URGN - Earnings call transcript Q4 2021

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Operator

Good morning, ladies and gentlemen, and thank you for standing by, and welcome to UroGen Pharma's Fourth Quarter and Full Year 2021 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. Good morning everyone and welcome to UroGen Pharma's fourth quarter and full year 2021 financial results and business update conference call. XX, issued corporate release for highlights and ended we of an the morning, year recent our and December this a providing press overview quarter Earlier XXXX. financial results on A press at Investors of our investors.urogen.com. the release website portion available is

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

the These call, and we making may filings, regulatory will our development include and commercialization change. timing success found statements. SEC manufacturing and disclosure among efforts, guidance, press ongoing on clinical regarding assumptions, that financial latest today's of A During current in XXXX release trials, potential planned certain statements and future be information, to Jelmyto, expectations description can research capabilities, forward-looking presentations, of risks our things. are of These earnings be forward-looking statements and documents. based subject other are data

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

Liz Barrett

full but Jelmyto, and the set growth quarter, detail for records Thank access of Jeff treatment which revenue, as testament activations awareness continue the on an in commercial In from adapting continue first on commercial global QX. access clinical focused drive QX. what milestones Despite further up XXXX solidifying at a new year patient stage provide low-grade and of the developing to we our as of the and This time our to setting team well the Growing patient and an added our of financial Total several led over in commercial solutions efforts, you, nonsurgical XXXX system revenue strong cases year population. us joining largely urothelial to is for patients Jelmyto, high Omicron you gain the the high resilience as made did challenges challenges quarterly efforts is more provide guidance. product commercialization for for to important with excellent product for will ahead. specialty XX% paradigm our product pandemic, to for an the am approved commercial on the for and increase cancers treatment fundamentally Molly revenue of XXXX new stemming enrollment of and and underserved was the net variant was in novel early We in perseverance QX, will Jelmyto's as adoption $XX line UTUC this today. FDA a proud with on COVID-XX and a fourth our in which new guidance only team. shortly. level, in transforming Vincent in setting throughout healthcare job goal review to help million we and us new by rising market thank of our I sales remain staff million, the pursuit shortages patient the in XXXX in progress XXXX. we site place for all everyone to Jelmyto, $XX.X results placed

countries, we year France, Supply of a Patient Named of last Switzerland, the expect in adoption we five outlook our European year, accelerating UK. the and business and and Late However, for announced Jelmyto, Jelmyto post remain confident which launch launch. Germany, the Austria the as full we continuing included for program second pilot

for of pleased the partnership During I'm Jelmyto, report had outside four QX. two of two patients the result The to the identification patients to been with in commercial patients Australia with of representing NPS Israeli as to patients received of time these expand the Neopharm a quarter U.S. in first these program fourth in pilot. first that in to efforts, treated these program of delivered the Jelmyto Israel XXXX of setting. this we Neopharm product addition with a with continued saw of the those the

we Jelmyto, lead made our and progress UGN-XXX Beyond trials. program positioning development the in program advancing important UGN-XXX clinic the human immuno-oncology for our

II the design patient. to similar Turning United earlier is risk carries believe approximately ENVISION impacting in Phase first bladder the States ENVISION, label, a single low-grade probability site arm, trial, we the that development to previously pleased open intermediate patients OPTIMA annually. Phase report high pivotal in the to an invasive the X trial, to ATLAS very recently as dosing trial. a we quarter, UGN-XXX, the X I'm Last and which to of treat shift opening announced first the Phase in trial replaced underserved indication completed first ENVISION is and clinical first a in result we success. XX,XXX non-muscle month, cancer, initiated which the X

ENVISION expect we end an enrollment to complete positive findings, XXXX the and submitting We XXXX. of assuming anticipate in NDA by

base launch. approved, which an a efficient would ensure with Importantly, and prescriber if share UGN-XXX will Jelmyto, expedient product

therapies. closer believe continue together potential billion of over to two represent realizing revenue to high and well $X start and the trial UroGen opportunity UGN-XXX promising ENVISION We moves these the of the innovative for Jelmyto us full

recently the bladder half commercial Advisors $XXX funds to a impact treating our to company will with for facility of foundation provides announce in have based cancer. study flexibility submitted to upon which with to approach secured initiate can we first in our Pharmakon by plans We have development us first and formed current flow the the believe multi-arm discuss patients, to toxicology for senior IND their XXXX. term on represents breakeven base up last what loan them that and million try thank FDA XXXX. been partners combination I RTGel an demonstrates belief facility of candidate Advisors. study by runway this to us human to efforts managed unique great closed Mark For to financial our necessary high-grade the first a immuno-oncology want UGN-XXX partnership. the gives in application and month, This an results we in study, from a non-dilutive and capital reach our their financial our cash Pharmakon continue expanding be we the and putting projections

broader sheet us Finally, of and to company. Molly CFO in to well today strategic leave I with want address Molly to her team, made decided leadership continue role led assume positioned disclosure vision. announcing transition our as a to leaving successfully our balance our another earlier a financial as our advancing strengthened a efforts role UroGen has

served a XX. her to transition her finance industry currently Finance, professional Strides to Don biopharma most Prior he Pharma, and where of is responsibilities joining Finance recently a seasoned financial Pharma, Vice CFO Head extensive Kim, with assume Board missed, of and UroGen, be to Don will Directors. will experience. good role Sun Molly the there's is a March Don who member with time leadership of the effective Zoetis, successor, held with as While President position of

administered from disease shift to away the repeated Lastly, UroGen, immunotherapy continuing function to goals patients now ablation to and continues to given in minimally primary oncology, surgeries management will and by Investor approaches. of play At treatment one better this our in success, to neuro specialty give and is the therapeutic our me. report of directly Relations options invasive paradigm critical locally role, tumors

with and our a patients enroll to in XXXX bringing normal pivotal advancement development patients expect the Jelmyto's more launch UGN-XXX, unique as clinical $X major our that, deserve to revenue we call for novel to for for company solutions expect environment Mark our We to recent high-grade development immunotherapy to that to [ph] a fully better. proud pivotal continue extremely expand for With of study cognitive progress care make turn discuss year I'm potential a Mark? to a UroGen goal toward our approach into represents updates. for I'll be and with and we tutorial the disease. our efforts which billion over of

Mark Schoenberg

Liz. you, Thank

a published UGN-XXX Missouri Journal to administer progress Murray development The retrospective of our was to experience Before providing our Urology, Katie antegrade comment update Dr. treatment on colleagues the utilizing recently of Murray Medicine in did of effective analysis conducted showed of and UGN-XXX, by and which the advancing real I'd of approach method administration Jelmyto. world that reported administration impact stepwise Jelmyto. antegrade negatively clinical University tolerated to comfort. provided Dr. an Jelmyto, of well on instillation like antegrade recent which School programs our study not a provided and patient

repetitive suggested urinary may protect help Dr. stricture ureter reported tract. the antegrade formation had been the which administration, instillation, instrumentation during the of analysis of Murray's manipulation that minimizes against upper following Importantly,

an as administration, for both approved clinic. As both previously be the stated, retrograde procedure Jelmyto methods and can performed antegrade and in is outpatient

by therapy our Jelmyto, ureteral administration the recently However, nephrostomy catheter the of ENVISION evaluating position arm, a for both patients multicenter administration we require and efficacy safety study, colleagues the risk guidance study and trained in designed with have offer I'm transition whereas may Jelmyto administration administration instillation, intermediate trial. last is administration requires single be and does is to Jelmyto gel pleased to by ENVISION report update, via utilizing as which practical guidance, and a not that patients initiated prior fluoroscopic as X instillation Dr. and chemoablative primary to the UGN-XXX, to performed confirmed. once completed nursing a her since tube antegrade physicians. professional from Murray fluoroscopy for Switching retrograde UGN-XXX ATLAS via pivotal multinational, Phase low-grade, NMIBC. physician may simplify antegrade of the

a that probability UGN-XXX control to require Importantly, comparing higher carries we does of given a believe arm, not ENVISION surgery. success, it

showed design rate of the XX.X%. and a durability response Xb XX months of to is addition, UGN-XXX which Phase OPTIMA of II of In our study XX% complete similar of ENVISION

XXX is intravesical who As in to dosing expected sites over recently at being Liz is we ENVISION. receive study X enroll instillations weekly conducted of once approximately which noted, began will patients The XX UGN-XXX. patients

drug In three FDA, will patient complete who intermediate application And with evaluate the full our a we terms ENVISION evaluable instillation. by feedback from the will of of new recurrent complete durability in at NMIBC. and three-month over findings, response time months assuming on the rate after the achieve the primary patients enrollment secondary submitting endpoint a patients we anticipate evaluate assessment. XXXX. enroll which in will estimations, the first expect Based The population, risk endpoint XXXX key low-grade positive end the include response

bladder home to we home with home offering We the at UGN-XXX, believe single the demonstrating the solution step is may many standard that or the an at the patients issues cancer conducting study bladder care of life of transurethral a quality intermediate resection risk access for of of in invasive study, of current are feasibility elderly and low-grade, an instillation. important addition with In care tumor solving arm non-muscle patients to face TURBT. ENVISION instillation goal of

an of an we We remains bladder current for we care. patients intermediate are becoming advancing the or risk leading on our roll UGN-XXX of six and transform Low-grade use low-grade NMIBC up of to the which therapies our program, MD administration chemotherapies by an that treat unmet disease, We IND no how avoiding to the immunomodulators progress the invasive treat target long immune RTGel tumor of nonsurgical CTLAX cells. high-grade immunotherapy with intermediate I'm power XX,XXX for via inhibitor produced at our unwilling the antibody potential believe with states. completion clinical to this of patients We alternative with considered update recurrence, UGN-XXX general affecting toxicity the XX that to also month, an these of expect to toxicity. is a The high-grade of Hospital. this has to standard in multi-armed surgery objective while this enabling been partners the good limiting those the UGN-XXX patients. patients, of intravesical toxicology for overcoming is may significant the provide associated non-muscle anti-CTLAX permit it announced suppression as program, to clinical supporting systemic demonstrated includes dose a Phase in the highly which the undergo treat foundation cancer. delivery the anesthesia, invasive There approved for half checkpoint combination an Unfortunately, bladder potent particular need associated which administration. us UGN-XXX that our ranges antibodies for repeated the developing expect are and molecule believe establish risk for first is development has estimated united anti-CTLAX FDA initiation X formed to TLR-X to study single study are non-muscle the monotherapy UGN-XXX or we this are leverage pleased TURBT antibody next antibody IND systemic months. we Last monoclonal in to monotherapy during unable does to UGN-XXX, as bladder of cancer other and has safety and our that year. risks the activity which in-licensed viable non-muscle agent anti-CTLAX submission, development alongside begin to is first cancer. including invasive with in by development and Anderson a disease. in of as agents and dose high risk in agonist, combination UGN-XXX, we

a to and and will fundamental XX study of take arm to approximately cornerstone We as the inhibitor, checkpoint view complete. potential first this The high-grade updating Phase X UGN-XXX targeting forward combination progress. evaluate months as its of begin the and UGN-XXX will monotherapy therapies our excited evaluating the look variety a you year to cancers. potential were in We of on clinic

plan to identify advance with research continue our we care to work Lastly, additional across specialty to urothelial that other cancers. technology and efforts medicines proprietary may

like most prioritizing update. to hope the of provide Jeff later would plans more and to And over in call to to share We with that, the this year. promising our Jeff? about the commercial a process turn are targets I

Jeff Bova

Mark. to rollout an you, with on Thank of Jelmyto. I'm provide you our update commercial ongoing pleased

the $XX I'm COVID-XX for market volatility XXXX. As first net rise year, quarter starts, throughout which patient fourth our of XXXX, a record a despite Liz we to some thus quarterly corresponded and to full third saw report ended variability new With basis, Revenue a of forms and continued year increase mentioned, in in the our into consistent ramp representing sales with on to regions period year. with field $XX.X pleased through compared full far QX week observed year from primarily more up and in the which the last was week force certain we that the we the revenue trends million million to Jelmyto physicians we've the enrollment momentum, XXXX. in three. back the XXXX, a in patient on XX% engaging favorable in cases, product to of quarter, in were quarter in-person, same achieved

XXXX. for of normalized a launch are this hopeful suggestive We is more trajectory Jelmyto in

last into ahead, in deductible QX, respect year look we As the first attributable for to is we sequential anticipate the heading quarterly similarities part variants which to with most to seen resets quarter. typically

revenue expected from such growth growing However, pleased particularly the with year-over-year expect a of for and product in as Jelmyto is of are of we new and despite our adoption physicians XXX, of seasonality was as data increase viable I'm with growth enthusiasm sites seeing both repeat The XXX suggests prescribers. we up steady an Jelmyto. November X March X and representing from number XX%. strong which on activated XXXX, as

of have on X XXX of more represented that one November increase number than to repeat XXXX. from the Importantly, XX an treated This accounts patient increased of sites XX%. or

gives these us and growth confidence from Jelmyto number to grown, experience an we've more conversion times As positive as which Steady and rising treatment a in repeat have and continue forms adoption from of the enrollment treated new see patient significant protocol physicians the a patients. of both established from XX down being accounts patient expected will areas both perspective identify of the accounts days seen has to in XX treatment is patients days, critical place. of in to we improvement suggest

has of streamlined encouraged milestone and by that the drive continue by pathway in treat can XXXX. to Jelmyto. significant continue HCPs remainder remain during The Jelmyto criteria that We seeing the CFU created highly adoption use within the another access we're representing to a a for VA. pleased which low-grade engagement system, trends announce within and opportunity establishes VA for see penetration to to are and the UTUC VA to favorable a what I remain optimistic we'll

the provide With treated long-term we providing QX. UTUC including make use of insight are on the to later Molly review evaluate phased Molly? this in the an expected with patient I'd to Jelmyto, over launch look into the year. and with progress UTrack the urology community, this the to financials. At feedback with turn initial select patients end program, evaluate registry. benefits treatment is this a expected findings study U.S. Data in its collected finalizing [ph] continue like clinical we updates time, world practice We that, the to sites additional of of build this Lastly, real on-boarding outcomes the and in for to with call before forward from of

Molly Henderson

you, thank to Thank you for and Jeff call. today's everyone joining

results, non-dilutive Before upon we XXXX like Pharmakon with have financial quarter to and reviewing Advisors. term fourth funds to end financing up the year touch by our managed million I'd $XXX recently announced loan

address We urothelial XXXX specialist facility achieve of will are and in believe what current track UTUC, the flow by companies. who our to to Pharmakon up based of in and and million well operating Jelmyto significantly landscape our record The partner on to life financial unmet the therapies supporting financial its models. potential position needs a to partner a investor loan broadest significant specialty sufficient In of strong we cancers. projections with positively treatment as senior with our cash $XXX innovative strengthens of secured be needs to supports our breakeven runway term revenue the Pharmakon pipeline for innovative impact an opportunity have Advisors, and experienced pleased with science low-grade as believes ability we

additional right arm the and make we interest time, interest million to prepay and loan the Pharmakon upon of prepayment in followed the the discretion, In our our we the ongoing months principal The LIBOR XX support three end months of and payments first XXX our years any to with mature single first and interest them. using before return, to we point At five on period, The to from the of immediately they commercialization by accruing year. draw and to continued only trial payments, now efforts of an will may call partner funding last we Jelmyto basis for begin $XX and Phase subject $XX full received for will UGN-XXX. X innovative quarterly industry tranche ENVISION a million of with companies. week will plus quarter XXXX. ended premiums excited results at loan reserve initial entirety it to our certain financial review flow X.XX%. I'll the experienced an fourth again, once with Pharmakon, leader biotech supporting XX, are December year committed repayment and was

Liz full period the Jelmyto of respectively million $XX.X fourth the and product This June Jeff approximately of net XXXX launch of by quarter UroGen mentioned, the to year of aggregating As million the and sales in driven of Jelmyto increase for million to the $X in compares XXXX, million XXXX. of for XXXX. $XX $XX.X reported same

expense quarter were year margin gross full our and anticipating XX% than mentioned, for lighter XXXX. seasonality million QX to Research the to forecasting. and end and the XX% million gross ended at period XXXX. were includes $XXX,XXX based same UGN-XXX, year Phase quarter of fourth to in XXXX the same at of $X deductible compensation XXXX Cost year R&D the general in QX XXXX to that, The the in Selling, were XXXX XXXX million and Jeff $X.X $XX.X respectively $X.X saying million approximately were the in XXXX resulting fourth million million XX, XXXX due $XX.X XXXX. resets. and for the we expense in which share of and development year revenues year million million gross for same $XX.X $XX.X quarter expense XX, fourth and includes non-cash XXXX $X.X to stronger and are XX% for $XX.X based to least for XXXX, are increase XXXX. in expense XX% compared first compensation as and and margin non-cash of year for compared for compared XX%, quarter December initiated related in quarter be million $XX.X and and in the to $XX.X of margin million, Research expectations periods respectively line the for and was of million December revenues in in same XXXX. by somewhat for respectively XXXX. million and compared XX, $XX.X and the administrative trial revenues XXXX to $XX.X million QX X for with revenues XX, anticipating potential $X.X compared for we expense and the general, million is and the ATLAS resulting fourth share and As of December of of million compared of $XX.X to periods quarter $X.X period cost million development ended full quarter respectively Selling, and XXXX December compared $X.X ended expense the to as of fourth fourth In million administrative ended to in XXXX. expense Full

product same in cash I'd time to us management Since important business and comment of Before moving to the we at our areas on patients exercised to support operating invest the tripled expenses. net allow our like gaining of effective while to fiscal access the beginning take revenues, that on, a moment XXXX responsibility to therapies.

adversely able clinical reduce a impacting without SG&A result, commercial our to were As in XXXX activities. we and

and As on in we ENVISION we trial UGN-XXX SG&A to R&D expect X study. and remainder Phase of spend related Phase to anticipated ongoing the look XXXX, consistency higher X

of obligation the For for million the Investments reported fourth million ended XX, and the related the prepaid $XX.X full year. quarter to December $X.X RTW was expense financing board XXXX

in May payments approximately The similar no for are made XXXX As that closed were to in the RTW there XXXX. were million. cash transaction expenses $X of total XXXX

to from on Jelmyto which the net XX% sales global XXXX made Lastly, as in product our it rate payments increase the in X.X% of XXXX. relates based be RTW, will to our them to on will

XXXX ended the share share or December XX, $XX XXXX. equivalents fourth and for million The million net received compared includes million we include ended in and for XX, share share and and to or net XXXX the share the loss same approximately and of year We quarter per $X.X million term from a million December non-cash expense same $XXX.X $X.X compensation year tranche in to compares does and or million under $X.XX $XX.X $XXX.X Pharmakon. fourth closed loss of $XX.X loan with the the based not year per reported $XX.X respectively the million This $X.XX million For for million $XX.X of and $XX $X.XX periods marketable first respectively. and facility This quarter and cash XXXX. we losses million periods $X.XX in cash, the per per securities.

a over for our XX% to million be net XX% million, our to We to $XX product revenues. to to including to representing $XX financial $XXX XXXX, million in year $XX range compensation $XX increase of non-cash the $XXX based be million million guidance operating anticipate range of XXXX the of anticipate share expense revenues full conditions. XXXX we subject million, XXXX market full Turning Jelmyto expenses in to year from to

cash. million related estimated range obligation anticipate in year Investments million we be $X.X expense to in million, the an $XX of of Lastly, which to to financing $XX $XX.X million full the XXXX RTW will to prepaid

programs low-grade take Jelmyto the the continue to exceptional call ability role newly comments. turn to plan played balance With to the I like and place, a bringing sheet to potential With earlier I'm Don have Liz's to and moment UTUC Board Kim, level and vision. a paradigm I'm strengthened market that, to demonstrated team's explicate professional UroGen's a strategic of confident in the address like and experienced a over competence. development proud highest of remain Directors of intermediate treatment who Operator? and would transform excited to leader to in low-grade Liz NMIBC. have risk position of the has and questions. like the UGN-XXX. thank very I'd Lastly, the I to transition CFO the to the capable of I'd company. Both of

Operator

comes question first Peaker Our Instructions] [Operator Cowen. from with Boris

Boris Peaker

for to and and taking responders? thank is My question you of question. Good ultimately is it need show my what ENVISION if you any and comment there can meaningful maybe on morning, studies, values you the for for first kind approval partial

Liz Barrett

that and take I'll to want you commentary? add any do Mark,

Mark Schoenberg

Yes, you the study the Well, in design, in target as terms thanks our question. course, for is current identical sure, of I of think, almost the X and know, to Phase population.

durability to what we in lucky we guide the our to And be Phase to the XX% rely response Phase to might Phase rate as a So was are on at the X in we what listeners, saw in the X us expect to Kaplan-Meier X. able by just with at remind complete year approximately XX%.

we compelling suspect but data to have those trial to I guide we see in trial, we this what the to are what Liz in want from terms helpful Obviously, of trial. and and well. do that's good this expect about to might a think So as we comment may thinking think

Liz Barrett

durability XX% The to said ever be they and XX% guidance Yes, the us our meaningful. a would first saw hasn't you this all hit we of our was, study, somewhere be clinically got before What we study meaningful. results FDA mean, think, is, number. it's say look, given to have I have specifically, we X to Phase like along, said around I felt

the field key ODAC. to So with is in believe this say, opinion be likely what you well an before, that will they as And leaders we urology contact and to as is about go they'll meaningful. do will do in do, talked we've

worked have said, for have we it who because So, good very which option. if the have the feel might patient, option, about, physicians but we they any

that in range specific while feel be can't XX% confident this we have we and that that if when even would range, we're meaningful. actually don't anywhere So XX% number, comment, clinically a we

Boris Peaker

the of my [indiscernible] from second part the there any And question, expected meaningfulness clearing the practically? meaningless, partial is for in kind responders of

Liz Barrett

we we yes much Mark looked sorry went to need allows and I the to to you've can about response. get believe conservatively didn’t a some a is, partial data. there comment in be but response capturing And, this had we're data. managed actually, what and that. gotten when we area which the sorry well, ability and far we -- we actually believe more not in back that's for some That's captured at and Yes, And we but you Jelmyto the of that an study. study, avoid also partial TURBT both were but actually seeing a that UGN-XXX, so want to may Yes, is and what as before, also

instillations if what they you to plan Mark, that a yes study two else is gave point, anything partial the to more make So a that. to even we responders. But add? in get there a difference? benefit see would we response if partial So your

Mark Schoenberg

No, it Liz, that's thanks.

Boris Peaker

question. for Great. taking much Thanks very my

Liz Barrett

Thanks, Boris.

Operator

Our next Jefferies. question comes from Chris Howerton with

Christopher Howerton

morning. for so Thank morning. questions. from you good Hi, -- I the taking this a me much couple

I if becomes Jelmyto and may, last side, surgical guess, ablations I efforts any to Jeff, been changes First curious relation a kind for focusing if made, then I'd Molly. parting for question of any an a in physicians you've Secondarily, know you've past, demand practice And know on able commercialization lot nephrectomies has me. been and you've I in the know that? wanted of like a any comments opportunity when and to I procedures made on the the all, radical the if question, creating meaningful if available. or patient make prescribe to either nephrostomy, observe efforts can from But perhaps UTUC you with excuse to on them patient to I'm on clinics if maybe perspective that Jelmyto. of also

if curious you in thinking as you. cash little the flow respect XXXX? give color Just to to a -- could breakeven with Thank more us

Liz Barrett

Jeff, do can then to you chime first take want and Molly in?

Jeff Bova

Sure. Thanks, you and we Chris. be could yes, to see ultimately option, end our the that's of Yes, Jelmyto want level increasing we marketing as of. because aware of so patient more for pointed an are patients of out, XXXX, what as XXXX

have patients. patient utuc.com, QR which their code, want talk activate we the in given that website a responsible activation, this, everyone but So have physicians our about as about as from then go the lot media, to just regards certainly able patient that patients we while and a the social not things offices awareness our perspective. the use as for a to patients well in will to their do lot waiting Jelmyto really about go both does, resource where do patients, a them getting we to I we but learn as the more room. scan to unbranded be various do we the Obviously, in, an And population, doing know do to to in can through some to Jelmyto. being more know a They'll as much really resource website is disease. recognition site we're

continue doing do and are to we XXXX. we'll more, more So in

your are good second Regarding question, yes, research market down. thing RNUs, the here in we've is going obviously, what seen

We to partner want continue to resection. endoscopic with

thing radical obviously that place is but two, So set is of, what which past we've physicians coming down the low-grade, with with for to will are do. in resection out good different patients the ways we've seen use endoscopic nephrectomies three years in in Jelmyto

So hopefully, want second Molly, I question? answered. take do to the you

Molly Henderson

Sure.

So bit see event on support But get Jelmyto believe in does of business infrastructure that our do can the getting alone. XXXX. that's approval with Jelmyto, that upon XXXX, we we're little to the said, as with contingent the flow it Chris, obviously from upon and XXXX. believe we by that the that be demand a already a the stand-alone and team for can cash we obviously but current flow revenues projection by expenses as breakeven have where end we based commercial we our from breakeven That the we've relates we models by cash current to for in UGN-XXX factor successful currently

we and have have So cash Pharmakon we have we that we comfortable to that there. feel again, on a with the path the funding get that, from hand

Christopher Howerton

Okay, awesome. that question, thanks again. did very Well, Jeff, address you thank much yes, so and my

Liz Barrett

Chris. Thanks,

Operator

with Choi Goldman Paul from Sachs. comes question next Our

Unidentified Analyst

This on for morning everyone. for is so Charlie Thank Good you taking our Paul. questions. much

a the with second on or are my other of in whether of XXXX and you. near data guidance pulls that be we be combination color little the completion maybe lower was coming until dictate trial be we future maybe looking hand? to be partner should we question the And just future? and with priority arm Thank the bit to kind combinations that expecting First related then in, of the wouldn't arm upper UGN-XXX balance guidance? some monotherapy there wondering partners pushes just expecting should combination potential the question be that then is the the started any and UGN-XXX should in me from regarding And monotherapy UGN-XXX, for combination that revenue more and what expecting

Liz Barrett

don't So add Jeff, and the take question. you first Mark why it and can then second I'll commentary and one, the turn take any over

Jeff Bova

to of certainly this to obviously, I to rare with factor always normal disease. Sure. for with issues. phase, COVID-related any launch Yes, for I We face-to-face regards a is is year, Thanks, get this Charlie. -- little with interaction the starting as for key big we're one guidance so mean, back physicians. bit but in That stated, drug

And that going probably to factor. so anything an That's certainly impact on have impact there surgeries the is could number. biggest the elective

grow far that we're go there. maybe think as discuss give publish there have and the continues on and And And that start opportunity we you could registry additional see certainly even have data that, hopefully, as see that start probably data out, to as of that continuing even then I it I to retrograde. XXXX, that we in further main obviously, on it. more to that grow that versus and some us there, administering from we'll data depending once that, going we shows, what could an generate to nephrostomy faster expected. mentioned, out data on the than And route administration, that get

are those do comment? want So sort lows. of and you the But highs Liz, to

Liz Barrett

guess right? have and do the about Jeff, quite continue talk those. it of only often to both breadth we is of depth thing, So we Well, to really accounts, my and I

an to Jeff go board not use. what But having about new continue on get standpoint the thing from in, to rep said only the accounts instillation. a to other of -- have is it's We but that have said thing they're going

sell. very So a it's high-touch

is able the So them account to important. go and work there being in

have account. to You hold hand their the of until to used kind they're

and depth. from both doing So adoption an both perspective, breadth

Jeff which just want talk combination talked you study? Mark, to about So do about often. the

Mark Schoenberg

thanks. Sure,

will XXX. to So need starting we be escalation yes, information study, that first-in-human It's with from and some acquire from we use a Phase experience. X dose

that our conclusion X complete permit to Phase has start us very combination the XXX. before with protocol However, of the elegant overlapping combinations team developed will

best So that. we plan to completion. we not before are start And another that to combination to answer use XXX will actively also XXX first But exploring and doing for the the XXX. work as do we partners are We that, at to us the whether we would in-human we actively use opposed some or verify preliminary are currently, do. agent, for other looking as thing that's potential to is

or be So the there's to within as may going more tell that about so. to well. comment to Liz next year want And

Liz Barrett

just was I science. going Yes. to we'll follow the say,

is that depend will XXX primary we work the several. will do. is it the to on be the But whether intention So, have

as agents, agents. other as just to So and targeted targeted agents other UGN-XXX, with do the combination intention but immuno-oncology well is potentially both not chemotherapy

that we to what work best So which appropriate. the few works through again, then quite and can we forward help the think at combinations. are will idea of those combinations Anderson a the them, move working identify to And test we're is team doing so with now and best what MD see that's is

Unidentified Analyst

Thank helpful. very you very that’s much. all Great,

Liz Barrett

Right, thanks. you. Thank

Operator

Selvaraju next Ram comes question H.C. from Wainwright. with Our

Ram Selvaraju

for necessarily be $XXX able wanted XXXX cash to revenue revenue of focused could very ones achievement that Secondly, scenario flow to to you was hypothetically discharge be with this that also level if if financial that's that would solely to on I would expect guidance my your you questions. also level of A as debt Thanks much and the I you first. Pharmacon taking wondering you million? possible? business assumes obligations whether in expect stand-alone even comment repayment confirm that specific a if couple be effectively quick on commensurate to above a Jelmyto, be breakeven

Liz Barrett

Molly…

Molly Henderson

I'll take those, Ram.

your year. achieve for we peak And that right where on question revenue first we upon see we've success you you peak to that can around probably point, is fully we comfortable that referring order can we share make what so now, we in we in right staying of is XXXX then discussion in what need XXX potential the to that, the it get the XX% And cash can to in we to do the that a side And can that be obviously of opportunity great if believe we And that believe the we have little make that is and a important to is prepayment, a make which believe can But But time. that very as a the breakeven. sure you're about we the Jelmyto. can back. able that XXX opportunity them assume that at million sure pay to if we've of $XXX to that with range be sure have always relates around market what movement So at extension, saying five achieve we to XX% years. we I'm mark. would partner five indicated from do within payoff to us payment be, feel Pharmacon based more Pharmacon that need feel like some we year total always and to level, said for flow bit

Ram Selvaraju

the more the a accepted standpoint a has an not ex-U.S. one for you've thing. Can expect it. What a on in the ask which question, in And Got gathered I -- on I United XXX Jelmyto, wondering in more and necessarily the could well, realistically products other I forgot now from just just comment years? perspective, States, subject then other touched I ex-U.S. comment upon for knowledge but XXX, been Europe, you is on opportunities simply on to appears from potential in from a and quarters you coming before actually, partnership, know if potentially that the was be countries, distribution before, it we base product. based could

Liz Barrett

Liz. it's Ram, Yes,

things know know reimbursement. going One, is be can we us we done, Japan, to for to we because priority that good the think get Japan. about what I needs be we exactly know two and

lot we able found haven't that be get price yet be China sort interest But other that. East. can frankly, balance the be have smaller, through of -- can the working to markets in -- So the and revenue and in reimbursement. Middle that to a to to we've good still decent gives the a effort, we will opportunity analog had don't get, with I price, we the of mean us we our that priority. we we're we've some honest the a And those get

focused We we're experienced the is you in was right? So Program, what these I've is Patient Named need did and that reason because happens in and really for champions. the which this past, my markets,

the physicians want saying, need giving to the this payers and we be more and medicine. price. consider Then You you access to patients they'll innovative going to a

we that Japan, a be it to obviously, that. But if continue because through still say worth have to about they're find the comparing to world, generic. around markets will careful work the we is is we'll priority absolutely an would So partner. we I opportunity most think

those track. we a areas. some these more experience of on lot little bit the in U.S. talking agrees named a we'll everybody I to to countries, and And I partners think and think have in been then in and right the of we're belt of we've sort patient get forward need our think some under So go I

Ram Selvaraju

Great. assume -- areas that antibodies? where RTGel's molecules study with of advantageous? like might lastly if characteristics you also zalifrelimab, not And there's I let's context a reads broader with could read-through wondering from unique then positively. RTGel utilization on of And body the the molecule only on not the zalifrelimab future that other but potential of of this in you the could to context other with might have if What beyond utilization context, for XXX, just monoclonal this RTGel, implications the get just out in possible potentially comment but Phase genitourinary be any

Liz Barrett

do testament many the watching delivery, it couldn't sort UGN-XXX, the be that better a work of right, myself, do what have I will say right, medicines. that Yes, we you're in local ability locally. Urologists And learning especially in you happens of local to recent companies some sort I of about the but cancers I'd of combinations available. bladder absolutely to think doing see give we definitely these to like to delivery, benefits in And work there's that. treat about Mark mean more it. particularly, that to is comment that sort for of we're uncovered the here. we've definitely

your to and specifically and head as like point, some And of and cancers work with we've announced some colorectal we believe, academia cancer. the so even neck in know, urologic but in that you beyond other areas

So we're to we which finding areas immunotherapy? local could the comment out want our just believe particularly in are Mark, sort RTGel you on do of delivery, about do many esophageal of other there very But the cancer body technology what work nicely.

Mark Schoenberg

here, the is clinically the part. generalizable most neoplasms epithelial [indiscernible] that I'll you the is epithelial there we would of this the cancer would Ram, immunotherapy, the local very system through a to that about accessible which also disease a of could And for very but understanding work meaningful exceedingly interesting immune accessible that own epithelium, of Liz. be question level our topic Thanks, I'm which, that appreciated have area locally the for some everybody in of lately be just appreciates others be may and not Yes. Look, us. when applied think course, our for platform a variety in be at an sure, way absolutely say an work and hot well a Lilly and

with in and the be now. the system it may and of at So working we in the of topic are ability the right hard profound, epithelium on cancer level this very to immune the interact context interested

Ram Selvaraju

very Thanks much.

Operator

with Kaplan Ladenburg Our Thalmann. next question comes from Matt

Matt Kaplan

of terms tube a Jelmyto you Hi, good morning in that percentage that? to impacts Jelmyto. how Currently, antegrade I procedures questions. guess, followup of growth on And help potential going the of adoption us route think give the and about nephrostomy just administration forward. and thanks us of then I can sense use the taking what administration for administration, wanted of that

Jeff Bova

on in than given we but label, have number, good we really yes, lot paper it's will that, we yes have Murray's of Sure. the commented expected, no, haven't The higher Katie that say didn't data. really a I until didn't it's we -- this the but

a more More the following get this. we five are able first the practices there's talk retrograde As And guide the about nephrostomy say come to in the continue interested more that clinic folks administering I to questions are more resources out then and and data go tube. would equipped more in it, dose and and with that publish just through and in. reps that are

there even expect in at is who they're it and grow said interest, launch So I data. to we grow, But tunes sort half significant continue with do will two and to administration physicians ago, the of and that – as they a year wouldn't I open route as it. past, ago, minds there can this faster of out years consider I more have and or to get said changed this a even their

schedule advantage So have is there are And this lot more and in the to the don't practice. of convenience do They a to the patient can the time. patient, discussions the real that their clinic. of are They going on.

XXXX our it's there, growing in more So get certainly significantly is out as yes, data that. interest, and see of do there's we I and and lot that of buzz a to lot do goal a

Matt Kaplan

the talk between and will then, little success of And you. the a question differences increases guess, Can thank helpful, ENVISION there? you Mark. bit study that probability that's II a think I Okay, OPTIMA for about you

Mark Schoenberg

same. really which low-grade is study the Phase The relapsing Matt. population, II exactly is in did We're the Thanks, intermediate risk targeting trial. we a what

think very Phase It treated of for number trials sites and as does being of essentially I give being ENVISION X good because earlier, I involved the the expect or treated what think in that identical, to is same the guidance the group the preliminary except I of the I as size, essentially manner. think, in patient identical might people we type So said are, trial. same an

obviously, the sense in the but would we to expect Phase what what of look think are a optimistic that X I like, give Phase have we does X. we'll So us results see

Matt Kaplan

right. you All color. for all Thank the

Operator

And showing UroGen's back I'm at the President remarks. Barrett for closing like questions I'd turn not to and any call further to time. CEO, Liz this any

Liz Barrett

you. thank Great,

interest company. made. unique building the your and appreciate that We're a progress we UroGen of in really always, very proud we've we're As

to So, we options. eventful promises XXXX be to to of partnering you and these yet bring patients all with year, better forward look another

So operator, everybody. we can Thanks disconnect. again,

Operator

disconnect wonderful gentlemen, you a day. and have now may and Ladies

UroGen Pharma (URGN) 21 Mar 222021 Q4 Earnings call transcript