URGN - Earnings call transcript Q1 2020

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Ladies and gentlemen, thank you for standing by and welcome to the UroGen Pharma First Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] As a reminder, today's program is being recorded.

And now, I'd like to introduce your host for today's program, Kate Bechtold, Senior Director of Investor Relations. ahead. go Please

Kate Bechtold

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

today call Officer; that the Chief on Liz Chief Barrett, Officer; today Executive me Joining Please Chief we Pfreundschuh, Chief and are our call and from Dr. Medical note President conducting Financial Officer. Peter Schoenberg, different Mark are Commercial locations. Jeff Bova, Officer

any our will a commercial Peter and discuss our the So, first provide we appreciate call strategy quarter corporate your the recent regulatory highlights will an updates. for overview patience questions. share have difficulties. summary we updates provide up technical and clinical open of our Mark before and we understanding will developments, Jeff development financial then and Liz for will of should

differ of of Factors those indicated filed Pharma's this constitute reminder, about from expectations, Risk of commercialization the statements as result negative UroGen UroGen we and from and other during report with results by materially in product a factors, with and today's caused various XX-Q investors.urogen.com. as during or making company's pandemic the plans important read company's We available Form as provisions Securities Form report filings. business be forward-looking associated These filings the documents the the effects Litigation UroGen's the SEC the quarterly any may SEC page Reform including all are well quarterly makes Actual XX-Q by Various investors to forward-looking of as under SEC Pharma website prospects, of statements on the well COVID-XX of a previously. Harbor extent Act forward-looking encourage as those Filings UroGen's this with development section remarks for company's XXXX. we to Investors on the morning disclosed these under section discussed plans Safe make that will the and statements. other not future SEC that Private As certain the call, on call purposes time-to-time, the at

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

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

will over I to the now Liz. turn call

Liz Barrett

today. with and Kate. lead Jelmyto pleased speaking low-grade I'm be so us for Good FDA tract to for you, quickly morning, of joining UTUC. you treatment you Thank cancer or upper patients of urothelial with following our product, adult low-grade the the thank everyone very approval

UroGen. in the flawless The events for execution first our new of team chapter of this sets the and quarter stage

about are a to officially more now be not Jelmyto bring company could stage patients physicians. excited the We commercial and we and to opportunity

this quickly response a demonstrating our high physicians positive We area. following need unmet have very received the approval, in from

to our As stakeholders, this landmark we we the and particularly momentum look event forward all of our from commitments XXXX, to the patients. maintain on to will remainder deliver

the Jelmyto innovative execution medicines. the Our of portfolio top launch advancement flawless include and our of priorities continued of our

need of to detail as the we received But pandemic, by through we and possible. our navigate say global contacted approval, therapy. I'm on activities. will soon focused bringing for that to COVID-XX to we our team Jelmyto pleased remains physicians on Jeff as patients more were as While continue quickly identified provide commercial patients as

solutions a As for analysis. effective launch commercial of team patients low-grade our the provided and OLYMPUS successful recent developed, a pivotal environment, durability week, XX% our the based response to Underscoring data our the healthcare this at Oncology to ensure mentioned creative in adapt Phase strategy engagement on-track a have with the results stakeholders. the the professionals interim launch, key on already current from X. platform with reporting X a XX-month And on June remains and for quickly UTUC the on for have complete momentum with Kaplan-Meier Lancet their estimated last XX% trial the publication pivoted they in team to just call, including virtual

and Mark on the this approval treatment moment, supported of Jelmyto for of in product but with a labeling cancer. difficult-to-treat data this will elaborate the results patients

we secured, identify these other plans accelerating as opportunities we approval we Jelmyto in to to the further on world. to to bring now are And forward the With of parts research updating look patients you progress.

areas Beyond pipeline that of unmet in can technology Jelmyto, need other our in to proprietary look our from could and as leverage core our expertise to continues benefit urologic medicines or cancers. ahead advance specialty we

population Journal and XX the treatment the a currently UGN-XXX of type and of April low-grade this abstract Urology. latest cancer first-line remain is for high alone. with annual disease and bladder published the by to in development with included challenging for Phase stage There this of rates treatable low-grade in part product US UGN-XXX. the Xb patients non-muscle the FDA intermediate was surgical of cancer. risk, need population, treatment by no OPTIMA the population data approximately supplement of this with approved Our from characterized response trial Patients invasive recently are in late-breaking cancer complete for XX,XXX intermediate non-muscle the patients II Updated patients repetitive of durability intervention. And recurrence the months is invasive drugs as bladder a risk bladder within patient of very of

of the patient the population. a have more UTUC and of profound OLYMPUS are and from confidence potential combined for by a Mark important data give UGN-XXX option better We data low-grade offer in to data, for the impact positive the treatment very encouraged us this These discuss which patients will the in large detail. with

pivotal study We to later with on-track year. finalize are and FDA this initiate the our

approval strong RTGel. our of evidence provide positive the of delivery of technology, actability Phase the of the in medicine II first innovative Our our data

to develop We within novel support to medicines and continue partnerships. UroGen activities through external

Beyond bladder combination we invasive TLRX/X low-grade [ph] disease, we continue for anti-CTLA-X to from an high-grade UGN-XXX, of our antibody UGN-XXX, Agenus advance a zalifrelimab, non-muscle agonist, cancer. licensed

impact is remain peak no achieve upon. remains COVID-XX we build we for of dedicated revenue fully from UGN-XXX treatment confident business and we $X potential to timeline company our patients foundation billion and new providing our pioneering The as build the based predict and options team one greater pandemic, approaches While our on company. can the a long-term alone, capitalized a and growth to can strong programs potential sustainable than well Jelmyto to

With over discuss Mark? that, clinical call to turn recent Mark to our I updates. will the

Mark Schoenberg

last come as The community. for see but been the you, very what's our for also have beginning UroGen. for of Liz. Thank as months I progress not to urologic exciting the a several milestone obviously company, only our recent major

and the a population approximately of care XX% risks patients and surgical for The improve host repetitive removal low-grade such approval low-grade therapies by cancer. XX% intervention low our elderly characterized a UTUC non-muscle grade develop standard diseases to of and comorbidities. bladder potential are technology an to in of applicability diseases invasive and in Jelmyto non-surgical of of associated with as and UTUC, and These is additional kidney potential validation

low-grade fuel UTUC molecular Literature supporting further risk to intermediate and these data continues between potential about low-grade bladder in and the recent approval disease. invasive in excitement similarities the and cancer. two our emerge clinical about In UGN-XXX non-muscle the of confidence

We published would to the in bit about months. Lancet ongoing have the spoken data of UGN-XXX leading quite the neuro-oncology several pipeline Oncology along a past today, And progress highlight our our I program. like over with

on safety, FDA designed we As single-arm in the most six the which were evaluate OLYMPUS achieved X United complete response. Study call, positive low-grade across standard study, the recent evaluation patients a of and six tumor Jelmyto on with Jelmyto to of via was in to administered results demonstrated The sites primary UTUC. Israel. the primary clinical the underwent patients determine clinical with to as of OLYMPUS this of and eradication And our last four participants enrolled pivotable installation, Jelmyto has weeks Jelmyto X approval Phase following trial was UTUC. endpoint tolerability ablative low-grade clinically significant installations XX effect catheter, at Phase adults patients weekly with based disease from discussed disease ureteral response. treated the that trial study States open-label a the was

the to months involves followed control the complete patients had evaluation from the included Patients who patients a XX according these immediate population least kidney with one tumors deemed These disease for obtained of standard were microscopic wash who cells a We at been endoscopically unresectable. of removal. standard cytology, current and intent of cancer. to remain to that of response durability detect to dose care, treat who, were Jelmyto. urine Jelmyto. up patients test the have would candidates received XX achieved ureteroscopy for Primary disease XX% the to of determine

population for XX-month response XX-month the reported and XX seven treatment-related in infection, was haematuria, the recurrence deaths endpoint As labeling durability, the not also approval The estimated to data the urinary time the the reached by at intent-to-treat achieved assessment of frequently of primary XX of was No a Overall, most Oncology, time be to of based XX% and approved remained tract and reports complete of continue labeling in response adverse of product nine occurred. FDA The Jelmyto were at that as point for complete be Jelmyto reports complete response intent-to-treat reported the months disease, on analysis. the events FDA Kaplan-Meier XX% Lancet response, ureteral in of for pain cut-off population. stenosis, had median of flank durability response nausea. patients experienced date. duration followed XX% in patients duration

FDA You particularly will given the evaluating approval differences reflecting and durability in based of immature results. know publication, in the the method durability label our versus on was patients, CR

be call, final data with to-date. at And will longer-term we our will the the follow-up. remain submit possible We have XX-month results The consistent to durability all patients reflect prior by to June. shared available the as on label as discussed believe as will soon data updated

for this care and the of two a as following surgical is to using intervention urologist extremely those tumors large are programs, challenging TURBT. to one multifocal development beyond patients control intermediate criteria, progress Intermediate candidate or non-muscle disease or rates As has as defined risk been the clinical our standard at intermediate with that of of UGN-XXX patients rapid cancer. for recurrence. developed most bladder our patients of with recent risk we We group, being chose treatment Jelmyto, of product on pipeline the which invasive focus the advanced is low-grade look risk disease,

This months, response achieved to via months XX%. evaluation adverse XX% the OPTIMA and a results six online commonly Meeting journal events the nine urgency infection. Association look haematuria, Phase were treatment a disease in data published presentation late-breaking recently dysuria, detailed Of majority XX% the and reported Most April demonstrated at and complete sharing of and included the response was mid-May. We durability the who respectively complete the rate to in as of supplement urology. virtual Updated those moderate Urological study fatigue, in in Xb And three II in remained and mild in Annual of trial free. to American severity. a urinary frequency, complete reported the response tract onset following of forward urinary underwent abstract

discussion study or mentioned, the in second X protocol Phase half communicate with our discussions Liz hope final as design of design for year. anticipate the the feasible, and finalize the delay to in but for the not We impact initiation. ongoing timing believe remain still initiating soon pivotal our trial as engaged As actively do to the we this FDA will

of the with that, launch. an And to commercialization as to planned would we we Jeff ahead ask I activities underway to provide like Jelmyto look overview have

Jeff?

Jeff Bova

and been readiness the on hit official good successful ago, for is strategies our Since takeaway for June adjust our yes, situation last our us morning, running. solution-oriented weeks We've And We've a diligently just continue the mitigation been on Mark. we'll COVID-XX Xst. few launch to ensure working help of our you, to team Thank The call, keep are ground we commercial to ready. launch. has actively Jelmyto key track the everyone. monitoring a

for prepared place mentioned Our as experienced now. commercial recent time on team in launch. been And our has call, quite for adapted fully they're approach trained some our to I and

support and The business oncology. educating on with and reps sales records UTUC. provide potential nurse unmet account-based of of reimbursement. in installation well that includes seven to by the both region training We as low-grade reach we team a in XX as need As in believe XX% been allow clinical reimbursement potential. January you support will access approach may field part of field They've recall, structure team is regional and and is ensure a is our this since take. successful comprised a the from Each around force patient educator manager the to led customers our urology track managers the to

Additionally, who steps our our are to more on about UroGen have science physicians a engage medical technology. we liaisons brought target learning and MSLs, team with seven appropriate taken interested the novel that or in

plan increase we the we to that this pandemic, of physicians During embraced the approach virtual offices to the meeting through the continue their really have this time and technology launch. efficiency dynamic found with COVID-XX

important three critical seamless reliable we reimbursement practice. the success patient the integration reinforce orphan think into for it's Liz when identified factors, this I company, and that physician commercial identification to joined indication, a

As part these of implemented our strategy, key addressing successfully to programs areas. we ensure we are have

effort Jelmyto multiple practices their new with UTUC practice. and recognized alternative that our company rapid are veteran the XX% to learned surgery incorporate treatment market treatment year, strong desire up option of Jelmyto identified patients critical the we've team team to and have the Through Leading for unmet improving of the increasingly and need radical element Urologists a over approval, adoption these enable for our dissatisfied our nurse relationship into a opportunities and The awareness, of upon between an need patients. current past low-grade spent and the diagnosis. research, in with navigators field urologists to identification differentiated will patients that our significant options for recent low-grade UTUC. for

is Reimbursement of adoption. element also key

and know Jelmyto we you wanted of physicians reimburse a many understand know, drug is we As buy-and-bill that to widely adopting. before

pleased managers time around. offices is that to questions reimbursement with the also And I'm reimbursement complete might for follow-up. and field completing of offices be need from those accessing any a Jelmyto. address potential to will when a hub that physician assist available to they're patient have requests hub customer that first team support to up requests. they that to prohibit forms around Our running and already say triaging they the to ensure appropriate We've correctly received obstacles and our developed are

treatment delay have priced Jelmyto in approval, $XX,XXX we to reflects at for At of of payers, with that the downstream low-grade Jelmyto. with dose. Jelmyto we potentially removal. This on remain we conversations value per announced sequela the paradigm to our the kidney associated transform UTUC coverage confident the Based

guidelines that to standard NCCN pleased Oncology. to care. the Clinical are we addition, report In cancer Guidelines NCCN recognized policy The been for we've in Practice the in clinical are added

the that the submission update application of J-code call, process. to announce an The the happy submission As team to our of also for completed in I'm has C-code. the application last is

a year disruption by COVID-XX We that of C-code the given is no timing, the if by there secured and October the end the will J-code expect continued pandemic. be to in

recently Policy In Jelmyto. Group how guidance addition, to Advocacy medications will on which course code to and the American for treat published installation low-grade to article apply an Association of UTUC, of Urological just with

a able to reimbursement. when for submitting Urologists and be will utilize as this guide their resource staff

physician processes as Jelmyto into make of staff. for practices. integration preparation seamless to possible and use the a on concentrated easy and remain we Finally, We've practitioners instituted as

needs behalf, help with Jelmyto national the an with installation, gel ad and agreement prepare mixture prior on entered a major reconstituted to appropriate label safety. of As Jelmyto our pharmacy is Jelmyto the This we exacting to USP to our that receipt be into and with under conditions patient prepared the the accordance ensure dispense partnership ensures of standards patient to in Jelmyto prescription. the following

and in the Annual American II with on of come not ability we to as address trial, unmet unveil any drive by trial Dr. foresee the and the Wang an Urological effective on barriers that maximize a look our Virtual OLYMPUS Meeting Under the engagement Based result to on we disruption booth remain bring Dr. addition upcoming way treatment and of stakeholders. key presentations towards These Association supply mid-May chain our to the latest pandemic. to in physicians our as Liz's urologic in resources information, Lerner do healthcare forward leadership, cutting-edge may include community we the sparing OPTIMA and we will option. launch AUA virtual technology. a fill interested to in professionals exhibits team's to our with in the to interactive the this COVID-XX confident need platform any kidney We

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

Peter Pfreundschuh

And first cash million equivalents Thank and We call. today's you, quarter in securities. the This to cash. of good marketable excludes morning Jeff. $XXX.X closed on restricted with cash, XXXX everyone

For share the reported March loss of net first same of $XX.X XXXX. or $X.XX for net million the per XX, $X.XX losses quarter $XX.X ended approximately or compares This million and in to period share. three per months XXXX, we

during the to unwind our period to quarter-on-quarter from settlement The net XXXX. million of includes of through three quarter a XXXX increase first share-based for months were one-time Research million $X.X ended $X.X three XX, The loss quarter million to expenses for $XX.X XXXX XXXX. million March million XXXX the mostly obligation and in ended compared the months $X.X non-cash company to in provided same on grants XX, period the the March XXXX $X.X XXXX payment compensation due and IIA is and to first for development to expense. the

and months three million March XXXX $X.X to compared and in expenses force. marketing Research $X.X field March months of activity ended the compared compensation commercial were share-based launch XXXX. to for in million period The of $XX.X marketing expenses increased resulted the the $X.X as period for the Selling expenses for $X.X from and $X.X XXXX. expenses the of compensation share-based marketing and quarter the million quarter same Selling first the XX, as of also XX, and expenses months increase include for preparation non-cash same XXXX. non-cash first as period million three addition for million selling include to development Jelmyto, which and expenses XXXX $X.X of in and XXXX the million million and March for ended same XX, for the in three compared quarter ended first includes

headcount for expense March quarter administrative General first million include from three months were to for same ended X.X increases months compared in XXXX non-cash XXXX and expenses The for first the for March million primarily in general resulted severance the XXXX. senior million General quarter compensation share-based in and of a ended in same $X.X XX, period XX, $XX.X expenses administrative XXXX. officer. and increase compared million of and administrative $XX.X as period three for as expenses and payment and $X.X the million to the

of to year. the we X be UroGen trial clinical our Phase advance development the this well capitalized prepare and programs, Jelmyto later of UGN-XXX launch initiation including continues as for

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

Operator

Certainly. first Selvaraju. Raghuram And [Operator our the comes of from Instructions] line question

question Your Wainwright. please. HC From

Unidentified Analyst

for Do of is reopening Hi. should Ram. Blair the the of you Jelmyto? [ph] conduct gradual permissions questions states selective surgeries to affect for calling of This and think the launch you. on Couple

Liz Barrett

anything. if then I'll Liz. add wants and Jeff to it's comment Hi,

all, and are been there not so state we've think as country saying seen where we've some impacted. what what the that in things first along have I is all been of far

his differently. will physicians tell So be New areas still had in such Right. Jeff New And decision. open. looking doing are can obviously it's of as Jersey to at he things where definitely some and slower conversations has York you a think We geographical

have do versus The is hospital. don't it about the to good alternative our that news in a therapy you

the And to where lot into a XX%. going so sometime been are due patients. what worry oncology because actually seen the lot a is of the patients and has other Board And COVID we've treatment of about all there read I've right, hospital, day that across down

lot don't that we projections we've QX really team again our do will believe the Jeff noted So to ask before, to it get in revenue that able because comment, to as point virtually this meaningfully at able our started see work timeframe be a QX, time, changing out. the and of I'll and expectations, has in been and

that? more they I which as do areas, do in But, be impacts Jeff, urban in any some you large are slower areas, patients think have actually other to to seeing in because these may comments us open. well, addition

Jeff Bova

Sure.

Just that to be to solutions Physicians states and regards with slower versus They to the may their for clinic that the hospital. more go add clinics open little the across be will Board. open. first are probably to will bit be open into believe looking the a the patients to

key machine patience, Jelmyto all targets CRM, interested to COVID patient the into a they center. So move likely surgery that center the the treating are Those we been is where talked now delivering there. clinic their about. of surgery They another to are to the they've place looking have a go, clinic. and is they which possibly Again, in since option would fluoroscopy wants patients have are strong affiliation have with more

but still and yes, there. could doesn't open delay that a - of handful mentioned surgery there states - expect seeing it that standpoint, will states And be slower, are patients centers Liz the a a we t from geography to little the is

Unidentified Analyst

program any the been Perfect. cleared? do transaction the And to that under AbbVie expect Allergan-AbbVie now changes you has BotuGel

Liz Barrett

we expect to changes them? any Do with our program

Unidentified Analyst

Yes.

Liz Barrett

Yes.

as that was AbbVie announced, acquisition think that And to soon timing which spoke still So, did forward - in demonstrates versus Allergan. planned. as update They are clinicaltrial.gov - as we they the a we where of both were. they look moving delay a bit don't and

of the the now then is you was that months June. it So, at end start and data. to after few their a primary have get they May Previously, completion date before

any we advancing priorities. we And interest have but to interest made BOTOX AbbVie have had that information at we if believe to other of them that their own, has have it So, in is I that it of or they and talk said our one absolutely only interest in very very think moving on clear point they're that the the continuing by clear time, the look made have would that further - didn't year. know forward we'll they've And thing to in of interested no this is this. except that end moving,

changes, don't getting actually really of see we any delays the then except pace, there the on pivotal study, and COVID some if thing, hopefully, So pivotal were study board. because other getting finalized study the and the or

Unidentified Analyst

last And X for it me. guidance for any year? you great. Phase one Okay, I of know the COVID see you reiterated but with the for because extends XXX, issues do enrollment the if and later

Liz Barrett

actually I patients said end toward that think, study would again, the We start the in. we've year. of coming the have

I a US, Clearly, does this get again delays. the winter unless delay, into not start in any mainly maybe, it think it a the if year, is back up like next So, don't but because we there to it study. global in just could goes see heightened be then

And so, we would the world. sites have around

our that doing lose bit all a add be slower, said we're time resources been may and this, things sites necessary to we on high of but make and it we've to we enrolling will ensure So, going sure all the our little to or any we study. that either talking don't X can sites are Phase that that put about

Unidentified Analyst

Awesome. you. me. That's from Thank it

Liz Barrett

you. right. Thank All

Operator

Thank you.

question next Stifel. Derek comes from Our line from the of Archila

question Your please.

Derek Archila

And that how June open to X? also Thanks. launch virtual or plan add are them practices the on info look more some now be of share many you do like? AUA do the What can treating play target, something plan. you you could then know patients if and wondering by to open Just

Liz Barrett

great. could be you that would if Jeff, So, answer

Jeff Bova

Sure.

bring AUA So, we're to the going to physicians.

the have able we reps are to innovative a of a of to they'll going go going booth have our are the the live sort of be going and the AUA. to to to stations actual And website. at could couple that creative, pop-up go physician - We are to

on the iPad that Gel pelvis. then instead, going fills liquid technology manipulate able be from to, So to temperature They'll for the example, and able renal to an able that the to be semi-solid. they're what's the to be see turn to

everything have AUA; - innovative So, the plan from the are going to is we're bring AUA to going going physician. for to standpoint to that we we're

apologize, around you I repeat the could the second basin? question And

Derek Archila

Yes.

that by treating know to June on you how guys to X? Do patients opened practices plan going are right in many open Just the target. or be you now

Jeff Bova

Yes.

want XX%, range probably it's June the from I as us those closer as begin back physicians to a well and physicians to patients target. will be Virginia, XX% going got they don't better yesterday, waiting obviously York spoke alone, from New - patients, open a prioritizing but won't July a are X, of they'll say, They've into states literally give a July load So soon, you be to give and I August. XX% drive - to US. I'll for about to just treating Others, I'd get to are to

Derek Archila

then And there XXXX both affect COVID it, I you to for - my I comments if you guys Peter, wondering respect I add issued Thanks and before about more still are us. taking R&D qualitative And so that's Thanks. how the was OpEx just Okay. that for one guess, holds. SG&A? know questions. for will any could guys. in you But guidance

Peter Pfreundschuh

Yes.

So, are with regards to reiterating we our guidance. guidance, our

regards I cleared million full to that to year. other for the million our to March. was numbers fourth in think, part the quarter. they which the at That With numbers this of first $XXX in $XXX fact in moment, guidance $XX we've IIA the the the laid stock-based that as guidance with embedded associated compensation, back earlier those payment the out so we numbers in Street operating Street, also provide was $XX and were full-year was to the settlement million, million quarter expenditures out around stand, for those of

comfortable income, all operating other feel which as of $X.X relative there very to of And moment. for numbers relative year. this guidance million no then is Again, And those was COVID-XX. the change we to

Derek Archila

Okay. guys. Thanks,

Liz Barrett

you. Thank

Operator

from Next Sachs. Goldman Paul of question comes Choi line from the

please. question Your

Paul Choi

so been has such you as help the force with question the getting change have backdrop? changed Great. how has of current and with virtual first at everyone. Can to been of help Maybe offices. sort the forth interactions. operations morning, to gauge, physicians' us procedures volume volume Thank us in on and you. the gauge commercial just comment to of sales just your backlog procedure maybe through what regard Just think terms Good in feedback

Jeff Bova

Liz, me to take? you want do

Liz Barrett

Yes.

Jeff Bova

Yes.

can - I their from backlog have time from guess a where cancer about about not These XX the is that are have - is XX, I better much wait gone month, extremely that it country are depends I time, presentations of depending reminded standpoint, from the more gone you face-to-face from physicians in I've heard. that what we've question, on longer clarify So minutes have same a to urinate engaged. just a so physicians institution you I they I that they portfolio, low-grade at couple patients can that have talked your It are but a depends a reps on second your because the virtual they a don't to conversations all, that institution, heard it. others suffer going virtual well. know mean - had first every question, a you, way Mark small UTUC, back. And have obviously a had than because group tell backlog. mean like said priority I choice, have bit thing always little some do certainly we

so month with the, and we've about they want heard the obviously, a is the of the because that but treated certainly get to they reminder have what anxiety that And cancer. two, or way the

institution. that say a the From I'd this prioritization on standpoint, depends

for hundred up not to got they've Northeast. few others, And example, like again in a some to are accounts still is there priority, patients they're know treating prioritize. I that the They've - got some a

So, hopefully that question. helps answer your

Paul Choi

for Mark Sure, follow-up. Okay. And for thanks that. one then as a

Just expect with when then number you to a present to on to next could looking very I you OPTIMA, And regard update of XX-month guess the update? from Thank much. potentially of XX-month just the the have sort patients minimum data? are we

Mark Schoenberg

Thanks, Paul.

view very answer of patients. able we've in I the know later response you a complete OLYMPUS give what give that durability the and year probably of is these to the we clear be the of already mimics best think experience we can to this rate won't favorable And seen very trial. the I is,

positive, the be to at story given have is I our as suspect currently year. be think very point. tell about a But probably we'd least to I should So, at this able that I complete the specific we that's that and this will directionally fact like be information later

Operator

question? that your Does answer

Paul Choi

Thank it much. Yes, does. very you

Operator

Thank you.

Matt Thalmann. question the of from from next comes Our line Kaplan Ladenburg

Your question please.

Matthew Kaplan

and coverage morning talk you launching Liz. Good the the taking thanks out the product? I year, that Jeff maybe as the guess and about for to you guys. roll Can reimbursement for first of and see of you're questions. kind Hi, expect during

Liz Barrett

if Medicare, get sort are that final Jeff a Medicare to drug a patients. remember making let prior of approved, always and that. the get the whenever on then Having I into details upon And can first important of is particular company insurance gets it's by Medicare I'll Jeff approved actually Yes, majority reimbursement that, as these But FDA - think said to reimburses. decision. you any a drug expand patients this

really big where we don't but our kind coding issues, you we Jeff stuff. So tell see can and are with of

that? to expand you upon do just Jeff, want So

Jeff Bova

Sure.

So, the happens typically, the is providers we patients the the patients is. way have right that now, that this or it - rollout

clinical presentation, in the understand to want the - rep and OLYMPUS data You the clinical [ph] physicians the will standpoint. all questions from handle they deliver a

coding with The that reimbursement. and effect doing is - call be second oftentimes the will we

Jelmyto. walk J-code, will of manager where which we'll and have that's to will we on the to with code, normally not you to is form those the that, to I our out, code, C-code. unique reimbursement the at through X that align hospitals have physicians, So And could have if time sometimes a believe October field fill the the of surgery pass-through until how The code C-code will most coding, so we miscellaneous process. have correct point call miscellaneous From second that C-code a folks, correct sort reimbursement, unique for the that's centers. the with a

So promotions code. miscellaneous pieces to will talk and the our

C-code that the all In we of that we then what and talked Once use. the fact, a site of obviously have we the AUA will year. the I they miscellaneous the code expect have the referenced with pull end pieces we by C-code, that replaced earlier and about article J-code

supersedes permanent the C-code. the J-code then So

of wait is as that's buy plan The as we will the So go and have miscellaneous current sort we it's be we providers C-code transition bill, out. code. because for the using a

Matthew Kaplan

you. data Jelmyto approval? will you - and Liz helpful. in ex-US of it what think terms that's Thank that for very suffice using approval guess do strategy ex-US for Okay, of I And for the

Liz Barrett

focused entire in of of we with some right that were of at the our was Yes. our to FDA time. the our do to you, ex-US past resources work the And We've and really sort hold be shared it because that and on decision on getting approval. information put that honest team all

biggest countries biggest So Europe reengage getting the being Japan particularly market. many now are they and with use issue or comparator. in to Europe want issue generic a we in do Europe reimbursement, as starting decent the really mitomycin absent comparator, of and regulatory to the will biggest in isn't the authorities, The obviously other a getting any comparison approved because is

would status, around so that five used is and different issues do to if discussions before the France what the plan there, that have see give reimbursement. drug, we competitors there. of And decent I reimbursement. they Germany a drug probably think question on They status to we'll could orphan being and revisit but big two a eliminate will orphan regulatory a authorities direct get view they And with we the would like have see with what

couple have Japan, into easier. we a a Right. Europe. going probably strategies little of So bit

there next right the FDA, see able regulatory the see then they to bridging in study conduct in want probably Japan. how small many patients study to a - ask are to are many want to get scheduling, step would how actually they we approval meeting patients our is a and be So, them with and schedule a to to Japan now population, going to Asian

other So, I will there world. and around discussions hit the first. think companies with had those we've But other do

addition Israel, that good obviously FDA. about is they the In the Israel, news to accept

were to we are an participants approval us So there lot from gain be for company considering, in the done important needs Israeli-based there, work Israel. but of study to some that and will be it's a

little that's then I think easier, be more mentioned So that when study. could before, the And XXX one and a as global do. likely would XXX rest be of but will bit a get probably we the will up again I running we prioritize world

I as of comparator plays of competitor. that you So and outside can the and US expecting with imagine with the most better direct think wanting them

really in which that's for again Europe, So the biggest - our opportunity is us. issue the biggest

Matthew Kaplan

Okay.

question And you intermediate for cancer? non-muscle you. the UGN-XXX for on details Phase bladder invasive low-grade give X some maybe and Can thank thinking last Mark. your for design us risk Okay,

Mark Schoenberg

I is Thanks, is Matt. randomized on internal FDA conversations based discussions, transurethral ablation care. standard the study and our Yes, primary the think, our resection we believe of comparing with contemporary bladder be to tumors, to trial going a that of the which

as design that I we've that well and think of received community. regulators type from the urologic from as this feedback positive the

directionally trial sort course take. believe the design the will ultimately that's So I the that of

Matthew Kaplan

on the for congrats guys, Thanks taking and progress. Okay. my question,

Liz Barrett

you. Thank

Operator

Thank you.

Boris the Peaker question comes of from next Cowen. from Our line

please. Your question

Boris Peaker

the and want a you been What many need time? launch doc see how me Great. Jelmyto in I from understand docs over trained before using training just of have start does And do [ph]. Jelmyto? perspective. that Thanks for this increasing squeezing they at training how to kind point,

Liz Barrett

think you maybe about of just ensure about Mark, then to our can sort to you needs of and and you Jeff a training the talk can physician plan talk education what physician. So

Jeff Bova

provide is complicated urologists, us, all basic the urology in skills this Sure. programs. the straightforward residency and Boris, to the thank acquisition instrumentation utilized this because very therapy taught patients stuff. for is of And is you. to Luckily not for the technique

across practitioners use Jelmyto slightly is installation. liquid, country do this to know is equipment to how of urologic cool which the the - is it and only is are therapy this, approach. inject to to how with when the The prior familiar So, already aspect how viscous what finesse learning

with the it's the to was familiarize them trial very a familiar and technique. it's clinical our a the So, OLYMPUS training experience participate very little to process with in trial, in

sense Jeff has also ramp And to of what with I would community. extensively physicians about think it take in and spoken the training has this up a

Mark Schoenberg

in the X that the with in - virtual after but that So, second, good. have They X. will of that OLYMPUS the physician people Jelmyto if we If What certainly yes, more aren't those there need typically comfortable engaged reason, we've nurses the a they assistance. first be with room, the Phase we nurse actual some be wants our there may maybe clinical also will - maybe team is educators procedural heard sites we've as Phase are for proctors. administered act offices dose,

you technology with that allow procedure. kind the the to the will have nurse we be So an a have - talking of - iPad through will have physician

were if on want something having room. So, see we've versus nine virtually to folks eight any got or of procedural those the roughly a call in or physician

Boris Peaker

you. Got

Phase UGN-XXX maybe Okay. question My X the on last study.

of you sense will long year, have how ballpark Assuming this get take? kind a study you it started later of this do

Liz Barrett

No.

that. we seen it actually week several hundred a I this having patients. are meeting We have it expect And finalized to not haven't will We be yet. review.

we be yet. but definitely three program, will exact we year a to So, numbers the two have don't

Boris Peaker

Thank you much my for Okay, very taking question. great.

Liz Barrett

Thanks.

Operator

Thank you.

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

question Your please.

Leland Gershell

taking Thanks morning. for my questions. Good

question Just for one quick Jeff.

across use the going territories of country of are place reopenings want As variation of versus reopenings to know and to efforts wanted the you're the in terms initially normalization? inconsistent, the irrespective your you pace if kind geographies, to inform as pattern where Thanks. [ph] of Jelmyto covering that you simply to

Mark Schoenberg

Yes.

clinical just I They'll of facing procedures is there - be sort respect just group patients. in drug. rep will a the Virginia place. engaged be very practice reps will now is mentioned, a large the Liz it in had on the stay recently puts know that that conversation. they'll they'll So and had - rep the practice the as us - identifying for follow really in with orphan earlier the mentioned the I patients key and The

a identify little the patient. and to the So bit navigator this with nurse time more gives work them maybe

not to across patient consistent stay to going where, after will to they'll regards rep institutions think just policies But, US, yes, with the the are. the I So what delay. be we're have

Jersey are virtually have For the contact example, both. us have area, those in we're - [ph] we those Virginia, to talk to their means them with certainly York, not institutions and I wait until doors. can said, engaging New if to just need We'll like you New physician that open

Leland Gershell

Great, you much. thank very

Mark Schoenberg

Sure.

Operator

Thank you.

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

question Your please.

Chris Howerton

much. very Thank Excellent. you

maybe thinking the was I Jeff, cadence for launch the So here. about just to

was that attain won't reimbursement. will the one So they're comfortable adopt physicians widely comments made you they of this until that

So effort serve? to a is the of Jelmyto physician how broader many costs, let's to guess what say, an doctors typically just wondering compared as a to do user relative acquisition was And I within I patients versus adoption their patients? generally

Jeff Bova

Yes.

of tract, there I and So of walk XX you group a each typical [ph] amount urologists, larger one be or that have two that XX the patients. but or then if bladder group a physicians into is is, or really different, in could a there's account significant upper lot create cancer a few where

see think reimbursement place be they're CEOs, put with our in widely with conversations have as to said, miscellaneous I to want they're adopted, some a of policies want the I while accuracy it first of and regard I code. we an We've some think quick. we the we standpoint. COOs the had going - in will around - from going patient, that to I do to say when that

think When in to once just it up to drugs start start you'll the the patients they you'll drug, used expect to but a are with it slow I Xofigo. anything down little efforts and bit little other up every patient, like I more, first picks They miscellaneous more find be miscellaneous bit codes accurate system a don't start with code. their see Provenge to their will to do I reimbursement, other say, adopted, to like pick - starts they like see treat once

hopefully so, that And question. answers Chris, your

Chris Howerton

be could I maybe a no, if what potentially around I given these if Peter, one. No, Medicare? net of to know color just expect Jeff would Yes. are the give another definitely us that for And guess that you or majority be some you particularly gross appropriate does. patients to don't idea you this the

Liz Barrett

we mean, net. I'll a provided about really I This just make it, Yes. guidance is to gross comment around because haven't Liz.

Medicare the I Medicare way But there I is I discounting think about factor be think that to alternatively around gross we really that don't think there. net, to alternatives. determining your - of you patients. if best right, sort know point won't even think But don't the was I Right. aren't

in that So, area therapeutic areas products to situation other many where in not you discount. are have no a so multiple and therefore, need

but So those gross is due think you the and to I we I to insurance some it with expect typical net discounting heavy fees types But of that's had you fees, company. discount sort net gross traditional your think - associated about it. way to of in context, think of wouldn't to with the way about think will admin best the to of costs best have sort

Chris Howerton

think already Sure, I we we later that month, might learn update and AUA. details that trial quickly for an okay. the know? we one, are I what get virtual the this And of part on in Will guess last is for Mark the outside of presentation then what safety

Mark Schoenberg

Thank you. Chris. Yes,

that give completed given interim a from I as we We and encountered certainly we it of the delivering. we're think have complexion overall far, are of so data, adverse we But data moderate apart therapy durability will now, you that be not right events sense understand incremental study. additional the some the which it will are mild, the obviously and think these understanding can unexpected say I trial

Chris Howerton

I much questions. Okay. very you appreciate taking my Well, you and thank

Liz Barrett

Thank you.

Mark Schoenberg

Thanks, Chris.

Operator

today's question-and-answer Barrett, any and remarks. This would hand session I does Officer the for like to the President Chief program Executive to program. conclude further Liz of back

Liz Barrett

everyone Thank interest UroGen. you, operator. for joining And in your and thanks

biotech I approval, companies ago, of to get reminding Just this and from day. my me when colleagues, weeks never couple most peers received a received we many messages that

mission urologic in exciting to ability an in specialty care treatment proud our and cancers time it's improve of us. pioneer our new incredibly patient confident and our advance to I'm team to for So diseases.

to Our who waiting. team patients to has been Jelmyto been working have provide tirelessly

on horizon, we as deliver the so staying as the approach exciting you, continue to and with shareholder - forward And look in value. deliver touch to events patient we we

support. for everybody time your and your continued thanks So

So, now disconnect. operator, you may Thank you.

Operator

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

day. disconnect. Good You may now

UroGen Pharma (URGN) 10 May 202020 Q1 Earnings call transcript