VRNA - Earnings call transcript Q2 2021

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Operator

Welcome to Verona Pharma's Second Quarter 2021 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 and six months ended June 30, 2021. 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. are management's statements expectations. looking forward based current on These our or and promises and important These different actual from cause be neither achievements guarantees performance factors cause involve or without the of on expectations recruitment the results, business. expressed may our other including timing or statements continuity are materially our of impact results forward by the implied and costs clinical nor status, known to and trials our COVID uncertainties, of statements, unknown in looking limitation, XX that may pandemic risks, it looking change. management's looking any this forward may so, do Any to statements such subsequent obligation date the to the elect as statements of at forward cause to call, company disclaims while its if represent views future, even estimates some such of events point update conference the in

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

David Zaccardelli

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

towards During PDE of inhaled COPD XXXX, continued the for our treatment maintenance first our candidate a the inhibitor, we second in ensifentrine, via goal X and PDE steady quarter delivering X progress of and program. enhanced of novel X class Phase product

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

enrollment based in on COVID-XX pandemic. of and expected, calls, As in projections the completing in discussed improvements continued previous ENHANCE-X our ENHANCE-X were

strategies mitigation COVID-XX quarter, past have Over the been our helpful.

However, related number and and challenges, numerous let's status With on COVID-XX more enrolment across increased new countries said, the detail a of put of timeline. infection pressure both trial. including rates Enhance that recruitment in review the emergence have variants hospitalization of our

end patients the trial those run-in the ENHANCE-X period, the the randomized entered of expect be enrolled of into in of currently end study. approximately August. XX% by had As we of Including ENHANCE-X to XX% July, the

ENHANCE-X from topline of trial driver the reporting XX patient recruitment for the is For completing the the a data of week timeline study. subset critical

of to and currently from disrupt Based randomized to ENHANCE-X testing sites safety As flexibility for and all such of to that we Including for in XX the manage program study safety distributing for site prepare sites and include to timeline, subset to into program the at the XX-week patients could weeks to Europe, XX% by impact. ENHANCE-X newly site Planning personal providing for equipment may alternative data normal projections, as patients pace those events the end medications collecting impact this plans on protective mitigation of XX subset effectively adding approximately enrolment of program the July, enrolment US we COVID-XX for current complete COVID in both individual of their the ENHANCE-X patients are the to at we implemented developing protocols, COVID-XX planning due The and operations, adhering strategies business protocols. methods to the These end Enhance the running around continues onsite expect include part the to in and August. follow coverage study. required program. the both had geographic sites, help enrol and visits the local of subset start of broad around ensure our end of the and XX% on critical weeks be year. the by of patients the entered enrolled in period,

guidance, American an XB in current stated XXX the or protocols we This a steroids Based Society or X ENHANCE-X patient addition ENHANCE-X patients ICS. strategies reflects Additionally, our ICS clinical report were amended COVID-XX, safety previous projections modification at are without in of our mitigation with of to a the patients to for XXXX X XXXX pandemic. ENHANCE-X receive during ENHANCE-X to the or second Thoracic LABA. XXXX. to with in line LAMA data as to and expected management were International our the ensifentrine the of Phase Conference. half to X, in and Approximately due receiving accurately broadens a and allow abstract up either XX% our for COVID-XX the of as study patients with demonstrated pool in XX% on inhaled improvement data more well presented cortical were and ICS. function and first to as or of In consistent lung use enhanced reality These of favorable top-line half reporting Phase symptom enrollment profile

to of XX enrollment This However, cardiac expected or any QX designed to XXXX and XXXX top-line support QT our should NDA conduction. our ENHANCE-X planned ENHANCE-X. ensifentrine study of for continue predict we have on effect patient in QX the challenges increase, models if in study. is COVID-XX related our submission, In completed evaluate be data thorough would

expect similar date demonstrated of report We subjects results this has XXXX XX to ensifentrine by placebo. involving profile clinical to safety over year. end a to trials In the

As clinical include trials. Enhance to ENHANCE assessed based the required we monitoring And adverse reminder, on data not were Holter are in being the the cardiac to safety interest date, trials. no a events in of

is millions of S the to maintenance served patients more X existing to patients treatment. COPD million preparing by in over deliver not market Our of treatments. the COPD there sales third Outside patients symptomatic. are goal millions and patients need million patients in the the well affects leading of where are remain total In Verona COPD China also ensifentrine, of who in and remains remain over COPD same, the and cause maximum the death. with Despite ensifentrine additional available symptomatic U COPD commercialize and Worldwide million. is COPD more than than medications, US Europe $XX XXX XX therapy million

partner with which provided up develop to US. Turning China, specialty consisting in milestone in cash equity strategy company in for value of and and Pharma. million an to Verona China, $XX Hong Biotech, eligible company to the $XX rights net million royalties regulatory in licensed Taiwan, million of certain and Mainland at a payments commercialize Greater Verona agreement to valued sales Nuance $XXX to clinical potential The interest of We to Nuance announced pharmaceutical Shanghai-based outside Nuance currently execution $XXX we strategic the on Macau. us commercial upon ensifentrine of payment territories. million a Kong to the granted June a milestones. with a is million on and ensifentrine is our to in collaboration with also Pharma, which future achievement of up tier double-digit upfront receive $XX parent the receive Verona includes entitled

plan has for including markets. to Nuance Nuance's working and highly leadership extensive developing Pharma, the forward are and brands drug products, team an treatment as bring application experience Nuance meet treatment China. leading to progress. look investigational file to innovative important We new to about we commercializing for regulatory develop everyone to growing with Greater in across and COPD COPD respiratory a of a intends new Pharma these to we China's with talented updating excited authorities

Verona's maintenance Improvements International American meaningful to four Chronic clinical Tara R&D on analysis improvement the COPD of The that We sub showed substantial the in XXXX. Rheault, Journal ensifentrine and the and Conference continue results analyses life of subgroups clinically published benefits added Phase Thoracic Kathy in therapy with of new Dr. ensifentrine XB Dr. April, XB COPD May, In support COPD lung maintenance bronchodilator the trials, which International Obstructive to weeks function reviewed Verona to demonstrated nebulized in in of journal in ensifentrine build moderate Pulmonary in both treatment Rickard President Disease. Vice evidence peer on to COPD. presented severe both treatment. In patients ensifentrine clinical after of were subgroup nebulized Phase our quality of symptomatic at from and subgroup groups.

pleased and are both call the ahead, reporting results. of trials [ph], look importantly, several Mark at presentations we TQT results to will over the including results XXXX. our financial milestones, we the as now in second European and important China study anticipate of to We our with International Conference ENHANCE-X quarter turn progress ENHANCE-X the in I review Society Respiratory and reporting

Mark Hahn

least equivalents our November our $XXX the to pro received July, million morning. $XX.X Nuance under both will million June credits in cash $XX Dave the in at the cash million an operating combination was cash XXXX. second Pharma Thank receipt in million. million UK with cash believe receipts programs potential of ended financing $XXX XXXX from expected tax burn the million. quarter the you, $X development by debt We equivalents, secured forma of payment from and position, operations of QX borrowings upfront through program, the our clinical XX driven tax credit facility giving and UK and After XXXX in at effect cash and and good support from We current $XX

for ended increase an driven reported costs to The the Phase by increasing increase UK XXXX, were $X.XX in same the year. tax six of in share-based ordinary expenditures change million XX, enhanced XX, the were the share, $XX.X ADS million was for in to primarily six XX, period Research due is period the loss per $X.XX the The for million compared loss charges, This to million R&D and For same $XX.X the ended share-based of ended costs for in charges. XX, program. to the credit same for reported months for months million was the incurred XXXX. after General in cost partially credit and XX, R&D the prior per six loss for in six $X.XX or of a same XXXX increase compared Phase XXXX, clinical XXXX. months same period June million costs ended comparative months to to $XX per in $X.XX program million of the This the June by X qualifying June compensation was XXXX. line the the compared compared or XXXX $XX.X period period represents compared of of X with period a for higher ordinary XXXX the a June tax executive ADS of XXXX. the an development in primarily ended six XXXX, the $X.X months $XX.X $XX.X $X.X million offset $X.X share million a per June $XX.X and compensation the with million increase in for administrative

We expect operator Q&A. the the Enhance tax credit for to the as now continues. two spending the call quarters the back turn on program next the to increase I'll over for

Operator

now will Please instructions] question answer Suji session. the [Operator And go the first begin Jefferies. question ahead. with and comes Jeong We from

Suji Jeong

enhanced taking by complete and could for number of many have of also were the the Hi, And also you target September good the are questions about end open question. trial the what's year? year, for at for you. enrollment currently of number morning. us What Thank study. the number the yeah, you study given may sites the the that of of that tell target? Thanks for that end the sites how confidence trials last what I my gives enrollment initiated booked studies

David Zaccardelli

Hi, Susie. Great speak this with to you morning.

just comments about let enrollment. trajectory give few of me and enrollment So a

we're time. especially As we of and the period bit September, sites to sites trial sites first especially and any started at so the tends recruitment online over the one be do coming the in couple typically and different building quarters so, lagged a you of and Europe of from end then online US at come in sites. or magnitude that although the of and the coverage, time, international saw

sites all or we're say guess so that up that if much with are the of you increasing running. the middle I And is that I would what now substantially in is is trajectory and us past and will,

it have, have the or record so you impacted to kind given we've But could type of quarter month be past we over we're of over as so now And recruitment of as recruitment discussed. albeit should we've do by of COVID-XX the the get a the to we August, month as we a by the see, that us of the expecting insight as getting will on And that of year. see, think basis. And movement see to that in part trajectory the from curve recruitment the weekly you enrollment us we're the course I completing there. that percentages by and July end to

with solve and mitigation continue all any Of to issues the course they that enrollment. to work have plan local we in to may sites our order continue continue we

confidence we so where I on and that really projections. recruitment based And we our think have are on on

as impacts may the running. through have, are slow far of and of as at not Enhance Each the mentioned, But and a slow geographic span sites for into, various have I sites, time. of down that any works in coverage. vast there from overall we I COVID-XX number As think down gotten one given variety participating program sites over of and and situation the sites them depending a as so or the have at on course we've those them any locally great up majority we of XXX those

complete have, the we're enrollment the by seeing can end I on of we we the trajectory, So, based that the number the year. the site, think

Suji Jeong

tell questions. would analysis it your more was XX% run-in that you are statistical the, was will they, and long or the you amendment the there us Couple FDA be at by include of is, period that now request about inclusion initiated and study and that on the company said Could ICS, affect Okay. of would also how plan? that patients, our

David Zaccardelli

Right.

during a As feedback continued that some and ICS, perceived ICS from being we from on pandemic change as precautionary that that the physicians far maybe patients KOL as based COVID-XX protection left COVID-XX. were initiated measure on

secondary endpoint, we endpoint study. we also data background the patients something the statistical LABA. and there we and of we primary missed? the that LAMA date that else can a course into on believe accumulated don't a it impacting the based plan data looked And X to in on Of our don't I will in had we at a that see Was analysis Phase that being impact those the that study or enroll our felt

Suji Jeong

The run-in How period? long…

David Zaccardelli

running The period? XX days.

Suji Jeong

XX days.

Great. Okay. you. Thank

Operator

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

Unidentified Analyst

for Good for my morning. on [indiscernible] you This taking And thank Joon. is questions.

first regions, congratulations talk partnership that you Nuance with discussions and progress to timelines Nuance First on the establishing speak the and on process you one with can in to Can second, NDA similar expect would would also they the the composition about other partnership validating China. your by have a in for Nuance? you

David Zaccardelli

the for Thanks Right. question.

a premature. little the China, it timeline in as may As far be bit

overarching for timelines discuss that the to plan nonetheless, with before mentioned, the I and IND understand As and that we'll in for development need then our Clearly but to meeting it's to we plan have targeted a for in that. process feedback the China regulatory wait China our they create the want US also and details. authorities behind we for wait we

and stated It's geographic As we other to far as other our we ongoing BD areas, of and that. do development, course, continue part of strategy collaboration and about outreach that. have discussions

data underlying and always but structure comes with hurry that in as of to Terms I we sure partnership a and of structure the make of Nuance. out dynamic we'll different believe and are is that And ensifentrine of can well. into we year. the deal continue the, the value we make through the it feel sure we're particular to representative want partner, this that is work the as year substantially course, no which the the with of are course be achieved again, variable, represents that next and that changes going on also think we as We deal value to ensifentrine,

Unidentified Analyst

is how on and more results outline credits. the as the what impact to tax one you model somewhat as They've dynamics of these pipeline completion at that then sheet. on tax for we last And your should the enrollment well Can dual these material for did you balance Thank color. credits me these UK you. point Thank and what credits the off? tax taper become

David Zaccardelli

Mark.

handle You want to that?

Mark Hahn

for Sure. the Thanks Yeah. question.

just on to a to our We an the tax spring then to transfer So it the in XXXX. July the and us. R&D R&D time, audited results spend year submission for UK the accumulate And wire money UK a we'll the We costs one do they government us allows UK is are where money credit program R&D complete. annual received do once related the to after basis. in the

credit to in incur will costs approved, the we early we then R&D XXXX. or and complete. XXXX, R&D as throughout make those continue So program changing submission R&D after getting again, UK sometime incur year amounts our report tax audited the next is The

be spend. -- likely will a be if R&D you our will lower So against it will, reimbursement there rate

through could it level tax modeling, then So and R&D XXXX. you I significantly you're think should pretty expect XXXX, a as of growing drop in

Unidentified Analyst

Great. Thank you.

Operator

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

Unidentified Analyst

you We perspective been thoughts any there of Thank real [ph] Xing one what's a taking would be ensifentrine. do from a what's and has you. Edward. the our has like you for [ph] insistent competitive or morning. close Good might for your Thank during for This half landscape hear your next to the question. year competitor the trend changes for year an think or changed past

David Zaccardelli

call. the for Thanks

that I going comment Commercial to Martin, landscape. turn I'm over think on Chris Head the to of competitive to

Chris Martin

the in there's And look as as dual Dave. eminent ensifentrine, pipeline Remember that one the unique landscape that in unique the ensifentrine. like molecule. competitive right as is Bronco or NC now, we dial Thanks, anti-inflammatory at first nothing

they KOLs need research, of is patients a very with the on So looks symptomatic. when and that we can something in that remain to marketplace they these that's mechanisms three and additional have patients look when that in and need unmet something market and physicians competitive significant appealing landscape profile there's need, this they idea nothing the them use today, great at we something that's when horizon, like ensifentrine's our the and to what's talk

the set favorable look we and will look to be mechanism the but have, landscape try it a ensifentrine effective ensifentrine looks molecule on with we how because profile clinical very when we confidence ensifentrine function and action. in of And lung physicians that will when at a safety position a of data also that place and improvement, also that very symptomatic symptom how then believe which that today balances patients. gives So in launches,

Unidentified Analyst

Thank great. Okay, you.

Operator

The with go Andreas from ahead. [ph] comes next Wedbush. Please question

Unidentified Analyst

for Leon morning. Andreas is on Thank taking you our for good questions. Hi, [ph]. This

but of at presentations we're there. couple what Just a you quick give milestones, see to to us as summary a have on bit just the we're Chest going term incremental a one near you of and ERS could a any to if Thank -- you.

David Zaccardelli

for Thanks that.

looks and we're working call everyone it So comment Dr. upcoming ask the today. abstracts publications, to on into like Rick going I'm to her

Kathy Rickard

Right? Kathy this Correct. Rickard. Hello, is

presentations So is for a European our we which Meeting, Society one coming have up, Respiratory at the PKXXX.

safety four MDI affects our and data we which the as liver. medication again that's dose from shows efficacy pharmacokinetics which XXXX, And is by meter basically Chest drug day that basically looks we looking October. very And at formulation, the have our at that for the very basically that is deliver one inhaler study, the that's second with trial, study. interaction we our in and strong bronchodilation which And data drug interactions. the seven drug really can that a this little shows show So

powder we've what confirms also. in our studies it So inhaler seen dry

So those two that in the up have are the near coming we future.

Unidentified Analyst

Fantastic.

Thank the And you. on progress. you. all congrats Thank enrolment Okay.

Operator

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

Sung Hong

morning. Hong for This Shrader. Tom filling Hello. is Good Sung in

will color little if the in be but market, thinking provide about So as of commercial opportunity on assume large like the also will I we're a more COPD reimbursement the the different pricing complex. the guys terms So be that I very know well in is could China? market as landscape you

on please? could just So you. your thoughts that provide Thank you

David Zaccardelli

And, for the and, and right. no, Yes, thanks you're question.

are dynamics market the think I different.

China in and pair pay, is different pay evolve. has They that pricing course process dynamics, have to Of private different. government and

is As also much into you that noted, the dynamic China it. number so of in plays and patients greater

comment substantial collaboration little understand in premature market that with the to you And consider in China, to I to worldwide Chris, on forecast I think don't exact want addition be Nuance? basis. it in to a although it's our know, from a we

Chris Martin

diagnosis very in the suggests No, The things out the is is it I in well within market think, thing newer that for keep coming increased standpoint to access covered the of to market there. medications. data more and to to and a double years. COPD from Dave of expected one medications there of see mind treatment that COPD one China's is lot A we that than due increased

to So and be kind our a there again, a clinical in as market, how and how perspective fit ensifentrine we're a working from Dave said, commercial both we of expect through that, market partner. substantial will with this

Sung Hong

Thank the progress. Great. you. congrats it. And again for on Go

Operator

to I'll concludes remarks. our for session. question any back over conference Thanks. and now turn This the answer Zaccardelli David closing

David Zaccardelli

your operator. and enhanced the professionals that BTIG, look like and their Thanks questions Wedbush I'd talented and thank Operator, at forward thanks In commitment. to we'll support patients We'd call. speaking investor to and today's to many to to of participating the at be continued for including shareholders August, and Verona like their for you for our healthcare Canaccord program. team several in concludes you dedicated presenting conferences, thank then. and

Operator

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

You may disconnect. now

Verona Pharma (VRNA) 7 Aug 212021 Q2 Earnings call transcript