VRNA - Earnings call transcript Q4 2021

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Operator

Welcome to Verona Pharma's Fourth Quarter and Year End 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 it's financial results for the three months and full year ended December 31, 2021. 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 pandemic progress. Ukraine from known statements results, factors are forward-looking unknown our COVID-XX and including, promises neither performance actual implied our on and conflict These expectations, and expressed materially by of guarantees risks, Russia, without may such limitation, cause and to impact or the achievements be that the different important statements, uncertainties the results and timing, of on our recruitment, And the trials. cost clinical status, statements such the Any estimates date of represents forward-looking management's as this of conference call.

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

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

David Zaccardelli

today's maintenance first-in-class completing Hahn, candidate Chief Officer; me welcome, of made XXXX, goal and With towards enrollment today call. Commercial. you and Officer; Medical a in Kathy delivering III Throughout Mark are treatment Senior Dr. of Martin, our Chris everyone, progress ENHANCE clinical Vice ensifentrine, Thank furthering significant our Phase President Financial Chief Rickard, to our our the program we for COPD. and of patient product our

ENHANCE-X longer-term for plan in As over trials safety over in of a and patients Europe the patients data reminder, of patients evaluating XX will enroll and The total safety with replicate weeks approximately and U.S., to placebo-controlled our moderate measures XXX weeks. ENHANCE-X Asia. each ENHANCE-X randomized, XXX severe approximately XX efficacy also studies, two across of COPD a the approximately enhanced to symptomatic double-blind, sites X,XXX

of ENHANCE reporting driver are completed subset XXXX, We line top in to Completing data from In the subset of a of data. completing reporting critical recruitment for December study. is top ENHANCE-X the this enrollment approximately we XX-week in ENHANCE-X. patients in program and XXX about enrollment excited line close

the We progress in to continue enrollment subset ENHANCE-X. of XX week

trial XX% of including those to patients XXXX. January patients end enrollment ENHANCE-X of XXX the ENHANCE-X the we enrolled XXXX, XXXX, the X, quarter around had March fully expect patients randomized of into second be with run-in the In of of approximately ENHANCE-X in period, more randomized. currently we the entered completed As study, than

data Looking to in the line results; and quarter XXXX. top ENHANCE-X expect of of third from we around the report to from end XXXX ENHANCE-X

of once We enrollment will provide timing further is the on full ENHANCE-X data guidance completed.

COVID-XX based lines in expected As stated continued on previously, efforts. were improvements of ENHANCE-X ENHANCE-X COVID-XX in successful projected enrollment implementation time and our our the pandemic mitigation and

the continue a sanctions on hours. most protocol being in TQT clinically monitor of relevant other progress conducting recent The Russia measures of to That COVID-XX the TQT to closely of in XXXX. with study and all pandemic or prior met these the the cardiac designed imposed continuing we reported observed no conduction changes U.S. activities, FDA to clinical said, for safety measures and the drug we NDA, effect, of and to upon study. interval the and to and Drug submission, in in first ongoing impact of international restrictions us NDA December In lines. on over clinical very inhaled review conduction Food global government the a expects planned XXXX, study TQT the an of a volunteers. healthy was evaluate support shown we ensifentrine the ensifentrine and successfully Administration not in trial QT submit either half With cardiac TQT impact results, requires XX the any, applications in pandemic. dose new ensifentrine were recruitment are and X-milligram time thorough new these X-milligram to application, multisite with XX interval or trials a to measures number Ensifentrine objectives a positive the other drug the company in during our Conditional pleased if

sales death. We continue deliver are of towards the to to is And to where market maintenance XXX well over COPD who affects advance by third ensifentrine our treatments. not antipentrin commercialize suffer from U.S., than patients million COPD Worldwide, preparing patients COPD. leading over the itself, cause ensifentrine totaled billion. to COPD In COPD $XX and Verona is goal millions the in served XX patients available of million more the

While remain tiered a with company. future to progress. in in more and responsible therapy, royalty Outside and highlighting XXXX, novel developing million existing commercializing and look milestone a updates patients. is relief partnership to advanced Greater strategy partnering collaboration additional execution received clinical therapies addition these million The up of in equity to Pharma, the double-digit at and the for patients we the the we to on for of need through million Alongside of pharmaceutical maximum Pharma Shanghai-based global of $XX Nuance our $XXX specialty their forward provides COPD, a ensifentrine Nuance millions payments and available in providing provide to cash medications than in patients one COPD progress U.S., symptomatic China the potential agreement. treat urgently remain of treatments. need are symptomatic strategic on our to

XXXX. with results reporting Phase now data turn We III excited about are our over this throughout to top call will I year. the to and from our pleased XXXX our Mark progress line program financial ENHANCE for robust review

Mark Hahn

with with our XX, enable planned the from and December you, tax expected U.K. the to We the equivalents at become We available and our expected XXXX, cash requirements million through fund will cash Bank capital least end debt equivalents. expenses of facility under $XX us to operating and funding Silicon expenditure credit XXXX. Valley Thank in XXXX at ended program believe $XXX.X and cash receipts Dave. million

to by increase prior reduction XX, compensation relating $XX.X primarily per related of the premiums, the $X compared $XX.X $X.X for increased December compared million year. for to was driven million million a ADS costs costs of the prior million Nuance and million of in loss charges year compared to associated This costs XXXX. XXXX, $X.X costs the tax share ordinary pipe costs were after III of agreement, partially the to ended Research a the $XX.X a million a for ended increase to for XX, This by the $XX.X insurance $X.XX $XX.X Selling, and of a ordinary in with for reported Phase was the December D&O loss after or were program. the to to R&D offset represents credit year and III million with the incurred year million XX, year the higher the XXXX primarily Phase XXXX, ADS for and The loss XXXX, general the For XXXX July $XX.X line ended ended in year. severance XXXX. ENHANCE year program. or was $XX.X per per the financing per for in by incurred December loss $X.XX share XX, tax XXXX, compared XXXX. $X.XX expenditures U.K. the $XX.X December reported driven in credit administrative The development is million tax with million compared ENHANCE qualifying R&D increasing share-based

in the intend terms of credit program, of over in XXXX first nondilutive amount expect turn to the we I'll strategy. later the to of submit to receive payment Q&A. tax the U.K. under quarter, last of reimbursement important for continues back this discussed we now an capital half XXXX. the in call be the the element and As R&D operator This source to our financing for

Operator

Argyrides Instructions] first [Operator Wedbush comes The with from Securities. Andreas

may now go You ahead.

Andreas Argyrides

All and right, here. thanks taking for for us good questions; morning, two our

Just to start.

sites -- in opportunity the tell many Russian say us thinking Eastern the Europe reiterate remind And or impact the III of And the the out to for strategy? ensifentrine. you're just you you a and of maybe when clinical conflict? design by are different are going see it you're triple kind other Can about studies can the how commercial you you and commercial in -- the how clinical dual So how of -- of Phase therapy? then -- just let's the us affected playing

David Zaccardelli

the start program Chris into to the clinical how dovetails strategy. then for it and question. our to over take outline I'll commercial to Thanks our turn one first Great.

to regard patients end XX-week entered point Russia, have in we the conducted. have period that a And over those And the well. of point. handful them Russia or in time with sites the have primary time sites XX-week So of while a of good the of patients or was passed past as being passed so have number majority study the

that now, to we situation. the you So the can imagine, be we're with no detected conducted continues interruption as although Russia, the acutely And with as continues study of site. in have monitoring the study

the that them -- the the we're and if contact in enroll also in close Chris, to handle commercial. course, study to sure continues study. to manage the you in patients and know I the don't Of want site with making continues

Chris Martin

Yes. Phase I our III trial. commercial with to can little a about talk regards the opportunity bit

important his ensifentrine Phase ensifentrine what symptomatic trial the COPD we we when we that, about today today see receiving we design we've are So data as treating Because remaining supports looking our are patient function, we symptoms and that we broad like Phase have to pulmonology about improve mentioned can think at have market that commercial that that's they quality And with knowing the life. that Phase help reason adoption that in where in to there of situation, dual a paradigm III no when about the data one benefit very II, over And remarks with opportunity ensifentrine physicians that potentially in options earlier, treater could this there's point therapeutic choice that million is why provide gets what out of the treatment Andreas, the is at done is And research anticipate community. And to and significant that's options and our when think no Dave the from have therapy. trial improve real III in know, the for and ensifentrine. therapeutic what looks patients a on time, help these and triple these them. substantial them. lung patients improve for help think

new remain it for give over well So entry one MOA a when ensifentrine and patients. first look them they're And of allows to because really patients profile use to you that's these symptomatic. That's again, at ensifentrine patients they the because million them in that those to antilabor the the that excited efficacy safety of immediate provide molecule this have physicians are lines need. earlier mechanism the allows new therapy you in that in us in because bronchodilator used But one. potential as tell well could be ensifentrine a most also profile,

how in as flexible So them it more to or LAMAs/LABAs a current treat are dual allows patients well. therapy get that they bit little on

Andreas Argyrides

Okay, I'll great. in Appreciate back that. jump queue. Thanks. the

Operator

Our Suji comes next Jeong from Jefferies. with question

You may now go ahead.

Suji Jeong

taking for Thanks question. my

to not all, in include that have last regards a comment -- wondering have patients. recently in any ENHANCE-X just the X. come amendment especially positive And question may the studies be completed for to you or ENHANCE-X may I to for Europe. changes hospitals guys Eastern guys patients follow-up into possibly XX% wondering you And change might First are the in was patients how ensifentrine saying steroid. if COVID there Poland in those and you patients that how I those as heard is, to of sites? how their lead enrollment how question protocol site, just to you or those the vision be communicating use to may able that some tested may may using if many from be for my patients subset study, is up the was in have second you Could X of and amended studies? followed visits enrolled patients for the and in And conducted on

David Zaccardelli

Suji, thanks Great. the for questions.

as Europe, part extremely NATO, I the the you for are think fluid and of and Russian/Ukraine in study Eastern is in the as know, continue fairly according Eastern the Right to as to speaking, as fresh, it. countries that the protocol you of now, conducted situation those mentioned, -- conflict broadly you conduct know. be and in we've Europe seen

about only or into information flow. a that that's course, Of so week

make continues be are we the not changes attentive continue with do We or that But contact to to any be the according that now, would handled course, other of If have we to conducted. protocol. the contract issue through the raise with study to in and at moment. an that we organization see research we're if it protocol our to right them sure issues, very

to COVID, for positive patients some as extent, far that's As number. a changing

You that the study. for from positive discontinued can as asymptomatic, were imagine were and patients COVID those

within discontinuations. speaking, overall has Although modest again, for relatively been, expectation broadly our that and number accommodated

So haven't be matter, they may and positive who tested. have that as who for actually or COVID far test patients because tested for as patients asymptomatic positive were COVID but

there's And of so variations kinds you can of all imagine theme. the

going it. I'm in on the world we All of sure, is that, know as

to many plenty COVID continue conduct written difficult patients are had there tested protocol of to patients that haven't be Because say how who to it's we haven't because they So probably going as tested. have and the very positive been COVID.

enrolled we're capture will of And So and which regard their receiving discontinued patients That have not with against that. of the you think and and With bit background of patients a actually XX%. I said, an up I represent properly corticosteroid than, was it's top can COVID course, accommodating. we amendment, have the number other I of up guiding the bumped a those on we we to who ICS therapy. a patients -- difficult to to as had tell cover. XX%

patients. So at it moment, least appears to to that enroll that, although less in at than be ENHANCE-X, continues the

or Phase function, the of secondary looked forward, which out Phase data ICS quality way. the of lung impacting The for II see the of in lung from at it it going function on data review and how on symptoms don't I and it our we in example. see life we read So view on don't endpoints how And of think and we we'll use impact based II the we -- material any our doesn't that. -- it

Suji Jeong

I see.

of Just for ENHANCE-X, what percentage to many ICS? -- on are clarify, how percent the patients

David Zaccardelli

confirmed did the still wouldn't can level. XX%. being but is tell Yes, hit it's I under we clarified not I -- -- want data to that it and you the XX% is

Suji Jeong

you. Thank great. Okay,

Operator

from comes H.C. question next Our with Wainwright. [indiscernible]

ahead. now may go You

Unidentified Analyst

Hi, hear can you me okay?

David Zaccardelli

morning. Yes. Good Perfect.

Unidentified Analyst

questions our end. few A from morning. Good

predicted criteria So FEVX whether FEVX? with being have patients XX% of to one you below who in curious inclusion of the have patient or predictive or ENHANCE so should ensifentrine studies XX% XX% is see XX% those effective your for that the I'm FEVX. all particularly versus

David Zaccardelli

going the the as to bronchodilation on Phase types those Dr. well speaking, different of for Thanks give question. the data to her use turn over to Rickard in clinically Great. I'm II of thoughts that as patients.

Kathleen Rickard

Sure.

Kathleen So Rickard. this is

moderate COPD. to predicted in XX% patients So the XX% who is to have severe

sometimes these and we usual, As treat bronchodilators usually patients with other medications.

a data in studies, a or see As would we data. would did between severe far Phase to difference the III as see the in patients predict moderate our similar that II we our not response our Phase in we response ensifentrine and

We Phase using response treated. being continue who answers additional ensifentrine we on patients in bronchodilators your of question. our II to additional are hope see that see top they're when I data that responses with

Unidentified Analyst

the an And patients ago? in three exacerbation Yes. with can enrolled comment other of secondly, on MMRC history years up the you plus and of ENHANCE-X mMRC profile study, patients scale the

Kathleen Rickard

of mMRC study. to at have a enter So to least they X the have into

enter as the are an not far to study. we exacerbation requiring history into exacerbations, As

Unidentified Analyst

got it. Okay,

upcoming one? hold the you what the achieved, response expectations and can the study program ENHANCE-X So if a readout make will threshold, successful for

David Zaccardelli

question. Yes. No, great

in significance think endpoint a III I hitting statistical Phase I on the always important. program, is as primary think always

week Just to have power which is remind primary XX. to milliliters X study endpoint in XX at everybody, a the difference a we of detect to FEVX hours XX in XX%

additional number any So same improvement improvements in improvement that in at there lung we XX important. same And But is designed I XX, patient think magic different are greater who function which look at the the somehow desired. mills that is at the are always is of any is time, all could to a improvement time, patient But in how study no important. XX, XX, needs agree the specifically feels.

life that on we extremely I and on endpoint Phase weeks by expect effect seen we are previous and addition in assessed the instance, the actually FEVX improvements was of clinical in think XX, a in III, see encouraged of again other four with end in of drugs on In important week data, to which Phase that these secondary II to endpoints. think these the And X weeks. effect being studies quality were based saw we primary and would over I based points this Phase study. previous also XX, symptoms the XX always measurements studies over II to secondary

it's key get So I highlighted, always important ultimately, it's elements. same and program. time, of Phase to a think a really in what's approved. benefit is what how are total the drugs picture the III risk just a assessment assessed that think, I I At

risk. the the So and And is what in is the total of use the what justifying in drug of picture picture it's patients. benefit is of total favor that

And of to all aspects want -- think an and always I it, when just to together the instead one risk structured so what put I really demonstrate. benefit I -- always at to is I is assess that parameter, look with NDA

Unidentified Analyst

right, All for my for taking me. it that's Thanks questions.

David Zaccardelli

Thanks. Great.

Operator

Lee next question Joon from with Truist Securities. comes Our

go now may You ahead.

Unidentified Analyst

question can LABA? [ph] for is to This and Are the III evidence LAMA trials baseline will information thanks Rana that able remind for Phase what taking patients any And of you versus strongest for the on you provide the us actually what ensifentrine on Lee. proportion updates. for patients work our the ongoing LABA? in baseline Asim Hi, with is Joon on

David Zaccardelli

Great. the No, thanks for question.

as II I We, we are used LAMA LABA demonstrated that therapy, a typically more LABA. have bronchodilation top acute as than in what's expected, think patients background we patients have that on Phase LABA a well. that although have of course, a data single on receiving is patients on do as of

a the a either back that on see bronchodilation that course, trial of we shows instance. different ensifentrine don't occurs with are the start speaking, differences we Phase or and II data, have of patients without they're a lung mechanism as And these acute that Of will a a LAMA in we of LAMA top it of Phase effects a or of in bronchodilation feel LABA. on function And, coming Pharmacologically that was any on a LABA. demonstrate to with because course, tiotropium we we LAMA larger on or whether data whether II fact get to pharmacologically, the adequate to have LAMA based or our compromised a all regard LABA. action comparable

Unidentified Analyst

Thank so you Okay. much.

Operator

BTIG. question Shrader [Operator next Instructions] comes Our with Tom from

ahead. go now may You

Tom Shrader

a I question have Good morning. It's a your ENHANCE-X. isn't XX-week go first the expectations, is a Thanks had the the patients? And enrollment to XX-week on Did XXX it? on fill questions. for trial, taking just run time of the heck into to a patients it easier to now arm?

David Zaccardelli

required of the all We the we earlier period rather were ensuring than patients desire the strategy had during of time, recruiting to we enrolled weren't subset. be XX-week while later. But course, they No, XX-weeks into XX-week a of a in sort and, of that subset. asking subset, consent they patients of the to were want into had recruited to mind that. had be XX targeting can -- keeping that patients they in it, sites were sites But would the to that we weeks and in felt XX-week imagine, you that that

of the the second quarter to ENHANCE-X. and lineup expect enrollment work the sites, and And had so period daily. And patients because that. in into again, we, our we on the in end that so of enroll we run-in XXXX course, the of current subset we trajectory, that in well continue we that XX-week And enrolled now, are already the again XXXX can of continue complete were we our that with and of patients where patients accomplishing pleased to are on based enroll manage as December to around

Tom Shrader

hours. for end point FEVX FEVX Great. really of approval matters the if I understand which dose a XX the And Chris. the trough at curious then -- primary follow-up think I'm is second over of the the a is average from view. for I commercial

-- think guys. you of are Chris I'm that's what whether the at. on marketing curious QD -- And thoughts that's -- people I looking for that's Chris' for just number drug, a key to is often used

Chris Martin

is KOLs Yes. the both trough Thanks, or change in the our uptake. research look something on that the totality ensifentrine. the the Yes, dictate of conversations Tom. not market community, commercial with at will the when our picture we It's number FEV for and

you in the That III over FEVX extraordinarily lung ensifentrine think we the quality profile which in of stated, compelling in which health that adopting -- and if Phase average improvements So symptoms X is produce is function as is, could ensifentrine life. the improvements the to care to profile of provider about FEVX XX, time.

trough, standpoint about a trough uptake essential So as changing for far molecule. when as we or the from uptake not think is commercial

Tom Shrader

Okay, you. the Good luck enrolment great. with Thank [ph].

Operator

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

David Zaccardelli

potential We shareholders would for about patients forward many of and continued for support like to in today's We months. weeks in finally, thank the coming like their that for and look of the care and questions your at their thanks. to and talented ENHANCE today commitment. call. professionals you our to thank health And you team Great, Operator, participating I'd ensifentrine the thank dedicated the and an speaking Verona to and concludes program.

Operator

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

disconnect. may You now

Verona Pharma (VRNA) 3 Mar 222021 Q4 Earnings call transcript