- Earnings call transcript Q3 2022

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Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to UroGen Pharma's Third Quarter 2022 Financial Results and Business Update Conference Call. It is now my pleasure to turn the call over to Vincent Perrone, Senior Director of Investor Relations for UroGen Pharma. Please go ahead.

Vincent Perrone

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

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

report expected and to filings are other development and thereof, and timing filed XX, our Form other efforts are can regulatory risks that information, and September future description including Jelmyto, certain making to forward-looking financial and goals, current These During assumptions benefits today's our be quarterly call, planned These trials, if ongoing be on heading approved, research potential the for potential XX-Q relating press the we commercial potential potential statements forward-looking ended commercial of the ongoing commercial include documents, our of activities based among of things. leave for approved, and UGN-XXX design of change. if for statements A ahead, expectations subject quarter clinical XXXX, found our earnings Jelmyto, Jelmyto, clinical and statements. regarding in on corporate for period expansion will SEC may expected presentations, Factors and data the benefits UGN-XXX, for milestones potential commercialization activities UGN-XXX, our of year end-use and disclosure the in the its release potential commercialization FDA's under the today. benefits Risk design, future and potential the the growth

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

Liz Barrett

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

is much at importantly, excited and to on about. there quarters and be just the last ahead, quarter Looking as encouraged this looking back

during were reflective quarter We've quarter to bouncing Although which, rise same on with XX% of the of the third a associated COVID-XX is revenue Last grew believe we of year, year. cases. type XXXX, test conversions before a sales sequential back seasonality, compared summer this last lower in protracted slightly in August. the come to in basis, were year-over-year period July

before quarter XXXX, patient of During Labor enrollment starts of patient Day. after baseline third from new the August forms conversions returning timing remained longer to to through

we significant in was more versus rate Jeff the territory. in this shortly, in expect more return to introduction XXXX, a of quarter of same of shift in adoption compared in rate a X. varies more decline Importantly, consistent Jelmyto a reflecting period to will territory decline the to treatment revenue growth requires revenue on and paradigm, but The bold only provide X% year. prior

One introduction be points expected that the a more is other on in show expansion appear in regions. and this clinical believe that resembles impact we've learned commercial environment and approach closely in also possible UGN-XXX. create of parts the serve results experience JELMYTO the more a country, key several to technology. Accordingly, and Jeff as made receptive the sale. JELMYTO will adopters positively and other have which Early of changes performance low-grade elaborate which when shortly. based conviction learnings, medical model for on especially what importantly, purposeful is familiarity strategic our device field, the and, to spread, the the embracing Mid-Atlantic and We've RTGel to the significant opportunity would of for strong We in to These certain urologists country. most important a our Jelmyto of proof is and regions in parts Northeast breakout UTUC

the established that anticipate We low-grade our to well as of been to enrollment Phase malignancies full delivery respond invasive we pivotal pleased a of to both it's believe this risk intermediate non-muscle with end trial as announce cancer mitomycin gel. early bladder X that the Moving well mitomycin types I'm in patients UGN-XXX in low-grade ENVISION, be in of derisked low-grade UGN-XXX, forms common with the month. shared tract success activity given of translate has to activity believe in exposure diseases, the RTGel of due may and similarities efficacy this to a the therefore, the in to program upper the We, with both API efficacy JELMYTO which prolonged technology. mitomycin, to of partially shown bladder. malignancies

does to After establishing the use intermediate JELMYTO patients, with of to a by is RTGel administered non-muscle starting a urologist expected office, regular a primary cancer other risk of an routine to our point products is may to designed treat procedure urologists, is urologists, Installation therapeutic with expected potentially anticipate the clinic and Delivery of invaluable. be as invasive from XXXX, and on UGN-XXX before easier OR or which, positive non-surgical in the outpatient approval first UGN-XXX perceived is doctor in an in targeting similar to JELMYTO. Assuming low-grade where in foundation staff filing UGN-XXX we experience XXXX. time support given this will a priority of and results procedure. approved, require for UGN-XXX be will basis. use bladder review If result and is NDA administered FDA the not it with much the specialized of than granted, as ENVISION, the be stronger if have end mitomycin prove equipment, scheduling of

long-term. we that and adoption this primary population, positioned strong for at is of patient the and addressable rapid driver generation tenfold and value of business UroGen's have over administration simplified UTUC, low-grade to the expect UGN-XXX With roughly

year macroeconomic While forces in our cash. around remain we geopolitical $XXX financial prudence, ability and call with to continue the in for to end confident million

capital We our and core assets, and elsewhere. in growth carefully development, capital focus investments on specifically preservation while continue sales to investment JELMYTO UGN-XXX scrutinizing

of device George Board Dan Wildman Wen. a over my has to Leana Health two Washington University individuals Dr. call colleagues, the Management Professor the of I'd to several the Committee and welcome Mr. handing Health, Corporation, Policy the to Glaukos Public Leana medicine Boards is is also She since XXXX. before Bipartisan including Baltimore serves on and and and physician executive Directors: Center, like Policy other served Community US-China Relations. and an at of Foundation organizations, on of emergency National Finally, our seasoned as prestigious the the School with surgery a initiative Dan Progenerative strategy pass call He more strategy to Johnson Auris XXXX over from he leading XX their Mark as the integrated also currently surgery, to guidance. robotic years on our Chairman strategic that, & acquisition the medical greatly will of an Johnson, you developing benefit for With the pharmaceutical companies. and with Mark? industry. digital a Medical, medical of the than Health. With I'll device tasked several update to clinical led is UroGen adviser and Dan development for and insight programs. serves in

Mark Schoenberg

Thank you, Liz.

evidence that follow-up of into and dose Dr. one jump a induction. share via and clinical a disease The and primary not XX the I months JELMYTO from Kyle of published evaluation did no the want patients I results at XX post recent conducted in study Urology disease patients analysis our colleagues our Rose found had median to who evaluated of or received study at tube. British recur XX% was of XX by retrospective least update, International. of Before The Journal nephrostomy at

rate retrospective Importantly, ureteral including favorable ureteral without stenosis in profile, stenosis that multi-institutional of safety of JELMYTO anesthesia. of X% study. a patient low integrated a occurred just This can analysis administration administered and be concluded demonstrated general

anticipated this expected of are of year support to treat are later reports UTUC. real-world data JELMYTO the to and use Additional low-grade

trial, for There ongoing. resection recurrent study approximately XX% is Phase is the care with It a as risk for are in procedure requires of single-arm tumors, ENVISION both standard that As the remains frequent or and TURBT bladder at complications that current repeat years. affects of approved and one-year Phase and are by international XX% no typically XX% patients five each six evaluating mentioned, performed patients with malignancy our to UGN-XXX of therapies tumor year restating of patients and TURBT associated UGN-XXX the the patients, ENVISION urethra to efficacy worth the Liz primary with anesthesia, and after of also experienced transit surveillance primary XX% recurrence After of chemoablative trial US after resectoscope on these multi-center experience X therapy evidence that in two treatment. non-surgical recurrence NMIBC. new of alone. recurrent XX,XXX safety through low-grade surgical is weeks. patients TURBT, our intermediate-risk UGN-XXX lifelong our show X

for for outpatient high if the an repetitive alternative non-surgical of low-grade intermediate-risk rate that it offer recurrence believe intravesical and medical the We risk option to need therapeutic high decrease the approved, unmet a that in procedure-related administered need therapies remains Given convenient intervention. has potential setting. UGN-XXX, a NMIBC,

to ENVISION II optimistic of in further recurrent the and for the intermediate-risk endpoint to of clinical UGN-XXX, XXXX, rate their because design at design on confident In a response complete for NDA with previously low-grade at-home parallel, key expect new key of of an assuming study, of utilize we including up included a a patients patients six response about as local as of build to trial, who data months delivery XX to are who the allow month UGN-XXX. across installation anticipate UGN-XXX. approximately primary end will be clinical completed single-arm, this We data who clinical pleased treatment In from NDA Both and be the trial To trial different to safety will at both about study ATLAS continue submission, ratio, complete patients. and we achieve similar complete and of of commented feasibility sustained potential a similarities her the potential response, included our the announce endpoint time for and XXX intend response planned on six first The patients to installations ENVISION in trial evaluate fully we in the based ingredient, intravesical we remarks, the will likewise receive assessment. our in OPTIMA as products its hours. three Xb once-weekly We readout mitomycin to duration soon remain sites, the submission mitomycin Jelmyto. opening over to UGN-XXX in will UGN-XXX. enrolled I'm exposure about planned albeit after results. pharmaceutical the enroll its Liz Phase three-month installation, which share with evaluate the advance which and secondary completed XXXX, to what durability positive

Importantly, many NMIBC biological similarities. both low-grade clinical and and UTUC show low-grade

that translate by similarly results optimistic the the are clinical demonstrated could We kidney the to in bladder. Jelmyto

is that be see and minimally support to to X receptiveness instilled trial of in broad and a is with of care in intravesical is novel urologist urethral we've immunomodulatory years over opportunity range Jelmyto a an approval. from to clinical specialty shown for by are option Meanwhile, and UGN-XXX, advancing including other in a KOLs indicating, of with UGN-XXX UGN-XXX, agonist, within catheter administration drug it to UGN-XXX, broad successful, non-surgical for Jeff? enroll. For development to as continue apart intravesical it potential the trial. new NMIBC. potential We UGN-XXX to designed viewed be potential for the in This a engaged at targeting, setting. for compelling X NMIBC combinations member our antibody that staff. have it bladder now RTGel, alternative commercial our via if the Phase as chemotherapy to indications other they is a of proprietary in-licensed applicability identifying Phase and update. and aimed two hand XX% provide immunotherapies itself already of in Clinicians likely a We continues treatment the a immunomodulators, urologic of sets cornerstone and study with for a outpatient TLRX to use may in inhibitor use administration a explore call dose suitable UGN-XXX into or RTGel, anti-CTLA-X this a high-grade a, simpler, our subsequent can immunotherapies to the TURBT to variety that, with believe clinic checkpoint I'll invasive administered therapies combination offer cancers. treat in Jeff combination

Jeff Bova

you, Mark. Thank

saw a the in last sales quarter As Liz Jelmyto third slight to noted, compared quarter. decline

grown a address we have Last long-term We XX%, a to to However, patient seasonality year, slowdown on result patient corresponded wider success to the sales year-to-date Jelmyto of likely resulting in enrollment forms, believe we Jelmyto population. XXXX. what basis, remain more a in attributed of third from softness need to a its unmet quarter in the patient of now rise starts. that and COVID-XX ability believe conversion rate, compared significant underserved cases. an confident a to We new is

in Specifically, September August. slowed right conversions PEPs through continued baseline holiday. slowdown Labor in and July in XXXX, before to the August down This snapped the however, after, returning Day back year,

to we're and Xst, to on compared to the repeat While expect this positive pattern trends recent the support quarter-to-quarter November Key for encouraging continue do based in was thesis. we number to QX see same feel on beginning were were to Adoption metrics, return compared not and consistency August to outcomes continue accounts data from learnings metrics better confidence low-grade expected, real-world growth Xst XXX XXX XXX give in about PEPs period. us converted opportunity. sites of the Activated the field October. UTUC to and on the in and long-term XXX

a demonstrate coverage of users quarter addition steady as of across repeat types. prescribers XX% new metrics at and steady each all approximately Reimbursement Additional remains expansion well.

larger success onboard. which better LSU, operations a expected to sales and to taken and perspective, has understand several their than dug away territories findings. online, We deeper From with continue driving came several to academic and including field what's several and institutions important reps Importantly, others. are outperform NYU referral coming longer

identification using that adopters key all these found early remains patients. regions driver, we for First, while a to patient be appropriate tend comfortable Jelmyto in

underperforming resembles cell a device within a in align that better several and made we response, with of We medical closely experience. relevant also proactively therapeutic. to In field, regions Jelmyto type territories the this to changes learned

on a business, to of As our Liz addition mentioned, impact to and we experience expect device is med positive organization. extensive Board Dan Wildman, commercial who a have device led J&J's his recent our Directors,

additional continue logistical to minimize facilitate and for for complexities efficiencies look doctors We patients. also opportunities and to operational

admixture end-use During of will to hours. and positively including period extension XX admixture We're an authorization adoption the eight challenges, impact, the of third Jelmyto simplifies update quarter, seeing positive and FDA solve has to -- morning and Feedback has and allowing the Jelmyto this from believe day we delivery preferred announced several installation the early for the before the nearly doctors. based delivery our HCPs. of is procedures which from the logistical before feedback already impact of helping overwhelmingly patients of enabling installations, field, the for is We on on-time forward. positive day moving a treating by confidence and both proved all provided

year, our at we HCP the before Looking all take fit doses current it with to benefit to next allowing Jelmyto Jelmyto installation the UGN-XXX schedules. be lay adopters, X:XX also adopt bladder day or AM, ahead This foundation to period in and will allows invasive and as reinforces of the for larger enhance opportunity but reengage who for potentially treatment does UTUC procedures viewed XX% optimism of as end-use was to low-grade to to this one restrictive. anticipate the hours too unable least future Not eight delivered risk low-grade scheduled place with cancer. for nicely Jelmyto much customers only of non-muscle and with prospective of us intermediate were before reluctant previous the

and of Jelmyto of continues flexibility need most to of scheduling As form Growing Jelmyto in more Mark OR of with adoption real-world tube, which Jelmyto patients to and of represents by antegrade than require the it avoids data, and the administration a analysis, retrospective since after the nurse generally nephrostomy outcomes trained support benefits performed of does evaluating offer mentioned, of UTUC. the via be can of publication more in the to the tube. continues HCPs placement and well. tube, recognize offers administration XX% installation which of efficiencies recently administration, an operational the as installations, benefits fluoroscopy not nephrostomy via from low-grade nephrostomy use

use clinical we of the Jelmyto, quarter, financials. third pass our our into our to real-world registry, During is I'm expected Don outcomes Don? call phased UTUC in provide additional the discuss evaluate over of to practice with the the patients its With happy insights that, to in US. which and continued uTRACT treated launch to implementing

Don Kim

last margin including non-cash SG&A $XX.X Thank Selling, XXXX quarter the to for administrative million, to the expense share-based to $X.X for compensation XXXX. from non-cash to were expenses quarter and resulting compensation Research in The to including compared same expense $XX.X of compensation in stock-based I'm reduction million, with XXXX $X $XX.X compared into third net resulted million primarily of today for you, XXXX, stock-based of call. approximately revenue XXXX. compensation scale-up increase XXXX. were is study in production overall non-cash for XXXX. XXXX compensation for Phase million, ENVISION share-based The efficiency gross in $X.X XXXX of of today's expense expenses XXXX. UGN-XXX, and margin lower for period million, of compares the expense ingredients you, by to million general of financial of million, in share-based million the of in quarter quarter September share-based Jelmyto, period third was in $XXX,XXX expense third the joining as for pleased representing X including of quarter same million, be from million. Jeff, for a to third XX% $X.X and XX, review the gross thank partially of third of attributed the lower offset third Cost you XXXX. non-cash million to results increase research reported of a primarily everyone, our product quarter $X compensation revenue the and ended the the $XX.X the This third for $XX.X period UroGen compared same XX% of of including XX% year. $XX.X development of expenses quarter a Jelmyto

XXXX, expense September related loan with prepaid funds for related financing the to to third the to Pharmakon of $X.X RTW to was quarter million managed reported third Interest Investment million $X.X XXXX. we For for Advisors to period the facility XXXX. obligation of the quarter expense the in same ended $XXX $X.X from million, by XX, forward compared up million

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

we a for reported September in million share. $XX.X compares For per XXXX. third XXXX, $XX.X $X.XX in cash, loss of third XXXX in includes net the of net XX, quarter to securities. cash in or to of compensation compared million $XX.X loss non-cash $X.XX third million expense quarter the of million quarter XXXX. in a non-cash $X.X loss net and marketable the million This $X.X per of ended, third quarter quarter compensation with the or share closed The share-based equivalents We expense, share-based

prioritize on specifically our assets, capital to third balance the responsible ensure emphasis our keen commercial JELMYTO capital we capital our clinical eye continued and as core market prudent of During our and investment in priorities. activities. and remain of We preservation, in environment a to operating development maintain on of clinical development continues sheet of management quarter, commercial cognizant sales support challenging growth and the UGN-XXX

shortfall in offset million operating sales, $X.X million in we activities, non-core net ending we acknowledge the or below suspending While expenses, quarter consensus. the $X.X by a were solid able with deferring this contraction JELMYTO to

the cash and to with XX, with XXXX, manage loan year receipt to Advisors, subject $XXX our expected us cash, the our is tranche our facility which December to ability on $XX $XXX approximately the customary which confidence gives second million under flow growth. assumes Our Pharmakon efforts the conditions fund deliver in end common of million to million in

avenues back that, carefully capital watch expenses Liz would us, call the for strengthen while the will ample we like also should the I ahead, revenue With potentially and to to available sheet need remarks. closing opportunistically balance our Looking of managing arise. turn to

Liz Barrett

Thank you, Don.

bullish to covered risk the in to bladder a operator very to on to over-performing several turn of programs on experience We look in territories parallel. capitalize We're and our cancer to look forward enthusiastic the more in non-muscle thank potential not-so-distant market sharing JELMYTO. As Q&A and with we increase we for adoption about allow advance in support even you the and opportunity that invasive are on learnings session. will significant data potential the And the future. for for approval intermediate UGN-XXX we low-grade I'll ahead, for your both now XXXX leveraging a continued as Operator? call launch prepare its over us

Operator

Dipesh Instructions] you. first [Operator H.C. with from comes Our Thank Wainwright. question Patel

Your line open. is

Dipesh Patel

you to assets. a JELMYTO to Dipesh few in Thank have I Ram This then the for for standing questions regards Hi. others Patel and the is updates. a other with few Selvaraju. with regards

method? remains beginning JELMYTO, of new target percentage So using switch potential with with physicians what JELMYTO likely to to installation the

Jeff Bova

to hard I patients, to has looking can XX%, Rose. We obviously from method robust. Thanks, since had more -- without new from week XX%, was and that we're only Dipesh. over that, at the now increased XX spoke last around which data tell last now It's is Dr. much nine measure. installation patients, and XX% you that

is the believe will grow. we this sales But as clinical help matter and will it's it the convenient convenience help, It things as will But expectation help a of from certainly going JELMYTO standpoint. both a the grow benefits certainly more it's make number, far and patient. an will first, it to do understanding the overall. exact obviously for So physician that

Dipesh Patel

use upon is And with utilizing how admixture extension the Thanks. physician how is JELMYTO impactful Great. this? the end-use at of enhanced for remarked the ease all period population and

Jeff Bova

installation provides multiple day shift that there of because surgeries allow some They In representative, for they're are the would those managers the do managing definitely business. cases, just job bring physicians able will the in the a a phenomenal not the around the that the this they It if sell morning. to to of Territory Jelmyto flexibility, to because had in and so done able dose get They've scheduling. we a things have to once go support the afternoon. business in to may dose doing in supporting morning, them mixed And before. opportunity have reacted and give an to to well. have same a confirm patient, used they're the physicians This been dose morning, that will until the out then to is patients. lot there that. allow Again, more

response the immediate. so a has have month And when now, number been think, before had, and possible morning in the already wasn't We've that the the administered gotten just accounts five product the this day higher I is ago.

Dipesh Patel

Great. That's helpful. And value then, have there respect been any in optimizing territories? to ex-US new Jelmyto developments the with of

Liz Barrett

No. to done patient work because of continued the ex-US, but talked any mainly have reimbursement. is as program, we've What about we do before, not named on we've

understanding that her for more in the price on So and provide that working to to out will talked that outside and it yesterday, with get government I valuable point to and products sort an and those named an done through you being the market. time, be start with payers types and being the the received at And market how that and of dosed program the compelling that value a about of patient ex-US then Jelmyto stories and for get got territories was to to be in is work personally. I them and article reasonable able price idea the just hopefully, appreciation that's in a get to on of patient, for Australia able able then payers can feasible, to the Jelmyto from into tell was the will to frankly, US. bringing go interested a be able us us

Dipesh Patel

might ENVISION assets. enrollment expect month, after approval the the of of UGN-XXX US? then of And just when completion able you. by couple now some might drug you the on line the to quickly in Thank a that file questions Great. you we in how And Since the see of regulatory III possible for Phase other top end this of trial data? be

Liz Barrett

Yes.

to already as recruited so before, our the -- news that So of just already to patients hit actually recruited, the need is target. date, we've mentioned enrollment number we've everybody we we've and good understands,

to here. the in of the recruitment shortly ability And feel So our it's very just confident very a from we enrollment. why matter shifting that that's to do

news for months to -- these XX-months have have great and that's before XX FDA. -- for need minimum So we of we all go patients, patients, Remember CR to for follow-up us patients. we the all that post can

the matter and end of a the it's obviously close the timing of just 'XX. And stuff. then, So that after until database won't on happen

So as with period. intention be and talked XXXX in about we've hopefully review have before, the and get our then work is able to a six-month and review submit able to to be priority FDA

try That's than is that to have the goal it's for us do important that's So quickly earlier. it's go FDA, working do approval, to we're data that point. at it appropriate more But the all to it this that what will towards. provide important allow when ensure the we of to we to them and review

the would time. us all of a XX-months patients follow all get of that's that have XX point XXXX months. have timing. than of the We in patients, lot again, So would all to And to need more at follow-up obviously, which

Dipesh Patel

then question, likely last be to Phase positive what steps added development that. And the results? X Great. color in next are of the I appreciate assuming on the UGN-XXX,

Liz Barrett

Yes.

but So the we should will do intention really what the we different to study answer, multiple with in with I to continue I really to Mark over agents. and is chemotherapies targeted is turn apologize, other combine this UGN-XXX that to place and have --

in data are most combinations, we ones will forward whatever and the would we we and those compelling are the we see that believe cycle so, through with. And move the

we on start So we continue should our monotherapy get enrollment before in the in happen to XXXX. can monotherapy the obviously and combinations, then have data we which

Dipesh Patel

much so for you Thank Great. the update.

Operator

Boris with next Our Peaker question Cowen. from comes

Your line is open.

Boris Peaker

anticipate well. XXXX? early an let's the XQ start in issue first, to Several we be How sales? also, Maybe as And guidance do thinking expectations Great. you Jelmyto. should for on about questions annual

Liz Barrett

what sorry, the was last I'm question?

Boris Peaker

guidance you of in call? XXXX, to annual results sales or XQ issue in Do your anticipate the beginning maybe JPMorgan

Liz Barrett

Yes.

in I guidance we results, where I Having QX. QX given obviously, are being to expect to we that I'm the say will growth that QX do -- would right now, in hit year. confident not able So, that -- what can't that, we return said think, this

early we as for will So speculate XXXX. too as guidance that I think far do on it's to what

So I going time, think think that's that we September about, and October speculate and as a again, good November But talked variability, given -- in QX we've point say quarter to-date. bounce is guidance. at seen in we're is an The the this all Jeff to for and too I important news -- back, we real about early us. to

Boris Peaker

lastly, it's Jelmyto And for traditional to an the with nephrostomy, economics you increasing you using it physician administration proportion about the administration versus when Can talk of comes tube? of it. nephrostomy patients. Got mentioned

Jeff Bova

Sure.

the were tube, go go or administer This surgery to build if hospital buy they the hospital, center for clinic, center and where for bill in the gives to it in the to to the to their surgery opportunity So the clinician to a would drug. buy they nephrostomy drug. and the the --

surgery the for to it the administer product buy clinic, or clinic. they're portion give that often They bill hospital, know a more, buy how probably allows in the or it the their really the clinic physicians But meaningful to from buy So where the center don't is. always to professional a the would go would fee, versus product it's retrograde. in the little in I product. their bit because and similar. There's hospital they're that buy-and-bill the encouraged ASC

Boris Peaker

my taking questions. you. Got it. Thanks Thank for

Liz Barrett

Boris. Thanks,

Operator

question comes Matt from Kaplan Ladenburg. next Our with

line is open. Your

Matt Kaplan

for good morning. my question Thanks and Hi. taking

your guess, how you do can in little the Jelmyto? to that a broadly the for strategy success your and I you translate about country talk bit more across Northeast to can now Just what is regionally,

Jeff Bova

Sure.

is region, have a like centers. They challenge each have bit each is So more larger academic The that Midwest Jelmyto territory community accounts. Northeast may unique. with is is not the The Midwest. the more may

And that best of We -- implemented share question, it's we're successful. you them are accounts to are that's work business is we logistics, so found background each unique, look the is to that what be region, where share not We very every yes, each each to the And great And certainly many to is to challenge work those those. every that practices business problem decipher the is practices. territory of the account a at really things and nation, important a tell managers them important successful. implementing -- But, across going at they they look manager Matt. and similar we're in territory are formulary. will But what applicable through to and the It's it's sharing just differently. for similar. through it because are solve, best operational is day, do

make there, to the and sure we so accordingly. person in to And we that we right have have adapt get

Matt Kaplan

about -- in have regions a something Have Jelmyto a combo it Okay. And about device impact should or aspect going certain type that sale yet, think as sale. thinking mentioned implemented do or an forward? you device drug of you that you

Jeff Bova

necessarily successful business device, we training. the work. work We have, in the Jelmyto. through successful We and that we the have territories in -- will. a but last this of folks patients fit once getting as to gratifying challenge, they perfect by talk is hiring board a It's can treated navigate It at and work, a more become importantly, And We motivated What's -- mean and mix. It's mix. its the a is we issues hard -- doesn't it's I and on does year, -- accounts for these getting look provided get It's frankly. that resemble and but are certainly managers, believe a the very the this consistent with lot have more it territory that hospital that the try device. certainly territory. to that quite

yes, and well right person in as the changes we've recognized the that have sure I talked implemented we to, So Matt, territory. as making have some this

Matt Kaplan

guess more $XX meet What in I in -- you Liz, to Thank that's first it are guidance? to was you. of now year. ability just months. No, that than, guess I the what question. And then helpful. seeing Boris' $XX Great. million given now prior with this follow-up to nine and previously, you a revenues terms in for $XX had million Okay. guidance for million

Liz Barrett

question, feel are I about able Having we that I for this said in very going. asked we that we're where I and not as we Yes. think do stated when that, know, Boris would I good year. hit we say will the QX to before where think guidance be

right, perspective, well this second would really, half, you from guidance looked some have QX last a half had have we you strong the first that hit -- give we would Just year we as over over QX year. if where last at to year, had growth the had if really rate translated, through even and But are. we

consistency. is good actually the think are more seeing what is news we I

lot a confidence while that QX, the getting that fact decline nowhere was magnitude consistent which -- a we a saw in the near gives to slight while was experience. there it of quarter-over-quarter in XXXX, we're in us we more So

other what note, territories is right? is like is feel have we And just that proven so how about we've not times. Jeff as isn't there. the was this important. the it's tells near of anywhere talking very of is What significant better that know many that that I product, us if territories expected. I talked we successful the and that some to the lower the we we is have the about, And it a what where So thing a our enthusiastic that's we're see opportunity We situation Also territories think average opportunity part of have there, been. about that think they actually

growth it, a slower It's about the a all it honest be just we So confidence combined be. just future. changes -- in expected to us those things of of really Jeff than the gives has about really with it's that lot talked slower a to

and grow. So yeah, middle the we continues point the to it that, -- we're COVID, now of in seeing and were inflection

We get continue positive. to very

on. We accounts continue to new see come

most and importantly, we see are We this continue standard that, to their adopt care. the using of new doctors them see as it, that prescribe actually doctors

are they So using their this of in patients. most

So to all where has to growth elements, unchanged. the again, we not confidence just give the at expect of been there. get peak those rate be It's great us

Matt Kaplan

Okay.

you. very for helpful. Mark. question a That's And then Thank maybe Okay.

that about in the for X study, result and you positive talk Phase can you monotherapy go would as combination X into that study what the study? a UGN-XXX designate before meet On Phase of a arms looking little bit a what you're

Mark Schoenberg

the Matt, for thanks question.

appropriate thing study identify intravesical designed disease state. to us course, in administration in an of this a dose for which, remember, is this of be help novel this to So very antibody, order doing is

then So But identify we what Currently, program, of and identification chemo we're study. we the as signal. to safety obviously the such looking agonist tolerability agents or into which which of TLRX really or and interested is the combinations if immunomodulators. it's can phase that's would an dose, earlier, of development mentioned a the our for be point a not other the saw combination, the next other carry with help Liz would dose. us be We efficacy as with potential

Matt Kaplan

Okay.

guys. Thanks Thanks. you. Thank Okay.

Liz Barrett

Thank you, Matt.

Operator

Our next Howerton Chris question from Jefferies. with comes

open. Your line is

Chris Howerton

Great. much. so you Thank

what BCG would to issues, doing the already agonism. with most is point can of supply I been similar of fact Mark, high appreciate was I think this curious the what are I always kind And XXX and I but probably about but other study have a have I'm guess, in mechanism about you approved of bugging there questions answered. the grade? TLR combination status BCG this at was. one, a that

a with combative I'll maybe you, question just to So, bit Mark. of a end

Mark Schoenberg

as just much, comment Chris. want you I'll may to well. Thank you very impression. Liz my give

the of One still does it's know, it about things there about works. a active many it about And that relapse. a a how does. an lot is BCG It also if it bit of area you people is although, what read BCG interesting hypotheses ultimately it, received as who mystery are and investigation, of how of

noted, would in and issues away And population. identify I from great. move I'm strategy BCG-dependent manufacturing combinations, short doing that immunomodulatory is practice, other glad because which challenged related So, real between the supply, currently, supply particular as to clinical this be novel would is for impact on we're it a this a BCG to you having think us personally,

patient do So, on potentially perspective, for face level in theoretical to seek we us need doing unmet be of is it in this practically acute. with do, the namely, lines you think pursue Neurogen, choices you as investigation work. like a does a from while not I difficult I BCG patients can to therapeutic other interesting be address are to these to that other very agree and which and important immunomodulatory when will some population, important types would clinical And combinations know, it

Chris Howerton

That's fair. All Okay. right. That's fair.

XXX about And so for what then?

Mark Schoenberg

forms of discussed, previously the XXX, current interaction that we've have molecule. between there data as synergistic and suggesting the XXX our for XXX for know, sort we interesting you that a basis a very As nonclinical program development is and and

dose and has planned the is are information of the XXX of contemplating provided one tentatively about of combination with So, X once we sort escalation the safety combinations XXX Phase us have dose study XXX. and with

combination So, antibody. we are the carry like still that once a have on we'd actively developing as to the data Phase that X we forward

Chris Howerton

Awesome. appreciate Okay. much. from data the XXX soon. all look answers ATLAS Thank to you I forward and very, the very

Liz Barrett

it. Appreciate Chris. Thanks,

Operator

next with Choi comes Paul Sachs. Our from Goldman question

Your is open. line

Paul Choi

who wondering was JELMYTO of thinking which is more it little you and as Jeff, understand oncologists be morning. if maybe which perspective as And question proportion a My more approach a additional therapeutic can help understand of might base prescriber us I from more help additionally market maybe relative the about about a treatment to the potential you Thank device-based think Jeff. portion target is to prescribers and segmenting good to just us are able medical for first you just maybe here?

Jeff Bova

of seen the device or I is the we've they're sort They're in with team, installation. are think team it's they're what our there. OR when whether assisting that C&E, part the -- reps of assisting nursing

clinic a -- company the a where -- -- it's urology it's business academic the or think larger lot experience, I just the institution the business think adapting maybe it's and the or institution, buy-and-bill has manager group. so if as of manager. the familiar, to as of a more And Even mentality they're the a I

bit appreciate support. training so, really And certainly when They at the -- that They that see give. with a device-oriented. we see think appreciate reimbursement of it's constant and the look the it's just are more it's to we're you a the appreciate hiring. the them to patients that nurse. and more we effort look at at patient, success. every you Jelmyto Jelmyto. the all manager. our looking where for manager, business But from benefit we appreciate early field that accounts that the have There's try we will do They provide that little consistent physicians, I just also yes, then support it And additional we of success find

doing we're that. So

continue need heard set that accounts go deeper You've true. to need to to in we me into the holds do But we past, accounts say still up.

in to on You well. are we And the large those as to accounts like need them device, than the so many heard that OR. difference. a behaving it's -- just similarities. We're different where more prescription to a to And more it's similar. do me the we procedure. in which physicians board. receptiveness. on support provide like specialty a and the open. is have more still And things they This mention importantly, is through LSU noticed are that, goes that we sometimes need because that have you We're call, a the noticed of And the mentality. starting accounts, board, success. -- see are This There plenty There it's difference doors But is really we write come many come we pill starting of it's see has a cell on the NYU when that pharmacy. type just just a different

Liz Barrett

these just to treated These ask, treat our oncologists commentary, Paul, medical by don't really And Yes. cancers. are urologists.

point, large you tend the when group can you large we success tube have have use what point, So have nephrostomy more institutions group is have found, than to really then practices Jeff's to where go you the administration. some great your Jeff's practices, urology and institutions. into you to your And and

really some it's we're and where delineation. with to you urologists. to just it's But not clear so question, medical seeing your oncologists, with that's be And answer really

Paul Choi

Great.

is you second maybe in of you getting do Liz filing. about commentary My filing? just when like or had Obviously, regulators thinking your what from year with could review your do you received, you, on in when for the next possibly the that. the for that on that XXX view question Thanks or comment commentary you success Can XXXX, -- your XXX maybe next some Okay. you of is sorry, you've year. get priority Mark, some I'm feedback just underpinning priority for review

Liz Barrett

point, unmet of off population, your study. that, the do based were get agency arm a just able patient really need UGN-XXX. believe to to on for we to the We agreed this high fact It's with when single the us it we Yes. with and moved

that there's a I that, high shows think they that need. recognize that unmet

an So when like feel data, you we why take those as of that's we I to opportunity well. as the a approach and which I we using things have lot consideration, it same you give Jelmyto get mean, into think priority think about when review. is UGN-XXX, Again, now

Paul Choi

financial, cash this is the after cash or But last you factor that which forward? for assumptions second loan. term your an is I second to tranche for maybe assumed what going runway the Don, me one for update Thanks clarification. can on tranche, your provide for second commented think year tranche excess you Great. is And the that -- in Okay.

Don Kim

Yeah, sure.

So Pharmakon, to is accepted. we which the give already notice

year, to XX December approximately we So with year-end. going we are of And the the end funded this are at before get that the to going money, achieve million year. $XXX

Paul Choi

to long is last assumed $XXX that million through? And you how

Don Kim

and invest spend revenue also million, all it's So the Jelmyto money. the and $XXX on depending at least XXXX, we cover and our how

again, to of anything we our on, one investment. and condition financial So and growth sales are Jelmyto stuff about or R&D pretty sales a market usually touch except lot business, we core going depending two not for the Jelmyto goals. much can cut But

Paul Choi

Thank questions. Thanks our much. very for taking Okay. you

Don Kim

Sure.

Liz Barrett

Thanks Paul.

Operator

question Oppenheimer. next Leland Our comes with from Gershell

open. Your is line

Leland Gershell

the nephrostomy Yeah, I on joined on apologies, trending? last late, been the call, Thank I method, out? forth. It that that's Has expected. so prepared has aspect quarterly bit you color? My provide with you. as been tube think use QX, you with touch more playing and your the you maybe and Could missed respect sales did not remarks. mentioned you wondering, was physician And had a that seems like how a And uptake in thanks. some was so the I been favorable I that of as convenience to supportive delivery

Jeff Bova

Sure.

-- Yes, are XX%. we So Leland. now hi over

last reported; that data will the we still from to time to without think I able there we that about be you're Rose, in XX% going And discuss see start XX to just around think -- is will talked I Dr. with go and XX% patients physicians. over That we QX. that XX%. Mark additional were out

slowly that So But just up Dr. with it that a Murray. will had patients from QX we of was even to small still be the reference amount going effects moving onward. of

a I I with administration. patients. think a still little in think doing nephrostomy additional big good we'll do data, probably this that were physicians So additional, reluctant tube that retrograde. those nine have increase We're just see on you'll with

Leland Gershell

to nephrostomy logistical how you into Okay. other is about a move exist, hurdles we perspective hurdles other further, And whether tube are tube, issues, to reimbursement, the bit years there and growth as seems the still think here I Could Jelmyto doing drill just uptake other Jelmyto. it's it's mean the by put to it like into that offset nephrostomy Thanks. the two-plus of that launch? role the whether is

Jeff Bova

month to place ago. And additional Sure. eliminate hours, going eight-hour with to that's XX stability that that hurdle the a couple a in I'll how was

the patient. convenience tube and for So nephrostomy the physician administration allows

just would doesn't a another to opportunity, We patient the to to the than They give dose OR, have a as surgery come more we would they to schedule know nephrostomy it may go didn't an same from start physician. to because timing standpoint. may surgery to a prefer physicians center, If not Let's clinic, work that they'd to the to hospital. tube the have physician to have trained with time. to out the the or or go would the have patients have center the

in to hurdle, the hurdle I fact, hours. just solid the question, up tomorrow, that. to And robust accounts hurdle. have now before those by doctors, by -- since maybe of talked we'll they have we're about XX a overcome, about overall convenience the going Dipesh's that to just know we have hit to not product certainly now excited or it's data more answered talk eight week, gotten -- So the we'll and -- that to it's a administered have I accounts They're that is the -- By day today, in XX was had with but the are that point, an doing your first before -- a could to morning. end

So they're to excitement is increase much that stability as getting probably -- that's allow just the flexibility.

on they they if OR, want this do to So schedule, to surgery center, of administer the their flexibility. in now in if they it the want can because administer

two moving really exist forward. existed operational longer hurdles these no So that

Leland Gershell

Okay. Thank you.

Liz Barrett

you. Thank

Operator

question-and-answer Barrett That over our closing to to any concludes I'd Liz the like call for turn remarks. session.

Liz Barrett

you. Thank

As UroGen. appreciate in always, your we support and interest

to some treatment continue long-embedded urothelial cancers we the ground very change new forge We standards. in of as

as open out. So the we XX have play initiatives keep much look to next forward over to months. We'll our dialogue key

now disconnect. Thank you. can operator, you hope a you I have So guys day. all And nice

Operator

program. the concludes This

disconnect. now may You Goodbye.

UroGen Pharma (URGN) 10 Nov 222022 Q3 Earnings call transcript