VRNA - Earnings call transcript Q4 2018

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Operator

Good morning ladies and gentlemen and welcome to the Verona Pharma Full-Year 2018 earnings conference call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] I would now like to turn the conference over to your host, Ms. Stephanie Carrington, Westwicke Investor Relations. begin. may you Ma'am,

Stephanie Carrington

XXXX. the release Good welcome December afternoon, review to the Karlsson, December results operator. joined Financial It this I you issued morning by today Verona on are, XXXX, market for Jan-Anders XX, opened. ended months Morgan, and today's Executive Officer; trust XX as update. this you morning you, call, depending was am or Chief and where Pharma's Chief On Thank the call Piers ended have that that the XX results as well for includes I XX, Officer. seen months the press operational before to

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of potential trials; additional plans its including, that matters line from on team indications. markets, to in the results, unknown to bronchodilator are forward-looking development not data; a and of These Safe the from address and the you fibrosis nor and formulations limited to management's of of ensifentrine statements the expectations. promising historical management's top Any known Harbor provide a by respiratory guarantees, During anti-inflammatory based should will the date and but be factors therapeutic formulations data the to relate important risks, uncertainties but forward-looking achievements ensifentrine statements. current statements these as facts larger the call, company's and considered promises company's other estimates cystic cause materially timing plans do as other through to, involve the forward-looking that clinical based These to delivery language. on the expressed clinical changes making the statements. neither as explore as We ability statements, ongoing forward-looking potent not effect for be ensifentrine; this certain remind performance its in forward-looking statements and All regarding be well statements agent; of implied are different company's such represent of its conference of its or may expectations actual call. the statements

will may line the I company future, at update over even that, the any views if obligation subsequent to statements do its to change. in such point With While some Jan-Anders. to forward-looking so, cause disclaims it to events the elect turn

Jan-Anders Karlsson

improve symptomatic Thank other you, of we a EU, that patents in granted medications. believe hundreds COPD beyond Ensifentrine, have inhibitor clinical a ensifentrine a rights thousands to symptoms, development the is and first-in-class in of life U.S., with the and U.S. and alone markets, of to despite quality remain patients China the in global XXXX. extending most Pharma's Verona current PDEX major It's RPLXXX, today. function, provide will have and with update reduce which lung known Stephanie. as pleasure you and formally increase we opportunity business PDEX unique to

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Our and dosed demonstrated patients to-date has four properties to this out route when the the in as COPD clinical Xb dose in novel is ensifentrine action a efficacy, have year. progressive involving clinical and last Phase order to XXX patients bronchodilator. in mechanism XX weeks, development trials market. of effective X which program that anti-inflammatory with shown X to is designed is In patients very Phase we that establish in and conducted, a for have evaluate study some [ph] It tolerated to subjects fastest examine tolerability up been well XXX improvement COPD reading causes symptom in to

corticosteroids. to which also we be additional patients the treatment In bronchodilators the inhaled that bronchodilators, effective of very a improve believed maximum function trials two confirmed We lung most study it our long-acting ensifentrine to investigate also designed in on have on could is top recent and of is short therapy. or dosed already whether when bronchodilator

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Piers Morgan

you, day to position today. Thank full-year want this our financial release you the results XXXX. course. and XXXX. and refer you I of cash thank will financial income, ended the Good audited for and months that statements we Jan-Anders. morning we joining provide release audited everyone XX, a flow I for our due of the in financial and XX December brief includes call recap of results filing to sheet balance a will be also issued press the for inclusive XX-F The

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nebulized requirements concept our and We than end to treatment our of the ensifentrine of expenditure ensifentrine cash the operating DPI capital of maintenance existing treatment COPD formulations enable and for expect COPD and Phase equivalents of investments Xb patients. that through our of developments the fund MDF for short-term us our of will studies and proof and cash, expenses more

for and in with back statements in tax operating to our And to end review the will like operator selected the we and in Additional open also of document. and data X and financial within included prospects and would audited that, pages financial up XX-F financial it be turn the Item our call questions.

Operator

first [Operator Our from Jefferies. line Lucy Codrington of the comes question Instructions] with

open. is line Your

Lucy Codrington

a for please. there, questions, my taking thanks couple just Hi

finding had thought just And more study? the you might more first safety if thinking the data the with including secondly, running wonder you idea idea study R&D? half? of that or toward particularly the I an be timings so the year meeting end dose you'll the should any finding how of whether Firstly, give terms at do X Phase Phase the that for dose then allowing dose looking with how number happen and we getting should the basis Thank give particularly think you've if of and/or the it could cash you about half could on in think us time of be impact the second and large especially finally, kind X greater end this year starting trials And us year of still the in could there you. FDA balances if of next of secondly, like finding that in should we the in the be

Jan-Anders Karlsson

Thank you, Lucy.

think on news start. is actually The really that higher good me Xb curve. the the and the doses the Let dose I is dose for study, we mg the X top response see of that

especially having of course doses many possible skip maximum also we and it with a placebo think mg effect go bigger level. be can study will a even very we dose We would as down even which index which we think a will is these explore down, already we patients maximum In for use add-on give we dose level instead us events if on will treatment. perspectives. next adverse will the us the an have X important and as effect, is several good reduce provide have low therapeutic if this and anything still further So that the to from we the a which

over hand balance. So May can question, in lower patients. doses the be last I the then take these

you about this of timing the study. So talking were

very the FDA. for conversation conversation, a right, is are good robust study a important You with

that that of as of with the data particular then balance? be year, ongoing our possible Xb you you the last more this for that do half during that take other wait believe to mentioned, about the year from in want we we will Do for will together year. we the study study the If the the start So dose and around would learn selection as still study we data you discussion ran first next we keep changes updated. X Phase cash particularly

Piers Morgan

Sure.

ready question. I'm get the So for trying to

we should kind study million. balances, typically but As forecast of that in you million study costs you of don't expect know, to a to looking XXX-patient at cash our the the the range $XX $XX of cost

So and planned of and dollars. DPI the both ongoing single low the millions inexpensive in are and study the digit mid MDI to costs relatively

So we would expect Jan-Anders to end to XXXX costs XXXX. months with significant. still the X XX a beyond costs be Phase end pretty of insights those cash X healthy as cash Obviously the give we runway balance study Phase which will of the design would excluding further than more will of mentioned, and get it

Lucy Codrington

Thank much. Great. you very

Operator

question line Joon Lee of with from Our SunTrust. the comes next

open. is line Your

Joon Lee

FEVX Hi four been see replicated really pretty that maintenance you subjects same which and And to in as up to of sort maybe improve continued sets? different COPD study? this due Is expect you maximal be a week to before, four-week in something that over outcome much [ph] Phase guys. to Thank quickly to something Xb you ERS measured first as or I've your medications by next Thanks four as that's unique perhaps with other patient week period. this Phase you. is trend would question. the that for by your your intrigued taking fact weeks is improvement my reported study, XXX Xb maintained previous but anti-inflammatory see

Jan-Anders Karlsson

much. so thanks Yes,

if really gradually the between the over effect We gradual and we that symptomatic on or and to it and a bronchodilator literature literature discrepancy The use, there's with we You longer it often reported data. the effect this be with then of a a month rightly may difference at that different see little and time onset look to improves from bronchodilators at improvement. is is course the look little exactly believe one other observed what an do in COPD same patients our advisors we a with And anti-inflammatory drugs time. a than that fully continually bit perhaps develop more is other come takes you of takes combination drugs.

rather other believe of anti-inflammatory published some data. we rapid have an we So compared onset actually to a effect

other that We scale the again that promising we and the the that sense improve in literature to we significant improvement time, symptoms only but but the that with compared RPLXXX reported is also what's also actually very and TDI we not also extent see the baseline quite other over statistically believe magnitude also what use, ERS for and same of in drugs. symptom measurements the with see of rapidly to reported

next believe endpoint this the but gradual Phase changes our in Phase for about, study. on patient's the we one patients symptoms advantages FEVX, treatment in phase, the regulatory focus the improvement a most Xb perhaps of important is it what we similar we ensifentrine, onset Xb saw the symptom outcome. see patients also that's So really in to a in mL compound complain important and study end on background that's is key is in improvement for the as why in a not expect previous And that we of do

Joon Lee

something measured one just at for Thank a be what could or endpoints as if effect branded the insight you medical secondary Have of And presented dose in sort on or any conference future? the to that gained any those XX explanation the you you. X inverse results magnitude. the Thank relationship near could more, you. of mg and be wider the in

Jan-Anders Karlsson

are that the You study reported is the… about last on talking

Joon Lee

the combo, Yes, yes. LAMA/LABA

Jan-Anders Karlsson

full set. their just are we getting Yes, data

together most an but it think the this all in believe do at I so all it's mg, is able fully. the to data of recent it's not experienced analyze haven't X.X it versus done, from that a the likely goes bell But been effects we of studies with study. I anomaly down and effect there we the what that response So variability of it’s mg that's flat. dose have we is curve the shaped curve course rather dose top doses, lower higher X response

very achieve do XX purely treated. XX close a being to And effect that our news have patients But compounds. all that as not can of and with and patients really good perhaps I we a compound the phenomenon seen smaller believe in expect it are other explore variability effects and X.X, COPD the of lower of with of before, and a compound and a mg X, good ratio much and we that's compound the therapeutic the course is with customary So maximum with that number doses the itself. is is we consequence can better also that they

Joon Lee

you. Thank

Operator

from comes question Adam with next Our Instructions] [Operator Walsh Stifel.

Your line is open.

Neil Carnahan

for this Xb In is follow on define I of volume a Neil you study FEVX LABA, residual in top patient population And the outcome of up. morning Carnahan positive one on measurements? Yes, This then both terms would upcoming and got in good Adam. guys. how Phase

Jan-Anders Karlsson

and breathing we FEVX Neil. is symptoms. we look instead course, a as much be similar plethysmography The put function structure the positive Phase study in assessment a this quite FEVX, particularly to will be significant but of to Xb to as outcome is upcoming or very of This a we the study That study. say in not directly previous related would will course area complicated in other hi box course look is and measured static aspects we think then patients in expect a residual measure The Yes, in increase volume you of expect lung of curve. function as and volume parameters. other them complicated a to curve the residual same measured able of the under And where body the of at in the or including we the treatment lung measure FEVX trough. and way, peak average at also FEVX we beginning that

particular and very the question? we think that volume any not as example important your changes endpoints for more in measurements in suited get sites, completed, answer as or we will to in readout is we for in see one Does that material. specific or variability but measure dose controlled maximum residual and will well three a reflect so And correlates symptoms two few too is sites studies that the much two data a and

Neil Carnahan

just you pretty top how walk I given Yes. behind think entrenched Xb one us commercially through And up, COPD you in a Phase ensifentrine community, there? thought this in the the LAMA, got of fit then process doing behaviors can on for follow are will prescribing just

Jan-Anders Karlsson

Yes, thanks. Yes, thank you.

of two that and to is this study course one are there clearly outline. question aspect aspects So

to demonstrate and Now this purely III a trials well-informed conversation are a study. clinical and that background, on Phase those with a and FDA study study uniform effective. where we well that can is tolerated are take safe This into to doses not commercial is appropriate is doses have that

this that's So study. purpose of the

commercially The of bronchodilator it treatment or other a second would we then could LAMA patients as a be to are very of is also you it a which is LABA to is for bronchodilator from a position our is LABA why to LAMA see RPLXXX, compound how one that question good usually in And and instead perhaps. aspect your going ensifentrine. use would

believe as we we patients the will these demonstrate Now good you least study, will Xb that our FEVX and that another adding Phase function at a lung improvement one. see in first believe that we has compound our we by in bronchodilator as to is substantial in as in have

an option. gives It you interesting. that's So

able and that other are importantly, that demonstrate patients therefore at time. study in already compound we same more an we in also our same is anti-inflammatory showed doses that a we in to in we symptoms have dramatic really as treatment. one on And believe will the be actually improvement Now compound the the

treatment a time like bronchodilators you symptoms an patients. patients this this a same anti-inflammatory few, for can in that treatment think to we help use not action. dual and well about to ask modality looking you that to options, just think on not on and more not mechanism that is triple you may for And are is of compelling of And avoid the are really Now a but contribution a briefly story. is and that have alternative very where a add treatment inhaled are some go compound And situation doctor an but profound and dual where through one to now no effects that the also let we today a situation if has a group just also bronchodilator, steroids, patients, say there are those we does take this rather opportunity is is additional course from that is talked great it help will other you is only patients treatment, will with there few to a today. can, of they at there you if be very that that them may patients here as be treatment a further patients. treatment appreciated to We meaningful about me

Neil Carnahan

Thank you.

Operator

of from our Thank comes with question next And Wedbush line you. Liana Moussatos Securities. the

is open. line Your

Unidentified Analyst

Sweta Liana. is Hi this for

In you a more evening questions. be there doses two the on of the do why Phase Xa LAMA/LABA, appeared that top and difference morning maximum between have and evening responsive? the to We the think was

Jan-Anders Karlsson

Thank patients Yes. fixed or of therapies answer. a therapy good a a and daily sales are question. once believe on I on most The double and remember, a triple That's straightforward once when it's you. combination day the volume got is then treatments.

of a it's So once category In having and patients. works well. treatment day that then day very this a is treatment the is perhaps once these the a category morning, patients of just largest

doing treatment. During of the effect is away. day with slightly more much the the pronounced the effect, XX-hour diminishing the longer effect This during day fades

that profound, evening morning. effect you you in company larger effect to therefore the dose dual actually not you more we as saw we an So if the type the you difficult in background a a that is see much are the bronchodilator a effect meaningful same same is of because see not was it effect see we should morning, that as then treatment the be so if lucky similar in would expect were, it much there and if and add add did

from different, and better improvement but improvement vulnerable in night. literature. these is have surprising. you that during hours, that And them a important a in now a have most a by be treatment behaving been patients lung So take. no there similar we that them. duration background science, concept of you patients problem in during is that deliver that's the is patients, not dose, symptoms so remember and Beta They the many function is symptom the life and symptoms of little can hope has itself fresher quite also will and actually of that top is quality treatment The and of evening really morning rescue for has these the the are if it sleep are also have the published where also Many an a the in in morning. twelve to can't you symptoms the with science course that on not is seeing when What poor obstruction. whole X We substantial rocket of It's which have it's other much you them we give to day. night. is quality if will as these is can of We help and during ensifentrine example are think good and ensifentrine relief explored in It other able of is symptoms way a it maybe give a rocket improvement night, believe bronchodilators is you - do it improve to an you compounds have rate to they the get that stable agonist after night which sleep. perhaps albuterol and increased have quality inhale of will like today heart and another much

Unidentified Analyst

you. forward Phase or question the move thank of of this more are plans, plans half be would the hear one first with in your And after about just we when the that? and initiation to fibrosis before 'XX cystic study Okay, X will what

Jan-Anders Karlsson

patients a Yes, treatment really that an We asthma important anti-inflammatory need for we It's it's think as matter. thank you. new to point. really, a that good see, like group of

to data us addition and actually DPI Phase trials. nebulized could of and us if progress tell the the we formulations this and X MDI for we moving X for the focus wish, of you formulation type Phase have The end that course of have to eventually is that dilemma on We into in COPD. XXX% towards

to into we you be XXXX. the before give And trials will and in progress. guidance correctly in be be any be to that we I to funding would able and resources the have it will firm So has realistically, progress longer we and need will XXXX them CF on how think do to patients to to

Unidentified Analyst

Okay, thank you.

Jan-Anders Karlsson

you. Thank

Operator

to Jan-Anders further questions, I'll over any closing back so showing not Karlsson now for I'm call turn remarks. the

Jan-Anders Karlsson

to look important in you. for March. next already the data forward Yes, thank set today. everyone We reporting Thank you joining us of clinical

Phase talking including our Phase that the additional in review identify the regulatory be the strategy commercialization. Phase ensifentrine this pivotal opportunities to generated We and a enhance pathways stage and Xb review data X about and regulatory able believe X of the to to from data DPI trial from do trials, and clinical formulation derisk clinical in were design COPD we late discussion it's with the our before. of have development around interactions we robust we'll and trials. So research development from study, next patients context With the market continue to

an Phase with FDA XXXX trials. complete of before of X progressing in meeting the before and Phase to late our expect to half X program second X end continue We pivotal Phase into

on Healthcare at Boston. We Cowen XX, Conference are the March scheduled to in present

look of meetings and one-on-one forward there. you, catching down This today's some you up conducting Operator. be call. concludes will We with Thank to

Operator

may program Ladies have great and day. gentlemen, you this the now Everyone a disconnect. does and conclude

Verona Pharma (VRNA) 26 Feb 192018 Q4 Earnings call transcript