VRNA - Earnings call transcript Q1 2022

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Operator

Welcome to Verona Pharma's, First Quarter 2022 Financial Results and Operating Highlights Conference Call. At this time all participants are in a listen-only mode. [Operator Instructions] Earlier this morning Verona Pharma issued a press release announcing its financial results for the three months ended March 31, 2022. 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 clinical or nor involve other from known statements results, factors are unknown our and promises neither performance actual our and impact costs status, Ukraine by such conflict These trials. implied expectations, and expressed the progress, forward-looking materially of guarantees risks, recruitment, pandemic COVID-XX and including, statements, the the may the timing, cause on to or and results achievements and be our limitation, that on without of the different important Russia, uncertainties statements estimates conference Any represent such of date of this forward-looking management's as the call.

While future, subsequent its ask views the statements the it forward-looking disclaims presentation, such to change. any events cause After do elect will to company if opportunity to today’s be obligations an update even questions. in at some there Instructions]. point to [Operator may so,

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

David Zaccardelli

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

to maintenance PDEX PDEX During candidate product treatment goal make Phase inhaled completing closer first enrollment advancement of the we X This novel the in delivering and a and ENHANCE continue quarter our of XXXX substantial in first us for brings our of ensifentrine, to progress toward inhibitor clinical COPD. class program.

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

for week XX approximately is enrollment in of their subjects recruitment in this from reporting Completing line XXXX subset XXX we this in subset data recruitment, December critical of completed top to ENHANCE-X driver of ENHANCE-X. Turning a study.

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

XXXX ENHANCE-X of subjects the XX% As randomized trial the had May of X, study. into approximately

enrolled We analysis endpoint. including seen XXXX, January includes XXX including and and the in more lung parameters, in to study subjects demographics, similar trial. overall population in Phase completed of randomized. than similar are two In severe second be of subjects XXXX. Phase key baseline the with fully to COPD. those entry trials, ENHANCE-X attributes quarter enrolled COPD enrollment and to expect exclusion for approximately the our of we was The life program This the which both moderate of with on based ENHANCE-X Xb function, in Xb To-date, well clinical program characteristics XXX quality symptoms ENHANCE subjects as as ENHANCE history, design smoking

trials ENHANCE current enroll study, subjects both approximately were therapy, XX% expected each approximately XX% treatment While to in which to expect to on of reflects XX% we practices. background enroll

well in the measured ENHANCE-X primary at second the are measurements will quarter of endpoints from AUC improvement around end to trials third ENHANCE-X week from as or force including lung endpoint, of both line from the function in Top Looking average report COPD hours secondary symptoms and ER-S include year. topline under to quality XXXX safety we health-related comprising results, of track the overall data XX, expiratory X-XX endpoints, one curve data as area life, as as as ENHANCE SGRQ data. on volume of and FEVX, the well in by and or dose post

Drug restrictions navigating posed and ENHANCE-X, in a and the the lines sanctions other ability data the new topline are upon Food and Russia, of by our time application enrollment XXXX. as drug projected our well to continue based ongoing on timing and half stated, previously ENHANCE-X to plans the in As to conflict. U.S. and COVID-XX as pandemic submit Ukraine the results, challenges Administration positive company first Conditional of

U.S., James front, key corporate bringing of our Non-Executive Europe career a NDA joined a our industry. biologics biopharmaceutical the AstraZeneca. in Director AstraZeneca. he division James as development in has our served during prepare Brady multiple expertise, his On discovery March across Board roles a served we licensing and to which commercial strategy. He strategic XXXX leadership, and experience at and Most Financial of commercialization and progress years will as recently, has in leadership of wealth of submit MedImmune, China the Chief Officer XX-plus be and as the

Verona in the availability remain treatment. Despite objective the towards patients itself, relief maximum millions remain COPD to treatment, commercialize sales symptomatic is maintenance additional it XX these per our the need highlighting to therapy, XXX continue of symptomatic third millions U.S. is affects $XX proceed served totaling of bring patients treatments. to the the patients, where novel over of on Worldwide, suffer for COPD product ensifentrine to available Ensifentrine well more who X to of death. medications over need patients million COPD and by than to for COPD the existing Outside with are billion U.S. provide In cause market We urgently patients. preparing year. more million of the not from of patients and than million COPD leading COPD

our San had year. to expect a productive QT Thoracic Francisco cardiac on clinically Thorough relevant we no XXXX abstract American In and LATE-BREAKING we ahead, another effect May on demonstrating Meeting conduction. at the present will Ensifentrine exciting successful Looking be Analysis Society in

help to X paradigm. York, current could profile third needs morning the in in-person ensifentrine’s unmet feature ahead manage we will KOL the of challenges Phase top the June event within KOLs host discuss current of On our treatment COPD This will line how treatment quarter. event management in New who an and the planned XX and novel landscape, data-readout the

turn in Mark forward to subjects financial ENHANCE over X will the this call about review final looking results ENHANCE-X our from to top first Phase We reporting of and year. excited the quarter the XXXX. to now enrolling data for later line our I program are

Mark Hahn

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

$XXX,XXX for March the a compared loss XX, and to partially costs the were quarter XXXX Phase Pay million primarily increase in March were by decrease driven compensation tax $X.X by million a decrease ended ordinary of XXXX. to share a million quarter, $X share $XX.X charges. claim million XXXX. based U.K. administrative loss after $X.X loss million million is R&D million credit offset in $XX XXXX million quarter period to the development for XXXX quarter to of the $X.X recorded SME, program to months to loss For of tax compared first credit the for to This You XX,XXX in XXXX. million a or based in of compared in to $X.X per was Xx the decrease As The share of recorded per related National to fees, a XXXX for was approximately represents $XX.X in associated primarily million The general and ADS established expenses decrease R&D quarter few $XX.X ENHANCE of of $X after ended with ended of ordinary due intend was Selling, March In $XXX,XXX XX, the per or and This million $X.X XX, $X.X a changes the by a $X cap, $X.XX March to of for $X.XX the share a the the compensation due the XX, same for compared offset tax Taxes. limiting for R&D a Earn tax partially professional XXXX. submit charges Agreement. was XXXX. of X $XX.X program, same to XXXX for plus charge million of the costs period credit quarter per million and in we U.K., a related R&D quarter increase a The $X.XX ended the Research the pounds the the first next million spend. $X.XX Insurance reduction for credit tax modification compared that ADS first Ligand $X.X of quarter the million in our

important source turn back our element the the later in I'll to expect operator continues reimbursement We strategy. payment to to an XXXX. of the non-dilutive capital receive be financing Q&A. now This over call for the in

Operator

Instructions]. will We now [Operator the begin question-and-answer session.

Suji comes Please from Jefferies. first The Jeong question go with ahead.

Suji Jeong

Good Thanks taking for about couple therapy. have my question. a of I background questions the morning!

XX% you who differences to you And those those the You on you. versus Do are see characteristics core share data one is in as Thank is not? question are what be background patients can second third to to on well? also, inhaled any are comment that expected quarter, background on you on the expected XX% kind the of And for the treatment. can to of be be said who between patients my based on enrolled the the pipeline percentage which steroid. are data

Dr. David Zaccardelli

therapy therapy touch Good XX% Yes, on percentage think background landing final background seeing I breakdown what to and range of Suji! somewhere on approximately. we're happy Hi No, not in XX% those on in that morning! the to those. to those is

and that Phase overall. powered line to difference detect that this background you four and therapy, think study, XX milliliter XX approximately study in powered saw powered, those those difference that AUC you XX with how are well reminding of that a also a a millimeters that millimeters is difference X-XX in-line for remind and weeks. Definitely XX% that we we we X, to over on FEVX, expectations with detect our this the patients I in in

the that and have you background landing differences done where to how background So Do is on we of know With demographics, overall. those assessing therapy remind baseline we in of are of feel and background. is and are on experience. There particular the things we to therapy course compared background on want know we those patients to still on any Phase on as endpoint with primary powered. that on you numbers comfortable regard total, see the that you still is and significant not those patient reason study significant we're no the are not population X background not

you remind and the overall. that the assumptions therapy, exceeding we enrolled we With how the as therapy, we've LABA seeing also that population baseline So to at needed capped their study and also seen we on demographics they of patient fine think on XX% within patients ICS well. to of in blend are regard that is or perfectly in it order And not be a course LAMA ICS background that at time. a to background

ENHANCE-X completed anticipated are results already has top we You was think did you I XX a for we line threshold, know that that the amendment. your the other the data on study or ENHANCE-X? amount know that week but patients so question for underneath of and which we based notable on And XXX enrollment are ICS accumulate

Suji Jeong

in third quarter. ENHANCE-X the Yeah,

Dr. David Zaccardelli

have week it SGRQ point also that's week for insights were study well, E-RS end from. as XX have well. but will XX and have will primary the endpoint comes we we of symptoms, as life, over related that to to that quality We’ll and Yeah, data

Suji Jeong

you. Thank Great!

Dr. David Zaccardelli

Thanks.

Operator

The Wedbush Please comes question Securities. go with Argyrides next from Andreas ahead.

Andreas Argyrides

for our and questions. thanks taking morning, Good

us for two here. Just

COPD uptake could generated on that evaluating And of the So, shows you symptomatic guys on responsive three to ensifentrine for not this current that. have COPD less the even are commercial of color you X effect but if have based FEVX, an exacerbations, anticipate then, be though on the on greater I any patients the any appreciate ensifentrine or the phenotypes symptoms, have therapies, will the Phase there is most data remain far. what or so a it. on ensifentrine would impact on impact

Dr. David Zaccardelli

endpoint Hi you know out, pointed in the exacerbation Sure. are You but Andreas! an the you morning! I think we study capturing Good is those as study. not as as study, designed events

still ENHANCE-X intent that moving look of mentioned completing course that analysis overall on and ENHANCE-X also to mentioned. have of a and is as is had study, We at combined and ENHANCE-X still enrollment forward our

the we to it study. events secondary any We are haven't said, again, rather broken specific exploratory exacerbation in accumulating it's a do endpoint. phenotype – not endpoint, and down we listed With but that an even

think be it we we quite endpoints, to regard and impact how on the I with way view this will primary it see. the So endpoint to final are But doesn't interesting interested looks that study how in analysis. secondary seeing into but the either

every better to and and You primary all ones better know, do of little as it's don't it’s do I and far secondary endpoints results, possible and do know an that ones data, as you and because how difficult that, which of endless permutation the bit conversation. much think better without which a

or function believe endpoint that to that's what's And the we endpoint is it lung We measured look endpoints weeks, think to over COPD. always as in required week specifically primary I the in design mind, secondary remember Phase of at demonstrate bronchodilation important keeping hitting improvement XX. is XX primary course at in the X. is chronic study

it's to secondary the and I integrated primary know as That risk and of is you on total whatever X everything is results, data. benefit the them the would endpoints. in to so related at are believe have based that to designed secondary are benefit; we that's that look is say, and an on what we and when at we But approved. drugs analysis endpoints studies evaluated Phase look really And ultimately

outweighed it to know approval. for the and risk You enough any is risks benefit strong

Ensifentrine, is had safety so quite then data, itself benefit that benefit I confident to of the X for favorable what at profile risk. we to remind that's on Phase it Ensifentrine based lends looking risk and a the which we're very And in ultimately, strong we've think everyone a to and are profile

we with everyone. and the forward see we’ll to So look sharing data

Andreas Argyrides

Thanks.

to June. the Looking forward Thanks. Investor Day in

Operator

with Boobalan The next ahead. question Please comes from Pachaiyappan H.C. Wainwright. go

Boobalan Pachaiyappan

hear you me okay? Hi! Can

Dr. David Zaccardelli

perfect. Yes,

Boobalan Pachaiyappan

from So Awesome! side. a our couple just

week be So process for that the are to XX patients ENHANCE-X, is complete right? subset of you clear, the to of just so enrollment left XX in order

Dr. David Zaccardelli

– the is of enrolled We guided XX% against to XXX study approximately patients. XXX approximately

So gives insight. you that you can and probably do the math

Boobalan Pachaiyappan

Okay.

Dr. David Zaccardelli

it changes time, so know reluctant I'm that You number. to an – yeah, you give all the exact

Boobalan Pachaiyappan

that's fine. Okay,

correctly. to So it wanted just I make heard I sure

mean, first for patients, math to were I R&D with for obviously XX so million quarter. So they expenses, roughly respect its $XX.X so. And the

for the to like the So for the how expect you quarter cadence the of do look next rest on year? maybe

Chris Martin

thanks Yes, question Boobalan. for the

start QX, the half for quite I think year. will neighborhood we'll R&D off then the it is to the what the taper by say see general and continue in year, for significantly that in of back should that end the

Boobalan Pachaiyappan

Okay, instruction a And one got final, it. so ensifentrine obviously then will hit meaningful this year hopefully.

about think cadence of investors should how the So other programs?

Dr. David Zaccardelli

as focused you served a and think years, have program No, and the ensifentrine COPD very well couple things of well past you executing make Yeah. that focus, and the I question occurred, joined Verona that to when the the know we've and on companies to that of one the we it’s great including did executing COPD that that sure was dedicated to raising we program. been that’s capital the know over

of indications, of other clinical enormous its profile. opportunity have We because with pharmacology and in ensifentrine

asthma, opportunities we so and approaches, there dose in DPI, that’s especially should cystic it. mentioned, part of expect and delivery that enormous other we as fibrosis looking is think that you opportunity, at MDI including in As and

says example We they so you with COPD also COPD of a overall, for program ensifentrine we're there's see familiar wanting relate and the and/or that, combination products, are with know as devices. to the space either again opportunity nebulized products you other that inhaled and see expect to combination for LAMA, and to quite but data could clearly

Boobalan Pachaiyappan

color. the it That’s us. Thanks for from

Dr. David Zaccardelli

you. thank Alright,

Operator

Canaccord comes go with question Please next from Edward Genuity. The Nash ahead.

Edward Nash

now filing ask, the two at to and getting just year. that beginning next Phase these giving we’re NDA readouts closer I you an of to X wanted now know

happening going beginning with starting of next towards guess structure. filing or the to Just year, maybe earnest of end this the be wanted understand kind what's to of regards I build in to year the commercial to after

efforts would and start Just are the approval? when that that what employing kind be on timing over you'd time, the and of before thoughts

Dr. David Zaccardelli

thanks talk turn review. great Great! for and morning, that to you you question, that this Chris to give to the and over with I'll Yeah,

Chris Martin

Chris. Great is This question. Edward! Hey

really the positive commercial commercial and work really start will to ENHANCE-X I data things to our one we discussions ensure and work we've and that Verona building for to coverage around that toward out the trial, starting ensifentrine organization build-out In we clinical think proper of milestone data get around the have and out coming upon milestones done ensifentrine securing payers is the being to the with of though with and access. first that that launch.

to that be activity the a critical provides ready It's the and important that prescribers get like that'll ensifentrine, what information ensifentrine field. ensifentrine, with molecule is we comes prepping ready get bronchodilation by anti-inflammatory mechanism I things molecule new inhibition market sure so payers as and making market’s we're like with one other appropriately, for and ready The that around going of and launch that effects. sure the a and PDX the are the making for be to that is important both is the it PDX when That as action we on we for market feed out launch. mean

and The and will as start us societies that's about we advocacies other how in is think their advocacy daily for groups too really to work ultimately important do to lives. – use take thing with this it medication patients

that next are see of around we’ll well. over months the hope you XX So and a we’ll I as there. the milestones the helps all conducting lot some that reaching those XX of us months, are to be XX next triggered that six activities over those of critical to those

Edward Nash

much. very thanks Yeah,

Dr. David Zaccardelli

Yeah.

Operator

with Lee Joon Securities. Truist ahead. from comes question next go Our Please

Joon Lee

taking for questions. Hi! Thanks our

could have around and commercial a and strategy ensifentrine IP assuming as your planned, follow-up runway, things about you I know question. your go to You expand talk

Dr. David Zaccardelli

regard think are it to think been we to IP I extremely believe that's with looked IP and for have and position ensifentrine start course of by extensively No, our with Sure. others. primarily constantly I we and an we investors quite to attentive strong at

we know for and protection a patents ensifentrine network have coverage You – a we of say that provide shall commercially.

You our patent. three of patent together, our are know formulation work they in and our grounded that patent, manufacturing polymorph sort patents

others course protection to XXXX’s. mid in as well, those we expect and have provide Of those to out the to we addition

which apply and as so for an of have confident protection to will also in quite life another the years, We up to patent five our one the extend are XXXX’s. extension, allow so we again on mid we past that maybe opportunity patents patent will

protecting as of far as As with of management for ensifentrine I different mentioned, other devices, that there opportunities a lot combination runway, drugs with ensifentrine. are approaches past lifecycle that,

So ensifentrine. enormous combinations, with delivery have between that, think I different other opportunity indications, we devices,

Joon Lee

than its And Okay. onboarding ensifentrine on are or is his guys see what for different someone How licensing Mr. great and of as your years of strategy you Brady’s couple caliber. ensifentrine. you have the you. for are Thank visions you to commercialization the past envisioned similar developing

Dr. David Zaccardelli

Right, board member about you're James new Brady? our talking

Joon Lee

exactly. Yeah,

Dr. David Zaccardelli

Yeah, great.

to it’s him fantastic know company. the You have join

I also a to and wanting Verona as ensifentrine about volumes of join. think that in speaks bit

As you for pointed out, example. deals you and experience licensing strategically have yes know an commercially, multiple extensive financially, done

So it's him to the board. have join just tremendous

very But much just you learning we're been action occurs. of making little that look a early he of know so where can we forward about also his into where of think it's and rest gathering a days contribution It's understands and of what through of XXXX, lot You months much and the to all a few course bit work sure XXXX I contributing and information that. we've this of doing been as he's of and been imagine. all as we and that

Joon Lee

you. Thank Great!

Operator

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

Unidentified Analyst

This [inaudible] Tom. morning! Good for Hey! calling is

market if any a collaboration color exercise the COPD. And So with any through that’s first of on into often additional Thank European is, the two Nuance what provide question you the too. as development and you. update on was questions, in then can is the China hoping potential is, the second sales the question licensing well force update guys in general the of field I

Dr. David Zaccardelli

Right, so thanks for those questions.

last very the example. progress. Clearly one our regard to we licensing and territories of and other Europe stated with Let for continue it's quickly to me handle think including I part strategy

turn best can to and imagine, that in Greater around as sort close China you represented of and you data, on with everyone's the I licensing the forward area. move best ensifentrine extremely think optimize the of in so a and wait by force now practically regard we course were well see ensifentrine We little over Nuance we're And the as so thought Chris that I China who Although it are having interest update data as well. our terms With that financials and favorable to that manages is to speaking, now. ability that, know licensing to data to then the deal with the strategy. the think we’ll get earlier, to that deal sizing, sales did Nuance our I’ll

Chris Martin

Thanks sizing kind China the of start with sales Dave. move I'll force Nuance and partnership. And then into

this us be sales into about and opportunity, When transition to to the pulmonology far pulmonologist, in care market our be that allows with XX,XXX and believe that and research what targeted patients at look is of at existing you ensifentrine sizing for patients is to the how there's will our symptomatic which as COPD, there, a utilized, that's on United pulmonologist States. be for force symptomatic, as we out that therapies transition out force in of primary top community are sales they deployment. if more see lot XX,XXX we continue we As look

opportunity. And And maximal representatives physician therapy. patients so of given as XXX over on the million remaining are a well symptomatic believe around we size, force we would there's X sales as reach that to sales that that be opportunity, well adequate patient the anticipate just

move and progress has sales reach effectively. China, force to very Nuance the Switching been CDEs could toward we that So potentially partnership over continue the course and of partnership progress gears very, with to them. XXXX. very forward They working IND, documentation move with that seamlessly our opportunity to But XXX we person with very on work to the and the their the as continue updating will been year, through their has look moving well. progression that

Unidentified Analyst

Great! you. Thank

Operator

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

Dr. David Zaccardelli

the like to and would We in for participating questions program. you. healthcare thank patients thank ENHANCE the your to professionals everyone Thank and

end As our milestones of the to positive third submitting a second half enrollment ENHANCE weeks. year; the reminder, near NDA line XXXX to FDA term you first the the XXXX. quarter and data ENHANCE-X and look ensifentrine the in completing on the ENHANCE-X many of a quarter condition in an from in reporting of of from program in include of in We X XXXX; U.S. speaking top Phase coming around the results, to forward about of the

I'd for Verona continued for that the and concludes support their and today's thank shareholders Finally, team dedicated at their our commitment. like Operator, to talented call.

Operator

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

disconnect. You now may

Verona Pharma (VRNA) 3 May 222022 Q1 Earnings call transcript