UroGen Pharma (URGN) 10 Aug 232023 Q2 Earnings call transcript

Good morning, ladies and gentlemen. Thank you for standing by. And welcome to the UroGen Pharma’s Second Quarter 2023 Earnings Call. Please be advised that today's conference is being recorded.

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

begin. may You

an investors.urogen.com. morning, ended quarter Good Web Investors call. at welcome UroGen release results accessed release to this highlights be recent Thank preliminary can XX, and financial everyone. of XXXX. results portion site second financial providing press a XXXX we the conference the of and Pharma's our our morning, corporate quarter you. for issued And overview June business on Earlier press update The

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

and foundry on expectations being to potential things. our latest approved, During UGN-XXX, and expectation efforts, market as A if research priority certain our commercialization release our XXXX planned forward-looking commercial disclosure and today's future and statements and making activities assumptions future review, potentially information, commercialization can are risks for UroGen for related subject regarding strategy anticipated found decisions description will regulatory ongoing including development and growth SEC goals include statements call, based guidance earnings forward-looking approved, be be driver among press statements. and commercialization These and financial that revenue These ongoing to opportunities, other clinical well clinical we are our filings trials, receiving milestones, potential data, may current activities if and corporate UGN-XXX of as UGN-XXX change. the in our JELMYTO, documents.

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

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

treat randomization TURBT patients to deserve We after UroGen. plus commercializing urothelial be who today. to you by and you compared in across this to TURBT joining a patient demonstrating UGN-XXX results is patients us or and three complete that speak to X trials cancers with the a UGN-XXX consistent TURBT received what for analysis. arm at for patients at XX% UGN-XXX in who UGN months for months three was to only rate survival estimated received XX% a patients XX% the XX% XX response complete Kaplan-Meier response showed the rate minus months a The arm also compared for compelling trials, endpoint safety three ENVISION we met rate treated trial XX.X% while also TURBT. multiple initiation of response primary of months only has limitations now had UGN-XXX and Both UGN-XXX for that risk their XX%. at complete following its therapeutic clinical TURBT. treatment. the showcasing population. patients of with believe committed in the what profile and survival, its demonstrated by reducing invasive as revolutionizing trials, recently overall non-muscle time can two a investigating Disease novel and consistent better. Vincent. to I risk death UroGen unprecedented by ENVISION trial, therapies, primary And bladder primary endpoints grade or care the developing specialty from I'm Phase endpoint thank Thank and intermediate In patients relative for to low ATLAS describe met by and UGN-XXX only met to of disease use to free patient you, the cancer. demonstrating meaningful transformative during recurrence results of of everyone ATLAS announced excited progression targeting clinical free patients

the of endpoint expected Looking of of ahead response the secondary evaluating is half first data in XXXX. duration

approximately first ever the XXXX. approval for to anticipate as to billion. quality patient primary or highly early annual improve from XX,XXX XXXX. having disease the than NDA of result FDA the the individuals UGN-XXX shift we UroGen's treatment we total of anticipate an in recurrent battling If opportunity receive market potentially tens of driver traditional centric US granted, goal XXXX disease. may be afflicting away impact non-surgical this submitting an would option of on year of $X dedication life end growth The review, early meaningful thousands more patients to which findings, to new the be focus as priority to positive The the potential Assuming in UroGen if for of each surgical care. with the underscores approved, care as in patient has This

a growth XX% pleased were in therapeutic same practice patterns. We're a increase to the case safety continued world and second record recent and see as additional data $XX.X from consistent the adoption year prior. across strengthens real quarter JELMYTO Turning net JELMYTO's quarter value revenues one to million, the for different

as shape we will success prospective JELMYTO's recent pre-commercialization strategy. UGN-XXX’s We leverage

strategic strengthen $XXX financial taken the parallel our our recent our ordinary us steps were for position. business, In placement private of and UGN-XXX. launch shares to resources strategy pre-commercialization support including million The with to anticipated provides

submission care a our with believe UroGen for JELMYTO for over progress and With opportunity significant biotech that, to urologic as quality a investors for shareholders. while plan and an address I'll in the thrilled ahead positioned pass of and Mark. Mark? call of who UroGen's the to cancer group in patients new believe creating We UGN-XXX specialty in value a represent portfolio unmet significant year. made opportunity. we and in needs XXXX billion over We cancers. road to of is are the UGN-XXX to dollar era am I high the and FDA partner we've urothelial proud together specialty next for pioneer revenue

Thank Liz, you and hello everyone.

stakeholders Horizons actual our you To and were the information and to at discussion topline New I event, If to the I'll and spend recent ATLAS would replay I attend. information draw not, like available I and through encourage Web would X of data, from has ENVISION by care. our this some able described so, time which and putting in clinical from hope the access recently site. presentation context shared Liz details As now key of the in our UroGen patient data panel strength Phase announced you to practice gone on do

a week results reviewed ATLAS of published the In earlier addition, highlighting X peer the Journal study. Phase this article Urology from

genetic grade people We encounter the cancers surprise characterized the US parallels intermediate medicines both. grade continue for with are risk when low molecular grade UGN-XXX JELMYTO two patient recurrences recurrences. NMIBC, XX% to It that urothelial is of When tract Of in tumors and while makeup the for the upper treatment often bladder patients And carcinoma. XX% similar draw is one we between learn the having with well are actually and of to risk or same different and Interestingly, schedules. NMIBC drugs, we the the similarities that over of alone. high RTGel of the with XX,XXX advantage, in with active and our differences more prevalent they those subset recurrence or work significant. most UGN-XXX while cancer to JELMYTO examine dosing more low is intermediate are the low leverage technology XXX,XXX with five similar

TURBT or population urinary oncology. administered advanced For XX% of avoid patients remains within the urethral data of Others population XX adverse But to most who surgery one TURBT that patients as risks offer practice procedures the provider on have Aand UGN-XXX a with because standard common the magnitude stands risk clinic TURBTs increased repetitive UGN-XXX of urologic nurse order one, of mortality. upper published using and and patient patient by risk setting based without to catheter. have this can care mentioned an encountered from in the is not for this a performed significantly a standard alternative of is approved, a in literature. treatment If events than UGN-XXX four of is an is two surgery. to the the be larger access population allowing shown while days to undergo easier also tract, for patient the efficacious bladder than associated JELMYTO.

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

Thanks, Mark.

second represented strongest for The performance our quarter quarter ever JELMYTO.

key ramp quarter, the several factors. of Growing saw several JELMYTO in in strengthening and attributable an to uptake JELMYTO During adoption increase territories. of developing we awareness and remains second the further

strategy our growth the deliver revised benefits consistency to First, the territories. developing continue of sales in and

setting, JELMYTO consist mixing real the finally, our doses logistical of time managers’ more of several has and Second, partner the the coverage delivery, data morning day to types. patterns. geographic And much period from reinforce for prior various prior early larger XX% day and admixture extension expansion eight our the continues lays practice at XX of and facilitating of and JELMYTO’s with of the strengthen efficacy potentially preferred across use of optimizing than payer allowing business as the a product real patterns. in remains Reimbursement eliminated easier supporting incorporate bladder the outcomes XX% Currently, world to installation. world to evidence field. territory non-muscle the cancer. increasingly profile, traction including delivery, and growing in multiple hours body from its This HCP of operational challenges, enabling optimism be reinforces proven approximately stability to multimodal across invasive all grade, safety the foundation our low practice for across and administer intermediate and in risk, becomes UGN-XXX opportunity adoption appears JELMYTO’s accelerating

our a well-established begun we With base the if organization commercial our heels of a ENVISION On approved. seamless in XX% ATLAS the UGN-XXX executing in preparation positive pre-commercialization overlap our and data, we've NDA. into prospective of and integration patterns, UGN-XXX plan for expect prescriber practice

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

XXXX. to to second June you, call. XX, joining today's everyone pleased for Thank financial review thank And I'm Jeff. call for the ended results you our

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

Investments training, compared per share share of or for a of research second period net related expenses. of obligation $XX.X and financing to net a on UroGen higher professional ordinary operations, $X.X reported for lower as UGN-XXX, is net the is million loss to conclusion XXXX. forward development basic This and expenses ordinary the market UroGen second $XX.X by as or and prepaid the to SG&A per XXXX, higher same $X.XX diluted of the the RTW cost the quarter expense for lower same study The for related million to expenses R&D due of period ENVISION related expenses the offset were of to $XX.X XXXX ATLAS $XX.X X XXXX. quarter primarily UGN-XXX. trial second For $XX.X million by for Phase research general the in to XXXX. and second Selling, decrease of diluted primarily in quarter on services reported for period were quarter to to the related for for the and million loss expense loss to and in compared million million. XXXX. the compares due offset same commercial administrative trial non-cash million Increase marketing, XXXX to $XX.X $X.XX basic lower

announced forward Turning $X.X in to be conditions. million this million in $XX guidance. to non-cash subject $XX to compensation cash. reiterate We to prepaid range expenses be financing of million XXXX of approximately from Of anticipated year $X year in anticipated to million, million proceeds on the to the amount, of $XX JELMYTO to equivalents operating and range $XXX including year securities, $XX.X full million range forward in million financing $XXX We million. million to company revenues $XX.X reiterate $XX XX, with to million XXXX the quarter expense the the XXXX. of related to full be is to the second expected product in Investments marketable the cash non-cash expense of XXXX million. share $XX and based to including July full $XXX the RTW We market obligation private The reiterate million net not ended placement cash

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

comes question from First of Selvaraju Wainwright. H.C. Instructions] [Operator Raghuram

I wanted on of first JELMYTO. focus to all

are driving the trends example, If a as now or -- you're marketplace issue go adoption? in appreciated. the whether the that right through expect seeing of much use you to extent, as that antegrade are give what installation That continue you what could if to us to could guidance as revise be we and sense uptake, key is for driving into of we get necessary revisions XXXX? And helpful guidance to clarify would underlying further very also you

for Yes, will we be changing think not I now, guidance.

I and we're where with are. we guidance comfortable think the

maybe month, how I narrow in QX at see and is try the think guidance want and As summer to QX we next so we call. wait things before to go everyone our the knows,

to it with Jeff So that, your I'll turn other and can he over questions. answer

Jeff? So

you two reinforced They in pulling, a ablative what So us We in theater, industry if pulling mentioned or from we there, of kidneys AUA disease. at those continue fact real they continued option. about we out had world guidelines, you put had low talk to grade with have shouldn't an where, lot be the momentum the presentations to an evidence, guidelines we you as urologists. partners know, all costs, shouldn't which be that

in they So in, they then and of six go they doses bring JELMYTO. endoscopically resect

positive So OLYMPUS a a been a out field I think seen AUA from and was lot access. the that of come answered We've unanswered has get questions year of this from it us. data able that to lot

also -- physicians they before, product are a procedure or the XX standpoint get they convenience happy to can We see can do the administer eight that stability in increased, when the time morning. the hour the day

all business the good the of about to momentum, lot a that of data. talk latest a territory just allowing opening So good of really things are and doors managers lot

XX%, antegrade institutions never AUA patients, go there are all at XX% administrations. I a retrograde. shows actually rate. but Rose see published antegrade, from see that the prefer that some You still prefer the Dr. to really to stenosis some physicians, data lower mentioned Jacob we are Dr. continue But I'll up, somewhere retrograde, -- that of

do said little physician a to bit or just of rate. slower But mainly preference. to a patient see probably due increase, antegrade as I preference So I continuing that's

model to a you being whether comment steady then just for respect can at world the that be with data are you to XXX, a analysis expect And pace real reported currently useful JELMYTO you would that kind collecting same a for real out… context come on the us world when of approval, and in the UGN-XXX if of use data product be to UGN-XXX will putative think about on

the XXX with adding by but Yes, registry not we with approved. will absolutely. And definitely when the gets more well registry only continue UGN-XXX, XXX expand sites and adding the as

the mentioned, around data how been lot Jeff driver. to that's can we're there, real I you we patients. a the of good UGN-XXX, use treating through physicians questions and to from same. world out learning, It's as JELMYTO we registry the seen a it's of through analysis big know way just good see their do And to way to really many uses different So starting a we've optimal retrospective for their see and a think for of us expect get way recent

absolutely. So

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

with out I'm had we pivotal that you've impressive on saw not data discuss file First of the question the to whether earlier ENVISION? study. the to FDA ATLAS Obviously, could be or is if study you very basis than there. curious for any interactions waiting a potentially allowing

not yet We them takes, a it a how XX award and requesting meeting them conversations with the be us the have of takes with so to FDA will as had FDA, long meeting. we days

them. them, so we we And talk as as to to soon talk will can

We only confident about durability had I feel the clear that but in think ENVISION. the the OPTIMA durability very them FDA base conversations the durability to from the feel We the I want with the important. what to very on case along given has that we is we very should very and think is they're data going been confident expect the based in see -- ATLAS. durability but all FDA not

we're the sticking in So a we current talk point with to FDA timing to far if concerned. to standpoint. wiggle this them say it's timeline at any will think But fair as I about that from time, room there's our as see is

question used purpose can the JELMYTO to get in you once difference approved, the My of a place JELMYTO? XXX? of question I sense and just can of outline between second XXX, be exactly what is, just And is is the guess formulation

can't that's the -- but them? it in talk about interchanged, be that you can differences and why Mark,

some So there very differences. are specific

XXX first The a is larger volume CC to JELMYTO. a which concentration of with compared much mitomycin per is lower of

an would that I by our not they use different based XXX while actually So are tract and for delivered on be the agent acceptable doses of urinary data. understand published think upper different medication it's to are important interchangeable are efficacious not in the both medications,

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

from me. Couple

section expect but the the company And for and clearly, the the lots of the as of going with early, you a existing XXX data? here feature infrastructure. expense First, both full data ATLAS that it's bit therefore, secondly, label, complement to we think about the I know would overlap little operating of forward, ENVISION commercial

scope to mentioned You for prescriber overlap its what incur company we expands contemplate modeling selling to expense think in XX% be base. may should the What need purposes XXX? we UroGen as about additional as

don't I think in label, else. will your launching label, leverage the to of But section the the ask those why Jeff trial discussions it's ability point, obviously clinical if a to with to with the expenses in see but FDA, data be obviously just have we that across don't UGN-XXX expect we any early. to we I'm of data But all comment would just on reason be know included. going the the I from JELMYTO. nowhere of not would and standpoint

Jeff? So

prepare So other synergies the yes, there overlap field. you the for also targets, for for strong significant Because say from synergies, we yes, XXX% expansion will the targets, be with with see take a overlap in wherever in the we can don't would the but with launch there of for the are we for XXX. I wise a obviously, we'll launch in events, we expenses that conference the conferences, will and significant adequately build JELMYTO, be But JELMYTO. XX% could overlap, meetings, XXX. for for overlap Obviously,

obviously, expect, for expect UGN-XXX. said think would we I be the you leverages smaller do, will But increase just absolutely a perspective. Jeff like It's from in a that, we that opportunity a we there we field. though, can will might just do geographical mentioned, launching do an having than of the and Yes, much but And as for lot territories will other some expenses UGN-XXX. there be incremental that add physical big

agreements or the question know of quick base parties. another third the have that's you've respect spend? about and any task by for number mind kind many that across community that urological done urologist or with that needs, impact would practice I need there to comes that is practices. something established for premixing we actually should a coverage And various How your have increased facility for on that's premixing you the for of think to

JELMYTO, Like for don't community mix. accounts prefer we to a that have mixed option those

same. do We will the

at We can mix The mix. the all that like the JELMYTO can folks will product keep would be a expenses mix model decision we so a are or JELMYTO either week. also it a it or on Monday, either administer are we just everyone yes, XXX% to during training very similar we're mix. there's now. stability And we believe everyone enough this. anytime looking What that deliberate that's incurred to do deliver product needed to but long mix is receive there's be there evaluating won't not It'll they efficiency, require and to operational mix. Obviously, that

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

of of and I BCG the you at given guess of the some shortage? just bit, how especially going in How given recent will it, the day strength the think do for comments back an members. enthusiasm MIBC, it a the do by XXX on the you utilized treatment think data KOL their panel ongoing be based little the

grade intermediate So have pathology. low focused risk obviously, patients think, with I on our data

want my setting new would in that in think, management JELMYTO of But are the be Obviously, approval patients. physicians would who for this of after either for available obviously, use we've expectation entail patients this or can be to promote. share be disease, namely Having which for disease indication, obviously I their could creative that intermediate comment that BCG and And experience, de novo well. my seen recurrent they with Liz histology, that and a to risk in that, grade is tool off-label recurrent said exemplifies use may treatment on appropriate who would have grade low new of intermediate the the disease. in risk have in the the not once as we indication would expectation be lion's So disease. high would them, not patients

disease. I'll just I would point. guess promote in grade high Mark's to add no Yes, way for obviously We

I I of the else ongoing treatments. think with for considering of data study that we we're think in do is grade so the things now underlines the study BCG strong, just the shortage the where high UGN-XXX. being one UGN-XXX need more And do disease, we

study. we the you'll still, have this lot think opportunity I on perspective, next. can high it we in Mark's see space. unmet I need and risk in in again, lot a where I patient really take think a of of it There's a ideas think But population which from intermediate we

help quick Jeff question commercialization, perhaps. ramp JELMYTO And can think from UGN-XXX applied approved uptake? of learnings just the the which to be once I you facilitate one for the to guess, that

convenience lift. XXX of the you just operational So as don't a big that have offers,

given As of an will so in be formulary can it by given about I I up be or off said product clinic, believe to setting hospital through don't this you have institution. getting at we extender, mix, this worry earlier, time the the if product deliver most

is for partners they the that we've urologists, definitely regards I mixed being that learned do accounts. think, aggressiveness level they're a need product And to having community So with something of delivered the surgery. we that surgeons, with

or making TURBT. for So six them positioning that are be who strong with to and seven someone our sure had partner messaging reserved and not

build thing clinic. that caveat the other buy and from that a this for as can be in the the that that certainly The well standpoint, be drug from will we’ll that convenience is business given urologists another

curve convenience of with the partner significantly but how launch to that's going certainly XXX. sheer we learnings urologists, overcome by So a XXX, of with lot we of how just be message, will then the help

showing Thank further no am time. this at you. questions I

back So the conference to to for like I'd turn Liz now Barrett remarks. closing

operator. thank Great, you,

taking the join today. time you always, appreciate As to we us

commitment for time, patients in company our in every patients by urothelial steadfast I'm colleagues but the I and day with inspired not their mentioned of for have it's remained earlier, unprecedented cancers. only advance ability for to belief our our that care an As need.

and forward next So to we dialog for interest in your joining UroGen months for today. continue to Thanks few you. with and look us again the

can you. now. you operator, disconnect Thank So

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