TGTX - Earnings call transcript Q2 2022

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Operator

Greetings and welcome to the TG Therapeutics Second Quarter 2022 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn this conference over to your host, Ms. Jenna Bosco.

Jenna Bosco

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

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

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

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

to like over Mike Executive turn Chief our Officer. I’d the to Now, Weiss, call

Michael Weiss

us morning, also ublituximab was Nearly, And good forms with PDUFA directed multiple and you launch. for and which efforts provided for thank prepared sclerosis if in but that relapsing us challenging are XXXX. everyone quarter FDA approval one December target being XXXX approved, one a us. focus. now sense successfully of of to of XX, No at purpose the TG a our all has doubt, and goal second dated towards a Jenna gaining renewed has for joining Thanks,

are dose. treatment has the We alternative patients potential dedicated MS and infusion MS convenience entire X-hour believe to added of an a offer the community a first valuable with after ublituximab to the

our we is great while exciting So provide XXXX expected, not that opportunity can as value gone shareholders. to an believe there of us has ahead

here Let regulatory providing me started brief get off by a update.

As many extended of XXXX. you our FDA couple we of that announced the months know, of May, date to at December goal the a PDUFA XX, ago end

the a shared there Officer in treatment are and but be allow submission let's advantage believe none dramatically to BLA The each continued the CDXX. in that participate early treatment see certain we that dynamics. see was with XX,XXX year. seeking this currently nearly Accordingly, smaller them we providers, competitors an marketplace are believe of submission competing are estimated is million at that the new to by team in for the information of talk me market have patients Currently, the is receiving room that hear to one ublituximab the about of XX,XXX given new levels future my to of requests, in relapsing MS all for health size demand the that, our and that will some In uniformly [indiscernible] approximately some our MS seeking larger enhancing opportunity patients three we most Americans a summary we CDXX-based goal is importantly, patients information FDA as expected. do additional in response on this opportunity well optimistic as unique our are Since CDXXs market, an Generally Waldman, the RMS living half that we care FDA. each Adam us to treatment It's offers and those that will the for we only speaking, as play as tells delay. With time, little are to review commercial FDA comprised with to shortly us which we marketplace. change commercialization. outcome experience. resulted the if [ph] forward is As will the a process, long-term to share is integration time approved submission with date provided the patient for my to they specifically to extended moving as almost clinical believe about and we from to MS-focused against the the attributes PDUFA process plans enhancing respond size bit physicians which previously recognize and a We therapy. the as our request customary during meaningful to commercial provided Commercial CDXX they existing nimbleness information knowledge, discussions join thoughts the CDXX these FDA. will related our Chief the that his review submission, and

to be our Sean Officer, also Chief discuss our Financial Power, joined will We position. financial by

However, us the cash our organization ensure of reduce I we current very ublituximab and taken have wanted our an the potential take far to efforts will burn that to launch thus position through highlight successful. as have been

up around This had truly I commend effort projected, for company-wide and lower even rolling was and order our and our a rallying goal or in around on our closed programs is there, paused the nearly and in team focus for $XX TG energy get MS. tightening their we their entire all RMS. million belts, ublituximab approval of near-term oncology burn quarter. the QX we in launch in coming Our sleeves to resources of ublituximab than To

candidates a new the drug ublituximab of diseases, our and on variety half oncology launch B-cell our of heels of revisit ideally across for year, the potential approval including in and next the in to RMS. first a expect We pipeline

that, So turn Adam on Adam? insights Chief me commercial some Waldman, Officer, for our to our share to let ublituximab. the over plans call with Commercialization

Adam Waldman

everyone. anticipated MS. pleased we good you, Yes. an core accelerate to and Thank in our as launch I update to provide morning, activities the continue am Mike forms on relapsing preparation our for commercial of ublituximab

profile. a to seamless for three, through ublituximab and providers the ublituximab demand position a team we specialists strong two, to: ublituximab community; one, deep Our are experienced drive the MS across approval and objectives in with MS of of ensure and landscape on of its the differentiated MS patients build knowledge with professionals launch are access for to facilitate relationships based at

half months, our execution with teams. have core team, market. these and hires XX-plus sales previously last making we access field-based capabilities the in key regional MS two date we over leadership to hired in areas field-based our commercial teams the key months marketing up significantly we general will our hired the critical few coming approximately the in to hires from years and PDUFA in of added medical. We the access managers Over December. team our sales, experience companies, their we strengthened team have over teams Both key build hire we for in continue our members Recently, and and several of field-based come They as currently quarters and next under roles. of will our each MS approach major field medical and continue joined

as an People to exceptional to able to and have attract hired are have to be receive momentum our this make a the wanting people from part continue building. see outstanding are towards talent the We team eager launch. incredible with opportunity to ublituximab our we with builds and of interest of what to been amount work individuals high-caliber and difference we already want join we

company people about biotech and We MS experienced this are and truly on able that care drug and undoubtedly laser-focused patients. incredible the will are exceptionally business a talented surround we but to be with small

in XX% told have U.S. CDXX, concerns therapy that established in dynamic said, and This CDXXs account terms the of market, they are well have approximately Physicians the dissipated continue In the around We become efficacy for positioned a will upon. the to era us pandemic in the Mike market and as of to in share therapies. largely now these B-cell using capitalize and future. growing standard ublituximab has significant is opportunity we market using comfortable the is gold grow believe believe that their

community. ramp activities, teams engaging up of Our continue MS the to key participants actively their

on Chief months focus our continues flexibility commercial to last and a will our learned We it there Ublituximab's launch. believe Everything that the the organization And the efficiencies, we know this aimed benefiting and infusion X-hour product. the continue are I'll bullish grow been good increases administration resources potentially experience ready we Financial Officer. engaging our allow alike. for commercial positive. as several remain attention, feel Sean capabilities launch. success. opportunity enhanced summary, providers the compelling is commercial execute very confidence on need all we making a feedback build profile infusion and ublituximab profile the We we our of very Power, launch it, to and we ability MS the to to only whereas and commercial patient and our as over with improved significant confidence. over our with is that, belief launch will from opportunity we our of ublituximab Our the and to time and at In objectives about and hand a preparations prove opportunity for patients represents have very MS the the With providers strengthen on this for has

Sean? Now thank for your you time.

Sean Power

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

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

burn we for savings report 'XX our is that As quarter in $XX quarter range measures. came are the Mike to alluded focused cost million million, of the streamlining which our at of $XX to, second determined under to of approximately our guided the result million and landing for and previously $XX pleased

'XX where approximately per $X.XX loss of quarter net second $XX we the which $XX of was for million of loss share. 'XX $XX saw net per decrease from share QX or million was of million $X.XX approximately GAAP a a or Our and

compared and decreases As MS preparation to our compared by oncology in and efforts. of a share R&D per in decrease months loss June across-the-board SG&A in a our streamlining in period-over-period. of shift six ended launch for $X.XX quarter, year million prior to a share representing operations of $XXX.X $XX development and was period approximately the driven million $X.XX per the 'XX, net The or comparable decrease focus to was a net the for primarily million net the loss due XX, loss to or GAAP $XXX.X XXXX,

quarters anticipated believe conference which trending In begin well remaining Q&A. project $XX average terms over will rather year. of With our turn the burn back operator the million, date forward, to MS PDUFA later now of from moving and we the expect us had I that, the 'XX for leaves $XX call this previously to down positioned the to we been sharply where we what we million between through

Operator

White [Operator Our of line the Ed Wainwright. from first comes with Instructions] question H.C.

Ed White

us wondering was your you how are the own sales going to team? on be I leverage First, the force Adam, sales if you're new any oncology tell of positioned to sales hires? you Were the with Or team? just MS able could the sales,

Adam Waldman

Ed, yes, it's a base. different customer

the hire for would people we to have So MS. no, new

We will sales our not be using team. oncology

Ed White

And on... just Okay.

Michael Weiss

add Ed, to I'll to that. just just add that. I'll

the of overlap. [indiscernible] will the of end have teams sales the much a force, the While other lot of is

and So their field same our access team basis. is the

overlap there's actual So salesforce be but themselves different. the will some

Ed White

reasons MS there's I for know to you but share you if us? And can get the pricing anything your just anything on Okay. not be to I say able strategy, might thoughts competitive with wanted

Adam Waldman

share. do point, than other to to this we're we inform we Yes. to don't share At closer our and don't strategy payer conversations have to to we lot continue engaging have lot get At in sorry. Yes, a as that this actively launch. we a point, will

Ed White

studies? that sales enrolled Are been any be already producing -- Okay. strategically, ongoing your enrolling me, have thinking thinking may. in are you perhaps outright still about assets? just I assets? And Will how you from for studies? partners are you patients we of looking you or last but oncology this? question, be still should not And if How data Are excuse enrolling about or a following

Michael Weiss

Thanks, Ed. Yes.

programs strategically, holding to I ubli most at and look the those are ourselves approval. hopefully side a preparing So of the we other think importantly, on in pattern

at think going those. going possible. studies So it's us It's we're moment. to of terms are made this I move in on, data how not obviously We about we with And but patients. possible some the for follow right any continuing It's to some don't not to forward decisions we And now. of what's collaborators. do core It's have high priority present data looking not out focus. come a a will some we're

Operator

question next Joseph Eric of JPMorgan. from comes Our the line with

Eric Joseph

current then competitive CDXX amenable And in a to and the also your to you better review formulation are to importance [indiscernible] there reached had that the ubli the as feedback specific things where And of are to a to cycle request thoughts information your get MS just formulation, subcu you’ve the the of of So the MS. is discussions? first, response any Whether in sense clinically? information the just ubli point to explore to whether to the get additional additional being a secondarily, on in term FDA on subcu plans extent hoping space? from wanted for

Michael Weiss

Sure.

In that back follow-up to a the that our I And delay. in made think the prepared as mentioned continue the on work to we we FDA, FDA the we submission further with have forth request. any terms had information not of caused and remarks, that questions we

research and to thoughts formulation. ubli I it, landscape. a been areas, if has certain subcu IV we amenable Again, where We strategic there’s successful. decided subcu subcu impact been is of right subcu to the yes, amenable just of formulation below In are it the in certainly doing getting to A mean, now versus that’s not difference. terms see number is areas for to X-hour a we’re us much if evaluating a for infusion, successful on subcu the the has ubli switch getting --

currently think made But we’re I So can be ubli subcu. a yes, evaluating. into

Operator

the Thalmann. Ladenburg Our comes with Kaplan from next question Matt line of

Matt Kaplan

how up question guess for of about I of -- thinking think and at the XXXX next maybe end year, how and if drive next December, about does should the do for a access for it especially that approved ramp we over kind Adam. you How access? access

Adam Waldman

the for Thanks Matt. Yes. question,

terms a possible. coverage will engagement been we've point. year with And those this engaging continue think of for We foremost, ongoing. getting and as to as conversations payers first at over early So help quickly in be

believe another that we on -- infrastructure help question, -- in this support that for patient patients positioned We not best-in-class services MS rapid in have doing the support from in can perspective, we I get the MS we important point support as general, shape Big coverage in they as this are been obviously, that's now. as and able we leverage space. upon that, we've and space. part Everything a we sure think that in access And quickly in possibly really we're general, that welcome They for a right has for that launch. new approval. aspect at existing of know with we of into is can back class. area to a good And services. we into access the is up well making We overall can. spend aimed patient decreasing XXXX with we in competition patient think hub the get net They believe potential this an building We're and sure the Ed's into market focus overall cost them. well. an to entrant is CDXX will making only have of of

Matt Kaplan

helpful. the been feedback in to differentiated there? very What's that's terms and others profile? could see that you've from ubli's the they characteristics do driving of space important And as help of demand. getting Okay, KOLs drive terms what then in treatment in And demand

Adam Waldman

X-hour I infusion. Yes. it's the foremost, think, mean, first and I

important. reported best as the noted ever being up continuously the infusion profile tolerability of important also overall the something efficacy that's attention. in better certainly that without I experience from being important. is Phase the is ARR III a eye-popping it's it to that hard have think an and least or at that although the perspective, something very is But claim trials, head-to-head get differentiator. I is ARR Obviously, been comes again, make as drug overall physicians study an that think people's

that profile, market. And the it so and it's safety overall, tolerability package think and the value-add I the entering whole into with I the infusion, the very X-hour a compelling and efficacy makes think

Michael Weiss

been Matt personally everyone of that [ph] and I've is And of road one everyone. I health the interesting care [indiscernible] be with that, providers. will not summer, but what's to it's top add other a this -- something thing gets on seems physicians see there that on on necessarily that top lot meeting to for

So as use your years Adam why OCREVUS? And I it’s Present X-hour at mentioned, OCREVUS, find typically, relapse every the XX infusion. frequently, sometimes tolerability every would relapse profile. X it’s one as -- it’s look what we’ll the overall facts interested for I mentioned, And people we’ve of in and versus data had most one course, in. and years Adam in the they’re quite see

across add out experience there some again, we’re the just lot seeing board. personal a road, So the big on top to on feedback of

Operator

Riley. comes question Next Mayank of Mamtani the line from with B.

Mayank Mamtani

review maybe So a discussions. the follow-up FDA just on

the and And Just and past? conducted pertaining geographies with we’ve have compare/contrast come can differences seen X-month you standard you I if KESIMPTA with ULTIMATE up? also, the if to OCREVUS the delays may anything care maybe in of similar the U.S. curious and in that has II

Michael Weiss

Yes.

at three by their months. KESIMPTA mean, pushed months, were three cycle look, review was I back also So and OCREVUS received the delays

specifically two. a than KESIMPTA related than was the the work not that to related in information it request. compare of us stated we And any issue way Ours to issue. information we request an do ordinary contrast in was to we to heard to have follow-up OCREVUS have [indiscernible] answering FDA and the other CMC was that FDA to have review with enough specifically any continuing Other said or said the it again other in remarks, and -- terms for that, request. And ordinary delay we're that caused prepared review, not the their try

Mayank Mamtani

Any them progressive might follow-ups. expansion meaningful proceeding that important any how gotten plans life either more primary Europe? please us of example, two remind for And – inbound just then be the And quick cycle for gotten or indication? filing, from to geographical if on to the pursuing standpoint. are And Great. a have a from in you interest MS a may you strategic, have that’s

Michael Weiss

now. Yes. I socialize KOLs. or We're progressive in mean with studies continuing those area would we I in have we the area primary great right not continue that a say to interest demand discussions.

keep part, may progressive most look we progressive I and for they view helpful, registration. an we're be picked and to the have not pretty studies think many interesting primary just that areas ideas that ideas extension do of we're or For on secondary But been most as much their RMS at of bouncing inviting up opinions think continuing possibly primary progressive. and they're ideas physicians here of for and KOLs will

Mayank Mamtani

on then Europe? And

Michael Weiss

Europe, application. are to continuing on On we work the

up to be hopefully come terms definitive behind in commercialization Europe, U.S. six plan our early approval. we're European the about with year. going months could is expectation that And of Our nine to next a approval in

Operator

Next line Agrawal of question Fitzgerald. Prakhar comes from with Cantor the

Prakhar Agrawal

on pricing centers, that doesn’t infusion receptive thread do specific on plan firstly, there might economics low different had making And ASP discount the a Are follow-up too the to pricing. unattractive? market needle lower making segments quick sure MS more this I of a strategy? to be How get pricing So the versus you for follow-up.

Michael Weiss

go want that one, Sorry, do to ahead you Adam. on

Adam Waldman

do say needs. providers' exist. there Sure. to what That aware Yes, out is price of believe both don't right to going the there a dynamics I said, think strategy and is very we're now payers be. that pricing And meets that we prepared we're our

the it through working at we'll so launch. all and to price we are be options different And ready

Prakhar Agrawal

Got the when the drug you time it. If gets code? a follow-up. what's And in quick J permanent December, line by a earliest can approved get

Adam Waldman

Mike, that believe sorry, is Yes. – go ahead. I

Michael Weiss

ahead. go No,

Adam Waldman

a the X-month It’s process on J-code.

many are there process permanent our will decent it’s not miscellaneous physicians And are comfortable offices. So the place physicians use code. it based code. before J people a said, everyone using a the X-month J on a on code amount is there’s and but with That in of that conversations

Operator

the for would this have closing and Mr. Weiss end remarks. Ladies question-and-answer to over back turn I gentlemen, Mike session. call of like today's to we reached

Michael Weiss

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

and Thanks, to for excited to Have be in us about and RMS. look successful, multiple great the XX, throughout analysis by date morning is As with with mentioned the a October. have ublituximab additional approved forward Thank at [indiscernible] for FDA this to patients potential focus sclerosis working of commercially on I the our to and primary ublituximab necessary joining we are treatment relapsing exploratory data the a you. to the organization sets goal of treat with made December getting for believe upcoming We with meaningful forms be again, the our congress XXXX. runway call, if day. the approved structure PDUFA patients [indiscernible] we sharing goal the to option of changes ensure

Operator

This conference. concludes today's

time. lines day. You for may disconnect you this your at your the of Enjoy your rest participation. Thank

TG Therapeutics (TGTX) 8 Aug 222022 Q2 Earnings call transcript