UroGen Pharma (URGN) 13 May 242024 Q1 Earnings call transcript

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to the UroGen Pharma First 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 first speaker today, Vincent Perrone, Head of Investor Relations.

begin. may You

Good First operator. Conference and to welcome Thank XXXX morning, Financial Pharma's Quarter Update Results UroGen you, everyone, and Call. Business

an accessed highlights morning, press XX, the website. XXXX. this issued release overview Investors March providing of can portion press be our Earlier quarter ended our the financial and we corporate The results on for release a of

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

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

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

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

call over turn Liz. the that, With I'll to Liz?

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

response our submission the study we year. near-term duration released have the catalysts, from several including we ENVISION of plan As of with this ahead expected to the XX-month in June NDA XXXX, look data

invasive if UGN-XXX. surgery ENVISION data bladder strong profile approved, cancer repetitive a of we a to will ATLAS from the minimally low-grade UGN-XXX And their nonsurgical standard body risk care trials option. and assembled routine The demonstrates advance intermediate primary clinical that a endpoint. in nonmuscle-invasive met have believe We of compelling both for

XX% urologists urologists intent overwhelming over preferred survey the of of a XX% patients Our research TURBT. study by with both in support the from and ENVISION reflects to UGN-XXX patients and over to use surveyed

are on from Envision The we will week time. that XX. ENVISION our database share that data occur sharing We very results durability announce to will and virtual event at June the later much lock to are to pleased the looking forward we final this host

upcoming Earlier this announced year, of in ENVISION will and a we completion the QX support NDA the we rolling year. this initiation submission, NDA of believe data of

could estimate XXXX. we is as the The overall size market significant. in carcinoma of seek indication approximately market XXx UGN-XXX. opportunity broad a launch early to Assuming as QX currently for addresses. the priority We urothelial intend JELMYTO commercial We review, that that the is

to represents market chance improve impact to be of and opportunity estimate substantial outcomes. company opportunity Conservatively, our for the a meaningfully $X patient the paradigms size This billion. we market the over and a treatment

$XX,XXX research range but incremental ongoing plan pricing to currently to the in we an Our will be expect sales per are Pricing include expansion. analysis market and ongoing, $XX,XXX force dose. commercialization

believe strongly response the invasive will to received, welcome Given alternative we minimally and we nonsurgical feedback TURBT. have patients a

in patients believe on will will to Jeff our strategy provide approved we UGN-XXX an will and intermediate treatment in few in more medicine While a patients, cancer, approved. TURBT with first bladder and don't be the details if nonmuscle-invasive only minutes. replace we all risk for offer expect advance commercial low-grade

of UroGen's proprietary pending step intellectual an proprietary of aspect for management patent XXXX. life our extend of franchise. Medac has urothelial applications, in XXXX next-generation December approved, important In RTGel patent coverage property Medac extended which the potential IND formulation cycle for U.S. our cancer and if next-generation our of next with of April, until program strategy. announced UGN-XXX, UGN-XXX, is we A our for X this key FDA formulation patent acceptance mitomycin technology protection is could the coverage combines into

We for and JELMYTO. being planned formulation in latter We the initiate by of NDA XXX to dosing UGN-XXX and of the anticipate this UGN-XXX preparing thereafter. endpoint end III next-generation our support studies UGN-XXX, to are patients UGN of clinical trial year, Phase shortly

an for As reported, $XX.X over million JELMYTO's QX XXXX. increase were revenues quarter, the approximate XX%

highest More indicating importantly, tested are grow. the patient to QX were continues ever, enrollment in forms demand

in past, delay resetting seasonality to patients the in we treated insurance. have As in of results due being a experienced in QX

We continued growth conversions and for have seen accelerate in April, providing of support JELMYTO. March

suggest extended some level, can released with are the experiencing recurrence about patients We for recent offer field a long-term by trial momentarily, no evaluated a OLYMPUS this XX excited will on findings disease-free JELMYTO complete but elaborate approximately at this experienced who to that the urologists. JELMYTO and its high very Mark impact in are post-hoc patients analysis the a from that We periods with of recently data months. efficacy response. optimistic

Lastly, our in balance our cash million marketable as March is cash and strong of $XXX.X a with remains and position securities XX. sheet equivalents priority, cash,

allocation to launch JELMYTO alongside and ramp-up bolstering strategy the continues commercial cells. capital prioritize its Our supply of UGN-XXX

sustain financial latest belief breakeven. sheet our operations robust balance assumptions affirm sales is Our our enough projections, our and through that forecast current to anticipated

additional to with do our raise capital plan. not we So current need

our medicines new populations company there our position a study further and sustained that, across to plethora opportunities longer-term is said patient for growth. of Having

sheet accelerate opportunities. remain with those and strengthen growth execute balance to potential capital will and diligent We deployment our opportunistically

I our Officer, Dr. will call a Mark? the for Medical to over Chief clinical update. now Mark turn Schoenberg,

patients the based post-hoc analysis results a of JELMYTO XX in earlier. doses long-term complete X-year The outcomes trial Liz. in tracked in long-term the on patients patients enrolled health with from a post-hoc low-grade and remaining of you, rollover XX rollover trial. non-yet-published response analysis start achieved chemoablation receiving use mentioned to trial. months. subsequent in XX of at for JELMYTO for primary their by of outcomes Thank weekly a XX UTUC the evaluated X OLYMPUS from I'd After like Liz response OLYMPUS complete previewing XX were from up OLYMPUS trial results months to and a

was median sharing date. complete of XX.X response months achieved patients results available. indicated review estimable rollover initially duration forward a who to follow-up these the peer of to submit promising patients XX median of as trial, XX% progression enrolled of these response of not XX plan patients signs median updates the or continue cutoff the recurrence the response to all duration in look for Among when for disease and based on to long-term additional no of months. XX.X data show by Results We

which Antonio, with a in American presented. X significant San meeting, total took place Neurologic a of had UroGen presence the at recent Association abstracts

received patients similar new rates while at new XX.X% at that by compared specifically, of for William XX.X% revealed disease-free XX and patients the analysis a in were for response XX.X% Wong both The of complete XX.X% UGN-XXX, TURBT duration that NYU DFS patients Langone. and ATLAS first and for used new which from post-hoc was The improve recurrent survival these UGN-XXX of rates highlighted alone. podium were low-grade for months, UGN-XXX patients with recurrent XX and without NMIBC response achieved patients analysis risk durable analysis outcomes This presentation was to a showed from or months. who TURBT intermediate Dr. trial recurrent

retrograde antegrade the to real-world product in and a approved be XX% the of JELMYTO JELMYTO recurrence in that for original long-term responded size, use is there for low-grade with upper the between was disease tract. chemoablative difference And treatment featured who were not survival at in AUA. rates months the location. Independent presented patients X urinary XX recurrence-free This tumor multifocality administration, analysis presentations methods tumor at does induction. initial appear or to of demonstrated

use with also analysis appears patients Although cohort, analysis that a of maintained XXX% of better long-term associated complete concluded at months. value of the The of XX-patient of consisted administration The evaluated recurrence-free maintenance a response to survival. significantly JELMYTO be authors the XX maintenance these

would I spend in UGN-XXX like talking the a now made program. few the progress about moments to

the for forward intend a of look Database the endpoint is the We company-sponsored later months complete mentioned, next month. share to Liz of at we this the virtual duration XX following June week, results scheduled this next sharing for program at secondary to a results on XX. is of response. response event ENVISION and valuation the these trial, As lock milestone

to proposition application ATLAS, Phase and like regulatory UGN-XXX of and summarize urologists. if OPTIMA adoption rationale for to study, well only disease-free IIb Moreover, the X-month our the the value across UGN-XXX a ATLAS prior the supporting as our ITT received approved, TURBT suggests were of consistency is response TURBT who who by superior the II. response following patients achieved. strength XX% in I'd at widespread a patients In ENVISION once as months rate complete demonstrated to in our belief has complete of minus UGN-XXX still UGN-XXX compared or ATLAS alone. response, is XX complete the plus population, had surgery XX% data

such abnormal attribute detect A their UGN-XXX cells bladder RTGel significant of be treatment procedures. to is for treatment in directly tissue because to sustained X surgical the innovative both release visible this predispose despite of critically all able benefit during time underlying hours. and recurrence facilitates mechanism, to delivery extended not which to lesions up cells that important expertise, its lies dwell This disease may urologists provides

treatment for UGN-XXX the burden surgery disease-free patients, patients. clinically and and intervals offers over believe a recurrence lowering risk improvement reducing meaningful We prolonging on overall while

development the next-generation formulations As UGN-XXX Liz are mentioned, advancing JELMYTO. of of actively we and

for The trials. drug year-end. us FDA, of proceed to was accepted the patients III to approximately a to application trial XX We clinical investigational before plan new UGN-XXX Phase by enabling initiate

next-generation Additionally, we development to a begin UGN-XXX, are JELMYTO, with thereafter. formulation progressing of the of sometime

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

evaluate Phase tolerability the as dose Phase as arm from study tolerability I conducting and mono safety to by for establish clinical late are report recommended combination UGN-XXX We monotherapy II as therapy. a We to XXXX. hope well, and the a data safety,

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

update. Now for a commercial over to Jeff

prior sales Thank QX. resets JELMYTO net in you, and were were to are characterized quarter, compared magnified Mark. which deductible by the first million in trends Seasonality $XX.X February years. January in

in the new ever an forms seeing a patient enrollments to QX, and highest patient in in QX the indicating Liz normalized path As enrollment start, reduction sold. We're trend in with a improvement between mentioned, demand. the and gap strong conversion leading were to units

expectations data and year. the of the typical remain from continued for aligned of track seasonality We with full the guidance. growth year with current rest is The anticipate revenue on JELMYTO throughout quarter sales dynamics

productive stated, the reinforcing Mark a meeting value AUA readouts was of data As multiple JELMYTO. very with

from about data powerful urologists. the the trial follow-up resource We will into serve These long-term which outcomes field integrated data, OLYMPUS have rates of promptly enrich real-world JELMYTO's and evidence-based further to body reinforcing disease-free a discussions robust as with to our engagement complete the deliver response ability periods. durable post-hoc operations data complement prolonged already

XXXX precommercialization early For an well is launch. targeting plan UGN-XXX, the underway,

the As we we a a to to launch. XX% get organization our additional field approximately There's to of our a execute number JELMYTO, and modest leveraging we force. prescriber reps streamlined closer will approval plan date, on sales commercial add existing with overlap

mentioned and has recognized intervals. and a risk potential strongly the amongst new that option recurrence As there disease-free a for both reduce unmet patients is earlier, to prolonged need treatment urologists

their strong overall preference options research reduce can our patient indicates Importantly, for a treatment burden. nonsurgical that

both method simple And poised surgical have data, with and approved, tissue we data provides care. sustained bladder of of chemoablation the bladder UGN-XXX patients non-muscle to to UGN-XXX to treated. treat we the Supported superior that clinical to appears generated cancer a robust intermediate invasive by pathology. the visible the current the be lesions underlying are directly risk to way suggest low-grade standard transform are and administration if clinical

know face XX% recurrence multiple patients surgical cycles time. of and that We resection over of

recurrence prolong concern Our market reflects new research may disease-free intervals. treatment urologists high that a and for rates, about options strong desire

the physician's economic UGN-XXX the will will that be urologist hinder delivered factors anticipate office. also in treatment of adoption not We as

focused to nurse removing of operational patient substantial the administer, use extender, use conviction that so on doctor behind convenience. launch easy urologists doctor, also based being merit a worry-free has offering are preparations any of clinical by their terms advantage Our the to and barriers alone. XXX either or benefit in on and can financial sharply UGN-XXX logistical,

considered process surgical surgery. or unwilling recurrences, fastest who patients are This for undergo considerably. multiple streamlined of X be are UGN-XXX would the the the on adoption research, recurrence we and patients approach had treatment failures, initially early market that those ineligible to patient for will experience occur the and enhances simplifies in patients patients. have believe Based who These groups with

are to and goal and UGN-XXX, will achieve if confident we adopt. broad Our approved, experience physicians adoption have for positive broadly a is

as into turn We will the insights address we will I call key now launch. as Kim we financial you results. to. Don for our over updated keep our prepare to plans discuss

Revenue comparable Jeff. attributable $X.X the XX, of of XXXX. X was in $X.X period made decrease with the in certain the prior JELMYTO million the months of nonrecurring The of is comprised of Cost mixing in $X.X you, payments the JELMYTO the sales quarter arrangement first Thank year, to in fees, with comparable cost. unit primarily period decrease decrease revenue and to million our overall $XX.X in connection million million XXXX, ended with compared for in was million XXXX. in $XX.X compared in XXXX March supply

for R&D was result well expenses primarily XXXX, in our The year-over-year XXXX with for of UGN-XXX first expenses and connection and the million of were in expenses a connection as the UGN-XXX. III study quarter as $XX.X increase R&D $XX.X of Phase respectively. initiation with regulatory-related million

and primarily million. including XXXX. million, $XX.X compares of in compensation attributable $X.X share-based $XX.X million, noncash The the was expense same UGN-XXX noncash administrative the period This brand of year-over-year to marketing $X.X of share-based expenses to increase including general first costs. expense Selling, for XXXX million were quarter for compensation

the million attributed restated to interest first as XXXX related agreement the a for XXXX, decrease expense Interest and result amortization of discount quarter loan the respectively. and the impact $X.X XXXX. and was million of on margin $X.X decrease in the was March of rate in the mended The primarily pharmaco to and loan

and share per XXXX, Net $XX.X of loss share was or first million $XX.X the $X.XX quarter XXXX million for per or respectively. $X.XX and

$XXX.X and cash, March cash securities. XXXX, we had equivalents of million XX, As in marketable

approximately proceeds quarter, our of gross ATM the we million. utilized $XX During first facility for

of our $XXX be to to in Today, XXXX the we are $XX reiterating full net product million. from range year JELMYTO revenue guidance million

We year compensation share-based operating expect to $XX subject noncash $XXX in expense $X to $XXX of conditions. expenses XXXX market million including full range the to million, million million of

to $XX full the million expected The $XX be to RTW is Investments financing XXXX obligation in are related be noncash to of expected this prepaid approximately the to to $XX.X anticipated expense cash. million. to million amount, million in year Of range $XX.X

been on the our of with XX-Q, details SEC. Form please further refer financials, For our to quarterly report has which filed

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

[Operator of question Tara Instructions] the Our comes from first of line Bancroft TD Cowen.

especially us from imagine of that So most think each be adoption you over and I'm of how wondering patients approximately robust in then users? do time, if those continue many included you you buckets may there, X And you could initial which awareness the of you to tell mentioned and the look education as efforts? your are adopters how

don't why Jeff, you. Thank you that? take

Thanks, Yes. Tara.

choices are XX% surgery. around is tells of believe XX% for no because data So around surgery. or recurrence. or there unfit number other are really, to or do We conservative number, with XX%, unfit But the XX%, conservative a a to for that X but us more to in unwilling surgery Medicare they About for that's have XX% unwinding XX% patients. have

So your recurrence. that then and also number frequent recurs same early is

a So X/X will X months. have recurrence of the to within patients X

for. really a patients that So number of physicians have will benefit us have UGN-XXX a told good

to where X commercial had that was those and I whether someone to or adopted whether depending drive the diagnosed newly around question that's or will second on every that patient, it's soonest, available think your it's then X it's adoption a it's have previous. And adoption. areas imperative label, team be Certainly, X then the -- the

with physicians how thing expect reasons of sense is we I'll and knowledge easier of the experience only for that with do mainly the guess the lot that adoption what we've in is already to faster to about being I to few these curve case that give add has be a And what seen have that talked than medicines. much the Yes. JELMYTO a it current and our Jeff and

last even we were for do same you math, you for much be over if it again, than just a If size, being expect JELMYTO, said it XXx on you quicker the we the can adoption it's at But million for So third market, same look the that JELMYTO. the the did JELMYTO, in what what look that. if like was $XX it going year, revenue year to like in was to curve something right?

analog. So good that would a be

line of of comes next from the Selvaraju HC question Wainright. Raghuram Our

give Just with wondering the if on respect following. some could I granularity UGN-XXX, to reimbursement for was you us

pricing upside maybe, it Firstly, clinical explain or range? efficacy incremental if that lastly, factors and that the And why just in potential from to of bit is launched? force little expect profile and that about applicable might code envisaged might might not could UGN-XXX as data a being and is work do Jeff, And be might can what approved you Secondly, a your you sales you think J headcount about then there expansion UGN-XXX perspective? us remind the a case the sales what not how change be force, influence you of currently you're applicable? it's talking to when how an

I'll the see over it questions. and to then for one Sure. turn the do other first the versus past. Jeff But Thanks, we've upside Ram. pricing what X yes, communicated take we in

a this real think it's Again, treatment going I low-grade for is be balance. to disease.

high-grade June that's absolutely think be an have pricing so will impact that. -- in disease, data to is the the So on shared we and also But disease going will I versus different. low-grade final

year, research the gave upper last that. out given had our expect an data opportunity Obviously, that we of we point, pricing So in think be to I balance us thing. June, the came done may push your And same the that what impacted. factors to when data already

now, at and will the higher that a we finalize higher looking what we range I So past. tell obviously, pricing, the the than but launch, even bit before you but haven't talked we're in about we've can little

Jeff? So

me And the comment J on Yes. code. let

all a January for will code, then as review, were second like the quarter permanent JELMYTO, nice quarter, we will XXXX The permanent B that yes, minute we until code they J reviews. So saw you quarter have in with of code we we though miscellaneous Part eventually code following for thing, to a J a take drugs, approved apply J a had we have the and a of XXXX. and

So will depending process. thing on these our now is approval timing, the nice quarterly the annually. that reviewing be that But versus they're

I regions expect as X So Current nurses the that reps those do account key process directors we take well same XX place managers, FRM. and headcount, by to UGN-XXX. territory reimbursement business as around have team, for are supported

but will well. X X those by up expand we right go will We anywhere XX representatives, number representatives of finalizing XX X, to functions followed now support region, well between as kind we're of from the and and as

So helps. hopefully, that

Very or the Liz you on want if to just that follow-up of don't helpful. company whether how expect on I of expect as comment that. the really G&A Don, you infrastructure or wake UGN-XXX's the And change much know approval a to change front? quick don't you in to

G&A? to do you Don, Yes. on just comment want

Absolutely.

So thanks, Ram.

demo after this So to see basically, we year. don't defer actually

pretty force, So inventory do some you be to but will this and it are to spend to add? we consistent. year, Liz, sales money into want build some going then an

No, that's correct. I think

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

of -- bit what in we in And drive as that be -- durability a you what we on data, for? little of upside pricing you the would and the as give should detail then, some looking terms on that us depending durability out, nearing study, commented now Just terms can Liz, XX-month well? data month we're more data, ENVISION

Yes.

Obviously, So XX-month what and the what expect I even from really I'm our of see if are durability be be current estimating. share what what number any beyond, you're perspective I to so we'll sure to saying a we'll and or we the mean you'll guess expect not on expectations do we safety see. do update just

expect share the to median of able to estimates of median be sort of be. kind we'll where So we

great so of And data. lot a

around the -- And health in data that in and we'll the the care physicians my from And that system. been point that value obviously pricing the that's will better standpoint. giving practice a where is is better we've pricing be patients

expectation. our that's So

saying that were what at ATLAS would look too For we data if on you those And a a patients where that be would be win, believe we XX% home I for or TURBT prior all data much, it were patients run. anything area feel and above, so would recurrent -- without was that there, we like the the say XX-month patients in had definitely would and the a XX%.

share we're that June. So again to data excited in

terms drug And what with the Excellent. impacts refunds year? of of impact helpful. the then the And was in Medicare discounts Don, the purchases, throughout maybe That's really of then of and magnitude for associated and XXXB that should -- kind forward quarter? in the the what going expect unused we

Yes.

Don? So

Yes.

in probably expect anything? more So you like think it's JELMYTO. similar I regard a to gross expect of want terms favorable to general, X or to for in more over provision, or XXXB this for number Jeff, specifically do but But X we better Urogen net, add Jeff answer. overall we

Yes.

vary impacts the provision. But that that from we sell see wastage for I JELMYTO remain I does the want and can same Matt, of expand But that not from either the XXX. deliver all the don't those XXXB, one the will more to think it Obviously, bladder will I should XXX reiterate, can just we percentage impacted. have of quarter-to-quarter. be

we be clinic, as its won't XXXB in given will there impacted well most so from be as the impacted standpoint. eventually So not a as of

Okay.

Are terms studies single of to products guess get each? pathways XXX. market? to III it take Phase contemplating next-gen in XXX And will question, for good. development what you just last I That's products, maybe Okay. and then for for Mark, these

Matt, thanks.

program this a of developing monotherapy, the is for this as not exactly probably a think program going basis information combination it's for because about you we I only XXX are, say is to but drugs out So bit really different how know, little types. of using premature X to play us

might be immunomodulators with X combination So chemo. different immunotherapy it a immuno plus

as So alluded on report Liz we for to X. Phase that this recommended II year, has dose going we'll a have, we're data safety year earlier, later to and in know

be But to more little these more for It's what probably on looks a much I as comment we'll probably as talk we bit about development may the able elaborate Liz data say, as want of the the well. combinations. promising combinations, pathway as to like should but most

No, questions. unless additional nothing you -- Matt, you additional had any

making and Just you XXX were about sure talking XXX. not and XXX

had XXX, of targeted I Yes. XXX. kind

Phase be JELMYTO Yes, smaller I both what but we know. original III and for yes, smaller, III acquired to new for than expect we I to for ENVISION, example, apologize, approval next-generation those Phase studies, single our than XXX. achieve for adequate products approvals studies from

Sorry, misunderstood I the question.

follow-up finish in expect is our which quicker for -- to therefore, because enrollment enrollment in we the we'll and why the for is filing 'XX our UGN-XXX. obviously should XXX many enroll which we to patients and UGN-XXX, generation much we approval have 'XX be next Yes, in have as for don't therefore,

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

A couple from us.

with when We question data, wasn't then XXX? call I be clinical see the the another in of far to this about enthusiasm when that for with has of would respect number just I'm that. data you we numbers XXX. there's ENVISION. to would company we on Mark. for we means bar should the say like us level just [indiscernible] you [indiscernible] And sure the XX% know gave sort to if to that what said interpret think respect urologist might how best that and to should wondering how when for the First, mentioned the you adopt mentioned past higher versus a you that

So and XX% answer Mark, always be about talked do of you're that adding. talk would about sort our that of then expectations the you want great kind to that we've

would the lower just and program, thought we that bar, care heard clarify, when its a Sure. we number and so XXX population. with respect practical meaningful. of urologists this independently, that call we before publicly say as chronically on projection with number and than people the came Leland, to We can taking Liz of what be know meaningful that in a of perspective, XX% I to a maybe this number a from many I from clinically think with clinically up conversations started utility be say the terms recurrent would patient was clinical have

number this Nonetheless, was our projection. XX%

the provided from clinical As also that number. actually Liz saying, of unlike better that remember ENVISION you our trials noted, recurrent patients. data was a we've And population than are ATLAS, XX% pure as is ENVISION

know subgroup, So XX% who the a recurrent Atlas for population follow-up when in and the of look data that -- we month microcosm is at XX essentially at those patients, XX we ENVISION important had TURBT prior that durability that the were XX-month -- point. time

what to and be that we would earlier, So mid-XXs, is for what experience. looking would consider something and consistent successful be with to very be as said likely prior the Les we think, in our we

be to ENVISION. the trials hope dose. year, the probably I is like the not have in is if II terms SUO from we're safety helpful. know of XX% then end of which a program. see So certainly just Later we when projecting. we'll and where final what we that's empirically what a likely The data. with exactly would recommended again, the clear, year to And in answer this is to We'll that our actually clinical question respect was we've XX% projection. something That's said own what time we When those at meeting by the present but is able the provide data Phase XXX.

I then may. And more, one if

of chemo regimen naive the the other BCG if compared to in time like other agents you're looking detail at [indiscernible] Given high-grade better results? gel gemcitabine agents and the chemo formulation as gel wondering part

me talk do that? Liz, want you about to

go ahead. please Yes,

So yes.

of of putting different and -- thought I that answer to from But comment the we question that. chemists certainly about IP issues talked are to So we've we may Leland, is the gel our a Liz formulation the drugs a about gel. understood some had know on commercial to if gemcitabine is, able lot you, and in the perspective related the formulate this. want in

As gel. can we X do where well in we agent we've as can we said before, the put know more combination than therapy

we of conversation. the So regard regarding But any going in to defer that had future gel. gem certainly the to again, to I'm formulation plans in Liz

Yes.

broader make to any comment Jim the So just we protection won't There on the but market. the other IP I'll get by then on in kind time to be ways. would specifically, like I'd comment of utility

with. that, the or in is gel in So are gemcitabine either other our Having looking process not be many we moving of said market that current actually agents that stages in something we whether are development in the the forward viruses, would in it be at at into and disease. target our about product, move landscape all be or doing or whole as next what and particularly chemotherapy would market, frankly, a we we're agencies all high-grade types

with XXX And CTLA-X. in important because have the very the high-grade we disease IP program, long do

that will So allow combinations is the some into with -- it we see why give that combination to anything see which being in with you'll allow move us that CTLA-X you'll have as would high-grade disease. to that us would case, have IP

think understood there high-grade low-grade I of of cancer different that looking really things but lot for by necessarily of is disease, So bladder a at, the different, appreciated lot patients. both complexity disease we're not for and a everybody, and are many

really, data, CG ways. really in works at different look at as show does does the populations patient everything start it to show different in that start data, you And look that TAR you really the to

where want products to multiple about And to across we as will the so that more patient these in we be hopefully year prioritize looking different we types. forward definitely But many go go next. we sharing later as prosecuting forward

us allows in our allows to And we UGN-XXX move UGN-XXX expect with that our be XXX. to within that say then generation there's expect population space, with IP to broader high-grade UGN-XXX, it low-risk the But prosecute and against next unwilling being opportunity to priorities, populations this suffice obviously, -- we also even given UGN us to like to and with more that unable also which what low-grade, into begin do extended on disease. patient and

Leland. helpful, that's hopefully, So

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

I This for [indiscernible] quick quick question is follow-up. confirmative in a calling us then and guess for a Paul.

your higher commercial You could data XXX, just overlap rapid if idea you I on maybe on year. the force, this And than just the that an provide that's what you're granularity just that higher-risk given expansion trying add when you that launch combinations populations like more some high-grade update mentioned or safety granular of on of and say. into might about confirm that maybe some might for you monotherapy later the just UGN-XXX data. you color mentioned regarding slightly be potential and some for maybe provide Any general the prescriber then timing disease? the might more and That's Sales to wondered JELMYTO

Sure. of is and Yes. it about talk I'll XXX there sort what just turn then to answer to our first Mark Jeff can expectation over and the question.

ahead, going sorry, Mark. backwards, but go So

Yes, sure.

the disease. start into as audience you high-grade And the -- with said is a be has I'm program as patients natural this would to unresponsible the looking aware, is of targeting take XXX sure population. high-grade refractory as you Liz BCG So the the sort disease, at place in program when earlier call,

timing of So the to in again, that's the with sometime respect combinations year, on end 'XX. the probably of XXX, data

efficacy will haven't we kind been of we data that, than respect in have those to with and would that safety more combinations specific 'XX. signal have but whatever provide on We any we

initially comment to And most that then population seems of approach perspective, into to from population expectation, refractory my a variety would then as the that the but out patients reasons patients. clinical want of a for in a terms of first fit a that of maybe for is this logical is well, program, may BCG to roll

want Jeff, just adoption And the you about to talk of UGN-XXX? Mark. Thanks,

Yes.

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risk we've X patients X a X intermediate category. instead fact, they of in have the that seen year JELMYTO, patients X research fit month to In a with to market

most have I about Liz the won't the We hear it -- second, so as the common operational then like I even just And hear I it don't clinically what JELMYTO don't And is, many call I objection, is earlier, but patients. to that. alluded lift.

give So patients, or -- way already nurse will extender these have have the these of BCG the into will operationally accounts days dose days. fit sort where they They'll in that and already they'll they treat. are right established gemcitabine -- that they'll bring have

be of give We they clinic. will it to will lot want formulary. in the patients of support many lift away. as given to we through operational then But have on bureaucracies formulary. lot so hospital is Obviously, I won't the different, that. and a we'll it And If and in support get a the of much get don't a that goes objection hospital, this have

I'd to further to no remarks. time. at Barrett questions showing for like Liz I'm back this turn closing it

Mark for you. you, June Thank mentioned really how was importantly, presented Thanks and again at want for that as we event It looking us I very XX. operator. I the with well, reiterate excited us. are AUA data great a as to everybody Thank joining was forward we're on the today. just data to And AUA. just

I of you So see hope you see here, to see although to virtually, hope all there, there. but

great a disconnect. now can day. you So Operator, have

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

You may now disconnect.