VRNA - Earnings call transcript Q2 2024

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Operator

Welcome to Verona Pharma's Second Quarter 2024 Financial Results and Operating Highlights Conference Call. [Operator Instructions] Earlier this morning, Verona Pharma issued a press release announcing its financial results for the 3 months ended June 30, 2024. 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 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

or nor involve other to known statements results, factors are implied unknown materially and the promises neither performance actual expectations our and These different and from material expressed guarantees risks, forward-looking may statements. cause to our achievements be that or -- important by uncertainties

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

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

a recorded for available As call this reminder, is and will days. being remain XX

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

David Zaccardelli

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

quarter approval to for COPD. and the by the this for bronchodilation was treatment believe of inhaled Verona Ohtuvayre The for exceptional nonsteroidal anti-inflammatory paradigm for and redefine maintenance both we approval marked COPD -- treatment COPD Ohtuvayre treatment treatment in of U.S. the first can Pharma, an the second FDA provide is U.S. effects, the the

Ohtuvayre pharmacies, now Today, and we announced exclusive specialty our is patient available begun. network of through shipments have

of the commercialization you confident that are successful achievement in our and very position are with We preparation us to share for this excited the extensive Ohtuvayre U.S.

or broad etiology, level. chronic without to COPD restriction label eosinophil including As patients a emphysema background or reminder, use across supports COPD all Ohtuvayre's bronchitis medication, blood

Ohtuvayre treatments. action on all across action, shows all COPD benefit-to-risk of our and types. Ohtuvayre's have market in other mechanism patient symptomatic novel Ohtuvayre's approved differentiates which describes prescribing of interest also it significant label HCPs profile, broadly research compelling mechanism from Based COPD The

providers. on treat market These COPD shows is to active patients, promoting XX,XXX efforts Initially, the practitioners approximately analysis primary physicians, and pulmonologists, focused Ohtuvayre care most our assistants. which our nurse launch providers are include HCPs that physician

are field and teams reimbursement field the fully and late been July. sales in have hired Our since

they time, being over that top over HCPs, with During X,XXX interacted prescribers. XX% have with

Although few a XXX Ohtuvayre. it been days, HCPs have prescribed has just over

we the II new X U.S. programs quarter. launch in third In initiate of Ohtuvayre, addition plan the to to Phase

developing via for First, we standard are and combination COPD, with a of formulation fixed-dose delivered nebulizer. a maintenance ensifentrine jet glycopyrrolate, treatment the LAMA,

randomized, crossover In the trial start submitted to we dose-ranging safety FDA. trial subject IND with in II a The clearance, delivered formulation pharmacokinetic July, an XX third assess the we in in to to lung via novel the X-week the COPD. And approximately double-blind, Phase placebo-controlled, of is a function, quarter. nebulizer patients to trial plan glycopyrrolates profile and

ensifentrine and identification fixed-dose assessing of placebo dose Phase components Following range, trial combination II glycopyrrolate appropriate will to the conducted. be individual compared of a an glycopyrrolate and

Additionally, The a we with assess group of bronchiectasis pulmonary plan II recent XXX in patients double-blind, ensifentrine third trial will enroll randomized, exacerbation. trial fibrosis a Phase with parallel placebo-controlled nebulized patients quarter. the to non-cystic to history initiate in

twice ensifentrine of powering, number and on at is weeks planned trial addition all will patients risk events observed. and the pulmonary in until where life. milligrams for X exacerbation of treated are a daily enrolled of exacerbation of XX robust they effect symptoms least as ensure rate the assess quality will To of the trial event-driven, The and be to require,

facility. strong sheet under million our on with remains future Oaktree our of and Lastly, balance cash for optionality $XXX hand draws over

over turn the to Mark results the to financial now call please review for ahead. go our will second Mark, I quarter.

Mark Hahn

at million approval. and $XXX million strong includes in equivalents drawn our $XXX facility is sheet Dave XX, cash under in June As debt $XX under the XXXX. and of with million at mentioned, RIPSA our excess balance This drawn

including Phase hand With II to Oaktree new cash launch remaining and our clinical we beyond potential programs. million have the cash $XXX X XXXX, Ohtuvayre U.S. access currently sufficient commercial the expect runway and to the on facility, the the under of future in

second of of expenses operating due levels performance-based historical to the higher XXXX of were payments for recognition expenses a as the Ligand milestone than RSUs. quarter Total for and onetime result

Excluding these the line approximately would R&D our onetime million quarterly expenses our costs, and for guidance. $XX with in be previous SG&A quarter,

of and $X.X second $XX.X of the quarter for a the of reversal compared million were for costs quarter million XXXX. Research development to net reported costs

This recognition largely the million compensation, increase due increase expense XXXX million $X.X of inventory and in by production to a to costs to RSUs; to an accrual $X.X $X.X of primarily XXXX. pre-approval related clinical expense million was QX million the QX from of driven Ligand, share-based related in increase $X.X trial approval performance-based milestone to

Selling, compared general XXXX, $XX.X the XX, and $XX for quarter million to administrative same XXXX. reported expenses the June ended period in were million for

Ligand, accrual to we due increases increase $X.X the compensation share-based of activities, performance-based first from an million launch-related million an in as million and of commercial increase costs sale This people-related driven out in organization, by expense. our by commercial million as driven $XX well was an other RSU marketing approximately $X.X built of $X largely primarily milestone as

Q&A. to call the the back operator I'll now over the turn for

Operator

from Andrew question [Operator comes Jefferies. Tsai Instructions] with The first

Lin Tsai

and launch. Congratulations on execution the

what rate kind one abandonment our there will patient models, if took be rejection we of ensifentrine? first free should and be payer a drug? is, you So can And around us remind modeling as we for

David Zaccardelli

we what allowing free them for And in those thanks a start to patients bridging become delayed programs to may that in call do Andrew, program for while short effect. drug, With the and drug benefit on support would have on regard place the those we do in have to for we example. term, based patients have need, questions. benefits also, economic

a verification. not benefit and Ohtuvayre there an that to those through is any sampling provide but program So patients ability need to per them se, there to is short-term it support

know, Chris the in understand payer that have launch to prescriptions on And modeling over it dynamics, incredibly at turn as early a from to on I'll guess current that I that, written. least With based been you standpoint.

Christopher Martin

and think the launch we're go overall to space. going the But about payer is to in the Thank Dave here. I'm the When early this question. using Andrew, abandonment rejection, very back Chris. within older nebulizer you as we mentioned, analog for

are under B lower traditional spaces, at see benefit keep but mind you Part through D can reimbursed historical within will what analogs which Med either exist side, what do on. see commercial, Medicare benefit medical a than in And Ohtuvayre our Those that those within early you looked Advantage. be medical a in abandonments be that primarily we've and under under Medicare or they

a have different regardless from co-pay, in have a Verona of it's a through if that a variety low assistance program patients, that ways. dynamic provides we medication to and zero, There's some But even everything natural Pathway may Plus patient we from prescription. patient believe of the that just walked away access

rejection rates and majority think you business. we side We -- rates how those will I'll if go benefit back medical our of run medical statement rejection the side like. about look versus same pharmacy Additionally, that through and believe on works, benefit. the the business, And data of of to the around benefit what have prescriptions within the rejection benefit there medical

believe a J-code. through and we'll that to be during that nonspecific product time, very the using freely. coverage determination flow exists, able J-code also That the local channel We know nonspecific we this is that exists,

J-code call, the would submitted did about and review the on talked expect XX. in a we we on as beginning currently at It at under our Additionally, LCD [ XXXX have be approval that in ]. application June product-specific of to we J-code effect. is CMS, We

question. your And it. that So again, with I I hope helps appreciate

Lin Tsai

secondly, of exceeding then million. assumed meeting feel number my And is X.X in or QX or quarter a more. for month, comfortable number September for If by Would Yes. calculation, No. get is the out average QX this consensus patients you XX? $X.X patient reimbursed patients an treated get that exiting of of or maybe needed we X,XXX who

Mark Hahn

be yet Yes. making about viewing note, Maybe into numbers. inventory math, getting prepared I'll not I that channel, way that revenue. quite that consider the will patient there will I we're have however, some don't take will do talk Andrew. impact its to you actually patients in to your one, the think

Operator

Rahimi from question Next Yasmeen Sandler. Piper comes with

Unknown Analyst

on Emma is This Yas. for

patient Firstly, how thinking and plan progress what how help to at share And color earnings on and with about to provide launch us do starting can you're patient that, that forms next ties expectations? November guide into uptake? any in type you you of future the track metrics

David Zaccardelli

Yes. Thanks for question. the

history, we our start you've part. in transparent as as we can the Clearly, we're progress. seen I'll think as I with latter as be

as the further our get which we're for the expect and we to are metrics still continually launch, We assessing next quarterly call. evolve those into

writing already uptake the with begun. just barely XXX a strong see, HCPs we've for over in days, can Ohtuvayre you it, As is just with quite and few

be course, again expect metrics understand transparent we and give informative, we that over change so again, and time. And to of will, launch you to dynamics, be the

Operator

comes BTIG. question Shrader from Next Tom with

Thomas Shrader

Congratulations. patients already all earlier? triple? people you I drug you've unhappy what's are on probably on Are they prescriptions. any annoying seeing the have Do but have written XXX they're question, who an for? Or you read try

David Zaccardelli

into Again, a mind few in I'll have just days Chris comment. this. that keep we're But

on the you'd comment. that, with all that But haven't maturing have expect so started I'll a yet. analyses launch Chris And quite

Christopher Martin

list. those they from have we just writers thanks come XXX is Tom, What target of our Ohtuvayre. question. And -- Yes, the for over we of clarity, about top for prescribers know prescribers

think reps segment segment if other and we on. highest I to physicians, X prescribing positions call back our that the are X calling So what are these calls, would both our

shift conversations throughout within have X.X The toolkit to [ year, and back it different offices our symptoms. last with of a in expressed Ohtuvayre it patients allows We're ways. treating also who have use that ]. in new from the doctors unmet very our of field for hearing And them They continually at numbers very reporting tool to as reps. years variety need their early a ] the look we've [ is for significant these in clearly the are high they patients,

give early to it's it. patient Dave have As looks said, of the like that kind profile analysis of these ways doctors what an of prescribed very the

every do that utilization they through the will know patients and are telling these have us However, symptoms, into well. persistent that go the quarter move we quarter time drive single our fourth as we continue and office into third the is what reps as that to

Thomas Shrader

fixed device try a in in dose. on you, quick that first? a device, get to To then combination in the device? a a Or And different have monotherapy handheld approved dose fixed do fact, the a try question you could in Okay. handheld

Unknown Executive

Yes.

monotherapy combination, I a a work development think a of formulation, device nebulizer. entire through actually, fixed-dose way you in the that or programs the that a handheld one for are typically whether the designed in or way another, it's

Operator

from Next Joon question comes Truist. Lee with

Unknown Analyst

Joon, This Jane for and your on [ progress. ] congratulations is also,

-- can other on could the bronchiectasis, edge give be the your especially about drug So then non-CF ] NZMS some I regarding you more this for with competitive over unique have with -- treating [ give other your questions compared drugs? [indiscernible]? drug offered better, can also, of provide compare some color like competitors this you mechanism And

Unknown Executive

Yes.

the in because make to including So both a and neutrophilic we targets has potential ensifentrine inflammatory difference inflammation, non-CF it processes. with bronchiectasis macrophages-based think patients neutrophils

in through It increasing of ciliary cough Sputum processes in bronchiectasis, dysfunctional that pulmonary problematic one particular is most also infections the and and exacerbation. that patients works function these associated cause and with continual it's and issues mucociliary further sputum.

rates course, the the in reducing saw a will mechanism, and very population. certainly of exacerbations exacerbations We is on to think based this bronchiectasis ensifentrine trial, of data COPD against pulmonary our that exacerbations. on population. extrapolate We the to of risk assess strong pulmonary in effect So designed

competitor the ensifentrine has other think just to patients Regarding bronchiectasis that make rather than rates. might with exacerbation really feel that opportunity drugs out compared these how we patients better ensifentrine there, to reducing are actually impact

be so first goal, are the this trial. we'll And some those endpoints that's the of in that and assessing

Unknown Analyst

But do have to preclinical support any have what data for you you indication? this Great.

Unknown Executive

in to with pathophysiological the not Well, Phase patients COPD, cough any specifically of III reduction wealth was of that processes program. similar model I'm and including with sputum But certainly, a relating bronchiectasis. aware important in in data we have

Operator

Next with comes from Wainwright. question Ram H.C. Selvaraju

Raghuram Selvaraju

engaged this to I respect in to Chris, on see currently for front what granularity us outreach. commercial with probably doing months you could you course the media on the in of more is to and front, are plan marketing social coming if what provide with do the the some On wanted you

seeing for as the COPD in process program support Ohtuvayre you so, also, terms physicians as on, about you're involving the what when And Ohtuvayre? commercial take? involvement of might advertising speaker that direct-to-consumer with And you advocacy well as part community? within anticipate what potentially overall might what in if And think of side for the forms of example, doing patient

David Zaccardelli

Chris. Go Ram. ahead, Thanks,

Christopher Martin

Ram. promotion marketing Thanks, and just of stepwise on point. to these take kind I'm our Yes. going through

of throughout in team One and was And very the that launch and up a specifically programs of -- things and a the to talked seen execution the marketing that job preparation to commercial be our we flexible side good did already. we've from programs very setting HCPs digital infrastructure about patients. this data for

you example give here. a good I'll

through digital with XX,XXX physicians team, channels to through have out and e-mail, physicians. avenues, marketing reached banner other to over of multiple ads Our times engage types

interacting e-mails, I they're course since over the over is engaged our is team highly -- our marketing physicians by approval with doing. And marketing they're And with to last have what they're we've that content mean almost over are the means website, we seen going the engaged month. on the what communications X,XXX clicking highly

do Additionally, they Ohtuvayre our go ready are high-profile with very leads can that quickly. what allowing give that's into reps physicians so to is offices them that to prescribe

a been place it's nice process So perspective. and a really marketing system from in

about Omnichannel you promotion support field our about some think messaging you the as with not is as well. today, on as only as HCP website, we the fully it's go and HCP promotion. the I from just other would patients side, I ohtuvayre.com things, is well continue website launched we speaker programs future the classify digital, -- for will launched, omnichannel fully we as Ohtuvayre and as updated if to what but talked think

to are continue outside avenues reach those to rep of standpoint. traditional physicians the So

programs. From program have speaker speaker will a we standpoint,

Our speaker reps the ability have to have programs.

in speakers locations. scheduling a have group already, physicians of their already future reps trained have We the and programs started speaker with

of So that omnichannel plan. that part is

collect channels. on When social website the about patient our It's reason think information a I data been why through a have patient also patients we and -- of It's reason we other patients, interactions our patient have plan. always today. part why our

We also physician with and offices, marketing, prescribing. there's patient think already the avenues interact where are to good point-of-care that very of patient in we're able the where future, the doctors

has the both these support that plan ensure very with they're robust, our team physician there as field patient, put So marketing physicians. we force to together and out a interacting

Raghuram Selvaraju

you read full on and just on bronchiectasis. on timeline Great. you data? And give to the have was could a I Or great the to non-CF additional potentially wondering then that that very quickly if the some reach color yet? us enrollment timeline don't if

Unknown Executive

years -- do the to It's just easy somewhat a essentially population set. is not larger this Sure. the could is population really the a around end this anticipate one project get to out. rare X than disease. we of take to Remember, But

harder patients are the bit find. a to So

Operator

Edward Instructions] [ with [Operator Our question Thomason Kempen next from ]. comes

Edward Thomason

on ] This weeks, And that There play reimbursement? had your was ICR pricing Ohtuvayre cost-effective how just into implications basis. I the Does [ question an a the for pricing. does any that recent launch? news quick in pricing on -- we've the differences. about strategy have from seen annual the is how

Christopher Martin

for to we we Ohtuvayre I the have that. you thank and think appropriate the system health at priced believe appreciate both question, patient. care and the that I value Edward, Yes, the

Ohtuvayre. look, you we on charged for had And provides Ohtuvayre month the that benefits we've could done significant a analyses $X,XXX of the of If pharmacoeconomic prices month upwards ranges have system. per and that we've

value our to know, for care the like you We an As health $XX,XXX. what WACC system. that overall price brings feel represents is appropriate Ohtuvayre

Ohtuvayre reimbursed to than how any that anything and payers indication is traditional with in be it haven't not Keep we believe medical that a our will seen benefit of price have is And from how an don't benefit, When reimbursement, under covered. mind, is dictating standpoint drugs it comes different pharmacy -- from that. we we interactions work.

payer from the team term medication that the the has and but to appropriately we reflects price work across again, long all the access well. the done So pricing to patient believe value get the as community, appropriately also allows

Edward Thomason

might us just I Can had can expect ] patient -- [ ERS the upside [ on CHEST that of the flavor what on might or we whether a in data or just be later then at subgroup those and don't ahead be just question wrap ] I year. follow-up in give analysis populations we And actually we that? background therapies that'll Okay. you expecting releases, the know, so a and

Unknown Executive

ensifentrine program, COPD not-chronic by look a And Sure. actually. cough At some chronic patient of to assessments reported those additional the outcome you'll effect all of and bronchitis see analyses that the things, the in sputum, the or on specifically at ENHANCE ENHANCE from exacerbation on ERS, population effects phenotype bronchitis. enrolled and was on European analyses pool

you'll on and again, XX severity COPD health bronchitis data also chronic from on analyses lung look of care a function an see or emphysema, resource analysis additional smoking CHEST, some pool on phenotypes, over At at status, of COPD utilization weeks.

Operator

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

David Zaccardelli

everyone, for call. today's you, joining Thank

can in excited see, launch the very Ohtuvayre's you we U.S. As about are

we're think And to I all just an you much. soon meetings to much in the seeing we a conferences. start off you to into very investor future. Thanks We incredible at very days look and it. look updating few various forward

Operator

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

now disconnect. You may

Verona Pharma (VRNA) 8 Aug 242024 Q2 Earnings call transcript