TGTX - Earnings call transcript Q2 2021

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Operator

Greetings. Welcome to TG Therapeutics Second Quarter 2021 Earnings Call and Business Update. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note this conference is being recorded. will Vice the President, I Jenna over time, Senior Bosco, Corporate this now conference turn to At Communications. Jenna, you may now begin.

Jenna Bosco

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

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

that operations and SEC statements and Private milestones, to in our cautions on XX-Q. various forward-looking Before found Reform that include reports Therapeutics' and plans remind including I'd our development results pipeline products. be These risk XX-K TG may be statements risks are factors forward-looking operating our everyone including to can statements our cause differ from the projected include these may most those TG that performance, Forms sales for affect of performance, will subject clinical and meaning materially statements that that to actual our filings, about forward-looking recent marketed we indicated. anticipated like Securities of expectations the XXXX. future we making financial Act begin, regulatory Litigation within Factors

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

would call to Mike to CEO. turn like Now, I over Weiss, the our

Mike Weiss

you, thank us for everyone today. thanks joining Jenna, Great, and

of first vision long-term -- into XXXX, focus our goals have half investors. hope and really the TG for we that for TG During come

strategy UKONIQ, Our only the the first zone our lymphoma. dual CKX-epsilon with relapsed phase marginal refractory of follicular and of of of PIXK-delta complete accelerated multi-phase first the lymphoma and approval the and inhibitor treatment or for now

for of patients received submitted refer novel estimate UKONIQ an therapies who we combination application our We treatment BLA and the the our are target patients treatment and momentum PDUFA Building the options. in a we excellent with our a for which prior anti-CDXX MZL commercial will for point each starting the March ublituximab see limited UX goal efforts. as combination we treatment be approvals have patients requesting for lymphocytic our of of very as UKONIQ launch, have accelerated plus seeking on date XXXX of antibody, to which failed of proud approved from have indications, and these monoclonal leukemia. glycoengineered We of approximately follicular chronic X,XXX XX, year approval

same Application, We supplemental submitted same PDUFA sNDA the and have indication Drug a received for also date UKONIQ the New for sNDA. for the

a prescribers our would treatment Not XX% zone to population we than patients, population not patient than we be each especially that combination to are bring lymphoma follicular, will for our and who that CLL CLL important chronic XX,XXX follicular. is estimate potential patient longer marginal year will novel but indication. duration a is will We approximately of proposed of be in the in current for seeking to the expect CLL be is currently larger that targeting of failed to only good patients and larger CLL that other new have significantly XX,XXX CLL about excited well. to prescribers are or multifold standards our believe factor as care. [ph] zone One those are We median who UX we marginal lymphocytic target be treatment and marginal for follicular lymphoma leukemia. -- same targeting note the that lymphoma candidates

should the translate building CLL efforts relationships our marginal potential and follicular significant in team has for made launch. nicely our So the zone into launch

in our population as forms we MS largest ublituximab relapsing the is a will with with single addressing, up agent. multi-phased patient Next of patients approach be is which

participate then next and targeting for a three the third and MS. and to will become data are X core of execution these target commercial market to focus MS. receive of is for attractive then expect opportunities, as Phase for $XX treatment our market regulatory one the per in the antibodies option and But a be relapsing we to MS antibodies the quarter Entering billion an treatment larger in also projected monoclonal of the $XX of will of anti-CDXX what date molecule raise year. a opportunities billion supports first hope BLA just with only CLL forms year three We We especially a patients anti-CDXX on quarter as submission MS PDUFA significantly commercial of believe to profile in MS. this our

combine hope TG-XXXX. indications to bring the into and combination follicular uses also continue should in example, to in The patients marginal outcomes of UX care to broadening to UX and and UX enhance new to will zone and combination better will standard potential also of potential our Hematology in in penetration broaden for the agents Oncology with CLL. of we new CLL, with lymphoma our venetoclax and own seek such by very label ability as CLL, We franchise

provide our our launch key that, On efforts with recent we build other well commercial MS. potentially some me programs. build UKONIQ the MS related in to diseases, and and seek let as to to regulatory side, as ublituximab programs efforts in auto-inflammatory on development will highlights seek additional With initial

let treatment marginal with and adult of the restate received and prior who the which at follicular based that of least First, patients zone lymphoma therapy. trial, anti-CDXX or with regimen, patients received Oncology. or of lymphoma for in UKONIQ of refractory remind just have on Clinical me for approval have from results at who FDA February, three relapsed the published primarily the adult systemic lines granted UNITY prior approval everyone in one Journal least accelerated refractory based NHL This were recently was the relapsed

extremely commercialization Launching efforts available performance the both I during with the to a overall, early approval, but On following a weeks approval positioning to pandemic for the launch thus can success steal Adam us join some the far. of became and shortly well of side, and want is some Adam again date. in I sit, our Waldman. done year. commercial and the I potential don't a but few metrics team task, is really Commercialization no where will commercially is we from global easy UKONIQ are under say the give his CLL job target circumstances, qualitative prescribers, thunder, Officer, to the UX level nice going us discuss engaging the leadership future high and of launch Chief next under educationally commercially with for the of believe launch pleased assessments has

above, CLL UX noted both which, a BLA of and for date been have the goal XXXX. PDUFA of as and in March Speaking sNDA XX, granted target

major X II in For ULTIMATE Phase Program, of results American positive pleased quarter Academy in I forms Meeting to and Academy the our the the be Meeting. MS able were to we two relapsing of of ublituximab trials at Annual conferences, and from Annual the Neurology second the MS Neurology European present evaluating

and and every infusion, first feedback low months potential endpoint ublituximab as following one-hour reduction have ULTRA-V growth. to call, treatment hope their in into referred ULTRA-V within a demonstrating be benefit believe showcase an will As their these results portion The patients met treat important with a levels of of RMS we especially viewed We future which to of trial. were of are been protocol and earlier special venetoclax, with relapse trials under in to These positive, ublituximab with very encouraging ARR. track ublituximab to I study treatment X primary treatment mentioned drivers forward programs far assessment to dose. the briefly our to both quarter. enrollment efficacious as now year. on during I annualized has a provide UX FDA ublituximab significant the are our with to and infusion for X six studies this CLL in highly the And conducted with our we moved for thus physicians resulting the one-hour plus this Starting completed ARR. combination and rate that's before the received for expert Adam, Phase has last both statistically we Phase The provide patients. BLA quick update an call submission want a over historically the option complete turn pipeline that

UX December, undetectable patients achieved Paul X rate in fixed therapy. Barr response of data look through of and complete there You the bone may to MRD his treatment. trial those view XX greater results duration presented cycles from updated plus presenting the marrow. than patients, this to double recall Dr. approximately in XX% the Wilmot of with forward included Center these first the Cancer Phase encouraging overall last from this the Phase the X as XX at results later cycles patients the patients XX of York combination, year number Rochester, that ASH was We of and we highly XXX% study results in preliminary study the in venetoclax which New from of In

with in treated and UX discuss were month EHA to trial TG-XXXX, encouraging with results that clinical our a as present to summer the a Oncology with to let's Phase updated during be patients continued We tolerable were We the TG-XXXX, Next, additional appears safety pleased monotherapy profile. BTK pleased combination from show paired including of see to it Meetings, activity and X inhibitor. ASCO, ICML. what TG-XXXX investigational last with

early commercialization of as stages are the the been TG-XXXX earlier, CDXX, view we of testing I these through CDXX Both as and to we and to a expand made into as on to as later we've of bispecific XXXX and our has Further As enhance fronts very the with both busy antibody early are to an antibody With TG-XXXX in year Waldman next. or us excited possibility therapy XXXX the and the regulatory cosibelimab. forward our efforts of utility to way triple to pipeline our to look strive the clinical trials commercialization a impactful efforts. year call end in Officer, this for some data moving Commercialization that, our of treatment clinical our CLL. over mentioned Adam? year Adam turn or as significant progress into and to I'm referred referred UX highlights share CLL MS. PD-LX Chief from

Adam Waldman

Thanks, full very the commercial Yes. a update I'm Mike. to excited provide UKONIQ quarter for of the first launch. And

qualitative then some and Let with numbers provide me start some assessment.

As of sales. release, which you've the quarter, in in UKONIQ net already second first million sales was press the $X.X we quarter achieved seen our for financial in full

quite In great our with extent labeled is projections. our by in our estimates, of ahead a is new indication. were we to which of our internal While X% pleased point capturing that patient reflects of launch the starts that X% view, UKONIQ starting penetration, our

in the their UKONIQ to by Part Part program through patient patients net D for sales significant. as our due doesn't out-of-pocket provided assistance of very to capture quarter are high the UKONIQ has past benefit and Importantly, the Medicare design. D figure our of Many patients this demand amount our costs covered been fully free are total

is in the v the dynamic the products. support This receive unfortunately, current high unlike second [ph] with their a to charge is to you sense patients give the quarter. free we assistance of provided out-of-pocket patient UKONIQ of available this free through CLL patients XX% our and addition, systems lack costs of the follicular offered, of financial a leading extent In marginal To zone percentage there program of at general patients to of bottles over to free product qualifying time.

of products As to we said proud we providing UKONIQ over we free be to to able and and are need our are by have over, patients those access in help committed the charge. the When of at demand, volume when for includes pleased UKONIQ. look volume the we by are overall products, which our -- we free at we uptake look extremely early helping

early $XX.X pace early build $X.X before, as to our expect access currently date, UX net PDUFA step goal CLL for believe next XXXX sales we accounts, MS on of the revenues trends as refractory and of net which PDUFA it. achieving in a for for in Based the similar sales. we've relapsed year As year a towards And is towards our ensuring million would prescribers see million a we and for initial allowing on to UKONIQ the have XX our assumptions, with of a this goal the by achieving million of hope puts those line with targeting stated support front patients both and positive and are experience who to which sales free XXXX patient potential between $XX date many $X we net launch launch and for billion the third we full have ublituximab sales from with us strong for are rate to in $XX remainder contribution further, get goal. corporate to for afford to targeting assuming XXXX growth and nice current in March to year for a these XXXX UX that goods CLL assuming of we all XXXX the UKONIQ be and quarter approval of wide million small in cannot we partial

Now, beyond let additional numbers. some the me provide color

into While significant and launch, with are our believe still date. execution we early made our have it progress is pleased to we

initial our been that we these eligible In these higher our well, many large percentage is and indications. of focus in accounts, seeing vast of approximately Our targeted utilization adoption in have which are and as our we we are are of we pleased within also community the view that and occurred profile therapy volume of representing job toxicities we the the clinical appropriate. on base and fantastic potential patients. a the the What growing still navigating build repeat of the as clinicians and patients early, doing sign. clinical view accounts both of centers supporting experience cases, from and team accounts, expanding educating for strategy we has with which fact, providers initial were prescriber has seen in most a in the with effectively prescribing This reflection confidence our initial seeing on positive X,XXX UKONIQ X,XXX hematologists are where keeping coming evolved is safely as And trials. patients majority is approximately oncologists a that although rates comfort managing and a refill the see academic that the

very recent intent marginal receive treatment UKONIQ strong our clinical show teams a how refractory When it healthcare We show -- patients. physicians appropriate to relapsed is follicular profile zone and continue and having differentiated recall, they have our see a engaged view as valuable performance, Insights have target for our providers, prescribe product on and feedback the to patients. both option message from once profile. studies product importantly perceptions tracking UKONIQ favorable launch

recovered you relates caused Marginal to -- engagements some persisted our did access our small to access One remains the throughout increasing trend with they populations other COVID although the given and decrease all most trends a related our patients labeled the patients the onset certain Most a year. And within is the been in we of Board. it delta have targeted re-institute the of engagements, back across impressive offices restrictions flow make pandemic, quite since increasing [ph] in in-person patient But weeks oncology may have as an visit even indications improve patient a have our that starts to in and trends to coming recent and once reducing percentage important customers these the that have reticent ability fall to to gaining related know, numbers COVID, continues of see believe begin COVID These initial treatment the the restrictions follicular, appears visits relatively most the pandemic behind elderly not uptake challenge. of modestly are variant this these affecting opportunities zone issue with, potentially only the our institutions an and have situation an our accounts. few patient However, lymphoma and be well of in in-person quarter, bode during for patient physicians essentially to us. and months. to yet. visitor and for visits. more are pre-pandemic we

an have and been Another quickly. More team payor have here, our a of The date. lives positive challenge than they Medicare UKONIQ has is coverage commercial to job NCCN compendia. note been broad confirmed label or has to done not XX% able very of that achieve exceptional coverage coverage to

strong We a every each their experience to TG provider from provider we experience eligible that appropriate believe with support patient positive a healthcare When they're positive are have the more the and has for additional the with in and patient patients making to future. committed prescribe UKONIQ sure providers, a educational healthcare UKONIQ. healthcare that and UKONIQ and likely with and [ph] access TG team,

We will of patients, CLL their also assuming this that UX. approval carry to through believe

As we base we're of within doing and estimate target this roughly in of launch. reinforcing XX% providers the across Mike establishing our mentioned, an there's what with footprint healthcare our lymphoma CLL importance overlap

hand that, here. it to much you I'd And I'd thank very for to like over Power. with like So being Sean to

Sean Power

we can and our Thank detailed us. be our thanks joining Earlier quarter which of section you, on financial viewed Media reported second the Adam. XXXX for Investors this And website. everyone morning, results, again corporate

$XXX approximately be XXXX. sufficient million we cash few brief my and cash call, on quarter touch which us the take We securities, highlights into believe our with and to I'll in from beginning quarter, investment position. the with remarks equivalents a will For today's second keep ended cash,

net the first to in revenue million of pleased quarter, are $X.X UKONIQ sales. we earlier, of product second noted report product quarter full Adam As our

non-cash decrease quarter-over-quarter $XX which approximately $XX saw for net a of from million Our was a excluding million, loss XXXX, QX non-cash the of million. of where quarter XXXX items second $XX items we excluding was net approximately loss, of

this of QX as quarter. that more this commercial entity, Given we what saw fully quarter probably to was first our year it's comparison a apples-to-apples

As saw XXXX of milestone primarily to in of one-time this is this approximately increased selling, million that of driven If of launch approximately and the administrative payments non-cash potential the and UX to million recurring general $XX a associated quarter approximately and increase ublituximab primarily items XXXX, first future of UKONIQ QX shift in excluding $XX QX $XX of for year. compared RMS. launches CLL decrease of and related licensing by the to of compare quarter we net where million, the we loss, expenses with planning was in

per net call for quarter of loss Our or to share $XX.X $X.XX inclusive of during a the that, XXXX operator Q&A. quarter compared loss million items GAAP will or non-cash of the turn share $X.XX back begin conference $XX.X per the million was to I the over With now to net second in XXXX. comparable the

Operator

And Fitzgerald. Alethia Cantor of Thank question proceed Please Young the with Instructions] from question. you. line first [Operator our is with your

Alethia Young

like color start indications? question like how profile some it might super Hey One, a still you around as kind the progress I just heme couple were experience. on guys, safety, X,XXX especially Delta there. far between about -- was COVID you bit the framework ebbed has then, that provide to little like, wanted slow congrats bit of as sales, like multiple might but early it penetration kind any know color billion a the the Thanks. the [ph] flowed and little to just have I to a said be light think wanted some and questions sounded XXXX the the And second hematology going trends, more about from guess thanks and follicular, get And clinical an just us talking $X how my then a of of the and just kind I breakout in about around and sclerosis to roughly is MZL that's by about get me. a early the into when launch. the just I in color I Maybe that onco taking differentiated with early, variant? kind of of for like much occurred how can -- of and give my you can how during how you bit intrigued on it's what just

Mike Weiss

those? Yes, you take sure. Do Hello? me want

Adam Waldman

I'm Yes, mute. I sorry. please. was on

Mike Weiss

Okay.

Adam Waldman

a little Hey Alethia, -- this over tough. you. it's thank in the Doing the lines,

So sorry.

I they -- mentioned relationships the came penetration, around team, really question in the and a hired given we've with I've -- are first experienced before, here So and we're pandemic, as we existing connections. think

The and product, penetration frequency your that, time We're can in penetration the centers our especially way accounts. is mentioned, been discuss issue get see better mechanism, so communicating. the top were So did to has engagements, often of a quarter. answer in more live a we into things with starting the populations especially take to -- profile, good, -- the I question, on these We increases take We're effective in as just patient which centers. working is with it the just good sometimes with and visits you with think very to seeing modestly how second top does frequency. does multiple full get some been and into it new the and

we the reversal Delta few in those of are weeks, with last variant seeing trends. However, the

And cancer to to -- so engagements we're start getting it's centers starting see -- again. restrict live

goes. But general, are we in watch to live it like have see how that feel we'll engagements and So better.

obviously a remind can Our Alethia, been good, has second me it's question? penetration the of you but situation. fluid

Alethia Young

of the the far use like differentiation as seen with on safety could that as Feedback be UKONIQs. kind

Adam Waldman

profile. They it very the the been positive Yes. see I mean, differentiated. really has feedback as on

that mentioned an when takes out year. these and I there. box himself, the throughout think patient the a basis a for black patients time up seen versus of differentiating and before, show warning see often PIXKs lack as just on individual a presents physician it is And I when the they As patient don't other

But a feedback the able frequency we're interaction that's there. from far getting we late then, as that are up, get a expect billion, the And has product small expecting I positive. a the to we approval been given contribution patient shows use. the we're in $X the MS mentioned, good in very when as breakdown very, of on when So year as

some have that to to approval. the UX quarters launch and use we contribution get from UX the revenue would And three given to and expect then We And promote our of the of quarter starting of second ability zone of CLL the in projections. marginal form continued is expectation. our continue follicular will base

Mike Weiss

in Alethia, to Adam just XXXX answer. was clarify, to referring his

Alethia Young

XXXX, got it.

Mike Weiss

That was XXXX. for

in $X that to that, at I the For but we've point. we XX-XX that contribution as be point, should in think as MS billion larger or toward XXXX, trending think at from don't gone a I far say

Alethia Young

Okay.

Mike Weiss

models the some flux Because between is have there in bear we cases. that bull are, and forecast

a so well. flexibility as I And think we're giving little there ourselves bit of

Alethia Young

follow-up. cool. guess a just Okay, I

and these MZL a I -- mean opportunity about itself. could be talked sizable follicular X,XXX which Just you

this to feel get So are trying and I in of I group guess, was 'XX you over being penetrate between to kind able a just time? confident core how 'XX,

Mike Weiss

multiple XX% I I don't think mean, follicular, pretty know for were in to drugs we feel fantastic there peak overall. XX% pretty marginal I penetration potential be penetration. I But that mean, about Yes. would I of available. penetration in think and zone is if expectations are the good what group we where any Again, terms

Alethia Young

thank Great, you. Awesome.

Operator

with Please question ISI. questions. from your of Josh Evercore proceed with the next comes The line Schimmer

Josh Schimmer

questions. the taking for much so Thanks

alleviate improve? here and reasons Second, UKONIQ, what it for if you will obstacles be? COVID, full First, How UX, is months of the maybe of much do And expect could evolve and access. what is it kind discuss may therapies? if coming last, achieve for reimbursement, would UKONIQ to adoption, years? consider much will you then on expect the UKONIQ or ordering of to the Thank is those you that? for take And obstacles awareness, it how talk is from you you to competitive much of how reasons how think could how expect pathway the And how even and those in you. or approval to rank reimbursement so, much

Mike Weiss

where don't why with see Yes, and things Adam, you access reimbursement you go heading? some ahead

Adam Waldman

Sure. Yes, the question, thanks for Josh.

access front, haven't the challenges. really seen reimbursement On and many we

the mentioned, I experiencing broad we have not coverage they think regards as that. broad any issues coverage, achieved are payer I to with and

I but that's can access I'll think the take be full getting I'll and question, talk whether clarify, and Mike to on think -- good the let we're the reimbursement you about what I may you we side. obstacles approval. competitive and

research, and the just it one the market they differentiated that COVID access. positive indications. and front I our I we front When see his positive in have as our it there, I product -- the feedback think obstacles and follicular shows which are obstacles we the a very There but And is interactions, there. in yes, get that's compelling very physicians, think interactions, is in we're mean, zone getting when as they in to on from those pandemic difficult. marginal launching a are remarks, in of have very in is we patients largely Mike in when -- them as for mentioned of mentioned get and they product, a continuing make I progress

away I I think the treatment get coming there when down some those mentioned, decrease think the just I patient or and and And patient the challenges. patients, the is I going be treatment line new pandemic start further alleviate some will think hopefully in get in as will biggest we to visits forward. from starts a reticence they given of

Mike Weiss

end. that that UKONIQ. then design hopefully in there with ideally in year then before finalizing UKONIQ CLL some CLL; be a of on will be with will approval The a process the into trial approval the CLL, a for full UKONIQ, so the will marginal and Josh accelerated of UNITY support require and pathway earlier And approval concept follicular randomized trial randomized lines will that trial points: follicular full and the and I study the approval zone the guess, trial full FDA, of we're one, slightly two of converting the will commence in

Josh Schimmer

Adam, to drug if you on whether that maybe of continue that's going something may why? XX% kind the clarify so, you free reimbursement, or forward? And expect whether the can improve

Adam Waldman

you. got I Yes.

Okay. to clarify. good Yes,

are I expect available CLL and this more We're a issue And largely ball is about much patient persist But an much with an issue so then this game different as it XX. zone change less specific overall to availability over yes, and Part funds we D -- in would Medicare co-pay large of Medicare specifically our funds. of percentage part zone with mean, expect A do the patients so given altogether. of relevant. get as funding we're CLL. and are MS this as age we indication not a in that, this CLL. for of support marginal would is available patients, into population. would CLL, large year. in we the general We commercial And not patients. follicular, then specifically, funding -- marginal for expect that to D in of follicular, the we that So see down lack Part available seeing of a on co-pay that's seeing We And talking come

Josh Schimmer

much. very Thanks

Mike Weiss

Thanks, Josh.

Operator

you. Thank

Joseph Eric JPMorgan. your question. Our next line with of from Please question is with proceed the

Eric Joseph

taking the for Good morning. questions. Thanks

CLL your use opposed sales guidance. anticipated I impact as penetration around different curious around in price get wondering to there any think the therapy to XXXX of franchises, And follicular your a just the strategies that sense and in I'm of also terms single-agent ublituximab net combo [ph] latest commercial then as whether UKONIQ anticipates EU or both what hemo in in and first European Thanks. and I'd as is across the RMS? to regulatory is what thinking marginal be zone. is

Mike Weiss

a to Let crack? want one. at me you do the take first Adam, take Eric. crack Thanks,

Adam Waldman

in. and Yes. Why don't I'll you weigh then start

Mike Weiss

Yes.

So I in the time assuming penetration, point there'll of in that year. the in we'll which from some be probably of terms into second terms we're get CLL the quarter, be of the contribution will in CLL, launched, think obviously given that year

using right more seeing of penetration, think the I numbers what found we and than In follicular. modest we're with amount terms than of now in UKONIQ -- even we're even MZL penetration

pricing UKONIQ in assessments. then we yet. the those in part finalized conservative terms pretty package, as pricing of the been yes, we've so have And not of And

become that come hard UKONIQ we really in anyone haven't price, any is because, will for come where on likely price think -- the ublituximab patient to the don't total pricing. to population. we it setting, give discounting we of -- we some the ublituximab But that and the much to most for basically a detail price guidance what us again, it's function to will with a I So what be but fair think knows it's up together too given

Eric Joseph

it. Got

European commercial sort the opinion product on Second, [ph] perhaps the of various opportunity approaching with franchises? latest

Mike Weiss

Yes.

-- regulatory We're I check So think the that the with and don't got moving MS. of process we're I working back yes, Europe first with the scoping forward still. team. in first may I application -- in But out we're think towards the to think -- I application be go in

on end back in just team, that. get of I interesting probably that cleanly it be then think is So first there. us very one big to in I We in MS driver opportunity moving we a up But think you than more Europe CLL probably definitely MS with pricing smaller certainly actually need we and to that's will and for the forward. may staging are second the a one Europe uptake. we managed and US a acquired But that

sure we with that how in we're that's out opportunity assuming But that still to that CLL make there's scope think case, valid. exploring assumptions still those the for European occur. are while pricing continuing interesting interplay we're pretty launch MS, a will So to

head for US. we're CLL to I'm with moment, second forward So going sure ex then and I MS first think the pretty

Eric Joseph

Thanks great. questions. it. for taking Okay, Appreciate the

Mike Weiss

Sure.

Operator

with The with Howerton your question. is Please of proceed Chris line the Jefferies. next question from

Chris Howerton

taking so progress. on for the much thanks Congratulations questions. the Great,

Mike Weiss

Thanks, Chris.

Chris Howerton

for think of -- me I course.

get be would disclosure? what least anticipation to ASH, data be we some full the data know to might respect a guess, Would with there head, not remember plus approval the my the with I sufficient study for then quite is. of expected path at the First, the is but simple that UX the what be the results. in opportunity? respect I regulatory I the at an just was X the guess, X accelerated And trials, pretty itself, would it -- question. venetoclax Phase some study Phase couldn't I

was it last particularly guess, So I respect is question then as would everything that And you. thinking some helpful. that go to relates just the to CMC, Thank with be to around ensuring ublituximab? good

Mike Weiss

Sure.

in focused last to ASH, So and three later So we've it's investigator, is full right? we've a and X we've been year this as that year's phases, almost Phase we a is been committing lead program, previously and UX-VEN terms -- the update what what Barr that of three present too. -- where X on we Phase at had Dr. Paul conducted presented

through we're between that XX think in for months in we XX the completion and around, So XX go the the I for XX patients first and months through of trial. XX patients had patients looking somewhere

that So presented as data UX-VEN that this been we've later year. the being talking is about

in as earlier said, In terms completed early year X into portion. of ULTRA-V, -- Phase we've enrollment the the this

all data after after months probably ASH, be prepared that XX would need well until so for two And -- not the ASH. months patients through have fact, to prior would we occur in data. And to

do. So I've as be ASH. investigator multiple this data could really or set wanted of if the to incomplete data set, a And what was principal present the not we noted partial for will times, a function ULTRA-V

trying to PI that. within And so frame were I if feeling data we're I a probably today But having it a time reasonable said I've whether to that all do that is do multiple was occasions, will me the out I full XX to year. months, could set want release we when in partial patients set. that wouldn't this general we'll a set of -- still And figure the close it a occur and were partial through my to this and not

data look at through have the through a in UX set. conversation patients we'll regulatory hear data ULTRA-V Phase his think all more terms to XX-month the point, the said Ideally, from full once be where more of So present with FDA. likely X surprised then, And we'll at is least moment, I we'll is. that see data wait the going will the we'll to for and he We'll be the not the side But from partial question, UX-VEN the is But it be set goes. fact, decision -- sit, if we wanted surprised in where X to data year. a have PI time. what data, And back the Phase see of the and be wouldn't I than next that he I'd at later that the this all. and I time year, approved where complete at

is approval, will We'll is course, NCCN they're certainly enrolling it Phase as being assurance So for FDA UX hopefully, usable their it approval over an Phase it approved data interested usable it multiple for approval. that, if to But and send said X and will venetoclax easier have not already will adding of of in Phase no the If portion speak. be we there's published. we've, the to pathway from And again to approved. the as already that X times, guidelines. being X be see

current the of status that's So program. that

Chris Howerton

Great.

guess Okay, just And that's anything I on awesome. note then, CMC? to

Mike Weiss

file. submission filed for section the The come back my forth. knowledge, CLL that far great that ubli. that back the note go nothing out is to it we there's and part team's but of I And been been for to for first concern to and typical the CMC, has as of I and that any is think know. Nothing as filing. we FDA And it's was in ublituximab reviewing application rolling that a the ongoing the to dialogue There's as the filed process questions the FDA,

Chris Howerton

Mike. hope to to Okay, soon. thank and you, Appreciate talk fantastic. Well, you it,

Mike Weiss

Thanks, Chris.

Operator

your C. the H. question. Ed Wainwright. The next question White is from with line of Please with proceed

Ed White

for Thanks morning. my questions. taking Good

higher. you R&D. some second if on there the guidance Sean, should maybe But can to the you how was expenses of the we trending this wondering in I quarter. thinking any about I million SG&A comments $X know question charge half first be was make So on gave the year?

Sean Power

Sure. Thanks, Ed.

last second higher over you'd -- trended expect, SG&A of over quarter, given So course, year commercial the as launch. last

prepare to a of bit the not up course said, and on of of I of that MS continue remainder the the R&D over much volatility whole a the over say, would I front, as little rest think, we it lot CLL I I year. the will tick all launches. this year, there expect wouldn't And as the

Ed White

trial on enrollment wondering just data can the drugs you any trends you other give Phase us Thank the X know at later year? will had at trial. questions, Can great. then, for think commented just how then going? Phase fully Mike, you. on mentioned for year And Okay, this Are there this in ASH X. just X And to had ULTRA-V update now some any when is enrolled? you be pipeline and in what look potentially let could combinations you we the Phase I'm development, see you the us

Mike Weiss

Sure.

any unfortunately, too of good when two So started in enrollment into ago. projection kind way full about terms we ULTRA-V, or it's month of to early, a enrollment give

data days big then see point we're obviously, -- got early target a the But enrollment the of of very It's to a -- So for in going for of time terms enroll well. we're it's would and patients continue to we later ramp stage the pipeline from In frame BTK. to that? better the the at have year, be quite more this certainly, in early some in of what for going TG-XXXX rest a study trial. we sense

out this continue then stages to early TG-XXXX, I CDXX, by sure, I will year, this conferences, have data potential next year, one data in again, keep progress that So to certainly on updated and that year, continuing at next something the CDXX the program. with people but presented are as be Potentially the for all will of eke those And year, cannot later -- for I promise noted. mean, this we we later year. and

moment, what out. know this data from of to there's said, the I this TG-XXXX other that final that are the -- see on. think terms data the primary the with. I are so remainder trials, we'll of different the terms you -- course, things UX year, of during But And sets data all of have at X I'm for expect probably of -- sub-analysis people I visibility two that plus in working team more sub-analysis And some that sometime in data Phase coming sets I on So, the VEN, are on of those think later more year, like working there's we'll remaining. up date sure the updated to to be the is out come

Ed White

you potential MS, thinking Mike. talking road then, disease potential? this further about than indications we next MS, And were the that? forms down auto was Should year? Or is and should my I of about thanks, other seeing in that start Okay, question be study how just other is; you be when mentioned final inflammatory we wondering,

Mike Weiss

year. working start to possible mean, for to think then see they a to come -- I it's start some year. I fruition, studies starting next posted expect We're some things sure. to studies if keep next concepts, I yes, on you and few some would We'll

Ed White

Okay. Thanks, Mike.

Mike Weiss

Thanks, Ed.

Operator

question. your Graig Suvannavejh Sachs. Goldman with The is next from of question line proceed the Please with

Graig Suvannavejh

on MS dynamic get of that it might certainly I'm seeing seems could. peak product the comment, be? relative penetrated might accounts Yes, and Thanks. -- just if too that And the you've positioning having is, that providing just alone wondering what and just with how wondering patients is number thanks. and comfortable in if Kesimpta opportunity mind, that portfolio, you Good just that's on landscape, to you and relatively very can might then reordering? to what color Ocrevus you're comment the the you've product might UKONIQ can but of UKONIQ, was provide impact an for at seeing new, be questions, to I anti-CDXX you but any any you beyond seeing to you're at Kesimpta prescribers you how that And you're be an couple revenue in marketplace. if Obviously, appreciated on for the then a get as just this Ocrevus or might good you sense early, just experience if overall overall is in be got UKONIQ in Therapeutics. able be be the the just the you're pattern TG if anti-CDXX on ordering And for would general? morning. follow-up UKONIQ if I a One, might a trying there believe what way currently and market a on I've launch but to got the and it be UKONIQ. update an provide with early looking it's of too good either moving on

Mike Weiss

the start and at the Sure. want but side, question maybe last MS Actually, questions through. Adam, There's to We'll reordering about UKONIQ accounts do backwards fresh, maybe on you some that question? is commentary. our some work way while

Adam Waldman

sure. I a conference week. Yes, there. Roche had around think launch call their Yes, just saw Novartis we was -- dialogue and just last There some

some is there Kesimpta on the traction continuing recovery get -- to like in now are getting market, steady that. not but be the both holding encouraged in it But it's here. growth pandemic seem it. the again on itself looks growing as and some a so is class the continues we're earlier some by looking -- to the from anti-CDXX in It trend. at looks they like we're space, So traction pandemic, was

and talk the the the to the we to earlier product be about class, excited earlier about that think in use arresting I physicians continue of very excited the disease.

think growing, is positive. is itself and trends we good class that So it's think overall the which very we

Let around think reordering. question me UKONIQ, accounts talk was about and the first the I

from -- we're we're are we accounts seeing volume usage that to is I where this seeing -- are around -- marginal know and our as revenue highest is usage our academic community. about seeing on UKONIQ. that mentioned, we're see was accounts. not XX-XX we a accounts split in We're I zone And seeing it seeing As is from in top specialty The the significant still penetration I specifically there. calls. lot And don't are then, in being so the a reordering. accounts. we look our have We we'd in question specificity of the don't We was good distributors, as seeing view has as And perhaps future I a that going around think was opportunity. into don't mentioned, But like question if and we revenue changed. for to follicular and preciseness our specifically. there reordering I have through for it's most we'll getting think top that peak coming But of

I remind said me what think Mike, we've in past. the

Mike Weiss

Yes.

that So, I'll one. take

the the TG before positioning to been So a before the MZL for now UKONIQ we as to in that said to months and launch, world. continue and launch, we four six That's way something after the launch, months terms us a we year launch basically, of the UKONIQ TG and UKONIQ that of over -- said not at that's follicular in and the follicular zone believe most dollar it's we've and be and follicular, is revenue -- introduction million marginal time. And about that could think revenues, still consistently, about impact introduce said future primarily introducing the marginal it's CLL. few a we important and opportunity for zone hundred

we I And million if sales away XX% But trend -- can that the point potential, of dollars almost think provide that's remember, charitable hopefully for organizations a in few support we're it's continues, a others, again, think at that revenue be TG hundred taking to with in a of position certainly help now. could a those fund that there's big discount. our right pretty patients. which

away we're have I so we that levels, marginal experience for see a like think not and all giving have zone it's it's I that's to much we industry, at great away if for almost that, wanted said So follicular, and to But made to it UKONIQ giving sure very free that But to happy said, we having these -- this it do the access. make clear did in UKONIQ. XX% patients fine. builds goods. and we anticipate We're in goodwill want interesting

on built maybe I to a grow the high as date. terms bull XX%, in we've and we've depending we this to we're expectations hundred the and continue million we've we follicular, and marginal message, be consistency we've I marketplace our from of XX% in of launch. that think about follicular, -- in few to order of exceeded extremely never terms zone we continue to that, revenues launch this And if So, a built scenario, marginal the the as and dollar UKONIQ marginal I follicular. not the is being somewhere zone been impression say back company think even of certainly from in of achieve positioning of and feedback Again, and zone -- from said phase are Again, seen, to launch we the opportunity. but on get having the on positive consistent going think that in where penetration the the that

Sean Power

just clarify we're accounts, reordering, of a comments both my the the the patients reordering of as Yes. seeing seeing well. reordering terms we're same from And and multiple Graig, refills on to terms in -- in

So that. just wanted clarify to

Graig Suvannavejh

thanks Okay, for that.

Mike Weiss

Graig. Thanks,

Operator

proceed line coming from The next Kaplan the Please question. Matt is Ladenburg your Thalmann. with question of with

Matt Kaplan

Hey, the good morning, and taking guys thanks for questions.

Are Phase ULTRA-V portion study design? X the there the on Can us differences give the you color, follow-up little -- some specifically, a I program. Just on from guess, study? ULTRA-V the there X of more Phase any are

Mike Weiss

So UX UX. is the design Phase X VEN versus study plus

VEN. not using to for But up schedule of much the for current the you but in just me of check let differences. you, terms think that potentially otherwise, in I again, portion, was Phase check the we double -- of for In up be but only match UX months used X with actual VEN, may to to Matt, terms but just the got I with double more plus than treatment VEN three we

Matt Kaplan

then, data are on some at current presented product have paths I develop What the medical respect positive you kind your inhibitor identified, guess, continue path regulatory pathways to or BTK to your And the helpful. it? of with to Great, or program, the thoughts recently TG-XXXX, you meetings.

Mike Weiss

that differences mean, the I in about spent a The performance lot quite really We've trying between we time impressive. doses, understand and of terms Yes. feel good the tolerability molecule. has been profile. of to

the tolerable has identify be goal sure have regimen we inhibitor. to and make most the BTK to to Our to continues tolerable most try

that. on hard working we're So

the the got registration, of good X we've a terms Phase few program, opportunities. In

yet. a one the expect picked year, next in we'll would be for TG-XXXX. by early But I haven't Phase X We

Matt Kaplan

going week, -- for very thinking to little product then, follow-up terms to in where your the next? good. on, indications, you're ublituximab? indications bring what's was it respect autoimmune guess I I additional a last current Ed's MS, autoimmune just Okay, question And beyond with think of What

Mike Weiss

Yes.

a We Matt, haven't And different on those. out given in of yet, any some have we'll but as we we're disclose number opportunities. place, soon that guidance scoping as certainly

Matt Kaplan

the recent taking thanks the And on for questions. Congrats progress.

Mike Weiss

Thanks, Matt.

Operator

you. Thank

line proceed the with from of Mayank questions. is Please with question final Our Riley B. your Mamtani Securities.

Mayank Mamtani

appreciate the helpful Good morning, And team. for here. taking Thanks our detail questions.

just quick Adam, on discontinuation UKONIQ So And then get therapy real-world just on any the be? but the a duration it's I -- just early follow-ups. to quick progression launch, might one, the to early couple and color of a have be days, handle rate I what what on maybe might of know

Adam Waldman

you the on to comment honestly, Mayank. comment know to We're early too for too on yes, Thanks it's think it's Yes. that. I -- that. -- question, it's early just No,

Mayank Mamtani

a path number helpful. the long-term the near then, sales, the color MS that partner guidance, Mike, for sales? number that on And does include and also was And one? on very for on great. then to XXXX Okay, Any profitability,

Mike Weiss

partner a then. should for in terms to It I sales, profitable our if profitability, goal not again, guess of $X billion be in we'll my we path of include does -- we And by a is XXXX, MS achieve think sales.

Mayank Mamtani

Okay, programs, about talk we side, maybe and may great. investors, And don't those we of two but to the to is to what you just the if CDXX much, pipeline you when so CDXX, a on for expect program increasing should interest on anything may? next expect just and IRAKX hear hear

Mike Weiss

Yes.

we've that terms that in probably So pretty some been clear forward moving now. for program is IRAKX, of time not

nicely. In next year. if is I US, this terms have data We've of one this just that like forward later opened the hopefully, CDXX, not said CDXX, later to then year, moving up into year, the and

Mayank Mamtani

on Mike. thanks. Okay, congrats, Thanks, again, progress. And the

Mike Weiss

Thank you.

Operator

you. Thank

remarks. for end And over the and the the call reached answer closing have question turn Weiss now Mike session. to We of I'll

Mike Weiss

you thanks, And Thank much. Great. very everyone, again.

So just objectives. by up review and today's call wrap upcoming to our goals once again want key

clearly relapsed ublituximab and efforts of course, the and of commercial on CLL So marginal capabilities those and preparation also, zone expand forms for UKONIQ to UX refractory of of in for going MS. and in and focus relapsing we're launch commercialization potential in to -- follicular continue

the the X Phase X option course, BLA working results hard everyone X positive as ublituximab our from are in is for and on And in based of treatment the We towards submitting this ULTIMATE knows, of of forms trials. then, MS quarter.

presentations you, the the for continued and And by for obtain hard CDXX. to at and date later PDUFA goal In length this to going enrollment soon terms Phase next year. trial, today TG-XXXX, the push the CLL is -- TG-XXXX, XXXX. hopefully I approval March TG-XXXX the tell ULTRA-V X Phase into to very early PD-LX UX XX, talked X of study, into of X forward hard about potential And which Phase the We've trial and continue we start CDXX, are pipeline the could is hard with the data we're to enrollment working TG-XXXX on obviously, into push we're enrollment working year. of the and

all behalf a have for day. I'd on to of everyone thank So great TG, and us like at us joining of today

Operator

everyone Thank you will joining us to today. conference. This today's conclude

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

TG Therapeutics (TGTX) 2 Aug 212021 Q2 Earnings call transcript