URGN - Earnings call 3 2023 | UroGen Pharma Ltd.

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Operator

Good morning, ladies and gentlemen, and thank you for standing by, and welcome to the UroGen Pharma Q3 2023 Earnings Call. Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker today, Vincent Perrone, Head of Investor Relations.

You may begin.

Vincent Perrone

Thank you, operator. welcome Business Pharma's Update and Financial Quarter everyone, and Results Con morning, to Third UroGen XXXX Good Call. details where Earlier third this can XX-Q quarter our financial find you press release operating morning, and filed we results. for our issued and our can the Investors be at our portion on accessed documents of site Both investors.urogen.com.

Chief call Commercial Liz Mark on Barrett, Medical Chief Joining Officer; Schoenberg, Chief Don Jeff and the Officer; me Chief Financial President today are Bova, and Kim, Dr. Officer. Executive Officer;

activities will filings we include ongoing our activities ongoing UGN-XXX, call, and During and data; certain may driver strategy receiving for our guidance, related UGN-XXX, potentially commercial making for anticipated approved; our research among revenue and today's efforts; statements. These other trials; commercial corporate future market review. approved; and including be and statements commercialization forward-looking UGN-XXX the JELMYTO, clinical regulatory priority clinical if regarding development UroGen, goals commercialization potential being growth financial milestones; expectation and decisions opportunities; as future and as our planned XXXX things. to if well

description forward-looking found potential documents. based statements information, A current and risks that latest These are press change. to can on expectations be release earnings in subject disclosure our assumptions and are of SEC

update are not statements. these to UroGen undue to any reliance place disclaims on You obligation cautioned and these forward-looking statements,

turn now over Liz? call the I'll to Liz.

Elizabeth Barrett

us you, Thank to today. welcome joining everyone Vincent, and

any and quarter, to I safety partners its top The the will mention and on and colleagues, is we and impact of regard shareholders portion mind. I attack assure With partnerships be our operation have our our remark plans in based contingency to we we have Israeli our business Israel employees continue want potential workforce continued international of to business. impact the smooth that our Israel, operations, in of a place October our sure Before must the X on to robust in of to while investors.

result, business do significant anticipate on not we a any impact our As or operation.

Peace the to possible. we and Finally, return for as soon as region pray to hope

XXXX most I'll quarters QX UroGen's quarter. now turn in to one the history. important of was the

During use demonstrating trials to extraordinary with bladder results shared UGN-XXX meaningful results treat III compelling the low-grade their we ATLAS points, evaluating compared the to third standard met top cancer. TURBT. from our and of clinical intermediate-risk and patients Phase of the the quarter, primary ENVISION trials care, Both and overall end current nonmuscle-invasive line

because being that of important of first the as more by notable particularly this about talk is that our in studied other is type this, will patient bladder segments cancer. developed being but Mark products understand cancer UGN-XXX are and various the This being therapy it's medicines. bladder are types for not studied nonsurgical delineate to

on meeting pre-NDA regulatory for held announcement, a path to FDA this we align UGN-XXX. forward Following the the with

As of [ FDA CMC rolling which which also of review, will pivotal for for our duration for NDA of ] plan The submission an agreed clinical utilize a a of support CR submission XXXX. following X the expected, the that planned the allowing confirmed of FDA January UGN-XXX, development sections NDA. early ENVISION at includes that can is NDA, months response current in trial, at XX months, the evaluation

If the cancer, with for who FDA $X recurrences, to approved, we currently sharing If a driver U.S. review, growth stands priority later. to believe anticipate represent from UroGen, Pending XXXX. we ahead, potential early quarter results, market XXXX. to the duration billion. UGN-XXX the necessitating favorable Looking NDA groundbreaking nonmuscle-invasive endpoint nonsurgical approval This a would and option suffering of submit need data second launch surgeries. months the we frequent become few approximately that the in the of for expect for low-grade intermediate-risk XX,XXX response milestone from a major in annual exceeding in anticipate multiple we patients face a granted bladder substantial

QX carcinoma. for XXXX disease especially is second for pleased was also pace in the urothelial We're academic treated upper strongest this growth JELMYTO, community of the when with considering low-grade revenue a centers. and JELMYTO quarter and rare both tract

highlighting to adoption approach as will growth value, growing continue multimodal We kidney-sparing of of drive increasing sites care real-world and to the management. meaningful body and part and of through a leveraging meaningful data, disease JELMYTO's

increase ever in opportunity JELMYTO approved For growth XX% quarter, remains reported patients. the differentiated we believe bringing first JELMYTO low-grade UTUC, chemoablative the third medicine to for an We approach a year-over-year. of net million significant $XX.X revenues, for there as

The third closing our the important of strengthened sheet. an was that our $XXX during quarter balance million milestone private significantly placement

position, financial that strategy proceeds for committed UGN-XXX, maximize and fortified while and utilize plan shareholder raise capital launch to deploying comprehensive value are we develop to a our Given the from to pre-commercialization execute sales. grow JELMYTO to and continuing

believe our through UGN-XXX. and support current organization position approval quarter our the line in low-grade UGN-XXX commercial Importantly, strong towards transformative will prospective bladder UroGen ENVISION from XXXX latest a and we forecast, launch for following data FDA, pre-NDA the our path we cancer. cash our an with top was forward have on for Meeting and based of ATLAS a intermediate-risk QX financial clear nonmuscle-invasive

footprint grow JELMYTO low-grade Now its to UTUC. in continues

focused is history. dedication urologic commitment in the era as we I'm strongest a the cancer specialty its company's across encouraging remain at most organization and and pioneering new care. point very on in proud and our of UroGen

provide pass the will to a Mark? who now clinical I'll update. Mark, call

Mark Schoenberg

Liz, I'd pre-NDA recent and from and everyone. our before the trials to you, hello, to on commenting with line FDA. results ATLAS meeting take like top a ENVISION moment Thank briefly the summarize

received survival UGN-XXX. who ATLAS was patients [ controlled versus risk patients. evaluate a to without to TURBT XXX open-label with ATLAS for its demonstrating The randomized new study or death NMIBC As UGN-XXX reduction UGN-XXX XX% endpoint met with designed Phase or TURBT enrolled disease-free primary an recurrent risk progression a TURBT superiority intermediate III low-grade of of in reminder, of trial ] alone. recurrence, and

for at treatment pivotal complete response insight randomization. for point. in TURBT. the ENVISION. and a group complete trial, a of complete XX to comparison months UGN-XXX XX% X at compared recurrent same months the UGN-XXX to only received showed These the in post subgroup which observed response months X prior one rate patients a in was is of at resounding XX% XX% least duration results TURBT who in is also patients, XX.X%, after who history of rate with offer disease, response XX we in months in patients time ATLAS recurrent effect received patients in at TURBT, only UGN-XXX achieving a response our duration or the of of UGN-XXX evaluate response arm studied compelling the When observed a population This the

During history of of demonstrating prior reaffirmed met ENVISION XX% with single-arm endpoint, that enrolled impressive study complete one treated serve experienced intermediate of low-grade our risk treatment. least recurrent at [ a months, response that UGN-XXX pivotal FDA meeting, TURBT. an recent the ] its rate for trial patients will is patients which The with as XXX UGN-XXX UGN-XXX, following a NMIBC ENVISION, pre-NDA initiation study NDA. X primary at

all consistency throughout. demonstrating a totality of and safety clinical and UGN-XXX of consistency endpoints in therapeutic profile the X durability response across data at compelling and trials. response demonstrated endpoints OPTIMA, looking the has A far, in X-month complete When thus ATLAS

duration response include maintain XX% population. radar [ rate we meaningful our this a ENVISION, view patient outcome For of and of of that in ]

approval [indiscernible] endpoints Given we for consistency from we believe the OPTIMA, the with which durability for ENVISION, potential works risk and intermediate anticipate in and ATLAS NMIBC. similar outcomes low-grade

like briefly Before of our turning in recently to over a reported comment from bladder to commercial on peers. cancer the I'd call the Jeff clinical update, data for several

are cancers urothelial patients the to deserve the build need better. As better therapies We of development innovation in novel options development specialty that our offer programs of Thus, a in is company, because the space. and that patients than current care. encouraged mission UroGen's are for may to there potentially new standard and solutions treat we recognize

cancer stages how clinical distinctions on and the we the distinct we not and tumors bladder to UGN-XXX Low-grade development and the by NMIBC aggressive limited bladder Low-grade cancer characterized widely recognized. be may differences. less low-grade as of cancer NMIBC and significant NMIBC, of is commercialization bladder horizon, lining and are prognosis. metastatic high-grade between the of metastatic NMIBC significant final with are near However, better bladder the discovering prospect typically even with of the types high-grade a for carries

other distinctions of recurrence the the treatment hand, a disease. has carrying bladder In The of on most distant to approaches, of advanced in treatments. necessitating stage spread and and lie a systemic contrast, progression. prognosis cancer stage disease, the key cancer aggressiveness, within metastatic location, and tumor where High-grade represents lining, risk prognosis cells bladder aggressive may cancer which the higher consists have more organs,

than opportunity risk to metastatic NMIBC commercial on is It's on impact understand believe high-grade landscape what much this UGN-XXX significant focused data densely nor plans that where competitive intermediate the we for recent to development pocketed disease our are disease. in is nor not releases Therefore, encroach do important expected current for is low-grade less program. a market

then battling life UGN-XXX hopeful and sizable bladder may first UGN-XXX approved, indication for by of surgical high also is are quality [indiscernible] of of We nonsurgical care the cancer away each serve of that shift of the portion a may disease. individuals characterized cases from potentially potential standard and this highly If recurrent care as to has year recurrence. of a for this repetitive therapy thousands which rate tens the the improve

call Jeff? a With that, I'd like to turn for to commercial Jeff over update. the

Jeffrey Bova

strongest seasonality the our We to our history small growth another strong JELMYTO decrease summer in sales second momentum a Thanks, quarter strong and and to is QX due what prior underlying was for commercialization. third year Mark. in of our JELMYTO. had from with continue full quarter typical saw see We the continued quarter year-over-year business. double-digit in

line were which for quarter from sales $XX.X the last This reinforces net the period low-grade year. represents opportunity. growth in in the top growth long-term third XX% UTUC same JELMYTO belief our our million,

of a strengthening ramp nonsurgical of differentiated patients indicated of regime. unique for meaningful UTUC of to treatment both commercial only offers clinical resonate being FDA-approved During execution. kidney-sparing was alone of its treatment the physicians. following continued the JELMYTO JELMYTO and treatment The of and several part JELMYTO factors, feature user key as endoscopic or profile expansion JELMYTO the the continues utility with third low-grade and including quarter, management base the result further

growing addition, reinforce body strengthen use diverse multimodal presentations. evidence supporting real-world continues from practice and patterns proposition, various JELMYTO's its across of value In studies to and the data

our Our bladder experience low-grade cancer growth this [ use product and the with for us foundation mitomycin and with in adoption for ] nonmuscle-invasive JELMYTO the reinforces intermediate-risk with establishing of a UGN-XXX. [indiscernible] significant by has optimism RTGel. given Consistent opportunity

use UGN-XXX, of if be However, UGN-XXX is of can be in offers procedure. the and administration support it including several not an that expected distinct or advantages much specialized shelf to will pre-mixed by approved, a given an JELMYTO, equipment, Delivery urologists does simpler X-week OR, be given operational delivered and over for lighter the a doctor scheduling outpatient easier in time as require staff clinic anticipated life lift. with

the that barrier be believe to we TURBT, not adoption. will for Importantly, to UGN-XXX, reimbursement a economics relative

the Following we U.S. launch. upon commercial the UGN-XXX in treatment U.S. into for option prospective ATLAS billion organization XX% a seamless the executing positive ever total in If a prescriber the year our approved, data. a in our began of We UGN-XXX than pre-commercialization the anticipate disease with ENVISION expedient and of nonsurgical will patterns, we launch more first overlap and With approval. well-established that each afflicting plan XX,XXX in $X expect approximately UGN-XXX be patients practice market approximately base an and preparation integration for

discuss financials. I'll that, call our to turn With to the Don? Don over

Dong Kim

thank to for Jeff, Thank and you, call. you today's joining everyone

our pleased September the third financial to I'm XXXX. review results ended quarter for XX,

We are growth. of another year-over-year quarter strong pleased revenue towards

third an revenues last the in to XXXX, increase of compared year. XX% million, the net of product approximately reported For same period quarter $XX.X $XX.X million JELMYTO of

lower research quarter million XXXX. as due third for to is the the XXXX, and to I For Phase for development in to expenses overall for trial same period by and expenses ATLAS and related million decrease expenses compared $XX.X lower for of The of related were $XX.X UGN-XXX, ENVISION the trial primarily higher production UGN-XXX. R&D of and ingredient cost conclusion the to offset scale-up UGN-XXX, study

training, for for general $XX.X professional in of is compared SG&A administrative million lower in million and and marketing, Increase offset period quarter Selling, to higher same commercial due expenses to primarily third $XX.X same were compared XXXX. by UroGen XXXX operations, services our period for the services in related Investments back to third commercial financing expense forward noncash $X.X million the $X.X obligation the of million office XXXX and to support reported quarter to prepaid XXXX. for expenses. the of RTW the

the was of basic term to UroGen same with of managed net $XX.X related million million period or quarter for reported loss per net per expense XXXX. million ordinary Pharmakon diluted a for to compared of or as basic million XXXX same $XX.X the Interest loss share the in of the ordinary $X.X a million and shares compared by third year. quarter the period for net facility, to the of third for diluted $X.X Advisors, funds and last $X.XX $XXX loan loss $X.XX XXXX, a

Turning revenues in of to $XX Investments expenses million. the related amount, million full guidance. year XXXX to range expected million from million year financing to to noncash We range full RTW million. be in is to XXXX forward cash. be million $XX.X anticipated $XXX the million. operating product reiterate in $XXX of The million to anticipated be Of range JELMYTO $X.X in the We to to to obligation $XX net company prepaid the [indiscernible] XXXX forward $XX year to $XX of this approximately full reiterate a expense

$XXX.X includes third from proceeds quarter. We and the third $XXX cash closed ended million quarter the cash during placement, private securities, equivalents in which marketable the and which million with

that, for like the to I'd over operator the turn call Operator? With to questions.

Operator

[Operator Oppenheimer. comes our first from Leland from Instructions] And Gershell question

Leland Gershell

the of for see this any few durability Mark, what FDA to would want ask you in agency like ENVISION, range me. the did have when a you Just from discussion data? to have I meeting, around

Mark Schoenberg

question. the for thanks Leland,

they with are regarding I data discussed sets. totality and in, our the that indicated previously, the As our are provide interactions a interested we think FDA to going of we've data

agency it the these has inform will will indicated approval. that But no of meaning, bar And been of the the bar has a for it outcome a be numerical specific so regarding as discussed clinical -- decision that entirety approval. will trials but

Leland Gershell

point? you respect as have with is will on at Can be ultimate view say, I the will those a How to X be label And of Okay. this or ATLAS part data. whether X [indiscernible]? much

Mark Schoenberg

Let that. me refer Liz to on

Elizabeth Barrett

the be the Leland. Nice so about is you. Absolutely, But that in ATLAS believe Yes. data the our agency supportive to we filing. that yes, and and meeting of data to talk the talked label will

the So filing, yes, that expect expect we that in use to externally. to and data we to able be be it

Leland Gershell

And just last one question for me.

Wondering respect to about your property any As where you protections doing been -XXX. in if have Liz, on interest talked past we've to the update lengthening with runway. you might for

Elizabeth Barrett

No. Yes.

that. is you that the hear tell stated in as future. you'll are to XXXX, actually what on very before it near be except we Specifically, more but And track And minimally XXXX. believe we to we've do will

So hope and working looks very shortly. update provide no show really stoppers, but details, through we an final to great, we're

Operator

H.C. And from our next question is Wainwright & Selvaraju from Co. Raghuram

Raghuram Selvaraju

or see terms where to on get efficiencies reductions? cost you recently. think Congrats you might just that being at over efficiency? potential of progress the realized reached if think additional all coming wanted in on think if the kind course the update operationally juncture, And ], quarters? an you are in [ I evidence G&A of line operating particular you've optimum identifying folks you Or on you any of some that this the of

Elizabeth Barrett

a to Look, with blockbuster. launch To you, to new got projected to great be a Yes. that question. one honest it's and remember, prepare you is medicine for a we're of be a about

at we're point. expenses reducing looking Obviously, not are we efficient. very So at this

much grow opportunity we're And from us UGN-XXX, is for right actually going of leveraging being remain do think of now plans. focus perspective. the from at important most patient we our As for JELMYTO We we're shifting a looking matter the and broader and UGN-XXX fact, of thing we of very that organization all I through operating efficient. have the a to some to have the obviously how

as at some at be we've see patent be Like but you'll So us extend looking rate. about an the R&D, expenses there. the study, in the to study in same But really absolutely. as is reducing it I some to adding a look we [ see study ATLAS don't we'll before, at life, reductions coming example ] close, areas a ENVISION the talked and won't

So reduction we'll some in and across looking board at see definitely we're the total. but decreases, we'll cost see efficiencies not some significant

as need, being infrastructure particularly and what we're ensuring need. on challenging shifting where are that adding team efficient trust we internally even like and we're only But inventory how and me, And can. things the we at we we inventory and look do much

we that have sort ensuring supply. to is The OpEx our note -- other are of we thing just also in

So we're expense. obviously, secondary that's, no and suppliers there's incremental doing to supply lot ensure some disruption a around and

to something it make have Although don't supply. sure that's with want significant, is issue we that we but an not that

Raghuram Selvaraju

just pipeline then question bifurcated the and potential And stage a portfolio. earlier regarding to Okay. the additions

can the you of via I at most anticipating the a that anticipate be particularly XXXX over M&A. course or the pipeline strategic also at likely us If give developments you're see you expect to sense oncology you could much of as people's that also any of what within think sense year, look pertain advancement the broaden programs the would you to earlier-stage XXXX, pipeline course licensing notable other you to potential And exception, forefront of UGN-XXX, important very portfolio looking to minds? zalifrelimab? add give a And next over these of of anything with if are which is the course, whether of you

Elizabeth Barrett

going the and answer Mark and I'm second one, to first back answer Mark? come to question. the Great ask question. I'll

Mark Schoenberg

Yes, thanks.

combinations study I high-grade part discussed us Phase master as anti-CTLA-X is program protocol a monotherapy zalifrelimab, for the permit the that of antibody. disease. the treatment And with will we've to advancing of this intravascular are previously, we So antibody for

the components the trial. in of of are those creating We already process

update how about year interest our to with as is going, you and such be drugs particularly our gemcitabine. on of able TLRX combination So well talk with to we our monotherapy agonist as work expect experience potentially other next would as

Elizabeth Barrett

that the to other market to to in the is our are that second combine question, as but part we products are like also that think I Yes. zalifrelimab would well And at answer looking that even standpoint from and technology. of with

we active your reclaim priority And Nothing us with are question. but external ] is it to now, discussions obviously for to so second right a companies. having [

the pharma a love with would bring space. know, something We in also this but It's in space, Sure. as large right area. active to you in now very biotech

I that XXXX, as into absolutely. doing be likely get we'll XXXX think that. But we not in

thing one business. and not is business in products add the infrastructure. have to going about meaningfully really in that's highly this and to portfolio The your is leverageable business important we being note to add a this multiple about you can think When uro-oncology, to

over So when give which very X us on line, post-UGN-XXX, get to improvement resources the our bottom to X, we the to continue this years you company long down significant to haul. build start will it's a that need

And and I'll in interested to the mean phase. only the broader UGN-XXX other in unable, is high-grade also are low-grade taking disease. to taking thing UGN-XXX unwilling, we interested We're

will just around that. of Development, looking will that to and the UGN-XXX. Louie So coming publications us. out And also Medical We're of our JELMYTO. Clinical road. on think other the President in the Mike seeing a here you'll with introduce I who's a doing start things with that And He's registry see lot to Vice there's look publicize and lot that is a at great down like one registry of data Affairs of we're lead new XXXX UGN-XXX things -- for at more is of start in I'll

Operator

TD Cowen. Boris next comes Peaker from our And from question

Boris Peaker

for Similar questions me.

given why specifically pivotal from First, wouldn't of that a reported? out hazard approval, the efficacy has as did ratio support you've just accept discussion trial had, and to very it, strong they ATLAS FDA the that, say just study they

Elizabeth Barrett

you do me to want or want Mark, to? you Yes. answer

Mark Schoenberg

I'll start and Liz out will undoubtedly comment.

think very [indiscernible] some trial, that we the were but really than continue The enroll plan I of strong with we of trial of think a statistical a number the stand-alone fact data would larger submission. the anticipated larger well. in in halt we enrollment the ATLAS may on than ultimately ATLAS to the data I are originally enrolled. patients comment substantially the to plan, a as the smaller probably FDA's of Liz aggregate position as But value inform patients want analysis number original

Elizabeth Barrett

analysis it initial No, We I the on data. clear stance is to It points that way They end reach Look, to tried think exploratory compelling. But -- that's significant for -- did that from thinking. be didn't not exploratory. that the is have the reach needed very of study. pivotal if think come about you Their it plan, data is made we right. is data given statistical the would data. we that prospective we to around a very the that

study. can came just to say, was back say well, Mark they -- will very and is as I So there this a positive

on the them. in meeting been. to It only. only have We frankly, ever see probably impressed they to durability. very see they There the no to We positive said said -- ENVISION most everybody durability, they've They else data. with was this which, was were the It's space. not want that with have to us, pushback the want

You hear hear you every cancer. time bladder in [indiscernible] that

matter was in really data more analysis not being interaction. hand it able of very have prospective, to positive that again, and plan but So a

as we we knew that would to to I durability date, -- we was very felt they and -- we it important durability understood that is what to been try, obviously, data, you've they've it CR. durability see see all enough like the we want was that did say, But but is they got was at that and ENVISION compelling exactly they along, said. But probability mean I mean which them clear want a Boris. it.

what So they they see very, position them and to marching we're towards want we're we feel want and it, that. exactly to a like when very see, strong with in knowing

Boris Peaker

here. And Great. my last question

versus is private that divide in you reimbursement want reimbursement or talk are more economics you Can that? academic economics centers what favorable about You those however -XXX practices than to just mentioned settings, TURBT. in various the maybe

Elizabeth Barrett

that. through we'll you take Yes, sure. Jeff,

Jeffrey Bova

isn't so you amount to were the reimbursed as buy-and-bill the tumor clinic that's which there's yes, ] what of predominantly. will if I the significant is. drug, But look do of the it than portion perception be the think maybe there for reimbursement insulation physician. to depending and the X TURBT, it's on a that Boris, larger carcinogenic, a in size couple would be UGN-XXX times as which an the of in well economics, anti [ given at you

the So a versus economics when that TURBT. very see compared would physician hospital. buy-and-bill look The good to

don't and a I -- tumor. to to or But we has reimbursement obviously see than down, reimbursement, overall, TURBT, [indiscernible] we surgeries expect be that gone need the people depends understand size that of of as evidence the -XXX TURBT. the on better

Elizabeth Barrett

profitability which Yes. right? It but thing better won't important feel have medicine not that we We very And will the about know our is to do I'll they detriment can't will be for it's like message. then out look, a them, focus it be do them, will we the money patient, are field that We though not don't reimbursement on. comment to with even do they're going that not right. a we That's very But only message, losing that. we is managers.

we that that discuss information made We a share frankly, standpoint. that But and important an the is in marketplace. from we you to a because in this -- how is to net mind, financial are did they know. keep share if be, way. obviously, it will our positive will that also role But make sure able get can decisions as Unfortunately, piece, appropriately the armed reps our

Operator

Paul comes question from from Sachs. next Choi our Goldman And

Kyuwon Choi

had specifically, was ENVISION Oncology is share maybe Congrats if for feedback Society gotten additional just good ATLAS? community the up on you've of I coming on the since Mark, any the Urologic you quarter. and you've from here, since feedback any additional wondering could Investor Day, physician

Mark Schoenberg

Paul, on thanks of well about lean possibility the to this. approval may of think people talk excited I -XXX. the actually But are I question. for And about the Jeff as

work folks understand in urologic oncology unmet everybody needs the specifically think I the -- specifically and need who population.

additional... you don't hearing I know positive. have I'm what colleagues that's But anticipation if Jeff, from So is

Elizabeth Barrett

You talk got at what want you the LUGPA? of to some about feedback

Jeffrey Bova

Sure.

the So an presented day. the types, It think of a we initial Paul, reaction Prasad of to a advisory was groups. data there. the was eager had Annual different I data. out option. feedback Meeting, we of their And We overwhelmingly that but Dr. to back, workshopped larger just sort from where the of got some they're and board LUGPA's saw around in couple different designed We get positive. have patient

the on they certainly not again and to do things, under a put patients general number have you side If of a conservative they want surgery. of that have

that. So there's

then it's much same for And attribute, obviously, in reiterated least if looks the for TURBT it's what of many that duration approved, like essentially a at ATLAS, key and a them response longer of which is UGN-XXX.

that really influential to XX, initial XX the us We'll that feedback, community feedback. So was as just an gave that in but advisers, reaction. strong was very continue obviously engage we that need

Boris Peaker

for also you, follow-up as Jeff. And a

the how your Can before -XXX look give with us sense are in starting might launch what maybe XXXX? Just forth early for you process. of you think the runway established And you some buy-and-bill mechanics reimbursement? J-Codes like and be the comments the so on think just regarding just will and

Jeffrey Bova

Sure.

will time. of miscellaneous any We with a with have you a did will period have we B for drug, Part -- As JELMYTO. code

-- with We expect miscellaneous that a with XXX it's manual as any code, process.

have had for with that they both because support drug code. how you up build this, to we're sure really out everything office will I miscellaneous than and say that on we be JELMYTO on with we clearer the to it will JELMYTO, fill buttoned waste. make that making So sure correctly

a So miscellaneous drug you had code.

waste You miscellaneous had a code.

you Here, won't have as many items. line

So straightforward. it much more will be

help the place sort a in to in put miscellaneous code. of and with anxiety will We things around

time once the approved, thing CMS to going now. is nice line We get. than if we're is year a in codes more reviewing The miscellaneous we expect, that think

will in -- things the But review to place more on So It process. that. I bit takes a hopefully But the physician we past physician it's get -- say play we sooner practice. that code. of put expect the time because those miscellaneous little J-Code a always

use And hopefully, it have to and your accurately then, and and we come that permanent have they'll their talk early share out peers. You'll hopefully, can by adopters they then J-Code. then that reimbursed be will a

Operator

call no And to showing turn I the to questions. for now over closing am back like I further would remarks. Liz Barrett

Elizabeth Barrett

Thank you, UroGen. in interest and continued for everybody, thanks, your

market few But we've I has a last tough think it's seen made everybody weeks. that significant progress. been as the

We both progress JELMYTO significant importantly, on UGN-XXX. continue and then to on make

have of up we key coming catalysts X appreciate, So a months. lot

appreciate lot. everybody posted. we'll interest, a It's your it. I So and keep Appreciate

disconnect. can now Operator, you

Operator

participating. for concludes today's Thank conference That you call.

You may now disconnect.

UroGen Pharma (URGN) 14 Nov 232023 Q3 Earnings call transcript