Earnings call transcript Q4 2022

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Operator

Good day and thank you for standing by. And welcome to the UroGen Pharma Q4 2022 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there'll be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded.

to Perrone, conference Head like speaker to now Vincent today, of would hand over the your I Investor Relations.

begin. may You

Vincent Perrone

portion Thank call. providing Earlier an and everyone, morning, we quarter financial Good press UroGen this and operator. release at can overview recent and a highlights quarter results conference fourth corporate of on XXXX be and welcome the The accessed XX, website December XXXX. preliminary update ended of business the issued Pharma’s Investors our year-end investors.urogen.com. you, press financial to release our results for morning,

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

non-surgical our regarding to non-muscle to future cancer, These related among regarding and ongoing clinical year our future further efforts, our opportunities, commercial potential transform and regulatory our goals, as During UGN-XXX invasive activities available the data potential research risk treatment for today's call, milestones first JELMYTO, low-grade we to ongoing treatment market commercialization trials, of the paradigm UGN-XXX will JELMYTO filings, statements. include if things. commercialization sheet and balance XXXX development bladder our may multiple be approved, for avenues optimism other corporate in intermediate activities and presentations, seasonality in guidance, forward-looking making for strengthen anticipated clinical XXXX, us the the planned statements ahead, to certain financial

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

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

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

Liz Barrett

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

JELMYTO, ever full increase Looking delivering in revenues about of with $XX.X to strongest in quarter ending future million more XXXX, a ever QX, growth I'm our net our We from the XX% than year on UroGen. the proud for year and XXXX. enthusiastic progress of product returned back representing

well for is the UGN-XXX much momentum gateway the think continue the by XX to bladder That in we months, XXX belief JELMYTO the enrolled just of over goes the This we experience both larger incredible clinical and trial. as UGN-XXX market concept cancer. proof substantiated as Phase ENVISION patients between of and for ATLAS X of In we've trials. our

our We less for In fact, non-muscle transform have low-grade quickly intermediate firmly we has year. elevate their cancer the of treatment base bladder UGN-XXX patients and the that than trial the potential to practice. based ENVISION, a way a that the enrolled this we are who eager how urologists believe in pivotal completed of urologists of for enrollment treat risk study to we invasive on

to line UGN-XXX of provide We both X top data from midyear. are our Phase planning studies of

an complete ATLAS, response on complete in also response in study. of provide will providing the We update endpoint while primary ENVISION rate the and durability

our basis these XXXX has submission in durability will results, positive Assuming once the of matured. studies form FDA

for a of be trial from future. address data main driver growth if the administration our of shared OPTIMA Phase prove UGN-XXX the and patient study much to the the designed much Xb larger pivotal the without to simpler follow-up year, fluoroscopy. JELMYTO will is UGN-XXX need UGN-XXX. population II At in we end long-term and we anticipate is approved, Therefore, last OLYMPUS

completed along a we year installation of greater a of In study. duration home recently each small with median these, than two observed response

data about of optimistic the are We nature ATLAS and potentially products. will ENVISION from further upcoming transformative the establish our

of growth our would the like revenue and million. XX% to reflect adoption in better balance my over JELMYTO million coverage to quickly of and now $XX to $XX growth over We've call understand revenues come on the to XXXX turning sheets. I address XX% XXXX expect Before to colleagues, to

While the UGN-XXX, to $XXX spend we're and we reduce in will be optimistic million explore a necessary. assets, that to strong focus strengthen cash for continue on in the to we cash, especially multiple year sheet with position further potential when our given we avenues market ended balance our core

and Overall, in represented progress I’m belief UGN-XXX into for execution very the We a on $X to revenue the road and XXXX. turn made remain and billion enthusiastic of submission we about in together solid for as JELMYTO an we've plan opportunity XXXX ahead FDA believe that reality. UroGen focused UGN-XXX

development further clinical that, With update to program. I'll to Mark on over you pass our Mark? call the

Mark Schoenberg

everyone. Thank world excitement and real data and as lead Liz's we pipeline JELMYTO. our advance our will remarks UGN-XXX underscore comments highlight recent from My welcome Liz, you, and reinforce program,

may cancer. international bladder UGN-XXX grade registrational commenced evaluate risk, you as safety for non-muscle multi-center The intended recall, we patients ENVISION intermediate of As of low- January XXXX. ablative with therapy study the the recurrent in invasive chemo and UGN-XXX in study to efficacy primary is

we data quickness As report out new by able The testimony complete for treating alternative trial urologists which were of this cancer. summer. a is the end a for Liz to this bladder noted, the from to this expect we to with interest

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

impact advantages JELMYTO, the Both to urethral its have designed and has features also NMIBC hours, in bladder exposure and common most low-grade routine not many chemotherapy. utilize practices. special on UTUC which six grade similarities procedure importantly, many biological and to allow responsiveness share local sustained for and It with JELMYTO. key for leads in to common low which and does instilled require is outpatient mitomycin catheter both products direct clinical urology similarities, setting, and UGN-XXX has equipment the for an up UGN-XXX clinical believe mitomycin we to including delivery procedures a over use. be to a in will however via important

intermediate-risk shared critical condition NMIBC. This a times that inferring We more UGN-XXX XX% results treating a advantage a will to significantly to from installation suitability XX demonstrated urologists and common recently of population. is eight low-grade addressable It's larger home XX% a that nurse physician. by at managed routinely a by be of study small supervision as visiting the of the under patient

Six low-grade to or not a few related starting of were eight Treatment disease the received XX% UGN-XXX serious in cancer response patients has of no confidence as may achieved who complete adverse us and detectable challenges unmet months of doses older events from social to weekly of from events at clinic, being study provide bladder treatment. added results our this novel We potential the subset anticipate and small investigational treatment needs the benefit treated of that with adverse mild with moderate patients genuine patients. home related. defined a versus were address after three for six therapeutic

follow-up presented greater we supportive XX trial in study long-term at median from II of up December, follow XX than and duration shared OPTIMA new JELMYTO’s data Oncology In study meeting. Long-term of the showed of SUO. at The data pivotal evaluable of also XX from UGN-XXX response the UGN-XXX were month patients. a Society Urologic Annual with

patients. these delivery long-term of and recurrence month potential with to bladder median cancer. The evaluable growing greater duration of survival to RTGel to the XX evidence urinary supporting low-grade added of free associated XX studies for than mitomycin a XX body study Together, response urothelial the of tract in showed the treat

or which with shaping XXX line precursor top ATLAS either an primary envisioned patients the goal and year trial review, would is catalysts, NDA line UGN-XXX FDA with trial, which be trial, important positive Phase the granted the or data XXXX. early TURBT, of potentially enrolled be mid-year end from in Phase XXXX an in submission the approval including ENVISION XXXX, to target to from preparing to results up for if completed assuming multiple top with may who the X at the treatment X results near-term result the from UGN-XXX for priority XXXX

the undergo burdened of XX,XXX U.S. in If risks recourse and with therapy nearly and new the endoscopic who for resection are non-surgical only addressing their will be surgery only as control. approved, repetitive the will disease patients primary anesthesia the alone UGN-XXX

neurologist welcomed transformative to practicing and trial bladder alike. cancer. is development for with UGN-XXX my by combination a be UGN-XXX, As RTGel bladder in X UGN-XXX, Phase who continues antibody patients. technology, including in-licensed treat enroll. our our non-muscle other be will proprietary that patients Meanwhile, the use potential high-grade advance in intravesical with would TLRX agonist, our for a This therapeutic administration invasive immunotherapies cares and to colleagues believe using I cancer for other immunomodulators, and chemotherapy anti-CTLA-X

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

of for as XXXX. viewed study of therapies The evaluating inhibitor variety first cornerstone potential dose completed be is monotherapy high-grade to half this UGM-XXX in as expected checkpoint UGN-XXX the NMIBC. arm targeting of second of ranges We combination a a

be as increasingly and urothelial year nonsurgical In we supporting an upon to therapies and closing, well important our will look world foundation technology of real innovative for data established the product of compelling clinical evidence portfolio and cancers. XXXX build

call that, to Jeff? Jeff commercial to with And the I’ll over a update. hand provide

Jeff Bova

in a take Thank I’d from new repeat moment highlight quarter. performance performance encouraging indicating conviction contributed and the new to like to few to demonstrate quarter of clinical fourth underlying you, trends Adoption Mark. adopters JELMYTO. to users. continue the our growth and metrics QX represented which a in factors ever JELMYTO strongest for our in accounts,

sites And March to accounts were This compared a of on to compared repeat same the the Activated over increase were year. period. X, XXX, XXX Xst on for XX% XXXX last XXX, last November period. XXX is

quarter, field skillset. types. our in appropriate to XX% efficiencies was part an facilitate coverage drug sales in approximately at key In and team JELMYTO including strategy driven of This and territories. increase last remains strengthening sales across of Reimbursement ramp device addition to uptake adjustments alignment in QX, saw logistical our strategic support the the all and by with we several of discussed operation the

deliver We far. of strategy benefits growth revised to the thus in seen are impact developing encouraged expect and sustainable the territories by our

of of performance label continues eight HCP an partners the reflects enabling body morning hours. to our allowing before the safety. outcomes JELMYTO’s installation. challenges, coverage or evidence We’ve doses shift stability data a to This the field. September early including from optimizing delivery seen QX installation, real geographical in which of facilitating XX operational of admixture efficiencies manager’s preferred of efficacy Our several business mixing world positive the time delivery, from day also expansion of logistical update, our reinforce The and today the impact has immediate extended the from to territory XX% prior XXXX approximately growing led in to admixture period of JELMYTO for and

our arming In JELMYTO number a retrospective OLYMPUS, the of answered recent independent of various commercial supporting across use not deeper with cases, addition across to use patterns. organization a multiple a JELMYTO’s understanding has approach of addressed questions multi-center multi-modal practice analysis by

this Further, profile two seasonal real outcomes approximately favorable represents dynamics body going from study and or the which of respect administration, After benefits world we normal. market data JELMYTO, integrated of as with growing additional new to safety add now we of years of of installations. JELMYTO XX% a to to experience to a forward sense with see variability back stability quarterly expect get demonstrating

in in from conversions months, typical stronger quarter, to as the QX stronger in Looking dynamics slow summer followed delay second as deductible slight followed in baseline. by return to resets QX expect ahead, we in payer PEP expect PEP demand conversions a resulting we the QX by play

proven as across in accelerating increasingly the cancer. JELMYTO patterns. the non-muscle and low-grade, adoption be undeniably and This larger with to traction is our lays the optimism product practice to reinforces incorporated opportunity intermediate-risk potentially bladder invasive becomes gaining for foundation and much multiple easier UGN-XXX appears administer

prescriber approved. patterns, into in a overlap practice the efforts and we well-established seamless of commercial XX% integration if With base UGN-XXX expect our

turn our that, to financial to Don? With I call will Don over the results. discuss

Don Kim

to sales you, call. On XXXX. growing Thank everyone year our grew strongest with an finished delivering We in annualized and for net revenue joining the today’s JELMYTO from XX% you thank Jeff, momentum quarter JELMYTO sales. ever basis, for

XXXX. the for quarter compared reported we JELMYTO of period million, fourth in revenues the to $XX.X $XX.X For net same million XXXX, over

On delivered line million revenues consensus the with estimates in full year $XX.X net a compared to the of basis, XXXX. for year million, JELMYTO $XX we

of JELMYTO. Our performance reflects adoption our and strengthening growing ramp

lower efficiency stock-based R&D The over quarter. million For $XX.X $X.X for is full Phase partially year related prior by JELMYTO, for higher of research XXXX, development the were was to production expenses million XXXX. million million X year study $XX.X R&D research quarter as to into ingredients compared $XX.X for compared compensation $XX.X and offset in development research for and expenses fourth to expenses in the primarily to and ENVISION XXXX. as of Full expenses the year XXXX UGN-XXX, attributable expenses million, scale-up XXXX increase in

administrative of million quarter. marketing of decrease for related XXXX year $XX.X expenses brand related The Fourth expenses full general, and related resulted and to as $XX.X and in stock-based million million XXXX, as offset selling, $XX.X XXXX $X.X the Full compensation a expenses year the were $XX.X quarter year compared general in to million, were in administrative prior million for SG&A compared primarily XXXX. from expenses. by compensation decrease selling, costs

be year global JELMYTO the XX% quarter of forward expense of cash obligation the to The product we in $XX.X full $X.X totaled of XXXX. rate of million. payout sales to For obligation based related RTW XXXX, Investments XXXX. Financing Investments fourth related for prepaid to million $XX.X financing million expenses net RTW prepaid reported will the on to the for XXXX forward

anticipate range conditions. operating expense be market of in million $XX JELMYTO to million year year expense to $XXX million non-cash We XXXX to million to subject the of to range full including $X Full is to in be expected the revenues $XX share-based of compensation $XXX $XX million, million. net

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

the by XXXX. interest Advisors loan with continue in only will In made on $XXX Pharmakon to facility managed rate be RTW to addition a plus at financing and LIBOR accrue funds X.XX% term of the quarterly million expense, payments

needs in into We equivalents, ended to operations proactively cash and we of half sheet the our and managing in to echo first which year To with $XXX million are Liz, the activities. routinely balance cash finance monitor XXXX. continue diligently is market to expected support committed of strengthen while environment to closely our cash development expenses and commercial clinical We’ll arise. our the revenues and capital opportunistically watch our sheet balance and evaluating also position to

call to With back the closing Liz that, I’d like for turn to remarks.

Liz Barrett

the to that team. have Thank through in from all to express patients participating right the you, ongoing my also the accomplished execute the benefits those to investigators to the by JELMYTO like and well and adoption and continue Don. thanks are my individuals trials. of on of UroGen patients as simply diligence pressing we as like to I’d leadership I’d our pride sincere clinical close that the and clinicians to realizing entire in

shareholders. Finally, I’d forward achieve. months the like that see unfold goal weeks of continue as over the apprised to and trying thank to look events are and keeping reiterate all our commitment the to We we to important you We our the ahead. importance to

over I’ll to session. the operator a call now for Operator? the Q&A turn

Operator

Gershell next Instructions] [Operator question And moment question. And for thank first And our from you. comes Leland one our Oppenheimer. from

line Your now open. is

Leland Gershell

the taking guys. the Hey, me. questions on for for and questions Thanks Two progress. good morning congrats

Mark. for First

early we year would obviously, top the II? reasons any response than we in from that saw saw data line and we As should what ENVISION, differ after next from OPTIMA we’ll wait think what durability get the – for we

And question then for second Liz.

size comment potential You’ve the about made just sheet. teeing market the balance opportunity of the opportunities to providing off you strengthen UGN-XXX the

commercial? wondering if lead to with UGN-XXX Just you Thanks. down you contemplating any get may the to should development about or as that strategic of sort be road arrangements think us

Liz Barrett

Okay, then answer thanks, Leland. back. and Mark, why I’ll don’t come you

Mark Schoenberg

Leland. Good morning. Yes. Sure, Liz. Thanks,

short the So answer no. is

recurrent was had remind all about who those Just to able disease. disease. in whether UGM-XXX will cohort, with were not patients OPTIMA new of between In were OPTIMA cohorts to based The listeners, de ENVISION, the patients patients this recurrent discern novo difference and evaluated we we there remainder disease. to have responses XX% or studied the in question of a a that the recurrent difference on When to not as cohort. had

is very expectation we in results we see in our will trial, what So ENVISION that the similar OPTIMA. to reported

Liz Barrett

honest with at I Leland, always to mean, everything. we we’re answer – your looking looking opportunistically question, to be And are you,

partnership, be capital. of it forms a whether BD, strategic So other

it we to XXXX, expenses expenses we keeps make further our cash where we we really us doing sure So we a just be growth. not can diligence really great some identified look, be and to But our that we’re with forced to strategic so and – the want make XXXX company thing keep into have do around our reduce that sure through to areas if sort it to to was and do accelerate thought thought would if we anything. partnership it able going of we was the right

lot decided. And so, look well. has as as we’ll But other continue options well to been a that as at nothing of

the feel data time think a just this given we about coming that’s summer, like to – is probably something. that good haven’t doing We up

the for question. thanks So

Leland Gershell

thanks for Great, the color.

Operator

And for next HCW. Mitchell next And moment from question. thank one And our from comes you. Kapoor question our

now is line Your open.

Mitchell Kapoor

for our Hi, Ram. This is everyone. Thanks Mitchell taking for on questions.

just optimize and driver main The And uptake ex-U.S.? the first one I the original wanted value to the intend launch? about does how how company since differed is that’s the to of ask JELMYTO now

Liz Barrett

then that Jeff, to question. you want and take take the I’ll ex-U.S.

Jeff Bova

Sure.

get other they also we repeat that. saw So, you Mitchell. to patients But help And the that users, we once as getting then, and could patient do the practice. the into codes and benefit really continue from be continues better, sitting physicians, in the get offices number that to from from look looking to data The they – hi JELMYTO. driver at identify they continue various main patients that to also, for increase identification down experience,

hands in the We, field. obviously, have this data will there be of out the

that available. reported we data So wasn’t QX to this prior just

have using you really disease they which coming as microscopic to which retrospective well getting the help that get installations is see in we’re they’re data back Woldu pieces as six and the allows about world a as been is the see, what is very interested It positive. with of the and JELMYTO, the understanding access. new excited data going endoscopic new about there’s real us data, very, can Physicians see, always follow-up, oftentimes JELMYTO. that integrated are continue evidence hearing the since in to resection, be paper doses about Rose additional couldn’t how they certainly talks which is can So to is with long-term of

Liz Barrett

today. the about ex-U.S. approval the I we’ve isn’t we on – we as data talked have challenge And with on getting getting really the question, reimbursement. ex-U.S. think an before, It’s

for rate, that’s reimbursement to go Europe, us for to a decent study. viable get a We at like there. market do for need a in another us So or partner to really

And so for we work prioritize reasons. here the we’re U.S. in obvious because that doing the

road, give So we we global do patients – the an but absolutely access. that to clinical us, opportunity get work see global that see down would more frankly

results now right after Program. to using patients, because for piece of getting start one success have it. had pay physicians actually do have Named a when actually Program through Patient Named And is the asking have we Patient lot had it We good a a few of with governments that

a get Named with Patient their some them to access experience ability to getting to with be and able Program So that and it.

U.S. So, sure what right to it but now do And we study on take the we’re XXX, another bringing making know require really U.S. something. it would and the outside focused would we’re

Mitchell Kapoor

ask, Okay. And strategy wanted then, to on if will require just any the the additional commercial U.S.? in infrastructure yes, and XXX,

Liz Barrett

around talk just you do that. thoughts sort to about of Jeff, want Yes,

Jeff Bova

not look a the in expansion. time. key larger will a larger overlap because cut I so XX% significant expansion down a reason XXX. at the of don’t hopeful for It take to a is a with significant, geographies on We’ll There’s windshield major approval always targets. require But see overlap Sure. resource

Mitchell Kapoor

all. you Thank Great. Okay.

Operator

Goldman our Paul you. next for thank from one comes our next And moment Sachs. And Choi And from question question.

is open. line Your now

Unidentified Analyst

for Thanks our Hi, this Roderick questions. Choi. for is Paul taking

real is, of to reach first the change in potentially maybe in the question stability anticipate could XXXX your label end on including So the Thanks. in to the drive what another physician’s higher JELMYTO adoption this world XXXX of data, And further report in the maybe question feedback based maybe and additional year? guidance? is

Liz Barrett

Jeff?

Jeff Bova

Sure.

XX% I’ll actually that have FDA XX-hour four the resulted I we greater delivered start three are drive approved pieces period data, day an to doses data with adoption prior. of already operational in being in going the to that’s of the that eight XXXX. think stability

to little So reengage we’ve of have been JELMYTO a eight-hour reluctant that may been to because physicians restriction. able the adopt

on And where significant. free? XX been OLYMPUS long-term the median but data to number long-term question a little follow-up. patients from months. The XX of the bit that’s able XX those very second How is the certainly is with follows months. now months OLYMPUS stay do a patients see upon disease long although the we’ve smaller, approval, gave follow-up us wonder, the median number that’s or physicians When That’s see at pretty well, question is – of we follow-up we

think the and term I go multimodal about talks in to really practice importantly, be be world that’s more pieces, how going a use multimodal, to and resection. be real with physicians evidence what key. the we partner two And with endoscopic the a partner

been resecting CR, will physicians and talk increase be difference able so And for you’ll the CR, in about have in difference about CR. the able you in the and may only holding representatives – in go that to say get off the the using to on when in be JELMYTO, and I talk those

Rose versus XX% integrated a we that stenosis X% finally with saw OLYMPUS. Dr. administration paper the And showing then rate XX only in patients the with

those that. data confidence growth So see from to of XXXX to me going all pieces give in of key we’re that

Liz Barrett

I’ll it’s the one – Liz. think I add more comment around hours. just XX

or the about worry we had have actually or now that. for don’t our hours it time, The they only it time going. dose that more of the you rep office when sure hospital up have that that the hours, make the other was doctor’s a to And cases, had got rep. wherever on thing to lot does to in Because frees eight XX us is

actually that’s very And so helpful.

doctor’s to generating sure So the they really for office. But questions. their the can demand to dose gets versus spend the more and time generating it make thanks out babysitting patients actually

Unidentified Analyst

Thank you.

Operator

Boris for from our next you. our comes And Peaker And And from question. question Cowen. one next TD moment thank

line Your now is open.

Unidentified Analyst

about ATLAS Boris. is you’re two Will Great, thanks. planning quick I questions data on for have question, a This ATLAS this of arm of the include ATLAS? allow I UGN-XXX that will a trial. releasing be release the patient also just read trial? worth XXX trial, on through the Does TURBT? to TURBT patients that ENVISION will And Nick the to for know you or data. quick then potential from from the

Liz Barrett

you then give do Mark, add any commentary. I’ll to perspective your and want

Mark Schoenberg

Sure. from the the question. be caution Thanks the releasing arms. is for would will as to I to data that be The underpowered, answer is that well. everybody we able the remember arm compare study TUR will the because not we

the us give of a interest safety will our area and issues an performance which surgery cohort in is probably this in as community more some population, it importantly sense of surgery in of or study around in However, this now. right

in population population substantial would it our the this to the see and in group as line previously complete occasions data ENVISION believe X secondarily given And we I safety patients. as do be will with and able providing again we not said we for then multiple in about that cohort comparability And be the being that to reported compare as what supportive experience, arms, have well. directionally and on durability with that will Phase we think the expect we response we’ve XXX of what well of data arm, to caveat, believe OPTIMA in reported

Liz Barrett

Yes.

you OPTIMA haven’t at if I was add look, study Typically, clinical So look patients. have so data, The – II only XX caveats, two idea. just I I’ll studies the right. seen no our and

bigger of You in a because right, population. decline, typically you see a somewhat patient efficacy, much have

aligned be we case. it Mark’s see. that we’ll But in point, So will will that definitely that be to believe

all just is that share we the top all the just a we a it will of review that to other to also – want we a that of because everybody because line data. data and we not journal, at want we we if the meeting. data, And review data, publication, that But peer will will give won’t presented get on The in peer a mainly thing to caution share want share, happen.

of will in we go we a we paper won’t get top a out So But line as as details. possible. that the give into quickly presentation data, as all will

So questions. thank you for the

Unidentified Analyst

you much. Yes, thank very

and home on Or see run to if be administration, so potentially then to like, for is this Just more an physicians plan the they additional you UGN-XXX, to? just need at for do use trial this? going to

Liz Barrett

we’re planning not study. to another Yes, run

were I couple our Chairman, actually Arie COVID, of right. was it. it We our in there perspective, a think from were middle when things, the suggested

then opportunity. think, in nursing saw most office, that is, into more You bringing even homes and heard, are do but hospital is in and that it an there'll hearing study, reality lot a coin we maybe and think it think that frankly, home in to patients most is of patients, we phrase there's we've is the I want we future, go that even a home but a the that around, be doctor's and opportunity so,

data an But an to large we'll allow study I very not anything is for they probably going be I we what not could So in think would once health But study. allow, XXX to nurse, in I is things the for think today. likely. label approved will home investigator-initiated health just approval, a after I us say go and through there's the that see through get of our absolutely doing support a mean, a home home nurse, study other likelihood the demand wouldn't like bigger delivery

do able need that. we sure to to be a that study So not I'm

Unidentified Analyst

much. you very Great. Thank

Liz Barrett

Thank you.

Operator

moment And And you. question one comes from our question. our Thalmann. thank next next And for from Ladenburg Matt Kaplan

open. Your is line now

Matt Kaplan

the questions. for thanks And morning. good Hi, taking

what to and little to want JELMYTO. your dig and revenue a thoughts the adoption and JELMYTO, talk little of guidance to in you JELMYTO to terms nephrostomy to in and Can your Just of kind about helping bit that in forward more accelerated are potentially of more of growth bit going tube growth specifically current drive administration use of the terms further? returning a of

Liz Barrett

Jeff?

Jeff Bova

go you It Matt. Thank continues the question. for to Hi up. Sure.

X% of or every quarter, You certain it XX%. listen goes a percentage up

think I paper, been to a going more maybe a in you're reluctant they data. bump Dr. physicians have just that with little really the wanted Rose if see

Now have be reduction stenosis. most CR installations. similar fact, better will XX a say is patients, in if you have it importantly a I XXX% and the a for then ever not – you I never of can don't

really catheter want the their patients back Sometimes weeks. in six for don't

patients, will installations. going because a to the the first we be do to quarter there what as the retrograde convenience attempt future I antegrade in at Rose clinic, it the or leads see X% and continuing at this next is always of So XX% experience of see to physicians to data, antegrade. give few every usually in subset being able attempts quarters But their

they identify longer strictly patients administration they give moved their as retrograde to fashion. antegrade. it a So no They've in

Matt Kaplan

Great. a obviously respect And impact think period, change, follow adoption with do you impact you'll think stability to kind a driving – when but full the label when do you in it's the then on improving growth? up of you'll see early a in on

Don Kim

time, we've go a I of it think day to XX% short before installations. period already from a XX% in QX, seen

do the just as see the the I But earlier need don't the if I representative. Look, that to think up, it continue it's is depending increase. going the day, think they can or you're day to it before, that before, what to time alluded still want on to XX% when – does of some freeing Liz procedure. day physicians

really from more so arrives. ensuring start operationally that And representative driven versus the demand to see the activities dose you'll

were we'll it partner of more get in currently the our If to adopt continue and that used we to that'll So we'll later the the efficient. mixer the use, they pharmacy, mixing practice. it And continue and our there. later as day become day follow required before, guidance to evolve the delivering and pharmacies independent

would be for So there we impact time on and day the in from as then frees QX, end the before. the up it the dose representative. QX forward, more And deliver the

Liz Barrett

have what And around we was slow to and mean, to think I is think Matt steady Matt, I I going the – growth, said, your growth. we continue sorry question see comment what just to I

continue will think think where We be a will there grow. you'll it stick We to unlike, don't a inflection So hockey time point? so. see that

that, And reflected for seeing more are stability, our is I year. think continue and more see seeing We you'll in the to that. that guidance we're consistency,

But, add don't of to have, we been growth we're that and the even does but that we'll great physicians. I and given get adding physicians consistent by around that XX,XXX about to finding being it Jeff It's – more more to back physicians. think we X,XXX earlier to physicians, data good We don't that. And treated these continue every think X,XXX happy we see patients there's the we've patients. what quarter. new Again, said physicians, get

they a in So patient. it's office identify hope the time at always of being that doctor's thanks I your helps. that the that matter for question. But

Matt Kaplan

limit rate – on And year, this for line elaborate you of you? in the product apply the limiting it CMC XXX, helpful. for just the it's expectation can to for XXXX, step, that's what's given a more question rate on top up? or then as timeline What's No, whether the long-term going step middle the to data and regulatory follow the

Liz Barrett

is durability the Waiting was that important. is and for agency really talked well, as It that durability. about very durability, very we've clear

though complete durability And the are endpoint, to is see data. primary endpoint So a strong responses secondary even key some FDA wants durability.

we to until, majority but need wait strategy with than The have everybody they we long-term of them therapy, remember, of more months we have go look And will months. a follow to for three and JELMYTO at that obviously patients didn't in have able then have we that. good to from of we with XX used up, CR to them. time the is there the minimum was were wait is, news of the started some all after we So those

months will CR strong for some us their to XX give have which in that and to XXX, wait we'll FDA. post For to data forward everybody go the

So We what's will the CMC this that's foresee really case, any we knock issues that there. is don't it on go similar JELMYTO, to driving smoothly. really in wood so timing. because think very

getting and database that a cleaned, it of the clinical that And just we and get really once is forward. so matter having data data the to go durability the

time a going we're we of to So given exactly file. when haven't

it let study, And I’ll is right. an you know, also driven event

number in well. have events we know, we of have So addition, certain as a to

what it. And so drive that's will

XXXX beginning saying review, or given saying we of comfortable So potentially could comfortable that, we're of and the XXXX priority get if end at XXXX. we're

Matt Kaplan

data, half that durability first expectation? So of the XXXX, is

Liz Barrett

Absolutely. exactly. Well, yes,

Matt Kaplan

terms looking Okay. that will when the Thank XXX, of question what reports And year? you this data be in on last for later you. XXX out

Liz Barrett

XXX? Yes. to about talk Mark, want you

Mark Schoenberg

Yes, sure. Thanks, Matt.

So what dose. appropriate we're currently obviously that is the and doing is dose escalating for XXX, safety predominantly a experience

I with and immunomodulators to do So going others Subsequently combine chemotherapeutics. and think be appropriate this plan the is dose. initial other the to is finding is, our

that UGN-XXX provide dose in been right we'll those year, share not But different and and this hopefully though, on. will be ultimately near-term safety. appropriate able JELMYTO which on focusing efficacy the population, in for high now is we've be populations finding to data combination than would what we're of demonstrating focusing is grade So evidence data forthcoming this obviously the the

Matt Kaplan

guys. a lot Thanks

Operator

our for from next from And moment next question thank you. question. comes Mao‬ Velasquez one And ‪AJ Jefferies. our And

Your line is now open.

‪Unidentified Analyst

is This Howerton. for AJ y'all. Hi Chris

here, arm the question confidence for sufficient SPA that could design the with like or for agreement FDA? approval? get consider additional a And one single gives is Just what you ENVISION would you trial, you

Liz Barrett

do to and Mark, can color? want the any got add I feedback from the FDA So about we also you talk

Mark Schoenberg

with do role the confidence them we Phase our can to X our FDA in UGN-XXX in about with conversations you, Thank practice. with the believe play and the interactions neurologic has long data presenting

the to and data would design we present trial the the the UGN-XXX our will be provided totality based agency, strength support that writing X believe have Phase of that of the as approval of upon reassurance as them. data, the decision of in we interactions So the on well with the ENVISION they and

Liz Barrett

SPA, things thing, add agency Yes, any the other SPAs I about think only doesn't and I longer. is do very the mean, two often I'll

had And have so we that done before. would've to

the a special our from for that an have have study don't that meeting arm we no, But minutes So we single a says do basis protocol the can with assessment our approval. be FDA.

we'll very to we're physicians And ODAC. win to frankly, ODAC, clear, an made medicine. know an that before we'll in want shared believe ODAC. we've We And it go this we they've very this that access happy to to go

they would and to is say it's what got expect the on We of that. very based the clinically is so And And say. would different totality be mentioned, it's we're expect comfortable to Mark to not them and data, as with which than they meaningful what say. confident

that good here in that And news only is, any a But done has get had therapeutic be other surgery. to what is compare to, has is demonstrate any treatment across another versus – mind not surgery. the there to we to to is therapy have to therapeutic a approved how the is in did UGN-XXX never area, there they to study where been keep that everybody had it

was looked option at an always It surgery. to as

part comparison the was with why agreed. to the comfortable, a that agreed, X trying approval of make we it the had Phase and that patients. around complexity surgery. just FDA they frankly, that's for just we asked to And ultimately and And XX They with so, comfortable the FDA our on weren't study. of And they discussions add to a argument, the weren't

them much larger need patients. patient So they're agreed the a like, on we XXX we with And population.

helps. So I that hope

‪Unidentified Analyst

helpful. Thank Very you.

Operator

over closing now like call And am would I the to remarks. you. for showing thank Barrett turn I to back questions. no Liz And further

Liz Barrett

that's appreciate share patients our be look able again, happening Thank forward what's as a appreciate the we'll goes that you, interest everything really for excited in a the to to And your with operator. we're medicine year on about highly us. for fact data been more UGN-XXX, we We're about always, anticipated year of of very sharing actually on. excited as And JELMYTO, very sort and number everybody significant company. we as knows, this

phone. know the always So have let on if any to us you questions, jump additional happy

everyone. So you operator, can to now disconnect. Thanks

Operator

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

You disconnect. may now

UroGen Pharma (URGN) 16 Mar 232022 Q4 Earnings call transcript