VRNA - Earnings call transcript Q1 2021

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Operator

Welcome to Verona Pharma's First Quarter 2021 Financial Results and Operating Highlights Conference Call. At this time, all participants are in a listen-only mode. Earlier this morning, Verona Pharma issued a press release announcing its financial results for the three months ended March 31st, 2021. A copy can be found at the Investor Relations tab on the corporate website www.veronapharma.com.

Before we begin, I'd like to remind you that during today's call, statements about the company's future expectations, plans, and prospects are forward-looking statements. based current are statements forward-looking on expectations. management's These of and nor involve other from known statements results, results, factors are unknown the expressed implied and our trials and impact our cost of and forward-looking promises neither on our performance, the actual without limitation, our statements, of or pandemic and These including, expectations status, continuity business. and materially guarantees risks, may cause to achievements the be that the by COVID-XX recruitment, different timing, important clinical uncertainties, the Any of represent such forward-looking management's statements conference estimates as of date call. this

cause While point views to in elect obligation to update some it future, statements events disclaims any at even the its company the so to change. such may do forward-looking subsequent if

this Officer. is available turn the and will reminder, days. now David a Dr. Executive to recorded call Zaccardelli, like remain I'd being Chief call to XX for As over

David Zaccardelli

today's you are to Thank Officer; me our President Chief Martin, our Kathy and welcome Hahn, of Financial Medical Chris today our Mark and Officer; Rickard, Vice Dr. everyone call. Commercial. With Chief

The to another year first tone substantial a set of Pharma. for be progress Verona exciting we what quarter XXXX for of expect positive

ENHANCE-X to U.S., we in months, trials, face ENHANCE-X the sites past clinical in COVID-XX patients Asia. our two into clinical continue the X across to Over three trials and the ongoing the trials program announced and headwinds pandemic. continue trials. ongoing Well data recruitment clinical we Patient enroll and Phase is ENHANCE in underway Europe, tolerated from from two

remain both of in enrollment complete our in the second and situation the navigate on We studies continue to on based enrollment current projections, to currently track half XXXX. we and

the conduct clinical adversely in pandemic COVID-XX effects to its trials. study our restrictions, community the However, patient increase affecting ability availability, enrollment and ENHANCE continue site personnel, to is on local and

vaccine the worldwide to impact and the half XXXX. steady complete we improve on While of reduce expect to of second our continue enrollment, pandemic’s progress implementation the we ability COVID-XX continued to make in the enrollment

XX will weeks. subset ENHANCE-X patients safety force of endpoint measured in ensifentrine of over health a symptoms In actions through placebo via volume reported tactics of and monotherapy by studies in bronchodilator is expected lung tools. to replicate XXX weeks also weeks longer-term recruitment as supporting XX outcome over quality after evaluate other studies validated assessed moderate two to with blind study as to double are added The efficacy on are effects ensifentrine specific and therapy. in are patients. to the or of secondary increased site FEVX Each function patient designed XX two include related XX designed addition, advertising single over and expiratory of approximately mitigating endpoints measurement second the evaluate randomized such approximately controlled and background we logistics. pandemic XX symptomatic COPD weeks. treatment. and COVID-XX to hours with Key The enroll COPD measurements is SGRQ The data life severe safety one patient of XXX primary improvement ERS including

or with and days a after ensifentrine placebo met dependent four COPD announced the endpoints function endpoint our to ensifentrine analysis. including of to severe formulation with inhaler improvement hours ensifentrine in in statistically improved treatment. Phase assessed. pressurized lung part by multiple and in compared metered study FEVX PMDI analyzed demonstrating post dose morning delivered also trial patients. will trough clinically dose February PMDI of will of lung a Exacerbations peak Additional be be seven peak In dose and individual we significant X the results primary with FEVX function, pooled from of over by moderate Ensifentrine positive the dose

statistically powder and with our no to safe clinical XX trough twice of FEVX meaningful hospitalized plan added from X and in with of of not hospitalized new that there or DPI clinically ensifentrine COVID-XX. adverse including These on and dosing FEVX placebo. four ensifentrine The in determine with The studies trial. opportunities and this with of patient with provides to we efficacy PMDI consistent nebulized similar ensifentrine, study, for study well a efficacy of daily variety inhaler reported an the in recently ensifentrine trials demonstrate tolerated not with evaluated XX and regimen clinical data of on was formulations. demonstrated development at significant ensifentrine treatment across important patients notable COVID-XX pilot care and signals on COPD designed are treatment with ensifentrine time. was data we study lifecycle to results of event standard any results was this ensifentrine in outcomes. single Based Last was added over demonstrating to do dry benefit hours, partnering. and Phase to pilot ensifentrine if standard formulations from were dose with of the study patients further of profile designed observed addition, -- The average management, the improvements with care the PMDI and for of support and and indications, efficacy a COVID-XX treatment in In PMDI expanded DPI a week, via patient

developments, significant portfolio. and across Lisa area products in Chief specialized non-executive bringing therapeutic Vice planning director. the respiratory Turning worldwide Business appointment therapy She of and to responsible to experience the marketplace. commercial and Gene other Board commercialization of U.S. for Deschamps, is a assets as Therapies has Lisa the President we global corporate with and and strategic pipeline our gene Senior Novartis Officer, strengthened

be leadership to prepare the extremely we and commercial will strategic valuable As commercialize to expertise team. ensifentrine, her and

we of life be Including presenting second in data Conference. three quality do ensifentrine clinical trials abstracts symptom, our XB Phase XXXX expect International nebulized exciting and in anticipate and Society be May, quarter Thoracic American XXXX, complete ENHANCE-X longer-term at with the will demonstrating during the announce XXXX progress, we we first the ENHANCE-X XXXX. both we productive from on in year favorable and recruitment as COPD in the first we line to will In of and safety, milestones XXXX several results. ahead, half another of from coming year Looking to important the -- based will the of study beyond. X of the turn review Mark we and half half forecasted expect to data over in second now to to of top enrollment trials ENHANCE from and our I financial expect call Phase

Mark W. Hahn

the in XXXX our $XXX.X development the programs tax with cash cash UK in of and into and receipts from We debt Dave. support $XX clinical operations equivalents. We ended first the million financing you, credits believe will cash secured November, position, quarter million XXXX. and facility Thank combination of our

XX, million development million ordinary first March million charges, million QX in a charges. $X.X a credit costs for and for with the quarter for primarily in of the ended March This was the costs quarter tax increasing share, Phase ADS for with the in XXXX based First ended compensation ended quarter X This for X XX, $XX.X change XXXX per program. loss for share UK administrative the last for costs reported first first of the first partially in the quarter a executive compared quarter quarter compared or P&L, and higher to share year. of to clinical the for compared ADS incurred the the increase were R&D the after at loss the per per Research XXXX, The or share first of March quarter XXXX. quarter of first of tax by was $X.XX to ended compensation an million million, represents of Looking XXXX in program $X.X the by compared XXXX, ordinary same period credit first ENHANCE XXXX, million, million for an qualifying loss and expenditures $X line the of $X.XX to Phase $XX.X was General driven due XXXX. XXXX the reported to offset XX, quarter increase an primarily March the $X.X $X.X were R&D $X.X costs the per $XX.X XX, increase increase to in million first for $X.XX based XXXX. $X.XX compared

coming to We the expect increase in continues. quarters on an spending the operator the I'll tax back ENHANCE program as Q&A. call credit the in turn the for now

Operator

Instructions]. [Operator

Suji Our Go first ahead. question from from is Jeong Jefferies.

Suji Jeong

my Thanks for question. taking

of to curve third that I'm in this mentioned deeper whether you're you this enrollment quarter the of complete first be expect wondering you. part quarter, I to so the to in acceleration you and by end seeing continue already second if the to enrollment think quarter? rate, just Thank enrollment guys previously

David Zaccardelli

are. the to mentioned thanks It worldwide. accelerated, There's Suji, far is constant XXXX, recruitment we're we've part And still enrollment evaluation on with and the enrollment Yes, always how on guided end Hi where as course to process. question. we I today the also I acceleration as so we the complete week-over-week think continues from we that of a as beginning that call. on trajectory our our and that for that we're how where progressing of are has based progress of by within feel of the

continue increase enrollment, steady to impact to mentioned mentioned, continues constantly pandemic I I As to COVID-XX our week-over-week. ability we as make progress although

best our moment guidance XXXX. a is are the trajectory enrollment us of that end that at on by to I the So that of completion think we gets

see that recruit impacting half that retraction And sites we're time continue unable a any still However, could trajectory, if globally we as don't improve the continue the second but to this year, timelines. of see a and have I make continues mentioned, progress progress. in enrollment, if vaccine level within also, jeopardize we our we in to COVID-XX see is to enrollment, looking even constant though would it At to the its the of we especially in situation that patients. to COVID-XX

So for of I sure on the continue think we're we as quarterly still you we'll on update mentioned call and the to call. next course, guiding

Suji Jeong

total question XXXX, half plan you. you ENHANCE-X, data? top Great report many that to ENHANCE-X for and Thank could how sites trial in the and for line follow-up of ENHANCE-X first to open and is you are when share do

David Zaccardelli

Right.

start I off won't as specific two. sites, far or think stating numbers we'll because inherently, maybe as one I So

to Europe And a sites XXX way on XXX Asia, we the primarily over the U.S., Korea. in global each characterize in I think best have sites So South in basis, involved well involved in over primarily well both and is studies, that's would study. in

our And We at look based with that order so sites much on we have to sites our the enrollment of a continually. right the we projections. very in interviews number projections, our believe, that support

the compared number, added the impacted by at to small quality feel or day, have. definitely We to That's have may of want currently wouldn't this we have study. replaced of a course been more we conduct have are. we any end sites we in we been expand But that the to sites total than that sites number of and COVID-XX. enough And relatively sites order

to data XXXX. on specific I exactly think early get too when reported be in it's would

As in XXXX. the second based the report we we where specifically the in XX that. are enrollment that into stand in on pleased based mentioned that able of impacted, as on targets We're subset first we the here track We advancement half are, be enrollment of of are of to ENHANCE-X ENHANCE-X our patients come half These on of and our ENHANCE-X in weeks the should where with subgroup today. the trial. the XXXX,

project XXXX. So times a but it's to too exact coming early little together in

Suji Jeong

you. thank Great,

Operator

Our next Liana from from Wedbush Moussatos Securities. ahead. question is Go

Liana Moussatos

Congratulations and taking thank on you question. progress for my your

wondering more which the tiotropium target PDE -- on and events three PDE mentioned especially just it mild with a look have were significant them on is which So any adverse would of combination and X cardiac mild, fluid PDE and GI inhibits events. and a both AXXXX. a and the abstract chemical of adverse for Ensifentrine, very or issue issue was X is the abstracts more X looked just inhibits I that? very ATS And ensifentrine comments modest top is Has you GI GI GI both data such that it it mast, symptoms has typically why.

David Zaccardelli

those general a to Right. turn make to data question the in speak Kathy abstracts. to the and Rickard over Thanks, Liana I'll definitely and I think Dr. comment

more think that regard the is first have route the keep a inhibition of administration favorable thing by the think of I with X I by versus profile the of ensifentrine a route, exposure. route mind course, to we oral with or in PDE systemic inherently to an administration, inhaled route provides especially safety

to route But from safety inhaled Rickard think standpoint. and I'll favorable that believe we efficacy Dr. the have I So date abstract. shown be to and the comment on definitely a has an

Kathleen Rickard

getting route is sun the correct and low when that's events. deliver a and exposure you which safety Dave. lot what of Yes, leads are The driving you're generally very adverse inhaled the concentrations,

an So we the symptoms agents. and by but spirometry can both these those of route, with types to of that delivering oral it get life, in of also effects are inhaled by delivery able see and efficacy wonderful limit we quality side

Liana Moussatos

Thank you.

Operator

Nash Our question next ahead. from from is Genuity. Edward Canaccord Go

Edward Nash

good Hi, so taking for Thanks morning, my much guys. call.

in For Chris not the quarter is we the it or expenses be second going more on just one, won't COVID-XX after further with see quarter first meaningful? a I any this to development. there quarter, anything had that's assume coming or I quick housekeeping won't the any regards just that anything

Mark W. Hahn

Mark. is this Edward, hey Yeah,

small a cleanup bit will program site, costs amount I the the just of was on that. very QX, probably significant. up not significant anyway, payments of spill expect spend that for as anything that we a but wrap There's a little So into program don't

Edward Nash

Okay, to than slow equally the being say lack So is, that's saying great. this could second And two being ENHANCE, COVID that COVID know or enrollment my first given site, obviously issue lost to patient of in be to and then overall lag number that of you're into is much is parts it's loss question. the that of kind is a maybe territories, more kind seeming with then across incorporated question of Thanks. to with with to taken territories pretty we'll patients care this of powering that result and of, related part follow-up of increased in it, we'd second mold and is rather compliance that constantly? resurgence the see to there regard seeing I all across trial? the more, my is up, normally an been tends their one than how's And follow

David Zaccardelli

so excellent of questions. thank of you for both them mind. Yeah, no, of those course, top And, are

wouldn't necessarily slow characterize I as First, it enrollment.

in I week continue and where we're over a And mentioned on as we're tracking think XXXX. the and our to enroll date trajectory patients enrollment on. from trial. it's enrolled a of we've we that into current pace projections sites complete I Week matter still to based to

have in if impact, that it if have However, means, continued we vaccination a us want continued or to I through that improvement do may say put other cannot would that. improvement on COVID-XX the we cannot trajectory not accomplish

we to trajectory that progress us made not currently still this see on However, the goal do studies. the both for and we're we've year date, gets and to

a we're I that be, can impacts. So, week-over-week something the confident assessment it think but as we is is of

countries in then, can are United difficulty that than as Europe, and mentioned we Korea, South States, on others. only as within geographically I you geography, are Europe. more globally As have far course, not of a throughout there some the diverse Eastern read And course, Western hotspots as of having

sites some more acutely. have challenges And

why number have clinical of those the study from the reasons issues. the was mitigate sites the start we in rug to of One

more COVID-XX by we in that all That that sites, more to while off example, so again, we able of far much continuing expect, us sites COVID-XX changes others coming to the and September, impacted are for our as acutely, have to accomplish may goals. be we August, And some challenged July, the may as that impacted less recruit. being months we recruitment in over to be the leading grouping and are of impact constantly have better are

progress. to we assess So and one we a it's continue make weekly dynamic process,

last very up your comment. valid think is I follow

to all discontinuations follow track sites clinical the constantly. patients to that or them general, trial, helpful a remind up occur. always loss we of work We are with never in course, context that of inherently in course, Of the but

COVID-XX an needed sample ability in to so don't built in at to properly, have powered if to And discontinuations. any we impacts of to the this is we're that in our we as the size we for we we built right already need those the it But addition, program. order already protocol, And something We into adjust discontinuations. had do time. in increase believe handle option now, believe that on

aware we're calculations. discontinuations fall that within our sure and our So attentive. we'll make acutely and power to And continue

Edward Nash

in Great. just been to bit any flexibility centers to little the more be I'm based to if And do jeopardize what could just protocol violations related I Clearly one thing have with COVID? have of protocols But guess, kind there's as sorry, I that not flexible, -- just the but any the you COVID on with today, obviously is of there probably trial just in to some, way protocol to had the violations. avoid a regard itself. with

David Zaccardelli

Yeah, again, assessment. it's a continual

study during I the of before because impacts. COVID-XX the knew we of think the we planning issue end of advantage that had that study started, the and the front

we had on have for would order the facility And in in multiple it the be that to flexibility, the adjusted protocol understanding all to assessments. order run in accommodate patients that to sites difficult day already, so same their

So the windows, but we still achieving endpoints. appropriate widen for our

And is of accommodate assess protocol designed the to the we'll basis. our conduct. vast scheduling look an that But so we that on at timing, to study and think any help impacts we that ongoing in and overall continue majority have related to the feedback, appropriate

Edward Nash

you Great, much, thank so very helpful. you. Thank

Operator

from Go from Our Joon ahead. Securities. next Truist is question Lee

Miguel Coelho

going comparing give data COVID-XX for third review study, random questions. Miguel versus the Thank standard versus have I analysis, pilot are good patients versus recovery patient this is And our side? home versus on that steroids can the option number clarity group were Hello, released of the treatment you you on further And then thank to aggregate requirements taking us patients the on a you from their follow-up, Coelho for full in regarding some you. arm Joon. and from data care hospital of release hospital from

David Zaccardelli

you I'll additional Again, the to then and just turn study, it the things we parameters A was of for line and question. of it to XX over placebo report course, in standard a we've We oxygen, to number of receiving patients, XX mentioned, Yeah, thank did for of relatively mind. placebo. of provide color. for so top signals of want care standard results top ensifentrine, on Kathy comment the and mechanical general small XX keep meaningful ensifentrine you as to no such when that, top use hospital difference assessing days between other use as on efficacy progression of of to which ventilation, related on care. oxygen, saw a or

care include steroids course, of indicated. remdesivir did Of standard when and

the to in signals additional to trial. we follow-up us if did and notable was this study so And see really studies, for see looking were not there any in

study We I appropriate will, add and to on analyze we as we appropriate, as ongoing know don’t as information come in course. out in provide will you that? anything the fully it data Kathy, addition this want in greater detail. additional we'll from it look at That's to due always and

Kathleen Rickard

the -- and had discharge Yeah, only all discharge say hospital. recovered just There at patients no patients to use. the study. deficit that in no after in patients placebo from one very group readmission oxygen And most was well, the

both the number good that's all treatment of year we on remdesivir. as all in to that patients patients very fact good mind a dramatically dexamethasone good and COVID treatment. outcomes keep but saw in the in very the need expected face said, patients have better has in than from of changed that and receive and that Dave we And perspective, you So

well. patients all very recovered overall, So

Miguel Coelho

still follow-up, so will you to results try this try if of light ensifentrine in question think your I these you cash treatment And runway? consider those and as that travel, standalone guess design my a to still is if of implement to would answered pursuing affect a which how

David Zaccardelli

time Yes, single a specific we regimen and data at have time, in follow that described. on it mind as And that signals a we've so notable clinical in we of standout X milligrams to we up based because see with to PMDI in studies dose have in do patient ensifentrine there additional no, productive b.i.d. this by tested the did studies, I keeping think not population seen would were efficacy at no COVID-XX. additional this or be on

at would that definitely we do that were this the However, we but in time. update not to if advise everyone change future, and see happening

Miguel Coelho

you for and much Thank luck. good so clarity

Operator

would question-and-answer to turn our over concludes conference like Go This session. the David closing remarks. to back Zaccardelli ahead. I for

David Zaccardelli

and to and for Thank you Verona for commitment. support another our their your exciting look and on for forward your updating and talented year shareholders everyone this and colleagues concludes families for we today's safe like We their team and call. progress. XXXX questions thank dedicated that is during would at today. I the Verona time healthy you you to continued and hope stay that your operator our

Operator

The conference you today's now presentation. attending concluded. for has Thank

You may disconnect. now

Verona Pharma (VRNA) 1 May 212021 Q1 Earnings call transcript