UroGen Pharma (URGN) 11 May 232023 Q1 Earnings call transcript

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the UroGen Pharma Q1 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 Investor Relations.

begin. may You

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

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

treatment activities sheet for cancers, making statements and ongoing in transform filings, development clinical today's the and products we commercialization the XXXX, trials, to goals, balance ongoing potential efforts, us planned During presentations, candidates milestones multiple clinical available UroGen's commercial financial to our of our ahead, UGN-XXX, among statements. our and seasonality These related year certain product regarding will in to JELMYTO our potential future guidance may to approved, the include be for our future activities call, strengthen and further regulatory R&D avenues anticipated corporate XXXX specialty things. data opportunities, market forward-looking regarding if optimism and paradigm other of urothelial commercialization JELMYTO,

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

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

Liz? the call I will turn to over Liz. now

developing remains for treatment largely paradigm everyone thank population. UroGen today. underserved a novel cancers goal and patient for of you, to specialty the you focused and joining we what is transforming the with Thank believe therapies fundamentally us urothelial Vincent, on

to therapy an to With first important improve tract care for step the bringing nonsurgical we JELMYTO, of of innovative in the treating upper designed launch market standard cancer. low-grade took an urothelial

have and to the year. for of in low-grade risk setting aims cancer, an we patients achieving program, chemotherapy the demonstrated non-muscle viability major proprietary need delivery RTGel goal, a development lead in address unmet of impacting which intravascular intermediate In UGN-XXX, our indication this to approximately each treat the invasive urinary stage United States bladder cancer, our XX,XXX

Turning announce that the to first JELMYTO pleased the since quarter our million, best prior. quarter and from year XX% launch quarter. to were revenues X net second quarter increase a I'm $XX.X ever same

encouraging, be to the in continued previously predictable. model we is assured we've observed adoption results, guidance are reliably see actual While further growth that JELMYTO our with may consistent seasonality indicating

community rural benefits XXXX the be As the we urology are the come Urology JELMYTO American utility of as world, by increasingly and at the in it has to acknowledged Meeting saw recently Association also recognized April. in

Jeff additional of from supporting the highlights of and level, the at the were strengthening conference. provide But real-world high will growing efficacy and its broad studies Mark reinforcing JELMYTO further body data utility outcomes use. presented a X

several the ahead, and is strategy our focus look we much of UGN-XXX on near-term as Meanwhile, at development very catalysts.

on summer. remain this from UGN-XXX we studies III Specifically, of to line our provide top Phase track data

approximately XXX we rate ENVISION, the of anticipate the response endpoint study. providing For complete who primary of patients completed

from will study. While complete and approximately the to patients provide response, we ENVISION, for completed durability the data that ATLAS, XXX predecessor safety

to result expect results, may if target end which or form NDA The early FDA basis durability results, XXXX the trial review, the of prospective goal in with of the measured. to priority in submission XXXX. the at would of favorable be will we appropriately positive In potentially granted, FDA an submit ENVISION anticipation XXXX. once can Assuming approval our be

II Phase ENVISION XX.X% using of outcome to of response XX% the of UGN-XXX months II complete XX OPTIMA response Kaplan-Meier potential the in of and demonstrated optimism at rate from similarity duration trial analysis. Our a which stems a

population. recourse growth can endoscopic of simpler only a as anticipate the U.S. the it if We the administration be patient address and UGN-XXX control. surgery anesthesia is future nearly XX,XXX will the resection JELMYTO, nonsurgical significant for with and UGN-XXX driver product a will believe undergo Therefore, Unlike without a transformational opportunity need will and in fluoroscopy. represent be much significant therapy of approved, risk the larger patients burden alone, primary the much as addressing a new we be who a only disease to repetitive

colleagues, my over address to quickly our to the balance turning sheet. Before I would like call

and to our continue advancing drivers: spend and on core prioritize We emphasize development. JELMYTO UGN-XXX rigorous cash prudence our value fiscal

significant a we are is appropriate. believe to we what a optimistic potential potential market we viable our for of of can opportunities strengthen number UGN-XXX, take Given advantage balance when further sheet that

pass over call Mark? I'll that, With the to Mark.

JELMYTO Thank like which real-world outcomes Chicago XXXX at commenting studies on Meeting recent April. you, presentations everyone. podium for were the Liz, AUA held by in and hello, accepted at X the of to I'd end begin

Dr. of ureter. largest these and utilization review commercial post UTUC highlighted first conducted results colleagues JELMYTO of the XX analysis, patients had and tumors Joseph tumors. of involving treating this from and by first was The In in studies Jacob the ureteral a sub-analysis

outcomes study plus only body JELMYTO treating growing in low-grade ureteral tumor on this XX of real-world supporting disease. XX pelvic demonstrated With to with broad difference endoscopic first Data tumor of UTUC of from cases renal the in evaluation in ureteral evidence JELMYTO at location. use no multifocal of based patients Adding tumors. cases

also on evaluation, based location. In no addition progression to tumor similar difference recurrence efficacy in at endoscopic and was safety results first or rate there

at ureteral stenosis had significant patients post-treatment ureteral with first evaluation. XX tumor

hydronephrosis, kidney new significant of with is excluding fluid clinically stenosis when patients in However, only which patients buildup urine. X.X% excess preexisting due the backup of a of developed to the

Craig was And Dr. analysis second post-commercialization colleagues. results JELMYTO. Labbate a highlighted sub same The from study of and of conducted by the review

in this administered resection. complete when Urology. the issue from of of and May safety Journal JELMYTO of endoscopic the published aims to following Results study The also were evaluate efficacy study

publication, complete first XX% response in the rate response ablation JELMYTO this patients complete retrospective evaluation. study, authors in Whereas UTUC endoscopic that following received patients a first at complete In achieved the achieved evaluation. study XX% rate noted a the in endoscopic OLYMPUS who endoscopic

to The also evaluation detected rate endoscopic endoscopic often study who followed by ablation tumor underwent of failure the by be the intended occurs for treat. for this XX% to the in post in endoscopic OLYMPUS stenosis, ablation months. only. resection ablation those the JELMYTO It's complete which XX% UTUC ureteral therapy XX% of recurrence drawback XX% first authors Early study incomplete was disease ablation in observed to UTUC study. in which a or ureteroscopic for primary compared of is after this The is may patients note due X at noted ablation, to is that that treatment

JELMYTO longitudinal uTRACT further enrolling report including explore in the manner the a are the for compelling We JELMYTO presentation AUA important providing large-scale, process evidence data warrant. use the pleased in outcome UTUC, that recognition are and full see potential data, to data the attention prospective to with the body and of low-grade population. To of supporting studies of for patients The of growing underscores follow-up. a standardized patient following to treatment, acceptance retrospective capture registry UTUC the investigators these treatment diverse further on real-world outcomes the JELMYTO at these of in of

I'd view believe a advance colleagues by alike. that transformative like will turn welcomed which to as and we be UGN-XXX, potentially my to patients therapeutic now I

summer. Liz by As from report the the of end excited to ATLAS clinical noted, this we trials are data ENVISION and

of outcomes both potential Kaplan-Meier of XX about II XX% trial their optimism Our complete Phase from the stems a using trials analysis. similarity which months XX.X% and response of rate UGN-XXX to demonstrated II is duration OPTIMA from a response

with and has allow sustained hours. utilized products for to Both JELMYTO. key exposure for delivery similarities up mitomycin to also UGN-XXX mitomycin X local

clinical bladder and And believe procedures many UTUC features, have which to its critical into the XXx low-grade outpatient importantly, risk low-grade has we direct that advantages UGN-XXX, clinical condition to by which a unique is practices. a chemotherapy. NMIBC catheter managed instilled common routinely urology more use. common be to not and in special X urethral over is to designed and and to common a via XX% as in however, is impact does most and low-grade intermediate require JELMYTO, including This both for will equipment be responsiveness on leads similarities, the share will It routine NMIBC several biological procedure XX% setting, urologists. an advantage of

for Inferring administration intravesical I our other use TLRX UGN-XXX, immunomodulators, with development technology to in chemotherapy Meanwhile, antibody agonist continues UGN-XXX a is other therapies using significantly any our potential NMIBC. population. in-licensed in larger addressable treat proprietary RTGel UGN-XXX, including and to trial anti-CTLA-X our enroll. high-grade for other Phase and patient combination with

the for identifying II at suitable aimed study This subsequent Phase is a trial. dose

monotherapy arm will ranges later begin of evaluating the this as arm study this arm, first this potentially before which completed first is be expected the dose The combination UGN-XXX, end UGN-XXX, from year. the to of could year. Results of of for dose our appropriate inform

high-grade inhibitor of cornerstone UGN-XXX checkpoint as for a variety therapies combination view a NMIBC. We potential targeting

for that, with turn to Jeff I'll over And commercial the call a update. Jeff?

and March QX represented I'm since prescribers of in XXXX from to on uptake XXXX, carry JELMYTO Mark. as first accounts. Adoption activated end quarter compared were quarter sites trends the X, demonstrate our in in XXX encouraging on strongest new X,XXX pleased repeat X, last patient repeat XXXX. see continue year Thanks, and the momentum to into launch. to metrics sites the for Activated second May

compared the same XX% across types. remains accounts at XXX all And were XXX coverage repeat approximately for Reimbursement to period.

and to take we held Diego, to first the key quarter, national During like several sales in a I'd meeting San moment our takeaways. share

demonstrated observed low-grade our once penetration their overperforming who to have pleased previously improving exists opportunity have strategy JELMYTO. developing shown meaningful in say is They recognize success in for territories, territory We've adoption which embrace the discussed top in our that we sales revised I'm in designed growth emulate performers the First, to physicians territories. accounts. UTUC sustainable

also that we from rolled the growing across and the has data messaging evidence practice viability real-world of out JELMYTO of meeting, the At demonstrated sales body patterns. various enhanced resources

our with to engage effectively existing these new resources patient adoption We in and the field penetration. and improve appropriate to expect new to further accounts ability drive team's

treatment again, Liz's of UTUC the option very states ablation a pleased guidelines. UroGen presence to are first-ever be for this of and disease comments, UTUC on to low-grade had as and Meeting. AUA with The at specific can which year's management. should we a be a low-risk a that SUO guideline the JELMYTO Mark clearly option Building for kidney-sparing AUA initial JELMYTO approach in see major management patients tumor part mention treatment

a response. With a patients achieve in durable the use with multimodal regimen, UTUC JELMYTO of complete can

as guideline important JELMYTO that the for impact, offer the to such can up new latest and an proud patients in by an positive we are in broad guidelines. and low-grade treating milestone treatment SUO recognition is And of important innovative by a and the have UTUC. UTUC backed low-grade advancement We therapies as This AUA AUA the treatment tumors. is view of

Our demonstrations the RTGel how booth featured innovative with meet care technology is in advancing on team to and allowed physicians. uro-oncology our

theater on and KOLs a recently featuring published outcomes Jennifer data JELMYTO case It product included and Linehan including patient which the Prasad, actual also data focused Sandip studies. real-world

clinical acknowledgment continuing SUO we and with communities and AUA UGN-XXX. look and our prospectively introduce develop Overall, of further as to JELMYTO we to expand to are forward clinician through impact society, and see real-world and filtering very we pleased and to work the progress

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

pleased for everyone financial to Thank XX, review you, to the Jeff, ended you joining be first March I'm quarter with for to today's our you XXXX. and results call. today thank

For million XX% with in of line estimates compared $XX.X product XXXX, last of and consensus increase $XX.X of year. in we revenues net JELMYTO quarter the the period same first million, to reported an

For UGN-XXX. primarily I million is the Phase The related for related research by first XXXX. lower for ENVISION due were to quarter expenses to and $XX.X the development and compensation same expenses of to clinical as higher the compared to period the XXXX, study in million offset $XX.X manufacturing trial, expense decrease R&D

affairs in million for advisory and for the compensation expenses million. to and compares commercial, same $XX.X period stock-based to expenses, This technology, medical XXXX. primarily higher XXXX is the due general offset Increase expenses. $XX.X quarter lower market to SG&A by Selling, information first were marketing, administrative access, and

for ordinary or the in as $X.XX million net loss a per share ordinary of same and quarter compared for XXXX, expense reported first $X.X diluted a prepaid loss investments net noncash RTW XXXX. basic share $X.XX million a net a reported quarter diluted the XXXX. for UroGen million loss $XX.X of or first the to basic $XX.X financing of of to to obligation period UroGen forward per and the related

Turning million to range noncash $XX forward the of year full to million $XX the million year compensation be conditions. $XX the revenues million. We $XXX operating of million, XXXX guidance. expenses $XXX to million, from We of to reiterate market XXXX net reiterate to $X product full in expense in subject anticipated range share-based be to including to JELMYTO

anticipated $XX reiterates obligation year to million. related the full company to XXXX financing The range noncash Investments in to prepaid expense million RTW $XX of the board

Of to expected to to finance into million the $XX.X is securities, be and XXXX. quarter equivalents in cash this cash. amount, approximately which with million $XX.X ended $X.X and We million is operations its expected in first cash marketable

support activities. balance To committed managing echo proactively are and we sheet our our in to Liz, and development clinical diligently of commercial

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

Instructions]. [Operator

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

you you retrospective if what a take from the the in practice to JELMYTO to seeing to on the extent analyses now, could us it anterograde you're inform for to to clinical to practice. Firstly, of how see I installation? use particularly regard expect of give changes effectively begin with real-world long And sense findings wanted clinical

a to and do want to add may it Mark, well. Jeff, you Thanks, take that as stab to want you John. at

So Jeff?

Thanks. Sure.

The to the data. So reps out answer is with the now immediately. right there question are new

it's urologists resecting they've to particularly and how a the able study, because better is hear to They're in practice. see JELMYTO. So what want Typically, physicians, rate. been bringing new CR about doing endoscopically they

using to as reinforce and it out you physicians to with this to about there's after those accounts then come that been big the so we're data. all new already using buzz that really opening to -- And know, how expect I are that are territory significant come that's the business AUA doors this yes, And of is talk the it data for managers seeing some it. on expect I board continue.

we continues Regarding about around and bring up rate. help go clinic. justify your the intergrade, the outpatient out to it and it that question, of will hospital talk continue up. to certainly stenosis The accounts the into Dr. lower data it continues go to Rose data in see and their It getting

as So with patients to retrograde to the that it to it want physician or flexibility do their provides or whether they antegrade. not

publication strange explored already using creative Yes. only in trial. the of to that evidence I were think thing is doctors that would actually that Ram, I sort way, add the that in a ways is in originally OLYMPUS are the a not this

see So think you I I C Jeff medication. the do what it's think support more will more with I And of very validating. an what and this. And publication gives said, we the indication expect to doctors of

Great. of on the us line and the registry And you expect Okay. remind when study? you that just be from uTRACT publication you can potential time what study data to anticipate then

I can line. comment to the time

standpoint. get we So recruit an IRB everything from continue the and to care investigators taken of

data, but meaningful once it's you of hit number Liz -- going continue number that's is The my So at the remainder from maintenance, sort in to registry. number to and really ureteral things patients, that are a point comment, lot when a But the let it's of of really data the year. through studied I'll looked standpoint, whether that of patients. of only. get sort retreatment, you of that's from meaningful A being

to add Yes. nothing really here. I mean

I registry. think ongoing it's an

registry. when and certain enough -- able there's and the be we'll mass have point, plan ongoing data we a we'll queries feel as like to publication continue we Jeff's to the publish, an -- to to mine So have around of

that JELMYTO assume could XXXX, But correct? uptake, registry from would possibly inform the there it's not information to that XXXX in useful and unreasonable be

sure. of about And real want mean an we'll your mean, understand to look, use We'll inform I data as in We retreatment. ongoing No, like the way physicians To have as are I more how world. absolutely. point, it I to stream about definitely, will, using understand optimal Mark's to sure, if out. point, we so commented, more Yes. Jeff said, -- XXXX understand as want yes, to not -- I we continue, coming to it. said, soon absolutely. to we continue earlier, by Yes, want We maintenance.

physician last Okay. you be approval. of can to to respect extent able and which larger JELMYTO data use is versus you regulatory a is awareness would for of that And with how effectively give timely the market sense the much to us size UGN-XXX you the question me to a ENVISION then JELMYTO and for start, quick UGN-XXX give receive UGN-XXX, positive assuming study running is target just

Yes. great question. That's a

compared what bladder intermediate to which with XX,XXX X,XXX invasive UTUC, mentioned we non-muscle patients to cancer the about to low-grade challenge, be consider is we as a there's right? who have X,XXX patients risk As earlier,

of always commented his that issue success or all prepared said doctor, see We've in UGN-XXX. our patients. patient don't factors remarks, about key along that you for that challenge JELMYTO with critical identification, have one Every these Mark was earlier as

see So situation is X do what X it's basis very to an only patients or JELMYTO the of us a here going and where with adoption these you the them big not will And and think that into on year, a that the they you're absolutely see ongoing said and continued head consideration of uptake, of by usage even I difference ease doctors is of between UGN-XXX the now plus absolutely continued use start the give taking a then, UGN-XXX. new familiar.

initially level. hospital to have versus where appropriate a at to most are center community be equipment. the and seen go in or is to And right, there needing you done be the easier, will clinic UGN-XXX patients where the really -- much surgery a

we've JELMYTO opportunity what for obviously, larger all into absolutely, for around RTGel. of But said population patient is, know that we bladder. lot get we us around our the is And biggest as proof-of-concept So there's a the anticipation UGN-XXX. along

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

Roderick is on This Paul. for

the study? that Phase And the you incrementally factors we invasion of it think couple questions. improve XX% kind is so could CR have Do IIb? in UGN-XXX one the rate a of first to And in upon what the help

really I sure don't not in frankly, that I'm studies. those expect, we anything around your but question, understand there's expectation different the

III efficacy. like think I We is actually larger be a thing feel move lose expectation our between a will two. to in when to similarities lot data note bit a -- typically, the you the the Phase we you is important that there's But little the meaningful. study, of

that the to I to I'm have -- don't Or you from see data. if Mark, standpoint, sure excited question... And misunderstood do not But we're anything add? the I

You same the -- the way I understood remember it's studying think understand way the II. people studied to in that and it important that we you Phase did, the I we're

So as be reason the similar. out, within for expect we pointed directionally Liz results to

And on follow-up it. just that. Got a question

the since your has So on forward uptake seeing from in any on the would increase interest probably your sales force? force AUA JELMYTO, in the presentations, sales the physician the feedback based what change

Yes, Jeff?

Yes, this If all preserving was product really reinforcing around removing short function the in been and the theater, AUA and what between the at had not it low-grade AUA X ignore space. AUA X going -- kidney presentations, the saying for answer. in what out, the coming guidelines of hard the we to years we have kidney

but preserve obviously, of those it the from everything to from hear is it is guidelines. one hear to urologists JELMYTO that Obviously, kidney. basically And says be you doing colleagues, part should we us from thing,

So super excited.

And obviously, waves. in it will be

weren't local Others we'll it firsthand. got Some attend, their able were updates continue from physicians guideline to hear that the representatives. to that there

Got it.

confirm, runway, into it's to cash guided so your XXXX, current right? Just

correct. That's

next our stand Please question. you. by Thank for

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

for quarter what bit seeing could first little you're means seasonality a for And product? the Liz, talk more the the about that JELMYTO? on Congrats results. you that

Jeff I'll happy add about absolutely. to comment any to commentary actually that end. Yes, ask at the and

Jeff? So

Sure.

Matt, see typical in on year co-pay So of the we early resets. patient the beginning your

And so January is a past buildup.

the taking And -- clinic hole. patient to enrollment to seeing vacation, some to seasonality as to OR then get reset. Xx wanting there or folks start not a into go need through building QX, then strong the we're is up we're from we Xx. the So with forms regards that And a the your result donut

And so strong QX sort you buildup hopeful QX. this past see, continued of in again, and

So over see We have QX we'll quarter, it's B that seasonality this procedures last important we continue in continue trend. quarter the year third the with think with and general. quarter. common drugs for believe QX that is year, But as particularly to Part is that, that to in quarter do do have us common to

think And at it's and it $X 'XX year. the the last QX only look comment of the $X.X about important 'XX. about this versus drop 'XX million. between Whereas QX Point QX difference I'll was make being additionally, from was of Matt, I year, to million 'XX of QX a is of

sort So happen, was we are same expecting little are with QX seeing you flat year basically, remember, and that gap bit, almost of close last QX. a if so thing the

sort flatness. the while a So quarter-over-quarter, kind of you see you saw didn't uptake of

expect we the the had seasonality that where it So in muted to difference quarter been compared in will and past. the be

at So think will the while to be that, level. we it to do expect same we see continue don't

And really the to the That's about ENVISION and you we're the can summer well. sense can give of same readouts, announce As the And -- are and come as time? -- you other? more? one little helpful. bit thinking narrow the you them terms a us before going timing Okay. in at Or ATLAS summer as a

like go really wish for the ENVISION from like saying really I sort lock could. It's time those I that follow-up by can that always we're of it wish it's away. XX that and of the takes But Yes, I around months days the held I I'm durability. database make

a of event is that and to the we're tell data. it we What the virtual wait plan I together. share do to have all going now will And right is where you sort

limited but as we of in a the get both those. it we meeting, well publication both can to of presented a be published will as amount data because share want medical to will We we do at have

of first of August. July July maybe it the say won't the end towards half be would or I but And X,

to we'll as it have as intention want soon those data, the at So do of sets we is share that, together as point. to soon this as but --

of Okay. That's the provide read-through helpful. for to you what for what response ENVISION? expect ATLAS think do will And type duration of

I -- differences Yes. and similar, be Mark, and the don't Mark, about comment maybe ENVISION we on why ATLAS we they'll well you it why want between right? but only think similar. The you be to talk mean, expect as may to this, difference that fairly just

Sure.

As to the I'm II remember, includes disease, both recurrent sure that what intermediate similar new saw the which in you in -- ATLAS you we is Phase patients trial risk have and -- what studied we trial.

is similarly patients actually disease patients only. and have that We recurrent ENVISION biologic a in or disease UGN-XXX. don't perspective, so our from with And think recurrent to who limited respond clinical that new to hands, matters. far

So what our data is and to indication should the expect trial. some ENVISION had ATLAS us similar that from the should give look ATLAS and that ENVISION to as you expectation

All right. And then last question.

year? the As with this to are initiate contemplating what you monotherapy later you complete XXX dose-ranging combinations for XXX,

you do want comment? to Mark,

sure. Yes,

antibody UGN-XXX, studied in anti-CTLA-X So we've as of with the preclinical know, is our our models, agonist. which you combination the TLRX

certainly that other potential we've So immunomodulators a But and both chemotherapeutics. obviously thought and long candidate. about potential hard also is

table And Liz, may so would for want certainly that. be plausible to on elaborate those you either, are not but UGN-XXX, off the candidate a

agree. I Yes,

multiple could exactly I haven't one which we ones. first, think decided all we do be at will but

doing in what we evaluating sort UGN-XXX, combinations that partnering as we're of one. is the well. best we potentially are But think interested TLRX, with the So know others

we it quickly makes is in depends that want and of sense those So conversations partnership again, hopefully, on one the go what see think others. how to sort and that all do with I would

by Thank question. for next our you. Please stand

Our next question line Rohan Oppenheimer. from from comes the Mathur of

Gershell. on Leland speaking of here behalf Rohan

one Just for me. question

comes authorities low-grade and you NMIBC in or current you do what alongside when what and it for see And paradigm to durability the efficacy intervention current looking think management? X NMIBC low-grade regulatory disease compared high-grade? do and surgical So are UGN-XXX, for to sitting X

start? why Mark, Yes. don't you

Sure.

data clinical of think UGN-XXX, to the what the totality are and regulators with Phase for we of it's meaningfulness the III of So looking the clinical program our respect for in terms outcome.

in of be about complete the that combination, rate that response will complete a So durability obviously, response and responders. the

attached obviously. we that There's complete that those patients that. are, and observed that need what in to multiple to no But response on Phase half patients what clinically previously be I said a meaningful. number the our of that And maintain the half line at would response patients Liz to if see months II achieve with continue program, and follow-up, XX of we have results in

that hopefully, So least sense the you will of a what of gives be the it thinking, we're at totality but data.

because at approach think, including are to, an already patients intervention, into Liz those about chemoablation primary disadvantageous UroGen. where terms our who of a disease, non-muscle as with will represent big alluded these many in of clinical a going literature as to real has chronic of In of treated practice, population clinical opportunity a us discussion already by surgical there's patients which a is approach is on purity which a is this patients elderly fit population recurrent invasive

we primary disease, how group And is disease patients So real trial. different with in some the recurring transurethral of is because for studying the different in think ENVISION a resection totally high-grade then therapy terms approval for opportunity that are to there that's of of replace the and disease, animal, nature hurdles the benchmarks the disease. compares high-grade with and this a substantially in we're

few you this a approach really So not to that sure, with may the studying. are it's population make on I'm and we want to comment comparison and the Liz

disease. you when in when you're It's looking landscape, that high-grade and agree. you is I do those all The at see I comparison. what of say hear being will probably a not competitive thing fair studied the Yes, drugs are

products because more FDA in longer studies, wanting that's the from hearing wanting more high-grade more studies you're the about and space. approved or studied So being now and comparative there's multiple

in only But of the And are III. early. ones we being near we're the but couple the case that about, the a in ones Phase that's they're we a be very low-grade actually will space. that only not There's and anywhere other hear

so in because are alternative -- situation a patients. the in for position be we very different And only think we'll these I

seeing as a again, to, of JELMYTO, XX% JELMYTO, XX,XXX, believe that we're and practice. addition But talk biggest also instead real patient to what TURBT. use are these with patients that pool. the for think patients, benefit But the population have in XX% I these those just with in may about seeing of UGN-XXX you is whole recurrent do when having we idea, the see of we the we're

pool prevalent and are they're So the patients recurring. those

And that more or we X or X/X more about them XX%, really about have recurrences of recurrences. X have see XX% and

to have we through fair going population. say access I who be expect it's already to these So to patients entire think multiple that the are that these recurrences. low-hanging fruit But able

question Peaker the from Cowen. Boris from next Our line of comes

Great.

First, ENVISION data, the or you is What the specifically perspective? FDA the comment longer-term for from follow-up? on you file data like hurdle and said see if durability could exactly on to the follow-up they'd X-month if regulatory can

Yes, want Mark, do you to comment?

Yes.

we're So which not response of endpoint, XX assessment demonstrates therapy complete rate and in X of that response our it the response assessment on of as is we surgery. months. key following for to compared complete the to window think primary the is the value filing durability the targeted durability The the exclusively approval we've months the

of to response both want elaborate may and combination also. a complete with it's the response and So rate durability Liz the

Yes.

durability is going the that FDA comment clear very it and we to agree. Just made that important,

And endpoint, so while endpoint. a secondary is an secondary important it it's

we'll all months, patients will the to we've go past data what have to patients we we've file of XX on that. FDA months all is allow ENVISION. and in some decided that us the beyond And with patients obviously talked about what XX once So at in

what this soon the data data conversations on depending we quickly can talk is -- FDA having we'll summer. this sure of how to honest that at actually -- day, and we all Again, end to we patients we with to so you, little have Look have how make out them, start to a earlier that want see data we're going months. get patients plays XX here. We something did at the of the level the access to with JELMYTO. we And bit medicine. did as that we'll the And similar and that possible an with the about see as be

possibly part do want review study fact Got the ATLAS on it. of maybe the to then as the And as that... well the you think FDA ATLAS, will considering approval

Absolutely.

ATLAS in than patients More ENVISION.

what in So in parallel case, filing? for the show do think if you to you need ATLAS that's the

Yes.

as the be may comment is data, safety. to as you I mostly around going and the know, we Mark stopped to think ATLAS Because want well, study.

So the won't make half TURBT, will be of particularly to will it, be safety data of around those so about there'll of about but remember, XXX but comparisons. be patients you be those half UGN-XXX, the able and

powered wasn't be because didn't so. make to won't -- it FDA The able do comparisons to we

so that from is expect safety mostly that in be going FDA And interested to study. we the the

Thank you. Liz questions At like this to would for time, I see Barrett the closing turn it back no I remarks. in to now more queue.

and us time mean, Thanks, an it's thanks, exciting for in everybody. I see, you XXXX. can as

every I think we've We I this to year, say catalysts a continue. year. year it's for of need but pivotal us, a lot got

We will to continue execute JELMYTO. on

showing how really associated data have feel of JELMYTO and a with like it's used. We lot we incremental

about to see QX, adoption. JELMYTO. QX, good so well. for to continue so but feel -- as advance know Things in And that far talked QX comment I about are we I continue will we to we expect

In lot addition and see to that, is data. about excited, to excited up. UGN-XXX I Catalyst is hear coming the a and we think everybody

let questions. So your and we know thanks any But interest staying forward company. to our have support for always, as in look in additional and if touch, please us you

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