Insmed (INSM) 9 May 242024 Q1 Earnings call transcript

Thank you for standing by. My name is [indiscernible], and I will be your conference operator today. At this time, I would like to welcome everyone to the Insmed First Quarter 2024 financial results call. [Operator Instructions]

I would now like to turn the call over to Bryan Dunn, Head of Investor Relations. ahead. go Please

by Good call Dee. results and to joined welcome provide Thank Chief discuss up Chair and Strategy . for day, who Insmed's each conference today am your I Sara to business Jane financial Lewis, first before today's a remarks Officer, Officer; provide Financial you, questions. update. Product everyone, Will quarter and prepared and Chief we Officer; Chief will Executive Sullivan, Bonstein, open it XXXX

that for to note on our please the risks start, risk call These more will Please differ represent based we results the the from Before factors refer that that actual as involve statements could filings results forward-looking today's and our Securities statements may include to and uncertainties the inherently affect expectations. current discussed. Commission of information cause our with judgment company. concerning materially Exchange and today

that II completed be from results will data our may not the include representative Also TPIP today collected and hypertension. is observations all observations arterial is study of pulmonary study once blinded call These note Phase and of ongoing analyzed. our in

any result, data this than data may readouts future and from different today. the the be final materially described interim study observations a As

sufficient call prescribing the for not not of and decisions. Finally, is the information on today's community. for investment purposes is is it It the benefit intended promotional for

prepared will over I for Will remarks. call now turn the Lewis to

Today, we brensocatib. company's everyone. to Welcome, the and main from Brian. you, TPIP of the ARIKAYCE, Thank intend review progress programs, X

with TPIP. begin Let's

ongoing the as an announcement with II pulmonary results study in pulmonary top hypertension. X interstitial important study patients our associated data with The in Phase update data came from lung examining first morning II line readouts quarter's the from blinded as disease of with TPIP this arterial of well of hypertension our Phase this

progress data couldn't review and Gene more pleased moment, a will that the we But with from Sullivan results to this that be just continue me detail. program. say in come these the greater clinical In let exciting

anticipated trial to line of of the highly Turning ASPEN second to release on Phase track The quarter. III the brensocatib. this top read out half in remains

one brensocatib. lines Let moment on and to relating take additional the to time demands detailed me touch

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secondary As the readout forward a will during confident result, that of to which is prespecified mid-May data end sharing as the results, have well and will and look lock data previously. treatment we across we that window XX-day completed. the the the come as the clean, include endpoints We primary work outlined the remain safety top from analyze June once to line to compile, arms

growth regions to our on headwinds this deliver delivered those of X geographic across our that will XX% announced in year-over-year regard were us to of our We ARIKAYCE growth which that the walk result double-digit and performance Notwithstanding this ARIKAYCE, through guidance pleased minor first quarter, year. her overall remarks. revenue for quarter keeps on previously XXXX. despite delivered track Sara compared in isolated you quarter In occurred the events, to we all the

which continue meeting pleased community. recommendation of I'm in it within study that held unchanged. I'm plenary later Diego results has pleased also Turning the resulted session ORISE selected Monitoring the and the NTM for excitement a ENCORE medical in the significance to expansion Conference to San the in full this the our the trial Committee a to the speaks which fourth month. ATS report MAC ARIKAYCE to presentation upcoming potential Data at for ongoing now all April, report the of that patients, of study to been to their that for

the are analyses from the there to so are that June, which built agreement for reminder, meeting. With on meet this statistical case provide on settle scheduled efficacy best regard we no a updates FDA securing Encore. will outcome ENCORE into late represents patient-reported We As intend PRO, the after with experts a study, now interim the once work final outcome is in we with at team the to that complete. you additional plan of to

synergies the to X treatment approach changing want community best of note they the Finally, NTM the as the I being to patients diseases. and by to care to and and physicians patient recognized possible contemplate the these to with advocacy bring take clear medical forward a that within are bronchiectasis groups moment how

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from the news over program. turn big to the results Now the of me Gene to talk let our the day, TPIP call about

patients disease, parallel Phase most in patients will been pulmonary arterial study data TPIP which from associated interstitial the recent our you were website to good the I'm to morning, hypertension blinded this I everyone. in running our efficacy lung recently TPIP. ongoing safety posted our pulmonary line results X top Will, Phase study blended the our from then with with of you, date we of through II . I walk with hypertension. Thank with morning. pleased from TPIP data in start completed that each of produced II have with share for to and will programs have

This scheme a receive as originally of PH with a XX-week result, an patients. to the study TPIP but XX targeted and The patients over-enrolled XX and with for X:X utilized were randomized XX XX period. treatment to were enrollment study placebo was randomized receive ILD. begin Let's patients randomization

The once XXX trial daily. maximum dose was the TPIP micrograms allowed in

course were to of titrated TPIP dry a dose increase micrograms of with maximum a times of reminder, XXX As dose total X up daily. the dosed first at visit. weeks dose tolerated roughly is treprostinil the of product, contains current over a XX% more X-week X treprostinil dose Patients which the with the compared market-leading daily as final the powder treatment their allowed

increase the well XX characteristics remaining treatment. balanced of for Participant not permitted arms. demographics and to their study weeks were baseline between dose Patients were generally

versus at oxygen per arm on However, higher minute female participants percentage XX%. Also, supplemental randomized required the arm to one at arm patients of placebo additional study were of the in the at average, liter TPIP XX% of TPIP baseline.

evaluate IV, primary tolerability including during of objective was of assessments and exercise. study's rest The the oxygenation patients and with to safety PH at TPIP in

week Let's the tolerability. Among patients with in TPIP maximum by those with XXX% to successfully of XXX begin the micrograms taking placebo. reach of were compared arm, dose X XX.X% able

TPIP XXX encouraging, TPIP given in period at look tolerability the titration is the severity who disease achieve reach threshold. to indicator micrograms patient relatively very patients patients that This included of and were of If this population were nearly least XX% of the the the by at able to of week considering short X, in we able the underlying trial, process.

more patients Of period a even trial. may higher titration prolonged more doses. we of the be In this could reach clinical purposes to practice, note, adopted of applied, which for a while titration for X weeks period allow

Additionally, XX.X% the event we an arm would XX% of the experience patients placebo the in taking less TPIP arm. that experiencing treatment-emergent lead a such with were that to compared saw them likely treatment discontinue patients event TPIP to to in adverse

treatment treatment We the rate consider higher versus a be noteworthy. to in discontinue very placebo

overall patients XX.X% Zero experienced to drug. a safety, the in event be adverse adverse TPIP placebo patients XX% of event had treated study XX% of and adverse In in the of patients to terms related experienced of patients was to arm TPIP compared event, serious XX% patients. serious placebo-treated which on similar either which of experienced that a to arm any

deaths TPIP and none causes randomized to arm were arm. X.X% in patients XX% to All the X or deaths including attributed were There of trial placebo trial to drug. comorbid and the progression the were randomized of patients related disease study in to

Therefore, in that we of of at One were the of that trial oxygenation. patients the pleased of key not oxygen reasons conduct in increase initial this an levels safety confirm very population to no taking supplemental impact and negatively for saturation rest no use TPIP worsening oxygen saw we would TPIP. to was inhalation

see. the decrease arms that lowest entire that which slight time, from oxygen after no between we hoped oxygen X% absolute after measured absolute also meaningful when to an an X-minute the the walk who see walk TPIP reached from X-minute want oxygen test capture found and on arm during I a continuously with to decrease of period Additionally, what during baseline we we test TPIP to measured in note is had compared the levels showing saturation saw of X%. increase did do and baseline placebo patients levels and differences saturation of measure, to the that placebo blood

the for measure trial was following emphasize However, timing that standardization I that recorded no would in exercise. there was regarding when the

significant variability be that point. in there likely data So to is

a drug effect reflecting As saturation of result, indicators believe the the of values oxygen are best the resting on oxygenation. the lowest the that we and the

previously those study results with available pleased the share would top line of this were not endpoints you we data have time do that we to our several report sure I'm any readout, have safety points we share the exploratory to of to Although in today. whether from at

Let distance. taking at using patients that the compared We for in pleased the comparison. XX-meter prespecified walk X-minute a with to week see were to improvement me analysis TPIP XX study's begin placebo

of study provide exploratory me overinterpreting that note However, a this caution in on let small. endpoint a

As emphasized includes we by the wide data amount have many the in in intervals said as substantial X-minute variability past, distance often see set. this walk of we confidence a times

this in X-minute group expected worsening. significance. the did arm baseline the small, TPIP levels, slight improvement improvement from statistical and a slight distance the placebo study NT-proBNP showed walk showed in not approach On a As a

this difference which not However, is study. to small in the groups be was between expected meaningful

clinical in was due hospitalization XX% worsening events on of study, from size. given X-minute small we a death transplantation, not which signal this Finally, baseline. expect or of we a defined walk this study's see clear, lung any to the cause a as cardiopulmonary or a from measure to be more measured exploratory indication, distance did To in decrease

be compared patients experiencing treated events of placebo-treated with of in worsening clinical event common were more TPIP to such XX% XX.X% However, shown arm placebo the to patients.

difference produced X.XXXX. a significant This nominally p-value of

sharing to the and forward of look an and results exploratory later and today's the safety with upcoming endpoints pleased pharmacokinetic more study from and encouraged this extremely year. at conference are We additional medical

Phase this Importantly, today's intend to initiate to in based study on global move program data, to a aiming III XXXX. we forward

which trial encouraging. among Now the progressing from monitoring The committee trial half let or ongoing our last to their TPIP recommendation was in XX% a of trial was to visit, meeting moments me able X-week of consistent held you arterial to very in achieved. spend reach enrollment review data changes. than is placebo, continue pulmonary patients hypertension. the patients with expected dosing, micrograms providing complete safety an the this first II maximum trial In and XXX the In XX with update well of matching target trial dose update March, the the more with few committee's and the our without on Phase to data is now were is regard the any as second to

necessary even up approvals dosing this where already X,XXX the in allow have in maximum to conducted for the to to countries is study open-label regulatory the trial of of extension daily. a We the amend micrograms once received XX being protocol XX of higher

data patient trial. we the We seen are XX the this data to have includes trial. on the mean excited Today, could blinded outcomes. update in an doses about higher in randomized far This I thus patients these share from potentially update what first efficacy like for would

discontinued patients, completion, to X trial the those of completed the full Of XX leaving XX patients prior weeks who treatment.

our the the result percentage XX PVR. the reduction treated past, roughly PVR is so the TPIP in a that despite to patients XX mean compared blend placebo in in patients X:X, comparable study placebo. the data of now completed results be pulmonary will produced with for fact with XX.X%. on baseline best is cutoff, the X/X observed at blinded PVR be of treatments to a This clinical Starting of or will receiving week TPIP prostanoid resistance reduction is the vascular patients. As reminder, on is and the this the as who Among trial randomized and X/X data

these that in What is the study are what is by to equally the PVR. from including On efficacy seeing patients. is improvement experienced across TPIP distance trial, in the arms baseline of we continue and walk also encouraging XX average, X-minute placebo XX meters. measure We're see for key another walk on who patients patients, X-minute we excited was distance, dramatic improvements these in which

I a variable blinded encouraged we is ago, seen interpret have few to on by As measure since what moments difficult a we mentioned basis, highly and walk so is especially are X-minute but a far. nonetheless

measures taken dosing or These both I've after potential recent was durability for It X-minute to TPIP's the efficacy effect. of out endpoints end is worth highlight the of today, described designed the intentionally and most PVR nearly distance. the XX hours dose. at interval that walk pointing were This that

However, the following drug's of maximum treprostinil, results compare key which dose it effect. of at period inhaled time the more the makes difficult the obtained other to these immediately in hemodynamic to the measures study reported

very we that this a full effects us in nearly in some are excited patients fact day dose a of after The study, potential our treatment. taking for profound the seeing makes

XX we the which final these numbers patients is X-minute change know generated. patient to on of first data walk placebo. reminder, PVR today continue have taking as and shared a in do TPIP As will we're more I which distance not taking And were

data today's TPIP best-in-class be PAH profile that potentially with a with and convenience a for PH of differentiated the view supports ILD, believe has patients our to we potential combining once-daily the However, dosing. treatment clinical

the to detailed quarter. turn from walk call through me to the over results the let Sara Now financial first

for share million. everyone. details to million of first to . XXXX. This and burn good quarter $XXX you, Thank equivalents. some the you cash of be with happy of $XXX Insmed's We quarter and ended in the the a represents I'm cash with performance Gene, quarter for of morning, financial cash approximately the

payout. stated As timing incentive higher we due the the quarters our previously, year employee in is compensation have to annual of first our other burn cash in quarter the than

payments In than for this services preclinical addition, was also quarter and usual inventory larger manufacturing impacted products contract clinical for our by build and cadence.

with now our which is cash line at-the-market quarters. since quarter's to are burn was use have $XXX approximately used When our last excluded, the this we with these underlying data ASPEN equity items recent the call, in and million, readout. last offering Consistent program we statements on and intend between not year, do not

U.S. XX% commercial Turning was growth we first in the driven were the ramping when for the In net first to since our million, to and of first quarter. ARIKAYCE the representing launch the net first forms quickly. quarter of compared performance U.S., of was seen of XXXX this revenues XXXX. for XXXX of quarter Global enrollment highest level of quarter in XX% year-over-year that up quarter to quarter $XX.X million, the prior quarter growth quarter fourth $XX.X revenues its XXXX. compared was XXXX by in have The year the third the

positive gain impact treatment. attack, new That the increase said, was treatment however, patients disruptions health medicines to had continuing across The cyber the help a the to to the due starting forms dispensing of care starting who particularly due States, difficulty access distribution enrollment changed for to this by impacted attack. are cyber work to United patients ARIKAYCE ARIKAYCE partially in of of mitigated, the which to temporary we

same over $XX.X quarter In XX% was last year. XXXX representing million, quarter Japan, first the net growth revenue

of this the on in exchange business, did exchange not on rate changes impact revenue notable. foreign our material was impact a have Japan foreign quarter in the the Although overall

XXXX, exchange average in if than fact, been XX% quarter rate. in the approximately of In the have first as rates same growth or year-over-year were they the double this were Japan reported growth the would quarter more

In compared of timing this in quarter the view decline of Japan Rest to million, internal the out the XXXX region collective Overall, well point important same quarter look in that and $X.X of in quarters. World, sales ARIKAYCE record sales quarter, also from up very Europe to a our the drawdowns would and net year in fourth to our setting on opportunity compared and which to progress forward led the to we are off. positive, first volumes. came in be Japan strength at the of continues paying revenue coming XX% I in that expectations in inventory as sequential efforts last ahead region's saw

are efforts Europe of the remain round the expect to and contribution we brensocatib we potential pleased especially the from asset to to global positive their as momentum, relative to regulatory to continue we assuming modest, While approvals. see corner gain sales launch

million year are we reiterating today, revenue global guidance XXXX to of million. our full Importantly, $XXX $XXX

guidance reminder, to XXXX, the that growth XX% consistent compared a quarter. the was that year-over-year As the range growth first delivered which midpoint of in with is represents XX%

on first as year's the measure, quarter our to contributed than for year mentioned puts due impacts both quarter full squarely Furthermore, quarter's track By slightly the of on more each range I U.S. seasonal performance call, guidance in to the same year. the last of total first achieve sales our and each that Japan. us X/X historically

of were approximately turn a now financial the me additional Let gross quarter in to XXXX, items. to nets XX%. few the In our first U.S.

to expect quarters in in net bit down year. As quarter the gross remaining a year in coming years, the before be first we to prior the the higher of the of

mid- nets gross will in the to settle high for range continue year. the full teens We expect to to

our of XX.X% product revenues, $XX.X performance. XXXX first revenues the is for or which of of with consistent Cost was historical million quarter

GAAP million, and were SG&A reflecting early late-stage expenses to mid- in both readiness $XXX.X pipelines development the research our as In Turning continued to expenses expenses. XXXX, launch operating well $XX.X brensocatib. activities were investment first for million as quarter and and our

keeps track in In to deliver closing, guidance. on our year financial quarter performance first on Insmed's us solid the full

remain our work of imminent More top million of substantial positioned commercial financially well optionality of investment positive continued growth With the us from the across in results clinical nearly clinical data as other readout. cash, ASPEN and side line importantly, giving and we global efforts, we our programs progress event. all the double-digit see on from TPIP, that $XXX

can question, the we first we Now Operator, the open to questions. your call take would like to please?

Instructions] [Operator from from of the Sachs. question first And our line Tan Goldman Andrea comes

you. I start with maybe could Sarah,

you what Just some that what high if this additional respect you setting. and frontline peak drug wondering rate provide assumptions your X such could quarter the billion a would seeing with color think forms in how estimated be versus refractory on you're sales used underpin to that of ARIKAYCE, drove when enrollment for the about the

their Happy and Andrea, Sure. At all territories. beginning performance. and the set impressed question. saw the to we commercial and QX, so team out to have that's for X address with continue the exactly in our that that, thanks showed to we be growth, what double-digit year, we across of of our I and

reiterating gives guidance So [indiscernible]. of us great the confidence really in

the patients clear regulatory you to to for line X- charge The planning commercial us the team a previously, mentioned a we are believe able We continues on if expansion. to And medical billion we laser-focused increase expansion. approval it's on into to out, in to deep including are think as the team commercial expansion that patients, to $X to we of attract of with as we do sight We able expansion a pillars, on of be a ARIKAYCE be giving execute. feel underlying opportunity continue we've label potential label label side the X-fold on for all the to we'll we the will forward carry the refractory, dive And broader potential price look as ARIKAYCE. across a opportunity. at educate you label the execute pending Andrea, point continues to hosting that today day other Aspen now our

blinded Gene, then, on I the data. And PAH you blended Okay. just ask maybe quickly could

and was? those Just if still the share improvement those, in cut Just -- I an of XX%. magnitudes curious wondering what curious their if of excess PVR of And data if patients have rate of some patients are still in what did commentary average there first able in maybe the of is proportion average it's guess XX%. to the improvement seeing been similar some to PVR you're patients around reduction the where see

that you X:X for very roughly last improved we ratio And said improve didn't Thank our was the of that mirrored time, question. randomization. clearly it the sure. we noticed you those divide Yes, could that as and and into

you at just And presented on -- data some those if so looked we [indiscernible].

of at PVR like their with Now we use all. who had very, in capture definition if negligible X% really reduction small, PVR. would patients, any increasing of patients some of number the We very improvement X%, improvements,

And that no someone the want so in was real answer To their PVR, X% exact directly, if by we as matter definition really take didn't like your that really that, XX% patients to improvement you wouldn't call have was it question who a representative. more of really decreased like responder. but PVR feel any again, we of how small,

And and done internally got of like the didn't which would groups is make analysis worse X didn't versus sense into want did stayed that sort the sometimes then same group it change like were responders that the like talk that about that of to time. we we that responded, we then, metric to last groups reporting divide from a but do We it so sort nonresponders. of groups, and

just we do So that analysis. didn't

progressive and that continue expect, if it's because not decreases, therapeutic would who who a their change in remarkable therapeutic have see investigators in a to you new without in very like a when impressed doesn't do a PVR, anything, had are sense this We disease. addition happen just you have in our client see happen. shouldn't patients XX% remarkable reduction the patients of that be What the regimen

Vamil Divan the Our from of Guggenheim. next comes question from line

of questions I This is can. I Daniel couple a if Vamil. on TPIP, on have for

PHLD. for one first the So

drug-related seems You mild. show fairly things XX% are It there that patients any this to I if the in cost of might done tension first that guess and extra that's open-label might maybe of question. an moving like be patients even -- if up curious like dose guess that But be be I I those for this for my [indiscernible] lower -- kind that can see [indiscernible]. to important was higher patients kind of

And the ex then this was second on previously if the views PPIP and can maybe if question hasn't between is broader down was more had a said data then billion-plus this? It I opportunity. maybe markets. indications like maybe was $X recent opportunity. curious on opportunity break wondering U.S. different between geographies the the any the impact I on of U.S. and just your you

Gene I'll jump ask and on question cough. to the I'll Daniel, in specific take just then

I we've comfortable today. completely will target not sort our we much peak go to is the opportunity, I in supported, -- into deeper think if product I to TPIP the feel that is. a seen what surpassed day at profile very regard think tuned, aftermath that production that in billion Sara going on made to of feel plus. the stay if tell the sales with the with reference we're this, to opportunity Aspen the $X dive And you commercial by the data continue data of continues,

encouraging, to and product that And we on exploratory question cough? measures, want is the the emphasize Daniel, in to I their is and I today, striking. they based on we've happening do but end being comfortable exact should ILD certainly, to Gene, PAH have profile say ILD for the are data while us. with, Commercial We study would They're suggested And the PH PH These generally, a commercial the up want profile, efficacy think, we'll comfortable target small, early. feel that, target Day. been very what's you about about take the say. more are

yes. Sure,

symptom in is PH-ILD where different lung a abnormality isn't really The in is most a essentially normal, cough the disease, first is PAH is and to some the the is histologic significant another. the in significant make the parenchyma degree of cough patients interstitial In PAH, symptom is lung to point than population. disease population vasculature, of that or disease, present the

do be the parencmal in part this go drug sort patients initial that who to and safety ILD, PH tolerated just was So disease. in how have of an reason to study see would the in this of underlying

that What association And there did in about point the imbalance with cough. study active that something it investigator patients particularly that that of the And believe driven in and the adverse terms by that out temporal was cough related means drug-related is so was you what was made drug-related was, the to drug. events, we an see dosing. on was

to discussions mild cough, they tended up able that in very despite that that the to any in XXX. it mild one they after right problematic, cough, rated in were So was of discontinuing treatment and pudding investigators. the wasn't titrate taking as highest to and be the so with It tends forth did be not drug and cough kind to a dose, imbalance the the proof really the in is -- result

was was the think it. more clinically good exacerbate data with be What I pretty So a underlying we to exclude about that's not drug the feel somehow disease cough case. degree really, problematic that underlying lung parenchymal that to we this in patients would their suggests and wanted

And so with we're really pretty pleased that.

think I will, more before, on higher. we is said question what if better, the arterial pulmonary clear happens as data you we'll see, is go when of prostanoids, the with hypertension. very raised with we And you

very go of you all get. with efficacy can higher can it's routes clear that the the prostanoids, more of you administration of Now

we the can we in clear mentioned, PAH. experience chose primarily ILD. better, higher extension the not more go not in these to clinical open-label to -- There where allow And regard. so -- is we entirely extension that in ILD doses just just data less definitely in for open-label amending kind I as of to do are for it's the the protocol to We that PH that in is PH see

So doses. tolerate we clinical patients, necessary. how we'd on start weren't And to they get it some sure PAH higher like also, to was information that

So hopefully, that question. answers your

means and on arm they punctuation TPIP that, in as that the arm what the to it in to of treatment-emergent in placebo continuing the final in in seem with I'll an actually a patients, Daniel, just to to which placebo drug, for events discontinuation didn't terms TPIP, higher adverse take it XX.X% the were be were impediment. reminder XX% than leading so be one Gene add able is arm said,

Our next JPMorgan. line question comes from from of Jessica Fye the

hypothesis changes Sort -- why you life, [indiscernible] brensocatib. Willow quality us the those or on and of St. on of can data, back the X-part measures. is question Thinking of kind to seeing what a meaningful really behind remind George's, not

So benefits measurable exacerbations, basically, domains? would that those are what on not but explain

And what of not part, cite. think makes I'm be I quality be the not they past related what curious I'm And Curious tell of is, suggesting life are they that kind measures, may cite not if hope sure to on they similar infrequent. trial to talked of you've fairly drug the off that given would tip about sense. in the in exacerbations can if kind are the it kind patients that And or that Willow. ASPEN of doctors second

Yes.

like Gene then So I'll take to a shot I'll he'd at further that, Jessica comment to. invite anything and

to remind and I X-month drug of think quality to full effect. about for it study, I was a a that with the regard month life, and takes everyone Willow that, get pharmacodynamic

on not life. an it's be able to capture impact to really, patients So a and of time express for quality of lot

study, again, we hopeful study the that see to key really attention turn would there. one didn't study. We're we're by the of I drug physicians patients XX-month may we is thing of trying of if which in confident focus conducting, accomplish we're be the utilized be are which absolutely to once adopted which primary But a ASPEN able enthusiasm. to see lot and is that is endpoint really study, the is we the exacerbations, that, with the So to the one will And then expect we impact. alike the and the

talk it's things are we in did this we to this has in physicians, that's And think drug, hearing about it. a qualitative huge a from and mentioned I combination salt, feels. their with on Aspen, we patients of take and of again grain it and always experience when why one different physician, course, each any a that to characterization convey hear of but the Willow patient

this or experience a greater that And not are with are of that [indiscernible]. feeling characterization occurring perhaps the they're patient's typically, is of the think degree they exacerbations. I related those energy to feeling if or

have All things different that patients are benefit. of experiencing they're experiences feel them these a make that collectively like

will And if will impact. I want achieve have focus capture And If exacerbation but it's that, the know, certain. add victory. we Gene, QOL of course, is we that certainly you so primary hopeful we're don't anything to our on then the further? accomplished not

really I that well don't was think very to anything have I No, said. to that. add

us Can don't can I on I give you but TPIP I quickie saturation if just -- somewhere, data know and missed it's oxygen each saturation. add the oxygen on the baseline a arm? PH-ILD just it for

that Gene, it's not, I we want If know address if don't that. to can have back. Do handy. you if we circle

you're little didn't Their getting that mean, in did Is during were lower. the the tended a that walk we bit little higher. baseline And some at results. of demographics indication to they test, I that more. use Their I X-minute included little the a that sicker. a supplement that frankly, a was something Yes. was desaturate TPIP little know There question. group bit was FEC we. bit that the at oxygen information baseline with there conclude [indiscernible]. Yes, don't in we've

So there were they little were a evidence bit some sicker. that

change measures. So for from each that's of why we presented the baseline

from Leiyang Wang question of Our next comes line the from Barclays.

data. the on Congrats

also One, on or data us for was arm. this if lack color remind inability the a week PH-ILD, time on it's collect to in on And placebo measures response can a that an distance -- Can any to the X-minute exploratory the XX and was see Slide specifically not to from the just because of So how XX. looking data? week TPIP. you available changed on of you couple to walk X, just characterize efficacy

those? Gene, do you want to take

fact the -- presenting X, baseline. that to we're is NA the from Sure. what refers that change here placebo-corrected Yes. in The Slide the

effect size. So week XX is that the the appears XX under placebo-corrected

there's placebo to the point no under put So data comparable arm.

meaning not available NA makes it's that if more So applicable, not than sense.

size is is similar with what the effect a comparable. so box in PH-ILD, that for for emphasize estimate X-minute trial trial, the estimate, it the that's INCREASE on estimate Tyvaso was to and we've included point of so-called the that point XX pivotal that in point the remarkably to And walk seen was

be want significance. -- we not variability. we even the indicators the of then to are to intervals to close However, put does p-value extremely statistical wide very, clear, square. and very The confidence in that is And

your -- is NA what I that -- that about question that to hopefully, think means. responds So that

trial haven't since emerge the points that the results we will the cadence that I will of And we fulsome the the be of about you sort And change not But presentations that data pivotal have decided from in is that see the to how top we to a end end. see -- focus released the we yet, think baseline asked to That's from to analyzed more start closely other, of quickly difference what would on. line that, improvement. data.

line Our next question comes Joseph from from Partners. of Swartz the Leerink

wondering strong very II doing up this? of to enrolled then the will on I to and health that I was been you TPIP talking allowing still authorities patients you have Or Phase data. follow-up study those of the data? patients see XXXX we XX just And on other And countries, be to a micrograms. titrate it TPIP are . when brensocatib. about have are how Congrats many the countries, which in PAH in the

Yes.

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Yes.

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

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comes the from next question Our Graig line Securities. Mizuho Suvannavejh from of

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

there disease a the was discontinued, was I I aggressive what brief of TPIP. Congrats some for Or AEs who said, discontinuation was be observed the little more small hoping was Appreciating you don't something in patients may. the cough study, the rate on provide the don't it especially the was I early data. as underlying look know, XX%, at like then these -- was, you rates this and schedule I whether it looks line, in received? twice color to it doesn't noted, dose titration Tyvaso That about could but the treatment-emergent are or on numbers, about was of a severity study. if X for source it's the -- know, and follow-up,

that? take Gene, want do to you

sure. Yes,

at favorably in of study INCREASE the we treatment the discontinuation graph Tyvaso we actually use of And I that don't the think shows compares publication that We BREEZE so the the you'll of benchmark. when do our sort with look in much as discontinuation to study. I active the the the Tyvaso. study in see arm think that as the treatment

try it as part the I'd study you guess the the better question to Breeze -- INCREASE I than the comparator So was. to second second And was then study. point the of

than dose that again, more consistent the Well, normally when schedule if something a received. was you've little something is with there out? amongst like what that something Tyvaso there dropped I'm they you X curious was see specific just Or patients. the the patients aggressive is they was said about titration there about bit these

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Yes.

on and that Gene in to jump one then comment. just I'll ask So

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to We tolerated push in dose max practice. them

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max thing of Yes. more generally, just the patients to than some say assumption to be first can effects to related spectrum tolerate the to PAH the I basic like to get I sensitive and of tend of to effects only tolerability of that side you prostanoid related with kind in mean a a a doctors -- And get the in get there add prostanoids efficacy. tends will the patients that, others. more just all, bit prostanoid the side is little that better.

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escalate. to to you does stay the up to dose You continuing include the dose that's pattern. get I to target up and the the and pharmacokinetic And -- you probably titrate label related not think then there

be So to able because continue TPIP of manner more patient's to treprostinil to other the can dose loan words, you is the similar a IV our to increase kinetics, tolerability. according dosed. hope in the to dose we way In the

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

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to there upward. either TPIP that reason On to cough other or emerged that the titration be you mentioned discontinuation. the titration was could that any TPIP unusual the stop ILD unique symptoms study, to I think impact Were main

want to Gene, do you that? take

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an a representative of just disease. As cough would of that be the lot patients underlying have these

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of If to XX% go you that, it's patients.

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Morgan Stanley. line comes next from Our question [indiscernible] the of from

then have And For any of TPIP the comment can if see based I evidence just on modification. follow-up. a you you disease data,

that? Gene, do address you to want

there Yes. detect underlying And trial that know presume fibrosis, by be observation which Therapeutics currently INCREASE effect on disease to may is referring fibrosis large modification, the that of an you're the and evidence. the to pulmonary that made conducting some was to in try pulmonary United that. a I I trial

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information not impacts expect that any could treprostinil we whether or the see So to don't pulmonary fibrosis. inform

Great. about then is education efforts you for talk you think how needed Okay. potential for physicians far just And and more started Can how [indiscernible] early. do launch? for education much come a that's fairly you still

for MAC that experience the in being first-in-disease approved ARIKAYCE drug report have use the similar drug a we ever patients. to happy refractory I'm the of Well, first in

bronchiectasis that be So approach informs represented our would brensocatib. once that to experience opportunity again using the larger by

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line question of Bayko comes next ISI. Liisa from Our the from Evercore

on the Congrats TPIP data.

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

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you rates Japan, looking that that, a regional take saying I would for that answer the when regimens account background use I example. want on enough confirm. on paper, the on regional you you're also a basis? to there's the but line yes, of last is I know monitoring in, sort up [indiscernible] And what also in of the to blended data blended I isn't guess, differences at just think basis, just the of much follow expect coming rate given Is are at are And into higher the does deadlines? say the with macrolide it we a that question, on to timing saw in a and then basis, fair

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simple we last point, what and honest light at the question know, answer if have. of anything see the add just you is and I we the the one. this Brian, I just to to most data unblind think in need want specifically don't about

good. I'm No,

PAH top III TPIP, question Okay. And data I are in were getting for walk could I on that on to you And PH-ILD still the a what sense of confidence the I placebo baselines advancement confirm, in the line if a say PH-ILD, wanted wide. was know powering. Phase arms? and maybe both contingent to if ask for better maybe intervals get But X-minute . change can what in Gene.

Sure.

is question III. Phase So and into moving the about forward Phase III

come of primarily based be and population. this this will that think in I on ones analyze as in the upon of results trial that results we these Tyvaso And will the subsequently. experience the also

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has second XX right, of given controlled. We've And think your the placebo walk to test. I do meters the with delta, question X-minute

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in say was analysis primary placebo just it there the is control. the patients the way saw would probably we broadly it to So That that what analysis. had best treatment be was decline that a the do patients. and to primary active stability general, among do among I'll In placebo

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Your from of line comes Stifel. next Stephen from Wiley question the

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back know or don't have the you. comment. to I the someone we'll to know if I that answer can Stephen. answer else Gene offhand, otherwise to ask if get Yes, wants you Otherwise, question, to is short Brian,

are them. is a And there eosinophils. comment The sputum have either is the inflammatory secretions, cells eosinophils. I'd make mean of of neutrophils all patients when of it just in a in driven. that even the Yes. actually, their who A are neutrophil elevated there's lot lot still nasal elevated only secretions, that or It lot doesn't means have patients of inflammation eosinophils

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milieu inflammatory milieu, are well. that in there there But of and as plenty the neutrophils

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the line Your Andy comes of next from question [indiscernible] Wolfe Research. from

This for Congrats is Aman the data. Andy. on

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this, interpret kind of kind was to would difficult success is modest bar. big this an it's but you internal there say a of So or

on can TPIP. the and one to do you take question Sara, expansion, force sales the X-minute take want the on you on So walk Gene,

U.S., Sure. Happy to. sales have force in about U.S. we the reps XX, XX Thanks the for in the question. Existing existing

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that necessarily So don't it's you very synergistic see. X products

Gene, over being infrastructure. the to about to excited leverage really we're So able you.

Yes, sure.

measure. of on the and the XX this who's blended so very it's So X-minute a when distance on course, on walk active don't we more and we who's importantly, say variable blinded again, meters, over placebo. And know in of

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that If you PAH was look at the Tyvaso pivotal XXX. in trial for over

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And hand to session would Q&A for that to management today. back remarks. our for closing concludes I like

Thanks everyone, joining very today. for much, us

This day. Enjoy your of concludes conference rest the call. today's

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