URGN - Earnings call transcript Q4 2023

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Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the UroGen Pharma Full Year 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

operator. you, Thank everyone. Good morning, welcome Results to Year and Pharma's UroGen Business Update Financial and XXXX Conference -- Full Call. for highlights Earlier this overview financial ended corporate an XXXX. release press and results December and XX, morning, we of issued our a the year quarter providing recent can on press at portion website the of release The Investors our investors.urogen.com. be accessed

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

today's of for and statements and have driver in transformative regarding being risks UGN-XXX, on goals UGN-XXX are data, assumptions description review information expectation guidance, expectations commercialization can UGN-XXX, activities are and anticipated UGN-XXX certain and include well including UGN-XXX, XXXX JELMYTO, efforts among During and will regulatory our is. UroGen forward-looking making and research opportunities, and corporate financial major growth and development ongoing commercial things. These for other SEC filings for forward-looking subject approved, the call, and be our release and A activities we potentially strategy change. be clinical if These may current our that priority revenue receiving milestones, planned found and press our a to our documents. earnings and decisions, latest approved, as based projections related as potential statements disclosure clinical trials, UGN-XXX commercialization market commercialization potential ongoing future to future

turn update to Liz. disclaims and these not to I'll reliance statements, now Liz? Urogen call over You these obligation place on undue the are to forward-looking statements. any cautioned

Elizabeth Barrett

The year for this joining you thank the trial very was everyone years Phase growth in the progress groundwork III Thanks, ATLAS ahead. ENVISION laying evaluating a UroGen, and Vincent, us morning. for XXXX and standard and to met of transformational of UGN-XXX and to endpoints. underscore to their the candidate, our The bladder advance product intermediate non-muscle cancer. low-grade both primary risk, data a be lead invasive development care UGN-XXX, and the potential successful

had regulatory enjoy will at manufacturing process believe of we great the meeting data an trial, UGN-XXX, from the risk patients that response the agreed clinical includes in non-muscle for treatment invasive January ENVISION The CMC low-grade June of company. We this announced clinical current NDA product, engagement on that existing stakeholders. double-digit share and this major submission XXXX. evaluation application. the positive and allow and review growth a plan current response this support The year complete which in started the UGN-XXX see and of controls, or plan that confirmed for of adoption have with pre-NDA from pivotal endpoint The growth if of JELMYTO, intermediate in development cancer. We for approved, timely held NDA months improve application. bladder chemistry modules to XX UGN-XXX is to facilitate which in value continues the early that, the year. trends. our create to our the of for the more objective of of of and of enrolling agency was We plan for duration FDA data lives opportunity with the ENVISION efficient was We potentially submission submitted commercial the to FDA late Meanwhile, and driver for a our be the development duration

non-muscle approximately as of estimate invasive significant. is each of expected, in first quarter. complete we as eligible the cancer NDA submission approval and low-grade XX,XXX quarter U.S. third of early review, bladder commercial in the in are intermediate year launch will is UGN-XXX data the granted that XXXX. The We the as we anticipate the opportunity priority Assuming If patients late risk

market that billion addresses. UGN-XXX and billion carcinoma around is opportunity using market total This in the of into when a translates XXx $X size JELMYTO assumptions. overall revenue a market conservative $X the currently So over the for urothelial excess of

with We develop to we mitomycin. novel Through also license announced formulations next-generation JELMYTO combining proprietary based mitomycin are formulation with in January RTG UGN-XXX. of that proprietary agreement and into and a we MEDAC MEDAC's RTGel this entered strategic agreement, our of supply

Our next-generation manufacturing anticipated in and advantages efficiency, products product to terms supply are provide of production, convenience.

has could protection cancer urothelial program issued expected for until with Importantly, to our protection and the U.S. protection last applications IP could XXXX, provide that, patent December MEDAC XXXX. if provide UroGen has additional separate franchise. pending until granted, patent of

and endpoint UGN-XXX for studies NDA UGN-XXX, to We support formulation clinical will next-generation JELMYTO. to our for of need conduct

we a this XXXX. products be into Importantly, both in directly move III will intend smaller and beginning development Phase to for program,

The revenue. achieved full in $XX.X number JELMYTO the million $XX.X Reflected QX of in nonpatient and to million this Turning some product XXXX. year sales cells. are for

patient net We Jeff to But drivers enrollment new for gross have also seen in an growth provide starts few details remain XX% approximately all doses, patient the in patient and minutes. deductions. increase achieving forms, additional most strong with year. will importantly, demand a

critical to impact toward maintain cycle management life through balance our it sheet a development and expand specialty and cancers. strong that to As new urothelial and patient is look growth, we treat of long-term we medicines the ability

funding providing million. expanded additional to Advisors, announce pleased with We our us up partnership of $XXX with are to Pharmakon

the down flexibility agreement by on of million to million following $XX draw $XX are we with tranche XX, source the to benefits part an utilize. amount if September of UGN-XXX that first now we approval, needed. The the to As up draw required this additional of are capital additional an the agreement, have we on with option of

We for to to the now and have the and UGN-XXX, to $XX Chief turn a with launch ATM our with our new Commercial balance cash if in the Mark? Officer. working have I Mark expect we studies. current look Pharmakon them partnership million clinical call and and future. approved, fund comprehensive capital closely a Advisors, potential execute will over Schoenberg, from sourced approximately to With the collaborative forward recently productive enjoyed and

Mark Schoenberg

Liz. you, Thank

Phase place were the We the to data Urologic We were ATLAS especially the with only meeting. that ENVISION of pleased have III data share that community November. ENVISION trials Meeting, the this physician X at SEO as for the designated the selected in at and late-breaking which oral of X Society Annual presentation Oncology opportunity took

potentially ultimately rates, in that that these complete and these duration living data The the our the XX%, bladder rate we for for diagnosis generated, body the cancer ability mid-XXs. of to and of Many the achieve extend of response XX studies age disease-free this will only months We appears response respectively. Moreover, nonsurgically the demonstrated ATLAS multiple average a achieved. at alone. those TURBT care without life vision alternatives XX% XX% all patients be experienced UGN-XXX is rates patients response and highlight II OPTIMA compared response the of study. OR high In to ATLAS UGN-XXX the need Phase complete been who need Looking treated study, surgeries with comorbidities in and has the observed received Atlas minimize UGN-XXX to of to of UGN-XXX UGN-XXX of to XX%, daily nonsurgical clinical the be patients across as IIb to data to were complete to Patients to has have patient population. The consistency easy as in advantage for urologist in well unique response can the TURBT. suggest office complete contemporary the the the in disruption surgery standard their of administer. associated being need has surgery. have treatment an of X once believe X-month superior prior had who

high data mentioned, Liz endpoint patients that next of patients the ATLAS, was at response the the XX%. As OPTIMA If this ATLAS XX-month of secondary subgroup XX-month milestone Phase XXs. duration will recurrent program from study of TURBT. be projected the in in ENVISION. had The at response consisted data, of duration ENVISION least comparable in from the Different XX-month received one response solely a duration IIb we of look of recurrent the

we expect will higher, improvement XX% be current months a this we XX care. of that of the at an believe is show As clinically over data consistently have to response the duration and is meaningful ENVISION we and or standard communicated,

UGN-XXX the therapeutic to painful primary lack of Importantly, only the care. in time cancer other treat that recommend less of patients, daily and invasive, life. to during ENVISION approved, standard and overwhelmingly and If they multiple interviews to conducted consuming than characterized less and trial UGN-XXX prefer patients nonsurgical a recurrence disruption highlighting bladder first and was said it of rates less subset high UGN-XXX the patient would will the be by surgeries.

RTGel lead programs, UGN-XXX is comprised we UGN-XXX, our our an Beyond using delivered continue advance technology. our antibody immuno-oncology into candidate, of clinic. anti-CTLA-X the proprietary to

and data monotherapy and and to Phase monotherapy expected We UGN-XXX tolerability the Safety arm the recommended are as Phase for mid-XXXX. clinical agents. combination tolerability conducting study II and evaluate a establish a in with other dose I safety, are for in

arms plus this patients. moves believe gemcitabine to as and evaluating plus We high-grade and formulation updates look TLRX proprietary we have NMIBC also UGN-XXX, combination initiated trial a this UGN-XXX, in forward area UGN-XXX, have imiquimod, approach forward. We of agonist a in unique providing our on therapy it

the formulations Finally, as those advance. keep you upper bladder bladder we that, And upper for Jeff? Liz programs and for will commencing with UGN-XXX III we'll forward look Jeff update. turn for track with the of call, products low-grade efforts the provide to over call and both Bova mentioned a at are to UGN for the XXX to I and soon, drugs our as cancers. We the pushing Phase tract urothelial posted clinical commercial ahead beginning next-generation of

Jeffrey Bova

for quarter unit in and achieving as Liz our erosion the million XXXX, Thank refunds Despite XXXB gross JELMYTO were primarily higher-than-forecasted remained driven nonpatient discarded estimated due and Medicare you, sales, of Demand drug, for fourth offset lower to net $XX.X targeted full the XXXX. each anticipated, was $XX.X million unit Mark. year mentioned, by sales, strong to by than sales. rebate and respectively. value

$XXX revenues first providing are today forecasting of and XXXX $XX JELMYTO year time the for net full to are in to for range be million the guidance million. We

additional continued continuing net without guidance few installation minutes. the the allows will in is erosion than discarded to despite CMS lower While for patient a reflects on consensus, waste. not important drug note UGN-XXX bladder gross our slightly provision double-digit to It as Don growth. that impact anticipated this will provide detail

in will since to UGN-XXX it doctor's will the administered sensitive office. less primarily Additionally, be be XXXB

operational for held business, the managers, added calls, JELMYTO past operational on focus which in and regional preparing every use. mentioned to new particularly accounts of facet roles opening we've intended As them

the Our growing is data of most evidence with most sites growing JELMYTO's sites a that continue show and are its role of real-world is care. There body value the in from evidence of reinforce strengthen successful studies territories in to care that proposition. instrumental

report X the the over will setting. meeting in that outcomes in at provide in am JELMYTO and We reinforce have the the safety registry reviewing years real-world I our additional market AUA to real-world aspects have the and insight data X setting. upcoming accepted from efficacy support into use been JELMYTO pleased real-world outcomes with evidence product's and

UGN-XXX, we includes now There groups. For plan our the are and is urologists base preparation launch leverage to XX% in for a JELMYTO, in advocacy executing prospective our which engaging with early us approximately overlap existing with XXXX. commercial prescriber patient This in allows pre-commercialization organization.

concerned seeking XX% between as get surgery of physicians the Our shows between much strategies or patients recurrence and often months the They're intervals to to are at TURBT. response X XX%. rate interval with recurrences or research these the prolong a of who of the other extend for between many complete the in experience tells rates literature range break limited patients TURBTs. The high us don't

long-term abnormalities is Our visible appearing disease surgeon. cells in this give in bladder of to treats the will may that rise the the understanding genetic to the that of Normal contain bladder these pathology UGN-XXX recurrence. always underlying cancer not is to disease lesions, we ATLAS treat and the also pathology. And way why longer we control study. background permits standard current a visible disease-free in better us believe not care disease but that of that that's the intervals our than only achieved

while that also the that paid is a from bladder few TURBT. surgeons surgeons cost of reality surgery as hundred a considering cancer treated misconception only generate the lot operation. are are how economics overall The of high, of are dollars quite per a We is income

UGN-XXX recurrence to be potential the economics for to fastest adoption practice barrier for better with would occur Given and have in UGN-XXX, those would surgical our initially adoption. Patients who who patients Based believe who to are undergo do be the on X had They patients. failures. outcomes multiple surgery. we research, a we groups early patients are market not ongoing or considered expect recurrences, with of finally, ineligible

I recurrent early Kim expand call financials. the additional progresses. over plan the groups experience as to confident that now if our patients, these turn to in all physicians UGN-XXX into providing We are forward year will to as approved. quickly look will discuss to gain insight our We Don

Dong Kim

the year quarter development million, compared fourth the study million in and full primarily in increased and full increase scale-up and clinical our in Thank year Phase trial, Revenues and ] to and in $XX.X year-over-year were office the ENVISION ended I for quarter were of full related as fourth million fourth back offset million, were collaboration providers, and in $X.X year volume expenses cost million, were and for with fourth ingredient $XX.X $XX.X $X.X million of for XXXX. million, media Revenues The UGN-XXX, respectively, million, million million quarter you, expenses. SG&A year result compared and research $X.X and UGN-XXX and The respectively, quarter and $X.X fourth XXXX, an for due expenses lower XXXX respectively, to million cost $XX.X period of These primarily costs with for to million respectively, commercial to were as attributable in for the XXXX, year advisory full and the and year-over-year third-party $XX.X full Anderson year and $X.X $XX.X expense XXXX. related compared the the period and compensation recruiting expenses. Interest was for XXXX. the partially quarter Jeff. the in quarters respectively, ongoing $X.X R&D for to comparable Phase $XX.X $XX.X year prior support full respectively, the by conclusion $XX.X offset second partially versus certain million, compensation lower Pharmakon comparable general million research the million $X.X brand [ JELMYTO full the and commercial million expenses million full increase year R&D the The quarter services quarter due were for loan and $XX.X the year-over-year full XXXX interest expenses, the was of fourth X million, decrease increase of XXXX was respectively, first December relates production by expenses overall year expenses XXXX, higher for compared of for of in into sales. March ATLAS for with to the in quarter $XX.X of December the XXXX. million $XX.X and compared the expense on to related and with is incurred services. expenses our marketing full expenses revenues the for and to the tranche and and to for Cost XXXX fourth given fees, the funding the of well XXXX. The respectively. and tranche R&D $X.X and III lower managed net million XXXX increase trial MD Pharmakon and UGN-XXX year million to ending XXXX fourth XXXX. for $XX.X compared was XX,

In to to addition, the year-over-year increase rates increase an interest Pharmakon loan. the was in related attributable

noncash on $XX.X $XXX Net of million, growth share or share-based current UroGen year million, XXXX. $X.XX per projected financial This potential compares forecast, is resources million through our XXXX. Switching $XX conditions. revenue cash cash commercial the be for was and to launch we XX, to to net million marketable full range full the expense million and UGN-XXX believe per support year and at $XXX.X year $XXX per and to to including $XXX now or of share losses our net December fourth of will range and equivalents cash million XXXX, year XXXX. The XXXX $XX securities full of latest million $XX our million. and the $X.XX $X.XX operating subject million and quarter $XXX.X in Full in JELMYTO year had early the full fourth $X of expense Based organization per guidance. to with market to million share compensation the in in $XXX.X or million quarter anticipate expected revenues and XXXX. position for share We be $X.XX or

to in million, of approximately related million of scrutinize of $XX.X to to expense Financing expected continue preservation. efforts cash million $XX.X We to the to prioritize million all prepaid cash. support our in expenses be $XX forward obligation investment to is in $XX to range which the RTW

In addition Pharmakon funds [indiscernible] with term facility on million by to the interest financing $XXX managed loan RTW Advisors. expense, on

rate quarterly be and X.XX% plus a adjusted of to continue made XXXX. software at accrue in We term

on XX-K refer to our with please further the Form financials, For on our annual details report SEC.

call ready questions. open to Operator? now are We for the

Operator

[Operator Cowen. Bancroft with first Instructions] line Our will the from come of Tara question

Tara Bancroft

us envision So XXX early hoping practice understand could the with more the I significant JELMYTO. you was look about you X could in what tell for there's how products like? overlap across launch I of

you're hoping understand the XXX you to and thinking as So to I expect how commercial that synergy about was launches? better out coming years in play how

Elizabeth Barrett

for it's and apologize message [indiscernible] my the Liz. I cold voice Thanks now. overcoming right for of a

turn Jeff, of to to say, going significant So ensure just early lots I'm synergy your we want uptake. here, also to to point, it but but over

color President But And around that know let permission are In details gross I so of you don't joined Market exactly adding also case going to answer question? anyone net. Vice wastage the the around Access, of the to well. wanted why as who's or Jeff, more Pacheco, call our But like? we that, can Jeff, everybody have put to because what resources. you we more want And look Sylvia that's the

Jeffrey Bova

Sure.Tara.

from expand regions. expand with said drivers main feel you there significant region So I we I a go Two have to now obviously, comfortable to confirming XX XX territories, is, look will X in and we TBMs. roughly have geography. some XX the to X past,

efficiency would are of lot with in bladder other we physicians So there the those more that the a increase cancer. then And is do specialize there TBMs. really

product, fact As on bladder. go convenience. and how may additional it significant and mixed X will allow buy reach significant with that There at message looking between earlier We targets. a the the the tract, are and certainly that as everything and frequency any and talked will urologists a a prepare [indiscernible] operational really that for areas talk which opposed build for recurs, Those upper to ready portion but thereafter of obviously, be focus obviously, position upper just more will about permanent sure J that a I number goal talked to tract, the on we'll want we XXX a difference then increase of and to have key we patient make specialize get JELMYTO. obviously a really And -- just areas launch. about do soon with lot of for of, code We're the product. growing we we that would I call, deliver on to the UGN-XXX. quite the contrary in bladder, to out candidate urologists the with the not this in those be

Operator

from Oppenheimer. of next the will question Leland Gershell Our with come line

Leland Gershell

for Two me.

share And could I dynamic that 'XX that JELMYTO kind what see Jeff, as to to business perhaps 'XX more expect JELMYTO? XXXB? in to a have guidance? may on First impact be guess on Or wanted your not I for -- and to its Mark. XXXB do terms of we question we then for a ask as more about beyond Is get through of a bit we is that also what related much of would which discounting. something have is you extent the exposed if I And just onetime for for concern

Jeffrey Bova

will Thanks, Lee. Why comment to think what saw last [indiscernible] and continue. ask and XXXB have I don't on year we what the we

Unknown Executive

this program, a we see by would certainly what be as that manufacturers. practice may in for know So the will marketplace for event. impact program. to in and to we point, companies, all It that in anticipate XXXB is space say What I And as of not macro as at -- XXXB impact we'll impacted And as expand about challenge to or continues similar XXXB be what community is the be the is mentioned, of how the we like therefore, say we closely though I the a program, monitor UGN-XXX, potentially as other continues adoption we much the primarily private UGN-XXX to impact much of the thinking the to the be. the have would future. of Jeff and start an that will continue forecast as

Elizabeth Barrett

very just expect feel And his -- we that, sort sure significantly but of to it Sylvia, want answer risk, for just to the like be but make we where bit continue a grow, to we erosion, to the may there Leland, compared I so we've little year, think of -- projected don't question, minor to versus are I that's some but obviously, past.

the So XXXB company, but view, said, position it's as years. And the in industry stable -- -- think -- stable -- of it's [indiscernible] my in as it's an more a over last we're every we now have discounts. couple challenge a biggest I probably

Leland Gershell

therefore, an increased sort beyond recurrent risk us medical from time urologists treating for kind terms patients recur, perspective who that productivity, highly that that the patients interest guess, wanted of XXX progression level chance friendlier progress but pretty Mark, disease. and wanted they And into of it of and option of recurrent and as does recurrence, grade might could of use you just come given as obviously, procedures? share all grade [ is is? progression MIBC. in to sooner in if helpful. strong the ask what of you, sort play see very and to to from Maybe, That's kind a could TURBT, then, be about should [indiscernible] have high of Is ] factor patients How ask disease low to Mark, a there those of there's will risk it a I even of than and

Mark Schoenberg

what risk low. even disease of know invasive -- It's clinical The is progression or interesting question. an experience, muscle population about X. this our of invasion [indiscernible] the In we muscle intermediate is exceedingly

So own in carefully is followed event. at in experience clinical UroGen Gap] this any population, from our [Audio which

very muscle So Change others the surgical the likelihood resection in you've chronically of say vision experience that Liz in scenario recurrence. occasions, as illness, unlikely. heard in very, and again, progression this which [indiscernible] relapsing have a why Gap] is to [Audio a near-term is in be on would our that many is others every time they

Operator

question Our of Sachs. Choi next will come the Paul Goldman with line from

Kyuwon Choi

My first is question for Mark.

persistent to installation market what the just the us I to clarify there period you followed my could period us? be? just seems here. ENVISION follow-up just think period you be for in XX some if follow-up for that for if correct, understanding X the again maybe confusion It's is by with will regard months, months total And for could confirm

Mark Schoenberg

hear hope me. can you I

correct. You are absolutely

months of XX follow-up, the you months do after mean we So XX in initial what say when [indiscernible] trial.

the XX from be months the study, disease the evaluation. beginning would of it So months from primary XX but

the you initial months So after are XX XX months months that XX correct. CR. So [indiscernible] into It's following trial

Kyuwon Choi

as $XX of to comp for how to Perfect. primarily of burn weighted correct $XX UGN-XXX that and And will XXXX? midpoint range the force RTW and and related when spend Jeff just midpoint Are take earlier in burn the if guidance OpEx I was noncash burn. roughly assume And we end just for to versus XXXX. is then and including months build my it Great. that versus Liz R&D XXX of guidance the much that cash and total get your towards stock of expense, well to a financing just the cash the cash million we Don, the referenced we If could of back-end the the to and with as of million time. of wondering that timing clarify for out incremental guidance strip your clarifying potentially maybe be second incremental you your items, accelerate. out question just revenue the of would we XX sales both Thanks respect

Elizabeth Barrett

let more around But give -- more So yes, I'll be in right, give end. the that? the But Don, do will to you it towards details. Don you color are you want back

Dong Kim

Absolutely.

$XX increase portion, in the this get cannot like OpEx, are And use this basically, before a is we increase [indiscernible] XX%, XX% we commercial, the the two because million actually cost. FDA product you of one million So cost correct. approval, big as $XX or or

So just incremental the [indiscernible] and inventory [indiscernible] another and XX% of we obviously expense it buildup marketing. use sales brand for is the portion force OpEx this of

more back mentioned the you just at So be that, as but yes, the incremental it's of end year, cost. will it

Elizabeth Barrett

XXX And R&D minor in starting because trial of the incremental the there's just XXX -- year. with this and

Operator

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

Matthew Kaplan

once September? a the just to I guess for in complete FDA expected staying priority -- [indiscernible] on review XXX the your chance the initially. What's toward

Elizabeth Barrett

it, the JELMYTO; can't that know, we a compelling. data now for in things of unmet review think our you going I FDA consistent data two, lot there. think the Look, favor. there's the but priority never One, we Matt, duration so right a had guarantee very assuming is I the the to out there and these understands the when need need out treatments we data see And is get that's

So we expectation. a of and we high priority our probability -- believe that's have review, a and

because won't the sure that asked you until So priority can't we ask we did get review, but we submission say for. rolling file we for know again, for and

know. you that, started have as We

like a do position to And we we're feel in that so that. good I think

Matthew Kaplan

should about sense. your that? we of And Makes terms what's think then after Sure. how expected And coverage in approval, ramp XXX? of for payer

Elizabeth Barrett

perspective? XXX the [indiscernible] don't us from today, Yes. payer a talk joined why you about

Unknown Executive

Sure. Matt, thanks for the question.

elements also J-code. And perspective, consider. I with So the from is of think the One Network. a the application Comprehensive the the National of inclusion Cancer payer XXX to in there's treatment guidelines of couple coverage a

a J-Code for application and basis, quarterly it happens the the is on on So a dependent approval. FDA

so So them here. we they can UGN-XXX will UGN-XXX. preapproval in the of get up engaging proposition value few of and running. the information next And we to payers providing with expeditiously J-Code the will aware and months start become clinical work some

Elizabeth Barrett

we mean, be But JELMYTO. it expect -- on [indiscernible] over I XX% to expectation, have don't for UGN-XXX. comment different coverage our We

We of gate. coverage out significant the expect

about it. population Medicare the an then know, is FDA that XX% because you As you if of get gets Medicare. covers And approval, covered

really commercial there. a and with where -- expect close And coverage. say initially, to even we I problem So be we we we don't pretty have an don't JELMYTO, to over issue with which -- won't we XX% it have are what we'll

Matthew Kaplan

bit you And III stated but us Great. more focused then plan of looks development you studies. little would it more it that one Can XXX Phase for the detail work, think? in Is Great. you both Or like just to start Okay. for needed of smaller just for give those? with that will of them? do XXX study path and both, each regulatory be terms you it and a how what

Elizabeth Barrett

like in Yes. our -- were trying we it, good we when that's that's FDA we've we because they think other if have so space. strategy we to What And spoke it, different we've any will to study. our come in, felt of part to do into about news right? they the company as And past, a clinical said that the enough needed actually others, around

efficacy but FDA see we is to So want line. but and have the really show time what and don't have same they about consistent, safety with discussed it to durability. and results have good continue them to with efficacy, needs we feel we But we'll the that, align to that

around be XX study XXX the patients. So will probably

smaller where we have you formulation. the up study think ENVISION at something to do for about that UGN-XXX with patient So ended we next-generation XXX JELMYTO XXX patients, if an than only XX patients for and

XX the prioritizing perspective. well. patient from then perspective. for the in maybe obvious to as reasons XX So follow-up a And UGN-XXX start We're

as long then the as consistent, So FDA consistency. open but on filing is results just to are the us data, showing less

And so where are. that's kind of we

So those this approval is that point at time XXXX of the both period. we have in our would expectation for

appropriate off those we get old of both and ability So to really them we do approved, formulation our the an market. the formulations good of are feel get kind before taking about where and for the new switch the J-Code to

Operator

to Liz turn for like back the I'd session. question-and-answer today's concludes Barrett call closing That remarks. to

Elizabeth Barrett

joining. and for thanks, thanks, Yes, everybody,

for out out of that for us on I registry to areas. nice about coming increase is of think data investigator-initiated understands and of and We're nice prospects adoption JELMYTO. We're some excited seeing continuing a preparing this events about UroGen. the our and at year defining everybody UGN-XXX

thanks. Thank as We'll you. really as guys and posted interest can you keep along we Operator, -- company. So our in things always appreciate now. go disconnect your you

UroGen Pharma (URGN) 14 Mar 242023 Q4 Earnings call transcript