URGN - Earnings call transcript Q2 2022

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the UroGen Pharma second quarter 2022 update conference call. It's my pleasure to hand the call over to Vincent Perrone, Senior Director of Investor Relations for your [Technical Difficulty]. Please go ahead.

Vincent Perrone

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

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

benefits in regarding clinical term statements. potentially candidates, data During ongoing reaching loan today's potential second the and documents, be presentations, filed opportunities, breakeven guidance, will relating our potential may Jelmyto, flow These the revenue XXXX, commercialization by our future current call, Jelmyto statements of factors cash including latest to subject making quarterly quarter and certain availability under activities These planned SEC for other of ended XXXX our description information facility, be and and statements our regulatory today. include disclosure forward-looking of research June on product report trials, to the we expectations risk of our up ongoing filings, efforts assumptions, our among financial that XX, heading tranche the and and the are found risks are A press earnings based XXXX Form things. can on XX-Q change. forward-looking release

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

Elizabeth Barrett

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

viewed of second our release, this XXXX As progress morning's press lines. summarized can be primarily three the quarter along during in

Jelmyto of the revenue. is continued growth our First

Jelmyto and is of between a the Second in thread our strengthening enrollment of real underscoring evidence clinical pace of is the setting. world common the benefit the The which third I execution detail today. to areas in programs, body discuss of further and am these shareholders, more is disciplined deliver benefit pleased from with and patients team value entire commitment to to to of determined you each on our

to remains reflecting for goal largely with from crucial paradigm overarching transform cancers, therapies. population underserved specialty a urothelial novel patient fundamentally need treatment a the for suffering Our patients and

of at is approved for our in the XX% data and from currently throughout detail, XX% outcome growth Carcinoma. revenue medicine And adoption prime describe Jelmyto net we Upper with guidance over see pleased example million, we that of acceleration growth option increased overall remain a and confident Tract our of with including a in Jelmyto will low-grade recently patients a Jeff AUA. presented need more commercial XXXX. adoption a results growth year-over-year review filling Jelmyto I'm continue suffering to But report of $XX.X to of QX. a of and Our expect remainder Urothelial original

end. clinical two on treat importantly, remains invasive ENVISION our actively UGN-XXX, by are III pivotal to in with Phase non-muscle expected development full trials a Jelmyto, year enrolling our enrollment bladder of for medicine Beyond and underway at novel intermediate-risk track cancer, ongoing rates. low-grade patients Most study

is $XX XXXX. $X with patient and and UGN-XXX review, to billion in opportunity Based on and cancers. clinical is to revenue filing a a models, UGN-XXX confidence are This reach XXXX. to application features on first first combined broaden targeted will similar anticipate to challenging million safety have UGN-XXX will approved, by may technology to anticipate year on the FDA Post facility with on with for flow leverage XX,XXX locally now. Jelmyto additional established of further If capital We base delivered from for Pharmakon product end by for recognize streamline immuno-oncology a targeting up the an Mark framework we by companies our NDA shortly. immunotherapies, revenue revenues data, many the as we our the to common range Concurrently, we expansion access the and funds XXXX million we $XX in our alone by U.S. XXXX our for we CA evaluate tolerability provide primary patients research, and achieve of in-human a our Jelmyto portfolio an we of full these an provides positive capital launch of as UGN-XXX ability $XX large the prescriber $XXX population which addresses and Assuming market priority and and Jelmyto. the term potential guided into managed a of tools Based our and our study million the update with of current of non-surgical commercial believe Advisors. cash the product projections that high-grade in believe based over right loan financial well to are urologic ongoing be million in approval XXXX. to approval, able patients. therapeutic markets for allow will inclusion treat given our to need breakeven

our not we term last cash. quarter's raise full need year Dong do a to additional expense updated reflecting slight our will near a However, decrease projection. guidance projections, operating share foresee in from

With recent over additional are against are our goal to weigh these updates. considering, studies our discuss turn development Mark I'll opportunities clinical to and profitability. reaching development of we the Mark? to there we that opportunities business While continue call

Mark Schoenberg

you, Liz. Thank

ENVISION is of single-arm each to which with performed and resection, for and bladder low-grade current on recurrence. non-muscle invasive the both due evaluating cancer. endoscopic I for no of chemoablative in that There the described, as are patients UGN-XXX worth recurrent patients with study, restating is trial intermediate-risk in the efficacy low-grade Phase tumor non-surgical time, U.S. UGN-XXX suffering repeatedly full the Phase multicenter are ENVISION majority Liz with safety standard XX,XXX and alone, of As trial primary therapies is our UGN-XXX III in international year primary approved disease and forward the on it's a pressing from this disease care surgical approximately patients therapy our budget. steam,

the to The XXX XX rate first key approximately across endpoint will once-a-week months the will a the who receive X patients who assessment. enroll patients installations complete month time at installation, sites response and primary complete We endpoint X secondary at expect the evaluate achieve response will after UGN-XXX. in evaluate intravascular over clinical durability X

potential As reasons. design confident for we previously trial the of several the remain clinical stated, UGN-XXX the and ENVISION of in

subset is experience with participants research which evaluated wake recently observed design Journal information like rate UGN-XXX a were article come published First, of invasive XX%. the on interesting non-muscle response our IIb where trial. points Phase recurrent and a previously in the of enrolled cancer, ENVISION of Urology and the of patient complete North Participants shares light we patients, intermediate-risk and of OPTIMA similar which study subset completed at Carolina patients Investigators take to study new low-grade to the at II emerged. questionnaire to And Several therapy our bladder of response in by by analysis be from program attention in Kaplan months this of of everyone's Phase detailed modeled. draw XX to interviews. OPTIMA by a in trial recently XX.X%. that IIb piece moment duration has additional II I'd the detailing the the this an to estimated an a in Phase to University start IIb Meier of ENVISION

reported following few patients with side effects treatment UGN-XXX. First,

considering other interviewed standard would patients third, And chemoablative recommend many bladder the which participants to most with Second, to had UGN-XXX preferred treatment cancer. non-invasive treatment all care of prior experience. for

NDA the for to by that results the of will complete preliminary, the plan new aim office-based While ENVISION could to in submission are for XXXX. end recurrent to guidance Liz's these NMIBC enrollment encouraging further the contention of valuable non-surgical patients. and I data, and assuming management of positive be XXXX we trial the approach support reiterate an

our UGN-XXX, completing and advance in I top also we UGN-XXX single-arm months. year. also our described for Meanwhile, April this anticipate with While track UGN-XXX is on for ENVISION completion remains which feasibility first-arm continue initiated at-home XX priority enrolling trial actively installation we study for previously, Phase within to a

via cancer. bladder variety we administration a immunomodulator care in parallel. More checkpoint combination I'd including non-muscle is with recall to since potential combination Jeff? other subsequent to a just We drug with to the protocol also our TLRX with to a to therapies in and indications commercial a for as immunotherapies beyond agonist, this UGN-XXX for targeting RTGel view program cornerstone and Phase specialty clinical it It's antibody turn opportunity will explore for will that, with for a development efficiently trial. development combinations cancer. This of You'll variety combinations an non-muscle a immunomodulators, and call allows see worth UGN-XXX proprietary invasive that RTGel and in-licensed more intravesical high-grade bladder invasive multiple evaluation as to a treat of advanced And potential update. design provide high-grade across administration technology broadly, the intravesical study immunotherapies our UGN-XXX, suitable in chemotherapy master use reiterating urology to our that ultimately II believe like UGN-XXX, potential in other novel cancers. and for Jeff provide dose seek determine utilize anti-CTLAX streamlined over multiple inhibitor a we novel study will

Jeffrey Bova

Mark. you, Thank

a QX, XX% year. As from last increase $XX.X increase Liz the period representing XX% in QX noted, Jelmyto sales at continue from and to grow million a same

previous million to the product for fiscal Jelmyto Our year of $XX remains for $XX net revenue million guidance unchanged.

May while ramp August May repeat were on XXX strengthened compared Our as normalize. were on Activated continues accounts XXX X XXXX. August on XXXX, to XXX to the environment X, on sites X, XXX to X compared launch

feedback and XX% installations the important approximately our force manipulation months. Based during trend has Nephrostomy confers increased more field in to and installation. from including multiple managers, and business tube patients directors, we This our Nephrostomy minimizing nurses, territory adoption on in past approximately encouraging XX% the track administration from the benefits, potential physicians X Jelmyto modes for business Another administration. positive flexibility scheduling, our over administration, offering of of is we of ureter the multiple regional believe metric of

In Nephrostomy at sterile placement fluoroscopy may to the performed under Nephrostogram by installation clean confirm be first rather does than professionals nursing addition, after and installation. want not trained require conditions

received partial the of examined Jelmyto XX Additionally, complete by presented Rose. retrospective a Nephrostomy world premier four dose analysis a a of exhibited American via therapy. Kyle was at patients went patients real by had another one meeting at maintenance response, Dr. XX who on described academic Urological This while XX how least recent data patients analysis Association of response. receive X patients XX of to institutions pooled

no stenosis function. were patients. no adverse ureteral events impaired in had There severe reported renal occurred Importantly, XX% and X of or patients

XX,XXX cannot than estimated and also of and we existing the XX% hand non-muscle our XX% strengthen, U.S. ignore recurrence. While $X encounter encounter prospective continues at business invasive market with recurrences, than and this Jelmyto billion, The the low-grade XX% opportunity UGN-XXX. opportunity two and intermediate-risk considers mentioned cancer have X. patients in is that more those to or more after with bladder

have In as addition, that with of physicians repeat anyhow. surgical XX%, And shows research procedures of to mortality these patients increased averse to market identify independent TURBT be been ineligible found or preliminary surgery associated risk. of XX%

call that relevant of of to discuss X avoid ease the within no that, would should they or surprise years to TURBT, the done. potential of to protocol of happy UGN-XXX indicated urologists approval. XX% financials I'm into treatment to their our the pass With surveyed adopt Dong come With limit and UGN-XXX over administration as it

Dong Kim

XXXX. thank you, second to quarter $XX.X It net today's be of financial product in of reported joining for compares XXXX. the $XX Jeff, UroGen million the you for pleased XXXX our ended approximately review of second the to million. everyone to results call. with second I'm to and sales XX, for today of you Jelmyto June quarter Thank quarter

$X.X XX% a approximately continue to Jelmyto and in net second million, Cost of compared $X.X revenues [indiscernible] year in $X.X product pre-clinical the quarter respectively. second Administrative XX, to of R&D the for full $XX.X. the of expenses Selling expense in expense the XXXX million. June $X.X $XX.X Urological including for a work ended III June share-based revenue and expense in period XXXX million between to to related of study million of Phase margin the of expenses expense expense in quarter million and million increase for participation Phase to compensation quarter compared XXXX compensation and million respectively. from non-cash in XXXX million offset XXXX offset compared gross to $XX.X a XXXX. ongoing Research resulting of anticipate $X.X the in I same quarter second meeting. second margin the of were share-based compared and ENVISION of XXXX, primarily compensation for SG&A expenses UGN-XXX American UGN-XXX for related the is second from was the includes quarter in of The million XXXX. to million gross of $XX.X XX% as expenses for quarter $XX XXXX. expenses and the year. by XXXX million non-cash Development resulted for prior quarter General the ended expense, study and $XX for We XXXX decrease second annual reduction were in Association XX, second SG&A The the R&D XXXX by the

for of expense compared related to XXXX. million was financing the investment prepaid the Advisors second same $XXX ended period $X.X expense million second June million to related forward the to to million funds loan For quarter obligations term facility, $X.X XXXX, XXXX. quarter managed with RTW $X.X the in Pharmakon of up by to Interest we reported XX, for

transaction of second of quarter was XXXX, the March in XXXX. in the As no expense such closed there

net For reported XXXX. $X.XX million $XX.X XXXX, to share XX, quarter of the a loss of loss the second or share. in This $X.XX or net ended second million June per per of we $XX.X quarter compares

$XXX.X of the cash, net XXXX share-based second million share-based closed of the So $X.X compensation equivalents, in quarter We expense $X.X compared compensation in loss expense to second million with securities. and for million includes non-cash marketable cash in quarter non-cash the in XXXX. quarter

further second quarter, steps commercial to our the balance additional support activities. During of development clinical our took sheet strengthen we in and

where take ensure needs assets environment acutely and diligent, term $XXX as challenging funds prioritized this we and our environment. a than closing markets million and As core to Liz routine, mentioned, to in capital our are market operating of the believe Pharmakon met. to facility the aware capital of loan management position of comfort We by responsible more challenging the with managed are up of March in Advisors are our weather

of term customary remains As of $XXX with million end before a down year, available thrown million conditions. to us. tranche the upon to second of loan reminder, Its a the bring total $XX the subject

$XX $XX range representing mentioned, in increase million revenues to to $XX investment anticipate anticipate an anticipated million related $X.X share-based million million non-cash previously our over XXXX in XXXX operating full year expense full $XXX financing million, million $XX expense of guidance As Jelmyto non-cash in of of conditions. for XXXX the [indiscernible] XX% we $XX We the the subject to continue product a expenses be to of prepaid which in $XX And range we were estimated year stand market to RTW obligation to of full $XX.X compensation net the paid to million, XX% the million, to from to year the to cash. to million, range including to million XXXX. $XXX

cash a Overall, to our I'd provide Liz to strengthen, call strong, for and to the that is closing financial and well our efforts our back hand. footing, believe in turn focused position our statement coupled anticipate burn, tools available manage sufficient guidance financial sheet is cash. When flow achieve OPEC is and And on adjusted the to the approximately we flow with models, in growth ending $XXX the financial remarks. in that closing, us runway with a on and balance in based and our million clinic. our XXXX. commercial by continuing prudently our projections execution our remain to like year revenue With cash we we current current ongoing So full-year fortified with breakeven income cash to

Elizabeth Barrett

all close continue team. Thank simply and you, UroGen by on to to expressing have my from execute pride Dong. I like in we entire that accomplished the

We continuously the treatments. as feedback thrilled that our stakeholders as with are clinical well receive we advancing close in innovative novel participating utilize Jelmyto, with are these contact those for and and And trials. receive in

for our thank not and to Our growth want our and operator them long to term long be We Operator? session. over possible our recognize remain our a who environment reiterate to and and and extend recognize on progress shareholders challenging Q&A would the the their sincere want to without commitment participation. meaningful to strategy business. the call vision build ability sustainable now I'll bullish for term turn a thanks

Operator

[Operator Instructions].

first Our comes line Howerton from of question Jeffries. from Chris

Christopher Howerton

potential me. a with a physician of I So I like institution, comment question. hosted guess two two on call of of least a it the get for able is really I you more a One of From the guess to kind a growth onboard on for to from at to recently larger larger and Boston drivers kind it would at their was be questions it One call. conversation, to took my seemed time institution efficiently. of institutions came board. months took process XX out Jelmyto like that that the complex fully

So institutions Jelmyto how available the And already we the which on was for you've coming in which multiple the expect which with then patients Nephrostomy potentially impact the administration. those call, one, of awesome, larger might the quarters? addressed was second

I the hands, see hand, administration, can was ease but you in the preferred his methodology. on think, not it of one

So readout moving -- one-year like that of have the to it's it that the adoption? route terms the expected one administration just a of Should I think receptivity question take data for are spotty to forward? kind two. continue I timelines just going Is to that for or be of going how the education that? would I endpoint. be The second clarification in you seeing it Is to that guess, be it's that

the of thinking we timeline about? kind that is So be should

Elizabeth Barrett

Liz. It's Chris. there, Hi,

just That didn't anyone the us. get for recommend sure not I'm thank I it, want if very was would of a listening playback Jeff definitely to And I the to Mark to time it. actually the on first timing but question. to the informative answer First turn hosting have line you I hear for it call. all, you that of answer to It -- if and great. I'll tube, then over it, and recommend can on Nephrostomy was questions two

Mark Schoenberg

Hey, it interview to in to than it ones it it depends accounts. did were range, thought It's a on at which as it were Chris. less on months. because of can these XX one actually They the mixed well. the at that be it X get champion have able I do months. the in well, he get account, does depends speed it pharmacy the formulary, as on the through Appreciate

data. months grow not faster I is saying -- more So X I'm it's And move it's longer numbers or in to as more there, good, usually, the take two to -- peak comfortable the to number which activated, we're we to as still where It the sometimes that. than really out months. as we accounts X to good of X get of closer can probably XX those we hospital patients. of Nephrostomy, accounts to can continue can are going there's going probably process. is I a your that. more formal surprised it But from bureaucracy data a we've months, take we it's number think anywhere there activate generate I significant with think have that I was to ones saw to and and And got accounts -- pleasantly continue grow with but XX and

I we there your up ultimately number go it's to preference. continue to greater said to data. out get answer going to to be that, you of going go it's more a they Having question, it also that still physicians year We able think a do and through prefer physician physicians have think half we're it from and with patients as they you but Nephrostomy and a now to of Retrograde would to -- prefer lot tube. and ago, heard deliver delivering it may, deliver we've a know Retrograde they're I

Christopher Howerton

late to So of number use Jeff, to at this Nephrostomy ask quick ask kind that maybe tube have a just maybe estimate very sorry, the the clarification tried point? just of Mark, I wanted it's, Can you could physicians -- to

Mark Schoenberg

can range has look can't estimate I certainly I quarter. think it even been But that. great. would the last into be this I really now just because too

So I don't have that level.

Elizabeth Barrett

I on that. think of just to comment sort

tube. move will As not Jeff said, Nephrostomy to everyone

do are don't have that well talked You who well, as have to you those frankly, current an patients, want Nephrostomy they'll some that. But and and patients approach -- with continue to also those who tube. we've very we physicians because to know, and comfortable use the actually

available but in Nephrostomy definitely more think be, I is will continue And -- of will on timing. question know before where all to the you it's ever Mark, I if in helpful. been tube will the comment move. the on and think be having to don't both quite but feel that a So differently, I data them I that getting situation on you that, think that utilization can very you don't of you move having clinical

Mark Schoenberg

And correct. here thing will patients they're exactly avail that's the is think of themselves administration great comfortable I there and will modes with. physicians most and two of are whatever

in provides the exactly how patients. meaningful flexibility of it's care So a it real of take we which is terrific. And world, lot

So remind we're respect this That's Everybody does said, 'XX available. that option And just needs timing year. own With a as and if patients what but that provide of tube you, nice on It's getting doing. to sense. me up. is all it we'll make Nephrostomy up. will lot month going a follow to enroll month let ENVISION, XX makes spend follow physicians XX it their decisions. we've

will data to be 'XX the the and for our submission So in FDA.

to also accumulating and Atlas you the expect all in we those And recall, some of as be 'XX. data those are available However, then. will data trial, share we from data

Operator

Raghuram next H.C. Our comes question from Wainwright. from Selvaraju

is line Your open.

Raghuram Selvaraju

you which Nephrostomy you understanding wondering for be base have penetration state running Jelmyto secondly, to year could then is accelerators situations the principal it's full you context rate now the in on My of was tube regarding vast going But Jelmyto. utilization growth your being wondering you was around the where visibility wind of the I of ultimately real administered? revenue steady right I of at think degree majority point at in in second what sort of half couple. to of delivery comment it's revenue do Just the year. expect this guidance, this the is if a be XX%. And whether up would of

Mark Schoenberg

depends data larger come And I'll retrospective you it hopefully on big your that soon. a question, To the that on range. it will depends reads what give out. think I answer

I XX%, around And between little with fact think as the being it's have this going see this majority, to to QX to of going I I early doubled it probably and it nephrostomy up that the high every would data. be be it's really And XX% but very will XX% this installation. high never could QX, to be data. believe the going be expected it's XX% lot tube, to been depending as from that a I quarter,

Mark Schoenberg

can And our help think retrospective that, as the QX, as that far data. as year of far timing QX guidance, it's excel The I end to do of growth. be going

marketing, more patient this year a and awareness. continue that towards help big We can of into end more We the to and implement is us patient so driver this next year. believe

aware. are well. This their they're discussing as help asking, patients with can physicians. So They're

would mind. those two the in be So things

Elizabeth Barrett

increase I'll patient add is to thing enrollment to demand. our an we in only and The patient see continue forms that

around was and country. more can't of just more approval starting the look bulk forms, and that as first see we some we've patient by you actually about just institutions enrollment some Chris course, at gotten purchases, you institutions. some also are so when you stocking you project institutions said, to before, on more we know, and of purchases, -- talked out as the particularly at question when also mentioned have in weeks are new that it seeing look the think for because volatile, around come are some the And larger the board, I

rest think see continue usage don't they else, I and things in us to an are or into about the so see as continue new see worry the continue I practices we the point nephrostomy tube that, to QX. fluoroscopy that you as those anything see board, So QX particularly help institutions coming the think will to to have you inflection get community you to on of

Operator

line from of open. is line question next Peaker comes the Boris Our Cowen, from your

Boris Peaker

is on internal My penetrated? little first Jelmyto question estimates, just market on percentage market has look projections, further the your target Jelmyto we of a if based what already

Elizabeth Barrett

we provided XX% that there. it's have way obviously haven't particularly, to XX%, still We but go a and long between and

it depends. So really

of things that continue I Because is linear. finding patients, think we to one the biggest they're the face right? not

So get there's every month, you -- different and know, identified that patients. you get don't of levels patients different

it's time. of any at penetration is hard sort exact say what your So to in point

at You have which to look million. But entire it think $XXX the market before, time. we've talked is, over about if you about what is

would the If the Obviously million penetration this for $XX would be you full -- year. what would year, think about than be? be it's bigger XX% because XX%

half of XX% to closer you XX%. the the that getting sort get So of year, into you're to second to start as

Boris Peaker

versus in time the Of do large long take a settings? these breakdown may board available to between facilities community medical a you patients which more the are general, of have that sense on

Elizabeth Barrett

Jeff, about you to talk want that? do

Mark Schoenberg

got to to folks physician -- don't for doctors to months to X community that part We've do. be XX-XX. they in [indiscernible] they the And there patients program a -- robust don't UTUC buy-and-bill who referral don't want this, the want are there to to get treat of some It's burden. either financial those want don't be groups that still do about are, for last continues or smaller

and that are of area colleagues get urologists administering. patients, a those not we want we that will with continue as a them will that to are connect That there And these will may we in urologists so provide an their And just be treat critical to do that. physicians lot success option. need to to Jelmyto because factor

answer XX-XX, So question. to your

Operator

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

Matthew Kaplan

advantage in guess Retrograde Is the reason would little looks incentive or perfusion, maybe a I Retrograde what patients why or the nephrostomy economic just for question doctors prefer future Retrograde dig bit be to Mark. tube? application. If nephrostomy versus the there tube the use a wanted Just doctors to the perfusion? would more some to data comparable to

Mark Schoenberg

argument looks able of the OLYMPUS ureteral at From narrowing in based data to patients, the preliminary perspective, be again everybody That albeit less least be going to a and nephrostomy it this as those an -- make the are -- transient manipulation very that seems issue was concern. people And ureteral, in nephrostomy. medical of argument is with to like administration. there that a may with less the trial, recalls, be on is

renal a is into matter thing that medical a from pelvis physician the patient preference really from perspective, in of you ureter However, the of perspective, argues actually comfort. more one how the this get a favor is the and bit of on gel more instrumentation. a retrograde very little in cumbersome, and administration done can little nephrostomy the requires the But Jeff administration let rapidly more And to is defer me a be it it economics. And office.

Mark Schoenberg

a doctor, they then to community institution reimbursed. the Matt, drug, B when gets go as that -- have drug doctor it's the you Part So whatever when buys know it's or

it's same. to advantage and to doctor clinic. that center the reimbursed. in here hospital, So is it's they center this purchases surgery the hospital hospital is is the the the If drug The their can the they surgery community the surgery deliver actual goes go center, purchases, if the reimbursed. The

doctor economics now going office This actual changed the that their then group the center have are ability buy who's drug other the going of of has they to been clinic. and get Xofigo given product, in their now the it's like the drugs So the the in buy to X reimbursed, a that from and or surgery X will or been Provenge they sort hospital, to clinic. to similar or

Matthew Kaplan

study. in XXX And guess at on point? process? of to the And then are manufacturing I what at and I'm ENVISION the where rate-limiting this filing What's question the that the step NDA you a where getting on is is

Elizabeth Barrett

What's I mean XX -- Everything of manufacturing, rate-limiting factor. great follow-up. not that. CMC, we're of months on the from schedule the that's really is factor is rate-limiting all our

even minimum XX that. patients follow-up, continue need we You XX then months months a will follow to follow-up, the of of beyond and

is. than faster months I So really, make before, as I've said months unfortunately, XX can't XX go

for way enrollment. like be now say our Happy August. through right And that through that'll so and to assuming we're July, on it track looks

we are So we're with with enrollment. where happy

take we expect the you the to patients end and XX year, we said, by So that be will to done as then -- have those months. of

of the saying 'XX. we're it would be So end

you cleaning, becomes time. it as locking, obviously, then know which So takes database

the make have the want do we We jeopardize would sure don't that data. anything to to quality of

we and get possibilities it's continuously for So all of on our be follow-up. to bit the closer FDA we timing about will a submission. But and data are as to the see that little talking different types the what the

that, it. have that the share we us. So as soon But rate-limiting factor is obviously, we'll for only as

Operator

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

Leland Gershell

other interest having wondering And drill can for treating the Is couple of installation. like and aspects broadening physicians limited with more an rate from prep may repeat or be also In kind they're want more bit into installations to also with urologists, either of for dynamic? tube tube involved which anterograde on if better patients of anterograde installation weekly comfortable much more kind nephrostomy just becoming who the I'm a expansion more. economic physicians. that those their benefits different driving seems any a patients out types the that think there, the of of those own up to terms the perhaps to and groups and this to who across time the to so in are the simply retrograde referral patients? finding Just Clearly, much it despite anterograde Jeff to of urologist doubling on longer discussion with reluctant docs of been the related coming center to catalyzing in than to outweigh amongst and forth for in seems the versus it therefore, be should Is urologists financial comment make option? How community of we landscape or potentially slower coming urologists same me it around with viable becoming the adopt about of time Jelmyto? may adoption our their I have the a saving data.

Mark Schoenberg

environment. first allows schedule time. surgery standpoint. time. treatment -- biggest It schedule just them one from comfortable don't they freedom a the It lot They center a So have of have is the feedback all go don't to get the to to to allows I a question, the more their piece patient

convenience just heard on centers. surgery And is biggest which a that the hospitals scheduling, I there's can But -- one I've the ends. staffing both seeing in most the think so the given the challenging be that and issues we're

the biggest probably driver that's So heard. I've what

Jeffrey Bova

things. doubling, a it's of probably lot I As of a far think the combination as

setting the everyone. when it's sometimes are tube. really nephrostomy think in for have the to and physicians of around ORs, we their data Even in they all But to start realize they're And they're physicians really is you option more much the think this there as administration. indication things the a and I now training, scheduling, convenience. they than using in an But It's of enjoyed to the mixing, we what because provides manner. challenges I indication. in would able it shown have the this versus I in greater that interest can areas, primarily of full clinic see interested it's that ease this convenience we probably some that though get more a from expand of start our to this using of it's and in ease OR. new in that's some like the see say do This dominant the I greater Jelmyto. it very were that convenient institution, not parts may I'm that overcome around interested can now days did up, into do. Perhaps they the now weren't now level it's shown they're the

Operator

Choi from Our Goldman next Sachs. question line come Paul from

Unidentified Analyst

on This is Paul. Charlie for

curious quick where anything? just I'm a to be that is made? just business about cost prioritize at you're looking particular wondering, one any the from those I or would was And or point. guidance the philosophy there strategy were year us. for anything behind Just cuts operation great. expense this reduction Any there color

Elizabeth Barrett

expenses lower we it down some just our in what of just Really, expected. than came to came

of Dong some to studies further. the the ask the clinical and of -- And So around I'll comment particularly work. some

do we could go approval unable but not on, some like in that the agreed we we'd something would the an other to study if it's It's the that that a the a study right? had think of us and unwilling population. to broaden that like has give patients surgery was I unwilling FDA patient unable, through stuff they that something believe that or showed those that,

that, decided anything study. into year. company is we this do study delay have current until started we want One, we as don't UGN-XXX that finished a So next to with -- to for ENVISION our

you think margin. to decided I stuff really But do the really postpone about comment just And to we the around is that. that? So want other Dong,

Dong Kim

mean cover. mentioned we everything in the I

we XXX we're we so good it. our that's yes, So but And Jelmyto on to really keep want focus we don't want covered But and reconsider, to trying have, well. wanted anything to -- as to everything. basically,

Elizabeth Barrett

physicians help get the activation absolutely is that urgency forward. just make of comment. sure say a earlier, adoption just would for that me particularly going haven't areas, to sense that of us That Let strategy that want believe anything, are that around patient we I anything activation, one Jelmyto. we patient we to with key from Jeff any making a other one is area mentioned really cut

on any but being spending, that very not we're everything just commercial we're we're So of our not -- doing cutting we're diligent doing. back on

Operator

showing not in the I'm moment. this queue questions further any at And

Elizabeth Barrett

the to before, continued Okay. of as our continue patients toward look fruition. forward We come keeping Difficulty] we're all that vision for you those your Great. appreciate we mentioned urothelial to Well, to I suffering cancers. very make events [Technical proud realizing on key from progress informed as

So thanks, everyone. Operator, you may now disconnect.

Operator

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

have great disconnect. day. You may Everyone, now a

UroGen Pharma (URGN) 11 Aug 222022 Q2 Earnings call transcript