TGTX - Earnings call transcript Q4 2020

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Operator

Greetings and welcome to the TG Therapeutics Fourth Quarter and Year End 2020 Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Jenna Bosco, Senior Vice President of Corporate Communications. ahead. go Please

Jenna Bosco

and everyone. our I’m Welcome Commercialization discuss for us Officer; Financial Waldman, financial joining fourth Sean Adam update Thank our and Chairman Power, Bosco And and and Officer. morning. Chief results XXXX end Jenna and Michael to Chief a with this business quarter are Weiss, you. Officer; year thanks provide Executive me our the Executive today Chief

commercialization of will our on Weiss, results our the Harbor overview for current overview will an the Sean Waldman corporate a Following call to who efforts an Michael as recent developments programs and an the financial Power our then to begin provide provide our the call over Safe before XXXX. update provide operator Q&A handing to turn of and Adam key goals our session. well brief statement, then over will as on pivotal update

XXXX recent cause most that Form may those found XX-K factors other risk Commission. results the Before make are Therapeutics’ everyone we with and materially operations constitute within begin, I the statements remarks the TG various filings and reform of and risks our indicated. Exchange differ cautions meaning forward-looking for our may private ended forward-looking that XXXX. expectations, about from that these actual our to Factors that prospects statements include act TG of to remind the plans various be that litigation future securities subject XX, would December like affect to that in we Securities year can

statements This any days. the www.tgtherapeutics.com, as to date. any be today should views on audio for or it views of rebroadcast obligation statements. where call for next TG’s forward-looking representing XX website, made not update forward-looking be subsequent this on being conference addition, is will our recorded of revise disclaim upon available call and specifically any only our as relied We as In represent any

Now, Power, over the to to I’d turn Sean like call our CFO.

Sean Power

for joining you, And Thank us. everyone thanks Jenna.

be As investors this aware, media website. can kick position. cash released you financial the our our section on I’ll be with of our things were and results off and may morning viewed

balance of us happy the $XXX the million to sheet with XXXX, cash, over and allowing our more to year investment course strengthened substantially in end cash equivalents We’re securities. than

results. for financial Turning moment to a the

increased items, the fourth seen loss quarter XXXX non-cash Excluding fourth in to compared million the that XXXX. of primarily we’ve The quarter our of for $XX.X approximately loss expenses launch to associated to was XXXX the $XX in of preparations the increase for XXXX. with net million the in is which quarter G&A related of quarter our as first and compared UKONIQ, occurred commercialization

or a Our per was the share non-cash million to GAAP net loss in for fourth of $XX.X XXXX. inclusive per quarter of compared during items comparable million $XX.X net share XXXX, loss of the $X.XX or $X.XX quarter

is non-cash loss $XXX.X the compared primarily net year The loss driven million in increase XXXX, December approximately $XXX.X costs year-over-year as XX, the ended an Our commercialization end. XXXX items excluding previously to million year was in by increase discussed. net for for

to was for expenses for million net R&D December the loss $XXX.X per share loss offset the prior the partially $X.XX net a in $X.XX by was a inclusive of XXXX. $XX we $XXX.X XXXX, XXXX during the end million and items which manufacturing year The GAAP On a in period. licensing incurred milestones front, XX, CNC decrease million compared or compared approximately year as per share ended or of non-cash to

Similar per expectations. to for with probably I approximately XXXX. think what quarter million terms our we in of forward, In is expect XXXX moving $XX line

down. some as R&D to decreases trials see over of the next quarters, expect few our in wind We large

by offset commercialization seen be expenses likely XXXX. over an will in this those increase in However,

Looking and and of will and confirmation of out CLL peak Similarly, in next potential through QX see XXXX, as XXXX, trials therapy pivotal SG&A pick further generation MS. we we up our enrollment launches triple and CLL. hit R&D FL further, MZL with in our study and expenses in back trials, in should our including our growth

without we and over accounting XXXX. Taken to now together Executive Chairman Weiss, will believe for that, our the CEO. out cash current us call Mike I’ll With our into revenues, take turn

Michael Weiss

everyone called you Great. Officer, the now Thank treatment Commercialization leadership zone this helped our with XXXX of first to relapsed a you, Waldman, us reach efforts. shortly start around are organization, Thanks milestone. the an our Adam lymphoma. UKONIQ thank achievement proud follicular made This the commercialization team provide certainly is exciting and for of to off approval transformed approval, along umbralisib, for and morning. With or Chief the for we an company thankful way will are our fully commercial already joining Sean. early we this of of some the Jenna. to who incredible to of medicine, us progress exciting under the And into join color marginal integrated and you, UKONIQ, all to has the accelerated incredibly was recent refractory

us let’s some of special positioned to Before the beyond. that and that accomplishments so. past important an some XXXX I TG hand With over months or working give to XX important team these XXXX to review it the of significant to the I over want to Adam, for milestones. achieve these exciting for want tirelessly for thanks developments I have highlight

received ASH, early both UNITY-CLL of trial, who adult received the well presented at approval accelerated good the First trial. and of granted that with refractory zone marginal At lines for month or UNITY-NHL was outset On prior front, TG. lymphoma we I and one based as of FDA the for at UKONIQ received results the foremost, anti-CDXX therapy have at treatment news of remarks, gets us our adults patients the at or or with relapsed from as lymphoma, December three about least mentioned as relapsed follicular systemic refractory data pivotal prior least regimen as it last prepared these exciting we our

data showed For refractory that zone overall of patients with the relapsed marginal XX.X% lymphoma. and rate refractory or study, rate in UNITY-NHL with monotherapy demonstrated XX.X% patients in response an lymphoma overall relapsed umbralisib or follicular the response

UNITY-CLL, relapsed and we naïve patients For well UX treatment of consistent survival presented data for chemoimmunotherapy improving results of that refractory progression-free the over care were as with CLL. primary CLL, as or endpoint demonstrating achieve standard those

in secondary end was the there addition, a significant response In overall improvement rate, point.

months reported the and patients XX of a also review from the rate UX response in refractory of the other investors marrow. Finally lymphomas. inhibitor. relapsed XXX% B-cell patients at treatment, BTK peripheral undetectable presentations. MRD ASH, undetectable XX bone refractory XX% patients at patients plus take achieving combo the ven from data UX CLL those venetoclax with we look in achieving I CLL, should in of triple Also, who essentially our the the data, with overall of with data TG-XXXX MRD and to also combination study the both XX treatment, we TG-XXXX of patients cycles In blood those in triple of plus UX encourage carefully relapsed completed XX% present another the or in folks do or

XX single UX at milligrams which XX% that dose response TG-XXXX agent in combination the XXX promising. patients level. the the once addition CLL was would In to data, overall looked very plus treated the daily I note

tox of very to So look profile to encourage I clearly the compare would milligram same and inhibitors tolerability active and a safety covalent the agent. that tolerability at also that non-covalent. XXX folks of and the BTK both best dose and

and studies. and our than of our X three studies interesting with were met anticipated a could in ULTIMATE and excited where data, find conference, their reducing exciting you’ll to study. be the X.XXX few after December, results think pretty Also less a ublituximab B-cell it of relapse endpoint we a in forms sclerosis, announce trials significantly the of of we differentiator. potentially that – of all II I I Phase of presented each rate primary relapsing cancer our much top-line two P-value annualized Both days ASH just multiple

in Our relapse was of X.XX that in less achieved rate particular ublituximab both than the interest an studies annualized was arms.

one breaking been any X before barrier, by achieved in as has has Something Phase trial. important KOLs been not that described MS previous an that

you about will RMS, line imagine, excited including top for data analysis, full which and results the are submission, to for BLA midyear. finalize half in to we That which UBLI, first these support As presentation, for secondary very is this hard the and can be used year. targeted we’re safety targeted working is of

KOL positive been the has MS our important opportunity noted supports community feedback an initial confidence from and As that for TG. the is very

our was ibrutinib for and in in able ublituximab treatment with a the in results dedicated published relapsed sclerosis X are commercializing unique with completion in we the in certainly data, commenced final with end was full-time multiple or combination BTK from based team million The patients effects in X with Phase Including long-term a XXXX, our in Lancet our where not we our we year XXX B-cell submission for new the we the finally, trial journal, diseases. CLL, in the first umbralisib umbralisib we PIXK Haematology. addition of high-risk submission strengthened GENUINE of by of plus with ublituximab Society sclerosis to patients or Finally, American last XXXX drugs for of Phase a that’s approximately $XXX combination immunomodulatory this of BLA also vision on in UNITY-CLL mentioned, December, data year. and the of Blood Hematology. are team on which with targeting in patients X CLL, TG’s Advances, of patients was half announced preclinical also year, UX but also rolling this that UKONIQ, stress novel developing positive And least recognized journal results impact refractory Phase TG in CLL members cash journal cash. intolerant Sean to final into high the were And number blood, evaluating to And journals with we were for options describing final the the side, medical prior who ublituximab for the the approximately as of data in the position published publication. multiple inhibitors the the evaluating of

But turn will over organization milestones UKONIQ, and we begin our for Officer, the Waldman, share the both approval UKONIQ, of follicular the Commercialization to marginal to regulatory that which a operator you in some can data last following or be launch and paved excited the way Chief lymphoma. of segue, the Adam? to zone session. year, see, starting XXXX, thoughts on our refractory impactful Adam with I’m is As was to Q&A achieved month where relapsed the XXXX in rich a call grew driven

Adam Waldman

us joining to of share the fourth high-level the progress launch morning. for UKONIQ everyone any accomplishments today. our thanks seeing close highlight of quarter, And the occurred provide this I’m will insights Because in far. into Mike. report Instead, what we on qualitative metrics will Thanks, sales the Yes. launch. some and the we I approval highlights excited some were not so after

As patient before their PDUFA with and to designed dates. reimbursement February zone Mike the prepared reminder, extremely TG patients marginal through approval up than lymphoma, and our support process. marketing and were both more date, digital patient is anticipated we the launched in for journey support mentioned, the refractory of were the lymphoma than hours distribution of and happened accelerated ukoniq.com, comprehensive UKONIQ we four and is And on and fully which even program a TG months receive earlier support X, treatment of to we follicular the relapsed was approval, pleased program a This PDUFA campaigns initiated running. to especially, materials approval, follicular launch. our in ahead their Within

customers teams on Our label trained medical, pre-approval one. day access with started on engaging were and field marketing sales, fully and UKONIQ’s across

We had mid-levels, with interactions and launch. positive since very pharmacists since have nurses, physicians, administrators,

standard excited and option first-line our with profile, discontinuations, modifications of have and and care of follicular lack the treatment a for diseases across tolerability marginal Customers have box had have overwhelmingly consistent after lymphoma. safety and with treatment. good is to low there rates a initial UKONIQ unique access dose accounts in black patients both been We efficacy of the which mechanism warning, action, the zone positive. reception to of to are target impressed no these new Many has been simple

conducted several UKONIQ We multiple key trained the help and speaker oncology the community programs educate speakers on regional I’ve expert community already have to within and networks. national

weather about the the We marginal for and for advocacy our moving We this within specialty now in been have closely lymphoma channel we patient the new also educating unprecedented States patients available thank committed excited are working Central approval remain of are pharmacy and the partners the forward. Southern Despite being they zone over and our about to XPL follicular and with treatment supporting who Drug left month, community is community facility them than week distributors been and of in have the approval. UKONIQ specialty prescriptions the through all and do fully UKONIQ processed. past United option. our one

or coverage along Our on market very see productive our with formulary its so added remain broad been the to our to guidelines and patients, meeting far FDA is lymphoma. of that compendium UKONIQ and for is also network adoption access a are have to pleased the and conversations Within team practice medical UKONIQ. comprehensive we national payers and marginal these label clinical with has with provides forward the follicular additional confident days team NCCN zone This been approval, we payers of for and achieve support to placed positive UKONIQ. step actively available the cancer to for UKONIQ the will that both ensure

start. we operator approval, will everyone over thus launch days, the to strong your early session. And commercial While we the I And this turn very begin far to time a to is you believe the morning. question-and-answer conference thank are the off for with the post-FDA call that, in very

Operator

with first Cantor [Operator will the proceed Thank question a with you. Young of we Instructions] conducting Please line At Alethia time, question. question-and-answer this Fitzgerald. from comes be Your your session.

Alethia Young

but been out talk bit Mike. more guys. over can said it play another way it, XXXX. I you questions. the sounds kind a progress two – Hey, really did One, just It [ph] flavor have is is for of if Congrats really How then of know, I multiple there little profile in around a is combinations. you because other are the maybe But little give Thanks. kind older totality, guys open-minded a was the bit or with or you And another like the little, just just a about the that around us market it that of the sclerosis maybe PPMS there. second question starting in that sense do that Is about some kind like kind evolving? safety well little of label UKONIQ maybe indication timelines the you might’ve on PIX it – launch. provide. the kinases. quite are thinking it’s studies, people of going UX more – in talk more with just because hesitant, how it And

Adam Waldman

Mike, me Hey, the want one? you to with first start

Michael Weiss

Go please. ahead, Adam. Yes,

Adam Waldman

the differentiated delta expecting the both with well CKX-epsilon from Yes. but as obviously, the are was Alethia That’s what different of overhang class. UKONIQ action from knew there a as seeing seen being Yes, what Thanks, specific we inhibition, is is as far mechanism standpoint safety that we’re – for class, okay. an the that Thanks. Yes. so we amongst the it to is distinctly and profile, physicians question. with

we’ve in the as we’ve is the and market from far physicians seen research what with so thought consistent very what So that’s well. we in seen feedback what the

Michael Weiss

on have the MS decision front, made we at say, And looking on we not we there. autoimmune are But want study I’d to and designs address how PPMS. a

some other at And before switch keep study studies indications. we’ll evaluate also to posted. our to continuing target looking We’re least for say, year designs from ubli. additional [indiscernible] have we’re study you end. is to at And open I’d one

Alethia Young

Great. you. Thank

Operator

Please proceed Song Your comes question. of from next Roger line with with question the your Jefferies.

Roger Song

to you. positive and But we signal. to us? progress. see zone, kind the for launch, next the moving of like, and you metrics for launch Congrats to what so the is since quarters, few pretty the on expecting question marginal for one Adam, some forward, Thank early tonight Great. Maybe this follicular UKONIQ update will

Michael Weiss

Yes, thanks for question. the

So in net on obviously calls, we’ll report future revenue.

how with demonstrate this, I and provided, and some our we’ll metrics engagement I and customer do addition, I course we maybe and the our In customer still appropriate. reimbursement. accounts just feedback and payer quality hopefully, we customer we’re to guess, don’t, maybe far, execution but of on going look work and question. – coverage market progress of we’ll sharing we’re it said, targeted but plan as your progress see through performance, examples working so that and answers but examples qualitative insights insights both but continue like to quantitative plan I exactly on where strategy That’s and performance at with metrics to and and

Roger Song

Yes. Helpful. Thank you.

question. that Alethia’s Okay. be Mike. Adam question the on may follow we’ll or And next We just hand understand for

have and ramp some you from your And differentiation For up, doctors. for during the quick just of already with. the the we part Because clinical class, ramp because expectations dock the but since from the feedback this community you studies. of the earlier expecting you’re know have seen PIXK kind the talking lots of been curious sales physician UKONIQ up, enthusiasm used UNITY-NHL

Michael Weiss

and a Adam. from on the to patient could add But ramps but… start the in into zone expecting Yes. when start on we’re I starts the with give take I we that, mean, play that, with very think to answer, I into top and go assume be ramp could CLL. – we overnight in want of I jump but But engagement don’t people you it you I quite the different so to want of a to with you corporate us we’re add think for early we’re with. mean, think can a still that indications obviously want going Street, tempered top great sit – thing I my are are communications I’ll dealing I Adam marginal to and think answer, approach. really positive. cautious follicular. relatively looks marginal is rapidly. small I may populations mean, really launching I as we still Adam, where follicular to

Adam Waldman

Yes, physicians enthusiastic on mean, I who about safety. reaction are the we’re differentiated from MOA profile – as I agree. and I seeing on mentioned, a definitely

we want get good. So of to that’s ourselves. don’t But ahead

just I – mentioned, patient these is are It this COVID much indolent think patients but urgency are I agree how patient and dealing have as Mike with as still disease small and and the relatively see come there’s an acute with and But it we said. populations. is Mike also in paced not we’ll will that with it be what goes. will to watch diseases and

Roger Song

the that’s Adam. have Yes, Mike good and Thank in again. yes, around – it. to Got me. color it expectation. so Congrats some you, from That’s

Michael Weiss

Great. Thanks, Roger.

Operator

next comes proceed the from with your Eric JPMorgan. question Your line question. Joseph of with Please

Unidentified Analyst

Rahul for for Hi, good is Eric. on morning. questions. taking the This Thanks

from Just us.

the Firstly, physicians more to can about versus And dynamic readout earliest readouts you anticipated of the PFS? how safety from in with mature, duration Calkins trial? secondly, comparative Calkins. of a UX we talk Should data of what’s like, or the response competitive expect end top about response And ULTRA-V profile rates relative the we view Imbruvica. think should something

Michael Weiss

Sure.

a take I’ll crack one and first I and Adam question crack chime second in. at So the the

again, a and versus some we’re is sort my has are So that about believe impression ibrutinib. ibrutinib, marginally of But the over better aren’t it’s profile toxicity Calkins Calkins drugs folks third who ours. that tolerability hand, where talking there

Calkins, an ibrutinib same inhibitors overall think have to grown to of in in we I blood. over patients is seen patients that off issue them check XX% of cleaner market will We’ve terms tolerant on I But ibrutinib in profile mentioned those with will another CLL, in that of that were of but that patients who the much go for be seeking numbers. study BTK was intolerant, terms think data in they and in the published a double ibrutinib have continue continue choice. leader showed we’ve was ibrutinib therapy of coming of intolerance did had

are So half about separate associated with I right? bleeding whereas toxicity also general and not going UX think, fit associated bruising profile, the issues. is So issue is see from with again, in, to Calkins, ibrutinib the still you’re they whatever patients with

contraindicated the the patients and/or patient see about, bleeding You’re of that percentage they risk. has risks cardiovascular be and worried need and drug-drug have to or interactions all have to with ibrutinib. still cardiovascular patients both particularly, several which pre-existing of of lots AFib And going with folks antifungals, Calkins are conditions they on if are some

who who So provides off tolerability have come either nicely and door really walk have really the issues single-arm I’ve in seen inhibitor UX doesn’t fits UX get trial. BTK respect – patients the a issues in of With some into or study opportunity for believe treatment a issues. a and in mentioned patients the patients the I’ve to we a data nice, is ULTRA-V, have that option to those that for

of for metrics over which the the duration That’s the duration we So overall trial, ORR important data. data course study important for disease, but the for and response residual in think, response, very not question be up this only survival. follow endpoints single-arm typically to is and of primary work I survival most the rates believe endpoints, of or patients, for But of early time and high response. how minimal is studies undetectable I remarkably or overall continues for also, CR well this

been undetectable undetectable that Again, XX X we MRD to in with as have months the mentioned blood So in presented showed a patients who other bone where XX% XX prepared rates XXX% completed the believe date. and overall of marrow. Ven relapsed reported I from MRD those Phase XX it’s UX thus remarks, had the therapies, therapy, that in patients, in were program response far. the rate only Relative XX% patients best to we undetectable the are

from endpoint to Hopefully patients be fulfill anywhere Phase that the trial then The once is that looking ahead the with the in usable that helps, that’s this we’ve would next a Rahul? room we PFS same get on a could those to XX look the will XXX to that complete will of metrics. to into that a open. But report of little So potentially portion, X approval. step the enrollment have will we portion for got we be program grow year, by end plan. we for X And Phase have

Unidentified Analyst

Thank you.

Operator

Ed question Please the White with HC Your of comes next line from your from Wainwright. question. proceed

Ed White

Good And taking for thanks morning, everyone. question. my

the mentioned priority CLL can get UX in just had earlier on XXXX. on wondering CLL Sean launch just your and thoughts XXXX. pricing. launches if your I get And CLL So potential that’s review, possible I MS to on we in think, for I’m also then submission, in if a wanted thoughts of

Michael Weiss

Yes.

that So fully do a receive we’ll a one right do we’re review, entitle we have puts prior on we think that hopeful toward Fast track to review. it Track doesn’t us designation, which but review, the priority priority

So UX we’ll and certainly of would competitive I able pricing And in priced priority – we’re be second anticipate we forward asking for the strategically be available. be be pushing versus would question think, terms that other to potential doublets review. that and for pricing, asking UX are

sense, pieces when versus point So nice ublituximab. competitive able the using be and really But right that to ideally strategically soon in out location a price we will discounts for some a make CLL. two now, that out are puts there umbralisib in us other put a at we have some price we’ll together doublets whatever price put

Ed White

on Thanks, just pricing. again, of launch, And MS question Mike. a thinking

it And in launching to going fit the about well. be launch in we treatment the and today, in oncology where’s is paradigm How there? to you’re MS. it pricing fit going So we’ll knowing MS changing the data in where thinking an should that also as

Michael Weiss

Yes.

and of move question back to start the that. second pricing part the I’ll with that after So

point, disease belief earlier the data disease think of the the that’s CDXXs of our we other haven’t to excited treatment halting and gets marketplace are CDXX seen this we’re in algorithm. is process. moved – participants progression thinking at So in of the diseases of of We belief people the interesting of look, about activity see measure the kind kind be but meta that, these I some going are earlier yet, sort and think evidence it no to our of and the and

CDXX and can continue data fact the our on that other you opportunity. CDXXs from really data that the That’s exciting process. support get you arrest assuming a So the them an disease if to early,

within think we and class so And positioning of again, our that moving the earlier, three be CDXXs. we’ll

believe CDXXs be largest we class So treatment has three. think a within MS of And that important class very of we that ublituximab options. will the position

convenient and MS patients As we’ve hour we of noted six fits physicians every within a very is infusion to with the and at one who their them six getting like practice every previously, a least in the and one months see think that months convenient really quite move hour good and more it’s physicians. is patients ability patient the the infusion is centers, to at premium. more which infusion a for And both the quite the for in always out handle and capacity,

to us pricing And pricing will to And team, the to We’re best now, right stands rate within as opportunity things be continue our date, way certainly We’ve – the to I’ll strategically now share. market to table but we help believe lever that relapse for what share also ublituximab on results. obviously market that’s data certainly annualized is we is going a into continued bring that goal is the our it head we – in believe try we to the gain aspect. have we optimize and think the will continue do to every based maintain the that largest to market that marketing for we we MS.

Ed White

taking for my Mike. Thanks questions, Great.

Michael Weiss

you. Thank Ed. Sure,

Operator

question comes Please proceed with Kaplan Thalmann. question. next line Ladenburg from of your Your with Matt the

Matt Kaplan

follow-up, for remitting, guess, – of guess, for guess, incorporating the zone lack for question. more unique relapse thinking protocols and I thanks marginal remitting I guys and now. about morning, doctors, are given into How their Good and maybe guess, regimens UKONIQ. it Hi. for Adam. the the safety and relapsed/refractory of I profile taking a not for I follicular treatment patients black sorry, relapse warning box

Adam Waldman

patient it In to profile it. see that. with to a And Obviously, it tolerability to you least where are it’s is they in liked profile. of being the setting, other to follicular But as they mean, right used very, after Docs population play talking talk very treating physicians at the such therapy. think we remains as we’re very order in the indolent first-line with have there, role and see convenience indications, is data been I patients in said seen. initially this but and impressed is continue and zone. a they be option. liked and The what about Yes. approved And in critical what top a physicians physicians there and approved exactly in few for that’s diseases, zone still follicular the fact a agents the as option relapse marginal an marginal appropriate about. mind certainly being

Matt Kaplan

That’s Okay. the profile some some far at tolerability detail you current terms Mike, ASH What of XXXX. that BTK data you from for are that terms inhibitors in market, so and you inhibitors mentioned seeing presented went you on for And helpful. in of XXXX differentiates think it BTK available? the into was current the

Michael Weiss

Yes.

bleeding my off low knowledge, as The come dose the bruising have good. thus – remarkably and AEs we for need the is call XXXX, for – you is probably They’re BTK think drug thus some dose it’s interest any I it a it So, far. But on with milligram And the is more toxicities. far. early quite looks – duration data, levels inhibitors. no what there. low quite I the look across, but XXX drug-related to patients start Obviously, risk bleeding and risk

agents. encourage we’re we profile in we’ll I I quite the for to looking update said, versus look. like more. data right emerging, close as the it’s of But range Again, folks get and think think I do established the XX% a now that to take I good XX%

with profile there’s plus looking think an safety what’s not good, profile that’s quite activity attractive. So better than potentially if emerging out a as there, I

Matt Kaplan

want Okay. Thanks. And Sean out. last question, don’t leave to

that were in in on that mentioned What you You $XX there million about radar? your milestone payments for are XXXX milestone out see payments XXXX. the

Sean Power

Thanks Matt. for including Appreciate me, it.

have first some umbralisib year. the of obviously the – quarter will here approval some associated we ublituximab approval the milestones So in potentially later with associated in of and with the

line with what qualitatively, fully haven’t we take those would like. So disclosed look XXXX. I But in

Matt Kaplan

questions. taking for progress the on thanks Congrats Great. guys. And

Operator

Your the your of from [Operator Securities. next question. B. question Mamtani proceed Instructions] Mayank with line Please Riley comes with

Mayank Mamtani

the our taking do mind for progress. thanks I congrats questions and being on

relative So step BMO the risk umbralisib category, and the on think is then assessment to as does how it kind efficacy matter what on of follicular identical secular that category label? have profile what but Adam, that? have the tolerability like How maybe of you risk have they benefit with on for led less, regulators on the different the you in had benefit you side, taking Or community a more you just which that granted think that do about do think that just back maybe NCCN to superior. about the been kind label, the variable, or

Adam Waldman

so you. follicular both the category. And zone. in a part largely the thank label. question. is marginal and Mike, first And it yes, is NCCN Great the Yes. XA Category It’s to

a as it well compelling is as think their see physicians what option tolerated for So risk I to it’s then very profile, XA lymphoma. indolent far a now as hearing Category your see patients as a they I answer this effective in we’re right question. in benefit And very really both I And the diseases. mean, option and think

of they’ve As would inhibitors does PIXK what I that’s lack expect, something box popup warning distinct black it’s the mentioned, they what differentiating. as from from seen or the other

very see these for I treatment good And that risk the a profile paradigm so well fits very specific into think patients. they benefit

Mayank Mamtani

number volume, then – and switching of OCREVUS starting merge are to any see MS, And processing to Great. lot any qualitative early have ublituximab treat could but guys do have? from you MS for perspective be the needed out on it’s guys you kind to I number have the treat. gets of what you the data know so that you done data say we’re you Do and for the to a MD numbers that on

Adam Waldman

Mayank, heard know question. I you don’t Sorry, the Mike, didn’t I the hear – if

Michael Weiss

think Mayank, probably to question, you’re that the It could was, see and I projections I what me is the of think – we’re expect ublituximab? seen we I to on some we patients of consumption too early as numbers see yes, asking Yes. for think Adam numbers the say, we’ve

Mayank Mamtani

of for number and do that data that we done needed across yet, reported the the could the kind know CDXX. it’s have you that sorry there guys different do the reimbursement? treat some important risk you And other that could the Actually, comparing CDXX, with when to to for NMD relative analysis reduction. I it

Michael Weiss

and them or that this that Yes. as we process at looked I’m not Jamie Adam, point, at aware of in the did yet her team maybe they’re looking at?

Sean Power

Yes. No, not yet.

We’re posted now. right that on keep in you that doing the one. of midst We’ll

Mayank Mamtani

And but some much could you’ve Thank on recent pipeline your in then pipeline, done activity stage just you. provide can on seen get question inhibitor, there? you’ve Mike, that conferences could the updates, any in. have I IRAKX analysis you obviously interesting believe the about recent of earlier that anything one these

Michael Weiss

Yes.

evaluate that the tox now concerned for we’re on looking new and Originally, and board letting in look, but have preclinical we’re them the right agent, folks about it. were look compound. that taking at some at process profile another we we So the of

new We’re understandings. doing some

ready. going it’s tests preclinical Otherwise do near the We’re some IND new to on compound.

new right our with So on folks at other a board. if the team, including O’connor scientific this look taking Dr. now

take with data So forward if comfortable ready with forward, determination some we can a they’re IND is they’ll to what a eyes about compound, and but fresh thinking close and reasonably move make pretty feel they and quickly. moving look the fresh it

Mayank Mamtani

taking for Thanks team. my Great. question

Michael Weiss

You got it.

Operator

the and of the back Michael I’d And to Ladies like Mr. Weiss have reached the gentlemen, closing remarks. session. for we call end turn question-and-answer to

Michael Weiss

everybody. thanks Thank Great. again, you. And

reviewing again today’s So I’d just the and up key call once objectives. to like upcoming goals wrap

of commercialization of list, So UKONIQ, the umbralisib of relapsed/refractory, top the the our at course zone continuing is of in follicular. and execution marginal

both Application, its the patients CLL. complete ublituximab including to Biologics combination with going We’re will with in patients that relapsed/refractory of rolling BLA License be treatment the for untreated, the and naive previously treatment the to submission hard CLL of work

simple evaluating for we final be from submitting look label that associated to in in a year. for Phase to forward results targeted ULTIMATE very II the CLL Ublituximab a will BLA seeking with of of present & this middle the I We and So that application. we X the RMS with trials, treatment plan ubli in RMS

the that available plus on again during Venetoclax. will first some our year. have to hopefully continue year, of And We’ve we that some from mentioned to antibody. looking presenting got by TG-XXXX, to we’re inhibitor in course more plan compounds course, our were We’re pre-clinical TG-XXXX of present year the of pipeline candidates on later early our BTK which updated date TG-XXXX. bi-specific data Q&A. the data the CDXX And in is the TG-XXXX, the CDXX, end, going our advance And TG-XXXX, we’ll at UX potentially then our

shape the but approvals pipeline. an the perspective, both up to as year, So coming be from registration as new exciting could commercial also from potential launch well filings, follow-up compounds through

trust to in of thank us all joining our patients, our for their and employees participate course, that’s as for Thanks have well of TG. as I’d and who a their like everyone and great continued again, our and shareholders investigators us, So trials day. support.

Operator

This concludes today’s conference.

disconnect may time. this you participation. Thank your You for your lines at

TG Therapeutics (TGTX) 2 Mar 212020 Q4 Earnings call transcript