- Earnings call transcript Q3 2022

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Operator

Welcome to Verona Pharma's, Third Quarter 2022 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 September 30, 2022. A copy can be found in 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 or nor involve other from known statements results, factors are forward-looking unknown our and promises neither performance actual implied our and These expectations, and expressed materially by guarantees risks, may cause to or achievements be that the different important statements. uncertainties date call. conference such statements management's represent this forward-looking estimates of Any as of the

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

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

David Zaccardelli

call. Senior Rickard, Medical our Commercial. President Chief today to and Mark are everyone Pharma. Verona our our Chief It's Kathy and another Thank of you, Martin, Financial Vice welcome Dr. Chris solid With me progress Officer; quarter execution of for been and today's Officer; Hahn,

to readout third clinical expected this During ENHANCE-X results top the our we line from announced COPD. the looking top year. data trial end treatment positive, X And are forward we ensifentrine line of of Phase maintenance of nebulized trials ENHANCE-X quarter, for of the around the

with conditions. and regulatory Silicon replaces of clinical $XXX facility strengthened upon Bank and equity available financing operating position have existing approximately in and Finance with upsized other million and achievement financial including our debt our million non-dilutive October. $XX We million debt $XXX The Valley in significantly access up million, to facility $XXX with million the August $XXX facility Oxford certain milestones is

planned funds runway XXXX, States. commercial least extend United future to end the launch pre-commercialization ongoing through We of at activities ensifentrine of the cash and these in expect supporting the the our

step ENHANCE to program. like take a Phase X a back clinical of overview provide our I'd and First, brief

subjects were XXX Subjects trials efficacy or United approximately evaluating either to agonist and data XX ENHANCE-X or a COPD over in longer a either safety also and weeks ENHANCE-X a subjects moderate-to-severe As symptomatic a for antagonist reminder, each or sites, received long-acting LABA. over subjects approximately of ENHANCE-X long-acting or a patients Europe. ensifentrine approximately replicate XXX added XXXX LAMA, enroll placebo monotherapy XX% weeks. receiving the in designed safety single a with as measurements bronchodilator and the muscarinic with long-acting across approximately term primarily or to trials of The of on a beta XX States total

up their may Additionally, or to LAMA inhaled with receive approximately LABA. XX% subjects of corticosteroids concomitant

successfully primary and similar As the safety endpoints to improvements met tolerated placebo. demonstrating lung function. previously statistically And ENHANCE-X announced, trial significant results ensifentrine secondary with was well in

exacerbations overall COPD reduction XX% those rate a to the demonstrated ensifentrine and severe was XX and not or powered Importantly, over of in placebo analyses receiving Remember, analyzed over subgroup the the these all subgroups. in weeks. moderate positive exacerbations course confirmed of for subgroups effects ENHANCE-X across population overall reported the compared in study recently

first We from curve, FEVX volume half Conditional ENHANCE-X life U.S. measured to a to overall related under from application data by are dose-at of XX safety FEVX, the top and quality reporting hours include in ENHANCE-X endpoints COPD drug the the from look submit for post are symptoms area plan one results positive to the as improvement by top exacerbation secondary the trial endpoint as following: including around the of second and and is function to results data The lung finally of of data very ENHANCE-X endpoint health these measurements exploratory upon to week-XX. well XXXX. the average comprising XXXX. line trough of end forward new expected peak results. ERS encouraged primary SGRQ These line FDA and we force in zero and

Our U.S. planned. commercial launch are accelerating activities as

outstanding fully the HR, commercial, IT addition top preparations announced positions of submission quarter line so XXXX. the in were we in potentially third Following We accelerate our the key to to launch leadership data taken with steps ENHANCE-X through after ensifentrine data and ENHANCE-X plan to initial in finance. NDA and continue are are prepared

China's Center partnering X studies begin X to Nuance Evaluation the in to received ensifentrine clearance strategy global our quarter of for in Phase China. and for Turning Pharma Phase third Drug from COPD

commercializing the in potential patients Pharma over responsible progress. therapy, in maximal on of clearance XXX milestone to developing cause urgent novel the forward Despite need symptomatic to existing treatment leading million need updates remain We COPD look of for to a Today, for this and further studies represents is and to is worldwide, China for million an death. X providing global ensifentrine U.S. patients. important patients provide highlighting for COPD these as than address novel availability ensifentrine suffer As it third these the Nuance treatments, more Greater a from expanding COPD. and medications remainder in the the of relief the

We PDEX product throughout readout. are first-in-class the the a maintenance inhibitor, treatment committed third ensifentrine, to our the and for financial of delivering Mark remain over COPD. are the results call will inhaled candidate goal PDEX encouraged novel and review upcoming about for our data ENHANCE-X now our progress turn We XXXX to top of quarter. I and excited by to line

Mark Hahn

Thank We ended in equivalent. of the million $XXX.X third you, Dave. XXXX quarter and with cash

States. our runway financial at XXXX including end position of the of have we United significantly least through the launch extend funds commercial ensifentrine in plan to the As cash our Dave our expect and mentioned strengthened

based million for our expense million of to ADS was million compared profit months For with associated reported XXXX $X.X XX, in or of period and ended XXXX. $XX.X per credit million were to per UK of in $X.XX million for represents million with $X.XX based tax for tax This September months ordinary the same share ordinary the primarily of a after the a for of decrease a net quarter, of share loss stages for period three compared later three XXXX after million to million and compared the XX, expenses XXXX ended the the in for compensation. September agreement same to $X.X $X.XX net $XX.X profit the to per a due XX, per to XXXX million three $XX.X quarter. or enhanced million share Nuance loss ADS decreases was in $XX.X $X.X million The XXXX XXXX. million $XX.X as in program ended The this reported million the third $X.X same credit The and development decrease other of quarter the to was $X.X for line period the Selling, months primarily of costs the development non-recurring administrative in to is spend decrease XXXX. for September and month the costs general trial a we $X decrease the compared million decrease Research XXXX. in a three $X.X the period share September were a of was in in progressed $XX.X in lower same and The R&D compared ended $X.XX R&D XXXX. tax clinical $X.X due compensation. XX,

by spend $XX the our XXXX XXXX. end payment and for expect a submitted related claim We to to receive reimbursement million R&D of the approximately have

Q&A. have the we capital non-dilutive As to important operator over element the this the I'll our discussed an in turn of source for now to be continues strategy. before, back financing call

Operator

go Instructions] the [Operator sir. Jefferies. Please have you, Thank Suji And from question first will ahead. come Jeong of we

Suji Jeong

Hi, good taking morning. question. my for quick I questions. have a Thanks few

time So do visit, you spilled also you to have to guys that study. for said that on XXXX? another ago, I you EMA European strategy think that commercialization is you us tell ENHANCE-X expect for data trial, could a could last based might early And the patient your comparator question and require when be long

August, discussions Europe? current and Thank you had strategy I'm just you the based you. the to in on commercialize data with ENHANCE-X So whether wondering any in EMA ensifentrine had on thoughts your trial

David Zaccardelli

call a calendar for that because are I'll you towards as know, I in that visit happen with patient We're Well, happen. cetera it's we're Thanks in November et that. windows, we guess – to start questions. Suji. variable the by Hi, the endeavoring still there study. of bit tracking and the first last a and

patients to regard with possible. visits, But holiday two that doing a everything cetera through come to et have time data in or think readout, across can we that and soon as the same we're transitioning I there. we're at as it the

how the with With where with the everything to is intention forward to in to intend we it but data said we're yet goes, can see EMA the we'll land. XXXX results So the European and do but we with and to regard meet strategy, on our so not that that plans not sure exactly based not, review that ENHANCE-X the will and to discuss that ENHANCE-X have purposefully totality, we do with there. them, do

we think interested variations reviewing and be know, going and precedent, I we They be in and that do data. all have within forward. them you the a understand on with ENHANCE-X, have therapy ENHANCE-X so plan context background of As so may comparator of based we'll

practically expect XXXX. soon to their that We can as with we happen as in calendar

Suji Jeong

you. Thank great. Okay,

Operator

Sandler. Next we of Piper have Yasmeen Rahimi

Unidentified Analyst

Thank Hi, you my this Yas. for on is taking questions. Emma

the contributing occur ENHANCE-X many set, you. post sales have of months? type data discussions hired? data what What's to the the secondly, that First, people how factors? what reason yes, if Thank misaligned game plan there believe a ENHANCE-X, be might over could be payer from will is been and commercial XX next And activities, the and ENHANCE-X in

David Zaccardelli

Thanks Chris commercial the first I'll so Maybe turn and to to much planning. answer it for second of then aspects the review the question. part just over

ENHANCE-X, ENHANCE-X, ENHANCE-X to criteria. to patient studies designed to regard the studies. the And identical the with two regard be we so inclusion/exclusion expect highly with comparable of between populations essentially And are

of I'll results. time, at so think is still from should this to misalignment they and course can With Chris With the study's be to in the plans. any intent said nothing. believe but to that forward reason study the any and to it all ongoing there study readout, in And commercial that look there's there's we over My a there outline standpoint. structure misalignment design that turn no

Chris Martin

questions. and If we with Emma, appreciate I'll payer with our the plans Dave thanks and the start – discussions payers. Okay,

XX over at covering look symptoms million lives. we to us to think about and discussions Medicare across be had Part primarily significant And as ensifentrine novel we've versus ensifentrine's would that function most COPD over seen the extremely we've talked like payer done so them payers B be that utilization reimbursed network second begin healthcare of the to I channel provide. is ensifentrine think high-risk how actually the continually through far we've of to be appealing ensifentrine is one likely be that told Part in landscape action, as with. nebulized We've will something mechanism reminder, scenario Medicare with boy – it'll And what improvement D exacerbation they've XXX A a feel efficacy would think and a channel. Part just the And and profile D. is an in for Medicare second that payer. high as I cover reimbursed patients payers to they to for that would at are nebulized they have reimbursed. we group a need because a lung the

data. about XX% that or will with see ensifentrine So we lives launch be XX research, around what at is of that – based launch over covered on in

XXXX, as that discuss to we, an think continue take and plan level that as place. how individual to will moving discuss to coverage I on continue reach we more we'll out

strategy, through DME pharmacies is Additionally, to we'll since is that able Part which working channel to that through ensifentrine ensifentrine at Medicare that B, and to ensure patients the through we're launch. that distribution that be covered get

shows in feel community done So and ensifentrine within of we've of value to on expand date that lot will payer really work and XXXX. highlights the I continue to to the them like a that

Your around second sales part of your was people. question

about that is majority force. ensifentrine initial of the the key sales for pulmonologists. sales use sales still the force will organizational by opportunity for the be Given the we toward our in, believe XXX size We size driven appropriate is milestones. launch gated That reps believe of

around the for So we wouldn't ensifentrine. till date anticipate sales hiring people PDUFA any

again prepping ready I course, so medical we as milestones. market will internally think individuals sales access, on marketing, force, come affairs still of get we're toward those with gated for

was ENHANCE-X first ENHANCE-X, The so second being and being on.

as grow process to milestones So we've significant and our the the structured within organization within we development. achieve community,

for the PDUFA I timing just back we the key ensifentrine. think that one a be we reps thing going need would XXX is think sales

Unidentified Analyst

Thank you.

Operator

from Lee The we come from next Joon will Securities. Truist have question

Unidentified Analyst

the Good is And stages retain just questions. an my option Thank from market at morning. then when launch? of And on Thank you This is can in that EU finally manufacturing readiness Les for there and for on us; what is looking China for like terms? And for rights Nuance what partner selection? your you what's you. expect to checklist Joon. taking remind progress launch? Can later separately, and then your we announcement

David Zaccardelli

question. maybe and take for with then reverse we'll the May it Thanks to be, to Mark manufacturing start order Great. about much in first and the I'll so agreement the turn over talk Nuance. I'll

think we're my well perspective. very On from the manufacturing CMC progressed front, I

and We allow very the API both great the both characteristics well. understand of for the very stability product. some is into on have We product. progressed API The data processes expiration validation, dating us product drug drug advanced and the well and

good I at time which So the planning, we course appropriately and validation CMC commercial on sure our our in shape very to overall to tied right make batches, strategy. the is a so all think of the make we're

So shape I in good think there. we're very

So with it Mark. turn to that, over I'll

Mark Hahn

Great. the digit what is there that multiple worth a claw to opportunity incurred it's in or think you're they to are market anything what clawback really there U.S. And With characterized that a doing a partnership back. cap relationship. as amount It's of it cost while they're include then single an in if inconsequential. Europe, Nuance near can if wants Les. multiple is that with structured Chinese rights that rights the you're and right; would cost. they've that it a mechanism; we that a or it's cap I'd incurred cap acquisition what China, is Hope have There essentially Yes. way in of people it's is in respect partner a Hi that have that to development is a, well. the

we're I think that's and – you also something about European partnership, timeline that's a asked for a on. working

line think that discussions I the review, important about with in we be EMA comments would any in of partner. Dave's would an that be the with type I think having EU element

Unidentified Analyst

you. Thank Excellent.

Operator

we H.C. The from will Pachaiyappan next come Wainwright. question Boobalan of have

Boobalan Pachaiyappan

can okay? you me hear Hi,

David Zaccardelli

morning. Yes, perfectly. Good

Boobalan Pachaiyappan

much taking for questions right, so All Thanks great. us. our two from

that publications protein patients exacerbation some seen serum C-reactive I've called of firstly, highlighted increased COPD that So, exhibited also levels with CRP.

ensifentrine noticed on CRP? So any have of you impact

David Zaccardelli

Thanks much for so question. Great, the

to that. over that her turn for perspective me Let on Kathy

Kathy Rickard

COPD always actually a consistent Yes, for we have looked us frankly, at quite the or CRP different they not about results show in long whether are time response and a not.

indication have increased scientific CRP, looked Some and they of levels data, decreases. no shown yet. have CRP, and there them see initial may are clear with do to a of it, the to show measure but data do did the we we indications we trend how decrease there on at Ensifentrine as is of interpret some that data again

Boobalan Pachaiyappan

on the thanks Okay, for have And one the I more subgroup color. then analysis.

So clearly more versus smokers in exacerbations in is non-smokers. reducing ensifentrine current effective

reason any maybe mechanistic from this standpoint? Is versus observed reduction XX%. there So for like XX% trend

David Zaccardelli

level on think, that. just first, to I Well want set we

we is conclusions subset careful weren't assessment prospectively to be that making on than to the need of any think different other. whether make about appropriately analyses powered one I

were this I subset that of in non-smokers, looking example think ensifentrine any there data. being we're the we effects to example, all based to differences the not wanted is the conclusions for analyses that really reduction is was where exacerbation controlled provide group real smokers across of any show whether between, subgroups. But on actually effect the by shown one the or at positive not

additional that. about provide careful on want don't you Kathy be if know I'd I thoughts So it? to

Kathy Rickard

ongoing we significant, group what is in exacerbations think actually people reduction group that The a continue smokers. actually this we show a is decrease including at, have in my significant see from to we takeaway especially matter no very look Yes, I who of smoking. effect

lot the can wasn't So because of powered by exacerbations make that. to smokers, a if reduce great he And don't groups, a said, level do think, between result. it Dave think you I that's as comparisons can I of

Boobalan Pachaiyappan

All me. from Thanks taking much for right. questions. it so That's my

David Zaccardelli

you. Thank

Operator

Tom we of Shrader Next BTIG. have

Tom Shrader

question. Thanks for morning. taking Good the

error you've I'm what the time curious commercial of think point as part question the as maybe about that, one wild more Should of front, of there still understand if thought about is engagement. there commercial limited wondering or as had sometimes some smaller Thank maybe driving that that? think is life companies you. some that? quality that partners as could huge readouts of we be you've the some time it information there? do to the to We you do tackle a second And Is markets. something lifting, see of when the ENHANCE-X On

David Zaccardelli

Tom. thanks Yes,

questions, take first. one latter the the For mean, I I'll

we're course, that soon. data and well. additionally is I think talked think, we ENHANCE-X of still informed coming looking into I as about by be it Which we'll as

the the in and to So happen a are where over studies discontinuation patient duration think that placebo effective to group I of observation drugs rates more right factor contributing groups, the happen which could be on time now studies of outcomes. in also in placebo reported tend

up As better” be that And group placebo contributing various the potentially who period. you factor. with than “feel more during a that had reasons those discontinued may the in patients end for

Tom Shrader

Yes.

David Zaccardelli

our looking we're in ENHANCE-X So maybe Chris, at think hand. well And partnering. and want one look as carefully then that's strategy the you if with commercially at comment thing on on we'll I

Chris Martin

so Yes, appreciate I Tom, the question.

partnering. just U.S. commercialize start prepare with strategy clear Organizationally general been an we've we'll partner. in that outside U.S. Let to the on very our me the

partnership our Nuance. bit think talked a and little about I Mark EU with partnership Chinese

that. continue we against execute to So

on physician or not to what flow and dual single, that understand remain when is an what pulmonology. therapy think of drive based market research, is and on important U.S. pulmonology or and large the U.S. community. utilization patients the symptomatic think care like? the And the does the will I we of that feature ensifentrine about look primary triple about our into we target patient is those of And either out migrate patient dynamics a community start move what

we In XX,XXX fact physicians about that to believe XX,XXX to need target. there's we would

us a do a that footprint commercial one And footprint of other limited that confidence ability reps. XXX very footprint is that's occurred of I our lot portion look think very we to not is a number the when gives ourselves So the things about to targeted this or in of is launches that generate – significant other needed out products the a at data large. that not of their business there is a very and on of prescribers have

I'll XX,XXX of examples two the asthma which there's to indication, of it's is if is only moving then volume we Trelegy, about spectrum, doctors. XX% doctors into comes the here, So one revefenacin, at about which means of COPD an YUPELRI, if because TRX end go and the of give that data the opposite XXXX indication, their which from about has look do primary asthma more there is I care that business. XX% And there

diverse needed very in even number is reach limited those number. the examples, physicians a two opportunity very to the So of

very are effective that confident physicians XXX plan. we XX,XXX a again, So XX,XXX to launch reps an going is to about

accepted become like can we've have effective to found be Zoom more the over with be very not but COVID, digitally as allow or too. methods smaller norm a biotech by that with can interact Verona with now Additionally, physicians many a Those physicians were readily physicians, that launch. in interacting new to ways

it a drive to and patients biotech them lot need more a effective the in. will as we to be nimble think uptake us that with reaching we allows physicians use ensifentrine in this So

Tom Shrader

Thank Great, you

Operator

Jeong from Instructions] [Operator Jefferies. will we question have come next The Suji of

Suji Jeong

for Thanks follow-up taking question. my

that your and and target ENHANCE-X single, care the ENHANCE-X therapy. you patients primary for are dual, on because from progressing you well, firstly, mentioned, migrate that the firstly are patients they pulmonologists triple So mentioned

that and If question how the of guys triple impact coming you ENHANCE-X dual impact you second the baseline about of Act. characteristics the remain thought enrolling my study? the is look potential despite ENHANCE-X symptomatic before what Thank at from those about the bill? might be many you. Have the of Reduction Inflation trials, And patients or

David Zaccardelli

Thanks Suji.

Act, the think, I For we looked have it. at the follow-up, Reduction quickly yes Inflation

Of straightforward not it is course, bill. the most

at specifically So, it different to inputs impacts outside different formulations, ensifentrine, looking you see all we're that perspectives, from getting around would how expect. we're as well. looking different as indications And

end into best so do a formed moving front then still of I and in think, we for to plenty the more gives continue strategy evaluating its get think, a, opinion us impact of So, to the with and that, we'll have time forward XXXX which, it. as I understand

and or being complicated were So, as as patients think, study I question that answer. is think a triple, enrolled I on symptomatic the many how dual far in to

all are we in I in what a either patients symptomatic. study the think enrolled ICS on LABA background or plus not on who who have is done LAMA, minus are

into sense have a you patients if as the or in are product symptomatic single on study. call who second all who ICS the So we dual, coming are

talked we we XX% or background it ENHANCE-X ICS are with XX% about and for ENHANCE-X XX% ENHANCE-X on As between ENHANCE-X. at to somewhere And therapy land XX% in was XX%. will on around they and for around ICS between XX% about expect background probably XX therapy

all of those symptomatic. patients, So are course, of

Suji Jeong

you. I see. Great. Thank

Operator

Well, for to like Dr. any conference closing further time. I’m call over the back We'll David session. question-and-answer ahead I and conclude go Zaccardelli to remarks. will showing this turn at questions our Sir? no

David Zaccardelli

very Thanks much.

for to healthcare you patients So thank for professionals ENHANCE thank questions the And your we'd and participating in program. like today.

of near half upon conditional the reminder, XXXX. and include top course, a of submitting of results milestones ENHANCE-X the term As an end reporting in the NDA around FDA XXXX, first from our positive to line data

we London, presenting investor and including Stifel, look Sandler, Piper many are of Jefferies then. at speaking forward to We upcoming several with you conferences,

continued talent support commitment. that for at concludes today's Verona their the Operator their team call. Finally, shareholders I'd and thank to our like for dedicated

Operator

Take may blessed have the team Thank a day. of has thank you the time call conference sir. for management to today. rest And the time, Again, your Thank you you disconnect this your everyone. you And now you concluded. care. we and lines. also At

Verona Pharma (VRNA) 9 Nov 222022 Q3 Earnings call transcript