URGN - Earnings call transcript Q4 2020

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Operator

Good morning, ladies and gentlemen. Thank you for standing by. And welcome to the UroGen Pharma’s Fourth Quarter and Full Year 2020 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

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

provide Henderson, Medical from Molly financial highlights Joining have an should questions. Jeff updates, Chief conducting Officer; Officer; full Dr. Executive President our and summary me Chief our and Commercial note of Please developments, on will the overview Officer. so we and our provide of Chief fourth clinical Schoenberg, for Financial the call appreciate any Officer; Chief that year Liz today and the to recent understanding Bova, commercial are a then patience before development your technical Molly open will different will provide updates. Liz a Barrett, continue we and quarter Mark difficulties. for Jeff corporate will Mark we we locations, share call calls

ongoing well Pharma’s from on by prospects discussed regulatory section During planned financial commercialization, clinical making indicated we will our various statements. among annual UroGen results guidance materially trials, ability those paradigm, forward-looking SEC UroGen factors, with may documents previously. and by the clinical UroGen’s development of and differ other the a including report Filings encourage well read statements any available and filings, SEC and commercialization as Risk These to filings. We as XXXX the in plans as COVID-XX from website and potential XX-K Pharma disclosed extent Actual negative future expectations, product report Factors the forward-looking other as call, those of all time-to-time, this our regarding the research important statements result that timing of section caused future company’s data or development Investors may investors.urogen.com. the morning, to Form with these associated as on at effects annual capabilities, things. efforts, business, the under of certain filed XX-K UroGen’s are page SEC presentation, Form include company’s makes pandemic Jelmyto the on treatment filings not manufacturing today’s other to the investors of This be with and SEC the and change plans

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

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

Liz Barrett

biotech Sara, to inspiring to innovation collectively, you everyone. thank an to of and everyone today. industries XXXX the face joining Thank us to not you, it’s for memorable have in the say benefit and that Despite we persevered the been how was see pharma society. challenges It’s understatement

industry our what am does heroic universally applauded. being that is in and this to grateful Although, day see out, I efforts day

low-grade become UroGen the individuals front on is with Last became for have cancer. has stage diseases do While that work but diagnosed. forefront, urologic approved and specialty first on the developing rightfully for focused adult many therapy they upper non-surgical center on been the cancers. don’t patients FDA our a approved and news, year, urothelial tract take treatment option who first treatments, page only focused been Jelmyto

certainly the the COVID-XX midst presented of pandemic in challenges. Although, launching Jelmyto

net product launch. June pleased with the of XXXX We first to the X, million two launch. since quarter for those responded has challenges We in sales full the in fourth XXXX quarters million way are incredibly and team recorded of our $XX.X $X

in, populations rollout we’re be environment of serve. including the the and vaccine the patient we mindful and to the its continue We operating healthcare impact system on

We impact uptake including trends have an patient the of months first on two Jelmyto these procedures, have seen XXXX. in

closely to remain executing the of details continue in us product in accelerated non-muscle initiated the patients lead even our progresses. recently, monitor, for with Jeff progress and Most and to and study cancer. we bladder for for near- of We outlook diagnosed provide invasive the enthusiastic and X shortly. progress come. will growth adoption our low-grade But clinical as advancing We’ve strategies. makes more Molly ATLAS our possible candidate, what’s year long-term Phase our demonstration on on what’s and we UGN-XXX, more made confident risk important And our the pipeline trial, intermediate continued

the very both and important for the showing for UGN-XXX data for encouraged share present The enough. its and patient many Xb potential therapeutic just patients durable TURBT approved, patients similarities experience no outpatient were reviewed and may is Phase intermediate population non-surgical UGN-XXX, the an published journal. learnings patients a deserve patient OPTIMA importantly it XX% and more prior options these UGN-XXX not is as UGN-XXX from low-grade of peer those in complete with apply enrolling and strong about and our our need annually believe across better are that benefit program risk from surgeries patients we We’re and options. these leverage supports recurrence treatment medical current X standard excited is unique had primary high a trial, meeting in in the for as XX,XXX response, the potential but population, significant indications intend We upcoming option reasons, approximately II the UGN-XXX’s for good at to -- primary a and received options. an we patients. these Jelmyto from by to data if treatment these identified risk We the patient study, trial. very or to Jelmyto These hope for and at first believe In U.S. alone. treatment We to the three this in there mainly unmet and approved FDA

beyond extends work disease. to low-grade high-grade Our disease

Our this disease options. initially believe invasive notably UGN-XXX, treatment risk and Anderson agonist early-stage three-year currently with research the our Cancer antibody cancer, high-grade life most We of this the Texas intravesical of for immunotherapy on bladder disease licensed has of MD provide anti-CTLA-X the an UGN-XXX, technology the high-grade we of initial a recently Agenus, invasive advancing progression. is TLR is aimed cancer in is with with non-muscle gel with transform for a potential non-muscle X/X available being announced which threatening that The our programs combined University studied UGN-XXX, combination UGN-XXX, Center to advanced and are treatment bladder UGN-XXX. collaboration focus combinatorial that at

Allison Sharma, We’re with particularly breakthrough who instrumental been have Dr. James excited immuno-oncology. therapies Pam to Dr. both in the of and collective experience leverage developing

realize These proprietary full ongoing to an renowned technology and inhibitors this explore GBM, Hopkins expand announcement continue reflected We our institutions academic non-clinical and week’s of platform. to combination research the in our our of difficult sponsored efforts agreement with a focus with potential Glioblastoma our Multiforme in to programs University utilizing in checkpoint Johns research our this pipeline world or as proprietary immunotherapy treat part two brain of with cancer. important RTGel expand are to aggressive

ensures provide we announce will funding to pleased with outlook this We a therapies to RTW, As life we advance of solid additional completed altering on funding important This mission to million. company. fuel strategic that transaction a will Molly look patients. $XX for we our this ahead, believe financial are serve transaction to bring our providing and detail shortly.

As and diseases. to how we we are a building look transform we ahead, specialty treat cancers neurologic company

barriers, continue colleagues commitments am and deliver work the are that day our have of on and We every an vision on all to I We to proud need rise doing. because our we our to a have impact of share medicines. patients face challenges we overcome and

delivering call have strong Mark over realize our leadership business With patients update. a approaches clinical discuss long-term to behind. that, left growth I’ll to to and have We ensure to new the turn Mark? foundation by a been recent that

Dr. Mark Schoenberg

is as time an Thank Liz. in the expand our uro-oncology. pipeline having exciting real see practice you, patients, to of impact exciting Jelmyto continue and areas on It’s we for important to world

to from be fourth study Matin with Annual upper expectations or time sub-population response and Oncology. The Anderson the which that see data need population previously which OLYMPUS were in with Surena evaluating MD pivotal preserving OLYMPUS to multiple both by and recurrence reduce upper disease. quality line options procedures endoscopic durable to analysis. the deemed procedures Kaplan-Meier X of or in unresectable multiple presented previously have Phase patients was quarter This safety were the invasive and disease was the tract the We achieved a as of not profile These patients our for carcinoma, removal entry podium endoscopy of from patients months to a life. of of our ureter, a XXst tract Urologic virtual were of in from urothelial treat Society the health XXXX, trial in was in the of the low-grade in Dr. reached. at XX consistent XX% kidney. a estimated a low-grade of for less Jelmyto OLYMPUS at data durability pleased treatment response durability intent have support with final a and to OLYMPUS loss who included the At results. kidney reported During Meeting may of data the Median patient use cancer complete where for of XX.X% the kidney both final Jelmyto consequences of impacting durability urothelial presentation

our for since have several to also our updates call. We program quarterly provide UGN-XXX last

the received patients, This In II announced was exposure moderate patients months the trial, previously symptoms consistent duration the observed treatment of of trial reported with primary as UGN-XXX three median over In patients we from the study from which months of analysis that shows safety reached. mitomycin is in was profile the therapy. XX% typical The OPTIMA of time. of result of intermediate and duration the non-muscle events final response bladder events start tolerated mild cancer was UGN-XXX not to that and evaluating was low-grade subset be in first were therapy therapy invasive mostly start of the response XX adverse related Xb Phase with data we to by topline to well serious generally complete XX.X%. to achieve results, XX, Treatment UGN-XXX no with this The risk response Kaplan-Meier of reported. with that adverse after and November. estimated XX

and study and XXX non-muscle in cancer. our initiated of trial minus X enrolling TURBT randomized of we patients resection compare intermediate bladder study actively tumor standard-of-care enroll which ATLAS a Phase plus global will the patients. or patients are mentioned, was diagnosed is As and UGN-XXX bladder approximately to with control ATLAS and TURBT alone, transurethral risk UGN-XXX or is low-grade invasive December

criteria similar patients endpoint will either is evidence evaluation population. OPTIMA non-inferiority and TURBT superiority. are enrollment and recurrence and the assessed to And time be upfront our and primary present either for monitoring the We complete response. identical for used evaluate survival either trial Patients will will Patients then this who under a on demonstrated one treatments one three the to following have Phase undergo at a monitored analysis will recurrence. have disease. study months three who survival of arm of expect TURBT or for to to response II event month or to is same trial in free quarterly enroll UGN-XXX or designed randomized free TURBT UGN-XXX point, Xb to a tumor in be recurrence. time The disease be in the Patients at

and the general of We today, water-based population, minority receiving There approximately transurethral are approved anesthesia to year take one and trial adjutant within a procedures completed in to three primary no are approximately this managed under with patient patients non-surgical chemotherapy. years. enroll therapies to expect patients repeated be by

five of recurrences I more surgery. and course and their two-thirds the or published one-fourth with recurrence have each in my throughout practice disease. have additional these of literature, approximately patients patients or more For see comes recurrences two an

that from cancer. and risk avoid as reported come paradigm for death patients our the year. unintended is risks non-muscle modest, to recently trial is and this comorbidities complications a real potential a trial later non-surgical risk bleeding the the multiple is look this of effectively enrollment as can designed forward potential repetitive demonstrate to of surgery and mortality following the from on ATLAS to UGN-XXX’s belief surgeries increased risk include change therapeutic the by these bladder treatment Although, they relatively for invasive providing infection, We of hospitalization disease well so alternative repeated that useful to is It TURBT. updates providing

many are UGN-XXX UGN-XXX, care. may the advances there both we believe ease While additional and One similarities important patient in differentiation important offer that with of patients. represent is Jelmyto administration

from Given administer potential received the a we’ve nurse the our including clinical feedback to UGN-XXX. for trials,

to feasibility installation. We assess the for are planning small at-home study a potential

final to currently start study of We in expect planning are stages year. the sometime this this and

combinatorial non-muscle We will provide administration UGN-XXX, on we’re this immuno-oncology but patients for progress, more patients differentiator developed expanding cancer. as could believe a bladder pipeline, and high-grade our important with ease of initially approach, disease. potential is with be invasive we details an also that being for We flexibility which focused specifically

non-muscle of UGN-XXX X/X a that are zalifrelimab potentially technology. some and TLR Jelmyto disease and recurrence patients UGN-XXX. high-grade UGN-XXX, antibody life cancer. respond progression on that malignancy we our High-grade Liz with BCG. invasive between to or our focus invasive cancer Bacillus risk or combined And by using disease RTGel UGN-XXX and As a know aggressive both significant invasive significant with There bladder high-grade we a anti-CTLA-X disease characterized combination and with we and cancer non-muscle is of agonist low-grade differences immunotherapy mentioned, have that to and threatening bladder an muscle Calmette-Guérin is

patient treatment So strong potentially for exploring predicate of a there is this immunotherapies better for rationale the population.

generated that tumor to-date resulted shared antibody our model. decreased and survival been very before, in has the program anti-CTLA-X data and non-clinical we’ve in of as the UGN-XXX encouraging, have UGN-XXX combination the an As improved murine size

observed potential applied trend support locally generated the a our T we that ratios. combinatorial Additionally, a changes immunological cells CDX regulatory decreased the increased and T-reg It data as toward in such belief markers of is immunotherapy. to-date

to clinical trials and with MD be thrilled novel their given Anderson this collaborating are We infrastructure. program, on in innovative expertise

the includes as and progress clinical well UGN-XXX UGN-XXX and expect for studies We non-clinical year, UGN-XXX for to potential as of which program the combination studies this UGN-XXX, UGN-XXX.

are we continue We designs available. and closely to they steps share details next Anderson are MD on will trial as with working and

inhibitors the options in our where stems an highlight Glioblastoma combination Johns where expanding with combined immuno-oncology GBM. program preclinical medicines to from or University second diseases patients This RTGel research explore in interesting the on is checkpoint The program our modulation sponsor Hopkins the of we new in for focus in significant Multiforme to make with a with other novel intend setting difference. agreement need RTGel with treatment provide may technology unmet and local immune potential a

with to and technology diagnosed the surgery per a less research, XX,XXX GBM, is treat GBM. X%. most and with survival our It model cases impact of RTGel treatment include brain program with tumor, typically combining anti-PD-X novel are to assess today is brain chemotherapy. limited and a mouse with the common an radiation difficult around on this than of aggressive rate focus Our options year. followed in examine antibodies, anti-CTLA-X and five-year will by survival we this GBM is primary tumor With malignant respectively,

to that, continue leverage I’d While with RTGel exploring investigate to options. may and and centers, applications a immunotherapy, therapeutic turn early, the Jeff? both key in over And of within with local platform potential Jeff commercial we call immuno-oncology provide our who working to of our explore in the laboratory update. technology academic our like to

Jeff Bova

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

extremely There consistent net the from a a of and announced established are November June Jelmyto additional product and to patients. is number The streamlining The it first team standardizes start the simplifying UTUC. reimbursement patients into and XXXX. on achieved $XX.X surgery J-Code we on observed launch launch are temporary positive in important of on hear feedback start and lives settings $X in physicians Jelmyto patients effect their and response issued received we’ve is outpatient, team and our adult we’ve and couple making response Jelmyto bring of what believe to now patients. the hospital trial. and sales growth helpful Xst of the We’ve Jelmyto with on and and working quarter care. this that early we remains we our we and recurring fourth through throughout product J-Code our of year. The the patients the illustrate permanent mentioned, launch XXXX, the This the the seen to-date the doing Xst post-treatment, a a of the to to for testament end is from that work CMS January clinical million sharing that physician physicians translate C-Code, themes treated the continues ambulatory treating heard of with replaces in points Liz achieving low-grade and to in who for and tremendous are early calls center Jelmyto, identifying impact and As success been help great the of the have with specific XXXX from physicians reimbursement in Jelmyto patient a office a represents is firsthand value This that data complete access and Jelmyto of J-Code previously consistent with XXXX. will a In I’ve can million took on. promising improved include facilitates which receive seeing surgery most in that their we avoiding to

activated The is site. first

sites XXX or are X, have Xst, March up These of ready as over sites treat to who our sites patients. XXX treated from XXX and sites end As the are have activated of XXXX. year patients we sites at increased November

reps hospital where to target to sales force grow community to treated. our XX are number this the patients and continue as continue of most expect We accounts,

The one other treated to than data accounts note that or repeat is patient. point that have important is more accounts

seeing the the of suggested are efficacy working have the and physicians clinical all gone well. reimbursements components it As process of the of the drug, other

we March have a processes accounts, that additional as end place of and from As patients XX using and this is are in the XX that in up clinicians November factor XX support demonstrating critical This working, of identifying Xst, at to number Xst. comfort are year treatment. and accounts increased gaining and

target usage but of additional expand we valuable launch. to providers early accounts, number to less the As it’s in stages believe we this Jelmyto become relevant, and reach continue expect of and

We increased have market a received results team’s efforts. compelling the also showing research to awareness, testament of level Jelmyto the

of As awareness approximately November XXXX, pre-launch. to aided XX%, XX% increased from up

We down viewing that also due data in on of physicians cancer see like approval the increase. evidence XXXX and seeing we’re These industry-wide see take diagnoses based towards nephroureterectomy industry to collected the we in to We highlight that it’s about market moment treatment to procedures prior own as what slight that were expect a for XXXX, pandemic. down the of than at less a COVID-XX. the to to are favorable Jelmyto’s January saw research, my today in radical IQVIA phenomena shift patients XX%. and delaying XX% and one-third impact and the are least I’d were

trends immune not and tumors are with seeing low-grade patients these are treatment. to deferring also We

as we continues to optimistic to in the potential pandemic the trends the share relates to month was that deaths and we’re COVID it future, While two want evolve. are know the for important as U.S. to January harshest

patients vaccine in rollout. prioritize will the we population being prioritize have in seeking up near-term vaccinated majority generally of and early continue expect the treatment. patients before make with and their receiving patient low-grade These the to UTUC XXs Given the is

I are the supportive potential are the quarter first Based patient practice. said, of Additionally, rollout and resulting prioritizing aware coming the that of high seeing and interactions because are XXXX are previously field a being at These are as their all the vaccine months vaccine. potentially physicians, we the hear hospital some the reviews Jelmyto delayed trends hospitals reflect physician I’ve its had into on formulary new that with indicators to patient Jelmyto recent leading focused metrics than in continue benefit being interest in on level, adopting of of anticipated. That we and patients. are in physicians to in starts softer

as But closely are and in a vaccinated. to physicians vaccination and months, patient pandemic providers continues. anticipate Jelmyto this are We improvement monitoring access coming patients rollout the and as environment treatment in to

continue will access patients to to have monitor ensure We and to adapt Jelmyto.

deliver didn’t patients. and Although navigating for pandemic, parties and many I the remiss involved, and we our external our as their including the well our partners providers I to unchartered of would be healthcare our territory this to are team, thank team if as continued efforts commitment continues

with Jelmyto Our believe approved. team’s for of treatment Molly financials. experience bodes like commitment if that, potentially kidney with patients sparing would well call and remains to our novel, providing and And to effective UGN-XXX we unwavering to over I discuss turn potential with commercialization option the our will who

Molly Henderson

Thank you, Jeff, joined call. you and who today’s to everyone thank

transaction fourth touch some discuss I our the Before provide upon with this announced like end and I’d strategic details. and financials, quarter RTW year XXXX morning to

met, for pleased this potential impact of to sales the looking the annual surrounding X.X% well annual are support and $XXX up as we continued in equal that above million an $XXX bring reflects receive the healthcare The UGN-XXX sales team believe UGN-XXX, the and meeting increase subsequently depending thresholds that’s driven certain development upon annual year is cancer. X% of sales whose million, revenue financial important and research innovative with UroGen X% annual of net of position excitement thresholds. to important certain Jelmyto return annual to in confidence future on new as funding net to launch companies in and a million and by Jelmyto investment to sales invasive between RTW non-muscle to their X.X% on from of $XXX to annual the RTW If and will $XX and RTW payments bladder first investor are to net sales payments in Jelmyto decreased will respect is million. of cash aggregate sales partner $XXX solid patients. sales future million net products for We the worldwide global opportunity based mission influential of has patients, Jelmyto net the net us RTW not the in tiered with invest net and puts

receive and addition, payments up $XXX FDA will million future $XXX million and of In subject RTW annual $XXX sales to X.X% of of annual Jelmyto amount sales X% the net of sales both tiered upon equal net net global above has of on based an sales $XXX $XXX between date annual to that million. to Payments to equal million, annual and RTW X.X% based on received net sales approval, UGN-XXX terminate will aggregate million. net UGN-XXX

XXXX excited to our We RTW, execute review fourth on quarter take of mission. solid industry balance are year of to partner sales UroGen the million. now XXXX launched I $XX.X which and million. an $X net Full to fourth UroGen net year June the financials. XXXX leader of X, providing sheet recorded moment a for the will quarter product with product approximately XXXX Jelmyto were Jelmyto on end sales

cost mention I’d trends as revenues, we to few like Before we’re turning start that to external watching XXXX. of a

XXXX be our impact the Liz vaccine we mentioned, expect continue First, on the mindful have quarter first of to landscape pandemic an evolving Jeff and to and as results. rollout

it that severe on shipments we cognizant Second, year to the the the in patients. impact Jelmyto has of U.S. this first throughout had of quarter are weather and of the

end QX $XXX,XXX. impacts year, quarter are three and carefully Based received similar over last XXXX. delays these several We in we concerns orders for the of first year the purchases at the XXXX to XXXX. potential don’t $XXX,XXX that around of anticipate of or we bulk shipment holidays given approximately book were recognized patterns our revenue the on XXXX monitoring stocking in revenues Lastly,

million, December for related associated one-time to $X recognize of of of approval we in and cost the XXXX revenues approximately research and pursuant as prior periods rules, Turning and inventory Cost quarter ended fourth to respectively, costs and development with year were to startup XX, costs certain $XXX,XXX XXXX. Jelmyto manufacturing of receiving included of the expenses. the revenues accounting and Jelmyto FDA and

building partially respectively, through as that for impact deplete and We fourth and Research FDA cost we development XXXX, on approximately launch $XX.X the quarter had million, and respectively, and XXXX, costs fourth of development $X commercial payment to XX.X and Setting periods quarter and end respectively, XX.X XX, share, increase the $X $XX associated XXXX. The the million that respectively, milestone and research administrative our for XXXX quarter expect year a increased per December and $X.X activities expenses for year-over-year. XX, $X.XX includes Research related for of aside respectively, $XXX.X of December share for in and XXXX. million, prior Selling, to Jelmyto primarily in with periods expensed period related in as compared same $XX.X share, development XXXX, expense a expenses XX, per to expense X XXXX. XXXX. related or of Israeli million, trial non-cash million, same The share-based million by $X.X compared activity. expenses included were and year approval. clinical administrative $XX.X reported related administrative of or revenues respectively, quarter million in for our increase and to annual $XX.X $XXX.X favorable ended XX, million license the expenses respectively, from loss $XX.X and $X.X $X.X to of The the and clinical Authority December expense. million, XXXX, included completion $XX.X year June million periods in a million same the inventories million receiving and selling, and XX.X non-cash $X.XX share-based respectively, share-based ended in losses and compensation fourth and general December $X.XX the XXXX, quarter fourth costs and company’s first net same the unwind the year million we and and XX, Agenus. for million UGN-XXX per fourth million ended XXXX, expenses million and $XX.X This or share ended regulatory offset Phase compared and and agreement expenses development respectively, $XX.X payment of in $XX of million during increased non-cash expense of ended year as million $X.X compares The million million, Jelmyto for were to $X.X the reduce of million XXXX for the and XX, respectively, one-time administrative of the December and resulted headcount the million the period to primarily of Research for quarter to million, includes general increase the expense the studies, we fourth XXXX. first or $X.X and from by loss obligations million also $XX per as and quarter to the XXXX, Innovation million XXXX, of the $X.XX expenses same December and to UGN-XXX for trial compared year costs. quarter million sales compensation including Selling, $X.X general force and compensation resulted and respectively.

initiation is expense This market the the in to ATLAS $XX Phase Our conditions. year. million. $XXX compensation million last non-cash expenses subject for study largely $XXX X of operating of by is estimated million This our million guidance to late range $XX XXXX, to share-based includes of driven

our approximately and position funding the post and $XX was we securities supplemented we cash $XXX.X With the in I the million million announced marketable morning for debt. This Lastly, year to end Operator, equivalents with on strategy. no questions. year with cash in we call over year from to fourth by like quarter the We and believe a -- end that, would and turn closed are RTW. solid in this execute

Operator

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

Your question, please.

Chris Howerton

all? Excellent. I so trends Good morning taking difficult to is really that you I’m for of, and want year. be with pretty the you’re quarter centers, Jeff, numbers, or of the to expected net is revenues. there’s all academic off, categorically customers guess, of thanks seeing, dynamics community is to And see I questions repeat a accounts. to what in -- kind wondering there, in centers then terms your just I the start that first things just if understand last of first the year tend any saw more what’s progress fully you guess I to terms the respect expectations through revenue maybe and guess for the that appreciate secondly, the Great, there

like payer were think, fourth some there something then the have resets plan us guess, payment then, might the respect And be expected just I that’s related first I a weather some for now to in and also quarter. I I dynamics there to you And that? was larger perhaps maybe shipment perhaps, said understand Molly, for also, orders better understood the maybe the follow-up. help it quarter and with there’s or environment, numbers? anything think revenue that delays

Liz Barrett

It’s and QX your Hey. How I’ll turn answer then, and a QX. to more Molly, bit can about over you? Chris, thanks. Jeff Liz. question first little are talk you it to

Jeff? So

Jeff Bova

the But well. the identified have community physicians Jelmyto that, question have accounts patients physicians first hospital. your have we it’s patient address to probably those one the have XX% XX% that multiple are And Chris. multiple more physicians do that multiple Hi, or than as that or the writing their single patients primarily to Liz. in or for patients, Thanks,

continue So this community, adopt multiple patients said number the But my into expect will community can are I begin as will treat multiple of -- some predominant the more setting. translate the the -- to of out practices patients. and expectations time the for to more I in I past, being, coming hospital I

Chris Howerton

Great.

Okay.

Molly Henderson

your question was other Hi, the so population and we at went impacts starting effect, as reasons To February think that in the that the vaccination year. into this or that. when was it of our we look to we we to patient both alluded rollout to And as the softness Jeff the getting we I of population answer QX around rebound weather. discussed the get see and A I to that in Chris. relates started see lot on January as to, some some queue it vaccinated. revenues, and vaccine same To narrative we’re serve, the patient the

seeing March. in line so rebound really the with of trends And that in kind we’re

in the still first We’re quarter.

more… provide to going not we’re So any

Chris Howerton

Right.

Molly Henderson

flag a more as are because expect, clarity we couple go. the where few watching. -- some … far to market, dynamics of But weeks because those we more a that still as that have wanted certainly the to we’re we

Chris Howerton

Okay.

Molly Henderson

as maybe, looking lot from Remember, then, any got get there last of stock in and/or practices saw charges some we upon delays shipment they about lastly, referenced stocking of of that shipments. was last And to the certain indication a were ahead $XXX,XXX it to estimate some season, holiday year’s relates year, concerns. I to a $XXX,XXX we based

some year similar to and advance we’re of So that in we not going see a buying saw last pattern.

well. of the into as one market and So that dynamic some queues of

Chris Howerton

And one the or what maybe there? a in question the in of schedule And of with delays be first Thanks. and the could in the -- shipment the that, just then how terms clarifying installation or you’re of of quarter, another much that question to for, Great. impact terms be any just kind Mark, did be initiation of you COVID in-home effect is maybe and like treatment, may that, helpful to any of in just so would clarification impactful would context seeing Okay. maybe treatment or that expect patients do very as environment that payment just of respect the understand? be impact outside not primarily

Liz Barrett

take Jeff, the patient to want treatment? do you to impact

Jeff Bova

Sure.

rescheduled. a So it that few did to be had impact. needed We

a designed once that trial everyone OLYMPUS seven dose not and it’s got was the was Fortunately, every weekly though days.

a delayed we miss were shipments to or the reschedule OLYMPUS had, or physicians those by given able weather simply a comfortable, trial, obviously, two patients. they just were day in two, day and that they So the held therefore

Chris Howerton

it. Got

Dr. Mark Schoenberg

Yeah, Chris…

Liz Barrett

Yeah. Mark?

Dr. Mark Schoenberg

about question the for home thanks Chris, installation. Yeah.

that has But is an think, fostered the concept I for by think a therapy. is this The care this it’s one. home which of accelerated really out is with was with box. possible and been, company, of recurrent I innovative patients example really in the disease of very innovatively something COVID, thinking which

positive accelerated because population. we to this do to interesting treating patients. And examine think of in that iteration right a makes want made explore And And so fashion. an it thinking I I step of have about whether this and way sense, direction COVID, it we think really order next obviously, study the to very us in the in it but we for innovative the think, think represents about is a has

also So But I completely think it has with times. had corporate as a with many I little heard, do bit Liz, think larger consistent articulated our it’s you goals, COVID. to

Chris Howerton

Yeah.

the great. and answers appreciate Well, the all right. so much all again for All Thanks progress. Okay.

Liz Barrett

Chris. Thanks,

Operator

Thank you.

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

Your question, please.

Derek Archila

the Hey. Good morning, on everyone, and updates here. and congrats the news

So just two questions from us.

in kind how or profitability, And just curious some Thanks. ramp the to first have now I think just thus the that RTW Molly, how you understanding the you is impacted you’re is with about J-Code of for guess, to one wanted may the be trajectory Jelmyto trends an maybe kind of I second of for, the the and then for think Liz first of things I way you can enough the and far talk is that this I think Jeff. that? the sales to happened get you quarter? it, run with now have to yourself maybe the thinking investment, get do some

Jeff Bova

Sure. Good morning, Derek.

Liz Barrett

can you answer. Jeff, Yeah.

Jeff Bova

Yeah.

Liz Barrett

Right.

Jeff Bova

community, code. anxiety the to J-Code the So so correctly how be for to liked -- little CMS we’ve give being a has J-Code, the not, in They’re drugs. the whether having little in or bit a they around warranted with what and to tends have the -- specific CMS. I the guidance community, build seen the particularly bit code it’s them trained miscellaneous with regards on product more

to I J-Coe. a community expected uptake to roles as So well it the certainly is as continue with helped in having regards permanent

Liz Barrett

in I’ll then your perspective well. on you give Molly, want to as do the financing chime and

Molly Henderson

Derek. Hi, Yeah. Sure.

this to that we’re excited announce morning. So financing

specific it’s safe that when any provided efforts to have the us to funding say to continue breakeven, on us relating but guidance anticipate and to trial and certainly allows into XXXX UGN-XXX. additional ATLAS we haven’t we the this Jelmyto We on ability launch gets

Liz Barrett

Yeah.

market raise other the to the where Derek, think, and going comments is I I’ll a from investors money, and questions around go to we’re to out of obviously, we’ve comment needing diluted other only non people and make wondering lot financing. this had back -- and is,

now. answers so things do question. need out a that right I it think, we do funded that think, and And the market depends go And we to to the we right need we’re just, now, this have I hopefully well don’t to to

tell, something, we’re excited I we find so right? if think we’re But you about, opportunities. doing in point be of about always the looking we need to change don’t for we’re financing excited we’re this time, where we soon. something as But expect might there’s can anytime development, question diluted think, business constantly find It’s sure and things. something to I at I’m that we get, funded be any new

for thanks question. So the

Derek Archila

Congrats Thanks. Yeah. again.

Liz Barrett

Yeah. Thank you, Derek.

Operator

Thank you.

Morgan. the line Eric Our next question from comes Joseph from of J.P.

Your question please.

Hannah Adeoye

This taking Good Hannah Thanks the is morning. on for question. for Eric.

Just a few us. from

that a the how to OLYMPUS trial? CR that. you was of then to I a able the speak So frequency mentioned proportion number you maintenance a now And setting? the earlier you’re and follow-up into of a little patients but response, achieving are been use therapy You the of determine able further to have what are to commercial launch, in after seen that have that patients a complete compared have

Liz Barrett

Yeah. Jeff, why don’t you take those?

Jeff Bova

Yeah.

physician we have that tell -- OLYMPUS is how that’s As consistent on have. what the it’s with we to I they saw We information said, trial. choose us -- the doing if the OLYMPUS whereas patient

maintenance. something doses -- the patients physician of that of, the maintenance the really, are the bulk but that will on haven’t We we maintenance, patients say I majority has six treatment, is putting more getting maintenance this, discussion. it’s the in with more the considering no physicians patients, been at have and

Liz Barrett

really at Yeah. what or CR. anecdotally, from comment, The CR, least capturing right? good anecdotal, is, as say, seeing real world world, we comment are But obviously, have We only about capture would come Jeff don’t -- to the what well that’s we’re I better not so real do about company well. we as we that but the the not only and MEA’s we’re and efficacy capture, in we safety have good tolerated -- and to feel [ph] it’s

question, follow said had up Hannah? So you you a

Hannah Adeoye

Yes.

that retreatment was a if trial, to interest come of in interest mentioned where pursuing any little had while and we might wondering a if particular just still timelines ago You fruition? that see there’s

Liz Barrett

Yeah.

is we right? the We’re study treatment definitely have feasible. because The patients start to and then reason as on have recur, and have say will So in soon that to I that it’s recurrence. well a interested do that as they

would that we are obviously, see treatment So months. patients six the study, in last start the on not the just starting

of It’s label that wouldn’t we said into have retreated, data additional in is to would year, XXXX. expect we stopping retreatment. were study like it generate to So site from this there know that end not our we retreating that, gotten on but physicians patients. probably in today, do patients till just the that start were really Having that the

will label. As I said, we’ll it’s even quite -- we part to study. of actually But months able to our be like start that that’s it would be data. few before a But capture

Hannah Adeoye

helpful. Great. for the Okay. Thanks Very taking question.

Liz Barrett

All right. Thank you.

Operator

Thank you.

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

Your question, please.

Matt Kaplan

me let my to congratulations add and Good Hi. progress. morning the

going to of a have backlog roll backdrop you been these bit in some by as Are seeing receiving patients this doctors just dynamics do down. little of that and patients patients sort a seeing did seeing, Just wanted and awaiting therapy the sometime to receiving of dig not you are the to think them and start given that in you treatment given the the and of kind year? to pandemic practices this I treatment patients, guess, you’ll you’re diagnoses see

Liz Barrett

there the nice that Yeah. he question. that cases went It’s Jeff for patients. our on am I Thanks see saw of you the clearly our before, COVID did up. versus go COVID went as in COVID Jeff down, some the work right, dynamics even somewhat when can did we Hi, And diagnosis understanding ask down and of patients you come patients were But would of in Matt. we not I Liz. beginning comment. does, launch, had to going think, that to speculate,

likely do first So the we in months that had launch, were think of waiting. that of the even patients kind been six

you I exists. we’d love quantify. to Jeff, perspective. But your to so, hard share Matt, dynamic for And It’s that with think,

Jeff Bova

that in country they And when the a to into Matt. the on guess been, Thanks, they answer they have did put I delay Matt, where that will are easily say depends patients. the I to begin cases open procedures elective you question, point, Sure. the I prioritize in And these it on in bad how put procedures. place in are, then have now majority do hold. electric put your had procedures to elective up.

going we’ve an down, And patient so as down, we COVID see with we’ve as seen seen going cases -- in increase enrollments.

Matt Kaplan

over That’s you your the sites have of number far? XXX sense a terms so that remarks mentioned prepared Can Okay. you now, And of sites guess, I those helpful. that have in us you activated. treated in give patient a

Jeff Bova

Liz…

Liz Barrett

Yeah.

Jeff Bova

…we yeah, those… haven’t provided,

Liz Barrett

No.

Jeff Bova

…exactly.

Liz Barrett

Exactly.

Matt Kaplan

Yeah.

maybe question that powering a the cancer? and non-muscle I Can then, low-grade the And ATLAS Okay. endpoint risk study. invasive a study the sense of bladder for kind intermediate you of, Mark in guess, for give the the us remind of on of terms just us

Dr. Mark Schoenberg

sure free I’m free an Matt. Thanks, probably it’s event trial. primary or survival. driven you recurrence the Sure. And is our disease remember endpoint as in discussions,

primarily the surgery. separation between look interim group treated are are primary that here event receiving is who objective So analyses UGN-XXX curb for those planned the versus There with driven. are to

our pretty occur. that’s year, the conservative will that a with what about expect think when recurrence those design. be approximately you control tell arm, we to XX% the at in probably shared been that along can’t And rates we’ve we I higher So fact know we we’ve or about

But And hope recurrence survival. So endpoint may that’s to the is free on further I Liz as want about thinking well. in terms this primary comment the trial. of helpful

Liz Barrett

No.

I think right. that’s

point your question, the Matt. powering your -- I to to think

us data from a recur own to a well. we the for on said, and as those the Phase will XX% and used are for -- around side but a meet XX%, only XX% risk, literature, if conservative we TURBT that, patients assumptions, criteria intermediate have used of our obviously, in anywhere knowing for Mark As X they the

technical So can from where in be a successful put a standpoint. we position ourselves

Matt Kaplan

detail for the questions. Great. and Thanks for that thanks

Liz Barrett

Matt. Thanks,

Operator

you. Thank

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

Your please. question,

Paul Choi

I comments here patients let if with world currently? we or first. if or at treatment like just progress as hospital? in my in of being if congratulations could, being potentially to morning, versus Good you risk my treated well. in the see does a population model is the want the Do revisit at secondly, just your then -- I potential of and potentially is add we’re as function And as to that with here, there Hi. this economics real and be on the paradigm team, would guess affect to regard intermediate this treatment me a it for clinic the home. ATLAS, regard treated twofold home environment potential maybe UGN-XXX question how just low-grade for

Liz Barrett

perspective, easy are possible think, Yeah. How Thanks, we make as our Paul. The things to want patients. as you? I -- from on

You about think start to TURBT.

misunderstanding is information, think big TURBT, deal. that, think I the one of people missed no of

have As the mortality. more patient in we TURBT, factor population patients more talking we’re three we our they of share about. the as study an more XX% had or and independent of And it’s know

So, saying And and population. work. one more what’s our know differentiate there how we which, we’re patient do from that an more, is today, doesn’t we therapy can elderly frankly, this

it all, it at through will easier obviously, think or some the I patients the So benefit these treat We of think to But those a are to home. They to at in health because it’s the opportunity doctor, on home, the the patients you will of just be get one to majority company. unable get would I having clinic impact unwilling still frankly, get to don’t to them. an will it make that, be patients treated. think additional home a at financials who would go way. -- treated

for if to again as an but comes that ability they to we the is money I the -- and important. office, that is obviously, more So the option, the patient difference think physicians, have guess would make into offer patients

us would associated change their see really financials the revenue the obviously, the financials into they for office, for the with came the office, if patient don’t So would that.

Paul Choi

you’re on and here. And maybe the factors doughnut Medicare given this Can seasonality that on in then those specific great? here this as as so point this Okay. to the just population that the help seeing quarter far in side? your more just reflective or for quarter, various concept, and in you of population would for you regard commercial conceptualize COVID factors? be Any you follow typical is us with view regard Is of such comments that first maybe with on Liz. Thank you your for either in Jeff, think historical to a mentioned the trends more put practice this or the to holes kinds and you up clarity

Liz Barrett

Yeah. add maybe Jeff, after. you want to comment and I’ll something

Jeff Bova

supplemental. Sure. No. But that the I sort -- a we’re we’ve of vaccine, a very so that and the we’re we That a out standpoint. get there’s don’t that seen insurance. had minimal -- provider. as accounts to with majority hospital that as don’t have there I patients patients the now a of of provider We have because Things to pushing majority normal both reviewing. number impact great good prioritizing are we is from that’s to supplemental are starting our thing have very impact much, are formulary standpoint within with -- the patient a Medicare accounts -- out off view back of regards the think small or pocket,

Liz Barrett

just… And Yeah.

Paul Choi

Okay.

Liz Barrett

will comment continue that … We trends. about the don’t way. think it that

As Molly March. it matter already start rebounding we’ve mentioned, as a seen in of fact,

that country, now Not the doing that out the says there sense physicians, hospitals in So, around obviously literature it that. the wait weeks, of few the there Board, vaccine. publications instance, institutions across There’s patients made that just tons around get a the across but available, vaccines one, the out that and the this and these Board. country are

that And be position. as we trend so expect see said, we in a don’t good continue think Jeff and to we’ll

hasn’t So right? the just thing. all, at changed timing on for outlook more the us, year It’s

Paul Choi

the for and Liz, Thanks Okay. call, congratulations again.

Liz Barrett

Great. Thank you.

Operator

line you. comes H.C. Our next Instructions] Thank from [Operator of Selvaraju from question Wainwright. Ram

please. Your question,

Unidentified Analyst

speaking and Mark for Ram. behalf Thanks is of follow-up. This two morning. Good our I questions a questions. then couple COVID of [ph] taking have impact on

I anticipate then the in being because [ph] do that Jelmyto months if you of weren’t effort in you coming COVID-XX the mean conduct perform to is I and in you but ATLAS they update sales And being logistical you promotional context trial see enrollment the mentioned, able of any are activities in progressing COVID-XX down Thanks. the to same what trial you able mean, conductive terms previously? provide do challenge using, mitigating are -- and to pandemic of the you how execution expect COVID-XX, First so, enrollment, there, the to that? on due

Liz Barrett

not I’ll delay, so study. about really, I expectations there be the likely say, we would comment for that Yeah. enrollment. our would anticipated

enrollment, of couple obviously obviously, then of it the anyway. a make sure amount the delay study. didn’t. there We’re There that, world were slow that did study, around -- that we that doing starts from sort countries but were We countries an started other of the

be And COVID, our sort sites of we if area initial to that to work or enrollment would felt we actually reasons we But with we we shutdown, of so that sites because to one expectation, country versus increase and the like we’ll that the is have continue enough make sure that wanted number of a that. able elsewhere. through makeup

want Jeff, do So, and promotion? on to comment you then,

Jeff Bova

Sure.

improving. week, fortunate I weeks in with what So out is the and get is interactions. was face-to-face accounts to ago face-to-face last seen increase some we’ve an a couple

So representatives do they’re face-to-face presentations have And they interactions. lunch. over opening come up to and open importantly, in more up to

that taking are face-to-face to an cases see as of the have I to lunches field physicians, interaction I lot face-to-face being continuing with down. reminders, that continuing continue. of what excellent those the limited of presentations to that’s open interactions does prefers or time. can mindful beginning a places But place, So say COVID virtual The limited, at Where -- slowly are happy yes, that, job that more up. this am and still office respectful virtual have we I there’s go

Unidentified Analyst

think the sites one Okay. over patient why they expect more next to you do Excellent. if number the of the of substantially that, number why between of the And sites quarters? the you And treated than activated Jelmyto with not, course several difference do have and narrow not?

Jeff Bova

No. one had to treating we I grow. opening to physicians that we asked sites more want -- I get mean, all want our I We’ve patient. question expect of a point than too. are to the I up. the think, mean, activated, someone where both it to,

You representatives are the office. you in to have champion in have ask open reps to the the a But obviously and go of physician. and goal the -- initially it other they up

So you have it.

number putting more as that that accounts on a on for influence or it patient, either of finding numbers to formulary, to experience either continue that that it looking once certainly both expect I formulary, have using peer-to-peer large then patients with we’ve a got patient the they So grow and Jelmyto majority during it of part all goal meetings other their is an that with boards of the tumor us or urologists Jelmyto that talked for account within to of medical about, I discussing a their agenda for their, urologist. sure considering these physicians Making key get patients. with accounts have the we’re

Unidentified Analyst

housekeeping two Great. final Okay. the And then questions. just

impose of specific require the within other on to these So, And by paid RTW additional does not any any RTW so from UroGen’s received have if commissions funding funding there or will if secured from additional words, time? any, of investments? consideration amounts are million of are conditions additional So, timeframe back period RTW in a IP right restrictions $XXX the tax?

Liz Barrett

Molly?

Molly Henderson

Maybe -- timeframe million answer over that $XXX achieved no commitment the Yes. that period yeah. is To Sure. there’s in certain event time.

no commitment. So no question, there’s answer that -- time to there’s that

interest that would they far these And IP that’s other nothing at Jelmyto. but BB security out prohibit collateral, interest a ex-U.S. as us activities to in the on main As products. certainly then tech have look within we of carved or well, certainly, strip as the believe

Unidentified Analyst

for my taking Thanks sense. Makes questions. Perfect.

Liz Barrett

Great. you. Thank

Operator

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

Liz Barrett

Great. Thank you, Operator.

what them. accomplish, we’re really that with have As progress we our with our able to XXXX, need well we access both exciting It’s back were our pipeline. medicines medicine, to our an committed in company significant patients that to in we’re approved made in pleased look and time first as ensuring as

of we continue our growth long as dialogue a pandemic, forward the look to you strategy beyond. hopefully, advance and other in with the XXXX we As and to term look side we

at interest for you. disconnect call As time this you always, today. appreciate and thanks company support your we can time. our Thank the and in Operator, taking the

Operator

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

disconnect. now day. may Good You

UroGen Pharma (URGN) 18 Mar 212020 Q4 Earnings call transcript