URGN - Earnings call transcript Q3 2021

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Operator

Good morning, ladies and gentlemen, and thank you for standing by. And welcome to UroGen Pharma's Third Quarter 2021 Financial Results and Business Update Conference Call. It is now my pleasure to turn the call over to Lee Roth, Investor Relations for UroGen Pharma. Please go ahead.

Lee Roth

Thank you, Jonathan, Good morning, everyone and once again welcome to the UroGen Pharma's third quarter 2021 financial results and business update conference call. issued corporate release for highlights ended XX, we of an the morning, September recent our and XXXX. this a providing press overview quarter Earlier financial results the release investors.urogen.com. at be press Web this of of our copy accessed A on Investors section site can

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

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

reliance UroGen’s Barrett. update to not and obligation any You are that, disclaims UroGen CEO, and over place to statements, forward-looking on statements. call to the now to my these turn it’s Liz? With pleasure President Liz such cautioned undue

Liz Barrett

today developments. everyone highlight we'll Thank day and us us for Many discuss you're last pleased earnings joining you, our our quarter recent week. thank where Lee, of and you with here spotlight today. third us you joined And we're

During progress business. and the both our third of we areas clinical quarter, made further development commercial in the

certain high made discussions access results. causing cases, progress impacts week's on teams to starts third in event. of QX development visits U.S. more and to the continued Jelmyto of FDA UGN-XXX, also Delta as team But Jelmyto quarter, the commercialization. is regions ongoing with significant last in have and detail the the execute declined, reflected at regarding regulatory patient to our in increase of pandemic our new revenue provide will rollout COVID the in on and commercial in decline, level, the Our especially which Jeff in a the the highlighted as the variant patient in face

small As strong patients QX revenue previously in a in Even quarter-over-quarter delayed included QX. in results, a reported, had patient the from enrollment given we QX bolus that versus a saw we increase QX. forms

Importantly, we highest-ever our October, months and starts momentum both patient accelerated September new forms. in two have experienced for and patient marking enrollment

our of revenue of third year strong. initial million the for we ability to shy was expectations. quarter, $XX.X the confident remain Although our the finish in achieved We

of patient be In progress addition U.S., for This driving specialty a recently Germany, making Switzerland, access into launched We division also Pharma and Jelmyto, progress an provide other step program a awareness to to Inc., provider Group, Gap solutions. a feasibility with expanded program pilot to we countries, be potential a initial the European five Tanner named countries, and is France, in a Jelmyto program European made Austria and physicians managed Jelmyto in of as UK. the to global will is access an in by will of experience commercial The Europe. which Tanner with determine internationally.

intermediate efficacy non-muscle demonstrating we risk and safety UGN-XXX the trial. in that more and Phase recurrence. study, replace are the excited This trial for UGN-XXX, of rounds appropriate for study patients for new believe intermediate study X new invasive initiating will week discussions cancer, single-arm were with low-grade Turning multinational who in cancer. invasive UGN-XXX design X a non-muscle announce is ATLAS bladder will current We Phase after at the with last bladder be new several we of to a FDA, low-grade to risk be

success, believe and increases more design We new of probability the will the also details. Mark provide

the terminate made recently AbbVie our and agreement. we collaboration updates, important decision these to to addition In

we urinary to Botox and was meet with urothelium. overactive did for As our of permeate Botox installation its bladder not intravascular last the trial year, inability effectively for combination this we X incontinence due believe in the to Phase RTGel primary of announced endpoint. And

portfolio, to As our potential property. we we RTGel to for leverage therefore most RTGel believe this evaluated with the flexibility the nothing was intellectual forward there to was the allow terminating maximum AbbVie relationship and agreement, path for compelling continue prudent

patients. Turning high With We our transform over to to oncology, leaders, and primary our to administered the our repeated one of that, and the tumors, update. provide and last UroGen unmet the extremely for this patients Mark, specialty surgical progress as for ablation non-invasive new disease. paradigm and locally need week toward goal. were in UGN-XXX able the cancer bladder lastly invasive is proud in to UGN-XXX, advancing call Mark procedures uro non-muscle watch treatments turn continue Spotlight to from as hope development away key immunotherapy from make clinical will we opportunity I'm of share to Event I'll recent to high-grade Mark? with At our treatment to opinion you hear this therapeutic notable of into goals in discuss approaches. progress well UroGen,

Mark Schoenberg

to our at Liz. you, for and UGN-XXX, UGN-XXX. Spotlight excited majority were for last we ahead my will path announce focus week's our Event to comments on clinical of trial Thank the today which change The recent design

risk and enrolling evaluate we that has design to study our a safety as a of single-arm multinational, in efficacy mentioned pivotal clinical the first have UGN-XXX events new weekly qualitative and the receive intra X begun Phase will of and streamlined same follow-up. this intermediate study and the The Xb will primary achieved OPTIMA efficacy therapy installation, we patients. month undergo primary approximately trial after similar process three vesicle the characteristics ablative substantive a patients same CR non-muscle Phase conversations UGN-XXX, for safety of endpoint endpoint with chemo of treatment with XXX trial low-grade key durability Jelmyto. will after population OPTIMA a the receive the our who at once secondary assessments initiating It similar The assessment. with in be the new As rate Patients responses bladder cancer. for months patient regimen the design have the the study be multicenter the new invasive six to the more same that which and the patients installations response will of the trial at complete in UGN-XXX of will FDA, three

longer most a The comparator addition the this study will to study. a and of new recurrence, is high we based benefits to arm of carries probability of on success, regarding duration design In design need new design the have that provide greater surgery. clarity one to that we the the no significant this believe should of time is

in of will in generated the treatment the continue believe knowledge continue we'll XX to patients first to expand the we the estimated across Phase patients these intermediate enrolled. ATLAS aim X ATLAS In risk expect stopped FDA around an enrollment we than enroll in this the follow have study, developments, and data We an in and in new low-grade to our patient UGN-XXX we disease. submission enrollment study play enroll important, mentioned, and of the less a light XXX as anticipate patients early as in And sites, XXXX. be currently to role that can from XXXX. but We treat year

is invasive low-grade study, for traditionally risk care issues the intermediate will new the at the of non-muscle kind. bladder home we in-office be UGN-XXX moving an into an patients treatment In that its at first that a elderly addition will health begun offering a evaluate setting, access to we in cancer home of what believe will of many address have patients solution home And qualified the study face. home to We UGN-XXX small administration feasibility by professional.

to to are with and aim We six enroll to patients up next months. enroll the centers, the to U.S.-based for nine and working XX study plan several

in to commonly the this a The antibody a anticipate initiating be in this the UGN-XXX, to the underway, our our Phase by candidates monoclonal able inhibition the developments establish the have addition immune UGN-XXX, of to XXXX. stage of and of UGN-XXX, anti-CTLAX study in administration range in pipeline combining currently toxicity gateway other associated X of We without with safety trial subsequent goal believe to most UGN-XXX intravesicaly, earlier progress first-half necessary anti-CTLAX RTGel. In XXX study dose delivering of serve antibody. systemic and We the around study. in IV clinical primate will as for notably toxicity we arms make is to planned with checkpoint non-human agents with Phase achieve we continue exciting X level and that for

and invasive non-muscle approaches, variety TLR-X our demonstrated as arm therapy checkpoint cancers. view in a UGN-XXX cornerstone both has combination will intravascular high-risk urologic other We bladder potential activity combine UGN-XXX, The the single of first the cancer a such fundamental inhibitor, administration, in agonist, and specialty UGN-XXX agent oncology, which patients. with of

in to call Jeff, potential the look We Jeff? provide details to over are evaluate to excited like to our progress. the that, update. And clinic with and a of forward next its sharing turn year, I'd commercial to

Jeff Bova

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

revenue was the for Our $XX.X million. third quarter

variant. the of now of parts during is engaging to restrictions August, we in July force month the with as person, field and due our country several primarily Delta tightening the a mentioned, of Liz While, physicians experienced in

quarter to hardest these was confined those hit softness regions, third the with Our by surge. COVID corresponding

the to continuing our the of in ultimate recently low-grade to August delaying with one the patient, COVID August patients. lasting administering for gives In on for XX already and XX sites on more the it an rebound, order four accounts such of these up XX respondents remain Jelmyto, to XX% in X, numbers they which and in in the September these and experience believe was us patients their activated enthusiastic mostly impact than by delays get sites the a urologists, increases X, with are the indicating of repeat and COVID on an of the sales average conducted November have November a We approximately October, of increase in XXX seen of sense and use of as to basis as months. number our X, physicians we Both of number positive a both physicians’ treatment of X XX%. Overall, UTUC, that evidenced from in-person survey the XXX areas on approximately Jelmyto, of increased or back adoption treating timing continued of meetings. of of now confidence from rebounding reps

quarter-over-quarter Notwithstanding decline we XXXX. forms. experienced mentioned, volatility in our had ended this are final the we past in experience Jelmyto start and and believe strong, September QX and Although hopeful to October largely wave, QX, COVID new revenue will of revenues and from year latest have number, will quarter the the subside, for are and as we we we we both much launch ever enrollment a a to that months patient Liz more normal trajectory for the patients were highest begin

work the what care we've our hospitals all will optimistic best and we're foundation of ensure As track to that a many reminder, and getting a leading remain by indicator We relates challenges seeing patient sites solid excited enrollment set very availability engagement, a for diligently adoption supply in patient to delivery experienced starts. we patients. the treated I and it XXXX. product physician strong and with are closely initial and as a and for forms companies future patient are to step chain, of

Lastly, over Jelmyto. made registry months, on for the progress a past initiating few we've

treated process We clinical and outcomes data be and XX collect the of to with being Jelmyto, first and captured asked participants. specific to Jelmyto’s are with treatment clinical of in enroll United benefits of Patient long-term States. practice evaluate setting will up the Jelmyto, sites important real-world to following the study patients the on its data use UTUC questions in in

have like financials. expect to in study initial that, over the Molly, the from call Molly? We to a XXXX. review to of I'd turn information this With for

Molly Henderson

of million in million year-over-year first increase XXXX. share-based Cost quarter same period ended $XX.X for of XX $XX.X quarter the revenues in margin XXXX. as margin everyone to resulting include to XX X of gross for XXXX. non-cash at to SG&A XXXX a XXXX overall in to in for due share-based spend $X.X administrative for XXXX. gross Jelmyto third of to compares third and XXXX. initiation same quarter to $X.X the nine joining the call. a to million compensation gross the third XXXX. are increase XXXX net XXXX. slightly XX $XX.X third for $XX.X Thank compared XX% compensation for $X.X XX margin period of the of in same development and million and Selling, XX% XXXX non-cash in development compared higher resulting of the XX ended driven of for same expenses related period compared XXXX. XXXX, to for Phase period XX%, administrative June commercial third $X.X compared general million product for of the Research $XX.X revenues in respectively expense expense of general of XXXX. by ended The of $XX.X margin the for September September the XXXX recorded quarter September the at launch you, quarter sales were compared aggregating ended million, approximately Selling, in million the $X.X million, expenses expense ATLAS million were period a of XXXX Cost in third compared ended and XXXX. of approximately nine months of $X.X relates to million for includes as This quarter in R&D the expenses million in of XX% XXXX. The first for to quarter to compared the thank $X.X was million period to in the Total study and million months gross in XXXX September for expenses UroGen were September a $X launch XXXX, million of of for you third Jelmyto today's were Research as Jeff, expense same comparable the end down in XXXX and

and quarter XX $X.XX This with September loss XXXX, or obligation third $X.XX of and million, RTW loss loss million expense net $X.X a of of for the the ended net million share-based net we was For $X.X XXXX respectively share quarter per Investments third XX related approximately reported XXXX prepaid reported period and financing expense. per forward compares same the $X.X for for to $XX.X ended $XX.X million the share. The million compensation XXXX. September non-cash a to includes

operating guidance for in XXXX, expense the guidance from $XXX are to million financial our to The to reduction Turning our million, our guidance operating million. $XXX previous we to currently reducing activities. associated expense million is $XXX the $XX estimated costs expense lower includes anticipated commercial share-based operating Note expense a to with this result that in compensation non-cash guidance of of quarter fourth million and clinical $XX million. $XXX

visibility year we as XXXX, near into we revenue. Additionally, have our expected full XXXX the end of

providing a we revenue in $XX million to full As to XXXX of result, the range million. $XX are be our for year estimate

XXXX. will marketable with and closed into the we current in cash quarter take us securities. million third believe We equivalents $XXX.X Lastly, cash position cash, our

call resources We in turn continue the to execute explore have to that, capital for over we our operator, to strengthen I'd ensure opportunities our sheet sufficient with to balance on strategy. With non-dilutive to like order questions.

Operator

comes the Howerton line of question first Our from Jefferies. Instructions] Chris [Operator from

Your question, please.

Chris Howerton

much questions. taking the so you for Thank Great.

two think me. for I

of respect obviously, the hopefully clear. is be the progress programs. of the providers speculate kind on can other kind to And we Curious does you growth that COVID-XX there. for Phase Jeff, you restrictions the appreciate second would the once question or may with the and going could the if R&D be headwinds. on activities ensure some the XXX will to with that First, and have continued not expect expenditures I mentioning there may was key X that commercial to of then respect were COVID-XX access to of that one factors that I

the trial? there terms the trials of or or capital either of us curious give new if other can ATLAS you. estimate, some you cost cost we per the to cost some out initial that thoughts Just relative in could the Thank of the

Liz Barrett

don't can So take the and Molly why then question, question. Jeff, first you the answer second

Jeff Bova

saw of I record as And Chris. I Yeah, October, go mentioned, months as being they in, in to mean, Thanks, August saw sell. and months and when Sure. the the coming rebound. COVID. were as by, July you patients be would kind looking September you then at summer without weren't much we're

continuing. good, strong we're September, just October, saying similar So like, are rebound, strong things

said And getting live greater first to normal. larger I you, patients back of as the positive a the told to this in we conference, things about Chicago. there amounts, say urologists lot back have got always hope to is yeah, back and I've as recent are so from in that coming group their conference Jelmyto. just also They a me

time, first for have additional Jelmyto. can board, patients board from seeing you're on either and period they're So accounts benefit that or time of coming for the finding that been on accounts

Chris Howerton

Okay. Jeff. Cool. Thanks,

Molly Henderson

before on balance. But associated Yeah, switch. cash exist point, Chris, the we which feel our a I guidance expenses, will studies, to minimize of balance cash there's two But feel get your we hard between it between working good. costs at question into consistent this with as and incremental two to and will a we've the I synergies are this any point, R&D this to I answer synergies CRO the relates comfortable XXXX, what still think the lot determine to spends so so Like is working with with us really at we're said that studies. provided we say pretty that

Liz Barrett

XXXX. Yeah. we right I'll bullish and had commercial year into the some at QX coming There QX in. not comments are a that, from things bolus a were talked patients the And we Chris, make couple just why One, play. the of rest for couple the fact more about on and

variant enrollment our are there the access, at increases we where Delta but coming pent patients and happening some we've increases, office. the demand, the all months hadn't as up the things far And to took an and what done fewer shows we I cases. thing said, doesn't in other The decreases the September of summertime, patient. a saw in into increase also in and an in then, another lockdown of we've was increase people And Jeff that sort and off that when of Jeff patient it of new as our a lot up that patient hump, over analysis coming the as was of we hope put in directly saw as summer and think vacations is we're starts us But what COVID think forms correlated also confidence as patient time mentioned, took and getting October, see hoping gives look And then those again. together the you maybe happen that into that reduction so. seen, definitely done kind I

really the said. like that's just doctor's what And they as kind bolus, that to it's flow. see of this are patient or back mentioned, a clear now, hearing physicians of normal, from as weekend, back you aren't patients normal Jeff but conference visiting you're then and we kind I the So were past seeing at office, more

patient quarter, identifying transition have in had enrollment And we enrollment And getting it's started. actually from give kind the despite actually us we less was than to the of patient an have of those every an QX patient patient increase seen indicator. patient QX forms a actually, forms. enrollment revenue, a forms So, we early revenue that fact that

continued kind in of rebound we've our patient but that quarter-over-quarter we a patient then form. increase give things seen as at us are of enrollment confidence that new couple those the looked they So starts,

million shows So be increase the that is to we're $XX QX. a to which $XX that million QX a Molly, going we know just with providing time, for first guidance, already over the significant reigns you

helps. that hopefully So

Chris Howerton

hop Thanks. does. back I it you, the appreciate it. Thank Liz, I'll Yeah, queue. in And

Operator

Thank you.

Sachs. the line Paul of next Goldman from from comes Our Choi question

Your question, please?

Paul Choi

centers? on the is patients Good of expect growth sort questions. one Or majority majority I was saw tied taking at So continue comment the qualitatively morning, these for these then activation of it on primary down could forms to Thank we coming to and you new growth the our the lay going? And sites? whether is patient just enrollment you you. of are are thanks that of commercial comment centers? Maybe should if on Jeff for -- you the to you the for can where existing wondering start new the newly additional Jeff, maybe piece. maybe activated

Jeff Bova

from I'm with to Sure. a What accurately Thanks it's things they hearing is colleagues. see for they're talk patient, of look how start to they question. go. And is, getting they out accounts for getting make Logistically, their reimbursed. combination want want typically, the XX-days hear obviously to do then one they patients, And sure both. that to they reimbursed. actively J-code, now they're start they'll what I The

of both. So it combination is a

to of And up you the a accounts. the we and in number as a of activated and a As number quickly recently. see update, that to up time again, the how patient whether a vaccine of sorts on number formulary continue accounts that grow of reported. saw and well, new And, sites all And affected things earlier have was we year, I'm running. came get we significantly last surprised that since lot not will the accounts running. latest variant, get the up That's

see treated accounts both, a for had patient probably patients from the up. little more number benefit other bit a they're to Jelmyto. You to it's combination looking to of a have and I'd activated accounts But say of go now start

Paul Choi

required for the comment look Thanks to potentially great. much the you remaining me, to our feedback maybe follow-up of regulatory regard here Molly. from then that ‘XX, first get growth for just, Thank enrolled maybe for on to with quarter just well, is to were slope for color, guess, one weeks Jeff. think with as Jelmyto what questions. the as here you for you on of Mark on very a for as the you perspective? the has Can we which ATLAS. that revenue been comment two And just next is the just how year could of taking headwinds? here. about more the for directional requirements sort fourth is you for what providing guidance regard for population? the I terms filing COVID-XX Maybe past Okay, And thanks just Molly, patients

Molly Henderson

Paul. To Hi, giving some Sure, we as on just, we color guidance ’XX, are on so spread said, ‘XX.

the determine for hard yet. working to we're is range So best what ‘XX

we So into year, of at on providing revenue, certainly as any options not on FX beginning this but the But look next at we'll for we're point, just also providing look additional the not color. the the we’re number. guidance

Mark Schoenberg

Paul, thanks.

are follow you ATLAS going to We to we're obtain patients, because we'll as imagine, that interested very the can by continue patients. in the information safety these following

So, even the followed, will the those be closed, will subsequent study information important patients in will incorporate of to filing. we be though, continue pieces a

Paul Choi

Thank much. you very

Operator

Kaplan question [Operator comes Our Instructions] line from Ladenburg you. Thank Matt of from the Thalmann. next

Your question, please.

Matt Kaplan

thanks taking question. the for Hi,

Just sense of a if given you of that terms efficacy status Mark. get ATLAS, on a you in data you the and single-arm some to that Paul’s number it, from expectation you have us you in safety study. study of the The well, are generate transition new study of terms even hope winds in of from kind data from? the question be down to of in Can as patients, can terms generate pivoted now that that you'll give the to data able your where follow-up as maybe the and

Mark Schoenberg

population this at to yet disclosed this. to But is I think going made point correctly safety. of don't Matt, this the that on was patients we of we thank provide the primary number think And be value you.

trial, fortunate even we very little we bit enrollment the of terms a of been in schedule as have the previously are terms of enrollment. ahead in in have We announced,

think of there'll safety we be So lots information. important

kind talk I think be information comment seeing we're gleaned of analyst. all the what from in it's could what of probably premature kind on to to unless efficacy this about experience wants Liz or at

Liz Barrett

I the mean, the efficacy including study. I think absolutely data, will we I data Yeah, will that from add ATLAS share

response have we So will complete rate.

decided We follow yet will we those how haven't long patients.

absolutely we well treatment have will durability, TRBT following And, both be as arm. complete the as we So arm obviously response but numbers. will the

able we to comparison, information hope gather we safety. won't we a be some as from will because able lot arm talked So, the get share and at two, be have that it. that filing, do in obviously about. But from be won't around powered again, to expect won't absolutely numbers we well, It there, to include one, the that can But our anything to we've that we point. that we

just with that our regardless And of screening. durability we doing are in as what XXXX So patients. out, as obviously actually it comparisons we'll share, number is, response share ability complete it And have patients the a still some rate. share patients of as more we to be we'll won't the plays around in because these

no even blind. have those we'll that study, have study patients share So, and once quite be are keep now longer patients where in XXXX patients, a so we We'll be a able through, robust, some it data to to it's from right. be make sure it we'll will few the ATLAS because obviously

And new as enrolled a be XXXX so study. that to in share we'll we able

we So information helps, share have hopefully start to and to all share. that the that share but will that as as of will we we can data robust quickly

Matt Kaplan

planned then X to from a that? ranging sense dose in have Phase see you expect critical Okay. the that you first-half going data What's and on and the study great. That And some question safety a of of in for start year. and UGN-XXX terms to sounds your how initial just progress, that's the when

Liz Barrett

also with we we multi-armed to, shift is then combination the with shift and to TLR-X, to with idea talked our expect to then before, other unmanned as first combinations. a So study to the CTLAX, And UGN-XXX. to the go about

combination lot for disease. therapy a there's that backbone So we've high-grade got the planned XXX using as and of

to that for least the share don't purpose I able one, of at But, efficacy end think Phase so and that X be by at be is share. the to, then we ‘XX, look to And some you but combination. efficacy, safety, initial have, the there'll to the optimal we'll obviously, ensure of potentially data the Phase X appropriate move

So in that, data least as at we'll the well. some XXXX, the on share initial able to be CTLAX of

Matt Kaplan

Great. Thanks, Liz.

Operator

you. Thank

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

please. question, Your

Leland Gershell

for Good morning. taking Thanks my question.

eventually want from other for Just supporting the the included on be have see X and ATLAS In registration we in of any submission efficacy clarify, part so purposes? the that the new will that data will as of terms rely Phase not to trial. can presumably entirely words, the will role FDA

to want Mark. you. clarify that Just Thank

Liz Barrett

Absolutely. correct. correct. That's That's

Leland Gershell

from thing might before, And we in sometime see the is cuts that same there as Could the when ‘XX? be but expectation any Great. initial ATLAS?

Liz Barrett

be month all rate, at because share three through able have mark. we'll patients absolutely the we'll the Yes, to least CR of

data So we'll complete in be able XXXX. to at response least share

Leland Gershell

taking terrific. Thanks questions. All for the right,

Liz Barrett

you. Thank

Operator

Thank Liz does question-and-answer program conclude session of you. I'd any Ladies for Barrett, the and now program. remarks. gentlemen, hand further like to the to back today's this

Liz Barrett

Lee the share study the well. very see the on ATLAS for having agreement launch And, in on and us, Thanks, to logistics. and one We're very bullish momentum potential can you've going our excited standpoint, see not talk first continue continue the with that, of that we gain working combination only heard data behind then we the momentum, the of UroGen. but XXXX, I to XXXX. of where rest FDA, data closely you. the into to then pandemic to with the for be continued UGN-XXX, thanks the in able FDA feedback and man Thank of that, get hope positive headed about hump. what work as from XXXX commercial with as study great for questions. the We're the XXXX, to remainder we the being hopefully you arm able through the with we And XXX, generate over getting see as and everybody and simplification we're that a

a progress So, as and development a both clinical from make standpoint. we standpoint continue commercial us, also from an exciting time to for

time. all Take support Bye. to guys and So soon. of you appreciate we'll And talk Thanks. your care.

Operator

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

You may now disconnect. Good day.

UroGen Pharma (URGN) 15 Nov 212021 Q3 Earnings call transcript