Insmed (INSM) 31 Oct 242024 Q3 Earnings call transcript

Thank you for standing by. My name is [ Jeannie ], and I will be your conference operator today. At this time, I would like to welcome everyone to the Insmed Third Quarter 2024 Financial Results Conference Call. [Operator Instructions] I would now like to turn the conference over to Bryan Dunn, Head of Investor Relations.

You may begin.

Jeannie. you, Thank and Insmed's everyone, a today's call conference update. Good quarter welcome XXXX discuss third provide financial to day, to results business and I joined will Q&A each and prepared remarks, for Lewis, Sara by the they session. Chief Flammer, provide am will Chief which Officer; Officer, be Bonstein, who Executive Martina and Chair Officer, Financial after joined today by Chief Will Medical

statements that our factors represent will prescribing call today's could today's judgment purposes Before investment for to materially Will risk the and we results Please affect current include for our with discussed. statements discuss company. The and community. expectations. intended based note to is we refer results benefit These concerning and may for filings today start, of the the information is It will not on risks more remarks. call uncertainties decisions. I of our Commission forward-looking information call as on promotional that differ prepared over involve now it and cause for turn will meant the Securities the to please the not the inherently is from that for actual Exchange sufficient

have data year ability to The execute everyone. of Thank and front be our by for will us. in you, we defined of new Bryan, welcome, Insmed, on marked of era many the earlier positive a announcement start ASPEN this the one opportunities that the

that quantity. not of to opportunities ability to but the our before sets terms them. also and continued execution of of story. The new deliver up to say are their exciting that Our significant, for chapter patients remarkable I'm quarter sheer team, in performance on level simultaneously of of a level have this organization, us on all across show only execution company, proud our impact their and the -- demonstrated terms of Insmed's potential in us this

tripling U.S. once team Insmed the again growth delivered should all our to been highlight regions. publish time, commercial working ability ARIKAYCE in rates track opportunities preparation launch trial. Today, build nearly and driving on on in have our while progress we at also middle add across brensocatib made why team this and I initiatives for ongoing by across our development third trials same file remains confidence the team the they NDA the ASPEN have to of out progress the in clinical clinical of to U.S. the this for time, of its multiple from sales was sales intend double-digit the infrastructure increased to the same example, For for XXXX. Similarly, force brensocatib expected quarter, the enrollment its year-over-year quarter, to in our working the and the At our ahead. at tremendous ongoing across execute present data in to

what with subgroupings, robust which heterogeneous, be trial. Phase in disease of brensocatib. how very how Let's similar the ASPEN we baseline and severity categories it be of we those with existed the measures. Earlier Annual subpopulation this prespecified was II presented presentation American comprehensive subgroups, trial known begin data XX from is to observed was. In month beneficial patient to broadly demographics, these in categories various emphasizes Boston, Chest College a WILLOW the across had population this on which XX from that and Meeting based Within treatment remarkable Physicians dozens comorbidities was data is brensocatib to at observed

the with the filing for first is acceptance the expect accepted, FDA decision to of announce a lines We the Presuming continue to the expected expect by would to XXXX. time NDA for this the year. along in brensocatib quarter file in fourth quarter we of that

launch sales I'm are commercial to field, where being U.S.-based currently U.S. our that preparations. claims in data deployed XXX. been sales total trained been to treated. the our and bringing are XXX diagnosed us reps pleased the territories showing report patients reps to on based all These have new Moving sales constructed have additional

sales Our day and in intention is X, care. patients of pulmonologists to centers but have representation in just centers many academic of the these community broad receive the from not excellence, where also offices

early force In to for position strong brensocatib the fact, on sized States. believe in in to that the approval. intentionally pulmonologist pending U.S. bronchiectasis every a launch call is successful these enable Insmed investments We sales FDA United will

with bringing currently II additional new BiRCh pursuing in polyps suppurativa. now and Let brensocatib, XX% more me Europe CRS indications study sites chronic X screening. in also the with nasal on many are without has and we without rapidly in U.S. in online been is the patients an rhinosinusitis and currently hidradenitis polyps than enrolled more Phase provide update The nasal

to continue of results We anticipate the top line by XXXX. end

one arms with then measured who also the XX would arms nodule the based Those dose. XX abscess week would to are randomization, those on baseline milligrams, join end study, receive being toward the total to first receive the is to until schedule count or subjects inflammatory be basis. percent will week before on Our approximately endpoint to CEDAR site this baseline to arm at XX. The brensocatib X:X:X expected at that will is is brensocatib called study progressing continuing on steadily randomized year. study enroll randomized which matching brensocatib of Phase The a placebo randomized in study its opened brensocatib same in milligrams blinded XXX occurred be primary once week II expected at XX have XX placebo HS The to per of change which also continue and day. from the

stop data have promising. If from we As the examine to us analysis data population is week board, patient approximately This interim study will that reach the once past, in an data which signaled early recommendation conducted the analysis half into include the no study to if blinded continue read reach monitoring will from the not would futility independent does the there by an analysis for XX. look the allow the they interim efficacy. will interim will efficacy no XX. that If top study, to the we study is stoppage data board. so by we to built overwhelming the to line after completion, is the continues patients out the reviewed trial potential early is design, There week remain due monitoring all results of

end for to of We the to available providing this expect trial more year, progresses. we as on this look before and clinicaltrials.gov details the updates forward become trial

XXXX. seventh in growth turning ARIKAYCE, double-digit quarter its revenue the year-over-year consecutive of Now which to quarter posted of third

this impressive. of is ARIKAYCE. from you when seventh it level growth in the year its achievement We launch, remember ARIKAYCE But the that more have seeing makes and become accustomed unique all now to post

strong ENCORE of able end the execution, patients ahead third strides Thanks to study making In we the Phase commercial patients little great addition a quarter. to Last we also very close by quarter, for clinically. stated III new we our are of to screening the schedule. new stop screening to of intention the were recruitment, strong that

won't target to randomized screening we that until pleased the X-week more all to have enrollment X- have finished the the patients patients While already number I'm trial's report process, than XXX we know of enrollment participants. exact

authorities. We using for the mean durable meet plan this the will the primary filing endpoint H powered ARISE culture under for Japanese study level to U.S. primary for of with data. possibility quarter well Phase successful discuss an health III FDA accelerated to subpart the trial as enrollment for XX% patient-reported the the of as over is regulators both conversion at the that this endpoint well Importantly, outcome

will As the previously of schedule to for require from a we have mentioned, the full to expansion feel set first data XXXX. most the readout the trial, ongoing remains ENCORE ARIKAYCE likely we pathway in which potential label quarter on

had update continued. that me that was enrollment that with has accelerated equally quarter, momentum Last excited as our and TPIP. had of on date. Today, target provide in II enrollment report an study passed XX% I PAH the of that pleased let of to I'm this share Finally, Phase we patients to

readout trial, line week, the report of in Pulmonary results Research for than us As Janeiro. results we more World We year PH-ILD, then. full Vascular study, our half look top de Phase Rio line those forward firmly in to of the had in the from May on II Annual Congress second which XX% XXXX enrolled the this at in to XXXX of target details Institute's of early to present we a top the expect last had track this XXXX. In keeping sharing

presuming so same quantity We are micrograms clinical to allow a higher up take which powder offered patients we also can single as This setting, delivered improved is be of working TPIP manufacturing how commercial optimize the delivery, doses using success. in in dry XXX to capsule and lower of the be regulatory doses. the would doses to expect TPIP to that

day, consistent Top in be maintain during a at which potential company, Science's half Phase Employers We survey am for this and seen the an this can where organization. we of and now across culture same my the announced these NDA the annual to remain years in to for I company. Last in date fourth The using organization, conducted Insmed's so an confidence as the as validates that as is other doses that kick only earned consecutive that which program future TPIP have to more of I have survey Phase I Insmed. are summary, product, we have core of for ranked able we that external employer strengthen Genentech. This was second we III that doing PH-ILD commercial-ready transform what work we survey even off required patients on this only for in would the our remain The a that III least using values. every our be recognition program with see operationally were track grounded X both company We in I to -- of culturally, filing. are we the XXXX. In optimized period growth be with in couldn't to of row the been progress year. adds unprecedented pleased as how top proud an history week, of of in #X future honor

For meaningful single the exciting companies TPIP representing represent a organization. At from find execute product like the our of us potentially a that X far, brensocatib, having at Insmed, once, already any in We not with program say are the we for each to launch responsibility walk we very develop financial therapies turn the all one in success. I'm like rare our a field, will now to at and also promising demonstrated to these patients we on late-stage position through through opportunity the it X ourselves most ARIKAYCE mechanism results. pipeline proud in quarter's to following of opportunities take the most medicine action but potential are seriously, these of paradigm-shifting this to Sara, clinical X to over potential programs new deliver so would only to the expansion chance label promises. I'll these of committed to the on to who

are few convertible and share equity term an better that financial our our our Will, August, debt, of strength in steps include start good financially. to due position. in balance our you, restructuring at-the-market sheet. XXXX we strengthen deliberate position was taken you spoke loan. When Thank everyone. today, with secure in to words program quarter utilizing These the existing I Insmed to to am even about actions in the I position our and a last morning, opportunistically to past want offering the calling very a I happy

Let on details me provide activities. of each these you some

quarter's to lowered call, approximately issued stock and improving convertible earnings noteholders, we notes, in to burden were $XXX our our shares called ratio. in debt-to-equity while simultaneously million our mature last August, on of X.X set ongoing expense discussed interest million which XXXX As which also

at third price we sales approximately the $XXX $XX.XX share. of ATM proceeds in an net per to our in utilized Additionally, raise million average quarter,

during was a reminder, in offering our sale share. recent As $XX.XX May, price per most follow-on the

loan this Pharmakon. announced we restructure able were term million $XXX Finally, with as our morning, to successfully

low $XXX rate to in actual a variable additional which set agreement, will the quarter. XXXX. interest based mature SOFR fourth to the in terms X.XX%, the carried rate mid-teens the the a plus was in restructured an and in to normally previously Pharmakon put As Under be on of paid million proceeds the reminder, received our provide rate loan us

full X.X%. was rate of interest rate principal lowered a on the fixed to amount Importantly, single-digit the

anticipate that In addition, pushed important which decade inflows the from latter the of part support loan was balance. out is XXXX, would of we cash to the easily during the the for because maturity loan our repayment operations

lengthened. reduced being actions, cash capital is runway is As a result of cost these while of our being our

of our end of an marketable million since sheet, the the which $X.X $XXX of of the increase of the billion cash cash, third balance quarter, on As quarter. and approximately represents we approximately had securities second equivalents end

to reminder, recent the $XXX previously $XXX related from million term reflect exercises, and of related reflected launch this inflows than payment was impact to of financial remainder brensocatib. quarter, higher million, quarters. made is approval of preparations statements. Net of for additional Pharmakon file quarter's the increase the to cash the this fourth a increase headcount portion of not AstraZeneca cash the As expenses our expected, the loan which and million higher balance will the intention to for proceeds milestone approximately does with brensocatib in ATM current from to resulted the A well patients quarter's discussed of for be the the the of of potential somewhat other related ongoing as cash due burn is our stock the as was treatment underlying bronchiectasis. The quarter to cash as $XX.X third in of which, option the announcement

underlying and commercialization. time the As increase that we brenso compared regulatory a cash expect result, to approval revenue, contributing between to burn assuming levels and historical now begins our

be move I yet our becoming of topic sufficient self-sustaining on, ambition subject our business important like would many We not the have I this on own, on until company. our continue of do a an its biotech as I is profitability reaching profitable to becomes of we address hand Before but of cash fund it to for shareholders. mindful to appreciate

million, Given second represents prior through year XX% XXXX. of rate starts revenues we highest have in our in our now period. you flexible the period, of we we in could new to as by year-over-year XX% strength was are quarter sales million, driven net performance net amongst be a the quarter, the record to future U.K. patients. In In net Germany year XX% compared position This compared quarterly was volume-driven compared to third patient of up continued the Global a our set sales. In which new quarter revenue the ARIKAYCE commercial $XX.X this the revenue performance history and was the we compared was primarily XX% treatment reflecting in a was financing needs. I quarter and the was existing to patient reflecting rest new progress year prior continuation higher This about net and in we million, Europe see patient a strong by continue quarter now in this to the its growth row of prior Japan, continued in growth in driven think for third highlights $XX.X walk world, growth starts, revenue strength XXXX. driven ARIKAYCE. up and global $X.X for the and by million, which This U.S., $XX up will for the period.

track Importantly, to million. of full our XXXX $XXX this year guidance quarter's $XXX achieve performance million to keeps global revenue us on

a Let few me financial to now items. additional turn

net U.S. to our which gross consistent was this expectations. with XX.X%, were Our quarter

development finds produced us the expenses to both third our We reflecting unique quarter of on settle and year for our deliver Insmed initiatives. In continue SG&A in is XXXX. will track continued for million full third $XXX.X XXXX $XX.X record-setting itself Cost historical and operationally. of were well and the pipelines nets in revenue gross the to closing, of third year and mid- product which performance. Research quarter with XX.X% guidance. high in million in to on brensocatib million, as or to anticipate was a of our consistent revenues revenues, to that $XXX.X as expenses position financially the in quarter, investments We full keeping commercial in were strength, early late-stage mid- investment readiness currently teens

the operations comfortably we in as cash, well fund please? late-stage to from and Additionally, our Jeannie, to to securities of would mid- equivalents billion take launch $X.X we our allows question, this sheet, the across period first one have as balance cash which us data your of like open as additional the brensocatib transformational to which enter ahead, call anticipate approximately portfolio. We may now we our marketable meaningful readouts on we questions.

from Schwartz first of Instructions] line comes Leerink [Operator question Joe the Partners. Your with

talk mind the should and as the awareness well we on? I early there focus state you about help analyst effective the if model on could activities more expanded be in at and Congrats how size first, can is for brensocatib prepare progress. for you estimates force sales how its launching of based you've in keep anything some much was And disease on wondering, the as whether looked it can sales brensocatib ramp? as launch terms we in

So that general had spending you, I've thanks with board, question, for some the think noting. I we are mean worth that X I and would on dimensions tell the I pleasure I time of have they think Joe. people the brought

are have of group always winners is, launches. had XXX positions. to They group. I done lot for folks they President's first we people. a got experienced multiple remind very a that like of more Club resumes X,XXX than in this The We've multiple

interest roles. speaks volume So existed for to these just of it the that

any ahead. So going to the tell I in this industry really you, I got And feel on I the hand the heart, think we and sales come best. would like would of match force best out against we're

To incredibly The those and people they patients an part that's important culture, you that focused about for our of delivering an part as second person, -- know. is on these a are they cultural fit. point excellent are and patients,

when the as the do, United think now, this every state And October that as I said, empowers what to as what right launch about with bronchiectasis. actual we the to capacity. you to familiar $XX the model because same of million States in doing ring mentioned, we of we million. about And more ARIKAYCE. ARIKAYCE, us calling importantly, by benefit and a on in kind also have field And about we took kind what may building ended literally an the $XXX early but a they're of call As and think is in Street of uptake than doing medicine indication patients. this the had education approach as stage to way exact is and ability can we year, X, $XX us medicine pulmonologist million we this up we remember, disease it about ARIKAYCE, doing the trained, they're clearly fully about is awareness because relationship to when first of you'll of provide launched as that's doing that both the itself

couldn't assembled I excited think -- group really we've be I more yes, performance. and best-in-class to So first-in-class going about see the you're

And wondering range expected XX-milligram aforementioned then dose, the sense dose whether for you're brenso just does to use flat how thinking both? or the to price the I'm graduated or it makes about refer XX-milligram pricing.

provides? do value payers For XX-milligram appreciate the that dose example, added the

your So time any one. I earlier you the want But what Sara, if that It's on back is here want the what expect yet. tell understand would can the I think do, to don't we know, decisions and that before a about to proposition. -- that to basis take our in to first forms pricing medicine do might value of we do. comment I year. to about we come all in made studies you going the be we haven't long clinical the objective

obviously sales Sure. It's while fibrosis brensocatib believe thanks the $X alone. analyst have said for non-cystic we guidance specifically in is on peak we we opportunity. question, bronchiectasis what for billion-plus brensocatib, expectations. Sure. the a provided Joe, near-term haven't And

as in I is tremendous well a in a point impact here to of from industry. as you a lot So patient. What would analogs the precedent on study some perspective We Insmed. opportunity value-creating

million. kind launch, some high millions you about it's TEZSPIRE, in so the see in X if their launches forward $XXX double-digit put respiratory first-in-class, then X the if to $XXX revenue. And of launch, in quarters And of quarters you million you like of they look up DUPIXENT, their FASENRA, into carry best-in-class of at first that next space OFEV,

the think million. DUPI with I about was $XXX best

revenue the strive specifically think and numbers. can't are like, brenso I these analogs best-in-class the to. any significant while that close of company And very on to comment would will So launches even I what shape come curve look

Your comes Fye next Jessica JPMorgan. question of the line with from

I wanted on to ask TPIP.

increased with the study have awareness in of strong expand think the to the enrollment U.S. talk is that Does that how III Phase little in And a off you more what So For setting guide? to bit to Just that? space? of headwind to start. then that bit to an also now how back to trial Should Or enrollment about can III to work a Phase as result happen like, then it look what of and referenced? you? increased you for manufacturing timing between about kind commencement it the you help of approved enrollment PH-ILD, the as specifically what can it's Tyvaso's the little can about year? it launch enrollment next needs to about talk so, you half kick in that a you going is the happening if in use the a and you enroll trial understand trying on in PH-ILD? once does drug we think ex there? And from Is take a would

sure. Yes,

questions. So thanks the for

drug We thing about underappreciated and has Phase look asset this would Phase think I when it's in III for year. say next at think I I most shown the about in already the the what portfolio. move what will do really to probably think our forward PH-ILD. PAH show I II TPIP first intend it excited is into I'm data we

for already work the of ongoing. lot that a have We

half i.e., that to go versus our trial off with wanting III The that preparation kicking wanting by Phase for X target well, approval the studies. is clarifies of that FDA particularly driven a III, really ensure the year dialogue Phase to X for both as next second for pathway

to confirm say, being work would that. And but of the which is in done is and have sort we most to expectation finally, then done need we'll parallel Our this. being manufacturing, all in only importantly, I one,

to Specifically, easy very what we make this want is for patients.

intend regardless take, much to like need And they of so drug or one capsule. be it how to to we'd

And remember micrograms, able dose get to a so single XXX go people drug. if relative it capsule really what now. of the up easy that, to do to you're as be high that to and also going able To high supremely with that's just to take to as are a the smooths utilization makes

when thought the the that's PAH merger all of the of enrollment, timing it is launch these there. the different are those we're always So because And These to for frustrated forces think trials space because that we're shaping as difficult sick. time. about is of drug. We the in trials patients enroll. have generally in in a well its the In bit we at PAH when by we Phase will start very are competitive density III position better decreased look a little in and landscape PH-ILD sense, other that

and to excited in the data half second this. III. off more about be PAH also answers see to couldn't really I'm next I that your Hopefully, Phase the kick year question. excited of So ILD the

the Your with Divan Securities. comes Guggenheim line Vamil of next from question

for [ is This Vamil. ] Dan today on

So term loan amended, raised some with questions morning the the money you around this financial the position it receiving general we've ATM. some been seems Pharmakon through that additional and investor

next year. more talk plans going maybe as now and brenso if wondering launch generally you your position financial forward your could was prepare for about you I the So

the sheet I by could strength going open Sara I up minute. depth just breadth it to I'm improvement our turn you, telling got in and to this over not to be balance quarter. of a the of last bet. you happier Yes, But about

on cylinders, helpful both strong be that position and take to all resourcing preparation happen terms development clinical is to commercial to in has, going next this it. opportunities breadth We are cause. and to company on financial very talk Sara, But to This now about want in of maybe be a commercial, the you launch. hitting of for we

absolutely. question. Yes, appreciate Really the

and the I've Insmed of company's achievements support get family in since comments and could everyone position of been we and on part holders. A took. the company all the the more onset, shareholders, that on been Just couple it's partners, we our to strongest that not Insmed at specifically the of the probably be ever since of is proud history debt from actions the continue the all noteholders, financial of

important ATM, Specifically profitable opportunistic level. small X% on that time. But that most of our company in market We think a period that raise that earlier and is focus that about not amount. biotech pretty the we tool average has ATM, It of an the piece price as almost our there XX% shareholders. the we year premium about is I used to on dilution raise. was for being sensitive the dilution at a is ATM this And think did cap to the and our utilization was every last the a overall the of much over

during of went up. of ATM, the trading price the cognizant very were pricing dilution, as on well time our as we stock actually So

very on So we that. careful were

a amount same, into it the the having of, restructure, brenso able By and the the able interest I and being part and we interest couldn't of was to On that company digits, rate out our principal couple single pay capital to payment. and willing towards the push essentially Pharmakon pleased have monies fixed that the there. we have burden decade. lower now, latter remains will back launch the to get important and the to on need Pharmakon additional I now benefit of be really to pieces put being think, additional more A

brensocatib we pleased we be is are appropriately more to that in we appropriately not where have that our opportunity the resource a sort of that sheet now resource position capital we to have and the to This a launch. now program. on be where of a once want lifetime us allow type will financially, launch of part and could balance So in with able are the to be we

comes TD next the Ritu of Cowen. with Your question Baral from line

This is the line [ Nicole ] on for Ritu.

think treatment I be going So of bronchiectasis? that with brensocatib. Do about question labeling And some be second specific additional expect planning some is, the think then adolescents might on well? of you there color exacerbations? on initial as just you follow-up reduction a labeling are language get for to quick more in to the you or hoping language do the it's more you Or including was broad

to I'm ask going to take on Martina first. So actually that

Nicole. Yes,

non a we be would label yes, language, bronchiectasis. broad expect -- and for that So do

on doesn't criteria. will They label been have for trial. that, usually, depends FDA's also the the the label It part patients. specify will indication. be speaks to but a we the language of We your expect ask And adolescent on broad exclusion language. or judgment It inclusion what

add only Yes. course, impress. have that comment we audiences different I to to The of that, would there's is

FDA, of the whether One not access. had more label. the be X the is our more is market a the other or bit consistent that's or on access exacerbations focused one going patient is has with to little Market them

will in initial accomplish come launch. to So exacerbations, while probably through the course, broad, to market language of be will, those interaction that around time more the little focused least to probably is FDA X label of at closer going attestation, we're be the that hoping a access, prior but and

Germino next the with Securities. comes Truist line from question Your of Nicole

in bronchiectasis and benefit -- around nasal big as questions CRS surgery. nonresponders given getting and We're potential steroid polyps patients it as potentially requiring be could potentially without the

additional a small surgeries? be focused is? will how And seems It many thoughts. to your get therapies how understand seeking could specialists? help care big or surgical how big of can wanted are patients like it of very repeat ENT us focus, And towards getting standard this it broadly opportunity So those but beyond be? ENT you or And

Yes.

So the I appreciate question.

as opportunity. right a are substantial to you perceive think CRS without polyps I nasal very very,

more million everybody, people, treat numbers the than XX anything approved U.S. Just without alone population to remind patient is that a to it. this currently, in

the that represent. And for repeat this bigger at Now a of we had that, not I to drug incidence, disease being material get impactful when talked state going so for have understand next on our these of are focus sickest the we as patients incidence of start prevalence, II justify broadly surgery XXX,XXX for opportunity It would broad a for we look than medicine. the our that that or there severity an is to and defined of just the that the year, of patients magnitude, group, use Phase eligible our medicine coming very patients this a we understanding And of market have about an rate a of but in we're with going that that's be how initial foray. We've sort to about them. would approach year, impact surgeries look readout whether clear to on is that of that in sort the patients, would on most may a but number having study. point

profile does. So patients what I more we you're the medicine of the study we understand this think hear impact the of nuances testing and is to we're lot -- this XX Remember to XX going study. know a that it, and within ability about this and once indication our both milligrams the in

a and excited a from about that in we terms specificity. also we program bronchiectasis, milligrams. to what in that's come XX did XX Overall, of and So distinction lot more where super had

quick follow-up. And one

For confirm share? bronchiectasis, what Or going both if you can be can how brensocatib and doses filed? -- you to are

Yes.

to the So is data file from both our doses. intention

particularly which is of As hands be the we've other that interesting to the selected in talked the found selected in secondary the doses that KOLs dose review. about have before, they or endpoints find and ultimate very decision the about on will based FDA some details we both data compelling. there's But be to XX-milligram

are to news want The So Both provide all is compelling. work. that we good data. them doses both

once be conclusion we'll FDA. commercially, and from in So on whatever the heard a have to that launch we'll FDA's information is, we've more position

comes Zemansky with line Jason America. Your of of the Bank next from question

color total Congratulations activity efficacy, quarter these Thanks the are from least in in Curious, at how the your translatable results the what of about BiRCh. maybe indications looking you the in And on for terms line for to sinus symptom then encouraged other the to and on its be progress. CRS? on are score top view? non-pulmonary

Yes.

address So to ask Martina I'm going to that.

seeing, level we is alpha CRS It detecting that but XX% powered of to of an X.XX so that difference. difference on what that Jason, it's we in we're on are Yes. do a X.XX looking for X.XX. we're that we're to that depends X.XX. point And treatment effect what show if for

approved Based X.X depending to basically spray, that, or only fluticasone. addition -- compare for and is you of is was patients had difference if is X.X, now you what the and have the treatment right really on that other that that, -- shown So that which spray nasal they these that a whether enhanced steroids to on in not. used

we're range. in that think I well So

in broader I and both I&I appreciate there condition pursue is makes strategies I for mean, But to what haven't that of ideal an here. you And CRS HS, brenso? efficacy your assuming some shared

Yes.

we same coming diseases, So the that is I example, in, -- we're indications. And of are impact without net of these a the reason both CRS that them can and well to The dose, X -- to inflammation. may it's the of dose that intensity there in even And polyps to a what have further we as an neutrophil are being think from for true formation. we as of that is see for there in XX push in testing see HS. nasal related XX-milligram higher both those is both additional see HS, we formation when benefit diseases, reason the distinct net both for and CRS, down those way, NSPs

realization with this with been has the What study that WILLOW is CEDAR unlocked And DPPX mechanism. BiRCh the diseases. of add brensocatib and neutrophil-mediated study I only we're impact there what its step hopefully ASPEN relates If and is, think thing from that this back, applicability to about and broader of inhibition we course, ability it. would a take to and learning the and this we to is

that down the to clinic bring in that into and refined second-generation to study, candidates end, that labs, of now has have DPPXs. the been WILLOW we So research extensive to initiated which after as intend to smaller some hundreds additional we produce and we our able DPPX number work a

coming we're that of is to the more giving hearing me that let the arthritis. one just be consideration about this years, rheumatoid highlight You'll but indications in

mechanism. each Another is learn one specifically these assume correct many is mechanism more which our DPPXs to think more we COPD targeted the patients. understanding potential These it library clinical would complete, populations. Each and there more be you unique developed, applicability we effective disease of novel target diseases, DPPXs I are And that this additional would the study that the of go through the in this with will about development of to beginning features that be at is hopefully process, will be that's to why being pursuing. but we're

of question Cantor. line Kim the Jennifer comes Your next from with

filing you brenso. the confidence in and your left and first you Can what's launches seeing on millions quarters. X us getting Sara, priority review? what pointed remind other one have high somewhat is for then I And related, to in double-digit

the at And look could I something on DUPI was Is their full quarter factor if this think the me launch, also of XXs. more drug, a to of new something like being of this filing launch. be first a should August people in based it like high that I it or timing into July looks models?

day that Typically, determination So XX. is -- FDA that is their by of written the by first made us. arrives and the priority to response review

response that until XX, they So have XX. It's that written that and in day comes important have understand around a to verbal hand, we then communication response on written day their there's from anything, writing to we to know quarter. this right? will in for won't on we we are that we -- and You file FDA. always it Well, want have track expect sure

granted make the crossed timing be of do everything that have If the will Nothing are you from it be the don't some gives when first hand, is will around fingers we're year. it about couldn't review. hopefully we with that. would but where in going. have XX days, indicate ready, in the quarter, expected. sense the greater and excited quick year toward And the it assuming positioned Either So put for review, how is get easy and middle I the priority of the end once if take as to the for priority somewhere it are be launch, we and -- end been have certain, for that goes a add just our of that way, we will share you, we'll that of going math, and we you quarter understanding. Obviously, that to everything more we

thinking the on different kind timing, each of just into perspective, the specifically Jennifer, the it I do like. for Was folks 'XX timing that's I models, building won't 'XX X I from that they Will shared, then, question revenues Was their around and for But as you call of brenso thoughtful about analogs walked And what that those. the are it first quarter be to details scenarios versus that sort a looks get months? a X something they're through think Yes. this of the as as of of on need of full months? curve

target quick week that period? give one ARIKAYCE. many to said any I screening you how in left could enrollment X know I Can If of a sneak X patients. you you've reached XXX on for patients already are color

going answer is of that know. Martina, She XXX. know probably the to I but may the head, does. know that I'm going just off So don't to ask to to it's I honest top supplement the my in she addition

Yes.

the to come that through, to to know, patients you have it as will for about we culture X XX X weeks highly we quarter. So confident XX screening an takes are I that in about we're the think in additional but And see that this period.

you And of how those normally -- would many

-- randomized. screen to normally the we on these would patients, to expect be At XX screen the so from another failure XX

Your of with next Evercore. the question line Liisa comes from Bayko

[ on is on for ] I This Liisa. have ARIKAYCE. Seema X questions

last no there to Japan, in this in quarter over growth quarter. So seems be revenue

shorter accelerated territory? And to think possibility for label label this this ARIKAYCE future question duration expansion enough treatment. is, frontline. my of This did the ARISE discuss data should year, to approval we second the consider the FDA meeting of in quarter in of an you are growth for expand not how So with of because Japan

like, that, patients. other it of Japanese including, So reason include not did

approval? possibility do FDA that to So agree the accelerated see you might where

Sure.

within but other long first So to over differently. this success think shot, the lot it's first realm here to the I'll Sara be regard are one. we and will is Europe rules we've There's really the sort FDA question what should appropriate compelling. full this think reasons is them each of very interprets has the of shot take have of saying then been I years Japan. and divisions take because an There and a of in compelling ask It's take a accelerated probability plus data data clear that the believe drug. With the in approval, FDA pretty certainly have that of found background getting we the long strict just history of and was that division that approval consistent second enough. But the to

if it, we So probability a is it's we have. we but course, of a to And dialogue think super low think to I excited. manage get would do of we success, think prudent probably this be

that. are approval We the ready we're about our a is way, be expected pivot to comes outcome. earlier to if I clear that this But to accelerated not expecting the launch so want highest than probability

say low. I'd less say I'd fact, it's In than it's XX%.

put to odds on. the hard look, So it's

way any as That set. FDA just be it of terms an well could the have makes I the for data right, think no. Japan them to difficult You're it always do didn't of indicative did overall sees to say in it But We patients. in early setting. approve want Japanese the

quarter. And then that Japan million perspective, was performance on this And about from growth. quarter, that I be over couldn't you XX% $XX listen, a the think the more pleased in for performance specifically year-over-year if the with Japan,

very the performance. So with pleased was

and I'm that inventory. specific There work some you old with we between at detail, QX. it. needed down open look to in the don't in level of QX dynamics new warehouse QX, a this and but into happy If get of some share was to inventory We Japan usually

dynamics mentioned QX. that we So there favorable some inventory in was

and and pleased by are some the hum of just Japanese in lumpiness there. the general, more the the The there really couldn't team's fundamentals great patient continue to rate is but there continuation new be is performance. really business great So starts

from next Stanley. the Your question Morgan of Hung comes Jeff with line

PH-ILD, can clarify, talk the that current in your endpoints? launch? you about Phase just III for been results the the study And to Just that thinking from like can thinking about about given have? mainly design? the in TPIP Is II then And cash Pharmakon you of the how Phase on talk $XXX influence million XQ you've that you aspects the any brenso the

want the Pharmakon? to you question on take Do

will reflected on our we specifically The million money from specifically financials. that QX receive don't sheet approximate that the have reflected in not say $XXX in Sure. $X.X that today. is be what That's we Pharmakon the balance billion will We top for latitude. to of fully are programs, focus of on shareholder we course, is which appropriately able and earmarked ramp have and that now that we ensure we up value, as resourced resource that brensocatib But we list, brensocatib. to are

PH-ILD question your on study? design first the of sorry, the I'm was

Yes. I be you results been thinking design endpoints any you've was that study might II the about and that just curious, the of Phase the III influence using? aspects how the of Phase

Yes.

design study where disclosing we final yet. the not we're that in are So of

patients about the what handful XX X:X think study worsening, say ability of go of compelling X-minute if a some randomized to remarkable like saw as improvement and dose findings what treatment that very and were there the patients you placebo, up some suggests had really less think safety and II than to I directional is clinical improvement for study, time high did. which a there the in are Phase I we would still patients to they was essentially on in walk, as data

positive. very are things these of All

lot of yet. haven't up us study, the sets enthusiasm specifics that but the for think of refined I Phase III, So we for a

of the Wang comes Barclays. Your line next with Leon from question

I on CEDAR. guess one

HS kind expect a and in XX-milligram all question So pretty for many thinking of weeks. clarify, on direction of of the also dose just at Should in But and primary terms of of as you XX-milligram primary studies what that endpoint? using the study, score are the XX ARIKAYCE. new high earlier want to you you XX endpoint in we standard are are kind for That's second a the as HS endpoint? And this guys mentioned I about studies. kick off heading

I in maybe your to pushes top is numbers of you reiterated be that. And end pulls on low high any say either might you right the now, end would guidance guidance. consensus give 'XX the of So and end? shift the the around on I have Can or for what the XXX.

Sure.

CEDAR the clear. a the on exploratory study study, want mechanism to proof study disease an in really this to of get is So on difficult-to-treat I concept setting. make it very This

information. many to not a is through about that know, also take the mechanism a But is right we're look to significant So a know we're take going to including data really past more important going analysis, everything, we're is we isn't, understand that is that to a won't if as this to -- for statistically take not get have That we're about study statistically important of this assumptions is and learn study. that. there require state. there efficacy with a there going just because this study. have do don't to or have continue reached Phase XXX we disease It's directional wasting We'll And that real directional action see significant What we information we're shut to it to of that we're II looking half very that's we're design we looking interim precious once anything if conservative study weeks, what we so more the result in benefit you'd Instead, are for looking if the now. get point, inform committee patients, resources. patients to would design so to of there we're the is, have down about in evidence. a XX

the talk that, primary little endpoint. can but specifics you -- So Martina, of the bit maybe, a with more about

Yes.

change that is for talked. in in the count. context, and in abscess percentage nodules looking So the That a endpoint, standard you pretty we're baseline as primary also from

key look we We as a XX well at as the would Phase for will secondary design the endpoint how secondary as informing be for those will III the of HiSCR HiSCR the first Both also XX. study.

-- the from comes line question next Your

take just about do another range can sorry, question hold year. you you want the because Sara, there to and I'm on the there was that? ARIKAYCE for

for question. Yes, thanks sure. Leiyang, the

to able range, be range, million from a that $XXX that perspective. remind I'll seventh guidance a $XXX of we're midpoint the our folks just of reiterate in after growth. the range to XX% on year And we proud were it's our year-over-year to specifically launch. million at So

growth up the of able still to very were regions. continuingly and put we across So each significant growth, double-digit

Obviously, we're million. the additional the So the that I couldn't of field reps do have but the XXX are we deployed $XXX X, I more in be in They been we can't October to and pleased. -- able confident have field. as $XXX now in reiterate million to to the share and range, be feel

question comes from of next Steve Your Stifel. with line Willey the

with perspective. curious reduction should thinking from can about PAH Phase trial. I out for materializing kind PH-ILD the if are outcomes. of endpoints about, given the a the disclosure, is nature consensus be also of just the hierarchical reduction there still it's PAH a that respect importance but I guess, a you little study, And looks Just proxy small lot the of imagine, correlate be II about being that as noisy. distance around walk be guess of to kind appear you're that thinking PVR communication mechanism II some how for would we I PVR disclosure of of doesn't Phase of like how clinical X-minute if the could to a that a talk then bit wondering of interest, And

well. just as thoughts see around you're the would to interested So going your importance the endpoints be in of

Yes.

one PVR. the And not patients. going understand we I spontaneous material PAH, is think to goals of that if to a is dramatic see is think about the make study common to of the in mechanism difference reductions in it

in study. that -- have make unblind basis, see is we impact encouraging. patient us certainly, would So to to to lead see And it on this in significant that would evidence very believe some we a blinded population, we the expect when

always encouraged. but is the walk But about X-minute saw was if it noisy. think study positive. the disease, we're I evidence reasons, for and And nonetheless, those we there, think right, we PH-ILD directional different You're

in I maybe, you NT-proBNP of correlated markers a have when other positive the gone you're Martina, all with right like on that can reflect way, improvement how this. directionally and we patients, here. see comment suggests this to those going outcome But on are think

Yes.

endpoint PVR the study. for primary Phase is So a II the reduction

study, I is Phase important not you that is in do the to Phase II something the you something think understand necessarily III. measures this hemodynamic in do

to So understand you want that. do

PK will worsening clinical as As of we look be these well as you as in walk, also X-minute -- patient life will populations. quality looking at have well that we and

from the comes Sachs. of line Newkirk next Your question with Andrea Goldman

on This is for Toni] Andrea. [

Just us. one from

you that expanded Now is ahead us the are underway if in of setting brensocatib could and also the remind with activities ARIKAYCE deployed, respect the force refractory sales what to just fully both NTM launch.

Sure.

a had place a kind XXX state draw We for case, That situation, deployed the X. the to first-in-disease sales very in So us bronchiectasis. that and particularly this you're force on relationships were those and that sets folks also is community, in are additional goal are doing best launch. we for significant also experience opportunity ARIKAYCE U.S. they They pulmonology ARIKAYCE, first-in-disease, about of which detailing October a the bringing a here. us our up disease was out with but and put when the to launch. The to practice keep build awareness -- they XXX

these You and way, conversation treat Obviously, that the we're if we're have to and these patients a burden for indications. need of natural that are with at many product. want in on dialogue about the not they patients shift these would calling the make that both treatment about ARIKAYCE, then the disease understands And when the to with community for offices to of we approved and also the X physicians' time sure discussing the that Many appropriate very talking going makes is established. now. But and of comorbidities and then be offices. that

community is to logic a our their that there's in folks are offices. the So when self-evident pulmonology here

line from the Mizuho. Your Suvannavejh of next with question Graig comes

got I've X, please.

maybe Just X.

on as got And was think think expecting. how OpEx the just than I rest is one perhaps year were quarter. first about higher It trending? next know trials bit ongoing. just I of just for the we and we The think to you've your a year, about the

the You sales just expanded force.

in for want to remind ENCORE importance thoughts then the all if then if know of context the And setting? you those could of readout of have just expectations study the could more earlier-stage give you've prioritization first-line that. And got efforts? I or stage on just late early stage, pipeline around the or missed the general second, you Just going in that's the ARIKAYCE I just on me, might some it, efforts,

Sure.

So take in one I'll Sara. go leave first -- reverse those to order and the

for in ENCORE, readout the early XXXX. part that's of the On expected

to get there As on which, know the finish. When lot we're last mid- as we is lot earlier-stage of you'll investment trial, off focus going fourth as the of on XX I there's about patients think like we this randomized to the is for efforts, We refer just a to that late-stage going of described, the the And most the to company pillar, there's well. and need and we enrollment is it, at a generally. length recall, the then months very there, running to group going from the on screened but start portfolio.

haven't spent describing on to So please a detail, there. that mean take not that not any but in things for time minute we that are progressing do

on in these of the I've I'm this various we're among the intention medicines be very Some X to as begin forward states different my that several of to community is year. of unfolds there's between comes clinical the clinical share going the the community. And disease time, data, seen I But and to X at continues in that that's That investment for preclinical that attention the answer that its is investment lot a to with when think impactful most really it. to the teams excited that going remember, question there, to pay be more and the data very when next targeting company want X And is will also to these believe about a to first at do produce bringing produce and forward. And again, a strong more will are question? sign data is here to a what ever is programs. seen diseases, what excited XX decade we the I've recently in going career. from for next super this company. Sara, next take behind portion And of the we certain novel the to what's difficult-to-treat approaches months. compelling in you using the first be INDs capability or medicines

balance to Happy kind what off take the to We first question. committed augmentations of did truly drive we Graig, in that most believe will for that sheet really the quarter, the and And financing remain table. questions. investing was this value. Sure. the you the to shareholder take Thanks, we saw the

spending to Our unchanged remained strategy on point. that has

be ben various mega we in we assuming an increase the the blockbuster expected, will will on sales to that and ensure lines, appropriate the comp activities see on we we will approval. a investing have and product, new in what in as as force believe regulatory launch launch brought readiness Specifically SG&A, world-class a

to So investment. see that continue you'll

R&D the life continue across the getting management on portfolio, research. obviously, indications, programs, ready brenso invest the TPIP the we'll into On Phase early-stage the and to cycle additional III, ARIKAYCE, side,

sure there. and a very for important investment prepare come right our important line, Also that's making the that and launches continue on as area affairs, that's very medical R&D an does you education. the through So we important -- see will to

we from to of with and meaningful nothing internal investments. make sort So and thoughtful different line our perspective, projections, continue expense in an there, they're

And the your comes question next Wolfe from Andy Chen Research. line of with

products the comment Who see in on ] Tuk on as PH-ILD? the [ upcoming PAH pipeline you landscape competitors here and products? also phone and Andy. you among existing It's competitive the strong Can for do

Sure.

treatment the a normalcy in celebrate would be, potentially PH-ILD and from can a coverage, X, our the to about therapy for drug choice there other available, prostanoid these data choice to other the opportunity and talk compelling treatment with PH-ILD, competitive PAH think of what in think our X good higher a very the and of of the play We in perfect much think, the the If patients to XX of to we and feel we these of remodeling it's prostanoid. improve This as is the treatment, landscape and programs, PAH for deployed. When other of And clear we saw TPIP some the talk PAH with offer including will So that's to achieved drug. state. that the stand everyone patients. the regardless day, sotatercept inviting complement is only setting. data doses validate respect why could that where a profile those to important I is patients, prostanoid of what think than for cornerstone my going return what's if is that. PH-ILD. Competitive of and TPIP measures, We companies about in it's kinds patient combination intention opinion, disease versus and about physicians breakthrough approved had therapy, PVR assuming all the be PH-ILD, the obviously, with familiar levels once in change very paradigm for role about at it's patients to obviously, that be that And hours terms we of regulatory we nighttime DPPXs. with we the that. We we think path specifically,

a we for as of couple that think I takeaways us. data, review

speaks other and the is of strength many that an sees mechanism to raises is First the that works. the data This particularly us, role of of the also this the state, for mechanism of to about these to competition. It awareness all, a behind play future. importance the there to it have in everybody the programs. Obviously, we years know that broad novel our in mechanism but diseases. going disease a we DPPX is validation welcome further important range about We're excited are relative neutrophil-mediated treatment

there joining. no everyone, This you, time. are questions today's concludes at this for Thank further And call.

now disconnect. You may