VRNA - Earnings call transcript Q4 2020

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Operator

Welcome to Verona Pharma's Fourth Quarter and Year End 2020 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 and full year ended December 31st, 2020. 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 of or 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 ahead. turn the and will reminder, days. now David a Dr. Please Executive to recorded call Zaccardelli, like remain I'd being Chief go conference to XX for As over

David Zaccardelli

today call. Pharma. our Vice year Thank you, our continuation XXXX Martin, a Officer; Christopher and Commercial. me Kathy and Dr. Financial Verona Chief pivotal welcome, Hahn, today's of was Medical Rickard, President for everyone, With Chief Officer; a our fourth are of quarter The to of Mark

During product raised Phase advancing X financing. we $XXX oversubscribed substantial trials million our the year, candidate clinical progress and made first-in-class Ensifentrine into in an

for enrollment positive we in ENHANCE end-of-Phase onto the on a significant metered-dose in X recapitalized therapy X U.S. or from in And X patients X set dose supported single-dose positive and And quality trial function with X trials in Drug part reported demonstrated challenges of placement, Ensifentrine Phase in Our Phase of lung importantly, Phase data bronchodilator selection Phase with with allowing maintenance million in of the a life received also COPD. we the Ensifentrine hospitalized The a included, March, initiated program. $XXX pMDI, data the to at our symptoms from we And reported pivotal July, private Administration we and, on a in goals from XXXX Phase initiate we company May, trials. data COPD. added January, the inhaler, pressurized for guidance and XXXX in in Food highlights our the study in COVID-XX U.S. Xb trial Ensifentrine despite September. treatment improvements beginning of nebulized in COVID-XX. Ensifentrine ENHANCE the finally, with We all September. of out pMDI executed And with pilot unexpected us measurements.

turn endpoint the we placebo FEVX, Ensifentrine to with dose-dependent delivered significant forced treatment. lung improved statistically or X of have four and X COPD month, severe dose demonstrating underway. second, days we announced already we this function expiratory of trial primary formulation met part improvement XXXX, of Ensifentrine peak seven to trials Ensifentrine in pMDI by one with clinically volume positive post with our in from Phase have after compared multiple-dose Ensifentrine pMDI moderate of As hours from to over data clinical three a results in and announced the patients. Earlier trial additional

dosing evidence the clinical and of nebulized XX addition, our placebo. These center statistical focus XX trough continue to efficacy future FEVX In support including similar mechanical in In of evaluate safety of and on we pilot a at progression near-term, Ensifentrine in FEVX attention clinical patients clinically very key meaningful hours and and again, and Ensifentrine four study improvements enrollment -- Ensifentrine's utility across but efforts these randomized, the tolerability, will of demonstrated significant data effect over mortality. status to COVID-XX Ensifentrine for Birmingham. tolerability, exploratory average provide will and and double-blind, Ensifentrine investigating hospitalized ventilation data the COPD. meaningful additional value via XXXX, life providing outcomes, of the and Ensifentrine, in with University twice-daily and on use, In broad with management pMDI formulation of a January supplemental clinical single the safety formulations placebo-controlled to safety oxygen completed opportunities. and Alabama devices, cycle treatment This improvement, we at study at of reduction and in

hours ERS remains measured clinical secondary of and are across health-related for the symptoms measurement patients. weeks with studies through Ensifentrine placebo-controlled background COVID-XX. function safety severe believe lung XX safety X its that evaluate regions. via mode both longer-term evaluating prevention weeks novel is over for subset COPD over The but symptomatic assessed single-bronchodilator of Enrollment significant unmet and Ensifentrine studies in XX onto pleased quality for XX are now XX therapy. symptomatic validated added of approved approximately ENHANCE-X We Ensifentrine, enroll effective help SGRQ action, endpoint Each and patient-reported with ongoing patients. two designed COPD The vaccines to trials, include over weeks. expected with ENHANCE-X, in is after endpoints moderate is monotherapy We of FEVX of by XXX are with outcome the are patients weeks, designed in and improvement COVID-XX, life to double-blind, measurements XX a patients treatments of could replicate global to efficacy and study XXX Key planned to of approximately primary tools. Phase also ENHANCE-X randomized, a The two as treatment. need

assessed. analyzed Exacerbations Additional lung pooled a also and function analysis. morning including be endpoints, peak will in trough FEVX, will be

quarter, milestones I'd from the COVID-XX pilot summarize In expect our this year. expect we to study. report important to second several data topline we Finally, like

now half XXXX of the half turn continue review X in ENHANCE both second our second expect call and X to of looking further our Second, is half on finally, XXXX. year-end our and enrollment we based the projections, XXXX the trials Mark the first from add trials clinical Phase over ahead, to will in to to expected ENHANCE-X ENHANCE-X in Phase the ENHANCE of from financial results. And I topline XXXX. data complete in sites, recruitment of

Mark Hahn

Thank you, Dave.

XXXX the For the This to $X.XX related year loss ordinary for XXXX, compensation to per XXXX. clinical the salary year. XXst, ended $XX.X $X and million ended a for million million for an prior year of loss we and were compared increase team. to expanded $XX $X.XX charges compared year $XX.X $XX.X share share $X.XX in for December costs share-based as $X.X an million attributable December year million after-tax to compared compared primarily development General year costs in the XXst, ended or administrative and million higher XXst, XXXX severance per ordinary our XXXX, the compensation increase premiums, December Research for D&O loss increase insurance was December per costs, a per million. of $XX.X or private development ADS million XXst, costs of ADS primarily XXst, December for related were year ended charges, the ended represents an This of to salaries, $XX.X the increase to $XX.X costs for placement. and the to share-based attributable the financing XXXX, was

of compared million the XXXX. to are XXXX credit to in a year received for Additionally, compared recorded decrease XXXX qualifying XXXX. is $X of for be Credits R&D expected the $X.X which to XXXX, million cash a in the attributable million financial $X.X ended to credit R&D in was XXXX year lower XXst, December U.K. in tax expenditures

support the R&D important facility, operator any tax elements financing back the the credit As in ENHANCE now in the years to million the the receipts clinical development spending We as with legislation cash the few quarters, aggregate Q&A. as to our coming next The credit offering, July XXXX operations the program $XX $XXX our XXXX. and changes under program combination strategy. and for under on of $XX over ENHANCE to borrowings turn We subject million $XX of the from in program all U.K. potential this could could accelerates elements into SVB these million limitations. which believe equivalents. call over I'll proceeds near-term impose debt the cash much and are potential PIPE million ended will

Operator

Tom now ahead. begin Instructions] session. the come question Our go question-and-answer with Please today from Shrader will We'll [Operator first BTIG.

Tom Shrader

Thank you.

mostly an It's quarter. congratulations. So, execution

sales your little for some partner the it in mention to are anything thoughts it? likely alone? didn't it's take go force. of early. spend. think you Or a about do thoughts. on your a thoughts might know Just you piece you your You Do Just you think I

David Zaccardelli

and are Yes, previously and prepared constantly scale. other COPD we've treatment sure. launch is well at using within done we in to our size that believe We that companies having for at nebulized Hi of preparing we think Tom. previously, that the Thanks. No, the capability, formulation. States mentioned that sort United evaluating, of the it are I as

we mentioned We that. looking have U.S. for continue are do outside also the we to partners previously, and

a We is offer as we XXXX, the sense. making on need. partner, they to the And be that it course, what depends XXXX broader coverage process in valuation ongoing especially view patients Ensifentrine and those may reviewed all want that we've of may be in through geographic that And to do today. certain expect make can have there and while that, provided that sure to an partners we in advanced as

advance to continue about, XXXX. we our this time, the in as coming program, Phase on And during execute conversations. we'll to So, continue data out X talked we'll partnering

Tom Shrader

that include are -- of hiring they us? Or you what included any Does in tell the is MSLs? And guidance? plans XXXX the can

Mark Hahn

Yes. Tom, Mark. this is

this board there's more of our team in program. person data Phase So will at now. say as the have years, XXXX, Chris we once as Martin we a point. done, on from He's our get continue are we get coming Commercial commercial the through and VP only as be to But commercial small right of being I'd that progressing, we really the on X amount significant work

launch. forecasts will to -- ready our spending the to We and company include get money

heavy timeframe, later would Maybe in in is the XXXX, be which small around in a will we've -- And so then the around let's kind some say, approval, would there be And commercial through the in, cash assuming XXXX, real -- of a be team build organization. build the spend positive time forecast a from small coming and data. commercial personnel beyond given of the leadership through XXXX perspective. which again, early the be of will

Tom Shrader

great. Thank right, you All detail. much the for very

Operator

that. misread question I next I'm from come -- Andreas sorry. Our will

Please next Jeong Jefferies. come question with will from ahead. Our go Suji

Suji Jeong

Hi, studies run the which exacerbation to have question is what wondering, show show program you. good I'm my do Thank Thanks doesn't filled I LAMA. ENHANCE are second benefit in prescriptions benefits? the you when of question. plan to And if just -- my additional my percentage nebulized is first is, morning. rate, for taking exacerbation Yupelri, about written?

David Zaccardelli

the for Thanks it's and Chris first I'll the questions. question Dave. then Yupelri. second Maybe Hi on turn the Suji, for over it on comment to

the As ENHANCE designed numbers not know, you endpoint well patients be specifically duration. studies, both by as exacerbation of to trials are as

in those essential However, well a with the I effect mentioned, us. and our show COPD at that we're FDA. that have It's we ENHANCE to as that as Ensifentrine exacerbations pleased the what will that the of very And are And results study. we'll the the on provide in not opportunity for data view launch determine the our in to for look analysis pooled discussions for as trials payers. see in physicians looking the measure

the effect and on don't want and for something we to so of exacerbation, the from with said, the that of will at But our do. determine that we'd the to it's we, necessary Ensifentrine based that completed studies the on of look outcomes that have have success time, data we launch if believe studies that believe essential is Ensifentrine. trials. ENHANCE the effective evaluation With Chris? at will after an this And of are data the those we

Chris Martin

their far Yes. because specifics Yupelri, I know what what's seen the going as pharmacy nebulizer on claims right is what this can't them, they important the and reported B now. in from of that what at talk things the we we've and Part But abandonment remember, of Medicare about are when time. Suji, coverage have within is as XXX% at their about that's Part B public they there. that an to we XX% think one about documents And Medicare aspect reimbursed through point the a publicly

within Yupelri XXX% access has space. So, coverage that

The also well. to is that said discussing very coverage level a other is as commercial and are thing increasing high their they've

both B taking this the from is from them a -- managed learn see launch can place the standpoint from to seem we and they're quickly commercial on Medicare So, within Part date, how care very traction from ends. there Yupelri getting marketplace. and a good And standpoint

Suji Jeong

Okay, you. great. Thank

Operator

with Wedbush Argyrides will from Please Our come Securities. go next question Andreas ahead.

Andreas Argyrides

Good morning taking for and thank my you questions.

the treatments study, study pilot COVID seen year, the or of patients To to look the getting you Regarding Are actually lot patients improvements, outcome? in And getting those extent -- amendments adjustments ventilators? over impacts perspective? there with made any those especially have a if improving. from or study there were especially were what made we've the preventing from during on hospitalized past to, on changes seen the whatever, improve observations that

David Zaccardelli

Yes.

So, question. thank the you for

And back this at keep at study at mind up bit, Ensifentrine recently by University of XX just that -- pMDI a little of to pilot institution. delivered via an evaluation the at top of care design, hospitalized the it single Birmingham. center Just is in done It standard a is had involves a the with of COVID-XX. study on Alabama patients been is

would in as course, of their a do weren't want based position, they to the on we course, appropriate protocols. to to what treat limit Of patients

single a study a being more of window. to I and say, there bit was over uniformity months, treatment time. treatment But in this center, over few the period in patients. conducted in course, a would fairly was study which short different also subject these always a shifting Although be narrow of conducted, is of time, was paradigm, a the relatively The

really, And for Ensifentrine the this we're to is function, supplemental impacts clinical learn oxygenation, around the of to example, study lung it tolerability think course, then, and on with of, course, what and oxygen from course, what of I have safety specifically start use. so could do and of looking

over in hospitalized. COVID-XX months, really this a occurring patients of few but continue what continued unmet this we so you which not who a period development or over take changing Ensifentrine in as months six on and, year the learn. first in in of its our next are where we time study on and to And the those of be look course, a all based field, It's to do And very that of it's want the only that's needs are results, a continue would And say evaluating results then aware next we the on. evaluation depending disease. next two at we'll and type we

what I first So, would think study then do to we of and our get look the the is results step a next. at take

Andreas Argyrides

were on we was results impacted care fact because require -- hospitalized a were oxygen on seen particular seen improvements recent going or the there they assistance, we've So, endpoint study the patients based in the have that et either -- were impacted cetera. ventilation by that which for, an

And two then. to -- that over age? that, based on Just under -- to What XX? and I'll follow-ups then breakdown many quick on Could were go patients speak the also, extent well, XX, how follow-up. with the you

David Zaccardelli

looking of At Thanks. the to We're of characterizing this or interpretable any we're finish No. study. Yes. sort. any time, not type patients the results

study and period within the of As but still active follow-up. you we're enrollment, completed know, we've the

still so it's blinded -- status. a status double-blind And we -- want in to

we make And that. mentioned, we as results, report topline get want you we'll out demographics, And through including to then the the at all sure so once.

Andreas Argyrides

I you the a very do -- designed powering will what study? is be study that Or And early would analysis? was for be results Okay. a of just provided it statistical Or context? learning in anticipate kind -- those mean,

David Zaccardelli

nature, There design. are no study pilot for It Yes, descriptive by as it will type. initial study be it's of mentioned, an as a this assumptions. be strictly I in should statistical

Andreas Argyrides

right. quarter. guys and very on All Okay. much congrats you Thank the

David Zaccardelli

Thanks.

Operator

Joon next question ahead. will with go Please Lee Our Securities. from Instructions] Truist [Operator come

Joon Lee

and congrats Hi. the progress. Thanks question on for the

the you that study depend be just line? could Can about EUA? that for any there outcomes one does do goal the have to certain chance prior the study. Or us question, that tell pilot need finish more I of For would outcomes? and to Thank follow-up. to possible get used study you. what that, Is the you And through up on the --

David Zaccardelli

Yes.

really, we to size think mentioned, I help that the and we these of variability mitigate. or key prevent as impact, said, look progression what think of of a at we're signals of we ventilation, that I as course features could clinical the receiving, study, oxygen supplemental So, on some we the on I type items mechanical think effect could the would them, oxygenation the use, take need and we

we to think study. I is to what keep need So, in the mind study say isn't That's not that by well-conducted it design. a

Just placebo-controlled, keep it's still trial. in double-blind mind; a

is descriptive integrity, it has going in to scientific it think I also nature, So, powered of not but have a for lot endpoint. statistics. any pilot We're

until handle the to at us should wouldn't I what tell time do we the and with we study could a results what so we actually want And this predict have what on do next.

Joon Lee

preclude nature from the of applying pilot the Does for you study EUA?

David Zaccardelli

around No, the I for mean, does. quite at think COVID fluid I are the concept don't I think it treatments moment.

to I think risk safety, utility from whole the treatment. comes clinical see, you benefit any as picture to that and of has that of do of always, it course, with the, the results the the the

say wanted in nature. I to is it what So, pilot is that

any So, there no that structured endpoints be to was statistically around the specifically are study -- tested.

we again, results first look to decide next. and to at So, then what need do the

Joon Lee

Understood.

how next what then to the they Thank formulation? question you us three a market, these the dry nebulized with potential formulations then in complementary? And versus you remind what to and to the competitive if different extent are Can the effect were dialogue powder Looking are the partner? is And actively again formulations. And be in that you. of pMDI magnitude the compares for was forward and with update. the

David Zaccardelli

Yes.

and perspective, these formulations substantially basically improved any There have more is -- provides shows function picture delivery the dose the the necessarily that about different and between as are measured So, which, look in there dry in we're could There's each delivery information as pMDI and course, three dose. doing formulation. same data delivered But effect by the lung you're nebulized. and the some be much learning little for on between as consistent I is studies, not we're to, FEVX, bit the across about different as variability, great devices partnering at you from on, consistent you very overall, indications, of pleased fact the if of specific a and flexibility because, methods. the of a a Ensifentrine provides opportunity nebulized, inhaler, clinical it relationships in more as we think would DPI, those of pharmacology that alluding equivalence we're performing pMDI and and powder I the function. and dose of think And these bronchodilation, Ensifentrine, very expect, lung DPI, opportunities. delivery definitely some And very one other those lifecycle it that devices, formulations also on management, us is

the COPD partners are As have as definitely would DPI, within applicable. MDI our you be more see be indications need approach, nebulized or MDI expect, Because would DPI looking acceptance, own up find be see for some that more MDI maybe be them we It we in a Ensifentrine. have When very physician patient expansive with and you to all But experience mature nicely much acceptance, to different also deeper progressing line an nebulized do a maybe some or experience be progress COPD. other it, an were More different its great opportunity focusing proprietary it bias Ensifentrine would nature. to nebulized or on point, in as in right, and to that with DPI, don't optionality is at and the formulation. where that we provides indication with the and MDI and much an or tends the DPI devices competitive market. in do successful payer to not the price need, word. I

are formulations. asthma, for just suited additional be complexities as And it also, And outright, may so such best other example. those there commercial for to indications other some

X So, that on with executing stay we'll nebulized Ensifentrine. continue program while laser-focused look our we at Phase to very in

Joon Lee

Great. so you Thank much.

Operator

will this closing Dr. There being Zaccardelli turn to conclude no conference questions, remarks. question-and-answer I'd to session. the back like over for any our David further

David Zaccardelli

stay Thank shareholders today. like would you, challenging for execution thank continued we of on updating everyone, call. safe important team you Verona forward and Operator their their progress our XXXX Verona during during you of of times. for healthy for today's Ensifentrine. time. I on that support We talented concludes all your and these hope another our Verona, dedicated to and look at the your goals the questions and for and family is year that colleagues to this and continued your

Operator

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

now may You disconnect.

Verona Pharma (VRNA) 27 Feb 212020 Q4 Earnings call transcript