account pediatric to an they their engage a spend that very the see time team to have able neuroblastoma to patient knowing is

So We plan that a we’re and that. trends way essentially tracking this. doing patterns the with going and patterns referral the that seeing referral is why we’re see those around

we definitely those And community so and engaging more we’re But the really expanding seeing in oncologists. from certainly engagement there. lot pediatric centers, but that’s with academic -- we’re interest and -- setting, a

Thomas Gad

your Alec, it control question, come in for X eventually after same to treatments. treatment the remission that works a the other and every lead it’s is the So full the KOL long you And existing of months where metastases, diagnose time X will way to no scans therapy in patient you into market. the normally there’s that CNS so second systemic omburtamab, fairly have to you’re

There’s So it’s the logistic planning basically same around floors. the doctors, same it.

the built that pretty radio can officers and safety is needs much MSLs that, besides that up. the So it’s But cover what team to same be same indication.

approved. launch ready fully should we get So if we to be

Operator

next Cowen question Thome Company. from The & Joseph we have from is

Joseph Thome

terms thinking I platform. you Would one, the mention opportunities, adult also you know I DANYELZA Maybe of the forward? you I both the for is visibility, take or kind for you said one first a for follow-up. indications on agent like that? Are over that because in one prioritizing then guess, to you months, And just products partner And of focus next few other? one these of how of partnership have SADA both about product? the in did are the both and

Thomas Gad

as indications GDX talking as great DANYELZA as is DANYELZA. and potential maturing drug is well a First, target. with many about very defined a

discussing of in and while going working partners larger footprint. for a global our U.S. looking and are in on pediatrics, that we partners are and into actually indications keeping the So we part it with

Going to multiple SADA. SADA, we envisioning partnerships. are SADA

also unmet platform and said the was also nicely with envisioning, the not envisioning as works the remarks, but I we my failed, those need indications. have medical going SADA index, one pediatric but very platform proven just can safe optimizing are saying, We keep targets significant in while have indications, the partnership, into platform. third-party manage large couldn’t therapeutic in we’re identifying be optimized on by that and together targets I humans,

done of there’s partnerships. So to lots work be on

Joseph Thome

officially DANYELZA, year are in second the into on then an program titration the update And we potentially still we And for practice? of data when half from X? see Phase expecting full implemented do that have could on updated osteosarcoma, we the

Thomas Gad

I then -- other your and will around question. the give I I’ll question, turn Vignesh take take osteosarcoma will So and

a well, it’s osteosarcoma, multi-center we -- a So have MSK. on trial going at

of CHLA. soon the do data as the And recruited we We sites; be share of is by MSK, it’s hope year. have and XX to We do it’s as possible. recruited expect that out Anderson MD able end potential to X be patients. we It to XX it’s fully

Vignesh, And we’re Medical hand excited well. as other Officer. question update I’ll our the that. your indication on to Chief that’s about So over

Vignesh Rajah

we this step-up have naxitamab, data and evaluating regarding So most we rapid referral we are The the which calls. gradual validating firstly Barcelona. increase with center currently this, expert a where for infusion experience status infusion is in the in the previous shared in of

an for principal data submitted investigator abstract the there all has and ASCO. has Our compiled

future inclusion this validation FDA or this after update or validation. planned it a plan for is that Depending such So And recruitment only that, quarter well met as our advice embargoed, we’ve done be embargo regarding X, also regime includes, data, shortly on date probably in even adult to involving for once a even requirement we’re is incorporate study our will data on that’s we’ve the our And the label X example, the course, of in a XX. targets plan protocol and indications. naxitamab. as osteosarcoma data to available the as the not seek our Once depending May our others studies but quarter XXX preparation ongoing, end manuscript. data of post-marketing but of

able then once obviously, to So we a we get, stage, communicate to community. are our be we and throughout that endorsement FDA these, this the to prescribing in from and position physicians our appropriately implement to plan

moment at the So this rapid the this with infusion is plan current vertical.

Operator

question next The from is Charles have Instructions] [Operator we Zhu from Guggenheim.

Charles Zhu

on lead My SADA program. first your one, perhaps,

Could FDA the they was patients with provide it wondering, towards given the So around you’re back presumably, a perhaps little ready of I’m I in IND just you as or dose of the last at responding? questions the sounds around asked like be on year as year. tracking to your has of topics, come well fourth third you’ll filing. end color guess, more IND kind which filed quarter bit either how this and

Thomas Gad

would I Steen, -- hand IND you some so process. question the this could on quick you update to I’ll like give

Dr. Steen Lisby

we very that correct with the we’re FDA. interactions have currently, It’s And the positive.

cannot FDA, have issue. very QX sites but in anticipate this do And that good will a or dialogue. the to there’s expect answer we we no questions to dose satisfy this and we have a in open to year. review clinical We ready And be QX

little bit different. process the a clinical are sites the for So

INDs time close order approach already their treat patients clearance for but starts to working to for if sites be declared, sites Some us the are in of where expect able we be when IND. with and the we could hope also the now to

Charles Zhu

bit a a have just follow-up on may, of that. I if And

on calls, for XXX of with dose this already think on you aligned the mentioned you FDA the that construct. had millicuries prior had starting I

that novel a might aligned CMC very construct? to So then with remaining questions presume correct already clinical this any the perhaps potentially you have am surround module, given is the FDA module that perhaps I the and

Thomas Gad

Steen. ahead, Go

Dr. Steen Lisby

disclose But and with the from of positive We very, FDA. very the unforeseen events have emerging. details cannot I’m clinical -- don’t any site, the I interaction see again,

FDA. of the So pre-discussed and we have with discussions been the very that protocol the are confident revised during

So we by clearance that confident can -- get get we hopefully, very unlock the are clinical FDA. we the trial when IND the we when

Charles Zhu

of And a high-level question one, more maybe among a broadly bit radiopharmaceuticals.

secret on manufacturing, given So had things radiopharmaceuticals from additional even like of more CMC that it’s chain, perhaps telling supply special and the a Novartis. it’s news some not considerations bit perhaps exactly now recent a

could recent internal So you relative perhaps thoughts to some on and as these needs? your supply to occurrences your provide of also up guys the just really well your stacked as how chain near-term supply

Thomas Gad

SADA And be Steen moving cleared CMC. or supply that’s question. any said, fourth we we say and Charles, with IND, the Well, in and as quarter. years parts is we that of to or one on issues WiMAX. some for with worked platform the we our are CMC. long can the a CMC optimizing third forward the don’t platform feel I the now expect of And see very actually pleased strong quite our We’ve

Operator

question have from is next The we Stanley. from Morgan Mike Ulz

Mike Ulz

quick a step the follow-up dosing Just for DANYELZA. protocol on

meeting. just update physicians you the that if change need any really You to practice? probably sort a is expect at upcoming you mentioned ASCO curious situation the label where adoption presentation or this to following of I’m

Dr. Steen Lisby

mitigating of will we as reactions, a which practice, ways So day-to-day particularly in interested speak interest discussing seeing looking believe Clearly, be when further this not a with this ASCO. this to lot physicians, does this address. of there from forward we Barcelona. who from infusion-related this, Certainly, data, it’s we they’re new been finding who, know Dr. to investigator the and Mora a at has driving are protocol physicians publication presentation potentially from infusion very evaluating

see, some in investigator-sponsored obviously, studies. be discussing uptake this is in Dr. been And experience. Now There’s Mora infusion on one interest also interest will already based what in with schedule. our of his obviously physicians independently of this on they based there adopting

but will a of will answer So a the your is, collection, the as of sure result have there through formally I will interest the this process of yes, be through data rigorous there to a FDA to simple publication, the by who gone need be validation the this expect adopt some make this. endorsed to question the go to has

So parallel the be full also of the will available year. in that later publication in and is the being prepared manuscript

Operator

Instructions] The from Tessa who is Romero we [Operator next question a is have Investor. Private

Tessa Romero

from Tess is JP This Morgan.

think if million you one second key the underpinning real-world And for be assume you me regarding treatment? is, do $XX First assumptions year? helpful out what is can to what the of any us for the DANYELZA guidance net? And trends for to this for million you have I the for just $XX would And insight lay of are gross then there? the question do sales it have like part looking duration what been for

Thomas Gad

Bo, you ahead? will go

Bo Kruse

be I’d happy Thomas. to,

the of U.S. it, is number vials our U.S. some the On course of selling to top figure. that then receive extent, have we what that, partners essentially, XX% of vials of would sold market and comprising of of the So less the income royalty we that. commercial the being of top during than a be. guidance are $XX partners of internationally, XXXX a which for price of course, very a large to extent overall of the $XX product like million DANYELZA internationally to modest million DANYELZA. on than price for But ‘XX, revenues XX% sold the at the And royalty sale income is lower would like

put a is much an company that revenues increase how it’s quarter-over-quarter the quarter in it how this of reflected in to our first newly guidance tell guidance. we take have And which anticipated you I to we of think that’s as doesn’t interval, ever it our the comes XX.X%, commercial from all with together. first put be meet can And careful to as build. really providing So

around last couple what net, be over a for seems quite seen so that But In factors all and it But the net It our in to significant great of and DANYELZA about now. really is percentage it’s the to of gross time. it’s other lot we’ve since forecasting And of of the stabilizing on to beginning fluctuations making haven’t a and lesson publicly. launch XX% a the goes XX%. been to the a much about year easier Medicaid see midpoint learned that ago terms fluctuating to that really like the the PHS fluctuated that bit. very we’ve that stabilizing been it’s the it’s has quarter, we But of spoken each question. gross quarters, the for depending into

Thomas Gad

the treatment, patients the next the question new set-up, is getting elaborate to as earlier. hopefully increasing dose Sue, sched can patient on, a average X thereby elaborate catching duration Meaning, little in the DANYELZA of second-line and for more we our in each trial moving you schedule our on bit. with -- But So to cycles. into line on down it can Sue more are that what’s strategy clinical which up --

Sue Smith

And good being X/X X/X actually third-line being behind [indiscernible] Tessa. them up used the our that thinking of patient. patients about for approach It’s of but very are question, really label, our further about revised a it’s a per are the treated

averaging much X the longer, around months. So duration response at of is

with other to also the label. entrenched community at use grow so closer option option. aware not engage so looking, by So of a in to us earlier, the to we then they’re so as us team multi-disciplinary an that looking looking us going And that they are -- our an we’re to as where in Thomas as are hopefully they’re X-fold approach said, products

Operator

next Schoot we van have der is question The Kempen. from Sebastiaan from

Sebastiaan van der Schoot

currently with I that GDX-positive program, indications naxitamab to the with dosing but evaluation believe a a of development safety neuropathic this not other the from the what on you’re control this program? profile And is of looks completely is you expansion on the potential with partners feedback maybe those You reduction was that like based possible step-up getting what dosing I partners. believe recap Can step-up pain were mentioned resolved. topic? on

Thomas Gad

part in step-up getting Well, to larger bring discussing are go but good forward global we of through And can I’m that. we we a drug interest safety and it would be these on indications into the not as and are profile, sure we protocol DANYELZA whole how indications, discussing for the that. very a footprint obviously are

know, don’t to I want overview a you the if So quick of major... Vignesh, give

Vignesh Rajah

infusion every I also all take such make is us we sure action think collection particular as as able which that, the do events, Grade X, that share broaden on reactions study component using you from of be was basis can And this raise X compassionate to that notable of the development relation observation to infusion or of use will for where our the I data I’m example. of data was not our key pain, you of infusion results to the debt mentioned incidence these this will hypotension. the adverse the naxitamab But is mitigate that came particularly for the going risk details that. reactions formalizing at for center starting to was kind to the ASCO. of the enable indications a where other basis see there initial share was the for can reduces that to this link which that point, infusion is for a want forward. as a having out was the Related mean, this such reduction conducted that in expectation recall, confirm is in a with Grade and reactions. in Spain adult of may infusion, in indications this necessary Absolutely, I we shared this to this

in explore population So of on we schedule to schedules the keen as in well, we the this pediatric necessarily also are results new based allow current will taking a this data. hope the interest this, different And us that in not with might day kilo adult patient more per X you other X, monoclonal explore infusion, on are indications the day amenable to population that is mgs neuroblastoma, the alternative day antibodies but see one, which market. X, a

Operator

[Operator So, we Instructions] the it session. to back are seems for I at Gad of end reached and stage, the with that, our question no questions. answer this would further turn closing And like call Thomas to remarks. have there

Thomas Gad

day. us Thank joining else you Y-mAbs, to a for Thank you. everyone you this you to everyone the and on Have line. morning. great Thank thank

Operator

Thank conference. and concludes today’s you. that Ladies gentlemen,

disconnect You you your for participation. now Thank may your lines.

Y-mAbs Therapeutics (YMAB) 14 May 222022 Q1 Earnings call transcript