Y-mAbs Therapeutics (YMAB) 12 Nov 222022 Q3 Earnings call transcript

Good afternoon, and welcome to the Y-mAbs Therapeutics, Inc. Earnings Conference Call for the Third Quarter of 2022. [Operator Instructions].

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. Such statements include, but are not limited to, statements about our business model and development, commercialization and product distribution plans, current and future clinical and preclinical studies in our research and development programs; expectations related to the timing of the initiation and completion of the regulatory submissions, regulatory marketing and reimbursement approvals, including statements with respect to the potential FDA approval and utility of omburtamab pipeline development programs, potential for DANYELZA territory expansion and advancement of SADA, collaborations or strategic partnerships and the potential benefits thereof; expectations related to our anticipated cash runway and the sufficiency of our cash resources. other other performance, XXXX revenues, including capital requirements and and future expenses guidance not expenditure financial are our our and revenue guidance and for years and historical DANYELZA facts. that statements estimates regarding third they these involve performance, of to forward-looking results differ statements uncertainties, actual expressed those variety not materially guarantees due Because forward-looking from and or are Form fiscal statements discussed may risks factors future and ending in company's implied XX-Q risk a by for as those on the XXXX. XXXX, SEC including factors, XX, of the on quarter X, quarterly September the with report filed November At this Founder, turn company's Interim conference time, CEO and over to the to President. Thomas the would I Gad, like Please go ahead.

you today, Officer; Smith; With for joining Thank Vignesh Danielle. Officer, Chief Medical you, us Officer, I Chief Financial Bo Rajah. thank me Kruse, and our our our Chief Sue Commercial Good afternoon, and and have today. everybody,

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

up and to QX report $XX.X to compared quarter previously DANYELZA XX% First been which foremost, QX up year, up date. million, our notably, sales XX% this revenue and in QX to record compared and proud had of to are we of best picked

neuroblastoma. the and and ODAC XX, anticipate regrettably by the November from XX, PDUFA of October on a However, favor FDA voted X XX decision reported the before of overall of We panel, of date omburtamab metastases treatment XXXX. CNS against survival in from the assessment the previously of for the

decision. scenario ensure outcome, like company you including development, potential into one. consideration the recommendations, had assure bound In the ready any its committee's recommendations generally we FDA that already but takes not is a for making this to the to unfortunate developed I light this of the planning were by reminder, As would when advisory

run rate and that talk We the for PRV believe is currently proceeds I into Bo structure any FDA's cash following existing call. omburtamab, our to our it's decision reiterate important about will on detailed a the which update cost more on and current provide extending operational without later strategic formal feedback. mid-XXXX based will

All DANYELZA to us approval of date a accelerated minor high proud truly treatment for to [indiscernible] refractory we able offer the and marrow stable to relapsed disease therapies. the Turning at demonstrated gastoma Y-mAbs of response, following have being our regional and and bone to DANYELZA, are in response or partial bone prior launch of

partner, Regulatory and submission for access Mexico was DANYELZA tail expansion efforts We refractory was or Colombia. submissions by also are U.S. in the in in region. neuroblastoma, and September Adium in forward to to expand relapsed the of of continuing making considerable on will outside in look approved LatAm completed We DANYELZA's commercialized to Brazil, the XXXX be by efforts Israel DANYELZA recently our Takeda.

also to We any see SciClone regulatory day in now. decision our a with approval hope on collaboration China on

in leading As Officer, I our launches and mentioned, an her DANYELZA efficiencies has U.S. potentially differentiate with prior to new Sue operational other global revenues by XX% and delivering driven as the product previous other Smith, markets. been primarily experience quarter, increased patents U.S. from DANYELZA in Chief our our highlight increase in leveraging Commercial and companies have

are Sue. our starting on remain strategic and and the our right to we We impact to $XX the to positive that, are DANYELZA execution million. pleased to guidance are that of $XX revenue see call today. And Thank on I'm and of Over Sue confident to you, development go XXXX its million you. reaffirm with plan our pleased track year have full with

strong our QX QX that is demonstrate and I'm have day. fuels -- proved every talk made. commercialization progress with all the revenue everyone. team of supports about today, to pleased I'm believe the growth. and opportunity be you the We the afternoon, Thank you, Thomas, we strategic and to at we've to happy good our everything The patient do third plan center quarter our to

drivers second, patient teams an and X, focused and from engagement; first, key on new growth key field aligned caregiver areas: identification; stem Our customers. marketing X

caregiver our our education provide meaningful support a First, and way call, last programs, are discussed and to I which education support. on

We parent continue that and here provide new meaningful dialogue of to to resources treatment. and lead support physician initiation

been team of and a indication is orphan to team, DANYELZA. This the the very the plans right accounts. believe patient of appropriate time what the small the an and formulary to target sales or also patient consistent XX conversion. until relapsed following with building an that been focus and mix This third, the on opportunity in qualified number accounts in at aligned converted patient has over inclusion Second, marketing we those are is and and marketing slowly message leads have patients, with a focused and has filling refractory is time you becomes right funnel also such a essential. identification managing relationships when focus And

and Thomas. we solid in those of XX. proud in trending on including on a gained of of your place had centers of number we highs for X result, Thanks of exiting excited or accounts is excellence. the for in By of quarter, number sales of back sold day ever X several team, XX% third We of had August adoption As notable in hub time, hit and the vials have DANYELZA quarter XX the celebrated patients new DANYELZA. you, and customers continue enrollment are DANYELZA. the and with the foundation I'm have building team upward more to new X when patients end market, anti-GDX XX several the in the the or highest in we highest XXXX. with we The terms slightly in to who the of QX,

introducing clinic, for while Thank positioned DANYELZA opportunity. this named for potential Cancer In diagnosed a We Y-mAbs Childhood improved important potential continue combination our potentially plan induction B therapy the BCCXXX to to our into more arena, believe of pediatric U.S. We end to renewal well and is shareholders. II enrollment study our in neuroblastoma. for during remember in explore it improved addition patients partnerships also adult chemotherapy benefits Further, patients that on to of Building dosing anticipate of total this multicenter is and initiated recruiting to it should We've to is Y-mAbs the with indications have a larger with you, which value the in therapy address plan already Research Sue. This to result Phase committed unlock -- that momentum to quarter. new multicenter naxitamab is of standard NGE-DDX to further the survival. we study. the a responses Consortium provide on trial high-risk osteosarcoma platform The have investigator-sponsored with creating third that to is and open We work XX target induction and to in the XX sites and pivotal to induction XXXX. XX we the patients. of is newly Canada. continue DANYELZA, trial planned in patients we

medical expand DANYELZA about very while we going addressing pediatric needs. you unmet the to forward As possibilities hear, commercial of the various excited opportunity are additional can

targeted our increase key believe now minimal innovative sites therapeutic show in significantly delivery Turning radiopharmaceuticals that off-target liquid to we effects portfolio is technology with in tumor to SADA of to great a opportunities SADA providing platform continues the to or their radiation. promise indexes.

continually As about potential it advancement we've for and become technology, the the even community. optimize the encouraged we the scientific more company represents medical

open GDX-SADA this for in SADA construct quarter, the clearance for IND third GDX-positive first we received and first tumors, our the During site the we to expect clinical solid quarter.

initial to options adults sarcoma SADA melanoma. leverage explore cell are potential partnership validate the to in our to We efforts positioned proprietary SADA by that and GDX believe With well we treating platform. lung small cancer,

Our derisk large imaging due X-step our due SADA method, use possible centers involve drug indications to is departments. making platform infused isotope send large the potential by is infusion for protein [indiscernible] injection, fact first, injection to patients makes programs And X-step that on. possible data nuclear us pharmacokinetic it followed our to having thus by the to avoiding to to medicine our as collecting as our differentiated an straight early to the technology it partners and in enabling highly unique only infusion, our

in XXXX. to patient first this expect the of in in treat quarter fourth this data late the trial We anticipate sharing and year

repurposing explore to optimizing them plan clinical constructs already been construct. previously also failed have that humans in of SADA We late-stage into by proven a

been programs. Moving malignancies CDXX on clear. We bispecific pediatric to IND of as address could product important most need. challenging pediatric has one unmet AML this potentially an believe remains medical AML for candidate bispecific our children the or The for

the as Phase this are patients; reporting in and We have study data to and treated first looking X, unfolds. the I forward trial fact,

through We the continue support commercial DANYELZA globe. to regional a across efficiently work global partnerships with to footprint

China. you a know, Greater SciClone partnership with established in As we expansion for Pharmaceuticals DANYELZA

especially for market an We prospect excited million potentially are will expected milestone regulatory to China about place on now determination approval any Asian a company. could take the DANYELZA's the potential believe a day trigger to important that $XX sales. in is for the and We this regulatory revenue be driver

LatAm a technology including to and pipeline, and the XXXX early-stage potential ended the quarter's work the and areas. to program, million this on of third We believe commercial to continuing in encouraging regulatory clinical of partners our and continue our support strong constructs. in advanced quarter milestones, outreach, among with also commercialization runway to are and have we positioned robust SADA $XXX.X approval and Europe efforts We well subject further deliver of cash. and DANYELZA covering progress a widening revolution witnessed support we our the Israel with our to continued relevant Eastern the

now which Bo? his We in financial Thank current you. with elaborate are our Kruse Bo will position, on financial update. comfortable

Thomas, you, and afternoon, good everybody. Thank

license U.S. $XX.X XXXX, $XX.X X compared where represented comparable million million increases Our ended increase million. and of product XX%, third XX% over of million revenues by ‘XX. million XXXX $XX.X worth of XX% and to license increase in increases was revenues new revenues $XX.X million which increased were X $XX.X DANYELZA by XXXX, months of revenues million, quarter months to driven we net respectively, September €X an XXXX. ended September in second of ended the X compared over XXXX. the $XX.X in quarter corresponding third primarily DANYELZA XX%, million in quarter and period XXXX. and the Net period for XX, the product the corresponding XX% product quarter $X the in included of respectively, quarter in of revenue period million reported XXXX XX, the XXXX DANYELZA months million in $X.X of respectively, patients The XX, of of September XXXX, and and for the revenues third revenue for and represented $X the

expenses. to Moving operating

to XX, Our million expenses the XXXX. quarter for decrease reflects outsourced partially trials, The by costs decreased decreased R&D ended by clinical $X.X September million $XX.X manufacturing. increased offset for for spending

expenses to compensation $XX.X increased compared million XX, related The XXXX stock-based was months increased personnel increased million SADA an costs DANYELZA. year $X.X primarily in to SG&A for salary the ended XXXX. X Our million September constructs. months period. million September during the by the of prior decreased omburtamab the and increase manufacturing and X to increase in XX, result million to commercialization partially to decrease by $XX.X of months $X.X outsourced the of the a to for by advancement X costs $X.X offset expenses ended expenses XXXX, XX, September and expenses, R&D million increase in reflects DANYELZA, dedicated our compared This SG&A ended $XX

a for and loss $X.XX an increased net SG&A of expenses increase reported September for $XX.X million to DANYELZA. diluted and We XXXX the XX, in million increase period by share-based $XX.X former profit the and driven the of diluted Executive of ended or a share to per compensation net XXXX. commercialization severance million XXXX $X.X XXXX, and expense basic million in was expense ended lesser as the was quarter months or The to related months primarily $XX.X The September the in in to the $X.XX SG&A XX, to net primarily Officer, loss quarter Our per of XX, extent, XX, for increased September XXXX. basic ended loss the to in compared compared share, decrease attributed a Chief $XX.X million revenues. our impact by ended September X X gross comparable

license XXXX, and Additionally, XXXX, in for the loss our XXXX. of we per ended sale or September for $XX.X sharing share to of include basic also X XX% related decrease increased gain and months reflects net September above, basic from September XX, and Officer benefits ended in Net DANYELZA The million diluted with diluted $X.XX priority per a months $XX reported Executive XXXX, XX, as the impact sale months severance the in process net or MSK X the net growing September the onetime in for the of compared Belgium. notes the a Chief partially X net DANYELZA's offset months proceeds XX, contractual million impact loss by review loss ended the the After a IND ended former of the X of agreement. $X.XX our share XX, per favorable revenues. $XX.X expenses from of earnings million

and balance million by decrease cash year-end cash second in $XXX.X XXXX As XXXX. XX% year-to-date during Thomas of our mentioned, of at reflects third of compared million quarter to a cash half position decrease year-to-date million about quarter as the the with quarter a third $XX.X the we of compared the to ended I compared of €XXX.X average the million the burn year. of slowed to that first the XXXX $XX.X

Our in we €XX.X now pipeline a and believe the and quarter. sufficient million quarter that mid-XXXX third in into cash essentially current provides second Consistent to and activities $XX.X solid highlighted our million prior support $XX.X million our financial cash the programs. burn our with in to is current quarter commercial runway fund quarters, to our first position from the operations dropped

for sale if to the guidance quarter, did that omburtamab, we understand, PRV assumptions a would and prior received assumption include on a noted potential for are underlying proceeds not the any of As received for in net we and the important be this approved.

We In product regulatory continue purpose to XX% growth no the and indications assumed see license assumptions. runway, clinical by in as the of BD-related increase refined fee expanded analysis lead the greater a hope and higher for corn or in partnerships that of to sources for are are assume Any omburtamab to the to come in and DANYELZA could revenues DANYELZA new years revenues are physician The DANYELZA addition, China. for new other of of our execute income also potential approval strategy we included a approval easier we to this rate deliver potentially adoption. commercial data excluded.

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

the year equity burn million of for continue purpose full have of we Also, assumed we to cash the offerings of operating not For million a $XXX to to expect previously million and expenses as total the disclosed, debt guidance, $XXX million XXXX. $XX or any $XX borrowings. or

our update. We call feedback a adverse healthy mission, expenses expect strategic now and omburtamab will multiple will FDA delivery in We operating our of review the concludes believe on no execute And Y-mAbs the priorities BLA and our based impact the final the turn I Thomas. our cash milestones. runway. This financial back on on remain to to position financial to support the

you, Bo. end This now Okay. we marks remarks. today's Thank open prepared for Q&A. the Operator, of up can

If to of through that, you want process go please? the

Instructions]. [Operator

The Alec from Bank first of comes Stranahan America. question of

Just from us. a couple

Sue. for maybe First,

or in before Any seek the the plan EU was XX% time demand? color on your EMA and a be wait say the DANYELZA approval and conversations in marketing you XX% demand you then increases of between the last the the will the at to a the and authorization filed from way? most obviously, XX%, XQ. FDA's Is growth Would Or encouraging EU? and either I year. the process stage trying XQ something get Just of over expected for differences think And year, third deciding in was same Looking secondly, near-term the to last helpful. the sense current still omburtamab decision organic? the in quarter, filing on like FDA would other meaningful that regulatory

In very we that see were saw quarter, that. happy the terms third also to of growth in the we

organic. was it think I

programs is are and of solid the fundamentals in in the and finding the team think the the priority we taking root. business put terms focus I patient accounts place of new on that

And It solid we win. a so that of just in terms foundation. continue on to anticipate wasn't

So heartened we're that. to see

you to of terms like omburtamab, handle Thomas, would In or... that

order. So with the some we had our the meeting explanation EMA raised EMA, objections saw we has along the and of major that FDA lines

month the come later are their meeting. maybe to waiting opinion this in we depending So December, out opinion. That's for on their schedule final the or of

comes from BMO. question next Etzer Darout of The

here. Congrats on DANYELZA progress the

of get when year? the progress could see in question the and to DANYELZA, on see data support indication setting? to frontline we progress Just and the to a next Osteosarcoma, profile potentially we sort similar incremental for a could that there maybe that frontline data And -- when wanted the sense then pivotals for drug's some supports

Yes.

have also, for read we -- trial. are frontline the we potentially to out So be MSK trial And have and trial submitted. XXXXXX we waiting osteosarcoma

a trial We of have XX single center have recruited, out patients. MSK, I where at believe, XX we

when of fully II an too. osteosarcoma. pivotal planning that trial, the will for file that's quarter are read for R&D to trial then global recruited, So multicenter out, Phase we XXXX in first And

question Maughan from Canaccord of Genuity. Bill The comes next

question. for Thanks the

given scenario the drug. potentially the terms decision have other -- to studying profile in the the playing the message way, still you you'd to would you of some do the So the further drug of of goes for unmet supportive think sort allow what done And commercial this you if data? were generate the do decide FDA support omburtamab, an -- if it somehow that need to have that on market, intact to

on PMRs believe I drug from a think and well approved work to committed with we some for we response PSK OS. are matter for impact we're goes. its and learn give PMCs. as we overall waiting response way long And we as the drug and very it that time, in from That no us think I this FDA now said, right will the the the

wait negative So be in a I program see it point, happen this what's we're in forward in of the going and think a at to would case with mode going outcome. terms

funnel time patient your the and rate in patients commercial on good you -- and and to around funnel patients the filling on I the maybe can potential the funnel the But the quantify in lag confidence help what launch, in commentary increase some know entering DANYELZA And the the there's funnel. becoming us from between getting those patients patients drugs. conversion

really to read anything revenue Just potential through launch to final metrics.

hub think conversion, in in enrollments the the it months. are us terms Sure. numbers leading of for past a number I for we number had seeing funnel of X converting those hub, of per anywhere reimbursement of want right that and just the number the enrollments XX of that are have can -- of of in hub in to our the refractory. a has months a the or to tracking But have mandatory that XX team -- around. we provides over patients consistently couple the XX systems and for services, support indicator is patient and terms a which our highest month really and give I been we become rates conversion they take to And have standpoint. that now, the the competitive formal a from to away percentages from don't relapsed Well,

I that Those indicator. to look insurance coverage, think that that to et through going cetera. have they patients are as sure make who a I So leading are

to team leads month robust of to I qualified, queuing product. we from highly And get follows. the own new the they're that sources most every they're the up indicator. in variety that to the then So a And leading continue me, think is

customers experience. that key So at core think I this repeat plus base and to formulary point, continuing the gain of and XX now experience

treated of or prescribers Our depth of more X patients. outside Kettering of and Sloan experience is growing have XX% our

with come and years another course confidence some getting our levers growth of the now product even post launch. patients more only funnel, with of patient of and not think the from X I DANYELZA So almost experience the but rechallenging

from JPMorgan. The Romero of next Tessa question comes

So what any the to gross of to outpacing compare DANYELZA, expansion first vials despite of are to disclose from XQ? your the curious, XQ or did MSK the one MSK U.S.? XQ sort vials that And on thoughts you the how your And just able in your are sold sold in why on net was sequentially here. centers from growing the

if XQ I Thomas, I'm almost that? I we from me on a So think had the XX% understand but vials And increase. you sure assuming your question QX the... to take want on I'm to -- side, not

Sorry.

understand basically your to net have was about what vials there But gross in to So talking impacted if right, a XX% kind revenue you're that is trying change? quarter-over-quarter any fluctuation increase. of sold, I'm there, could

tremendously. Not

I mean, No, the gross to was the gross to net, you to Bo, net comment. right? can I QX, mean similar

what it close has prior It's the in improved but of in little within It's negative Medicaid quarter. a bit, same. the of as been essentially the quarters the some same a minor accruals, it's percent for but a level actually prior of exception saw of to adjustment net with the we couple is

at end for see a in And then maybe up venue? XQ more a we providing we're the small the a I do that know early likely follow-up call the on of is XXXX? kind conference January? you investor anticipate of here, Could How guidance year. as coming Or

Yes. Bo, to you when do give guidance. want

be... I it think will

we're I little a bit undecided. think still

in Of course, December. approved have we will a go would We usual budget through procedures. our

of point. the uncertain would be know, a bit it would we So is this publicly exact little timing when available at

last one, can. I if And

and the U.S.? omburtamab a from in here guys, path indication? of for complete for response progress there's the the you do this help think Would FDA the see curious, indication? as you in letter path in do month, what Or Just event the the forward forward you program the a still

That's a question. good

risk believe outlook. response would But like to there I complete depending to that a the we'd see have and content that they be in think would kind entail, what do of on I program, wait could letter it. what

from Thome Joseph & The of comes Cowen Company. next question

remind and in Maybe does depend you and us just Can on of CMS FDA of terms progress you kind -- omburtamab. first outcome in DIPG with LM? indications where the stand these DSRCT with on one continued development

So II -- MSK, few we and Phase DSRCT XXX that indication Phase patients. to XXX --XXX do small the response enrolling iodine. going take Obviously, trial were a as plan FDA. is see here a a change we the is deep to is trial, to a what we change very to see after the at close at I FDA breath reevaluate to need a where and end up the decides whole and and omburtamab a from we get from

Okay.

then on follow-up burn. us cash And prepared in you were DANYELZA good. the Sounds Can a assumptions just said growth your you for your remarks. what remind

said in about I is we the line think or any that? guidance? think Or a should sort formal include the Does the of you XX%. implementation new treatment this And how earlier protocol? movement infusion that maybe of

is calculation applied and conservative cash the The XX% XX% question. asking a that very for The only you're I'm that of happy runway. --

different a rate the see in course, coming the to Of we hope and completely growth years. quarters coming

way it's a of runway our when optimistic. nobody a overly estimating just So is in matter

not constituting out calculation. conservative assumption I'm specific So for it's guidance. kind any laying just the used the of

Sebastiaan der Schoot Co. next of van question The Kempen Company. from comes

data programs missed Just the for also And all but expenditure costs on for what R&D also maybe program. some maybe can give the expect then I SADA is omburtamab maybe on it, can the bispecific you omburtamab. expand guidance Can the then on when product? And for you on we combined? current

spend do want you question? address on Bo, to first the the

spending external largest oncology historically, sums to the you've sorts certain I R&D have seen in has profile quite not programs. been We're data We we with as where even taken move provide seen registration conducted. will the of a our this modest. MSK. from this reporting specific the had you from that And separate invested is in for for took set But a course, of But overall not we activities number purposes, program omburtamab the statistics have reporting the nowhere though we second various statements, our the through program. you. by for

modest, investment it when that especially consider we took through overall So the is relatively actually to registration. you

Okay.

the address data. bispecific to And

up the just pediatric centers with we centers opened or another X out started shortly. We've opening So CBX. X [indiscernible] of are CDXX, XX program

take So far, going dosed patients so only so to while. a we've that's X

Regarding pharmacokinetics SADA, programs and imaging, these it's the as I said, due early possible to the quite derisk on. to

it data time goes with some and out on some XXXX soon as as with dosing patients in coming are we So planning hopefully or end depending possible how before.

The next Edouard question Mullarky from Guggenheim. comes of

to Edouard is if dosing someone know just the And end already for on a you platform. for SADA maybe for out the got by I Charles. year. I cut This But bit. apologies asked starting patients guided the of

Just there. targets GDX-SADA beyond also INDs SADA programs of for the some just And maybe what cadence remains other color and potential maybe for for just on the targets.

I'm maybe I think in and BXHX, the HERX not past, mistaken. you talked of about sort if

be would color you give any there great. could So

we speak. sites as we right opening are So now,

we patients. gating dosing dose we but and the that's to between, So first Thanksgiving are the patient in factor for in December. And prescreening hope

we're Day December that DANYELZA. we're coming up XX, INDs, an think additional focus SADA having Day with R&D excited R&D Regarding to I and hold on and

able will be by for we to date. that So second hopefully, do

Regarding inpatient close we in very, to at data are partnerships, very time. this point

order validation of terms So I in milestone validate parties. scans think the is to platform with a next in this third further

potentially are looking at platform. we on answers optimize other research our collaboration, SADA question. I that the the working that with companies, and We your we're hope constantly could with targets failed also corporation

I now turn call over closing further point, that no for At to back Thomas Gad the are remarks. questions. there seems this it will

very Yes. today the us your today. day. time much. call This Thank for on call. with and this Have Thank you ends a you for questions your great

today's presentation. Thank concluded. for attending you now has conference The

You may now disconnect.