Earnings call transcript Q4 2022

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Operator

Greetings, and welcome to the TG Therapeutics Fourth Quarter and Year-End 2022 Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Jenna Bosco. may you and you begin. Thank

Jenna Bosco

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

corporate developments, Following Sean overview the recent over our begin overview Q&A to Safe of on results update call will statement, will financial the turning before brief and will an provide Adam session. our Harbor Mike a of efforts, an our operator to the provide our commercialization provide

we the statements the operating projected forward-looking anticipated expectations products. will clinical be Before and Securities I’d Private statements our our development performance, marketed plans we of begin, making meaning include within that like XXXX. of future Reform financial everyone to Act Litigation about These for milestones, statements forward-looking regulatory and remind

risk found that statements filings. affect our from that are cause risks may differ that to include results be SEC actual indicated. forward-looking cautions operations various Therapeutics Factors can that those these TG in subject may our to TG factors materially

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

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

Michael Weiss

disease. which for referred The treat us of as thanks we multiple also FDA movement good to of Jenna, sclerosis, relapsing RMS, with Thanks, today’s XXXX progressive approval clinically of active received relapsing adult remitting isolated disease, a was includes call. syndrome, quarter morning, and Great. milestone patients as BRIUMVI an forms for fourth to TG and secondary joining everyone on

trials, studies, and for results ULTIMATE one Phase which and TX BRIUMVI number monoclonal reducing of fusion & the as enlarging following of can BRIUMVI X starting primarily over the of based approved on the anti-CDXX superiority in lesions. II rate, endpoint was a demonstrated and year twice be lesions the the a approval is of first the dose. TX the antibody significantly hour as which the now or of teriflunomide well relapse primary This that I was Gd-enhancing annualized only RMS administered number new the

Two important of secondary The last marking England endpoints, results in Journal trials published Medicine, were from the II accomplishment for New XXXX. ULTIMATE major I another year & also

time take and in who us point. entire team to to I patients. for TG their trials the also this I healthcare their get and our thank families, dedication the participated BRIUMVI providers available the to to want making to to patients, want helped the hardworking thank

BRIUMVI talk launch. Our Chief phase. us launch Waldman our briefly Adam also about But wanted to the touch will shortly Commercialization Officer, join I on to early

to as well community. imagine, working the is MS that the As BRIUMVI providers BRIUMVI. Key you can to data other our educating introduce is of team attributes hard as effort to on healthcare the

patients. as MS to feedback continue positive the team thus make RMS with is to work possible The community broadly has received as and excited available to to far BRIUMVI

new seeking it X estimated are As the is to XX,XXX that and treatment million discussed are with past, a MS have roughly year. each in XX,XXX Americans living we nearly

anti-CDXX therapy. suggests are research internal prescribed that about of treatment these half being currently patients Our seeking new an

following the available a now year administered the for one hour twice that as to excited only these therapy as infusion are at is a patients anti-CDXX RMS starting We is dose. BRIUMVI that

an for provide the enhanced patients infusion can therapy times believe those overall infused where can currently and other those experience do on therapy to that for some also anti-CDXX infusion BRIUMVI anti-CDXX be for new We prolonged.

and hear overall many asking Last many gratifying week, the of healthcare are had at opportunity leading entering I the them It market, the for was enthusiasm BRIUMVI in Diego ACTRIMS was the MS to San had on already label. was with profile to name. firsthand the enough my BRIUMVI for to interact also fortunate the differentiation and product providers product nice attend patients meeting. to Conference It the hear that

I very interact work and during know the ability with they’ll with to impressed of of I who all goal hard to providers will this the BRIUMVI. year ensuring and that community continue to team’s engage want stakeholders all access been also course to have with that healthcare with levels, patients the have BRIUMVI, MS our on other

We following dose We brings branded to by twice this class in profile benefits treatment. anti-CDXX starting to power across continue community, to BRIUMVI excited the of entire medical providers, any significant and believe at be patients centers provide that price convenient payers. lowest we profile MS year healthcare the of believe the one including hour administered the MS should the patients, fusion per a

days let to that, in RMS. call of Commercialization launch over to Chief the me Adam our Officer share some turn on our Adam? and thoughts With Waldman, early commercialization

Adam Waldman

Mike, happy update you, the to share a to and on everybody. brief good BRIUMVI. of launch very Thank be I’m morning, Yes. able

excited availability, reaction BRIUMVI the our MS at post-drug weeks four around share color so seeing insights it’s initial approximately we’ve community. still progress and and quite in early, We’re to some been the but I’m

at awareness, objectives me. barriers Excuse approval, strategic focused have to driving BRIUMVI. on of our been minimizing laser building accounts, Since access teams launch and utilization targeted our our executing

believe on BRIUMVI. flawless the for these will set long-term each for execution success We for foundation areas, are which of striving we

to awareness investing and mix Raise of stakeholders RMS. a across meaningful of both we a We patients a are encouraged the so far confident the support in also profile, appropriate webcasts of resources at with of from media, to team, field social while in-person weeks received and coverage BRIUMVI’s and potential are promotional expectations. following BRIUMVI programs patient initial MS to our of conferences feedback ensure exceeded for presence all optimal we virtual peer-to-peer highly attendance by that experience executed national our In approval, successfully wide multiple variety digital leveraging the and community internal enthusiasm programs, marketing, our are and difference make with we’ve the medical education. in and

many trained on with peer-to-peer already have speak the major across also key targeted have specialists approval. since programs healthcare highly the MS to providers We several behalf top MS of our executed gaining and in country centers

our continue progress of awareness early here increasing good throughout community to the the year. efforts throughout making increase are BRIUMVI MS and and We will

are and potential at adoption teams driving on our sales Our working high utilization targeted accounts.

networks about have with meet far, engage have initial more Our effective been eager and education. profile. very targeted us allowed since approval. accounts engaging provide them to with with learn customers to Healthcare quickly seem to teams the our Their so providers deep BRIUMVI our

overall the of In infusion related label dosing of first consistently one-hour the experiencing on in two customers for the perceived infusion, not using pointing positive patients post the product the monitoring general, the feedback XX-week infusion been with and advantages pre-meds the to reactions infusions. BRIUMVI has limited with schedule, oral option

option for emphasized top for specialists highly with line profile They last board the get differentiated felt they’ve feedback a week tolerability with BRIUMVI held an the teams. early faster effective country lack overall to in of that patients. had and the also strategy of launch. the CDXX that meaningful the in with advisory at complimentary was on their cancer field-based is ACTRIMS MS profile, the breast our also expectations with a We the and agent and safety They some potentially label, was infusion, Conference interactions the the in also pricing risk very of were lower early the

we’ve received excitement physicians there’s the engaged, product. using start significant we’ve feedback continue in so on and interest we BRIUMVI – believe RMS for have all expressed their have the many patients far, to Based utilizing with to that

We really just and the have enrollments four just was after the in available. patient in a patient Columbus, after flow the today. already this patient Ohio a nice days There’s article drug business seen first in was days and February made actually BRIUMVI drug our on was about four business infused fact, commercially X, made – USA at hub, of

by infusion far, centers which has also also been experience encouraging. positive so very highly the reported is early The

Our I believe codes working BRIUMVI. access highly to logistical teams on coverage our challenges focused committee obtaining accounts and optimal achieve miscellaneous teams minimize doing J fantastic to on are patient access job P&T for around a approvals, barriers expected are and early working with BRIUMVI. obtaining the navigating

skilled, have offering support deep patients patient and the built reimbursement program dedicated in high-touch process. throughout support account case an We staffed reimbursement, access with outstanding managers experience by specific

assistance, – Today, help while challenges who quick have we’re program and eligible patients accessing been with has provide no we program, assistance patients programs, comprehensive this to who BRIUMVI program eligible financial interruption may have may to coverage. for to BRIUMVI. patients and will this continue successful on BRIUMVI copay provide part very appropriate As centers robust working gaining including of work cost and coverage a team that at we start challenging

have already importantly, several at national and Most plans. regional we early secured payer coverage

place on the coverage now for happy the of covered I’m ahead lives we share lives very majority for our XX% first very covered and the the of that U.S. goals In to we coverage half track approximately meet U.S. fact, in across policies by our much internal in are have goal have of year. to of the to

the validates these I’m we teams It today. payer We account but made decisions very across and of and objectives and strong early and BRIUMVI’s progress the of it early, launch pleased strategy proposition, work and our our value commercial are hard believe reflects the course, extremely coverage is clinical still our of by have profile pricing proud national teams.

payers, given to detail we’re road I’m to only patients We very pleased point, signs with confidence few look sharing with lot the next working launch with of forms And to access and BRIUMVI advocates call. we the relapsing for so this that our broaden look to the that about reinforce forward and a positive to progress forward quarterly providers, We Sean? ahead. in a weeks into more and at far date patients, MS. not are we’ll go more seeing to are where but very continue into

Sean Power

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

today’s which approximately in I’ll fourth below well $XX the For report to burn, range. guided for previously begin quarter, we our million quarter pleased are call, with came at our

of in accessible In which to terms that equivalents our million ended under us total, we with and XXXX means $XXX facility, including capacity contractually cash BRIUMVI. With million $XX became approximately cash, approval of investment upon that securities. our for available of what position, cash Hercules the

million $XX quarter approximately net $X.XX which where GAAP was from net or Our $X.XX for of the we the fourth quarter share. sharply in million comparable or approximately down per loss loss of XXXX, per a share, XXXX was $XX saw

With decrease to our and last focused ahead approach spending by of driven the disciplined BRIUMVI December. the approval

of in triggered by XXXX, of Our QX from the loss FDA the $XX $XX approval of quarter QX of million approximately where we BRIUMVI, expensed loss which GAAP was the result of was a which $XX net XXXX. of net one-time was of million quarter-over-quarter XXXX million, a primarily payment an fourth in increase saw milestone

in share. is loss a in December $XXX per or loss a per year XX, was compared the and the The for loss earlier, $XXX for our discussed efforts XX, year-over-year million ended December XXXX net GAAP the XXXX. of ended as to share of million, $XXX Our or decrease streamlined of year net approximately XXXX result million $X.XX net GAAP $X.XX focused

from of expenses, inventory expect quarter. BRIUMVI during operating coupled with exclusive when mid-XXXX. quarters assumptions we of BRIUMVI, feel the approximately ahead, we terms capital our to we build of XXXX, launch relatively the incoming $XX million on positioned revenue a per we million in standpoint modest In well will what from into $XX are average And expect the

that, will operator back over begin With I now to the conference Q&A. call turn to the the

Operator

you. Thank

go Joseph Eric be from session. [Operator Instructions] a JPMorgan. question now Please have conducting first ahead. the We line will We with of question-and-answer a

Unidentified Analyst

taking question. This Eric. on Hi. Thanks is for our Noah for

BRIUMVI from nature centers the one versus quick different a to have in pre the given infusion access going been of vastly J the two hospitals stage fusion is zip centers versus the Just code those this hospitals. settings with launch us. How discussions of at in dedicated to the

Michael Weiss

want and you ahead go answer that one? to Adam,

Adam Waldman

Yes.

J the academic the I think between I both. question not and there’s a if So across infusion sure – understood about the code, same I centers. issue the believe, difference I’m it’s

more and institutional independent centers centers on formulary the of I think is are formularies, at obstacle a streamlined just whereas the the getting academic process.

through. So seeing formulary process earlier go are a there’s there access we’re academic than to the where we seeing at centers

Unidentified Analyst

Thank Great. you.

Operator

with from you. Josh take Please the the Evercore Schimmer line Thank next ISI. of go We’ll ahead. question

Josh Schimmer

Thanks questions. for taking the

who patients quarterly need infusion or then studies the or XXXX contemplated was to and dosing therapy, there just Thank to one hour they that? initial switching from the right OpEx GAAP are to confirming for antibody So do to protocols other an enable non-GAAP? are through guidance, on that that anti-CDXX move are the you. any there is opportunity And go same

Michael Weiss

Sure. Yes. Thanks, Josh.

as OpEx? Sean, infusion. So switching have period folks the you to should go per time, now, necessary. the printing we’ll folks is of together be rule we’re on coming label per a But through as dose. whether have that that through that starting do launch four-hour for assume switch over, label, on I study four-hour some perhaps would go right the soon We do educate the and

Sean Power

Yes. Sure.

side, is GAAP it On non-cash a number, but compensation. that OpEx the excludes

Josh Schimmer

to And have follow-up, two that switch you including four-hour to do being obstacle go those to then patients it? Mike, infusion, if see first infusions, an a through do

Michael Weiss

So appear does an far, that to obstacle. be not

that indications after, four-hour but skip heard be the the perfectly would love folks from still Remember, lot doesn’t I fusion. mean, before, the and dose, are comfortable I we into – just infusions one and having four days and to folks four-hour switching hour hours. of are the using early still we’ve people to it getting one OCREVUS from it over think to a switching again, lot certainly of them even hour are other that seem an these issue that the chatter early at one plus are here. a trouble are on

little that do the in to skipping one of understand people going that. could can dose extra of a trial And that it’s run bit we So no dose, a investment doubt. help risks we’re if

the which way. I I the and be looking of out try get into get you’re months make But sure we we setting. mean, and conference essentially. as that folks obviously, we that’s We trial we to commencing. do pitching And those but four-hour, is want something, and won’t that Again, will have that to piece study be, that results just have on that understood will we’ll three but a are And guess, at to get about a not, case. one that the from worried it’s sure a safe get to started, think, will that’s just make early if there once good in data quickly relatively – educate not problem. trial dose we folks we out if that’s that it, idea, it’s in a in fact can more information away

Josh Schimmer

well lead as to that label transition Would to include amendment a simplified dosing? potential

Michael Weiss

about I to We that we’re that trying possible. today. would possible, talked – It’s can but internally be we’ve promise see that and if couldn’t

Josh Schimmer

much. Thanks it. very Got Okay.

Operator

ahead. next from H. of take We’ll go with line Please Wainwright. you. Thank question Ed C. the White

Ed White

questions. my taking Thanks for morning. Good

give of number just year second or So on be percentage taking the this an of should assistance I of free how in the of the patients And drugs programs. of wondering us advantage of are that we was programs half on if percentage idea first currently patients drug half? the you the perhaps versus about thinking perhaps the patient patients can

Michael Weiss

want you go Yes. Adam, one? ahead that to

Adam Waldman

It’s the as the through of work programs the and higher the continue me. is still I percent front expect in we coverage that of issues. don’t with do pretty first in have – half higher precise a free of first the do goods of I Yes. a in year can what year engagement say We half Ed, we numbers early. – our to

as process. good still I but a making gaining progress, mentioned coverage, it’s We’re

we And beginning should over year expect percentage and the higher the in so that of a decrease time.

Ed White

force Okay. on or just your sales adding your size expect do a force. Adam. And question to sales Thanks, your now be Is right you to footprint?

Adam Waldman

good feel We now. are right about Yes. where we

we consider now monitor right it’s but to of to we’re we’re I help would something we Of would say where that and for focused. felt need like see if it’s the we what and we that right an would – will us, continue opportunity we kind size as feel engage. course, continue we

Michael Weiss

chance ACTRIMS, same the just managers with them a comfortable and that Yes, add at had team and business I’ll the our the of question, I east and to that now. to size business west coast that, had Ed, ask two everyone very feels meet with right

Ed White

always strategy Great, update months behind Europe, if give thanks can six you ask Thanks. Mike. this, an and there? question, to us I on And my may, be I timing you what expect any on nine thoughts last will the the but

Michael Weiss

you us. nothing Appreciate Ed. for question so asking changed. Thanks, always Yes. has that Yes,

that whether time feeling XX terms about the from the identify in still still ourselves. hard strategy, total to working we’re or U.S. to in it a months want we’re in we partner and We’re behind of approval do

We getting have call. will we’re May have here, quarter but in say we have I timeframe, call, assume to a more little be the bit of which quarterly close, time conference probably our after some first

keep So we’ll you on stay tuned. that, but posted

Ed White

Great. Thanks questions. my for taking

Michael Weiss

Ed. Thanks,

Operator

We’ll you. the line from next Agrawal a ahead. Prakhar take Please with of Cantor Thank go question Fitzgerald.

Prakhar Agrawal

good taking Hi, for questions. thanks my and everyone, morning,

the the center So or BRIUMVI, until number do is enough? use had attractive discounts approval, a specific think to MS couple types of for you that find it BRIUMVI one, there be over meaningful established more economically are might may You that follow-ups? ASP not it

Michael Weiss

that? you Adam, did get

Adam Waldman

have good the ASP, a we even how and Yes. I good of be physicians with we but when where that think story there will are mean reimbursed. economic ASP, strategy feel we about pricing in for advance is BRIUMVI, we

ASP of of the ASP, be I’m about So be in a not would understand aware the trying advantage. economic there there would to I’m advance an that – early your in question stage, that

Prakhar Agrawal

so of helpful. have treated seeing you on weeks, patients details treatment could the provide you’re it fully patients? switching the And be And far, four recognizing but some patients, profile who you or naïve color mostly could if the any these are OCREVUS, would provide more these it’s of only switches – been from on that seems Okay.

Adam Waldman

me want you to take Mike, that question?

Michael Weiss

Go ahead. Yes.

Adam Waldman

Okay. Yes.

We’re seeing We’re CDXX. right? both, from switches seeing some

this We’re early, encouraged seeing it’s patient course, types types seeing all newly we’re of we’re patients from of we’re seeing we’re diagnosed so But come array at still that of Tysabri, but an switches up. seeing point.

Prakhar Agrawal

you very much. Thank Okay.

Operator

the line next ahead. B. Thank from Please you. We with Mamtani take a of Mayank Riley go question Securities.

Sahil Kazmi

Kazmi really comprehensive Hi, Mayank. launch This and here, early on the update team. on Thanks good is morning, for metrics. for Sahil congrats the

I there’s Just to one study going understand subcutaneous dose even setting? of behind know to the what question, into the you investing started in the perhaps a background. also sort might help get switching that’s tree here or us decision internal primary be expanding higher consider Can

Michael Weiss

Sure.

dose that our sounds primary things doing to compete are higher to with okay. and subcu, So competitors progressive, like us try

certainly don’t we So need like a dose. higher higher dose,

I anti-CDXX to compete chosen dose think us it’s monoclonal antibody. higher very to glycoengineered that study competitor has with to more a clear our efficient our to try

to for there. So us there’s nothing do

dose of deplete We’re cells efficient at rate. the these already our highest in theory to most ability the because

I see to don’t that. So any reason we’d want do

I that efforts think in for are fantastic their us. area

can seen that need shows, we’ve insight better whether a to in the our dose probably is a it’s what to way not I try they clinical that believe and compare true or it theirs, shows trials. our they than one, in to that compete is higher think me data that

think lower, Again our that’s what trying to I they’re for. and ARR in just go significantly a is cross-trial comparison,

turns the from them. model, what there’s have So – infusion. for right? And our main see – then the we’ll be markets part not here, two competition long that think extremely is if we I a two business think the markets pretty right? So we clear that standpoint, developed. feel subcu that’ll subcu is it’s out I how in But that have

one of the to looking want do a into only the subcu do is appears portion turn it patients for option drug other to those subcu, patients and in Some a that now, right but market. IV to that compete that there’s

have So a us, it an IV subcu to competitor have product. they’re subcu sounds going to like the to going and they’re to

can to million. us we cost. know So we a that’s the $XX for come are marketplace it’s whether going million If with better we to subcu a subcu cost the $XXX and product then going to we up what evaluating do

you So that’s have that to to about makes do something And whether consider. again sense asked we’ll investment. it

the and subcu an of doing it BRIUMVI see, first to doing format rituximab, of is we’re We’re like. but – if numbers the what that research to now evaluation see the look step would

forms I million, for think I it’s two the and again, see participants indication not $XXX thing early going the MS. stages And understanding to PPMS, just So of sure market $XX right? at know we’re think a we’ll to It’s same cost the somewhere that that markets all we how in that, of and – goes evolve. we’re PPMS order distinct the as that from million view relapsing of

sum subcu for think this to us study that’s approval folks at subcu there I really that not market the there’s something who So and full have to point. whether a into studied have have also run the chosen invest

So but efficient not I certainly evaluating glycoengineered do doing smaller to capabilities that probably CDXX consider before good our think we helps. of some it, to just and the that more studies there’s understand PPMS can we’re reasons

Sahil Kazmi

question quarter of the how mix And Thank through for Sean. maybe end should remind and me going just and about one Could for the Excellent. No, you think the helpful. more of that’s we that. G&A position the R&D you at then very cash XXXX?

Sean Power

of The current quarter? at the end cash position the

Sahil Kazmi

fourth the quarter. Sorry, of at the end

Sean Power

Right.

build. in we the then as our million, SG&A mix, of said includes which guidance available of in is under prepared remarks $XXX So terms that of And BRIUMVI provided OpEx R&D $XX the we inventory capacity as stated around the I million exclusive facility. and

to would opposed it to side SG&A as I R&D. So be the think weighted

Sahil Kazmi

a Thanks questions. for Thanks taking Great. our lot. Okay.

Operator

Kaplan line with a Thank the take We Ladenburg go of you. Please ahead. Thalmann. next from question Matt

Unidentified Analyst

Yes. for Hi, this our for taking Matt. in question. Raymond Thanks is

the could next months? you XX on over you access congrats wondering XX Just I our months and how the to beating goals elaborate internal would if about coverage and think for just coverage.

Michael Weiss

go Adam, you to want ahead?

Adam Waldman

Sure.

What end goal we to the think get point. the to the year, our about XX% are good end in on get the about to XX% want past that. feel lives we we do was to good we of also we’re date. the the of of said, of year. is we covered this said, the half where track I to before majority And first before feel at As to which We

And good we’ll we continue to processes, at we reflects about set far. we we’re work We And but of for to good feel the like through with the BRIUMVI. that proposition we’re continuing where all value feel so it that, and goals feel make ourselves. the progress

Unidentified Analyst

And Thanks guess just on the that? for estimate you would be permit would the follow-up J I that. that, get you to J code, when code

Adam Waldman

Yes, July X.

Unidentified Analyst

that just then – cadence And plan registries Okay. commercial you switching there study, which is and this, the of maybe postmarking trials that the mentioned was on I or further opportunity Yes. Thanks. studies other yes. up help any wondering is Cool. nice. might very you flush of I kind guess touching or

Adam Waldman

Yes.

some none prepared we We’re that studies, looking have, at probably is We commitment do number do. a talk studies of have about. do which we to to we’re that have available. post additional And

working as So we’ll be well. those on

Unidentified Analyst

Thanks. Okay.

Operator

to question-and-answer you, floor for Over comments. to you. and back reached and the Weiss session, end of the gentlemen, Thank like to now I’d have closing we sir. Ladies turn the over Mike

Michael Weiss

Great. for morning. this Thank And everyone thanks joining you. us Excellent.

successes exciting us execution. in and on commercial an schedule. ways of discussed these progressing many call, today’s year of early believe for are We initial we launch ahead As position the well believe activities

we to joining the We to in for who providers worked believe to value BRIUMVI get great RMS. the today. committed their day. to a patients And supporting families again with the this landscape We remain significant the Thanks call add MS community. us everyone healthcare and Have us to treatment point. thank and

Operator

and today’s Ladies you. Thank gentlemen, teleconference. this concludes

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

TG Therapeutics (TGTX) 28 Feb 232022 Q4 Earnings call transcript