VRNA - Earnings call transcript Q4 2019

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Welcome to Verona Pharma Full Year 2019 Financial Results and Operating Highlights Conference Call. All lines have been placed on mute to prevent any background noise.

Following the speakers’ remarks, there will a question-and-answer session.

Before we begin, I would like to remind you that during today's call statements about the company's future expectations, plans and prospects constitutes forward-looking statements. These forward-looking statements are based on management's current expectations. achievements promises and and may or other actual performance neither unknown known cause implied are different results, uncertainties materially statements. risks, important or by statements the nor expectations, involve guarantees and our from forward-looking These our be expressed to factors that

estimate statements date of of this Any such as forward-looking conference represent management's the call.

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

a being As recorded. reminder this call is

now I to Chief to would David Officer. like over turn the Executive Dr. call Zaccardelli,

David Zaccardelli

of And operator. Financial you, joined and today on Mark welcome Thank Officer today's Officer; call. the I'm Verona. to everyone Rickard, Dr. Chief Hahn, Kathy by Medical Chief

market for are in of Pharma With to patients time has other Verona differentiated I COPD single is an in and fantastic or ensifentrine at from respiratory We this development. suffering and of therapies join mode to the therapeutic both important from anti-inflammatory in and the is become delighted molecule novel action exciting potential a properties millions the disease. opportunity its believe on bronchodilator a development. Company's truly with this ensifentrine Mark

we In the strength the and addition Verona were experience Pharma of to the opportunity potential ensifentrine, of to attracted by the team.

through many Our highly ensifentrine accomplished X therapies Phase respiratory leading of will in has and instrumental been development clinical advancing its team program. the be in involved

those globally. COPD over receiving Organization. patients. than severe maximum treatment. according million the pulmonary cause worldwide more not X.X therapeutic more COPD, limited, from years, Yet for population. the and become patients to despite particularly of million As people to need despite unmet remain size an by development, many Health COPD the In alone, leading treatment options Chronic are in third disease, area significant large innovation disease obstructive of U.S. new death predicted respiratory for benefited XXXX affects World drug is XXX the symptomatic, chronic market has medical

safety were and X,XXX a studies is Earlier with conducted with The Phase substantial XX over published this from this in as of ensifentrine month, all nebulized results ensifentrine COPD nebulized in significant for treatment trial XXX Research. clinical as individuals. medical trial receiving at symptoms Xb -- evidence efficacy backing clinical we placebo. announced a journal patients Respiratory well the ensifentrine's to-date compared in Highlights in doses improvements patient as to of COPD bronchodilation, COPD therapy include

from dose as plus leading you a addition, tiotropium. COPD agent results ranging In Phase second nebulized either January trial, tiotropium or patients antimuscarinic XXX long-acting announced of to trial. Xb many In were plus we our this ensifentrine, moderate-to-severe know in receive randomized placebo with

improvements four we and statistically meaningful compared all a of previously, tested As tiotropium produced clinically stable lung reported at the significant to doses function added regimen ensifentrine to in arm. placebo

of placebo in XX the FEVX, observed tiotropium. improvement were ensifentrine improvements FEVX dose compared in study. tolerability for FEVX dose the X an milliliter both function peak when other and average lung in of dose X cohorts The safety hours. similar Dose-dependent The showed lower XXX milligram the was peak to milligram added and to impressive and over

function advisory standard on by board improvement been Leading the impressed nebulized care have of magnitude demonstrated top our ensifentrine. those therapy with pulmonologists, including lung of a of on

quality progressive and clinically Another in important improvement life. finding in this of health-related meaningful study seen is the

trial, COPD MCID measured ensifentrine, measure. seen weeks. milligram validated four using milligram weeks, difference significant four higher is doses which and important treatments, these minimum on clinically as rarely SGRQ in in in produced in two X.X of doses statistically with symptoms the COPD The improvements Patients or met just the especially X the

is tiotropium We ensifentrine is when highly result, that achieving to added this believe differentiating.

dry our the powder compound also of We for to ensifentrine, a ability announced well year, DPI in behind the deliver inhaler X formulation handheld evidence as in last convenient as clinical August or formulation. Phase the reinforcing positive results device

In function, supporting and safety documented favorable data clinical the addition very our asthma, treatment, respiratory study are severe as broad fibrosis programs, as to of to cystic the in across ability tolerability improve potential ensifentrine's use lung other well for COPD well ensifentrine diseases.

of for substantial of end the is for data FDA, plan and second which XXXX. with We clinical a we have CMC X the our meeting pre-clinical package Phase to quarter planned submit

COPD major background confidence compound profile role for As and can ensifentrine, and in many development COPD is a well-validated Phase in favorable positive the gives play regulatory after COPD my patients. the and of clinical drug ensifentrine unmet me that treating need in of you clinical approvable X therapy large pathway know, medical an results

I $XXX as Pharma the Swedish Dova I Verona President its CEO served CFO. as as I by Biovitrum from Mark up to million. and served Pharmaceuticals, acquisition for XXXX Dova, worked closely until joined at Mark where Orphan in and

in the has has million pharmaceutical led I this for exciting Verona am career, Mark the at $XXX joined Pharmaceuticals. and at significant have me U.S. that the also experience Mark his operational and pleased over in During I IPO raised opportunity. Both Cempra space and Mark

XXXX Verona year. we'd share is a our to year this key for Pharma priorities and like transformational for

second agree program end-of-Phase mentioned. meet quarter and First, which the an with I the is we will expected the in X meeting on as X FDA Phase for

we our Phase Second, initiate year. in this X quarter clinical third we trial of program for will anticipate the ensifentrine which

out study reading early with and portion the in the proof-of-concept of or complete half in of Phase we'll multi-dose out the single X Phase portion the inhaler clinical of format with this year. pressurized ensifentrine the quarter study the part second MDI second in the study metered-dose of dose the handheld Third, X reading

for adequate we our will Phase nebulized progress program operations. acceptance work X plan company and pre-commercial on finally, for health the reimbursement Fourth, we including to additional we'll ensifentrine ensifentrine. fund have capital ensure our And analysis and

for rest moment a like take their ensifentrine over the work to the program. advancing Before to the years hard X achievements Phase to thank and I significant team Piers, Mark, over Jan-Anders, and call and through Verona turn the the I'd of

results our XXXX. to financial I'll the to Mark for now turn call report over

Mark Hahn

hello everyone. Thank you, Dave and

I Before like joining Verona about I'd results sentiments Pharma company reiterate enthusiasm exciting to financial and review about at Dave's stage. for the share this XXXX, my our

to press XX-F the please financial this we SEC. also release that a to morning results, the the refer with as issued Turning which is filed

that in Given our U.K. results reported financial we British pounds. are headquartered the in are

a XXst translation U.S. we've rate December based For on year-end $X.XXXX. your the to convenience, also £X exchange of to included dollars

XXXX. XX income $XX.X million the XX, December was £XX.X to XXXX, for operating ended for million or statement Turning loss year to £XX.X the in months million the our compared

after-tax $X.XX share $XX.X share compared of a a £X.XXX December million million of $X.XX ended £XX.X £XX.X ADS per for the year or or or prior per the was ADS which diluted loss to XXXX. for This The million per to a year. for XX, represents XXXX, for of per £X.XXX XXXX share diluted a loss loss loss per compares

Research million Xb by were representing study and in year XXXX. The XXXX compared increase the December in XXXX Phase there X-week that as XXXX. to $XX.X of were compared an costs Dave of clinical known XXX year recently trials £XX.X completed million, XX, trials trial a majority related clinical XXXX £XX.X in to study the four clinical to two development costs for XX, ended the ended discussed. million The XX% or fiscal increased trials as active of December cost

was million primarily $X.X compared increases XXXX. were million the for increase was or year net of attributable to £X.X in ended million year. income expense for to research prior the December costs for This in ended costs XXXX compared XXXX. and the million, ended XXXX December December to XX, million Personnel-related and £X.X personnel. in market the increase Finance by the million year or compared of administrative increased finance year XX% $XX.X to XX, £X.X year General XXst, £X.X an

and by income Finance largely value from in entries short-term fair driven non-cash differences expense exchange investments the the the are of liability foreign changes year-to-year. cash and and warrant on

costs compared the of XXXX. a Taxation including tax to was for or in amounted million change expenditures. year, XXXX research qualifying million development and of our £X.X compared mix credit a million to to of $X.X prior credit attributable the in increased This to a £X.X

short-term $XX.X at cash million with XXXX million, and £XX.X to £XX.X compared ended XX, Verona or XXXX. investments December million in

that raise nebulized additional to existing to and XXXX fund cash current investments fund through short-term will enable to of ensifentrine we COPD. our us level will Phase While treatment need operations program earlier, capital the our X for we as trial expect of our Dave mentioned clinical in

I'll now back Dave. over to call turn the

David Zaccardelli

important upcoming both handheld as the and formulation development are the inhaler milestones supporting creating the regulatory of Thanks ensifentrine commercial activities our believe well as value nebulized directly value Mark. in formulations. that We

open up I back to will answers. the now and call the questions for operator to turn

Session Question-and-Answer

Operator

of Tom line comes [Operator Instructions] your of first And from the question Shrader BTIG.

Julian Harrison

is taking Julian my Tom. on for questions. for This Thanks

only have a possible here. Phase you're two the one you of instead considering dose sense this Thanks. development time pivotal X, exploring First, for cost I for at the understand the of outcomes if just relative possibility wondering for

David Zaccardelli

Yes. Thank you for much question. so the

once include we date. Phase we X timing. after course, we the believe estimates in the will scenarios X I report to Phase actual I think generated depending be the on the And upcoming this and on meeting. need to program, Clearly, that's that FDA clinical data covering cost two on the the satisfactory after should the everyone we'll the cost various fully X Phase we program, we in dose X with doses have have may one the meeting to X although clarity that program And of developed Phase think Phase understand that be back topic the definitely we based meeting. on in the

Julian Harrison

That's to anything have upcoming for but at to Phase understand could formulations Thanks. there it inform fair from ensifentrine these helpful. everything arrive is plan or a And you development final you help Great. that for pivotal distinct MDI I the Okay. need this say data-wise time X? nebulized already at readouts are then is

David Zaccardelli

Phase think ensifentrine, nebulized program X to adequate the it to regard with we data stands. as support have we Yeah

hopefully evidence development and MDI of in ensifentrine. the look Of benefit to fully the continued of effect creates the form we will that dosage data additional and support course, on forward and further

Julian Harrison

Great. Thanks questions. my for taking

Operator

from next of the line Moussatos your of question Liana And comes Wedbush.

Liana Moussatos

taking you Thank my question. for

you serious the So strategic discussions, need second do in half? for the wait for MDI multi-dose to data

David Zaccardelli

Phase program regard use in our in we strategy to good not Liana. for your morning nebulized for to supporting handheld I our a X, wait we're data. with Phase understand ensifentrine. information do -- its as Clearly if need with doesn't to guess think impact it MDI in But demonstrating program in interested on plan formulation. regard ensifentrine with formats nebulized for additional it to X our other I question, overall, regard Hi, the I

Liana Moussatos

What about commercial partnership?

David Zaccardelli

Yes, data is supportive. well I always additional think again

that about dosage nebulized DPI we've making for we as we're excited progressed conversations. data imagine a having sure an attractive, that can MDI ensifentrine that You very and partnering also and have forms are very and

As I you know in or joined so. Mark and just last month the

So best getting and but shareholder for creating we're strategy and globally. partnering for ensifentrine the our our arms not strategy aspects actually only U.S. all around in value best the of

Liana Moussatos

Okay. Thank you much. very

Operator

Markets. of Capital And from your Trucchio next comes the Berenberg Patrick question with line

Iris Long

on our morning. Hi, for This for good Thanks is question. Iris taking Patrick.

Phase and questions. endpoints regarding design So a X efficacy have few the trial we

intention two So if background bronchodilator single conduct to is or treatment. months six no the trials with

So would first, anticipate in you these many trials? be to patients enrolled how

therapy of And therapy? with on on then particular Is type no be proportion background treated that patients bronchodilator there should patients of background be would what a treatment? versus

clinician standpoint finally as would be be to threshold Thanks. that FEVX well then perspective? the what regulatory a from improvement necessary is expected as of a And

David Zaccardelli

of Thank that going provide you would one. of it, to to end-of-Phase an unpack And although amount I meeting the outcome with it I the our say is to be very there over thoughts to fair that with Dr. to turn want agency. her on much much a for X is that Rickard question.

Kathy Rickard

So on are two calls, in studies. as previous we discussed XX-week planning

improvement some of the of that meeting including numbers see Phase the symptoms as form This including so what as we'll other endpoint plan be evaluation. We in FDA of FEVX secondary X type where primary including a be finalizing endpoints patient will including at and study. on with of the Our will and far end forth. some discussed extend lung be we'll improvement all

the So that'll this be of second coming quarter towards year.

Iris Long

perceptive. you. thank payer And more the Okay, then one regarding question

your anticipate formulation. for could secondly discuss with and to inhaler willingness reimburse the we then for versus their novel COPD you And can So payers therapy? pricing where work nebulizer a

David Zaccardelli

the for you thank Yes, question.

commercialization, have although research and We're some attentive We to mentioned. payer from time research. also market doing are extensive topics you away been still we the

COPD. are that would for We a payers therapeutic comfortable pay novel in

to for approach mentioned not current We continue with our nebulized discuss payers. prescribers as commercially goals both products pricing We're with and least think this supported will to for that point in the in the COPD. year I could our and refine price continuing be at, concept payers at if over that

Iris Long

Thank you.

Operator

Stifel. And your comes line Adam from the of next Walsh with question

Adam Walsh

and thanks my your there. taking morning on question this Hey roles new David for and Mark congrats

start Let let good company. the me start you your That at would been in have not recently since start? I whether and a me -- changes David arrival. arrived be the just could speak broadly to couple Maybe you've since plan strategic a Thanks. or any strategic to Mark place there've

David Zaccardelli

Thanks for Adam. the question. Thanks

think strategy I with for to same. remains essentially regard the it Verona the

well We as mentioned in opening executing laser sits product COPD. greatest is It focused very the my around for the in the that emphasis we're patients Although III within again, think program focused remarks creation space. to as Phase help advancing on value for an as company. I shareholders our

will the in my I we to forward I around execute program, continuing mentioned So think to as remarks. look COPD

that, strategy that, assess of We'll look year including as payer continue the to continue was best do to as execute approach on again prescriber the partnering as program. activities III the forward company. the I the for well we as next other the two of or the mentioned All continuing to Phase we dynamics, to as around

Adam Walsh

So just about little know on questions the worth PMDI a dating whether And data for front a but there you're maybe more were I on partnering looking, some just we bit constantly multi-dose the granularity discussions that? that partnership. to looking mature? those XX potential course meantime months? for the in non-diluting financing terms kind are you're as data in something mean you of that a hold Is over mechanism of the continuing of earlier next the

David Zaccardelli

advancing its in I own on a already But partners and created as discussions data ensifentrine nebulized look Yes an of think of incredible right DPI. more is to our I course right. data think addition always MDI support that we in with to progressing data forward is formulation the the that the opportunity

countries about in in countries the those the partnering U.S., in help are requires partner. ensifentrine has as And with we when we think talk hold IP expertise It we partner in the commercially that other probably really who we the and worldwide rights ensifentrine already that a commercial impact which where and patients a product opportunities well to U.S. there could progress but substantial. in can place, has well real also make is nebulized do engine as

on but global on executing progress the I program products. have other consider with understand and discussions, secondary or MDI our will with do other type opportunity technologies for the of COPD. focus the partnering what the in they the that them that gating perspective asthma I other think have And and indications I used on to may helping don't partner over diseases. partner see in think guide the is the it Phase consider conversations. we fits coming I any the advancing months enhancing in formulation and Also helps on past the to respiratory well partnering that them, of entirety of any in its X a depending potentially assessment

Adam Walsh

that's helpful. Hey, really Thank you.

Operator

the question Peter next from of Welford your of Jefferies. And comes line

Peter Welford

Yes. of Hi. Thanks. left. questions Couple

seem can just study. regards to if just and you for the of challenges be data the of a that a the are that. guess PMDI, I to Firstly, for does planning doing seems potentially I of multi-dose setbacks to sort with there back the that relative for initial what the wonder bit of why to sort series timeline multi-dose outline, slip

ballpark. average other X be extreme program? you $XXX most Is with the regards being I example, single of would Phase just to for assumption is sort to that cost is hand plan the the just your the should, around X that FDA in room there with think decision the the so Phase for an that say, or in Phase or would million the placebo say alluded X, of that or on be dose probably lower for on you potentially your Secondly to management then prior

retain you more much a rights to DPI, partnering, a for also geographical And focus MDI or regards the as regard while nebulized that doing then formulation? of possible you executing very separating formulations the the I'm it I'm do commentary on do product? regards finally thinking deal your of think it I for this to separate ensifentrine that with it's consider expeditiously very to just you program, but to focus possible by to with you. different is formulations difficult is curious Thank the guess,

David Zaccardelli

program Thanks just MDI slight extended study the not very that We has timelines right I start are want a it really in I'm there shift the think material. the to has much and regard do have guess with sure for delays the enrolled patients required been that to we recruitment ensure any the and I be questions. in to to slightly.

an first So in But said, part, in half clinical study pointed in not the on fairly delay. with, already, you've enrollment we're best to of the of the study from data out of on then I that on and the we research, best a the yes, the timelines part clarity effort rest the as do will year. I think target have the science, second of rest look finishing to of the do the progress part the get the and but first the only at slight

the fully Phase mentioned. regard to program, aware the With generally numbers been what of of X cost have

are program. design with of final the regard confirming study Phase that the X We to

really after cost, meeting. the have want that to go program, into we that once in many Phase to Phase of of you, the clarity X are the with was end doses come regard et back We how As number mentioned, there total to a are may with X cetera. factors

But we program back are that think think for working date clarity to long to the a what it's we fine what estimates. and have to mentioned numbers when we want to take. how it's better the going X going perfectly on I you to think I is, Phase come much cost

partnering, overlap understood a options. Typically, well of handheld the because have nebulized be sort an there're in within as looking the such utilization, and disease. understanding geographical and to patients regard like and it your different all and may With formulations; taken point works we're is at now how in to same best and license potentially used people

but from it partner. initially, at looking we're the to on we're think, with I all depending the the circumstance geographical basis So, approaches open

Peter Welford

you much. Thank great. very That's

Operator

final from Liana line comes question Wedbush. your of And of the Moussatos

Liana Moussatos

Thanks for taking is X.X X a you milligrams question. Phase second thinking X my if there're dose, doses the X? and If single would it and are two be

David Zaccardelli

Yes, great. that. Thanks Liana for

looked we'll to and you've assessments clarity you're you all FDA, of we guidance be course, come the and data time, we'll and X At at the the we what from was as should those do the once program. providing think our let the back think, them we you I know what have making with in same and are reasonable data, those Phase dose rational. And that agreed. reviewing

Liana Moussatos

you. Thank

Operator

further are there back And call time. turn I'll this at queue over And to questions the no in Mr. Zaccardelli.

David Zaccardelli

you, developmental support for on We ensifentrine. thank you look So, our today. progress clinical continued forward your to for and joining us everyone, appreciate updating

all much. soon. with Thanks talk So you very

Verona Pharma (VRNA) 28 Feb 202019 Q4 Earnings call transcript