Y-mAbs Therapeutics (YMAB) 31 Mar 232022 Q4 Earnings call transcript

Good morning, and welcome to the Y-mAbs Therapeutics, Inc.'s Earnings Call for the Fourth Quarter 2022. [Operator Instructions] As a reminder, today's conference will be recorded.

Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. 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, and our research and development programs; expectations related to the timing of the initiation and completion of regulatory submissions; regulatory, marketing and reimbursement approvals, including statements with respect to future development of other 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; DANYELZA revenue guidance and other guidance for 2023; and our financial performance, including our estimates regarding revenues, expenses and capital expenditure requirements; and other statements that are not historical facts.

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 Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 30, 2023.

would the turn company's I to conference time, Gad, Thomas Founder, this like the to over At

Interim CEO and President. Please go ahead, sir.

morning, me company's Vignesh Rajah. Thank us Smith; and Chief Good everybody. Medical you Sue thank you. Officer, Chief for Commercial today. Officer, With Bo today, CFO, have our I Kruse; our And joining

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

quarter $XX.X are foremost, revenues million the proud Pharmaceuticals, picked received and up of to in quarter, in approved for record sales up we First DANYELZA in DANYELZA as to we and approval company. compared the resulting product report net QX Further, profitable SciClone QX fourth million, XX% a notably, in was China milestone XXXX. from $XX a net

as equivalents planned quarter of estimate cash more as which an any we expanding further when which will cash for operating will reduction later technology. expect in operations The expenses development, and quarter, announced on this be plan, the million Bo DANYELZA XX, combined into developing sufficient development reduction talk plan, that XX% as anticipated about the XXXX. and a to XXXX, omburtamab, of business we our our the XXXX. DANYELZA as After restructuring well anticipated first support a with in December This of revenues, our $XXX.X focused and this excludes force, XX% plan SADA currently call. implementation of of commercialization annual Earlier of potential includes business in

DANYELZA. to turning Now

minor treatment relapsed patients bone or bone offer opportunity stable to in neuroblastoma therapies. accelerated launch Y-mAbs and to-date response, All the refractory disease response who a of and the of proud high-risk for following DANYELZA at our partial demonstrated for of us approval children prior have marrow to are truly the and

planned December momentum, DANYELZA clearly XXXX, the start, of the modest a are access In to in making U.S. we we XXXX product conditional China China, look of SciClone. approval outside of to agreement our in with efforts are to expand the and and on during gaining launch collaboration DANYELZA the half we received After considerable first forward

DANYELZA you the the partner, in continuing high-risk Israel in in The tail is Brazil regulatory submissions to LatAm refractory by and neuroblastoma expansion relapsed Colombia. recently commercialized forward for and recall, region. be to of As September Takeda. by in completed look We efforts was approved on XXXX was our in Mexico and submission Adium DANYELZA's also

WEP in access In December XXXX, with Clinical in agreement early program connection for with Europe. we DANYELZA announced distribution a

seek partners DANYELZA We continue a scale. on to to to provide access global

positive our successful from the mentioned, the quarter revenues from increase see I 'XX, we in primarily new are fourth XXXX by development as execution starting sequentially for XX% to As increased on our driven the an patients quarter third net U.S. a strategic DANYELZA results plan.

that momentum. gaining confident are are we We

of DANYELZA Having end note year guidance $XX top year $XX net for million revenues we we of the that the of reported landed at of $XX.X XXXX DANYELZA pleased to of full the full million. nicely are our to XXXX, revenue million

the have you. Thank I'll And call to pleased turn now, Sue. over Sue to on I'm it very today, you and

strategic have revenue everyone. all pleased We with our growth happy us about to and and believe positions progress today to I'm made. morning, Thomas, organic further in commercialization you, the that be demonstrates we've marketplace. to well talk XXXX for plan that Thank good you opportunity growth the the QX

pursue everything of is as shift For patient us, center at the we the outcomes. in transformational a patient

their home option of experience and schedule them allows potentially team go and disease an transforms that DANYELZA, a of the about Our terms urgent administration safe understands to need to the in the control that use market treatment educate at effective night.

on now marketing expansion right identification, full caregiver are focused customers. field and team aligned key in and key new ahead areas: a on three We patient very engagement, steam

programs are education way and to provide caregiver our a First, education meaningful support and support.

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

relapsed an a the by relationship very that role to or identification and their This DANYELZA population, assess the patient the the focus targeted orphan journey patient rare in a physician disease intervention of and of success of team strategies once patient's tracking to play implement the cultivating the indication and in the in track been Secondly, a commercialization therefore, central also with has way of therapeutic. the physician becomes refractory. and

the team on target are plans and aligned third, are with where marketing treated. sales accounts patients And opportunity focused these and the

As upward a quarter trending anti-GDX result, fourth XXXX. U.S. the exiting DANYELZA adoption is in of and market, market the share

customer new and several building have on we to of had we QX excited two notable with five the or for are team, excellence. of end By centers in had DANYELZA. including who XX and continue those of in accounts accounts patients of have gained We place proud we XXXX, 'XX or solid XX I'm the on foundation DANYELZA. the XX% more

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

diagnosed Y-mAbs to study study, Great. benefits into platform Thank unlock the now This more are actually a while patients our by induction multicenter on to believe for further explores so naxitamab with dosed Phase patients shareholders. BCCXXX sponsored potential therapy positioned more far. provide This Cancer five We neuroblastoma. standard that way, is initiated Childhood newly new to with value creating and patients In Consortium. you, we study three recruiting well clinic, sites, is II our high-risk Beat which the the investigator-sponsored Sue. for Research of trial has

of of treatment to and result the improved addition aims of in patients. in total end the XX the induction to BCC induction the and enrollment We survival. of have XX to believe in target a improved may Canada responses process chemotherapy early XX and therapy sites anti-GDX that U.S.

to work multicenter potentially our to Further, trial osteosarcoma DANYELZA to label expand continue pivotal indications. for we on our new

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

drug to naxitamab's on create to adult preclinical studies year. Anderson We activity is to by breast potentially in April in larger AACR triple-negative provide indications a presentations Our look for this also poster study proof-of-concept ISS cancer MD at shape. in taking a strategy in forward

We're adding also is and up December Day recruit to an in follow of naxitamab investigator-led to Ohio Ib Annual for and QX this year. of study our year, State aiming and plan Phase naxitamab R&D cells. study in we awaiting gemcitabine at approval University, This NK at providing to is IRB patients this

in now radiopharmaceuticals with to therapeutic our believe great to we increase minimal significantly effects, portfolio, self-assembly creating delivery tumor our radioimmunotherapy platform pre-targeted in potential Turning a it two-step targeted off-target key of SADA, sites to and to disassembly, show promise is platform. SADA indexes. technology opportunities continues

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

the trial. year We ago lung are in our started from open XXXX. small York have construct, XXXX of data few GDX The cleared Center I Sloan third in Kettering opened a by and later including up in IND in-human this at solid and this imaging SADA sarcoma with pharmacokinetic November GDX-SADA, point, the and for cell positive is to first our site A that total share Phase New intend Cancer melanoma. first during patients actively quarter first opened which weeks cancer, we four sites, Memorial tumors screening

against Lymphoma we we announced our IND, potential to the R&D also in second non-Hodgkin's a next construct December the Day SADA 'XX, as our submit months. second FDA plan three to At to four within CDXX-SADA which

SADA and myeloma treatments who are excited We radiation-sensitive as aim have failed technology. CDXX third-line to antibody of in multiple address the the patients unmet a target need context in about the

believe that well expertise We streamlined to positioned are SADA to explore validation. our process priority our team's leverage potential partnership we options our platform, and

as ability collect potential infusion our potentially removes two-step enables two-step it for of pharmacokinetic departments, This data advantages. stems the and facilitates nuclear to and infused as infusion drug a two-step to partners to makes isotope from direct to method existing SADA's other us send the programs unique centers This among injection med/onc need by by the early. use protein-only involvement to followed possible injection. technology our Moreover, medicine is an our differentiation our access large patients candidate the imaging.

that previously them a window. the potentially rapid studied improving into been the to profile constructs through We limitations also potentially of SADA already therapeutic those plan clinical late-stage to overcome explore humans optimizing failed by potential construct significantly SADA in partners have and

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

about you the market As to continued covering markets, to Pharmaceuticals are XXXX, Eastern expansion in among we Israel DANYELZA's for to in Y-mAbs. which We could relevant with marketing approval believe driver milestone Asia. regulatory revenue million for important this took to areas. The a SciClone regulatory quarter other fourth in of demonstrated and know, the in China, global partners DANYELZA LatAm, place be approval established sales an DANYELZA and XXXX in that $XX regulatory that Greater the potential excited our China especially December for Central gaining triggered access Europe potentially a support we partnership subject in progress

January a early-stage recent a demonstrate A includes bispecific Type effectiveness made initiated vaccine consider and the risk on substantial of omburtamab in to we which for the profile. during the and to January programs, a omburtamab deprioritizing in terms and benefit our held favorable of meeting to CDXX We Moving designs In recommendations including restructuring and XXXX, us DANYELZA focused XXXX, SADA FDA other plan. programs. It strategic of platform. GDX-GDX trial evidence

to point, company and creation. the the DANYELZA development biotech expansion a program, a SADA for Though label been focus our focused making commercial-state program we development continue deprioritized. consider of are value has we revenue on sharp omburtamab At constructs opportunities us on growing and on-label, future with this the

approximately reduction combined XX%, expenses result plan annual revenues, the workforce we We in when runway XXXX. in expect, cash which to in our our extend have we business of a implemented into DANYELZA will reduction XX% revised for of our XXXX, QX operating anticipate anticipated a with and

that want I new far point, Y-mAbs, -- to the and to brought to to has their all cancer. whilst this been this and my for colleagues gratitude us with sincere has for develop that dedication service for pediatric treatments striving work At extend our patients and appreciation

to milestones commercialization of We in believe fourth technology quarter SADA programs we ended well commercial XXXX to advance effort to with our further a robust runway constructs. our and continue clinical the the and we and pipeline, strong of cash stage $XXX.X the million With earlier continued cash. support DANYELZA with positioned deliver revolutionary are a

comfortable current our are financial with We positions.

give to will Over us financial Bo you. now update. And Thank his you, Bo.

Thomas, and morning, everyone. good you, Thank

million net and million $XX.X Our the in and $XX.X quarter December million for the XX%, XXXX. of of and XX, $X.X comparable increases year the 'XX, fourth of million ended XXX% for represented $XX.X over revenues 'XX, respectively, periods

of revenues ended in license the quarter million, XX, ended million million for in no $XX ended December of revenues XX, included December license Net license year revenue December the to XXXX. and year XXXX, the revenue compared and and quarter $XX XXXX, $X respectively, XX,

and year impact approval During of of the approval the Pharmaceuticals revenue ended case, December the DANYELZA for three milestone capitalized was from share P&L. China. this we XX, regulatory conditional months and million of $X.X $XX in milestone a In that million did recognized XXXX, not the SciClone for approval license accordingly

DANYELZA corresponding product XX, over periods million, and and revenues December the $XX.X $XX.X quarter the represented million increases year which 'XX. was of respectively, 'XX, XX% and for in ended XX%

The million quarter in million. revenues increase as momentum. of the quarter in by by of an compared 'XX, fourth building primarily product in 'XX, U.S. quarter of driven 'XX of fourth $XX.X new to increased we're of was net third the patients sequentially $XX.X XX% DANYELZA increase the

to Moving operating expenses.

decreased $X.X trials, outsourced for Our research million R&D decreased December outsourced to spending the XX, manufacturing ended quarter expenses million The $XX.X 'XX. and clinical and supplies reflects decrease for by services.

This Our to 'XX, during clinical decreased compared decreased trial in December by year. the decrease $XX.X prior ended expenses 'XX. million $X.X the year activity million to reflects R&D XX,

in in related SG&A $X.X December compared increased costs $XX.X XX, The primarily of to result expenses the three quarter the primarily December related ended decreased costs months 'XX. XX, the million three decrease of to was SG&A a of DANYELZA, to decrease the by 'XX, commercialization million to 'XX. months million $X.X in the $XX.X ended for for fourth million launch

December the in million a Our related of and SG&A year $X.X to for our expenses increased $XX.X attributable increase the in expense was XX, XX, primarily the ended in 'XX. This to by former ended increase million December share-based severance CEO $X.X XXXX. million compensation termination SG&A year to

diluted or for a quarter for $X.XX reported share share $X.XX and per December net ended million We basic diluted a net loss the basic of XX, compared 'XX, income million the million per $XX.X and December XXXX. $X.X impact to in driven fourth quarter of expenses. or of net gross income the of The a primarily XXXX favorable increased R&D revenue from by and the 'XX 'XX the was $XX XX, sales DANYELZA license in net decreased change impact loss to profit ended and

for reported diluted XXXX. and basic XX, per we net net for XXXX, share the December $X.XX XX, diluted million million to $XX.X a of Additionally, a the share loss of year loss and $XX.X December $X.XX or ended basic or ended year compared per

the former the was after of December Net impact net December the onetime also the our contractual impact Voucher. CEO; and loss 'XX, ended in by as $XX XXXX, favorable above, in severance revenues. year XX, ended related sale earnings partially the of Priority noted growing The of from year XX, million DANYELZA gain decrease offset our to a in Review benefits reflects

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

quarter our license fee quarter license burn deposits $XX in national fee, about was the we XXXX note in line includes in when quarter. of fourth pleased banks, our cash hold major and that cash XXXX, reflects to a $X.X 'XX concerns recent of Also, securities the average. that I'm million all burn at the given the excluding received bank. This Our million cash fourth with the the

We fund a quarter the of into commercial programs to support our cash our our as and prioritized operations believe is provides initiatives pipeline current current and first solid XXXX, planned. to sufficient runway currently financial our that position

the No this the are new to to of or product included by analysis quarters, DANYELZA we in the BD each guidance As important year previous runway. 'XX assumptions in 'XX new other understand. revenues for increase noted is this purpose partnerships assumptions. The income are for in assumed of XX% underlying and

refined see could the to hope execute to that DANYELZA for adoption. as We work and deliver to and data commercial years higher potentially to our strategy a growth come physician expanded in indications clinical we greater lead rate

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

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

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

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

Okay.

Okay, end you. this the today's up can At prepared open for for Bo. This questions marks remarks. line the we thank of you, Thank the operator. time,

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

us. Just from couple a

dynamics on maybe how appreciate Could the activated maybe -- in for the around patients of XQ, patients? quarter on you quarter how First, DANYELZA, from dosed a were was treatment centers. Sue. growth the I give at launch sense of commentary us sort many the that that already a the through therapy just initiated of much versus start newly on of base of the

And SciClone of a around of to revenue is get to in out DANYELZA follow-up, maybe expected as a the much prepare China trying opportunity? comments just patients launch? sort and to on what And sense then dynamic follow-up. DANYELZA the add got China, any to of on is And how for Just the a currently. the doing I've

Sure. Thanks, question. the Alec, for

of of existing but is we of there about the about, the growth of quarter-over-quarter. there's asking a accounts I in depth. of the depth quarter. occurring, increased seeing you're a an really cycles and from are also five as patients our trend coming both then seeing have patient five received a number a as patient well we're in customers roughly think And is we're sort breadth the rule good thumb base, new per XX% and a And or of about cycles, of adding terms growth more the

And Obviously, by one of on new rule those specifically I XX% of have that seeing largest, dosed at about the thumb asking outside focus of high-opportunity is But least substantially we of significant are about customers quarter. the Kettering a you're Sloan overall, but MSK the -- the increasing growth customer, remains team’s these five think Kettering. patient accounts. our for Sloan outside most

leader terms on Thomas would team they of defer opinion plan strong key then the think guidance, have excellence. China, I hospitals, a targeting to And I engagement in And the centers about very plan. has revenue there of have good a place. Bo And in They a that. or terms of XX-person in team XX key

over in in Sue. about the China clear can and XX I hospitals, of of thanks, advantage the positive talk of in first can due We XXXX. a think the about half Well, experience China. drug setup hope don't treating very Yes. year of and pediatrics current outpatient the an talk hospitals to we to launch zone in patients that. there pilot last A

it impact So very on will we it ex hope about and excited a sales. are U.S. have significant

just Okay. I growth cash How of terms burn cash and that the any goes into on more, burn in Great. other one appreciate guidance. expectations the if that. assumptions, revenue color guidance? color your though into feeds the there? on DANYELZA's But may, I And what

Yes.

'XX, recently. that 'XX noted, probably the some through you and growth been safe rather just side has conservative be for company the we as So applied 'XX have assumptions what given the on to of going

less spend end is whole what's to well. course, than current we cash $XX more that, guidance in exactly of expect we reflected the million the if a would money. $XX also lot as of to And million selling So up numbers burn

of Capital next Etzer Markets. with the BMO Our line question Darout from comes

SADA. on one First

of platform around thinking the the for and you're isotope of cons selection about SADA opportunities the alpha beta moving the for forward? emitters? some pros you how about consider Just conversations wondering and also And you're when sort thinking partnership of how platform

Yes. Thank you.

current to know the as with is comes construct GDX-SADA that is lutetium, you which all, the So isotope, the linker on, first of the which initial our lutetium-XXX. platform was a from developed

attach modular. different can work The as We isotopes, platform are is well. we and emitters doing alpha on

different of at not are necessarily research, will I other supply at but the lutetium emitters doing we're also think considering happy alpha stick and very be looking forward chain we and alpha as well we alphas, to -- definitely emitters, point, this with actinium. going actinium

And communicated also any out-license strategy targets, taking those and in-house and our on indications then the that SADA third-party keep strategy, optimizing is partnership to larger have we at pediatric constructs subs.

next from comes of with Canaccord the Our line Maughan Bill question Genuity.

So I have questions. two

First is, looking guidance for it at seems of you end above is high the rate, run us which year, can conservative. the current the -- to

So which then guidance in return year beat a in results long don't full to which can scenario growth you describe and term? -- guidance

the for past And then the you has has SADA a it's platform. of from that's months sense that get the it different question is been couple describe was to patient happened just first that past first what kind couple in imminent. been in. expectations? of longer the taken second patient The dosed that And Can on little seems of months

first to our asking know, don't want you -- I your you're was -- if asking guidance? if question we don't Sue, so Bill, reach

XQ, so -- rate you at $XX.X million already if to exceed. No, you're run at a in

hitting like? So paint to you the will exceed, what expectation but trying of guidance I probably picture think the just looks is that

Yes.

we'll to at can time. on And... basis think come our we quarter-on-quarter continue conservative based as be wanted very out think we in I firm conservative, point necessary. conservative. are are clearly monitor up we to fourth quarter, and say and guidance this the and don’t guidance I So But our

a this XX I could those think I rare currently you if I will, are dinutuximab main that ongoing or neuroblastoma dinutuximab add, the -- market in super trials like think pediatric XX is are Thomas, with and constraint, beta. just there If of yes,

think a will. if our there options, small So you patients #X competition, that's and so different have many when such you are I of number

option that people, overstate I numbers with we're is just we the ongoing while a different humanized of that one, So because our biggest that's and parents right I the unknown. think to excellent an think is don't the and probably oncs engaged in small want number option want variable the ped the and different just trials

on Got it. And you. patient the Thank SADA dosing?

Yes.

and internally, the to And never It we patient. is to drug first activate. we So before. been once in you first-in-class also I come humans and good market happy that's this dosed We've been And sites. the are of forward we out news. into to a look we've update I made progress we But takes some what of first kind think and really four come patients opened we've time open with forward the look selective the give trial. think

Tessa Instructions] next from line comes [Operator JPMorgan. the Our of question Romero with

And color the confidence how been data dosed in year? clinical yet? This dosed kind and this gives a patient SADA first is I follow-ups on my been hasn't Phase on Taylor that question would that you you be think do had last expectation there patient you'll I given program some there, was And have to need did would I SADA update? like you show what trial. give the guess, then soon I we've the later would that you wondering, able for of from Tess. be, some still patients more can a be many order the have challenges why to on give any to seems

Yes. you, Taylor. Thank

I think So unusual challenges. we don't any have

due a third-line fact out and I the first it come hold, patient. when once that have lot dosed also they through actually that we good up two think the to I timelines some will the are you this for option. patients we has in when on These update doses open that on limiting we've confident a treatments takes think And do still news our drug patients. screening patients we humans, for time and are first-in-class you that and been been come are of the never

is for of validating the -- are what we looking mechanism Regarding action.

we don't spec we showing do scans cohorts we our third that any you up cohort by to color. at we exciting protein more summer. We do hope on off-target actually by and into believe are And we that the that light time, uptake Day believe this of see tissue that if the then noise. protein the can updates tumor be Phase two and some -- through that will R&D then normal share and So some then on gives will I and be

question next Guggenheim. the Zhu from Our comes Charles line of with

This for Hi. Zhu. you me? Edouard on Can hear is Charles

Yes. Yes, Edouard. ahead. Go

Yes.

Okay.

you're another for? Sorry. color the of about on SADA. you're the screening. aiming Yes, just you're more you the said or -- screening Maybe kind question being -- some on if patients on color Maybe you selective just just patients any how that you're your -- types that failures could of or

-- And patients dose the be follow-up for that Day? in then what need think on as or you'll data, do sort many later to how you dose of a order able levels the to are present imagery just R&D at

Tough questions. Yes.

as that, lot have So to And know. ton a exposed or a as of side are that with effects, I fourth chemotherapy. line said, patients third been comes you of these

first-in-class in need recruiting to don't prescreening. through be we'll I think with get and think challenges we So the and we successful unusual all of I I time. think And you'll see patients always have in dosing necessarily any challenge kinds them echos that's drugs. and

are millicurie milligram speculation. we possible. in see It's hope see what to as millicurie lights for, X.X up. is What therapeutic at patient protein and said second paints the noise we kind as mechanism as have classic and the of to initially something? to and each lutetium is the And on X see plus XXX looking starting which don't validate we I dose the X. protein we before, reach cohort uptake, the order soon imaging We're That's on a tumor milligrams off-target XX X moves the to scan, any a dose something tumor dose and of if would

guess to protein point. the make dose this at hard a it's So qualified on

no there for would further questions. I to point, Thomas over conference this At closing now it seems the turn are remarks. Gad

joining are been for international us. has well. were going Thank And undoubtedly you, of for and us right. ever, a QX everyone, today. quarter very thank higher busy you. than DANYELZA All operations all revenues

operationally. So as we financially well-positioned believe remains well Y-mAbs as

bye. with So spending Have for Bye, time thank day. great you us a today.

Ladies conclude and this does gentlemen, teleconference. today's

You day. may for at disconnect Thank this and your participation, you a wonderful time. have your lines