URGN - Earnings call transcript Q3 2024

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Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the UroGen Pharma Third Quarter 2024 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 now begin.

Vincent Perrone

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

Financial Joining Chief David Mark Chief Dr. Medical Officer; Executive Lin, Chris the Commercial Officer. Schoenberg, today and Liz are call on Officer; me Barrett, and Officer; Chief President Chief Degnan,

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

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

Elizabeth Barrett

for Thank joining this and you, us Vincent, thank morning. you

made drug risk dedication successfully of to risk low-grade bladder our is therapy UGN-XXX the It we pioneer were step goal June the in and a submitted than ahead paradigms progress a bladder excited October, August. regulatory testament new of XXXX. And pivotal PDUFA highlight in FDA's for UGN-XXX, treatment we changing urothelial of schedule, achievement. a pleased the acceptance As groundbreaking NDA we've toward I'm treated. is we represents to intermediate XX, how date intermediate non-muscle cancer continue announce milestone new our in of the team a non-muscle innovate invasive cancers, the target with application for This our low-grade more invasive and to with to of cancer

and to committed with FDA our initiating activities as FDA-approved will more during introducing this to patients while company estimated are with addressable patients currently $X market billion. in represents total JELMYTO recurrent our larger is treatment outcomes enhancing in the market with will approval. UGN-XXX position medicine clinical addressable to of transformative robust are earliest market and first provide extending oncology. regulatory serves solution on at market This XXx annually opportunity. Our could we for be that teams approximately to closely the this the we review the process U.S. become details more an than a the patient reshaping a toward for rates ability ourselves UGN-XXX over XX,XXX for working approved, The opportunity the move commitment treatment. neurologic If launch aligns to and the UGN-XXX for our patient David to time has Meanwhile, novel significantly population, deliver reduce between UGN-XXX paradigms than potential the the potential pre-commercial shortly. a

QX straightforward from which increase. urothelial [indiscernible] risk a In is to which carcinoma, also [ by regularly bladder a demand for and intermediate the million underlying cancer all nearly $X.X in market and in revenue included million and compared patient existing period into of same XXXX. third quarter, equipment. but need XX% seamlessly widespread in year-over-year special for non ] strong and administer dispersed net upper without in to the contrast XXXX JELMYTO UGN-XXX the JELMYTO Low-grade tract The million revenue managed outpatient is and representing urologists. integrate to $XX.X invasive reflected low-grade practice Create episodic. opportunity delivered is is disease, the $X.X workflows XL rare product

high-touch product, the our the the focused is nature we strategically demand key accounts growth to we frequency half and with which increasing on of first quarter. of to compared Recognizing improved contributing this this in quarter third believe in reach year. the

increase enrollments launch. prior versus over all-time Similarly, patient since new we XX% a fact, prescribers In continue over high year drive ago. XX% up representing versus in healthy an increased in year, new to a QX

able the signs growth to are of variance low revenue year to headwinds in JELMYTO seeing net We Despite momentum double-digit continued be quarters. XXXX. gross we for in expect full for deliver to and recent QX early the

in management JELMYTO, our technology This for combination life extends management Patent UGN-XXX, of licensed ahead, our of UGN-XXX RTGel unique respectively. our from the the a critical growth our is cycle issuance, step patent we intellectual success Urogen's that a patent technology next-generation a is life U.S. the providing long and at the receipt September, and used of proprietary core will covering Trademark innovative with and for and and long-term the of of franchise. and extend ensuring of December In notice strategy UGN-XXX allowance cover MEDAC. the key the property term. franchise therapies portfolio development our and of through announced uro-oncology for from Office a Looking in Upon formulation strengthening XXXX mitomycin cycle

provide in in Dosing in clinical UGN-XXX demonstrated commenced Mark the this momentum October for will III exciting our development. progress. continued details Phase on early trial further utopia

He shortly. publicly at [ worked at Galera companies, extensive the take want and growth. CFO held reporting, In UroGen next part October, is accounting Relations, strategy, [ with broader Berica at Therapeutics will SEC prepare of and Pharmaceuticals more call UGN-XXX as this positions He on quarter has results He team take for enhance XX us and I expertise Chris' senior our Chief has leadership provide Chris ]. Investor and to and ] Endo initiative than we to Degnan compliance. [ Chris ]. appointment today also appointed welcome joining the the biotech to we as International most to recently financial to broad opportunity Degnan financial AstraZeneca years. and Officer. to of Financial formally traded for has stage the experience commercialize Chris is

also Schoenberg, David Mark? a welcome the update. Lin Officer, as We turn for will our Commercial Chief Chief June. new I Mark in Medical clinical over now to Officer call our

Mark Schoenberg

Thank of sentiments you, for I is UGN-XXX. the want FDA's significant company. acceptance begin Liz's a our by Liz. echoing our regarding milestone for NDA This to

is were of highest met response recently, successfully a ENVISION had XX.X% data The look that this primary closely Kaplan-Meier revealed endpoint, comprehensive an who collaborating represents teams by to duration clinical the our UGN-XXX meaningful profile. late-phase population. impressive agency of robust complete first across and trial, response duration response months. response months Phase by program of with supported along response rate patient a a acceptable from clinically and as safety of strong analysis NDA in NDA the serves three regulatory the of XX-month X UGN-XXX. XX.X% rate with its X in which through demonstrating the this and More at demonstrated reported the that ENVISION trial development III durability complete forward achieved an duration The review patients complete Our process. trials, for pivotal installation Notably, a response clinical after a

durability article the to ENVISION online the I Journal published The early of report am were that in year. also from appear in recently pleased long-term print data the trial Urology. will next

we in for to cancer. risk this expect proactively notification intermediate of preparing communicated, will a advancement anticipating early low-grade advisory represent committee an approved, have treatment meeting. believe of we are has are FDA and we in invasive As timing, significant us If not we non-muscle but XXXX. notified the bladder the The UGN-XXX receive

October, Turning clinical now as we of evaluating pipeline, JELMYTO cycle bladder evaluate a UTOPIA treatment is risk first III III to safety cancer. invasive dosing and multicenter efficacy low-grade trial Phase plan we the and UGN-XXX, designed comprehensive UGN-XXX. of of UGN-XXX. Liz study the patient single-arm mentioned, announced in have Phase The to the trial management for intermediate the non-muscle the a life In

goal disease assessed patients trial Patients risk as ongoing of evaluation approved, having with X the a the a Our defined no Efficacy new to clinic detectable enter in intravesical and X-month application once visit weeks. installation period XX anticipate of complete disease filing response. enroll intermediate and ENVISION rate XXXX will in every for the return the the bladder duration they XXXX. that complete the the FDA will mark. recurrent via at low-grade launch assuming based this X the in NMIBC The on will if be months of commercial response, which is drug UGN-XXX during We study for mirrors to follow-up protocol receiving at week with a patients. with response

UGN-XXX, study early to our and similar III next-generation for of next commence a foresee We year. JELMYTO formulation development Phase a plan single-arm expect

to pipeline. Turning high-grade our bladder cancer

We UGN-XXX. technology. to immuno-oncology delivered develop proprietary an continue anti-CTLA-X our RTGel antibody is our UGN-XXX using candidate,

a We tolerability dose are for to Phase I establish a conducting recommended study to Phase evaluate and II clinical UGN-XXX. safety,

UGN-XXX an upcoming X the meeting. Urological at Dallas. We in through will present our update program Oncology of scheduled of December Society X for

for for response David? Olympus Lin now Jelmyto meeting to including promises update. a David This duration our envisioned long-term trial. be And commercial particularly data the follow-up accepted team. of poster presentation, productive the Additional results to abstracts from were year's over and for

David Lin

Thank everyone. morning, you, Mark. Good

UGN-XXX, with top priority an As to in we anticipated the focus ahead preparing continues for my launch UroGen XXXX. journey on be commercial

have PDUFA With approval now and line XX, for of launch. we date a XXXX, June established, potential time the target clear

pre-commercial strategy the to making accessible and is Our for executing adoption. will UGN-XXX solid widespread a immediate establish medical foundation a priority robust community that driving

and invasive We it strength enhance cancer. with of opportunity intermediate outcomes are to confident low-grade clinical risk patients for data the non-muscle transformative our presents in bladder the

of launch multiproduct disease-focused rare to The specialty-focused team. a would evolution UroGen's organization a from UGN-XXX mark

scaling capabilities and our are support patient infrastructure. We commercial distribution including

sales JELMYTO. from expand reps learnings force at to Importantly, plan factor our force our sales significant in to to decision launch. our with XX from a we over and A XX expand experiences stems approximately

more practices. sales responses engagement to more teams We effective clinical and our support from leads have learned that from

field are an launch sized appropriately committed by UGN-XXX. of that To end, we place having the in force to

Our UGN-XXX. frequency we our market. is updated in are interactions with actively time, for of At launch advancing same the our ensuring significantly impact plan the the activities increase to physicians, prelaunch designed we maximize targeted

of awareness risk programs intermediate Our raising the various invasive unmet at aimed focus education non-muscle low-grade in includes bladder need cancer. through

affairs sharing data of proposition the While to team appropriately also ahead is our clinical value communicate our approval. medical

will To for UGN-XXX of we protocols comprehensive the into training including integration professionals staff. and support, facilitate care treatment office their provide health

XXXX June engagement initially billing, that would about a miscellaneous assigned upon a date, for on new are for UGN-XXX approval, January secure to PDUFA initiatives is be J-code coverage UGN-XXX inform unique practices to XXXX. will both and important options drugs. permanent reimbursement. J-code standard Based we clinical the implementing It's and to Additionally, we note expect patients by for UGN-XXX which

permanent UGN-XXX miscellaneous navigate to a of robust turn for will J-code reimbursement Degnan support oncology are smoothly, process the important setting. to may to community While fully and the challenges pose J-code is in particularly discuss coding call integration is providers seamless. the Throughout over Chris I help hospitals committed this to our fewer period, we ensuring offering interim financials. the now centers,

Christopher Degnan

David, and good you, morning, Thank everyone.

we into with ahead I drive for Before for significant The take a would the join such a of the unique our work and long-term that pipeline here to for to shareholders. presenting to moment financials, say to first value have innovation. get growth help patients to therapies I'm that and to moment company. a opportunities market talented I pivotal bring the UroGen our I'm time our strength team the at thrilled and transformative excited like

quarter. the to now Turning

reached same strong JELMYTO to million third revenues growth. Liz net for demand $XX.X period in quarter in Primarily XXXX million underlying driven mentioned, As the of XXXX. product compared the $XX.X by

for with increase to consistent and solid The frequency provision to JELMYTO XXXB accounts due positively key the gross Volume generated net by our to relatively focused utilization. in wastes to gross continued year-over-year which results. momentum, efforts was impacted Our Medicare part partially reach overall rate QX quarter-over-quarter. offset growth was growing erosion and net

and the our costs initiation volume $X.X lower $X.X for scale-up year. arrangement Research with the offset in was million of increase $XX.X XXXX. costs compared UGN-XXX, Cost by trial $XX.X of nonrecurring by were development third the in expenses primarily into in quarter compared partially million period attributable The made with for sales the in related JELMYTO. production with research payments third of quarter offset UGN-XXX clinical for III slight The higher was of increase certain connection related increased Phase prior comparable primarily partially UTOPIA comparable ingredients, and costs to XXXX. quarter was efficiency to million the for the in the in JELMYTO, attributable trial and revenue the supply year-over-year million the to the

and period expense administrative rate. was changes third quarter noncash quarter for noncash $X.X million share-based primarily $X.X noncash $XX.X general of prepaid primarily million, in reported including million This Selling, million million. third to share-based expenses to the of We The XXXX. was financing of underlying compensation including RTW with $X.X increase million the The million in in investments. expense obligation were driven the compensation in in pre-commercialization for the compares forward by $XX.X the comparable This relating effective $X.X $X.X for remeasuring activities. increase driven assumptions compares same of period UGN-XXX expense year-over-year XXXX of by the XXXX. to

of facility term comparable related was third Interest decrease amended interest $X.X on million the agreement March the Pharmakon Pharmakon a loan the margin to with primarily quarter expense million compared [ the attributable the result and as the ] decrease was related rate in XXXX. loan of [ the restated million to to impact the XXXX. for discount loan amortization in ] with in Advisors The $XXX $X.X period in the and

tranche and late funded September was amended $XX third restated agreement of under loan in XXXX. the The million

basic was Net in and $X.XX diluted loss $X.XX million loss quarter diluted same a $XX.X compared of share in period ordinary as share for to third per the the basic XXXX. million per net or $XX.X or and

With we XX, XXXX, September sheet, $XXX.X cash we business objectives. four marketable of five million our cash balance capital requisite execute cash have securities. and to equivalents in had our we and to As believe the and

forward Turning to guidance.

our strong Although the year fall quarter, saw of the to previous low JELMYTO underlying end revenues guidance. we demand below we in expect full

the growth recent the quarters. believe will for revenue deliver we to that year JELMYTO full However, gross do low despite higher-than-expected double-digit in headwinds net

$XXX we guidance, Regarding of $XX date expenses timing million outlook potential year be of full to to preparations guided operating in previously including share-based XXXX noncash commercial million tied near range of reflects of expense to of $X target operating This the UGN-XXX. midpoint and the expense shift million. for now the compensation the expenditures million expect launch to our $XXX PDUFA

million in is million. the range the the and The prepaid net anticipated expected obligation product cash component full year the be to related expense sales to will $XX XXXX The for RTW RTW of investments to noncash to financing in unchanged of be rate of XXXX. global JELMYTO $XX obligation XX% of

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

Operator

this Thank Instructions]. you. At conduct time, question-and-answer session. [Operator the we will

comes Our with the Bancroft question line Cohen. of TD from first Tara

Tara Bancroft

into other your letter clarity decision have It's First Or perhaps wondering interactions? that was XX-day if the of review? standard great based received all, to you you from letter, the And really insight got the on made aside I do any acceptance. NDA for congrats more any and the why from in see. on writing, was on

Elizabeth Barrett

in obviously, the are letter. Yes. didn't talked They provide It's which questions, ENVISION profile -- They acceptable. role for And the what's a review demonstrate overall, say data review Liz. efficacy just is about, enough priority the Tara. of about anything Thanks, to Atlas. does

meeting point where just So in the yet clinical the they but they sent had what -- back we in in January portions time. typical FDA not expect portion. the actually in We had at from time they data. we We that kind our reviewed our them that the application know that reviewed the at say know of with not do and in reviewed review nonclinical, correspondence you initial point from this to did the

differently. And My as is always can saw obviously, a it if why. we prior been, we to we it believed on view them can have We a great look, and guess very would you obviously think has review, wall they well, they from sit argument go for surgery. much the actually the put against timing but to And So back that's that here qualified don't argument. priority standpoint.

So we I said ODAC. that is expect and we've the an thing -- think other consistently

priority perspective, them a again, period from we timing have I short think, so a time it of And would think, had I for very been, prepare. gotten review, to

have, standard sort the way we timing our versus mentioned. the of only nothing guess -- the and just that's one or other, us potential us even they acknowledge review. three but and gave then gave So your priority didn't are I I review issues here that the

Operator

H.C. & the from with Our Selvaraju of Co. next line Wainwright question comes Ram

Raghuram Selvaraju

if discounting wondering to a UGN-XXX? elaborate not JELMYTO could be expect that factor a on points, net and particularly to was couple I respect to gross Firstly, why the of with you for you commercial

Elizabeth Barrett

do take Chris, that? Sure. want you to

Christopher Degnan

Ram. Sure,

two one yield see don't of size the the the second from kidney to been setting, seeing And in we expect expect we've is then we should the community XXX, wastes to with mitigate time the full XXXB apply with of dose the loss XXXB given the we wastes is over XXXB bladder. do mixing Medicare JELMYTO. just able provision. net, pricing seeing headwinds big respect exposure we're use relative in that a of which to JELMYTO utilization to within on some be to So the provision the perspective, gross the the With more that the and

Raghuram Selvaraju

us activities application. receipt a respect to shifted And for NDA And sense approach the date? expect incept the specific prelaunch PDUFA with UGN-XXX, time respect as for you to can might maybe when review standard the then with preparations of commercial you of to give the have you line how XXX

David Lin

standard is any this doing of review terms we're doesn't major in David. education. The things consequentially, change Yes, prelaunch

an from the in clinical share bladder need cancer. data medical standpoint, is the non-muscle invasive top educate our unmet organization continue with providers uro-oncology. mentioned, And priority in field on intermediate the of now teams to we As our low-grade to right is

So to UGN-XXX. largely the by preparations Xx And we the otherwise, time field preparing is intact, as launch networks mentioned, infrastructure increasing the of that product considerably is our take distribution about on our size by we which larger. team remain be new a will and we our

Raghuram Selvaraju

just then And questions. two very Okay. quick additional

Firstly, I remarks. office application -- that was prepared your expect formulation Liz, covering you the mitomycin MEDAC you of patent action wondering the if on the which with patent on timing in the could covering mentioned comment you

composition on on what there, appreciated. the if this And also, to panel know would any but want qualitative basis, a to comment maybe, just AdCom you Mark, don't had much be you I anticipate the if you future time at be that of insights

Elizabeth Barrett

Why don't you go ahead, then... Mark. And

Mark Schoenberg

Yes. Thanks, Ram.

think other I answer don't is, short the it would reflective suspicion I in know this of other AdComs, by that the space. would while So be particularly reflected composition, drugs of the evaluation my be

Biostatistics. urologists, particularly would this imagine in expect specialists and some well treating in expect surgically. also disease as I there then we'd So will medical experience urologic with oncologists be But oncologists

So cancer. fairly familiarity the typical have urologic probably group, non-muscle invasive who some expected and a of oncologists but with composition certainly, bladder

Elizabeth Barrett

Yes. have I'll we'll I let from -- it to you I'll the around Unfortunately, Ram, know. question IP, and GC but an don't your find the out answer

Raghuram Selvaraju

progress, the for the particularly company. all NDA on Congrats acceptance very important the

Operator

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

Leland Gershell

or you wonder respect to is us in to is have any steps wanted can give hearing scheduled, IP [ being to a with total visibility litigation. I hasn't with fill respect the if on maker. just So the the lines net ] scheduled been Markman time any next on you further

Elizabeth Barrett

this happens updates waiting closer any XX-month have the additional Leland, obviously that what point. But mark. Yes, to typically, you We're date. see our to don't trial is get at we

information in have to we likely that So don't happen we expect XXXX, that yet. but

in forward feel are at we're very moving and we I position that. all of honest our has point where good changed be you, around to feel strongly, with to to that typical So relation of the about this very We just with have that. do and nothing things sort we

fully forward for but that and So the that outcome. prepared date and sure just making again, going we're preparing we're for waiting

Leland Gershell

were for over to the prevail, to carry other With if the be XXX. then those that IP. would for a ability you conclusion? the presumably Is the fair with whatever implications words, given UGN-XXX outcome [indiscernible] And ensure Okay. presumably, overlending would to is JELMYTO. that In

Elizabeth Barrett

fair anything. a yes, get reality expect can't the And we that's do an Yes, to on they it conclusion that. that But approval, until of happen. we is fully

XXX. for we actually put both are patents even We approval in expect a little stronger other some them, it. where with do UGN-XXX, will So will around remember addition, we UGN-XXX and formulation just pending is UGN-XXX which the in that keep in have to make for things next-generation other 'XX. than mind difference for And that just of that think

would ever UGN-XXX. -- you on was we market got actually that be even So for regulatory before exclusivity the up

that good strongly built we really about feel good feel we've very but patents, with are we around where the our also kind them, of So feel about around it. strategy

Operator

the Our of Goodwin next Guggenheim. question with comes from line Kelsey

Kelsey Goodwin

to you Congrats Is the months. an guess, the which progress us, from do the expect first J-code the on initial the last in with around quarters few after from hear in there or it to in impact could a all uptake what J-code to XXXX. expect would time the you versus ODAC permanent I And timing miscellaneous when second, likely the be UGN-XXX ruled scheduling? FDA then out. extent

Elizabeth Barrett

on David want to David, standpoint on to Yes. the I'll from ask nice first? talk But take miscellaneous question to you -- that. of your We to last Kelsey. that Great. do of the comment code, And you, so sort

David Lin

launched of have that the Kelsey, are in period not lot drugs expectation initial that Yes. that other our that phenomenon. same is terms of unlike billing a

educating space. there's plenty in launched only that expect examples from the products more we that intend be So also terms other showing but we be And draw to fully how with reassurance but billing that of our a of them of to we JELMYTO, little manage not may operations adopting, can in and have bit during some and training on to that around cycle. customers promoting reservation have

Elizabeth Barrett

like very what think around very think sites that Yes. for in -- We're than look, JELMYTO as they in community setting And more To I hospital the think expect exact the you care, were in clear. we've the much ODAC, you in is been that, I question the of the around the timing reason. well. would beginning, addition to I

We expect an ODAC.

in full for ODAC. are We preparation

We this to to by these treating beginning is completely really driven that fact agency been a on and the patients from -- has the new want hear key stakeholders. expect of they ODAC clear from very the that way

So we that expect to happen.

The on X to you X usually, months timing it, prior PDUFA. the ODAC see the to

So time we we would as as It May. expect the could X-month April expect the ODAC in frame. X- to late a And go notice.

So if if it's May, March, then we the of the beginning on March, in expect to beginning find February, depending out of when maybe April, by it April.

been in timing the of ODAC, would at February actual meeting January, acknowledgment us. timing. the in a update May that just an least is physicians to that sounds do I sort time they actually We believe ODAC some we frame. preparation. welcomed given that be and actually know we're and for practitioners about always review We April, get meeting full we ask idea there So helpful other the but think and mid-cycle for about odd, is actually this. And kind have what that an -- ODAC. But with know step we way meeting. We've at in the users our And would the that be we'll of expect next that that, ODAC the for them. know will and of on

around The external be have patients and and ODAC that we'll ODAC in excited will like on believe clinicians and our the team UGN-XXX. the the on mode said, I and talking a planning experts medicine that our be at welcome physicians will have very at including that about we opportunity behalf. talking actually to behalf And the so much, us we're that like

Operator

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

Matthew Kaplan

controversy Just bit on there's there to on can also guess, III that could well. that -- XXX. a FDA as any up I ENVISION controversy, it ENVISION the follow single-arm how I further a are have study study of design some designed called the And ODAC similar the approval is is as to respect ODAC. about you the wanted as there you trial design to suffice frequently, with from buy-in little talk and Utopia's the guess, very also, Phase the if

Mark Schoenberg

Mark. it's question. for Thanks Matt, the

I'm But support answer in to ENVISION agreed approval in was, long So which story the to we from of ENVISION short UGN-XXX, the FDA, potentially is a during a a fact, to the trial with which trial. randomized the writing that gating compress into meeting going single-arm the to the try could conversation answer. had transition they ATLAS

So a that we feel that quite there was on meeting of minds question. the comfortable

to a the are might to UGN-XXX underlying the respect need about what we've urologists with controversies of what question sort your been be larger doing and With an that patients also or about potentially the paradigm-changing think I present for invasive ODAC, idea approach non-muscle bladder cancer.

public urologists good population would the treatment UGN-XXX, mean room like currently of patients. application in experts the that FDA reason, armamentarium in of of terms and to for the vetting with So we inclusion about to in that a of to hold practical with what and this I think talk the would believe, its the available

Matthew Kaplan

just then think year helpful. I question respect With up half coming guess in of a for very cash runway, how that? next pending to about finished a That's cash should strong we for with quarter the XXX. Chris. And Okay. position. the second But You launch

Christopher Degnan

thanks Yes, for the Matt, question.

five to off our balance we business profitability had to of off four $XXX we get a to the objectives million with the exited June business in based the believe based sheet, PDUFA of current we that and So requisite date. cash cash,

Operator

Thank you. Instructions]. [Operator

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

Unknown Analyst

of access perhaps of NDA process and with regard challenges perhaps whether process the drug I itself, of you would to This UGN-XXX, to with could the of the that acceptance that's cetera, urologists Congratulations the reimbursement, et provide on calling a administering the the XX,XXX-foot improved really guess whole for be plan just in face actually could is view. Paul. be some like context helpful incrementally updated JELMYTO, the like for Clay how the get in an commercial overview

Elizabeth Barrett

David? Absolutely.

David Lin

question. Yes. Thanks the for

When of patients things. risk of what and low-grade we've nature intermediate draw the invasive we think couple a think we from we about learned unique with also I bladder cancer. treating JELMYTO, So take on, non-muscle

of about financial that JELMYTO has operational What is couple clinical discussion. a So the to we things. support follow learned the immediately

that JELMYTO, them perspective. from So treating with have that immediately to doses identified up make then once conviction around a reimbursement patients clinical and and six and there's helping the support follow operationalize the we've education sure actual we with identifying they

a is is hold because it -- All approval. offices, a UGN-XXX do clinical into of from more workflow. of identify how still cancer the upfront, we a the And also requisite bladder physician intermediate what's But process one will help will important is the perspective. their What's much will understand potential that is non-muscle still do different that that low-grade fits things risk this also is I'll how we they invasive right true to UGN-XXX, them the patient. say, with familiar with training

we will upon all as population. means also financially. all to new JELMYTO. operationally everything that approval. just we drive So leverage clinical about together, of pivot that we and to And conviction will But them learned that continue accordingly patient of the We'll support

data urology invasive PDUFA, ENVISION our in unmet And non-muscle educate to risk ahead worth low-grade community that need of medical and the affairs cancer. the the it is continues intermediate team reminding bladder on

Elizabeth Barrett

rare not versus just to to of things disease rare of couple And nature add of JELMYTO remember so nature the UGN-XXX. One, versus disease a the that.

of heavy these point JELMYTO And patients. in use. need and nurse a heavy your to it's about physicians, equipment. done will lift learned you that ease don't for physicians a It by And practice lift. we have mentioned a hard. earlier all see office, is the special I the gets So say, The the

bar the we of can. different. nephrostomy of really I we've was best definitely have a job You good think, the have got or track right? a though so tube. supporting And done, even the And the to is day, very it as you've it a have manipulate either At is, upper end fluoroscopy, to what

question. spoken the to, and it's be ease situation. you thanks got at that to when think practices from for we've look spoken a going we've we've of that, use that positions I so And we and -- from different heard to the and But around the feedback . all very the very, the UGN-XXX

Operator

no further it I back closing you. for to would Barrett I Thank Liz now time. remarks. am turn questions at to this showing like

Elizabeth Barrett

Okay. Thank you.

uniquely believe shareholders. to these do and continue the with make practice priorities for progress we We our bring company are change and company bladder also cancer in our positioned really across a to value that the patients to significant to

we always, your they arise. support, as keep as things on appreciate you posted and we'll So

So Thank you. appreciate it.

Operator

This program. for in conference. conclude participation you your Thank today's does the

disconnect. You may now

UroGen Pharma (URGN) 6 Nov 242024 Q3 Earnings call transcript