URGN - Earnings call transcript Q2 2024

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Operator

Good day, and thank you for standing by. Welcome to the 2024 Second Quarter UroGen Pharma Earnings Call. [Operator Instructions]

Please advise that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Vincent Perrone, Head of Investor Relations. ahead. go Please

Vincent Perrone

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

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

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

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

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

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

Elizabeth Barrett

of UGN-XXX intermediate previously patients quarter of product announced study We morning. complete the and rate from of months. everyone this clear The invasive X cancer. highlight candidate, positive was risk, in XX.X% you evaluating response duration our second bladder ENVISION for data from Vincent, compelling low-grade at you, XX-month a the lead response with non-muscle thank our announcement Thank of joining

response patient duration during X reported presented by ever XX.X% in was Kaplan-Meier event event CR response This leaders data included We The highest population. who patients on in had a these opinion months of key virtual achieved expertise by the durability duration with data several this months, urology. at June showed XX that of at XX. presentations The analysis. an the a for those is unprecedented

We interviewed who experience a in standard of ENVISION with his surgical challenges patient and the that also the about spoke the care. trial come

the to to This website, on community. to was urology available clinical hear both the perspectives and is would The opportunity supports excellent the and The of our physicians patients body that replay. listen in join replay to those unable of I an encourage the UGN-XXX data all across with II us is in rates Phase across trials study. complete ATLAS OPTIMA in very improve UGN-XXX of of patient outcomes ability the compelling, to impressive Duration response and quality consistent confidence was prior ENVISION, of also X-month II life. giving response

priority non-muscle rolling our initiated NDA complete in immediate intermediate NDA UGN-XXX cancer, very The submission to for submission low-grade is is expect we earlier this invasive Our bladder the term. a was which that year. near and risk

opportunity an would this expect the FDA-approved first is estimated the be approved, and as as approval we for review, quarter decision population. XXXX. The it of for if priority Assuming market early patient medicine $X billion, first over UGN-XXX

market invasive treated in is There U.S. This year. the risk tract the as transform company. We the expect estimated JELMYTO non-muscle our UTUC. or carcinoma this an as intermediate UGN-XXX XXx bladder the are with will treatment size in low-grade upper cancer urothelial for patient patients population well of paradigm over XX,XXX each

and urologists. UGN-XXX it practice by more Unlike treated is disrupt nurse is physicians fit prevalent wide nearly critical contrast, physicians utilizing a current dispersed seamlessly making to by and believe their UTUC feedback. based most it staff administer. diseases, regularly be we This and episodic, expect rare distribution by we can of concentrated, patient Perhaps for as can not is physician most is bladder staff importantly, are which by their easily administered is into constant In minimal as the all physician not special treated challenging. and they cancer relatively or range could easy extender physician's equipment. a better require expand would with on practice does it practice. Instead, training and

market have penetration experience past few if are approved. aggressively to years over our the from for We learned and prepared UGN-XXX, drive

David appointed details provide on Chief few our in will recently Lin, more Commercial minutes. our plans Officer, a

and with FDA technology announced marking our until UGN-XXX of utilizing a and XXXX, medac, additional offer issued through June licensed efficiencies December manufacturing acceptance IND medac potentially cycle in patents. April, management for current to step life IP patents UGN-XXX with from In and significant pending the our U.S. the protection we Developed strategy. XXXX expected

first our sites near in activated expect first and future. have We our the very patient to have dose

approval, the sequentially path data This headwinds prior due XXXX. quarter. represented well contraction UGN-XXX a to wastage launch of of first of second part year. is from period and and versus positive as quarter the in the This half next-generation the to product previously conversions product as growing and first in provision generated X% same growth over XXXb in the in XX% net growth million XXXX. JELMYTO assuming plan the As in we approximately revenue disclosed, $XX.X

the higher in rate of as the discounts growth lower in compared year muted forms enrollment on While continued to the a in in we saw remain demand. were growth net revenue, of period year-over-year first low-grade the the the patient same below Notwithstanding conversion patients patient the single-digit optimistic The XX% revenue actual expectations, half we and JELMYTO with results UTUC. XXXX. growth for

our $XXX.X strengthen our also advance to priority. to June, in our the development flexibility offering. Our leadership we In be continue approximately and balance which capital proceeds of specialty raised million, UGN-XXX. urologic took will resources gives to of public business us opportunity to through support sheet launch successful a It net a evaluate opportunities the This cancers.

sheet, $XXX balance a launch approximately the the UGN-XXX. support strong We year which to expect of will end million on with

Assuming that sufficient of we business estimate profitability. our financial on and first have models, cash XXXX quarter our we in approval to and to support now through latest the and based projections

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

Mark Schoenberg

latest was of of results experienced low-grade risk at We within Thank represents intermediate this invasive enrolled past the XXX X/X and the during approximately cancer bladder in few discussed recurrence ENVISION in TURBT least our year. III detail a of cases of minutes X with bladder invasive Therefore, non-muscle A the of U.S. patients had XX% in Phase the annual me risk you, patient median intermediate low-grade estimated a population after were All patients in around returned was clinical patients bladder XX, let patients highlights. ENVISION cancer, weeks. study estimated months approximately age male. spend consecutive cancer. The Liz. virtual X enrolled. were annually. UGN-XXX for Participants response. total X non-muscle single-arm first and but to multinational on equating event the June, determination was cases administered pivotal XX,XXX for of then weekly installation installation once intravesical the via a

that treated response urine median progressed a endpoint by estimate duration this disease, cystoscopy, progression key on which announced too the visual XX.X%. response complete of It's from X for disease those X% a months, months Among cytology. than June, duration XX.X%. the response is that of were went high-grade few lower who response results complete was who unprecedented patients estimated response achieved not to at was X-month early biopsy duration have and given the on in [indiscernible] rate patients responders, achieved response. disease so subsequently disease during an XX complete TURBT. In published secondary patients based recurrence. to with at of than The to we patients of complete Of response less observation range Assessing was of

for However, responders of predictive such which as estimates we response XX can thus a data duration based use far. secondary of months a model, the [indiscernible] on models complete median

symptoms duration The the see were, vast IIb duration for moderate of study, patients of side alone typically general, urologists population were results UGN-XXX. effect These mild clinical severity. manage. And and was ATLAS, those strong and of and demonstrate in for estimated the the these are previous XX.X%. response in tract in duration in that UGN-XXX clinical response profile and urinary demonstrated XX-month II events response with commonly In UGN-XXX Adverse lower was receive Phase across CR the trials. that latest X X-month estimated a rate, The symptoms, a majority OPTIMA consistent in can XX.X%. response complete was trials

FDA approved. evidence these of the help body overall case consistency obviously us compelling a widespread of use for approval UGN-XXX We by believe data and support The if encouraging. make very will for urologists, is

current risk resection. will low necessitating is of monitoring essentially This characterized standard for long-term a by management. X patients IR in initial postoperative patients and TURBT these require to rate, NMIBC recurrence of condition transurethral high mid-XXs. is The will a X age for but The average care is chronic, XX undergo progression. typically form recovery. typically days Approximately X/X of of the of diagnosis cancer for this complication, months who surgery. some experience procedure within bladder of is Low-grade

of great mortality anesthesia not the cognitive literature these population risk. rounds risk elderly indicating a surgery. decline candidates in patients the of potential Repeated pose many So also a for are with of

and negatively life. can bladder of patients, Additionally, damage TURBT younger for repeated cause cumulative impact quality

potentially to UGN-XXX recurrence durable of complete of while patient reduce intervals We provide population. extending believe to that this will rates in ability an nonsurgically and the disease-free responses the care advance achieve

Phase UGN-XXX, successor the are of execution Liz As mentioned, the UGN-XXX, for to trial the clinical next-generation progressing well. III single-arm

to the We U.S. in and X enroll sites patients. plan have onboarded approximately clinical XX

the enrollment in half half patients dose to the first XXXX. an in few the approval anticipated filing the weeks, expect and NDA We half a with XXXX potential full in first the of of first in of the first and next XXXX is

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

our to pipeline. Turning

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

as study with plan a in plus Phase in well and updates to as establish formulation conducting of a as We the forward. the arm initiated to tolerability report safety imiquimod, proprietary to therapy recommended UGN-XXX and UGN-XXX, UGN-XXX gemcitabine a monotherapy providing for late look as UGN-XXX program dose are We clinical therapy. data combination TLRX the to safety, arms monotherapy our evaluate XXXX. We've forward moves patients. tolerability and plus We evaluating high-grade I NMIBC a combination also agonist, Phase II

for David Now over update. a to commercial Lin

David Lin

morning, on of UroGen. team done care. and at has to Thank everyone. a patient you, I'm Officer take good revolutionizing Chief incredibly fantastic job Commercial The Mark, excited the role

significant potential incredible there the of is value commercialization opportunity With creation. for UGN-XXX,

UGN-XXX. JELMYTO #X to that of of prepare year While value we the the maximize my will continue is product, to this support to commercial for adoption of priority launch

key have launch we early with remarkable that components year all learned with of apply already and evidence the assuming plan well targeting our to discussed on clinical of the underway, will if as highlight details further is plans approved. UGN-XXX JELMYTO UGN-XXX, Mark like commercialization I launch, commercialization priority We review. X planning with UGN-XXX. the of progresses. supporting have an our would Liz XXXX body

engaging invasive as bladder cancer community needs awareness various are upon product medical so understood proposition of the We to data, intermediate well with approval. through in as is initiatives well broaden clinical of non-muscle already low-grade our the the value the educational risk,

professionals staff. it treatment offering approval. care streamline into easy UGN-XXX their comprehensive can make to for support, to want by for office we We integrate and accounts including process upon health training this their protocols Second,

Third, we supporting reimbursement. informing in will confidence and on access focus and

planning will better fostering outcomes as from both offer to experience for well stakeholders goal collaborative processes. Fourth, inform for patient-physician with decision-making process. of ultimately We the are we and that potential burden about UGN-XXX's patients improved as productive reduced We reimbursement coverage a want engagement with options will dialogue XXX clinical that a drive initiatives a currently believe a surgery. the

launch rare the planned will UroGen of a a to product potential. means selling Finally, disease has transition much specialty broader diffuse focus UGN-XXX that from that

there infrastructure capabilities, is our already notably increase distribution overlap an significant and scale support as prescriber noting as JELMYTO. sales incremental that our with force, commercial will in well patient We

our leveraging the we of JELMYTO, support that with with these we respond practices think JELMYTO. experience and with are certain are with accounts on better interaction sales these to our learned findings, about contact increasing Based now there to clinical that frequency personnel. we tend As have increase

months This that is note collaborators academia, real-world opportunity community. and with to proposition I'll with JELMYTO. data new we continue the JELMYTO generate to great urology Lastly, was value its recurrence for together that our featured very induction. patients a reinforce high for survival free AUA. at to long-term X initial The included recently in of XX% presentations data independent, XX real-world responded at who demonstrated a analysis had

interest data with better into of maintenance recurrence-free to appears will to new incorporating discuss affairs now value be the are studies teams AUA, their associated clinicians. I of communications survival. also Kim generated turn use and supporting to and JELMYTO These our of medical maintenance and commercial Don now a at were how the There significantly lot over call our them with financials.

Dong Kim

David. you, Thank

reported the June the revenue prior year. the million. payments made XX, was for for For product connection $X.X quarter in JELMYTO quarter quarter primarily net arrangement Cost year-over-year decrease with the certain second The our XXXX, of of overall to ended second we of $X.X XXXX, in million compared nonrecurring with attributable million $XX.X second of supply XXXX. was revenues

was period million, costs manufacturing of a The for as year-over-year to R&D trial by study same in costs. as in Phase well UGN-XXX connection expenses UGN-XXX and due initiation the of as to to million Research the expenses development XXXX. $XX.X quarter were UGN-XXX, increase lower for clinical compared our primarily overall higher offset with III partially related $XX.X in second

were compared $XX.X overall and same million commercial with in costs UGN-XXX the $XX.X primarily was The an attributable second as increase period marketing increase year-over-year to expenses the XXXX. for in brand well costs. operation Selling as marketing in quarter million

advisory expenses ended ongoing to marketing compared administrative attributable services was The activities, quarter $XX.X second related services. General UGN-XXX, legal in were to and and the million the precommercial for increase third-party with expenses million managed compliance second primarily and communication $X.X XXXX. quarter

investments XXXX. of Noncash expense in second related obligation $X.X quarter the million $X.X was for to with prepaid RTW financing million in to compared the same forward XXXX period the

related the of loan as quarter and Interest The expense interest agreement $X.X XXXX. in with to to decrease million restated loan margin the rate compared decrease Pharmakon primarily million attributed amortization a was in amended was in period XXXX. discount result second of impact and $X.X same on in for the the March the the the

million. million in loss basic for loss $XX.X ordinary net was equivalents as per loss June or Cash, Net marketable compared the ordinary securities million $X.XX cash $XXX.X share $XX.X $X.XX for to diluted or and quarter and of and per the second period XX approximately XXXX. share diluted on net basic same were

full proceeds and at $XX.XX offering purchase ordinary of million we of issuing ordinary in at June warrants sold XXXX, to purchase approximately shares deducting purchase prefunded and lieu underwritten a completed investors underwriters XXX,XXX Growth the and certain of option expenses an public shares, we of offering In July price approximately discounts to underwriting end our per JELMYTO to ordinary full price see a offering discounts X revenue XXXX noncash year that XXXX proceeds guidance, provided to to this to towards be higher respect lower of provided This range. before expect deducting expenses. With year OpEx compensation of previously and we estimated million offering expense the With range of our shares. share-based of to path to growth added further with market million and the end subject $XX full previously the $XX.X company prefunded shares a per share of to million. In approximately $XXX.X X.X the before XXXX, million, million underwriting commissions conditions. overallotment exercised warrants. were we the towards guidance, $XX.XXX commissions revised $X their respect additional from estimated

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

for XX, our please including SEC. months the has filed results XXXX, financials, Form the to report June refer X our ended on details quarterly XX-Q, further which on For been with

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

Operator

Instructions] [Operator

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

Tara Bancroft

for like back-end the wondering whether give by expectations such mostly So in some will can guidance for look as else? weighted quarter be JELMYTO the or could your more you it I was year anything if to us of revenue detailed rest result what

Elizabeth Barrett

not question, won't to we're the it's provide quarterly and so. we've going -- never Liz. but provided we Tara, do I guidance Yes. appreciate

the important guidance variability of additional seen so we first rate to think is said going gross what for date. to We've is increases in that we've that we've give thing the net. the seen the year time I not Again, given we're far seen conversion the this decline. to

prudent things for And are. low end what like things so months. of path leave just well because to they of go feel to where it's if of few that, probably see more the we said we've is the And the guidance we do that a next kind

Interestingly, you from from top XX this being this a look is learn XX top year. accounts year, accounts at last they're if what to disease; the continue very we rare not the

I over to really support you I doing, right? love patients, just they I'm we do into where provide need So to high ensure touch these to going want really now. it that need what the do also know digging comment, to we to are, to what David's turn don't because David

place month, they're in different one X or Again, a place. in

So and our increase of ability it. to our the and nature high-touch frequency reach

go color things of year, can some David, we some rate? the ensure of back the sort see that the that actually So and you're working rest just our of additional normal you to on give doing up that on to conversion

David Lin

enrollment the all of and doses provides time support really to questions. the Yes. physicians learned from conversion that one because significant. seeing really significant that component Thanks I'm particularly has way important treatment. their enthusiastic patient the organization seeing of we're is is practices X the UroGen about for the receiving with JELMYTO, is And that the through things the time need what an the to of unmet that the through over

with doubling of JELMYTO, their touch reimbursement in are sure at administering are the down in we of only components many a are that is confidence supporting also seeing high higher volume terms of we to very make but appropriately, more the logistical patient them sure accounts not and that making around level. access that So

is So we are to to getting unmet looking the in base and there, treatment. their patients customer need continued very much our forward supporting

Operator

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

Raghuram Selvaraju

what saying some just And could towards you you give wanted look introduction us were see of commercial speaking just the as granularity perhaps UGN-XXX? you I about to So to if more potential approach before, us Liz, of some continued to you and want marketing how qualitative UGN-XXX. give both high-touch metrics implement commercialization JELMYTO. infrastructure that to take the support sales to Maybe again, intend to you and quantitative regarding the

of Ultimately, sales force UGN-XXX terms in what when existing to expect infrastructure that the you both the to like, field gets look as online? of you think product comes And well targeting going the of much size how as support to account is and UGN-XXX new service be in place once of the to as able market.

Elizabeth Barrett

Sure.

I'll don't David, in you additional and start, So why any add commentary?

David Lin

much Yes. for question. Thanks the very

As talked for transformative and care low-grade UGN-XXX patient opportunity about, non-muscle we've intermediate really bladder cancer. invasive risk we is think

into things is at the data need sure around the make point physician and that commercialization, unmet of UGN-XXX well we got understood. the the take terms in account to this remarkable around we'll So educate base we've know also

as comprehensive confidence reimbursement. into scaling force. stated, we've do in in we'll on driving is their that integrating I a that previously modest up The we around second workflows. How And anticipate access then support and sales we also importantly, our think into focus organization? thing translates will our increase we ensure UGN-XXX have

territory We sales we reps are and between or managers. somewhere XX call XX business them contemplating

specific we've that larger the thing important supplementing learnings how the the which UGN-XXX. be Because Matrix also that will patient JELMYTO at considerably have as everything said, support JELMYTO group, we that capability the as reimbursement, appropriate of the will to level is instances. for and Most slightly or population -- a actually as nursing we're field then scale team all up us provide can we handles surrounds medicine of the as is of well that for to support taught it that pretty such leverage new and scale then And looking doing larger, appropriately. in much

those So being final right now. are planned tweaks

Elizabeth Barrett

Yes.

the a about here integration there's difference, difference, into the so about And a David this think and about I when think talked talked what thing lot, physician right, that the practice. we've -- the you and we significant

important data they make oncologists seamless experience for with most have the as will the regardless the look, practice is. well, to So is thing or and for you how of their physicians product it not this adopt great

has about to because do seamless and so many #X the talked as been hard. times fluoroscopy. on JELMYTO difference, have you've the focused And UGN-XXX the David that that's we've integration. between And we how hard is got a ensure thing is JELMYTO's It's been

it done -- you So a have has by to be physician.

of a these days" to center Very surgery nicely. fits can most done an in different. extender, by already the be the to "IVT you, or to So hospital. very have time, They UGN-XXX have go practice. their

that. we support current things already has to So of into need have we it assume he nicely we're need we not up point, the that that. that David's make case, do that, going where David sure we the and be roles to the feels will that to like augment to sort of and plan fits that very do types in to brought And but

increased the have but really that and play And at for new don't of we're as we adoption then nice UGN-XXX. with although it are overlap. plug a ensure we will do looking launch, We a fresh enough acceleration a JELMYTO, to just fortunate

so are physician that about built standpoint, JELMYTO physicians have the that are excited UGN-XXX. about excited that from Physicians -- relationships about -- UGN-XXX. not you are those used we and JELMYTO excited have So used

we'll to it additional work Ram, around works working next And we right color that now in continue provide so months. as in out that we're of again, the all is the on as and, few

Raghuram Selvaraju

UGN-XXX, in well? might to the that as provide itself, think JELMYTO and a you sales of do actually of just And presence tailwind

Elizabeth Barrett

believe after little more It's dramatic engage, work it's UGN-XXX, think Yes. bit experience reverse difficult physicians actually I harder be That's to also they been -- see may I willing as call with I've for with do a and very what will a anything do JELMYTO. more because their patients and is when educating productive around there different that ensuring is sort sort annually, shared of of But of can a opportunity XX,XXX X them, Ram, there. halo X,XXX that there's and only the absolutely and engaging of we decision-making there's of do and dialogue I between engaged become agree, more well. that halo that there's them before. when very patients patient-physician the said reverse that to them. an for patients

Raghuram Selvaraju

quickly comment of said you on earlier profitability. company and the plan can the potentially But point, well? includes XXX to that expect in the achievement specific think of in when also very to financed may, make strategy be not at this sustainably management making efforts as the this to And pipeline, and just accelerate be you life you through to investments to on XXX central XXX, expected well that you but XXX you as any are as further clarify XXX your development cycle which

Elizabeth Barrett

We that beyond, we need Great we do be what just about, given absolutely. with you and where the and profitability including Yes, to XXX are talked question. believe including XXX. financed through

as obviously. we've XXX, make both the we of still them as way. that our those get -- financed didn't One and but expenses accelerated so we we we to is quickly possible, and guided XXX end the They're take because done sure are that range, to reasons we want and well, that so took within up, higher we

about very we're sites about cycle as with then we that. have comes be already started clinical as to cycle And We to that already they that And The obviously management, is have they're dosed We excited life can life as start smaller. that point, started. XXX. nice shortly. patient studies UGN-XXX. thing have So And with behind anticipate again, management first right? your as we'll don't so announce out. quickly that We've those big,

what would experience in with able patient this typically there what they and own UGN-XXX, JELMYTO discuss we population expect FDA the medicines to Now -- see. to that with is our with we're

to a So deliver in fewer to as long range, as those they should be with go we that able patients. -- them

money those should going to allows gel, to and their other those companies us our areas. accelerated. a be are talked to So of well, to talking those. And announcing for those And current over as some that about their we'll -- next continue to collaborations. our medicines this, We've of to be still be putting financing interested do that we're months, the allows we and in have few few other and -- us

Now we and we a our we taking technology and acquisition, as to space. able medicines can't as out to adding as potentially but and into new this massive do go technology our collaborations go will forward, finance in fund be well going using

missed, that So hope know. helps. me I I If there's let something please

Operator

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

Leland Gershell

potential [indiscernible] mitomycin of guys at in could to to either Wanted with high-grade that Wondering or paired a own ask agent, respect role been another perhaps showing NMIBC, high-grade advanced look perhaps has to UGN-XXX there there technology gel on the be in benefit? with you that that dwell its contemplated turbocharge could -- if gel disease. it have data higher could perhaps be more a time larger for NMIBC, sort potential and in given that and for

Elizabeth Barrett

relevant. definitely We part get We -- we Absolutely. planning. are know, more you cycle our that's of be probably disease, do combination into that high-grade as as will therapies, life believe,

have will at we definitely potential We list as be we and we up and looking go his with speak but a next, opportunities, do are so in right? of it, will where that doing high-grade Mark disease. UGN-XXX work And to come team

Operator

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

Kelsey Goodwin

Two quarter. the on us. from Congrats this progress

have extent what durability in color JELMYTO on recent risk that And us hearing to remind what headwinds hand, the you about the face. think more separately, from Maybe, you've you we then you when in weeks been data KOLs now in provide UGN-XXX? just through ENVISION you First, read relevant have to can that could they're or intermediate space?

Elizabeth Barrett

Sure, Kelsey. question comment. David for also first to over I'll Mark and the ask turn to

any those, Mark, both David, please well. of as then on add So color and

David Lin

Yes. Thanks for the question.

JELMYTO, as on on we discussed, XXXb So Medicare drug. a refunds the chargebacks lot from also were gross to headwinds the net of question and with regard perspective for discarded to a

threshold. expect UGN-XXX, with where would when comes considerably drug We community those And to in we heavily think under and provisions, when it that to anticipate less it less significantly practices. you about be regard to discarded exposure focused UGN-XXX it be be will the because be then to more administered,

So as will think of less we look issue. headwinds forward, many of those be an I

Operator

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

Matthew Kaplan

the near question, potential how about for priority as for first the UGN-XXX you think should submission here? Just we granted a being review

Elizabeth Barrett

My Yes. great give all the high -- wish because achieve I guy don't question, very but laughing I'm a them thinks he just Matt. Look, very, likely. better I time. Because percentage, than regulatory very, probably very I it's it's a confidence. has

The no reason about, we've compelling. The of is There right? talking been are the very other approved. data because things is drugs

Of if course, -- into there's at the their FDA publishes fit what but we you around there is a look review, priority surgical, guidelines.

And that believe so priority we we review. get should

that guarantees. we Having said to all know there's no that,

definitely priority that review, us And that's confident we we obviously, guarantee and get our we days acceptance, But to can't priority acceptance. into the the we get have as be they'll case. But when which we when XX we'll soon tell as review. file we so nicely like be feel but we get whether feel that obviously sharing, we later, then very will And fit is that.

Matthew Kaplan

little a second growth for commercial how improved JELMYTO. performance That's to shifting Great. and potential the Talk bit products, just and -- going about then the the during quarter helpful. Great. forward. And your

terms in of some treated headwinds as address of you're patients unused to there queue Specifically, chargebacks, well going and can just the drug running in transition forward? patients into, of are and the the that the the that you

Elizabeth Barrett

Yes. to David a comments then question. turn and look, great add few over it's I'll it a Matt, make to anything.

their Yes, top of most out obviously, I've country, I clinically there's absolutely every around space treat maybe are they institutions of JELMYTO. every convicted. single believe talking I who I'd major couple in is it. been KOLs our by for But in myself, their that clinically convicted don't. this patients. who Those use one. say single to are And Yes, there the one And what are a that all physicians that part, the use they JELMYTO mean patients.

conviction tells believe there that JELMYTO. that they That clinical in me is and

of XXX, believe talked we had really And the patient is about Linehan, biggest largest the barrier event even the logistics and single JELMYTO, real that we largest I about -- being And she what what David lot around it the talked actually a the Dr. adoption. earlier. to So is is identification. around hear for -- barrier around when just the and

patients, X,XXX got XX,XXX got You've urologists. you've

the from than we than different 'XX, mentioned There's as our some so when half accounts take And look our earlier, that top XX of It's at obviously is they're accounts 'XX when just using. in but in are negative a 'XX. XX top not overlap, experience, not more ones And of XX. the a I top there a patient there. therefore, matter is it's not and the they're

over there just that identify think I David has so those are the we ensuring to we is really implemented our improving frequency that of reach that few and And is are things and weeks help one patients. of on. so the that And one increasing that the last we're things focused

a To they your and point, the what net summary, are, wastage, the in be Those going to uncontrollables for respects, us. they are. to lot gross of are

down adoption, one on conversion. we the reasons. and of to and focused is patient a but what that have Nothing thing, we're beginning to There you when from the So that's have we was identified. myriad do different are what there to identification have double on -- of patient no be and

in enrollment we just or last quarter within quarter. would If had this have first a the patient we be would had well not growth form half, -- we translated miss the

else that demand and So are those there it's something is and holding it up the me that's tells on. the we're that that also things working

I David, you to to don't know, that. add any if color additional want

David Lin

as Thanks, well what Liz. is, experience. with we've conviction as thing very of about, particularly the would add JELMYTO that that and to clinical their those have experience positive patients a them No, I customers talked it's speak as the administering told only the is is we high,

is being at place, at the the patient time, very it is challenge Our right population. right diffused biggest a as

a process supporting we we most to that when upon identified scheduling. the incumbent training So can them a deliver is with has seamless patient, customer are with in us and it

strong, to flawlessly patients. or are and that down we fundamentals when very think find we offices identify I doubling So our execute are make sure

Elizabeth Barrett

Matt. Mark want had to KOLs. all your I'm answer lot we to ask got obviously, I interaction Thanks, I'm do just back of didn't go And a question. back with He And event. recently Kelsey. to going sorry, second to comment. a we've from BEACON

and can the KOLs, conversations on give Kelsey's recent with answer recent your second you event color maybe to question. some Mark, So

Mark Schoenberg

it's aware the predicate network, the cancer the for there approved. the very an and may as the data and the as availability is in know, excitement time II potential represented of ATLAS advocacy for data is growing this audience question, the community trial. if Phase already And thanks bladder this exciting about as OPTIMA, as drug, ENVISION well by Kelsey, of

A treating be heard beginning just this the possibility in I at really understand, it setting in-an-office to from is going disease. complex the about a technically the it of have think And and patients that for is for KOLs option week had the available for past much lot chemoablation are people possible really than available this San meeting. to TURBT heretofore I as JELMYTO will this this who patients, delivery in provide Diego less that that manner to of excitement only make

from in patients we. as Patients for UGN-XXX and people say audience. potential would about I approval both the a this the So This doctors is industry. -- are and excited aggregate, and are mixed and of docs both is

So exciting as times, conversation. I reflected that think, by

Elizabeth Barrett

Operator, questions? any additional

Operator

Yes.

of Our Sachs. from Goldman Choi is next question Paul

Kyuwon Choi

for impact ongoing a you that and waste And onetimer forth, device, this the you on the mitigated regard of prefilled so do then a more JELMYTO? Or to anticipate the XXX, do in drug whether mix here you having more and that? with for just offset expect is to be by is sort of to part you XXXb My this question and elaborate commentary. a follow-up is on Can this seasonal think quarter? just first

updates to you just then line And have Can filing? Or and I 'XX and programs in timelines my second you've whether you you 'XX? regards question elaborate or XXX the for results planning detailed data for XXX. appreciate are that to Mark proceed interim out, would is the those present with maybe Mark. laid top any potentially with

Elizabeth Barrett

Yes, to ball of variability And quarter-to-quarter. I gross had just where a crystal a Paul. that's net. comment concerned. I'll on wish the I We quite bit see

So discounts. to hit We'll I I see that. do continue we going -- -- a place where the we're to think the back not go lower to have to higher think

year, in I going think be over continue the think to I so I so headwind. that quarter-to-quarter, there very see it but continue So to aggregate to a as that's that do But -- making variability difficult. I we're think

I obviously variability don't nephrostomy than said, we've the other. do much because with a it as more I administration Like at only will low new as think see we with tube increase now. much seen it's you already don't that

Although I do is issue the industry facing think our single this today. biggest

XXXb. You of from lot a hear it people around

discount, get buy I need even an and account. they a think practices what addressed that though have seeing into we XXXb you're out they to delivered the to figure it's because institutions, is way

to further So erosion, going what gross stay that I to be to but perspective. is net a that is here here I think see from think don't we'll

and mentioned net I good can headwinds before, learned to as provision, what we've at think again, the pretty now, anticipate. the with even wastage of gross we I So

an and demand it's upon patient translates drive think actual us I and ensure that, incumbent that demand the to being to treated. drive adoption

that, something really, really that's focused is David, again, on. And

And the far, I And dose. better be to third in the don't want that, that's if months, I every be to translating So where and even simply that, had the done had so of not patients seeing we ahead we again, think with headwinds, to that which needed we're what the that's in key, would quarter ourselves. a a but X identifying get we And we we little first patient to be. going saw bit the seen before.

So Like the there's believe end the stuff I said, I of we guidance. good really feel is the good about our implementing. lower David a ability. feel that to about path

not that have we'll underestimated of that do But will make will we the we -- not right, be -- again the only we a practice and so that, to very different assured, where that. JELMYTO, all use, JELMYTO. with to ease continue we won't we that be be slog, know drive UGN-XXX, but learning it's economics, to we don't that do and underestimate that the and continue And ensuring things with logistics. than the the we going which Very,

the really one David's And so that of that's on. things really, focused

question you and the why don't XXX? answer that, Mark, around with So UGN-XXX

Mark Schoenberg

Yes. Paul.

she's certain we accruing because But to going approach we already to and smaller an do of from rapid have they to because to premature Liz trials the accrual not be program, as I'd release anticipate data about and data are to going want availability mid interim have to of is her timeline again, said which those to already as I is XXX 'XX. Candidly, either Liz sort on in would rolling, how a we So in familiar. remarks, with I'm with trials. defer on fast with releasing that to that. to XXX. it's respect completing to to to disease trial, are it But interim early Liz, the defer talk approach

Elizabeth Barrett

Yes.

to chose not anything integrity the to of their and do durability right, consider to that, data we out the giving, to important able an thing may FDA. would In with data, the is conservative and think given question The jeopardize share we for most able have any we because us have of data that updating We being want basis. so on did that and don't of have very one that to on we CR of in the is thing our not we want to in that. is reason that itself, some I FDA be there sense example, the been the our ongoing companies disclose other been the all -- data.

that, So think would be what we that could that we And think anything at But durability would And our able we don't is other share not to the but would data, initial jeopardize I something filings. share we'll doing. look it's we that's durability. I said, sort CR. share just practice. think do of want good to on like the than that, I ongoing a not I don't

conservative that very will we perspective. from be So continue to

Operator

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

Elizabeth Barrett

thanks, joining and everybody, today. us you, for Thank Yes.

you I us is toward heard real in from shift think today, our UGN-XXX. focus

very posted on we've share our We'll order finishing things. and the feedback talked anticipate be with you that filing will We after and that, in about we'll and short shortly, you. the keep FDA as we'll from

for UGN-XXX our potential the of both always transform that the durability, show the vision company. been think That's to JELMYTO, recurrence-free and survival, are the mission the patients and nature these our frankly, for the I compelling way and our have treated. data, we ability that

but not said, for transform will we our only they that also for patients, So company.

you So posted. we'll keep

questions Thanks and can and you we dialogue. the for Operator, disconnect your participation now. ongoing forward today, look to

Operator

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

disconnect. may You now

UroGen Pharma (URGN) 13 Aug 242024 Q2 Earnings call transcript