URGN - Earnings call transcript Q3 2019

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Operator

Good morning, ladies and gentlemen, thank you for standing by and welcome to UroGen Pharma's Third Quarter 2019 Financial Results and Business Update Conference Call.

It is now my pleasure to turn the call over to Kate Bechtold, Senior Director of Investor Relations for UroGen Pharma. Please go ahead.

Catherine Bechtold

Thank you, Operator. Good morning, everyone, and welcome to UroGen Pharma's third quarter 2019 financial results and business update conference call. a highlights providing the and September XXXX. issued our overview quarter we XX, corporate recent financial morning, press an release of ended This results for of be the The accessed release at investors.urogen.com. can Investors' press portion our website on

today on Medical President Chief and Liz me Peter and Pfreundschuh, Officer; Joining Officer. are Mark Executive Dr. Barrett, call the Schoenberg, Officer; Chief Chief Financial

Commercial. Chief Senior portion Joining this call of Mullennix, the Vice Stephen Bova, Jeff Q&A of Operating for and us be Officer; President will

Liz of development and regulatory provide will summary quarter Mark before open-up will financial update. then of developments provide recent corporate third we our the a our will for of share and an call the XXXX highlights for clinical overview Peter questions.

we Form Various Litigation Private SEC forward-looking from making of other this forward-looking that of result for factors, filed UroGen statements important with various results in as those SEC may materially report call, those the will and time the these plans make future during statements Harbor discussed As of quarterly be remarks the of on about Risk we prospects Pharma’s from provision with including Factors the indicated UroGen this a statements. the section time. morning, Securities a differ XX-Q by makes the company's XXXX. and filings purposes to Actual Reform Safe call Act expectations, during certain that forward-looking reminder, constitute today’s under

of page on UroGen��s XX-Q SEC These under filings. We investors.urogen.com. Filings the available encourage read other the company’s of all and documents the quarterly Investors investors at company’s section Form to website the are report SEC

relied views today, not represents this and conference all date. our of addition, provide be information representing as of In as as subsequent our views only any should call we upon on

account any events information, forward-looking make on these or update this on to obligation of update call to new the future undertake point elect in at statements statements may we we forward-looking future, we some no While may otherwise.

turn now to will call the over Liz. I

Elizabeth Barrett

Kate. morning, you thank morning. everyone, call this you, Thank Good and joining our

by on announcement to start in to open will the NDA decision tract comment submission completed that Application or agreement like I yesterday our upper candidate the about acknowledging a by just with came of out low-grade But with complete, treatment urothelial our that have call UTUC. moment. period news FDA's licensing low-grade year-end. to whether the determine want a product is I the FDA rolling New The review cancer communicate we today's or for a Agenus, the has and that I'll our for UGN-XXX NDA lead FDA day submission the company of filing to and XX the Drug

high level support review is the drug month preparations We're for low-grade priority in UGN-XXX UTUC be planned to thus we the will for and with review, end have represents half and with of working first UGN-XXX eligible for first patients the a engagement may PDUFA closely the for on anticipate a eligible launch treatment the be advance X,XXX and track approximately six date. To commercial are a XXXX. significant the UGN-XXX. and approval of that who a FDA approved, If of far. treatment

pivotal minutes. and rate, in more presented of We discuss in primary will final the month trial response from complete the more endpoint OLYMPUS few the by X importantly, month by our data UroGen and excited durability. a remained recently clinical Mark very analysis for X XX and detail strong Phase a

and strong team, developed commercial plan ensure uptake experienced a an branding assembling rapid and to and adoption. are We

the the urology built this seamless programs into XXXX to has they've been gathered a integration and busy year as team, practice. ensure for intelligence

force will potential. we are planning patient reach And cover of to that XX% practices. and able approximately force sales XX As representatives be of to this swiftly the urology for a reminder, our nimble we effectively a target believe

in on the of start is we team team the complete anticipate board, management eagerly January. The and

sales and field In managers and the as we have around addition well nurse of training support provide access to reimbursement will installation, to team ensure reps, as reimbursement. to educators a small

a Earlier in in engaged of XXXX, MSLs more interested we UroGen who hired our learning team technology. physicians with appropriately have about and

of Additionally, market UTUC clinicians a including on urologists we an void for and research differentiated treatment new educational ago. that campaign of the year option low-grade a we is Based XX% from their a all patients XX%, up unmet and have launched patients. UGM-XXX current recent stakeholders, to need, establish and learned filling among XX% and awareness desire

navigate reimbursement. access we of the and As world

We move need will approval. be ensure are access to our this are access to review enacted pleased and that offices quarterly a to it. permanent Regardless, with the and in of CMS to developed to programs have and hopeful we patient that able recent for prior be medicine support progress patients, will any J-codes at our

launch by bringing our and team physicians. to successful is to and a forward looking for patients UGN-XXX prepared be January, will We

Beyond with low-grade, recently of potentially study. were risk, our the pleased OPTIMA share complete over positive non-muscle we're response of half next the from Phase Xb patients intermediate UGN-XXX treatment therapy, bladder patients lead invasive accelerating development for to of candidate the product data our We on transformative cancer.

rate with a will of Trial intervals. patients ahead patients II completed Phase XX% to interim durability achieving complete these XX schedule, observed data to the the an XX appropriate continue enrollment of OPTIMA at intent with Xb In report follow We a analysis, of CR. we of response and

about it's resection know via cancer significance non-muscle Transurethral a no invasive from data this options, Bladder treatment low-grade, with bladder patients. or patients Mark Tumor surgical of repetitive of will talk Resection risk, intermediate this of have to large aside population more to that But patient XX,XXX TURBT. the important approximately

in path for to as the study recurrent Based a requesting meeting first registrational with Following we the primary our look their quarter free of FDA, of are UGN-XXX preparing protocol with time a previous endpoint. agency TURBT discussions UGN-XXX. at interim XXXX the head-to-head a data, are a with discuss for the on we the verses

in non-surgical that innovative $X sustainable long-term potential in billion, options. leader UGN-XXX low-grade alarm patients we peak products delivering believe revenue are a strong a focused to who be a providing than As need of build to could business. growth foundation space, greater We UGN-XXX of on the and these are that

a urinary Commercialize progression UGN-XXX intravascular in natural treatment with with of anti-CTLA-X our As delivery. agreement antibody worldwide pipeline, excited AGENXXXX very the cancers we're exclusive and announce and the via combination to for of tract license Develop to Agenus Zalifrelimab,

pre-clinical currently shared. Agenus This be with expertise invasive the and muscle the and built leverages our high-grade by leadership Zalifrelimab we agreement in development PD-X evaluated in will built UGN-XXX indication as bladder data monotherapy upon for recently is capabilities we with have patients. non supported by being UGN-XXX. encouraging initial Agenus The and refractory uro-oncology cancer,

NDA preparing our With our and barriers position of the diseases. urologic for specialty major completion in of as mission have nimble are and the recent agreement, success cancers in strength a data a efforts today unique across extensive to updates patients bring company. We treat license to step result forward a of and diligent submission, planning overcome solutions taken we that

turn to in more discuss call to programs clinical like Mark? over will now detail. Mark, development who I'd the our

Mark Schoenberg

Thank you, Liz.

of X response with was be our XX% was Durability six to demonstrated XX at disease the analysis patients OLYMPUS UGN-XXX, low presented by of rate in endpoint grade XX% UTUC, and response months a previously results. pivotal complete consistent after primary estimated trial with with the Starting for XX% Kaplan-Meier, final of our Phase which primary months, evaluation.

characterized patients The patients XX initially are in follow unresectable have to immediate the by the the time months ongoing. the would as the treated candidates physician according study XX is XX entered who who kidney still were which up, estimated to patients standard having endoscopically These recurrence care be are median There was of of and XX treating for removal. tumor.

and pain, being The urinary infection, renal included the characterized treatment are utilized. vomiting. urologist, of common dysuria, and emergent transient. familiar inseverity disease were adverse these most treated ureteral events as the and adverse mild The moderate given majority flank tract to events nausea, hematuria, to These instruments impairment stenosis,

initiated is that end, retreatment extension as we potential OLYMPUS have this with We've frequently ongoing. to patients retrieve asked to about protocol, UGN-XXX. And been the a study trial. To the an

Phase CR non-muscle the bladder trial UGN-XXX, intermediate low-grade, invasive the at with encouraged X risk, Looking in from very patients initial we by cancer. are OPTIMA Xb data

In XX%, this patients adverse achieved most treatment common and observed of complete urinary majority the moderate analysis, or transient. interim patients, XX dysuria XX and emergent the cohort frequency tract The the were word fatigue, response. or events crematoria, In mild infection. urination, of

three distinguishing that centimeters highlight interventions, recurrence standard risk, invasive a to number of cancer as a intermediate or to intermediate bladder features, rates is It's by frequent multifocality greater clinical entity is care recurrence. has control tumors than using of characterized difficult non-muscle specific including low-grade, and disease that rapid risk important emerging

TURBT these the population chronic result received a cancer. annually, patients The patients is few end as care to surgical of The contemporary repetitive perhaps consigned their standard intravesical who of to for in intervention XX,XXX many patients, bladder as U.S. manage are chemotherapy. is a Agenus

for future. relapse. in these options to and first the chronic data Phase the UGN-XXX option provide for of We near immediate on has the of line, we analysis, in have design surgical trial the pivotal X treatment observed with an interim Based to trial UGN-XXX the potential believe, review FDA non plan the a patients impact a with

portfolio excited an based As in study to anti-CTLA-X data combination non-muscle UGN-XXX, mentioned, you cancer, to to shared in in are TLRX/X on preclinical September. read a in Liz the encouraging Agenus antibody release bladder invasive our and we high-grade we add with

patients we'll later on details clinical further with and are designing bladder We provide non-muscle at for currently X this invasive trials date. cancer, program Phase high-grade a

novel Tract a As patients seen part XX who his little to it in the treating past program Urinary be to career patients is has innovation spent a Cancers, urologist, exciting practicing have years. bringing of with who therapies

establishes of UGN-XXX, of urologic leader a portfolio UroGen cancers. combination Our the xenophilemad as with UGN-XXX, UGN-XXX in and

call that, like to discuss would I to with turn will who Peter, the over financials. the And

Peter Pfreundschuh

Mark. you, Thank

well everyone to quarter potential morning marketable XXXX. commercial to programs of on in the cash in efforts and advance in We good our for well equivalents call. development clinical capitalized preparation million UroGen as XXXX cash, third planning launch securities. UGM-XXX approval with of closed as and And today's our $XXX.X U.S. is

This September and compares in million, net loss The of per share per in in share, $XX.X XX, quarter XXXX, third nine for the the to $X.XX stock-based share we of non-cash compensation and same million net $X.XX per in reported or months $XX.X September ended for approximately nine net respectively XXXX, or third the respectively. million or months million, $XX.X million, the $XX.X and or losses $XX.X the losses periods share, expense. million, XXXX. $X.X per For $X.XX include XX, and $X.XX quarter

$X.X to the expenses quarter compared for ended for we're $X.X and million periods and months $XX.X $X.X expense XXXX XXXX $X.X nine development million XXthm and same XXth, million, stock-based compensation and and in $XX.X September September and million Research third respectively. the included ended million million non-cash respectively

attributable clinical the to from of increase with X Phase increased expense, trial, to headcount compensation clinical mainly XXXX year-on-year activities. stock-based Excluding XXXX increased costs an UGN-XXX clinical increase costs Phase clinical and activity UGN-XXX trial for was trial, and associated Xb supporting related

expenses respectively. XXth, administrative in expenses ended XXXX $XX.X and respectively $XX.X includes million were and compensation $XX million $XX the and as September months for and General and third stock-based million for periods million in million non-cash quarter the nine same XXXX compared $XX.X million to $XX.X and

commercialization an was infrastructure other The and our in stock-based increase related increase fees, well XXXX increase support from costs mainly growing in to XXXX in expense. consulting an personnel to and outside as and as in and business compensation and increase services, attributable increase to

of expense a and range still plans, UGN-XXX As the into XX.X compensation on of carry our million ordinary Based successful is announced year subject $XX million we XXth, million XXXX. recently track of still to the Including loss us to on deal, $XX September to in market million stock-based shares range end a for approximately $XXX year had million, which of non-cash Agenus our cash through launch XXXX, current the project with to expected net we a include company conditions. $XXX in to is well and a balance outstanding. the

would turn over operator, to I like call that questions. With for the

Operator

[Operator Instructions] Eric comes from from And ahead. JPMorgan. question Please Joseph our first go

Turner Kufe

Thank Good you question. morning, on this Eric. for my taking is for Turner

you. patients six choice XX you X post-TURBT. XQ heading the plan hoping I'm meeting or FDA time free two non-inferiority test elaborate additionally Phase who into could months primary to study. superiority TURBT? would the include then And endpoint, or discuss on just whether as role relapsed Thank have of Just in the treatment-naive the or would recurrence or CR rates? to you one to patients would of And also instead who both enroll are you you for XXXX

Elizabeth Barrett

from we had you as the you great share know, data as we know soon as XXX, available. questions, the So data actually

report to we're the of we so a right requesting So that the that's to in meeting, now now. prior together right agency our happening need process putting to send down

send We expect that able be to down our in agency. the request to to next the week

important ago the To has it's to things. - agency before the be we and that a will direction met free from been recurrence around with UGN-XXX a year the over we think versus a can do I agency, actually couple it study agency One, interval. note the we TURBT. head-to-head your point, started

but the would that I So CR you know, about is about discussion some think about it the been that it know was I rate recurrence-free there's always be with and time, timeframe. agency, it's not misunderstanding

recurrence. to time know you So,

that, get who probability an given of and we FDA. - a from both but study on sure very risk two approval of intermediate believe study, this make that us that non-inferiority recurrence high that allow the the a superiority rate success the and we shots to have also of goal becomes the will high patients a we have superiority So a

your depends down, expect first it So, but when half the on quarter. the go yes, meeting, to be, question, a agency first gives to of answer to we we the us expect

a protocol endpoint. down is protocol, to to being will against recurrence-free briefing the when have proposed endpoint the - we will our study FDA documents TURBT we already send which are being the with We finalized, close it head-to-head be

- enroll we allow both we So, patients. enrollment naive recurrent and will of both will

allow the Just information for but patient, as well. XX% the would of were that about about recurrent have did in XXX XX% patient’s patients your so study we naïve we

think of all your know. that if I So it let questions but me please captured didn't,

you. thank So

Operator

ahead. next Derek Stifel. go Please comes Archila question from from Our

Unidentified Analyst

for my This is call. Dan Thanks on Derek. taking for

thoughts Just on out wondering stood at? some XXXX about what and looked if Thanks. you was else can then share to anything

Elizabeth Barrett

about what catch heard the second the didn't the what first but I part was else I was anything part, XXXX question? and considered, first

Unidentified Analyst

share about you XXXX? - to can about what you just some if stood Yes, thoughts out -

Elizabeth Barrett

and many Yes, like - that time portfolio. I that think partnership felt of a were the we lot was allowed look but did compound arrangements different in. and types Agenus of the us and options different we spent something very we And access, CTLA-X to at own XXXX our we within interested

both commercialization, the was space able to So in actually local delivery the our own and being and - it manage we lead of development and uro-oncology thought really important.

feel so unfortunately the but we diligence, understand of think A toxicity, side great all I limiting for delivery patients we - has patients or a also can experience think molecule the believe We it systemic that to imagine And is patients, is molecule that CTLA-X as some effects lot has of CTLA-X. you take molecule. a medicine. our due able either everybody with medicine the not own I dose caused comfortable long between and we great very team believe internal advisors and with does external

advisors effect again delivery get that feel is we a CTLA-X a systemic context we side that dose without a a we the in for some and CTLA-X. believe with local like, effects of of patients, option see you can with typically this - our great So CTLA-X good

and UroGen's see our for team patients. as into a to was and good we and that into was that to sure everything And that just to work excited across with. board there. I came this did comment to - great it we're the has conclusion partner bring the us, So for out development diligence around We also a them great on want been fit pipeline

Operator

Please go ahead. Selvaraju next Ram question from comes H. C. Our Wainwright. from

Ram Selvaraju

clarify additional to get has wanted potential of you certification for CMS example just words you been approved when from in think other UGN-XXX assignation the might the once of So J-code? timing

Elizabeth Barrett

we quarterly as that quarterly happens to used and moved. you to actually just So, have a trying are CMS, review typically with once done approved. formalize year reviews do been some officially although they they have already what on they've actually know that They medicines know it

typically that So, a at once they look quarter. would

be expect side. on So six the conservative we to months would

that months. should line, think to said done questions also the the to because we are They a to really of center. or Frankly, we surgery three in get C-code eligible the months. it's also note about within these a also procedures institution able on permanent that, this, you are a have if but six important permanent six Having C-code, I the and further any that, J-code be be to Jeff's able first in within for will get

UGN-XXX. would J-code a within and/or basically we're C-code six - So to have able be for saying months, we permanent that conservatively

Ram Selvaraju

this six approval? just three to of to So is clarify within months

Elizabeth Barrett

Yes, correct.

Ram Selvaraju

respect received physicians from potential OLYMPUS broader study any And UGN-XXX? utilizing of specifically additional regarding the the you with Have profile to data then set. safety feedback

Elizabeth Barrett

to that? do want comment on Mark, you

Mark Schoenberg

positive the No, in reported we this the were feedback actually with received what context that fact, is technology. in more AEs disease that of contemporary or treating expected

we've what none doctors is reported expect represent and utilization. adverse of they that exactly to would would heard in So the barrier this what fact is from events a

Ram Selvaraju

with of potentially then, molecule comment your with if cancers? the granularity And about example, combinations for some like us deploying beyond context inhibitors, plan wondered on Thank the UGN-XXX. of how also how checkpoint deploy to give going you you forward. checkpoint and - systemic administration combination Agenus the of NIVO+IPI to forays oncology, I it you. relative urothelial cancer, on relative urothelial in could in were into positioning if inhibitor respect this And thinking the you additional could to you just the

Elizabeth Barrett

about broadly you do about Yes we are AGENXXXX with sure, plans want can what initially Mark your then our question. talk more to just talk and

Mark Schoenberg

from non-muscle refractory of has already invasive is announced, conundrum those is particularly demonstrate of physicians, think a represents pretty Sure, group. patients recur BCG, which obviously and real in the presence with to disease, the well the I things behavior standard first were the high-grade who Liz which deal for this problem known is that this for of or care approach

So, our medical first is with approach to need. that unmet deal

the Day. and suggest - like we working survival with Because we setting the will preclinical in have And XXX potent urine are on XXXX Investor so, reported the we me in excuse XXX of strong very combination prolonged be that our recent combination that system. actually on molecules very reproducible model information

advance that's So to attempt this our first program.

Elizabeth Barrett

about with actually the combination in the around plans beyond invasive to have to we TLR-X/X I this non-muscle think bladder given we where UGN-XXX the thought competitive will your is we the today, or have right. to concrete ability agonist CTLA-X, out was Yes. potential approach to take but that, applicability important that landscape, there's data a very it beyond And different think don't it, that's - we there question anything cancer. high-grade And with

to are on are be with technology the systemic in a the is, but plan space There ones PD-X is our our looking TLR-X/X in an a installation. lot CTLA-X. And finer just inhibitor, only would then just more that happening we proprietary delivery at checkpoint our mechanism for CTLA-X. both that the with plane, we studies this of And use this be RTGel, TLR-X/X bit little be would would combination

access no ability one technology to So utilize have we that the to. actually else our has

look beyond the But this is the today. of are cancer. that we where R&D And think other there invasive have applications we we approach see that's to if And our will high-grade have unique that. looking that non-muscle a So team that. we'll outside for bladder data

Ram Selvaraju

you delivery to a combination with a extent was, inhibitor And UGN-XXX principle have checkpoint with an on were position drug just property like respect or clarificatory just you were, localized based in a anti-CTLA-X as of as intellectual whether it then of what to privileged do the directly. or saying what just point

Elizabeth Barrett

Yes.

continue So we really But our we're with family so patent RTGel within on where from so and will. something XXXX. our broaden we CTLA-X technology today, it's clearly and our protect XXXX to technology, is the standpoint, to is that continue that patent able is to our patent RTGel in combination protection to will our a

protect ability nice forward. a we going So have and that to

Operator

Cowen. from Our next question ahead. from Please comes go Boris Peaker

Boris Peaker

CR the curious, will base do that study first be the assumption. kind we Phase is X which you My What XXX. just is plan I'm question of control anticipate a on assume in current that rate to as the if using of control be on? TURBT case

Elizabeth Barrett

that. Mark, would you like to talk about

Mark Schoenberg

Sure.

very and internal of people of XX recur, literature rate control this somewhere a about group would talked high we've so have group expect with that would so year a recurrence given care. XX%, based rate published the experience As recurrence expect largely whom of to in between a in is on people as we of year it's the our before, high we a and group, would also standard the of be their treatment the as and

Elizabeth Barrett

really the but question was - question But initial your CR. was I is or really Boris think - around around it that

Boris Peaker

then XX how that's durability, months the both. want Well, say initial there's want this to to going and was I CR I - kind of so

Mark Schoenberg

so about of think piece But - primary other of it Transurethral is will Sorry, get I considered conversations, important widely okay. gold Resection that although information in that durability. this. which the back the to step discussed think that standard as is as treatment for doesn't and you one these focus of on it's to CR, was earlier respect Well, be mentioned with trial the

rate is The in fact XXX%. CR not a

stable augmented that rate, literature So order the this is XX%. when technology on Resection published on control recurrence during CR of rate cystoscopy be we would Resection white the there group. for with Transurethral that is based would probably Transurethral a we light somewhere expect example, know used Because, for

results think think think the that when would what about “experimental” I or you trial you for look like So to need group. the clinical about

Elizabeth Barrett

if not response. CR UGN-XXX, with on can't but I UGN-XXX, The CR, of you just durability initial it's mean, I right, the the know not is want UGN, focus important. to it's get with focus Yes. the even

it's a not, So in you with which we TURBT, to if if know closer we you go even if get, know XX%. it's it's XXX%

CR is as and know, And the you again because patient from as very right? not literature The that as is quickly often. this high is such has Mark you And, well unmet has those the back the, need patient reason that physicians If so very to unfortunately we in initial recur three population a know they months. we've spoken that very patients. know, said helpful, from they're everyone

an more just and to is than by you're some this at patient doing have harm TURBT. point, elderly And good continuing repetitive these

So are, both news that and to up specific is, have so guidelines patients with can to who identify the likely good the is you these recur. AUA EAUA as come very them up they're front,

as again, patients then our the were our of But in patients. majority I mentioned before, study recurrent

patient comes incident So biggest the recover the they - frankly to pool of of that's more patients, majority be, to that months is six a three because patient which prevalent is patient in, our the than this later, the and pool population. the population, likely

Boris Peaker

could that? question you've you path comment is a single cancer. a just possibility, that in Is And still on designed arm the my mentioned bladder for last potential past forward a study with

Elizabeth Barrett

the understand we we're with a I again issues can any there can was We almost TURBT. do Well, meeting frankly, I agency, won't know not very the everybody protocol, we're the to a FDA, enough writing having the conversation versus and do good right already that's I think our from discussions that did we with agency job, that we we in want on - have the probably I think strongly with requesting we're be that. do head-to-head that, protocols feel a finalized,

patients, much out agency to be expected to if want The results the study, arm how or a next talk and question evidence to than faster is over want a given them do this good If if the we'll we would with we are real-world be, it's there's path would that. we but available that study maintain making to we stronger might months. few that a have they - the single it had plays a to we durability see control then to to whether whatever see

with that want the do head-to-head to we're conversation not going we But study. of to have start the But agency. delay our

You past, think to likelihood never head-to-head we want a conversation study. based the with in on know, them that had we've the the they see

don't which within need few and educate likely around is months. patient, I the they to that also them a think patient intermediate high recurrence probability understand that we has high, risk recurs a really of this

So, we that have want to with conversation them.

an So, with is. TURBT forward is where what we we've and moving do Sure opportunity? a with. that do But can there that's head-to-head study as know there we

Operator

Our go next ahead. comes Oppenheimer. Gershell Leland question Please from from

Leland Gershell

Thanks for taking - a my I Also of couple question. guess for two, one questions on Mark. or

reveal Thanks. tell of patients sample for you be further might next that number think could study see the have follow-up. may a you terms if may clarity powered OPTIMA And when head-to-head If Then be any in us the of what adequately to might required size you the the for endpoint? on on also, current we needs study? I have

Mark Schoenberg

working and and the final the down to as on non-inferiority stretch that answer Liz on the coming I is I to superiority we're designs working first question still really balance So, power. trying think we're Obviously, that it is think protocol. fact impact of trial they emphasize the

have we'll that to probably going clarity That's think I opportunity So, involve our is say. and more the to we've design to a talk is of patients, and question that I can much that agency. going many on hundreds once know this about the as finalize is had as and that to the we're how then specifically on trial be now we working

but are to that durability And defer I timing, we that that Liz of I on then and II, of data know information in OPTIMA to cohort on additional we XXXX. to the in advancing have we're more the think the going program terms about half have of first lot a

Elizabeth Barrett

see that that think I mean we Yes, and we'll I plays what out do data when feel meaningful, we'll it's like enough have how we we'll the is data data. share

it about we when we do, but sharing it want make enough have we we be that to sure make So, shy won't to relevant.

Leland Gershell

you And may forth. nature to also to on of the terms next product, mixing infrastructure, modeling have that in question expense in then given the may other about commercial the one toward expenses selling addition requirements, so XXX logistics, relate wanted commentary hear and salesforce for as of I year any to we Thanks.

Elizabeth Barrett

answer. the on know We Peter really right. he I'll other since but Yes, expenses asking expenses just then about within specifically do and our obviously chain I has questions. have you're line, Jeff's any comment supply can if

means talk - distributor, this chain the a to about typical a ensuring to require our the ease before of key and which will will to as specialty us products. for is strategy So it fairly of go then these is supply - a very us for which we use mixing types that partner

And are included goods of our so of to looking all that. have and you would we be at know those so, cost in

a strategy. like will of to to lot adoption I the be adoption it's again, of do Because, it positions. be as on it's we it, early say, key to priced it's able part that a think very sense. big So wouldn't and making as easy possible our reasonably expensive, makes overly quick

Operator

next Our question Chris Howerton comes Please from from ahead. go Jefferies.

Unidentified Analyst

This for Chris. is [Syed] in

on work, and that the non-inferior if that your comments so, start really clarifying The both trying or were for on and superiority to I it two pivotal. would study there? first Did one you one you say was please a comment had how question that a could you make

Elizabeth Barrett

talked many, and bound the do past. look it it's many basically, and say when yes, both you be review you I'm this is and did - standpoint, lot to as know, of you So, at if the if But I a time would you, and happened, if want we ability this then to a non-inferiority - - I a did would has you when say a have, superiority day, sorry about. that, I the employing what we is, data times in that the able

be more follow So our the look longer patients, free that and at, non-inferiority. superior. point the you to we these are where, potentially in likely - can recurrent but you a you rates, case to of to have claim want similar could you And get a if

where non-inferiority. have for a study, been to they've superiority to are then able So both follow design it's and easy times many done you a

we that we cover would a So want “a all of likely earlier, we sure bases. to make our have you later” again but non-inferiority just superiority and

seen will have Having get likelihood good we're said feel you a durability, and going very is we holds data, that, we that know have you we with up, to superiority share the superiority if think the that a we've a that data to looks study. strongly pretty the then high right that

that multiple another care. have I versus Again, the add on management in which and point another standpoint, actually will just having standard we benefit a of an from to that area non TURBT with that is believe have guess we current color advocacy you is, associated clearly if a inferiority

that's I helpful. So hope

Unidentified Analyst

helpful. the that enroll that very population does you remaining trial? that's are for that to are you it mean have enroll possibility saying is relates of you the for as guess But superiority the to one trying versus I'm trying open are the I non-inferiority, that, you Yes, question know, is to to I larger superiority so would both, need patient what what you - if for to

Elizabeth Barrett

numbers the decision. make data, yet, so that that haven't we'll have We seen to

understand I finalizing protocol. will the statisticians you working is we that what we the know, As said, couple a exactly with We're sure what that make need. external of team

So that be dependent will the your on it to - will point. patients of number

Unidentified Analyst

XXX know, was but launch. that were Thanks on providing the color commercial get I the And question remaining to kind the steps all I this of wanted for prepared for had last what earlier, commercialization. to the

what be steps I'm you're You said to year, next prepared remaining so by last are? very going the to curious early know

Elizabeth Barrett

line. on we absolutely. Commercial. have he's of our Head He's the Sure, And Jeff Bova,

can you take please. Jeff, So that question,

Jeff Bova

Sure.

another by Liz so if label, be have label product regards step. - call bring Once earlier, on the as them how on background we begin practice the the a patients. a option the the final to will early we do to they're field So, so things training logistics disease. they'll they'll while when Once training, the they're for brought to accounts into that on on some board, as hired we they'll and able go with mid-January, understand will to so various through we're account profiling, immediately force the also approved alluded have work, the promote

as not we're ready approved say, We we're know, now if journal now, We're messaging you for will right you place. our ads finalizing a getting everything in be getting, know also, that from standpoint, marketing approved pieces will campaign.

standpoint, access we've market already a hub. From the chosen

will provided Our hub the be product. how order the customer

well distributor. and as our PPL hub is the chosen our specialty already So as

in closer So get move through able to and we hub be those, approved, to place as it it like now. or those will get the provider. accept, are all order an once, wasn't launch, And if it to I the to said, be into take able

Operator

questions President turn to at am closing back call I UroGen’s for no showing CEO, time. will further over this now you. remarks. the Liz Barrett I and Thank

Elizabeth Barrett

and So the thanks thank for everybody operator, questions. you

I exciting time. very think it's a

yesterday, gamut addition you've heard morning We've you pipeline, really see and our of As Agenus covering then announcement trial the got can of XXXX that uro-oncology. with think UGN-XXX. this the I CTLA-X we're the

Now of addition UGN-XXX to then eight study launch will go begin a with will agonist next with - mid-year it or Expectation a pivotal year UGN-XXX, and will and we in tail delivery be local which to CTLA-X have is year high-grade advance now seven, disease. filed. the next into combination or

an complimentary that'd us forward. a for be time exciting to move nice So pipeline and

So again areas unique as our uro-oncology bring new we and we a leader high value to more these be innovative in couldn't needs. importantly and for position our in patients options build both of unmet shareholders to grow treatments as excited

and our for to thank continue call and you year we UroGen. joining continued we'll in interest So of come as this milestones next for you update year through the into remainder and your

everyone. Thanks, can operator. disconnect You now

Operator

Thank you, gentlemen. ladies and

may now You disconnect.

UroGen Pharma (URGN) 12 Nov 192019 Q3 Earnings call transcript