VRNA - Earnings call 4 2023 | Verona Pharma plc

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Operator

Welcome to Verona Pharma's Fourth Quarter and Full Year Quarter 2023 Financial Results and Operating Highlights Conference Call. [Operator Instructions] Earlier this morning, Verona Pharma issued a press release announcing its financial results for the 3 months and full year ended December 31, 2023. 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

obligation 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

call being XX this reminder, a available remain and for As is recorded will days.

I'd over Please to now Executive call Officer. the go Chief to like Dr. ahead. David turn Zaccardelli,

David Zaccardelli

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

year patients importantly, pivotal and for Pharma COPD. a from was suffering XXXX Verona of millions for

Following our drug a Phase submitted of application U.S. COPD. to seeking patients treatment very new with ensifentrine we program, approval of FDA positive a the III maintenance the ENHANCE data for from

As NDA and a June committee meeting for target NDA. accepted FDA the assigned not of you indicated XX, action hold review date they and an advisory the PDUFA XXXX, are know, to our planning to discuss

years. for for of preparations If to inhaled of in expected launch review. the available commercial advance be is ensifentrine U.S. planned during to XX work our COPD first continuing forward to the with and ensifentrine treatment novel over the continue look our the mechanism We approved, the their in FDA

month. worldwide, the more and mechanism providing nonsteroidal suffer to the days is for treatments death patients than activity from and persistent million XX the availability patients leading COPD. than COPD symptoms experienced Currently, it believe cause globally. COPD more for XX% potential in paradigm anti-inflammatory existing We third dual treatment approximately has XXX of per the of Despite bronchodilator U.S., of its change the

who maximally In therapy, are therapies investor where dissatisfied. This patients. comprehensive could update preparation. or COPD addition, and relief XX% we October, In hosted to be patients, provide effective on dual an bronchodilators we to our for their event treated of considered on continued new commercial highlights presented need HCP's a approximately triple launch

infrastructure commercial make to quick team and continue and on and and launch. plans, We tactics, progress allow to actionable programs, HCP branded data engagement our front, and service finalize continuing our to this distribution and strengthening patient including capabilities excellent insights including patient during key our internal our sales

team. care. commercial the We ensifentrine have approval the in Overall, also is continued to June. This position our COPD, the patients the on the patients' deep in CHEST impact on Meeting. believe campaign the of our in need we highlighting disease help capabilities dialogue of we a significant Verona a pending better their optimize COPD, in awareness confidence of encourages are and to Unspoken at strong launched severe to engage COPD The the rollout unmet ensifentrine, lives and of preparation, successfully campaign, HCPs based profile which novel experience and launch is actively

we launch the X development Phase ensifentrine, U.S. In progressed programs. II addition planned to new of of

mechanisms combination in believe nonsteroidal combination Fixed-dose through fixed-dose pMDI with exists complementary treatment therapy, of historically and that DPI first research, COPD with the commonly LAMA and fixed-dose an nebulized a a for maintenance First, bronchodilation unmet we X we a a ensifentrine patients combination fixed-dose could delivered used the ensifentrine COPD anti-inflammatory for are are Based the provide on the need of combination also developing COPD provides effects. nebulized combination market of therapies treatment with and nebulizer. glycopyrrolate, LAMA, formulation formulations. via in

program we ENHANCE LAMA. on adequate of XXXX demonstrated a the in for added confirmation combination clinical support to plan Upon to efficacy IIb start a a drug fixed-dose placebo safety of assessed Phase III. plan submit where was on robust compared Phase and formulation, to an combination LAMA ensifentrine half with an to and the added FDA second investigational program intending to the application dose new to selection in This

combination this a In glycopyrrolate components a combination, using COPD versus the trials endpoints. program, factorial design. second patients a function of in Both lung a dose-ranging with fixed-dose in are each patients, identify dose planned nebulized approximately XX dose-ranging trial we and trials crossover randomized the anticipate with trial in to with appropriate fixed-dose as double-blind individual

exacerbations, to of bronchodilators, safety to nebulized antibiotics, and ensifentrine the no We steroids, in non-CF in thinners will planned The this patients. treatments, to surgery approved efficacy with in the of the of including tissue double-blind, Additionally, abnormally is become symptoms could HCPs a an trial. cough ensifentrine therapy. Despite of lung bronchiectasis patients, exacerbation be condition is profile an lung that in effective and for approximately believe a lung we severe and clinical with the and II Endpoints mucus treatment rate over function cycle the chronic plan trial leading weeks. bronchiectasis. of be in placebo-controlled damage. of in XXX,XXX to Phase reduction trial affects as a based use half potentially condition commence where XXX including currently risk, patients exacerbations The randomized, white, the fibrosis assess the This up cause symptoms on improvement infection, treat of sputum, patients bronchiectasis noncystic approximately trial in and patients approved there a assessed U.S., COPD clinical ensifentrine in lack observed XX XXXX. is second non-CF a inflammation and airways to and

upon up commercialization Moving and on to we our to access sheet. continued our a as enhanced expansion, financing $XXX facility through may financial am our our $XX well finances, the million. under draw available are In million milestones in to in ensifentrine. ensifentrine position cash this other on Future pleased to programs. We clinical activity report strong we draws pipeline debt to borrowed at balance certain commercial we our facility, $XXX million and are proceeds additional balance new I approval support advance launch conditions. With the in expected a upon of of debt believe financial closing as providing U.S. flexibility current we our strong available as December, and an prepare and

partnering global our to Turning strategy.

trial Our of development is III in treatment partner, continuing a Phase maintenance Nuance ensifentrine the in for enrollment Pharma, China. COPD pivotal of

Nuance As treatment for has the addressing key develop a exclusive and to Greater such, role play need for ensifentrine COPD. novel will in in right a a commercialize as China, and reminder, Pharma global

providing forward Nuance's progresses. as trial look updates to We

pleased and our regulatory new We with development. accomplishments, areas, in are including important progress commercial program preparation,

financial I to results XXXX. will now to review for Mark over turn our the call

Mark Hahn

Thank facility, at runway Dave with ago. million the hand end cash the cash to the currently anticipated we you, including a ensifentrine expect through be XXXX, sufficient funding moments with $XXX planned few $XXX.X on We Dave. programs ended and XXXX Phase in equivalents. discussed our believe of least have to II U.S., commercialization of under the in and approved, closed strong, the and development and balance debt the recently X available remains We sheet if million

then as build-out million regional costs the marketing associated affairs loss market to by was conduct. Selling, prior depot ordinary presence XXXX, prior million $X.XX a ended reported net and December the represents at Research primarily $XX.X million for whereas of for with XXXX, of as compared the now of XXXX. for which ended loss related key medical to the were XX, general XXXX, and III the XX, back year count commercial expenses, expenses or development team's $XX.X administrative our tax XX, significant national medical information or compared local, head to compared to incurred cost $X.XX after were the ended million per less the infrastructures, $XX.X the share-based inclusive December ordinary This XXXX, medical compared and $X.XX turn increase year $X.X program, hires million of costs was in on commercial loss and in was the well the costs of $X.XX conduct per costs a year. in share to million year December the the expanded million net for and This a of early driven ongoing reported by in we ENHANCE call increase million completed year. Q&A. to after positions per and a associated in For for decrease with loss $XX.X study increase compensation, development per incurred were conferences. I'll ADS $XX.X and operator with $XX.X increased share year as analysis related tax the technology an $XX.X study for XXXX. affairs for Phase XXXX, ADS the and our driven This

Operator

Tsai Jefferies. [Operator Instructions] The first question today from Andrew with comes

Lin Tsai

update. the Appreciate

fair a couple I'm realistic FDA for So basically curious know Comm. review, to be not it X X to a And ongoing continues ready a Comm could to issues I no launch to CMC side. the the Have inspections? the early to juncture? be since review, away just been? if out be I was Ad NDA this months the the first dialogue if real approval indicate But how one there is our And we're Is finished or for And no rule on at the guess Ad from PDUFA, they the would case? seems this how yet? FDA potential And secondly, with you possibility? essentially that with has scenario an

David Zaccardelli

questions. for thanks the Andrew,

me let So about talk Comm. Ad the

sort us to Comm. planning forward. an possible. have But think, that FDA I to they're not as And the of is you to continues communicated has course, anything outlined, of Ad time twice move

that. on So But operating happen. that's be let's our can that again, anything philosophy aware

the it that regard is inspections. think to would I clinical review, I mean, we've with just to regard I ongoing. say think continues had I And inspections, With and

court. agency, API think that launch? product are PDUFA think we drug and about inspections June to just facilities early to regard to many manufacture both the approvals, and with I it, how I That's would and their yes. is our that say we how XX. so prepared adjust in we'll they're accordingly. Are managing is the And ways, that known In

an aspects that that very affect approval overall, supply when that the I the always are artwork, chain. pleased happen the our end no occurs. final we're of some we with label, things with distribution But at are timing the matter packaging, labeling, that where think

Lin Tsai

And are more it what if approved could in and of launching just guys let's go Okay. immediately, say Why doesn't is, potential maybe speaking, launch be case? up off Just these look Hypothetically about curious doesn't are trajectory wrong strong right think second you're thinking half. and Very you would that that. ramp the you one risks? good. just how the how

David Zaccardelli

Yes.

So I'll statement. make a general

to I'll done with research, we've all work feel our our all we need that on will the work based confident have think market that well date, HCPs, the ask is done in launch and view. I mind -- But is to that there to we regard go on Chris comment anything his with the think I the risk. that on that

Christopher Martin

of Andrew, reimbursement about by to as ensifentrine. is appreciate Dave, launches see I in that slower essentially risk of lot I it that the ensifentrine you what slower, you, B but and not with mitigated to due is a partly medical uptake Thank launches of think question of product able will being the typically are we that launches, reimbursement If flow that risk that access, pathway, pathway Medicare Yes. is we've through of the channel eliminated, been mitigate think well. challenges market Part a primarily new

internally, understand pathway. ensuring a we I very job that of done And we've that think good

about those -- dynamic to that about ensifentrine's that pharmacies accredited network specialty other in are launches be adjudicate the something we of talked distribution is way. and DME limited prescriptions really for we always in think mind. think people meeting versus appropriate the with, allows Our access And understand that would familiar is launch when the we back potentially that how market your October

meets as that add in in ensifentrine the flow of will symptomatic. spectrum we an we channel we've that of to the market That because the and in launch. reimbursement dynamic, willingness across in fashion a believe into appropriate variety what ensifentrine through is think, who fashion forward us I seen which is move research, But remain physicians' patients for channel, very persistently a favorable

Operator

The next Sandler. with Piper comes Rahimi question Yasmeen from

Yasmeen Rahimi

label? is, have in your all for agency few to questions we discussion your pricing tell I have A much possible share so regards label you the is to what you call. comments. been will ask if you. you X wide. you're the junction with able us a the position question Thank go as to is, Part X. pricing perspective for guess in label to into June be the you XX, us That's obviously, part on your that is negotiations? started first you in regards is What that range be to a going once quite and the available, has Could at host given maybe guys also the

So you're love the allowing payers perspective to your team building perceiving question this you get is it we thank third which then thinking are is year would to And and And you're commercial infrastructure? next and range? how a how OpEx X-part for be thinking ask for about me about year as over questions. that how should Mark, these again,

David Zaccardelli

I the agency. with review would early X so still with, to to out first or and go. the we one in that months fairly on with is maybe the around with it regard point forth really labeling. Again, the start back all won't I'll process comment

think so process early we in and from think need end the all a I trials, expect think things. And the course, course, and, results aspects in on the of the for be, with regard that now everyone the ENHANCE from forward elements represented the of put to I with that that we reviews comprehensively their right. were label, with the right from program little where I course, But that mean, what's past And of CMC of COPD, the think that experience important included. emphasis and I course, nonclinical of would labeling in the regard different I you to other is that my it we to the from are in the own all many but treatment maintenance knows indication of a about label they're of clinical to

nature. So I think in submission comprehensive was our

Chris -- that on approval, have comment of I'll think pricing. regard ensifentrine. range the we'll I With to just be pricing pricing, But with in ask we're yes, well-versed our we'll how to

Christopher Martin

Thanks, Dave. a we have When as to well. fairly And question pricing, Yas, I there. the appreciate comes it large range provided

think I $X,XXX use know of in are products Yupelri also range. of we we today, a that then current $X,XXX month about think the upwards somewhere Dupixent month nebulized a like when the pricing. the an And as market kind of bound we upper

that system. marketplace, the brings work ensifentrine understand symptom we standpoint value that kind function value physicians have is exacerbation done to substantial. the that benefit-risk thing about we the believe to high. we We think is from patients, times, When other profile The a that is described believe lung data, data, of value improvement to the data, that very numerous and Dave in

the be we've side, nebulized LABAs. they've when to told are what or Medicare products. single primarily is with us discussions premium a the so LAMAs expect Advantage payers, current And those on the ensifentrine to had they current Remember, nebulized with products

So bronchodilation profile is the different. ensifentrine of very nonsteroidal with anti-inflammatory

the the marketplace. ensifentrine flexibility we value do some brings believe based on pricing we So have to

in are including Act I specifics that it system. a physicians we'll to to dynamics appropriate we're good as Reduction at other are and very to that pricing and Inflation that. patients able to the we be also be the said, And that to play, Dave looking around value PDUFA provide Mark, ensifentrine come the place OpEx? provides in ensure think

Mark Hahn

the take I'll OpEx Yes, question.

million, million. $XX little a QX about the yes, OpEx for So was over $XX

XXXX way, couple the the can it a to caveats of today couple will be think tick the year. more double get up to maybe expect is I bit that spend. Along than little end there a and in course bumps of with you of over a by the of sequentially where

GBP million [ to upon ] X due is have payment that's Ligand. approval, milestone One we a

presumably. expense payment will to upon then milestone an incremental Ligand launch, due have $XX we QX, that be So onetime in a And million well. as

payment expense launch. onetime period another So of the in

Operator

question next Pocher comes The Wedbush from with Securities. Caroline

Caroline Kimberly Pocher

on This for is Caroline Andreas.

XX, does date more which only for and PDUFA the a potential COPD of So Dupixent just of date. be ensifentrine ensifentrine's PDUFA your launch be one and after Even broadly, about this commercial strategy? change June anything the though has COPD approval for noticed patients Dupixent a in us. used subset and We proximity happens day can to sBLA

David Zaccardelli

I no. think Caroline, the is, answer short

and also and the for attention But how the view this a would fairly it doesn't patients of severe think of the small we subset as in of population the who our great is under I the in good it's to mentioned, are you that's symptomatic getting. entire treatment. across ensifentrine, is that, for general, disease. think noted the utilized it's ensifentrine think I be in And spectrum applies patients U.S. COPD change that Dupixent disease well, as I COPD

that for that pharmacology matter, as and really there's conflicts a know I Dupixent And if anything from ensifentrine don't well. with basis

the did before. So we ensifentrine's see as we same application

Operator

Genuity. from An comes question next with The Xinwei Canaccord

Xinwei An

This An, Edward. for is Xinwei on

Dupixent a ask about mindshare. to of the Sort follow-up one. like the question after physicians' We would

the So they would foresee feedback -- have how that preference maybe have do do you prescribers, would or collected based they therapies? it a on project if you different from you use in

David Zaccardelli

Yes.

So you question. Chris I'll on comment in general. Maybe the that so thank for much have

Christopher Martin

Thanks, expensive. market done at market When the I research Dave. we've we mean, look is research, extraordinarily our that

What X,XXX it I I'm nurse spent we going surveyed and both of think things. a that pulmonology, focus we've to X see in lot close all really to physicians also research primary to over specialties, care, across practitioners down we're boil market well and on is PAs.

continue hear We his are both unmet Dave patient persistent newer And also of ways these in broad drug when excited from see is utilization variety to it need we to of as this when they today the very these lack they symptoms. the also our least that line treat a of in One of and a patients and research express as symptoms they're a ICS What later is we to persistently symptomatic, that potentially symptomatic, persistently drug patients exists. but At about market exist regardless classes persistent or therapeutic described us in on patients. wide is a maybe of this we how can own -- They half from physicians. are therapy. And therapy. comments, patients see used to the places, options patient steroids add-on opening complaining, see consistency then see in that remains having be physicians and as have. they an push all its see to potentially ensifentrine couldn't a this why and

Across all of the that adoption to is what is research, try ensifentrine our high. the see we and very willingness

I about we Dupixent talking are XX% think of months. when That first the either potentially we other did in or almost adopting talked the that products pipeline. the in of change represent October, ensifentrine with within even surveyed physicians entry about XX doesn't

patient foundationally, doctors regardless populations. within ensifentrine Because all across that novel of have what of desire their to new is that patients the the their Regardless works provides it their eosinophil them allows them really background therapy practice. first counts, mechanism a broadly and therapy, foundational

Operator

Joon comes question next The Lee Securities. with Truist from

Joon Lee

fixed-dose are color this quarter. this expectations ensifentrine plus there the What helpful. on COPD any being nebulized with your Any unlocked would Congrats Are be for LAMA space? populations specific in combo?

David Zaccardelli

then much comment to ask make the as Thanks a question. just Tara so Dr. and well. comment Rheault for I'll brief

bronchodilators may our the in COPD it's products are and products together. think natural treatment you very I different combination to commonly in the is that combining know with anti-inflammatories a view for as regard that progression used

combining ensifentrine I LAMA, a with think, sense. makes And natural

And address typical to make that, our turn this with comments. broad view over well as it I'll Tara COPD it think fairly that would population as treatment. is I any a to is a

Tara Rheault

Sure.

bronchodilatory we're got real preparing the with pharmacology of fixed-dose with combined X that another anti-inflammatory important of think features and that ensifentrine the is bronchodilator. you've I combination

bronchodilator a essentially So essentially an mechanisms nonsteroidal, the combination. in you triple anti-inflammatory you in of X fixed-dose the giving mechanism have that's profile

alternative So few to we quite think it a important will for be very patients. therapy a triple

Joon Lee

was, maybe for to June. on I sorry, And forgot This mention.

Operator

Tom question from next with ahead. Instructions] go Shrader [Operator BTIG. comes The Please

Thomas Shrader

been We've for Good a PDUFA have date. the product. waiting luck forever. on on follow-up mixed this the I

early Are you've already the you awful you would an get the dosing hope efficacious trying really -- the safe that some product different of be than you that of shown lot and at would doing in to saw when maybe it's at You're data? combination that your is a synergies doses. and this

David Zaccardelli

strategy these Tara, Thanks much, so you'd question. if that selection like comment dose in and on for Tom, that our exploring trials. to on

Tara Rheault

Yes. Sure.

formulation. So new is It's a product. and feasibly the new That's order to a requirement ensifentrine combine this in LAMA. a

see. let's What of part was And question so second the again? -- your

Thomas Shrader

data is, are of there of interesting between ensifentrine LAMAs hoping preclinical Well, that? to capture and some are synergies you The early action. rapidity about in question some the

Tara Rheault

mirrored Of long-acting muscarinic we some synergistic of course. That glycopyrrolate antagonists, early ensifentrine Phase and antagonists. III data top other that certainly did was and with data show muscarinic and the saw effects in on

Thomas Shrader

COPD you up Okay. And if you're kind it product? to develop points might I be orphan could than very the on a because an price quickly second Would different bronchiectasis. follow product look so try in the indication, Would of different?

David Zaccardelli

formulation. I No, the progress our current Yes. with actually strategy is Tom, to think,

its very [ that's patients, orphan, an incremental we're addressing in technically And ensifentrine be in current as is course, it's I which closer number as imagine. helping Of while not that an another great appreciate indication, could I is formulation is indication, to the that think dosed orphan, what just but you can efficient, ].

Operator

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

David Zaccardelli

the Great. in and talented we dedicated like questions And Thank for to our the you I'd look your everyone, for you, all our next progress and their commitment. addition, And continued today. over for Have work updating Verona team great their forward a few to months. support. shareholders on day. at thank And

Operator

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

disconnect. now may You

Verona Pharma (VRNA) 29 Feb 242023 Q4 Earnings call transcript