UroGen Pharma (URGN) 7 Aug 212021 Q2 Earnings call transcript

Company Profile

Participants

Sara Sherman	Head of Investor Relations
Liz Barrett	President and CEO
Jeff Bova	Chief Commercial Officer
Mark Schoenberg	Chief Medical Officer
Molly Henderson	CFO
Leland Gershell	Oppenheimer
Chris Howerton	Jefferies
Ram Selvaraju	H.C. Wainwright
Matt Kaplan	Ladenburg Thalmann
Paul Choi	Goldman Sachs

Call transcript

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Operator

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

Sara Sherman

Thank you, Operator, and welcome everyone to UroGen Pharma's second quarter 2021 financial results and business update conference call. issued corporate release for highlights ended XX, we of an the morning, June recent our and XXXX. this a providing press overview quarter Earlier financial results of accessed the be investors.urogen.com. can release site at press Investors The portion our Web on

from call Commercial note conduct Joining Chief Henderson, Barrett, and President Jeff Dr. Chief locations, and that Molly Mark to Schoenberg, different Financial are and me today calls have appreciate Liz Please Executive we we Chief continue your our should on understanding Officer; Officer; any Officer. the Officer; difficulties. Bova, so technical Chief Medical patience we

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

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

Liz Barrett

and all to options, is treated Thank corporate better uro-oncology development. recent and joining fundamentally you, we provide us patients change and on thank deserve our progress for in an way At Sara, steadfast you today update today. our the as we believe we're UroGen, approach

priorities adoption platform. Jelmyto, reverse-thermal remains second-half from hydrogel the of technology increased the into a one of therapy XXXX, our move we key novel of As first approved the

first-half UGN-XXX, well Jelmyto sales broader of recorded Jelmyto into XXXX. disease for quarter with As other of in provides with platform $XX the as we the disease proof We as $XX.X and million July, expansion second we million this believe high-grade both success types. and net for low-grade announced early product in of XXXX, concept for our in the tumor

patients. changing where cancers the we on to recent been We our invasive repetitive to area for years. way a surgeries well-defined patients are no which a It's and/or treated, from an as of are Jelmyto critical have including associated opportunity urothelial negative alternatives to general first see for focused make significant advances have And in have impact there positive the use anesthesia. outcomes morbidity,

novel cancer, risk technology there being UGN-XXX, expand Our product options. a enabled second bladder non-surgical candidate, with is has uro-oncology primary non-muscle patient and which invasive large population Jelmyto intermediate treatment low-grade in to investigational us no where deliver our studies are

we approaches, the Our but around to the develop world. we pleased enables study, therapeutic novel UGN-XXX Mark about us a Phase to provide from the progress X RTGel their and ATLAS more and interest detailed enthusiastic these potential. on update platform are with date will are centers

regulatory approval our coming reimbursement on expansion pathways, we two While done pivotal in believe we a have Europe. on expanding look Israel as in The patients regulatory of collaboration, role for regions in Neopharm, supply strategy and Based possible. more UroGen providing was to to possibility have our Israel. founded and priority as look and to license a months. ex-U.S. forward the plan other to are the also having for we focus detail Japan in first and commercialization work forward treatment Jelmyto's innovative near-term and on access agreement, quickly the key made Jelmyto Israel, pursue this have we for our today, a expand presence. which and our we geographic commitment We they announced trial. involves our with in played pipeline, in We to Jelmyto progress

And standard of by the doing $X of our as products remains goal end for strong two by assuming low-grade way are our regulatory foundation of revenues approval of We over billion two patients UGN-XXX, communicated, with a these have we to care, establish these the our set XXXX. disease lead believe As company. changing so, deliver goal medicines first peak to is treated. our

Given the of and is a total and million believe UTUC size non-muscle risk is over leader market UroGen $XXX we over this invasive $X as uro-oncology. goal low-grade bladder cancer in low-grade attainable, intermediate billion, positions

well to as these programs. Mark UGN-XXX, talk expand early-stage collaboration. Beyond And internally both and and we progress will continue more with Jelmyto our about pipeline, academic as

for technologies seeking that, treatment, the for We opportunities turn will are adequate innovation update. which And available. Jeff our where are patients. I'd actively commercial like make to expand no to areas call with over as can difference we to new share medicines and provide and there And to Jeff? in innovative updates with a portfolio a

Jeff Bova

our you, on update pleased Thank I'm provide Liz. launch with to commercial an Jelmyto. you of

closed physician impacts we respect to physicians. the XX% to to access the may have pandemic some patients. level been Jelmyto, of XX% of sense potential business, to do the in-person we offices with During a second monitor a interaction. and And quarter, commercialization with return saw able the physicians, further as remain benefit normalcy and the evolving from and representatives to Challenges higher COVID on to have situation, the of

physicians, be education meet medical virtual, is will and conference opportunity meeting and allow Association, the year. Jelmyto. XXth, held in-person hybrid, look urology the AUA in American and the including forward major Vegas, at presence to through we urology which space. September largest AUA, conferences, this on As in to from will key we Las the fall having provide will the XXth It conference enter or Urological a the season, a with UroGen be

builder, of technology and We'll from paradigm in and a and moving to transforming leverage drug Since with the booth, first including an enthusiasm to theater, to is how patients has innovative will growing demonstrations possible. sites patient as product Murray virtual the number interactive We its the increase to in-person patients, treating each on a we've both therapy treated have of been UTUC, Dr. how able chemoablation response physician have treatments focused in the site. launch, surgical hydrogel number of Katie well on our been Jelmyto low-grade away pervious the kind. makes positive, as treatment Jelmyto

the active We continue, expect we field alongside sites as number this engagement. growth of expand total to

As processes are of completed them patients August the as have X, either we have to XXX treated up increased of that the to treat to number XXX, These patients. sites have of allow or May all internal required from X. activated of sites

are of of benefit the components smoothly. increased For as and up the that all to May that reimbursement clinical therapy from repeat have X, is of running XX This suggests seeing the patients, efficacy number the and process accounts, are repeat we as XX, physicians accounts August to of of working, X.

hear accurate identifying our believe and are Jelmyto seamless Medicare across physicians critical patients, reimbursement do more number are education the as consistently timely in more from of office is We additional as from drug and orphan focus disease. and and strong physician this and vaccinations ensure practices, and critical, integration and commercial the who first impact the that And patients therapy. to receiving received therapy, in that quarter. and seeking the treated UroGen's physicians support in quarter, given then We for the lives. there administration are that remains watch quarter, returning their comfort with were gaining staff some the the who to engagement to that from their we're on Reflecting nurse educators of also we that second our to well the covered using In-person for And continuum physicians was patients an wait decided is their treatment and the our along field practices treatment. this team. of important pleased nature

see importance of of depth to the year, As the in account. the we we look second-half each

on peers Mark? to and the physicians our clinical expanding utilizing and Mark our patients focus the increase will the to updates. I'll physicians over of current treatment in our turn have therapy. We number recent that, experience with to discuss the positive With leveraging call accounts, our

Mark Schoenberg

Starting clinical paving Jelmyto, the do way programs Jeff. Thank in I'll with now have our are we we you, upon something made non-clinical the touch this and on uro-oncology. quarter. different progress to

and and a generating committed to to support and on understand appropriate better is the are start are As to working and in most And think for clinicians Jelmyto data the nephrostomy in Jelmyto we registry, practice. success. also through incumbent optimal to ways manner lifecycle physicians utilizing patient us to with of optimize are to via we clinical treatments explore ensure We administering stakeholders. patients our management, it tube use plan key the

We later community the data in year. see tube from use expect this to nephrostomy starting

trial ATLAS TURBT And for UGN-XXX Liz the non-muscle mentioned, the clinical actively invasive compared enrolling in ongoing patients to our of is program TURBT, leading treatment or risk plus intermediate low-grade cancer. UGN-XXX, As are we bladder late-stage minus alone. studying

relied II later Phase trial. to We We additional two X we seeing important Europe, trial enrollment a trial, surgery. the ATLAS significant a of an event-driven patient demand inform as this in Israel, study the care there anticipate Xb take in on Phase approximately study, years the talked current and targeting help at are assumptions activated providing design potentially data where population, a that in sites forward complete, about meeting results design expect of momentum we journal. nearly the the and will final is We've is an look And for approval very is publishing and to OPTIMA year. is XXXX. presenting the standard we to with one year, up. medical how for an end by kicking to repeated the updates for II this XXX this as the This the well it enroll, As year U.S., and OPTIMA and peer-reviewed our

preference options cancer In non-muscle natural in to of OPTIMA work population. including treated a non-muscle bladder of cancer, bladder and non-surgical history the to special variety invasive sponsored in have of the addition on a publication, research for areas HMO our patient invasive relevance we U.S. programs, II in

the goal to the feasibility academia in study XX-patient have year. study, expect healthcare meeting colleagues and a financial the we to rates the home to the the by We examine UGN-XXX demonstrate from later with professional this track small and setting. also administered installation can medical these a a be presented complication with at data current our be for studies in of to second-half be on with in we associated impacts standards NMIBC will The In that care trial in ATLAS medical safely worked parallel home our U.S., to begin are year. this trial, of

combination and inhibitor, approximately five antibody, and this CTLA-X centers are enroll UGN-XXX, immuno-uro-oncology and a to with made We as we foundational June, UGN-XXX with we've see other touch path U.S. patients monotherapy UGN-XXX UGN-XXX which We intend non-human and as pipeline, study agonist. we progress early combination for cancer. like in move this our combination UGN-XXX, on in refer toxicity TLR studying UGN-XXX, in the is our initially in towards UGN-XXX, submitting to as as the in combination our therapy, We agents. a the stage In checkpoint expect to upon this asset. as a primate non-muscle well high-grade bladder an started with invasive study of for as at agent and UGN-XXX, I'd including namely critical X IND

to toxicity in submit of the And expect the an by the end XXXX. of toxicity UNG-XXX have We first-half acceptable an for IND assuming of the the study results we'll profile, year.

UGN-XXX our track understanding between assess We a with are are actively progress this study activity the the of MD humans year, working later further start UGN-XXX, in on in the synergy with to UGN-XXX to immune-modulatory to and bladder. Anderson and

treatment therapy. additional how Last XXXX data announced checkpoint of see administration throughout be with Johns to and a University, agreement quarter, non-clinical the combination glioblastoma. inhibition in from to useful the both understand expect Hopkins may sponsored We we aiming research local monotherapy of

with work tumor possibility expand are Johns other the molecules exploring to and to really types. other and Hopkins, continue We to

over solid to to working, I'd our both turn with is Our discuss tumors. to with own pipeline that, in our team Molly, in other the who other also financials. explore will centers like And actively labs, call academic and

Molly Henderson

everyone Thank thank for Mark. joining call. today's you you, to And

$XX.X As mentioned gross XXXX margin Cost million we recorded XXXX approximately for by $X.X XX.X%. Liz a of the in net of first-half million, quarter product and second million, the revenues and sales for for of XXXX. resulting approximately were of Jelmyto quarter the second Jeff, of $XX

recognized we mentioned the previous to expense. on we've calls inventory Jelmyto, of FDA the periods with in Jelmyto research receiving As as manufacture for and cost related and development approval associated

to We inventories expect impact FDA of receiving this we expense to of second through deplete as that continue had to XXXX, prior cost we approval. quarter revenues the

to of selling, period quarter As primarily million quarter, June were approval. were annual had the XXXX. to the XXXX, expense. expense a for in $X.X million if in and the versus expense XXXX. Research million, administrative sold million, included expense prior have ended quarter, general, resulted in XXXX. and Research expense expense compensation launch in as the result, development ended our as administrative and gross UGN-XXX, units XX, of share-based second been the a XX, for approximately June the general, ended brand $XX.X over as million million initiation non-cash increase June to overall the XX, margin includes compensation period development in study the in in the June ended not ATLAS Jelmyto for X for period $XX compared preparation to for we as second compensation same XX.X% same for same general, the $X.X for XXXX. higher at of $X expenses Phase from for period non-cash expenses second XXXX. and XXXX would quarter the decrease share-based share-based to expenses expense compared as three-month and Selling, XXXX, well the The second XX, XX.X% Jelmyto, end quarter in in compared $XX.X Selling, R&D in June the XXXX, decrease million XX, second our million XXXX, administrative of of in The ended XXXX, in marketing relates same for also $X compared the to the $X.X regulatory

we For XXXX, the obligation financing forward expense reported second of the prepaid RTW Investments ended June related million. $X.X XX, quarter to to

Accounting Jelmyto reported to income sales accrue payments which operating May RTW to XXXX approximately Cash As financing in line. Principles, related equal million or closing. X.X% previously the reported, will and expect to in we recognized accordance is million to $XX subsequent in the net Accepted $XX with Generally expense U.S. XXXX below non-operating loss transaction, of the

per loss For XX, quarter, ended The June of share the for loss in approximately $XX.X XX, ended non-cash This to same $XX.X we XXXX. loss share-based or compensation $X.XX compares net share. in for $X quarter $X.XX the million June period per million or second the a reported XXXX, a XXXX, net includes of million expense. second

the compared the XXXX, This net six was in loss driven million, operating the of to for million over $XXX,XXX by the our $XX.X as year. period Jelmyto slightly, in expense million, period first operating to the prior million of $XX.X year. compared as $XX.X in as improvement was revenue For months decreased $XX.X to same prior compared in prior year. $XX.X the million, loss Total to

$XX share-based market million unchanged, $XX $XXX in of Our and operating includes expense XXXX guidance expense compensation to is range million. $XXX remains for of estimated non-cash the to subject million This million, to conditions.

which funding plan in we Lastly, operations cash, marketable $XXX.X current from $XX fund closed on million and position, in we with the and RTW, in million the year, Based May. quarter have second which our cash in includes announced This capital XXXX. we into operating closed cash believe to will securities. and sufficient we the equivalents, early

As Mark to a our company, always evaluating are biotech we the use indicated, platform expand and opportunities technology. as of

the turn we like operator, our will such, cash we that, are questions. I would needs to for With call to to our in As future. evaluate investing ensure continue over

Operator

line Leland [Operator Our comes question Certainly. the Oppenheimer. Instructions] of first from from Gershell

Your please. question,

Leland Gershell

congratulations Hi, Jelmyto. the taking question you nice questions, my commercial good performance. Couple first Thank morning. for and on on

feedback in again. Jelmyto location tumors, of in Thank using at terms getting what's on a more and the I And to those you're if Jelmyto with the Then seeing may of centers kind wanted types degree increased see respect physicians of interest their using patients they of pathology increasing sort color Maybe centers. in of an so forth? follow-up. you're that of and kinds from at could you rates mentioned which number be You'd of share have to repeat you. the of

Liz Barrett

don't follow-up. And, Leland's comments with take Leland. Jeff, why have once and let's if thanks, do you done, is then that? Hi, any Jeff Mark, additional you

So, Jeff?

Jeff Bova

thanks. Sure,

of of it's far so And more one things. treating are number the patient, couple a that than accounts

did practice, obviously we expand peer-to-peer their a they're said sharing hear that obviously Clinically, motivated that peers influence patient. are You've from and that on perspective, positives the so account. what in how got that colleagues. within it depths we ask will go certain and go their with as in a physicians are earlier, representatives to field Obviously, really

reps, doing talking representatives patients. the accounts That's job multiple number of the and why really we've seen depth in a to So treating expanding increase good between an the physicians. the physicians

a have in XX, accounts, still given to the of XX, within lot XX-plus There's some We given these are continue we'll do so account, that. continue accounts of potential that. to urologists

going because it's As treated, indication. so far newly as pool, expected that of their them expected of treated, newly coming patients XX-XX, We've treated, that recurrent I and more have we half it'll I'm been hearing have the maybe diagnosed. that coming resection -- is the the challenging. or to diagnosed has more at it diagnosed, as I launch, been half seeing more evolve been many say have from into be patients I'll from the newly probably had to pool, recurrent across get recurrent And -- the at

Leland Gershell

that's you, -- a Got you. Thank

Jeff Bova

Go ahead.

Leland Gershell

Thanks. platform? if Thank much a very MD of of academic-type terms in maybe should collaborations sense you with you potential potential the forward for obviously, just additional as us materialize the then could further go Hopkins you, collaborations, that's And a helpful. these how of and Johns then Anderson, give RTGel in see question application we Mark, glioblastoma,

Mark Schoenberg

we heard from other of great can using we of deliver a for Leland. of Molly, in A opportunities And we're body. molecules Liz very lot of are within that interested the different types a think exploring and question, venues the different I gel platform. Thanks, types lot for know and you've the from as

you expect to on is very to actively pursuing the further, think the more And Liz is this. that think I but So, would horizon. I more see comment want answer may time. We're in there

Liz Barrett

Yes, in using my only interest academic and We do comment different is lot is centers a with of it. them in and that correct. see

in months. get works we We've on the in the time we absolutely that interest any next about absolutely can -- few so, we them. And follow-up inbound got couple talk a hopefully now we right an

In addition gone believe to to And whether then to is those -- other we look to we say will that, about as companies. we continuously haven't proactively well. actively think And out pursue opportunity. there we we'll

So, technology believe unique usage we have that our continue definitely, opportunity the in to of we an to RTGel. the very very, expand

So, Leland. thanks.

Leland Gershell

very Thanks in Great. the hop much. I'll back queue.

Liz Barrett

Great.

Operator

Thank you.

from of from Howerton question next line Chris Our comes the Jefferies.

Your question, please.

Chris Howerton

morning, and taking the questions. thanks Good for Fantastic.

guess, that ask what I I be locations, going surgical that physicians you to opposed instill different additional some their the an status to current of wanted utilization as just think the that could center. there Jelmyto types, to Jelmyto seeing to First, is offices trends of discussion equipment center I in was Jeff, of in of were ambulatory augment able their with to

I'm you kind then there second of trends that what question features just kind types terms had that So, frankly, just centers? the the were I the And seeing guess of you're the touching in basis if for with -- of curious AUA with may, found intrigued most variables had is, just any that different I you Mark. the I UTUC. mention was of mention at the I interactive heading then important of was so third see physicians was the patient builder or had for And you. And from still I been clinical question or experience. had into AUA intriguing any you of or there Thank or educational at hear presence the is most that presentations kind that I if didn't important to time, pre-clinical either wanted describing? the any to this of just that

Liz Barrett

specifics, can share you with why lot can happening AUA. and don't have share first you Jeff, We definitely but two, what a around the able he So, at Mark AUA. won't definitely to be we take

Jeff? So,

Jeff Bova

[indiscernible] it physicians the tube hospital, ASE, center, you trends Chris. to Yes, an is, either can some that results or so or they of via they seeing the outpatient give as a Thanks, the arrangements in they you clinic nephrostomy give we're this as into make in clinic. bring surgery a -- know, Sure. said,

most more is I'm we're hospital. still What expected, have trend seeing in our place get As in a the we diagnosis settings. of starting taking good to administrations that the community in

So, that's out. to starting balance

you're surgery see You're starting strong their a more a may see to have setting, administrations own affiliation diagnosis starting which with. community or in the center, they in they to

the see. lot that center the to starting via they some that or we've and are it trends whether to of We in around But the a in administer it they you're do and administration community administrations portion we and if is so registry. in lot uptake start of we a clinic, both do are think it's when I it, entirely, the small fine to in It's Obviously, community. to still of data get surgery to as the collect their it, the hoping seen, go and And them. to it's questions those very nephrostomy a tube, obviously, up of hospital growing. but diagnosed see And expected an the diagnosis well. I that's

that your So, first. was

yes, The excited second, The this has patient builder to this. we're designed I to is right the capture, as indication. so for entire builder; now. patient Leland, was field talking the The actually

recurrent, So, it the tumors, of the it then of newly representative tells that's is us And does, OLYMPUS. able extrapolates whether what a to number that's data patient, tumors. diagnosed, build in whether size a what out

we that every to it entire the considered. talk allows to Jelmyto field every see the one to sure is indication to X,XXX make really those so, that of X,XXX year, And patients

excited patient now. builder expand that a reps But live We're we'll that. AUA. the upon right yes, for So, have

Mark Schoenberg

up unfortunately, And year. the research lifted. roles formally for asking related been the organization bunch to to, has as during AUA. has about this have be will a things The the meeting for not coming presentation specific embargo embargo But, at meeting. accepted we thanks Liz Chris, very the of about that presented alluded

to although of I transparent to couple that we hopefully busy, will expect lifted So, all the and this point of research. stuff have And about talk about very be at lot we going tell specific that it point can at you days, we're present. exciting is be can't to we yet, be more next the we'll that in able and embargo be the a

Chris Howerton

Okay, very clear. Well, hop Thank taking queue. in that's I'll questions. all you right. much very And back the for the

Liz Barrett

Right, thanks, Chris.

Operator

you. Thank

of Wainwright. question next Ram the comes Our from Selvaraju from line H.C.

Your please. question,

Ram Selvaraju

Yes.

if some So, and you some perspectives what be capabilities could, region? background might the the first Israeli in relationship of all, on regarding us maybe local give Neopharm's Neopharm, and with market that

Liz Barrett

companies Sure. Israel. Hi, but to one and Ram. They are say want partners many the top, distributors, commercial for of I in

So, the capability, our they already nicely interest very already I -- the commercial Israel But from you like has in we arm. considered lot very of ourselves. they're companies fit there into mean have We can actually we, multiple imagine, they felt work as doing. a we also was the And infrastructure. be Neopharm do to have it a it do what

of we've we and were very to we what part big right, financial very as Neopharm, with the for I because they've made company, Israel. we all sense for it's do and -- a companies, are Neopharm, And rose of started prideful a all a of different an huge work really partnership. it's the the a a let's market, realistic at standpoint, looked, it with. their But look, from capability a said, them that. worked we've to been -- done. great They to both And capability. of felt it's we Israel. So, most not And top the closely like options, like, us, in about But Israeli right,

about very So, partners, frankly, of we'll good that decision. And looking we type expand similar globally. for we feel be as

does You can -- Neopharm that it not going that we're capability. want that bring extra believe we that in if do to added partners And Israel. that ourselves, that

Ram Selvaraju

partners Neopharm interest would seek Has update territories? those Neopharm for progressing? expressed Israel, if in so, us an from to discussions distinct give countries of how you the on And any product outside -- need commercializing the in or are

Liz Barrett

were thoughtful They that for countries, the about very top to And partners partners want what geographies, both about but right. also partners who also make we the really it's we have partner before, do, we as potential the think other have talked which we I geographies. effort, worldwide. to sure are one we important sure Sure. in but interested We with want many be our so in think the dilutes internal we that don't is in a make partner resources, those to to have bigger us

more world, again, we I thoughtful. be say partners So, different in just, that in inbound interest even little we interest. not the but But every had had though we we have much a started, have we've And would inbound world regions. to pretty XX be don't region bit have the around XX careful want different in different regions

have forward started the actually make and plan regions. to us we that those Europe? in to we've have really understand close the conversations expressed to proactive And And let interest. where does time some reimbursement take on have is it let having will feel approval place. approval companies contacts get laid does and a then also and knowledge at we what those get develop, what with we to like set companies What in out, in it take And in with focused been So, we've full us the we Japan? then are path very reimbursement

that both Europe Japan, China; partner a just I'll potentially ex-U.S. Israel, are and and so one and of at outside company looking say we So, obviously. has

that And to at then we would have sure potentially it's it we on. what maybe our conversations, markets. Europe, and negotiate kind those doesn't make that's will Japan, will for exactly be because just know a that our partners China, shareholders our in focused those take. preliminary while ideal, you look up obviously with So, until We deal probably very take markets. and is to that what I China again, that be If successful we it think, we'll But in some been And of for had lot finishing what ways. partner we've successful in unique. exactly work company are a would out, of can't and the want best

-- we've experts lot company this experience have I, in in a run area. engaged have had that in obviously, of we've areas. other the So businesses; people have global we

Officer for relationships. Our several years, Business personal lived so China she in Chief has

the have really conversations, the we've start and sure possible. So, we're we make putting when the in we to knowledge that leveraged best that that ourselves have situation do know-how those to

see decent in get to would it's updated start the an a think that study. the forward efficacy. is will path said there. you say, what like always about do this a in compared patients; we months the want and able we And possibilities Japan; an looks we more give getting to have take. those on They over So, we medicine generic have can what understanding reimbursement, than was But are know Europe, reimbursement of going two bridging be to safety being and mitomycin their a of us there. it to the not And to exactly fall. I've that like, before, what a we'll next, I it think that I

start of more understanding it takes, So, now those we an have feel of we'll that we what exactly like conversations.

long-winded to answer that Ram. a So, question, your was sorry,

Ram Selvaraju

of evidence that, in interested the could So, a actually any not potential all see be before but do to would reimbursement commercialization think regulatory follow-on Jelmyto partnerships getting with stone? that, just want to in is be partners that are also before the consummated set within context involved? Or completed Europe, of that you potential seeing assist approval, only they discussions you as to of specifically

Liz Barrett

payers. the Well, what two with months of last those we've having the over some actually is conversations doing been

that experts we some with. we've been So, working have

So our felt like we understand, wanted decision right. that that to was we

the of who the have perspective Europe, said somebody is on they one need, they would that their In get can have And some look a number capability So, government. you like. in probably you good market with can they negotiate the that there, partners what want access, capability. that's has deal

discussions. to we'll able position we'll that where a in But -- knowledge those I we that be we're have capability. So, looking enough enough for think now that information, be start

Ram Selvaraju

something given restrictions quickly, placed the recruiting evidence you the clinical face-to-face if either are of new or on activity activity, very promotional just are that variant, rise then site the Delta seeing And any and/or continued restrictions both further trial Or that confident you Jelmyto think Okay. the in this manage fronts? in way? is ATLAS if of affected, be you that and can that rollout do would through you those on feel what enrollment so, of

Liz Barrett

I Well, open changing change to I COVID. down but couple Jeff that said impact. where family the things it would there access just that personal no system experience comment, -- they're with shutting going if get of get I mean own now because we've last maybe the couldn't bed my a of daily. access. couldn't I think be a would accounts I seen are hospital had were weeks, a remiss can healthcare even have member

And so, to don't say have I that it any won't impact, that, know right.

We are we access. see do -- to restrictions, good continue see we We see right. - still

it's so week-by-week a we And day-by-day, - thing.

we of different lot get a because areas like, XXX can of to the heard, feel we the concerned do And you have around world, is got one which is ATLAS we as we've we versus actually we have wanted and pivot in and that others, if actually sites running need patients that, the as more sites reasons up sites. and activated. to that more far one area As that

think, that shut business, I at standpoint. ATLAS in if position, will I Delta sense. the think an So, us that help don't this point, from our that COVID, to or would down variant be makes

going a we're we're in position successful. to be be think where continue not to to don't I So, able

ramp, in going some to going think personally physician able that do nephrostomy think excited be you patients now, are think administration, to surgeries sure patients of especially an that aren't administration. more to vaccinated we increase we'll And those So, and in then down the are and -- support be elective have I able be about shut things to procedures, are make to position been to. may that if route more it might that a offices, hospitals tube. going that am are able elective Jeff I need see don't still to - impact to tube. comfortable to And continue out or impact do very about it's but nephrostomy I comfortable And the the talked there.

Ram Selvaraju

a non-human missed actually timeline that. the provide Okay, with sorry, and did I'm for you if of lastly, UGN-XXX? I then completion study primate

Liz Barrett

you anything do Mark, I okay. we comment that's to don't if said want just time? that? on No, remember bout

Mark Schoenberg

We're at We're actually data moving year. haven't. the we expecting along. Yes, the end of

So, that end decide we'll I suspect of the to that talk about the after year.

guess -- [multiple what the that's speakers]. I probably So,

Liz Barrett

Yes, [multiple speakers] year, next yes.

Ram Selvaraju

Great, thank you.

Liz Barrett

Ram. Thanks,

Operator

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

Your question, please.

Matt Kaplan

quarter. on Congrats guys. the Hey, good

prior to Just another dynamics up the momentum the digging you have, I to with little with more saw use And How out able more out terms going and guess, guess further bit you impact we're now terms of third I range? changing that wanted been in also the of study third Mark. only that and of the versus Jelmyto the new in tube of been here think, not second of second forward, this, the of maintain respect nephrostomy then variant? after but maybe given context follow to a the for question have question quarter data, in sales do to Delta the quarter, kind shaping in and the how quarter the starts And quarter? you pandemic, will uptake in

Liz Barrett

not month-over-month to really around patients. we or come I say Yes, Matt, Liz. enrollment We're would patient data forms providing in. continue month-to-month see

new to dosed. see continue We patients being

talked about. growth see Jeff that to numbers the continue we in So,

months, that expect few the we we and over see to adoption So, increase continue beyond. will next

Jeff, answer representatives the to just the helpful and that. going, able study. for physicians the over that maybe very reps, you Mark we would and around seeing are things and think what comment in But to field do? be remain I on So, can the and to they're turn on around bullish the how what it about out you're question

So, Jeff?

Jeff Bova

so It's deeper you accounts to where are see growth, thanks. into and to Yes, continue will reps going exactly that. see what continue said,

now that. live excited have indication, to to said to expand a the full I timing well, finish as first good as it'll strong tool year the help be meeting. got even to so, earlier, And they've And I AUA; think

Mark? So,

Mark Schoenberg

through Yes. of many of it a a the meaning that is done think, asking is because And, the the is in answering placed a the through the acceptable The a need drug you're launch, kidney. skin was interesting sure tract the kidney And urinary I'm pivotal I there's perspective. then as from The very tube the question. also about. through a placing placed an just instrumentation the nephrostomy study without no back Matt, byproduct -- [indiscernible], for tube the practitioner into deliver make the urethra know, issue, kidney, lower in what catheter was to nephrostomy entirely the is directly tube started into instilled direct into retrograde it's into the manner, practitioners Jelmyto. to right hearing the and that have order the provides delivering both which, which from for a patient we're And drug, what anecdotally and method access bladder,

encumbrance I think be would that an was as viewed an the initial worry inconvenience. tube patients and nephrostomy there by

exposing the patient into well into home. practitioner port, office, both office it out, workflow. pulling the effectively, goes tolerated, significantly a coming the their the the tube and patient simplifies shirt, access the instills and up the the actually kidney; turns convenient, it As is drug, very Imagine

tubes. investigators papers field about So, And that of there from in acceptance we excited a now advantages, to the year well we're this. lot presentations there as a a some and perspective both know actually the coming in are as hearing, patient workflow anecdotally that see are We are this. studying using nephrostomy

mode workflow patient I because said, a significant anecdotally it as we're that in-office advantages be of delivery, if like terms So will of, again, a what acceptability. has continues, there hearing as in uptake lot of this of that both well

Matt Kaplan

I for added having. one at footprint helpful. And question, change detail. this that's success very your Thanks been last that given the to guess, point? you've commercial plans Okay, Any the

Liz Barrett

nurse No, We to support at one the not adding things may, clinical couple the we really. that we very want is the helpful sure success of offices. a of provided been -- the and that's make that physician we're that educators, because we

first the the should footprint nurse clinical be need So, who time to they a stay couple or other installation, than same. do the educators of the second there

Matt Kaplan

for very taking the Thanks Okay, questions. good.

Liz Barrett

Thank you, Matt.

Operator

Thank you.

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

question, please. Your

Paul Choi

Good congrats, Hi, thank and on Liz you. the and morning, strong everyone, quarter. team,

reflective next from wave of by here? couple Jeff beginning you tiering and this of this on more of setting, starting elaborate community just a us, target community in penetration team Just more with the early a the little comments is practitioners more could of their and trialing if maybe account just your maybe or sort sort is

Liz Barrett

Jeff?

Jeff Bova

Yes.

next the So, wave. I it's would say

bring I surgery revenue back the they're think looking revenue. see to bring push a back been community; big to starting in you're There's obviously to center.

they starting I've level just this see like having comfort. And there's to the as well, you permanent more like -- know, so, J and you're code, said as a of -- the little Code, they don't and

center." continue into be And that to grow of going so start gate, grow the the their I'm this diagnose we're in in now community. we'll hospital, my So And are continue the hospital as to on surgery "Okay, the going of hospital. point, community to the going expected, your -- and the grow, in saying, the to this we those see to to doctors that going to community do we diagnosing in in -- more were and to to out you're -- but and

Paul Choi

sponsored, pipeline just the one on you would [Ph] on Okay, you [commoditorial] or thanks this analogues market, mentioned would -- be solid an be additional for excuse primarily you Have comment of would your as the Then go? that completed me? company regard based earlier additional And it primate this then a that for -- sort or to see the tumor us, company side a combination you year-end on you the pursue would I types. development But where that identified; non-human I trials -- investigator-sponsored these for guess, question, in so. with as that directionally asset at to either work know color. directed around XXX, point,

Liz Barrett

Yes, great question.

we are to just right. that look both, would I areas. it I think And see starting think be to other

other we with in We other we studied, assets may to would are good the seeing have when might being investigators opportunity it think, certain ways, do marketplace a see do out companies. we where that. that also, wow, us And in potentially used then are some a that for and we that "Oh partnerships interested we combination," be do in

the at just this in feedback specific anything yet; different we well is don't is known. Anti-CTLA-X I work we to XXX. we're known far So, started efficacy areas. with the is think it as so -- getting looking continuum and with the well we're have of But that

and an our So, advantages, locally, both efficacy we has from believe, it standpoint. safety ability deliver to

And a lot so, there's if we're combination, think in able to there. of opportunity that do we

Paul Choi

queue. Okay, much, back in very hop thank you I'll Liz.

Liz Barrett

Thanks. Great, thank you.

Operator

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

Liz Barrett

thank joining everybody Great, you, operator, to for today. and thanks us

promise these and As to we we patients do, to provide have, deliver both look pipeline poised year as we we're continue efforts forward innovation. We'll commercial we our our technology continue really the the of our our the really to little where in always has novel advance therapies priorities. to efforts, updates, to been there remainder proprietary bring leverage on as areas

to we it, come the as patients do get our and eye mentioned that it to on before, keep healthcare landscape, close patients' medicine. feel So, positive and I system. the ability a the daily, recognize We and optimistic both has is COVID impact still potential and while we in very evolving about

impact. we fluid; there to the And now we we and the to the we have consistently, know because whatever said, But work. adaptability patients have it access I that remains committed adapt that predict is, situation Jelmyto. we flexibility So, to can't like ensuring are to

our now can in more dialogue. forward operator, And, thanks interest company. you again, for So, look We your disconnect. to

Operator

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

day. disconnect. may Good You now

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