VRNA - Earnings call transcript Q3 2021

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Operator

Welcome to Verona Pharma's Third Quarter 2021 Financial Results and Operating Highlights Conference Call. At this time, all participants are in a listen-only mode. And earlier this morning, Verona Pharma issued a press release announcing its financial results for the three and nine months ended September 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. based current are statements forward-looking on expectations. management's These actual our nor or trials our in results costs forward-looking our involve other be clinical implied known statements, the statements cause factors are of unknown materially without and limitation, promises neither timing expectations our of may or status, and These different and from achievements guarantees risks, COVID-XX recruitment may the cause performance results, expressed and business. or that continuity to important impact pandemic by including on the of uncertainties, Any to of point while some such this so, events subsequent do such forward-looking views the statements date call, at obligation represent statements in management's even change. if the update estimates conference its to forward-looking the cause as future, company it to elect may any of disclaims

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

David Zaccardelli

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

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

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

report, excited nearing continued COVID-XX previously, November XXX in that successful efforts. on I’m patient of by projected and the COVID-XX enrolled. our be the implementation is of were in and mitigation expect enrollment the XX XX% completion pandemic patient subset enrollment the will ENHANCE-X timelines end As to XXX of the expected, ENHANCE-X approximately trial trial improvements both stated our week and based we and ENHANCE-X ENHANCE-X

substantial to with and to international progress multisite quarter we’re recruitment make trials global the pleased in continue advance our pandemic. during third clinical ability during a We these

due still Although to the We approaching holiday week XX slow of pace the ENHANCE-X complete effects compounded health and subset industry. to the enrollment year by the season, to of end COVID-XX expect pandemic ENHANCE-X enrollment expected is around of on XXXX. continued the care in

our reviewing entered November those X, XX% Specifically by enrollment we randomized expect into the the Including running currently progress November. end of approximately the as be XXXX, patients of in enrolled period, study. of ENHANCE-X to had ENHANCE-X approximately XX% patients

complete subset XX ENHANCE-X As completing November week driver XX Recall X, of the study. study. of patients XXXX. the the approximately week had full from in the of to recruitment the critical second line in Enrollment is ENHANCE-X in ENHANCE-X XX% subset into data reporting trial top for expected is of XXXX, randomized of quarter

expect XXXX. of to data XXXX to around report forward we line and the for Looking ENHANCE-X results, ENHANCE-X end for mid-year top

by and enrollment expected make in a COVID-XX The further implemented QX be is XXXX allowed could should ENHANCE increase models look related would the scenario, data ENHANCE-X when timelines our top challenges XXXX Although, strategies predict In guidance for progress. further, shift of line completed. quarter. the QX to mitigation at this solid recruitment program us providing to ENHANCE-X. forward We have we start for

Developing to and ensure and both COVID Europe of the manage impacts. only visits on broad study personal site normal US testing collecting could coverage for of adhere sites to their flexibility and operations, individual in safety as geographic such As essential all at data may local sites for Requiring repair protocols. alternative protective distributing to around equipment the follow to methods COVID-XX site disrupt providing a reminder, these safety that medication and for sites site help events from plans protocols. for include visits patients. to inclusion of And effect adding

in planned of study support thorough Looking is December. ahead, the effect to to cardiac NDA of study submission, XX ensifentrine, from expect any we on results patient designed in QT evaluate our our conduction. report if This

of a clinically meaningful lung event inhaler Dr. improvements and data presented powder or International and the of individuals demonstrated study Congress. fluconazole nebulizer In pharmacokinetics continue DPI at positive similar on Society placebo. effect showed ensifentrine ensifentrine delivered for with moderate by pMDI the to interaction with in not February Part pharmacokinetic with Tara fold, Annual formulation well Phase had or Phase data B than of the benefits of study, President Dr. add patients tolerated the to support in from on assessing two pressurized profile healthy Research our Meeting. dependent Rheault in European at COPD Data significant Respiratory the in first COPD. over are part adverse demonstrating ensifentrine. of data nebulized clinically Vice to the XXXX, function In of X inhibitor treatment statistically co-administration progress two clinical formulations to of ensifentrine of dry and of X and The week we abstract severe fluconazole consistent evidence drug-drug effect These ensifentrine September, measures from the Rheault, reported substantial dose provided relevant less metered-dose in ensifentrine. maintenance to our one addition the presented CYPXCX In in an was the October, of trials, for Development CHEST inhaler effect describing of results pMDI

the companies has announce at Pharma across pharmaceutical President Diaz she small regulatory efforts, built starting approvals function marketing me. first and delighted bringing As in as Ms. Regulatory Quality served I'm worked at the strategy than experience as Senior the we we more of regulatory to our Affair, to both ground be large XX of she and resulting regions. prepare Mark ReViral submission, Vice the as implementation President further led the next key Regulatory prepare Vice Diaz Dova, Regulatory regulatory Dova company. Verona for NDA for where and with Vice development the are planned for team. Her we well pleased to President, will invaluable week join as will in and Pharmaceuticals, from At years and as up expertise Caroline and Affairs, her welcome previously strategy ensifentrine

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

review in milestones. the program call results. over for the we And QT our anticipate study, our of the and XXXX. are to trial data third enrollment financial to look I ENHANCE important the Mark line several We we with top quarter include from trials importantly, These now ENHANCE ahead, turn in as results progress. completion pleased will

Mark Hahn

third ended We quarter Dave. in you, XXXX with and Thank cash of equivalents. million the $XXX.X

and relating cash from During programs our tax the R&D We financing through a combination clinical qualified R&D million the UK position XXXX. Pharma and payment support UK potential of $XX at the $X receipts of to the received third the borrowings cash operations from license will program and credit quarter our tax million we upfront expenditures our agreement, least debt the development under credit program XXXX. expected R&D in and Nuance from million our current $XX end facility believe

months million XX, accrued to of payment driven with credit XXXX. I'll a line $XX.X element from XXXX, of or with R&D intend to $X.XX Q&A. ended costs million partially in associated consideration same the share, after in decrease XXXX this expect in by share profit million, with agreement. For first the costs months represents partially $XX the relating was program. was prior per costs be along operator approximately to same Nuance period ENHANCE The and compensation Year-to-date, to for important $X.XX we quarter, compared a over higher period Research of for July per the driven three three qualifying $X.X XXXX under sometime turn million, million the $X.X to strategy. ordinary of $XX.X the with Nuance The ordinary administrative $X.XX $X.X and third Under in the this of a in in tax compared the financing. development the due the fourth three we year. increase $XX.X This tax ADS primarily or to increase quarter is September now X PIPE for tax XXXX, net million September for of the million aggregate primarily profit to costs credit in the by $XX.X were capital half same call share, XX, submit offset ADS of Phase tax the and in The amounts $XX.X ended General to program continues credit loss is the for by million $X.X XXXX, UK $XX.X the $X.XX This of of for the of period to clinical offset ended program, the reported three recognition reduction for UK agreement, same compared period of the for months million this receive the financing incurred to to profit the this a million XXXX. non-dilutive in back R&D after net the have be the to XXXX. in quarter program, per This increasing compared source expenditures was an later we compared a per loss upfront accrued based reimbursement XX, amount a to for the charges. year. of by the were relating costs reported our any XXXX, in $X.X for the the the the period million in months same ENHANCE X September XXXX. R&D XXXX XX, million the ended XXXX, September Phase terms

Operator

you. Thank

begin now question-and-answer the go [Operator first will Please Instructions] Securities. We ahead. the come Wedbush will from And today Andreas Argyrides from session. question

Andreas Argyrides

how guys do reporting or being update an study, And ENHANCE-X NDA a any Good taking data Two you the for plan morning, ENHANCE-X and quick be time? submission? you results, our questions. providing from Thanks. ones. from you you at that thank on of envision the When then part will QT

David Zaccardelli

Yeah, and so the good for morning, thanks question.

be report around I think ENHANCE-X when line top mid-year we we still on course I time at going that ENHANCE-X. XXXX, somewhere in will from of think our this data

study reporting although for think that it's our know have them and findings, for reporting and any results time, of but plans So this study is are with will update, more we nothing I we're to on than any as Again, element of with NDA an an the QT provide a where ensuring of course top don't we'll chemical NDA required them an in course, expect in consider that ENHANCE-X, that thorough submission. line we a regard new merely anticipate the completing of the unusual and but FDA, entity. understand discussions we this time. QT where don't year from expected see we specific our at in we at And later and the I status a reconfirming elements may results study,

Andreas Argyrides

you. Okay, step I’ll the in queue. great. Thank back

Operator

And go question Thank H.C. from next from come Please Ram Wainwright. you. Selvaraju the will ahead.

Boobalan Pachaiyappan

dialing is taking question. And for for thanks in Selvaraju. Hi, Ram Boobalan this my

trading any I But So fibrosis? with just know advances advancing you ensifentrine in programs. are curious, ENHANCE cystic of for made really busy guys whether terms

David Zaccardelli

Yeah, for the question. thanks

including others. for treatment as we be ensifentrine maybe guided The to that, previously, respiratory across that mentioned diseases, fibrosis, continue number of profile as believe PDEX, diseases. asthma applicable a and cystic PDEX could think be I we multiple a a inhibitor, respiratory and could to

do incredibly on to we we experience though even program. cystic in ENHANCE and be promise, the and – asthma that great course previously of fibrosis show focused continue have, completing However

our that place occurs, and ensure progress to diseases, development NDA, to that we as we the attention course, in the think continue of potential and will I have turn to a of beyond other progress as ensifentrine right to we COPD. funding also

continued be with at for least you diseases. XXXX focus the to ENHANCE X of expect there program amount then and So progress a and from can ensifentrine in I fair we'll program on think to other around execution Phase

Boobalan Pachaiyappan

clarity. the for Thanks

inhaled pirfenidone your So what down thoughts by Avalon are on being Pharma?

David Zaccardelli

it. really I think any have Well, we don't on opinion formed particular

mechanism we a new think our as will it from as and perspective, be ensifentrine come to I really product see, That we landscape is first continue our of think continue don't we progress. the and that, with mechanism any development. a products novel development But for I inhaled really routes. we and out. action, update issues we the to to thoughts assess course, other as of see

Boobalan Pachaiyappan

the cadence expect shape Thank to how see of for And remainder you the for you. of the and how want XXXX, cost year like. do sort the like R&D evolve look I or

David Zaccardelli

year? balance for the what next this asking you sorry, the I'm and Were the – R&D to expect we year what spend on be of Boobalan.

Boobalan Pachaiyappan

costs. Yeah. With R&D to respect

David Zaccardelli

Yeah. Great.

was So of of the the million. the And about the for program. quarter in we're kind this belly enrolling $XX.X beast Phase as R&D know, of expense X patients in

this would expectation that I next kind the get the back QX and when they'll as into down than Phase through think, of QX. from spent the lower an QX be in seeing of then perspective, should program. cost and increase bit that in are the year, then might in X to peak, we're taper QX substantially being remaining on it a think as of majority we you start And we're we and still QX, year

Boobalan Pachaiyappan

for for the Alright, thanks taking it from that's me. questions. my Thanks –

David Zaccardelli

you. Thank

Operator

from go Please ahead. Truist will question the Securities. Lee next from Joon be And

Unidentified Analyst

morning. This is Joon. for good Hi, Maddie

finding would by you you. you have is question question And commercialize US related you're selecting if the Thank plans your color or outside business be yourself? to some any process for Our on that having provide partners. the the that to could if next and

David Zaccardelli

Right. the question. Yeah, thanks for

it the second for outside look the partnerships the our that first we've ensifentrine, US. the is US – are commercialize to in take strategy outside our US, me plans but as we Let mentioned, is, partner to for

see have can on strategy. we that You to begun that execute

Greater pleased China our with in partner, Nuance in course, Nuance to China, have Of we’re progressing in collaboration and ensifentrine place Greater agreement with Pharma. with partnership have our that very

you execute on plans, continued needs for and timeline, with we an it's see, scope continue an we've far looking criteria even though BD as the as This again, our the be So process focus. outside or difficult that partner ongoing the and is exact our partners efforts, to US. and have as It can right right to to it. capabilities

be Of course, the, with in ensifentrine value the monetary aspects marketplace. of any partnership the also that have consistent to of underlying

the we're you progress progressing program X we the to with increase continues of and As as proposition ensifentrine. know, through Phase that development value

progresses we'll on as we depends that plan then partnership, economics execute the to capabilities, how see the it those and together, So come of partnerships. But their on in XXXX. those

Unidentified Analyst

you. that behind Could the for a and the study? CYP question reason notes. on cytochrome Thanks, Thank follow on reason some up doing and study, study different you insight the provide

David Zaccardelli

may development, way on of Yes, looking In especially type may And at NDA. at look very drug-drug metabolic required of is pathway do, ensifentrine need drug-drug I say, into other its go again, are different impact metabolism. and what our is on the merely the again, work for interaction studies, drugs disease, just are and we've we same done planning This updating it's normal that what were to elements NDA. typical an would drug typical an at the in the also agency, case other depending plans, your to interaction and completing under to more used, that Each this when in course it the looking you're metabolized. think, typical, you typical comprehensively, the this drugs they studies, are we is requirements that CYPXCX And know the understanding just this is to is I all drug-drug impact as product and do. interaction that the instance, the which pathway. through of the specifically were studies, doing we presented

Unidentified Analyst

taking very much. questions. thanks you And for Thank our

Operator

next ahead. Schrader Please from The Instructions] go from question [Operator will Tom be BTIG.

Tom Shrader

COVID good luck. that for is The interactions? really of I FDA? an evolving follow study, questions that the the braced morning. just explored. with of drug-drug for quick ups the have And all We're a fluconazole have on couple is that it Or holding Good Thanks process call. for winter. sort been

David Zaccardelli

where that? believe I don't do this comment to that's we're at, on time. at I any Kathy, don't think need others. want to I we if you know

Kathy Rickard

interaction other for this no at have drug-drug currently, Yeah, requirements time, we studies.

Tom Shrader

the then with do is into saying but about? don't is and the think data to on we QT Okay, go essentially there speaks data should You concern, that nothing? animal preclinical you Or anything study, any sound that? there that

David Zaccardelli

Kathy, want Yeah, comment? you to

Kathy Rickard

I don't data us all is think have we and a animal showing the effect. that been cardiac significant reinsuring

results that expect we that so study the that in on we're we'll see And shortly. expecting

Tom Shrader

you. Okay, Good great. Thank luck.

Operator

Ladies the Dr. turn question-and-answer to like and session. gentlemen, our over Zaccardelli any closing this concludes remarks. for I conference back to would

David Zaccardelli

you, like to and like your we and talented of always look program. speaking dedicated Operator that the professionals support, be QX, of presenting questions ENHANCE London the then. Sandler today's thank their to several everyone to and conferences we that I'd concludes the to their commitment. Piper healthcare to for including team thank shareholders Jefferies and and I thank Stifel, say will in our Verona just at to at and course, many call. Thank for continued operator. forward like patients you for In investor participating

Operator

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

disconnect. now You may

Verona Pharma (VRNA) 9 Nov 212021 Q3 Earnings call transcript