INSM - Earnings call 4 2023 | Insmed Incorporated

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Operator

Good day, and welcome to the Insmed Incorporated Fourth Quarter and Full Year 2023 Financial Results Conference Call. [Operator Instructions] And finally, I would like to advise all participants this call is being recorded. Thank you.I'd now like to welcome Bryan Dunn, Head of Investor Relations, to begin the conference. Bryan, over to you.

Bryan Dunn

Thank you, Gavin. welcome XXXX conference a financial and Insmed's to business everyone, quarter fourth results day, to call today's discuss update. Good and provide Chief expectations. your Bonstein, will based joined Officer; remarks will today's before am today call it Will include start, prepared Chair I on up please open for that by each provide statements and we our Financial Chief and Sara we Officer, questions.Before current who forward-looking Lewis, Executive note today of differ and involve statements results represent as These cause to judgment uncertainties and results discussed. may materially inherently that our risks the actual from Please the refer filings risk Securities company. the concerning could Commission that and the affect Exchange to our factors information for more with The today's information for the on is community. call investment benefit the of for sufficient promotional is for turn intended will now prepared it and for call decisions.I not over Will not the purposes remarks. is to Lewis prescribing It

William Lewis

we be the for few today Thank what I you, with other from portfolio, the and speaking Bryan. late-stage we you will uniquely and our which our relevant Good results be morning, start the for meaningful expect next serve. of of trajectory across fundamentally to In the data could just pleased a transformational at everyone.I'm patients updates company believe change Insmed. year months, the readouts

our see preparing have potential, opportunity that show of billion data points more TPIP next. they drugs and what and earliest great in tend we We collectively $X us a long one programs, I themselves moment represent is size. will but for If said ARIKAYCE, respective peak believe be us potential successful, for showing carefully couldn't this excited their brensocatib sales their have time, been the ready especially company, staggering compelling of to that for more to any a for out It they coming than and are they we from it. are been early. signs announce

without the in more that am a the assets, any Insmed company. been the I of one other X, future of biotech we form even confident basis of the these could never successful fact, believe today.But once and just than In have a quarter I quarter increased a me before moment again new I the performance. let XXXX. on us fourth set guidance sales ARIKAYCE to in exceed record get to our for caused range our spend future,

for Importantly, reflects also the demand this personnel the of and infrastructure strong effectiveness Japan our ARIKAYCE, result continued the in only not and U.S., sales Europe. but

in flat with us near the of to they relationships the spent resources as years to ASPEN able me call will fourth leverage hand readouts XXXX.Let that commercial gives we expectations, at-the-market commercial the used quarter. results leaving hear as essentially I the billion important a an strategically potential moment from enter building the launch see same it are with balance colleagues you and more positive, if greater to further keep we on was quarter, than many important compared to about This they cash will more leading of be our to prior realize we clinical have or our program because ahead, company equity our same Sara, update outperform ATM, team be in the $X.XX ARIKAYCE.As offering brensocatib. it ARIKAYCE. the on start the and in me As already These will ability continue confidence with points that

MAC or recurrent strong to with NTM newly shown be excited lung our in We we in set. X have excitement in presented the that at generated now will are ATS the line detailed results continue which about out data not trial May, with was started top last More who expected which diagnosed disease the results antibiotics, year. trial ARISE Phase read anticipate patients be Conference from the reinforce this to

have in tools experts of in trials. patient-reported in at I FDA the After we've clinical been feedback have who with outcome mentioned review before to and X meet glean coming late to team they written the our As statistical may additional used confirmatory study. XXXX, feedback that any them guidance months the with having engaging finalizing for plan ENCORE expect previously, we Phase received encouraging the

include work position into MAC updates there H you We the will NTM after an our be with accelerated be whether and to under incorporated is plans, ARIKAYCE provide a of all pathway Only ARISE could using all to approval about FDA would additional received lung to Subpart with that once disease. approach the patients is the label feedback that we complete. data in expand

of trial Safety held we are progressing as continue planned. unaltered. that The outcome ongoing so outcome these futility believe our itself efficacy for discussions Monitoring There recommended will filing. this be the happy positive the that trial we third either in for reviews no represents review in to ENCORE study's Committee As protocol, have and its is the possible. report interim is that said this trial that I'm likely or most November ENCORE safety most required before, Data the meeting

Importantly, in ENCORE enrollment strong. remains

second We on continue us half read scenarios the highly bronchiectasis. give different laid quarter. results hoped readout to had to with track of we ASPEN brensocatib in in the forward the for out remains progress to moving and let expect filings I month, you The regulatory out update result XXXX.Next, anticipated Last latter an would that on as line in top in me continues brensocatib.

of additional But with let how X.XX, p-value will this None than adjusted we expect for measure to less than would be the reducing changed. an p-value Let's achieves on take of forward of the And offer move of either adjusted if pulmonary on filing. achieves also dose those a endpoint primary of exacerbations, again. to that that less rate moment a review clarity win. very clear dose X.XX an point trial. me success If has either of we an a

patients payers, exacerbations alike have pulmonary in for the brensocatib We from a bronchiectasis. with an reduction option of rate treatment around achieving and that attractive patients of make would XX% heard KOLs

the then market X.XX, where we reported think one at or that If is that a drive approvable, see p-value would than we but have of potentially situation a in rapid is particularly is like treatment the level ideally will I higher, a that also XX%. to least treatments. than drug magnitude effect not approved higher at uptake a less the only in with X.XX, of no effect but So

just the greater currently nasal indications a we is that confident this the drug that $X we the billion, believe and has potential peak have As the a for ASPEN we X said bronchiectasis sales reminder, currently success. And of without is CRS pursuing to than presuming are just we we and get fact, a that feel. in excited a readout, operate.In polyps we and geographies more closer where clear

to patients before sites volume world lesser with of the from starting the and is the exacerbations thinner fewer continue anecdotal reports doing compared and across trial We in better to trial. in hear sputum that

it patients we blinded have to acknowledge is brensocatib that investigators just But which even we sign. believe are course, and updates so, us which placebo. are Of the to taking an encouraging a remain we providing on who as are are these

site rates country individual been even course We by also and monitoring exacerbation trial closely region, the trial's of throughout have conduct. the

that recommendations our demonstrate.We at unanimous safety the in resulted through no line designed been and study effects expectations are meetings, concerns all and that know that events which So safety also now to of X are consistent with in without treatment rates any with been has independent have the trial the occurring we to alterations. have continue monitoring

XX-week XX% had enrolled first pulmonary look study we results resistance the second XXX who time, up to our ahead Also ongoing the enthusiasm X seems our PH-ILD we with XXX sharing of to up XX XX we were been our part the halls fully to quick to Phase X. blended to study, of or our colleagues Last our the update and one we patients, the XX patients randomized almost XX a data. and to last program. ASPEN's study in these provided successfully results of grow simply of have day quarter.Now All in TPIP some top X who average week patients, it with of data forward a that TPIP trial the that titrated received vascular for we great in disclosed We PH-ILD. call, closer quarter top safety Indeed, to studies titrate X:X. XX.X% able the PVR. excitement an amongst the palpable dose shared if difficult PAH not each the is add that received the And of a at walks all ASPEN line TPIP study we line on ASPEN the the patients patients readout. Insmed, and we anticipation by in reduction quarterly on indicators with At the first generating highest release in expect placebo the those of on had from study that micrograms to details X the blinded the quarter, of those our now includes PAH that saw the the who This by in visit. our is as That get in daily in micrograms readout. week is or X notice patients latter second all completed once just

achieving we approaching number When study, for of average data encouraging of we If PVR. for also would is decreased the year, one them range line best-in-class seen our the whose and and results relatively our as patients. to in PVR clear approximately will in those the blinded next expect study have the the want view, the is second XX study, we XX% in a reductions your patients planning the in ASPEN normal a reduction it results that from unblinded considered a share the time from that to look you updated view during the above study the at than potentially PAH XX% would small before albeit PAH any for be quarter this data which result blinded greater results, PH-ILD data. XX% with point.I These be we were intention release reduction announce patients the blinded given PVR on several was at top is purposes XX% PVR achievable this today and to that of

proposed have of current study to other XXX X,XXX the have would investigators continue micrograms micrograms PAH In our which far highlight to open-label protocol submitted amendment it This dose open-label to continues increase amendment of tolerated. TPIP extension encouraging unique from to XX% of a is the well and than once of up implemented, join our over once addition, to which max daily, daily More for I who so to the have be once in want Insmed the allow another FDA authorities. the to the once position Sara, it we completed in regulatory sign view.Now presuming study opted itself. those again finds before to turn the I extension,

spent years that We short meaningful window. company have clinical deliberately programs constructing multiple time would have over a meticulously with and readouts a

of aggregate and With the are hope top finding Insmed in undergo ARISE X of now months data year, one type transformation company quick line and which billion may successful to vision in couldn't in pleased and a confidence clear as long-term we industry, the capable out. this over will expected blinded that to in I the I to to walk currently observed generating If want be be in data we establish them. to outcome in second and analyze, positive investigators programs Insmed rarely reports for to our sales. stand. XXXX from now in only I'll with data our data product succession compelling greater committees across the where just the we the of of away TPIP anecdotes have things be continuously financials more profiles biotech the a in independent call readout the more the far the peak $X we our to the successful, of involved through quarter. late-stage potential that positive top that so with excited ASPEN I monitor to studies our for from previous detailed we the generated to Sara X from hear the line complete are come PH-ILD sees of believe quarter all findings, in or this data for turn each safety we September than the trials, mid- increases positive the

Sara Bonstein

we you today, were QX offset I been proceeds the share year I our everyone.Earlier cash highlight XXXX with Will, remains position usage our quarter during XXXX. this reflects and program. am would a I relatively the results for has proud financial were while good we this and ATM. quarter to to of like you, investor position building cash Thank quarter majority from for able those our unchanged year-end issued that XX% The pleased burn this that million am significant of results our fourth as we $XXX the recently. press approximately ATM morning, stock that under our of to some details release full quarter interest increased detailing our now. fourth our utilizing the of

I proactively. recently, Having do I clear ATM, know be our the prior there equity can new with upcoming raise near as While do may under to choose be are plan as of it that to concerns not that many we to readouts. term, we on substantial you utilize we spoken data large to point. a I this have in want capacity our

means our anticipate all be for equity the cadence a see simply coming year, prior it equity to nor possible normally cash of payment We of most our choose raising time, Instead, term.Looking burn to is in remind avenue ASPEN options balance augmentation sale appropriate the burn would take due at in for stakeholders. incentive Given those at not the sheet timing we many raise the in our our to and let that me need quarter for and usual the readout. capital, every of employee and annual than of you currently patients to shareholders, see action no to position, a year intend the as first need to that tools we our strong evaluate our do we the near options other us, higher bonuses. do expected cash available the the is significant beneficial one by preferred

performance. operations $XX.X me continually revenues cash current of timing commercial that were over our ARIKAYCE range significant enough top XXXX. highest now through representing results the Importantly, capital balance strong the ARIKAYCE, million, due XXXX and of had us had.In basis, patients than us leaving readout.Let revenue teams already Japan, and regional Last our the year. optionality side year impressive to support This our of the up were beyond, XXXX turn at we've earlier ever investor even the recall This year-over-year year for that global exceeding was when new performance the $XXX.X XXXX the this disclosed an growth top who end On other expectations. more with million, month benefit been with on provides the expected we net more of guidance year. raised that by XX% revenues the our to fueled ASPEN outpaced our is to million net to from was growth $XXX.X starts line of to range compared you the the in had may conference, execution for representing strong which internal U.S., our that a making XX% new identify growth in XXXX eligible of prior patient for treatment, our XX% result

in such significantly increased of year-over-year pace in to X% and half highlighted the As expected second want of implemented The price this had in you the going Japan that the Germany $XXX primarily a in support from guidance in any growth in month me we in led global Today, result this at performance of X% growth decrease put by June. remains reiterating year-to-date the XX% in year. sales their half growth driven the in despite gives leadership XXXX growth XXXX, leadership of XXXX effectiveness year, the we year-over-year of region, for last XXXX planned half second our place remarkable in which we quality The ARIKAYCE new XXXX the first for are full I to confidence and team revenues Europe to being world, in million early and previously, to XXXX, $XXX strongest came range rest revenue trajectory growth phase we that acknowledge view and a U.K. was Japan million, our year Japan million. outcome the beyond.In strong past of ARIKAYCE to the growth net in of with in continues and $XX.X a that continued in the globally. gave for

think U.S., the Medicare the to to our will quarter about cadence compared for the sequential I in remind copay sales about for and deductible typically a year, you patients resets the As the sales lead in this drop you quarterly fourth which quarter. first in

commonly our to gross over sales. well. is in in a when that to another were the same items. year in XX.X%, now to U.S. XXXX, Japan of quarter our nets performance few additional expected the In mid-teen me quarter in strong addition, XXXX.Let Historically, In guidance Despite us consistent turn financial each with sales range of both out the lower from of we Act. our little high-teen has nets will the XXXX historical to first first X/X well set to timing will due resulting for the this Reduction performance. Inflation of budgets and trends marginal seasonal reset mid- the implementation XXXX, range certain and to gross provisions settle In we in impacts which expect hospital of impact positive, for as a year's first of contributed XXXX. quarter believe lead region pressure, dynamics up very that total We these coming believe the were

remaining in of before was years, product of operating year or revenues revenue, back As remains the bit in coming the Cost our GAAP XX.X% first be XXXX our to performance.Turning of a the $XX.X million for expenses. to higher quarter we past down consistent gross year. in prior with which of quarters expect nets to the the

For continued SG&A XXXX, investment brensocatib.In closing, in is in and charges for reflecting full resources activities on expenses catalysts call in research we we related please? as forward noncash late-stage both year financial well that XXXX position believe the were to pipelines acquisition launch and a asset open to I million, very on and development readiness billion $XXX our to and $XXX.X our Operator, were deliver near-term expenses balance million. $X.XX early mid- look as to ahead.Now over the to with multiple lies to clinical sheet horizon. question, questions. have and like using I'd strong great the on the potential first take Insmed its We can

Operator

from Instructions] line [Operator question Fye the of JPMorgan. from Your comes Jessica first

Elias Lenard

Nick is from This us. Jess. on for Two

hoping what and make remarks, plan around agreed latest First, initial on to you with mentioned when additional FDA for the the was this potentially the if is upon changes any you thinking in needing ENCORE provide time and your to do stat or final any but the I to could some needing maybe not details based lines prepared you expect have around feedback? PRO

William Lewis

can our an example where with I go this date dialog into We'll would one one. elements have control in a out. a them in Perhaps through of clock. mean FDA is been And satisfaction. as those to straightforward that's PRO reemphasize don't of court. ball pretty they meet give over in we to with talk interactions detail unfold. that to I guidance remaining of very their person, I things of This It's So have able how the positive. we're for the soon are might just us their the sort with as the

this contained been in the of FDA. group the PRO have really separate the the PRO right, is of relevant whether a from color that patient-reported inside within They a questions And within about the is sputum. that One group contemplating FDA, is the of outcome. that's context a asks the question

ways. in question indeed, And it need what way keep works to no or So both we both how not we analyze ways. the to question, We've makes keep executing. it do data whether that we're they run the that or difference us ARISE advise

we would that not about But we finalize ground look we're in communicate in we're as time you locked review down concerned communicate would coming as it's to the us to for the approval of is hope expect is plan tell it. the exactly available. to But terms us with would in soon there. statistical My all adequate and we NTM the just I the the before that do to therefore, ARISE you case again, earlier for engage file full expected this base is needs it and going detail and that to like. will that's willing line dialog happen need to approval. run secure And would then return would So and assuming we that give analysis as say, kind what months, division I opportunity, we is be can progress indication? ENCORE MAC FDA, it think will they FDA. ENCORE But our to of need and once

Elias Lenard

to And instance, about bronchiectasis, level overlook a are to how but thinking you the Great. a it of not CRS each driver HS thinking and obviously, being then involved pathology terms relative neutrophil disease? beyond of mediation of nasal bronchiectasis back of the taking polyps in maybe without in ASPEN, about, and step for

William Lewis

Yes.

polyps to about third like these particularly chosen population neutrophil-driven CRS exactly without are are surgeries. often that's and without something we're with those polyps patients that we our approved They the second when quite nothing nasal within indications treat as diseases, X CRS now, why versus CRS to has undergoing targeting nasal pursue. we've So polyps. are nasal talk Right it. that repeat

indeed, off How neutrophil-driven be hidradenitis might that other we detail study. year, without polyps this much CRS kind resulting looks that on as is of which are be for that that to that threshold structure to study nasal look suppurativa that magnitude we're forward HS shut in X. anything models high and aren't will in we will intend now is this all we benefit to go see medical response we early. need in or unmet I Phase we CRS impact and neutrophil-mediated is if final kick And great out. really the seeing we're diseases regard mitigate neutrophil-driven And world they should way learn is to to trial animal Perhaps good good. for will having, not We going the quite end product inflammation the to into the that. presuming like don't and the in these that to that through a of There cascade HS. ability do by nasal study need X a the think BiRCh it read here we ASPEN some down this influence why inflammatory a polyps, to HS of by diseases. because pretty mind. is So carry of ASPEN exactly mediating But the in X trial of cascade point a that with where a we look interpreting Phase data would that good think the in are that spot we right with of patients,

Sara Bonstein

that just just in is obviously And thing U.S. alone. significant is XX with very would polyps add a I CRS nasal very significant market without million CRS also a market remind the diagnosed patients one to opportunity. folks opportunity. bronchiectasis

end severe more the target ability influence obviously will very we it's a that, to patients. significant and TAM of While

Operator

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

Jennifer Kim

brensocatib. rates with with exacerbation that in know are I said expectations. occurring you've line start just Maybe

to before from up suggested further expect rate reasonable it's COVID. you've that tick as to we away that think I move

for history that the follow-up? just of is covers us in given else XXXX there I'm recent XXXX these you and timing wondering, expectations more can literature And exacerbations So is what patients your sort enrollment embedded the natural and timing? the in of remind of

William Lewis

Sure.

was is just think gave blinded on I and study, X.XX. that what remind bulk on blended there the the a year engaged to a patients snapshot time of only successful. with WILLOW And a exacerbations in it study guidance that was saw had you having rate And going do that all at having like. many everybody, the which, rate exciting us we know, So parallel completed was in been the the X.XX over of we study, what to we're to in that, that to to what what trying a give looks very was is that as little as ago you we

So very similar population it as of though was WILLOW to population. behavior looked the the this

baseline We released the identical studies. almost between which X were characteristics, also the

the any impact that when COVID what It's study. ARISE respiratory think on again, is to possible Phase scaling X, like what was impacts. study condition. a other seasonal didn't strategy any saw nothing we doing as on all we on result when influence of seasonality, little We COVID, as we a similarly knew in the cetera. study exacerbations, et population, see it's once the So just so the would see in share about really but we're the of as we things study.As I or didn't did small using brenso behind CF different a change there we that was successful patients, X influences reflect replicate new we it design, add up a Phase rates

the And to a feel backdrop how patients and and we about the those The study have things these good are large reasons, that more were into be study. time restriction to time COVID X or study recruited after of have and had at to of the the we likely not during of exacerbations what been get this vast the COVID in have so recruited have collect were documented lifted majority recruited those a for an or can restrictions been expected for influence.

that the able events our this its blended evidence so impact. study of in being means drug's site, successful enough key consistent indeed, the with does or the be that should mean? the level, to the blinded that enough that rate expectations and we're is to things can country witness So at events what It are of show regional our having seeing drug and examination these that impact all we And treatment.

Jennifer Kim

the that I The question one across maybe the And symptoms. is in said individual May, ARIKAYCE. presentation you efficacy ATS Okay. conference think on pretty consistent before

new anything the would you there that is to? detailed data So highlight in

William Lewis

gun sort here, to of you the just Well, I close ATS. look encourage without would at a jumping take

earlier all is even actual number the X I when and be there are among if and year it's really other promise going do data can of of came experience at conferences, saying refined there other I those among doing those compounds that be and that think key from last first leader heavily all the of different ARISE out of of for these set. to What's featured to ATS results and illustrate be to of you what some discussion that which of subject or best-in-class opinion results represent we're that ways communities, try or and whom stage that treatments different had have in work ARISE, lean you great indeed know And each your potential peer a we ERS to are discussed compounds the something quite WILLOW sets at the of populations. us drugs a look, will, a out TPIP. we're can trying the more about are of on to more to

Operator

from Fauth question Fargo. the of Wells comes Tiago next Your from line

Tiago Fauth

X Just ones me. quick for

to It for data, efficacy? wondering recap what feels get to cost. TPIP, we how the you care skepticism the of on the to would story? in I'm data And of more patient maybe a of just more see? ARIKAYCE use going investors out a focus frontline then again, or opportunity, it's just a mostly there still similar show-me seeing replicate actually to else ease going I get I even what like commercially? are readout. some on of And get detailed based of QX? So want safety that know But we're PH-ILD ARISE, play lot assuming could But when standard can either on PK/PD are bit we

William Lewis

Yes, sure.

not, us are best-in-class there So I TPIP a the mean, for is basis on giving on we've the don't a if that phrase who know that I asset. there right that blinded I blended observation is, many think seen credit therapy. front, everything are the I share this suggests

I a think miss very that's bluntly.

looking in just PAH suggests the in that best pretty at that, profound look so disease profile you the class are that if I the impacts study responders think represents, far in that state. this we provided drug at

PVR small XX% of to be it X more to study PAH point to we class. we specific direction, would need We in if and But So year, We reduction, acquired the unblind early. it's which sotatercept, very number and be see we a Phase It's consider a today continues next after of patients. was to tried data. north when best in remember that reduction. Even it its far, at drifts the down, still And showing responders very as nobody seeing profile in reason it sleeper in for compelling that so XX.X% credit to currently our reduction And giving lot within is drug dose a think refer if XX% PVR. I among is that study I a that's the we're company. a us a of for. highest the

it they the data but But of second, patients providing we look commercial in going strong study looks slide without data drifts it little gotten this those that blended was about our can as We to the PAH sort of And that get as have are if in the And PH-ILD max been? number PH-ILD negative can I data know to a be incredibly effects which common want more is it's enumerated it you there study, get website has class patients it XX our on soon data other and a so we've and if blinded think points. continue on you We'll are think And the as I experiencing as even question, get about bit, is there. smaller talk safety of and those line therapy? on ARISE as the well, to than of will it be both a data to can. we at PH-ILD compelling.On the to in the the as in dose? front, like each already potential second I'll the There update what XX% that data far. time also deck itemized I study, say, a there top and points.Your which the through NTM so side from down out go we does the results, of

convert a conversion patients. that a the refractory. saw and disease of this was to are after showed we challenges know from incredibly we put XX% Let data, this treating marketplace everybody on looked who And patients When what's mind of the at rate our ARISE were of way. we treat months, state. We in patients, CONVERT and in X to the XX% treat it going remarkable able to accomplishment this this difficult me just you effectively. in NTM in to is disease an that

than in So was could terms converting the ultimately I goal don't it be better the how of much of who have in ARISE positive accomplishing sputum. patients know data

drive the KOLs going patients to patients. natural these to the chance to have with That So eradicate need to alone in if with because early and want them will to X the earlier a ARIKAYCE. shift and already a I driven what of treat has see anything, you XX% months treat think, ARIKAYCE is dialog you're to among up to

Operator

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

Andrea Tan

one Japanese just is culture there note this the the durable exposure see desire of Well, here. PR, XX agency to has that question conversion. regulatory and treatment this months In

ask Just that wondering requirements, similar approval you if you if potential have the mentioned. and this for accelerated to in context sense frontline a this of I FDA the will path have

William Lewis

Yes.

patient impact approval In impact. on have won't So look PMDA Japan, meet profound and because its culture our It's conditional equally examining at specific. FDA when the very U.S., the different FDA's started the as the back to they there not true When and the of so European culture refractory want conversion. really wants they impact perspective. granted on specific. we going mandate themselves, needs And conversion. focus indeed is key from to conversion. FDA or or drug, an the isolation people see to of In get reported the MAC right on was This PMDA is centered world of that perceive is impact culture on to landscape their That's whether all saw access the indeed, the To They be been conversion. are they drug we culture tool authorities, evaluate the in to they requirements. own regulatory this clinical to important outcome. it, why PRO. leaders, the this that on the It is how opinion it's Japanese the first the effect the want the for FDA look PRO. at see They has patients market

looking ARISE is, to a them because And PRO. of data, at question totality why will approval the evidence ARISE So PRO always on a FDA Subpart the have we thing on improvement the consistent the that presents of that's about your impact while the did to be answer looking the the H are direct they to opportunity us see results. the approach in is

already that the as say, the reasonable And of for. positive earlier permit basis a that, this you think file study largely we've impact on ENCORE knowing us and approval, is it's so we be them to enrolled PRO, and secure to go spoken review, on to given would also that to to had and willing

they following So common a to worry concern through, FDA. which at don't is not us have about

all for ask. reasons, legitimate think it's I a So those

I reiterate earlier FDA and strong will argument to data I that of we full be set take right on there. think now is to go a it. approval. made clear will advantage for guidance be if also And our ENCORE want to get that the there's we But opportunity then needed the is that, an

Andrea Tan

just estimates And plus. it. brenso $X billion sales of then peak the on for your Got

if curious is $X CRS get how us by And polyps? assumptions nasal walk the you could that through bronchiectasis billion? versus Just you that driven without much of that to

William Lewis

Yes.

know key on at thinking the So drivers But modeling we are haven't want a gone lot you about look I these. into greater of each think detail of front. to who I that here, and

would price. So asthma is assuming we When the diagnosed think be that like the the as effective FASENRA, we assuming floor think product We've trial. here, that about about specialty ASPEN at the saw about target year. a addressable price, we're suitable about what that based we've to results consistent patients we about would These which we are When for in $XX,XXX WILLOW. a criteria and X of historically with meet WILLOW price the is success, the in products time the market, think million on talked launch. subsequently very of that treatment patients profile the talking referred likely

guidance. we're of building a explore of start to with the population So there's addressable going opportunity rate. And that penetration out that's a an gate, very to then but interesting that, a beyond point as

want released of north majority which vast CRS modeling think now TPIP will to in shortly to incredibly investment this ASPEN that more be will pillars. is Where think top this to new data, pillars conservatively, their my put in and the X have treatment I wait and There the rerating it it And in and week, to see the date, bronchiectasis something people once-a-day through that, being need than safety update the very the really penetration we any we data nasal for after to PH-ILD, between a this for $X we as side assumption can a for HS a positive, bronchiectasis our take That modelings on data all to in of I data. day, We community trying after that rate. opinion, obviously, we're PAH have brensocatib line going walk we're of will We'll financial some PH-ILD to readjust quite can another virtual put for is we programs important is by the to get to the your date we're include $X think get you and sort consistent was lens thinking in good put how terms some other represents. going that of without and the my a And I a in or company, give data ASPEN. in to of NTM, and shortly WILLOW, CRS you are that within seen where peak sets to we revenue think forward. not the think each going doesn't rapidly is we TPIP specific it's highlight healthy there's and think be move if are commercial to penetration product. and polyps successful a about out each as like will, data think a sales opinion. but has ASPEN you and billion novel and people very holding comes conservatively, modeling brenso on are very billion-plus of drug go ARIKAYCE low we I a that that have think and would And data the I alone a frontline the And of conservative numbers moment people and they is commercial But very credit effective MAC their out in ASPEN in about who intend PAH undertaken generation. because late-stage have so would folks PH-ILD with category. which to efforts.I X modeled know presuming billion of is all bronchiectasis for in with it do as ARIKAYCE really that day TPIP been to $X behind PAH There rate we what sales. potential rely we've in that. on better going first-in-disease the then, us product. I'm it in that modeling given a data ARIKAYCE, a both in compelling right period in for the very at least that's and peak very is it's mechanism much from with pill, burden be of financial WILLOW that that these date, And

to top going we're and through days understand, ASPEN to here, a lot a lot of the walk there's you So it line within to model results.

Operator

Your the of next Partners. comes of line Schwartz Leerink question from Joseph

Joseph Schwartz

for Thanks all the updates. Great.

in of Difficulty] couple a have I bronchiectasis. [Technical on So questions

to wondering well drive some seen like response to The and in blinded first other things you're and And do think clearance to trials. this. to could adherence the you what anything more? exacerbations factors incur impact? placebo that there this We've consider? as of for airway able to other drive anything rate in effect reflect I'm pulmonary in placebo bronchiectasis was ASPEN whether lower blended treatment most placebo the just I that to can setting the are is, biggest including able we've these both think, the are factors better you as trials, heard Or wondering effect if could these to in since you control do which reversion WILLOW. mean are things minimize could that effect,

William Lewis

Yes.

So aspect there are things when exacerbation study, of several we look the in at remember. particular rates the important to

to to do that patients strict. exacerbation the definition the by the everyone, an The into That including trial first the trying and want our either change exacerbation declared then so response an has adjudicated or third not the an they antibiotic document is event very that admitting definition. to is There how an how do that exacerbation patient physician, physician are using patient of very by let and exacerbation event you then or treatment, in I makes address. that but to be hospital is only the to substantive you prescribing a a define has a remind treatment party.

and we're seeing been around to events definition fallen. protection where past, ensure of where been hasn't of the a are there's in of So the strict, studies they've real there little other several events. number as bit In layers the are that what shift

significant WILLOW. of on used a definition on confidence measure both why we into have in think such It's And impact one. clear that it's we the going this I we doses saw statistical why this So study.

And so. right think ASPEN, are conservatively. about observed assumed assumption We in we in at most X.X for rates had or X.X. the that trials WILLOW. We we As assumptions, kept around X.XX X.XX saw more

than patients been Where lower by the the of studies, patients that entirely has by from So have get study because relative from remind Europe Eastern that in particular driven clinical Eastern observed I'll from drop were in study recruitment in receiving came actual rates them medical patients one where areas, you There's to is from fact less case very Russia. and and drop better they of this XX% that commonly no from where the they patients Europe in other healthy results almost Eastern had a the is or Russia, Russia XX% rates. it areas a about patients are it the rates placebo trial powering that care the the up medical placebo from recruited to having care. Europe, that recruited including better is or rate. were XX% the in WILLOW a no ASPEN placebo simply those of

our in that So feel kinds the And the probability for having study is reason, those of we extremely powered. like study or of well is low. aberrations influences

We this right of level we will If blinded have the seen it drug be a in in X. events want treatment blended capture it to able to. that has X, we effect Phase as did Phase

Joseph Schwartz

of in behavior leads to kind that That's to question, think regions nicely in kind wondering sense? if propensity antibiotics behavior? looked around it use anything ours. even are there's actually different and at as you potentially just the WILLOW was to at do that I'm for different to in very Have my next could And some that able such which prescribing helpful. the particular, world countries, I be confounding antibiotics And given a within all? control issue of on you

William Lewis

Yes.

what we patients for do Happily numbers want small is eye were idiosyncratic some you aberration a difference that. controls once effect example, not those not Interestingly, they that So WILLOW, that most may close is any have it who enough or we that a given macrolides the kept study, enough with anti-inflammatory were responses. patient associated to probably with give did we that have from I'll the use in and or these variety again, studies come antibiotics them. that because see important given on in of an between

any across patients arms in influence we of that you're being the looked and the at because that. distributed see the And up us to flow aberrations be if it. from carefully. the clear, of very end X, as going want were talking an numbers any different larger didn't it though, so those just hypothetically study. distribution might from are equally didn't it there, I in the we study But that and across was Phase but Phase from distinction be see about, kept exactly X, what we to we and should protect it to

evidence the in compensate So prior we have all good about that it X has these some Phase design of feel have Phase studies because X tried failed. that, in of different for influences cases, to been

Operator

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

Ritu Baral

Will, then I analysis ASPEN question ARISE plan. just some second questions some just versus ENCORE. And the statistical have my was on on clarification

be what X.XX you're or And that that powered range going said milligram low the I you describe stats, XX today? p-value effect you For wondering splitting sounds previously just about, to how that of show and XX type like was that using that, XXs of X.XX between any to down the to you an I'm when the study was are alluding analysis said it think could to you of further that, you alpha versus said analysis. a size X.XX into reduction. now sort that that guys dose you and mentioned milligram the the of hierarchical Is it then correct? plays had

William Lewis

Yes.

least whole alpha what's set do we'll conceive details look at [ and plan, the done preserve to we've with you our finalize we at of thing independent statistics as you control basically know the is of in the different reveal how ] arcana FDA use know is better multiplicity? for to in it the what most another. understand approach the final where truncated the I So you one Hochberg to is, data analysis each now, right than we dosages And as statistical analysis of called some of

at secondary look secondary look alpha XX So can been and to permit if This to we endpoints statistical XX approaches preserve we one look fails, then used both. endpoints Not is still go commonly. precedent. XX. XX all If underneath that. still that in we has analysis can XX It's wins, at at can with and

preserve doses multiplicity we but how the for about endpoints. the endpoint for don't the So at we're to some it that's look and thinking both the alpha ability and for each control the primary anticipate residual being controversial, of secondary

detect we talk And approach. that an to so XXs, about low contemplates effect being into when able the it

the to responsive that's hopefully, So question.

Ritu Baral

are XX? it. And first that before testing Got the milligram you XX

William Lewis

the Yes, that of to support some I think points however they alphas it, whether hurdle amounts not initial of equal clear you XX residual or and for preserved for those end under about want XX, doses. think, then get secondary you each or the

Ritu Baral

the Which reserve of have you alpha to Got secondary it. endpoints decided for?

William Lewis

reserve effectively endpoints not clear you whether you alpha and then Well, see to them, you of for secondary them. the through go all hierarchically or

Ritu Baral

Got it.

paper? will meeting like meeting. it that Zoom down statistical be nail sounds on And to over at an be you're And or like Okay. are any having do in-person meeting on questions to ARISE? ENCORE analysis ENCORE waiting QOL-B you'll then solely plan, left Or the to ARIKAYCE, frontline there versus they anything that do questions or the usual on around that

William Lewis

Yes.

groups X there FDA. dealing that So are we are with at to be clear,

blessing sent have exchange additional PRO happening. an in run final We've meeting When them. We've in-person that can turn There's and written to any and data is first based they has information have. sort ARISE, review be And tool been At That's for an encouraging. for questions review with always division should once request we patient-reported go all stuff that that We at the earlier this the goes first conclusion for the PRO ARISE very therefore, around that say, this for ENCORE. their on subpart PRO going at that to they the it that's finalized creation The that pursue an suitable them through, for pathway looks to analysis. to remaining the dialog been are elements is had in unfold of that's here. used. that FDA and is it. meeting, ENCORE that cascade points ground have and outcome the in-person in we moment, exchange then the they specialized and a fact ENCORE, suitable at the and want. appropriate the group have approval is so then we MAC-NTM?"And It's or then PRO for group that's to H where a to of necessary use reasonable

PRO. view. or have going to go to talking use We're be analysis that's talking constructed, would like difference about of things review from frame the are parallel, where their with FDA's is we and see the what needs specific is, in to it. we it and point to to an ARISE are go discussed fall, So more question what really go plan the PRO out statistical the they FDA that H level ARISE they Once to the clear, effect last whether division blessed PRO ask we based about elements are of important the adequate And be that it above we division? the PRO it Subpart is treatment with could going could We minimally on for then that is ENCORE PRO to be want below the will as with then in in about for group they used under that, proposed ENCORE. earlier final shared the the approval.But you whether be

drug works all the of That the fall. settings because the real PRO matter at doesn't levels. breakthrough it all was last us, moment For in

up at, them going is is So the the fine. sets It really threshold. it be to appropriate feel FDA whatever what they we're to

Operator

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

Vamil Divan

on the then on follow-up one Maybe on ARIKAYCE and Great. just one brenso guidance.

you sort a any as with what at been Question investors obviously, particularly with in in is was months? a more treated brenso side little I'm times you trial we particularly few you on I concerned where guidance, just level, on how and then less than terms WILLOW. know visibility, relative So global seeing Japan XX-month growth longer sort of patient gave the sort but expectations this of look has long on if from the brenso, the you're on there's anything ASPEN to opposed or patient trends comment there what you're sort at you're maybe a the it X there to can we've things to safety And curious a trial U.S. of maybe about saw bit as just of speaking your of side in point gotten expecting you Japan a in a and just broadly XXXX? for in is the have of

William Lewis

Sure.

help dramatically should of and was think time So tell when the curve, versus about Kaplan-Meier study, exposure the we I us think would ASPEN about separating it that if because in the study you you WILLOW the X-month to frame takes placebo, and quite doses that pharmacodynamic different remember to to get this about X a weeks at actually versus full the drug effect. was strikingly, continued time apart that to and trend X within

the and encouraging. months unbelievably impact dramatic WILLOW So we study that of effect looking X were was an to at of see about treatment really in

But can this that's one Board at been Monitoring out I place met ASPEN safety have should we and was look the that treatment did for point. X that patients think it the than on WILLOW to at repeatedly. for as extension patients number we've is placebo what profile as arms. just publicly, than Data that drug. of and to And we in we're We're really good. see terms least the events as through looks we've years going share take year study said what events And have has So as drug a had of more seen open-label on in Safety been good improve. we blinded. in the we in in obviously the we WILLOW. in the help special And dropout dispensation and a will of some in the seeing, rate a I higher had striking

looking So safe. quite I think the drug is

what we FDA the a we at is other obviously with advantage really say our is, they take profile there, regulatory world, point the know we if patients we really the to to FDA, effective drug then do-no-harm is so that drug And Is then that in the other examine see safe? mandate the goes way. we and because For look encouraging. data looked is And In safety. confidence We has the because authorities But have have can and obviously the detail. the We here the have in how really tolerable? efficacy. it to start a of far, positive tend why saw the we drug WILLOW, real it safely? regulatory this safety and do safety heart

regard to in the ARIKAYCE, as And good.As would mode. think this looking help good turn the the in characterize we I guidance for will think is I growth us time to safety Japan a element very and both the I for year with revenue global ASPEN. So very U.S.

about to growth in results. a unique launch we I trend mentioned middle of our is 'XX. the from is remind think as be out 'XX the always X launch current there the To in Europe that revenue-generating Europe we see 'XX but we the I'm year-over-year And a in think for To where always we're particular, a think year the rare is is are commercial and would will that's is in strength do guidance capabilities that as first very But the off going of also team. feel region, that's in a because And is testament her but Europe. on the each I of work ASPEN the launching quarter that encouraged that in year to U.S. little it first is to smaller we that opportunity year caveats that that produces a launch opportunity quite coming year good in encouraged very And very variety half Sara impressive commercial of the regions. in launch be we've the then first we would smaller think to the coming for in remarks I growth challenging be important I will would of our U.S. at 'XX, in well. and It's reason, highlight really reasons. the to of best and Japan. ARIKAYCE the of our base. and and respond really drug's I going bronchiectasis in what the class. to by looking this of think a a and double-digit been Japan expand sixth everybody, seen

to are it be these well X think and from of probably be underway years far in this and third. of the a So rapid launches of away we'll X it. going not to our that now, succession way, regions on I from mean we're the way

Operator

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

Lee Hung

scenario? What like you for then would in How and see on the that pipeline, would the that through dose in dose doesn't happens the early-stage than win. X.XX clear be statistically a months? you p-value a milligram benefit? What think mentioned is muscle And brensocatib, less the INSXXXX? the a progress milligram achieving show one but updates data would For significant, coming any to XX you if XX statistic biomarker biopsy

William Lewis

Yes.

question the get If it's or of stat to really either win. the XX whether below on We sig matter that different doses, asked a X.XX milligrams. this So threshold, dose XX glad it's us a lot. I'm clear and the gets doesn't It that. you

impact to we it doesn't, and plenty at well XX, have approvable XX one it in evidence that successfully one milligram for higher doses if at continues these necessarily there precedent treats that will linear right XX have the dose community. our and And but see have the and the an dose but data higher If that we've judgment, at treatment trying that doses way? the don't we a we way wholeheartedly of drug patients XX examine to at these What FDA from negative safe effective any in there is, dose. that's don't embrace there's a in work don't drugs to of perfectly We on see studied. all and acceptable. milligrams, the data a have. the that we're is We as fashion response that see through And curve hits a dose XX up the to work doesn't out

if And them we forward XX both here, of that have so so dose and we victory shots X I brought again, work, we may one XX only would forward. think, bring But goal. on

them to not we're we're the right works, one clear progress that, bring matters a suggest that of can forward, make and of of to we them is there other XX let whether dose the that's across very one I behaves now be the dose and That's forward. will the fact, trends In it's fronts. me very one only it likely and XX be threshold good continue to case.On earlier-stage think safe fine. one What and whether going say, differently, number does just the matter. different pipeline, bring If only or

fourth for the we'll And that say else ASPEN overshadowing spent going filed, about frame next announce because a to a out But going down to the to phenomenon haven't INDs in at there's the cascading you expectations encouraging. time lot there in really that. both I and We on tell try that company second will ARIKAYCE once INDs data pillar of that's because the course, have making those we're very early this TPIP the pillar. going talking have will and is progress to been lot I at everything we're the where of then, going fourth data think part is about this half of year have multiple and year And to the we of that And we filed. once timing are release. happens, on,

Operator

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

Liisa Bayko

let's secondary able doses X.XX then the little this actually just in procedure, for if a of then you so you And just than left whatever you that X.XX statistics work? about other to got p-value to as to whatever ASPEN say, that over and from with the, less all, you to then for recycle first does bit I endpoint the one are more Is let's clarify, PH-ILD. subtract the just of for hit is statistics, question understand, you've endpoints? now, apply how alpha to the this or the go wanted down Will, secondaries, and Hochberg a

William Lewis

Yes.

understanding, people ] school, this. and capable getting me to remember of we're are I'd go details, my the happily again, [ than So arcana the more into on to statistics, to have which back graduate

FDA, go as be this is expectation get is the I if controversial will understanding the that But our do this. that through is of alpha can point considered other measures. here my view from if contemplate So that wrong, and plain it. And as any the way not recycling clarify utilized it is recycle procedure we in we alpha that this currently back in very this circle we will, our of you so approach and of vanilla, endpoint we

Liisa Bayko

you And favoring one are you alpha allocating equal Or X between the the doses? are other? over

William Lewis

that doesn't, using hit. this That's benefit claim that multiplicity. other control the we'll aside for as could endpoints be earlier, under you hits But the the set milligrams a not a of We're not a milligrams and scenario, secondaries, does contemplated intention the alpha priority the have and the the hit, one then XX that the examination XX there goes still dose but go where preserved your XX with favoring world hits that The like, way proceed you first, procedure the looking to milligrams secondaries. through as begin you're one just to if then you to at say, the and hits that's And XX behind how hits, could dose let's over XX endpoint secondary was under does but where for X we dose and other so you it's do secondary and then in other. procedure. and clear you dose a

Liisa Bayko

to Got doesn't one any hit other have just like And it. on clarify. the it's impact doesn't X.XX, of dose, well the doses it above

You go analysis. still down all can those

William Lewis

That's correct.

Liisa Bayko

Okay.

don't to of when about I'm already get efficacy. just to for talked given to XX% I know you've now, Can a of you explain FDC PH-ILD, For any we far, you PH-ILD? why we get, understand know what lot that like going already now then get so trying because not guess we information are at what will are patients additional give going data June you're mean we And max the won't we it? in might I I see new right dose.

William Lewis

Yes.

do and think isn't. we're to to going we're is and thing we're So who who's first going unblind to I know on drug going

looking and are walk, we're improvement or efficacy to will also be And endpoints data. PK right? it, results exploratory of PK is issue be not we going sometimes And suppose so showing. secondary the that of in endpoint I at that But be in in function So improvement going one stress, It's improvement to unexpected, at then efficacy available get can. X-minute to announcement, capacity as quickly exploratory biomarkers at of look we'll the is are endpoints tolerability and the go vascular time we as there primary we the is lung out is when safety going we what but top my that and line exercise through at And are be data, it as of and looking quality improvement NT-proBNP, and life. pulmonary volume cardiac in expectation oxygenation.

understand see are get of in the core we've doses, higher Now expect to for we the top to can is And to at a just show study very of that. the doses value really because are how prostanoid this safety you results be of a know response won't works flow you need put once the because being tolerability that a achieved available and curve endpoints time to know those the which do out It takes those purposes, longer I line. study featured, at process is would higher a the established, is and it's it what you do this think to patient different exploratory the all we dose examination. already because the benefit X-K in know up of we efficacy that of the safety able that there is populations. and important

can we drug, and expect then profile other be not we placebo achieve the tend patients really goal. you've patients to severe, that you precedent patients patients max make you populations, different. presented your than that and PH-ILD PH-ILD is if the are more X PAH think more other that's fact that to sick, When be we've to one having that is tolerated point. we're think about remarkable. want to XX% the I and show benign, to achieved getting I more on So would in AE itself dose are the gotten XXX that of so in to a that, dose this. micrograms than said and studies But max of tolerated noisier see of would PAH, already these and

or patients what the on all are that will placebo is. data. think And interesting reveal or not we'll I drug Now be whether and drug mix those and

Operator

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

Stephen Willey

kind of to PAH the just I I if to Just days at this just into all sotatercept I'm how the background one might And of of TPIP. of a kinetics X sites. sense or availability seeing requires least curious on whether are I can guess about potential guess you're these not therapy. impact pace you're you get next that enrollment the trial trial speak not for and month think, kind stable just given, eligibility enrollment of XX thinking the U.S.-based trying within of whether or that criteria or and

William Lewis

it's the attention a to enrollment are little I the to this. bit of Well, say continues well. People aftermath go Yes. blinded would blended picked release. in paying the up data really

you of a competitive a handful There trials. other people out, to it's As run talking market. are about there But point trying that are we're out patients.

we So are in I population. introduction don't are sotatercept to we the just on of available profound heavily think the have U.S. U.S. nor in the not is reliant going a patient And impact the

fact, are abroad patients the there treatment and drug In an in PAH coming from approved the PH-ILD the of of many U.S. because is for

that proven expect places would that to to from able perspective, be like I to us. very beneficial has And continue. to go being to So Europe

Operator

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

Leon Wang

are using was BD to transacting? And do to continue a going the utilize front, active of How forward? have between I X. expect method two, 'XX, HS, noncash and thinking about patients on stock and the level insight polys BD most diseases? have CRS do of as you you bronchiectasis without any so this So equities. into on you relatively but overlap in for these One, And you other were

William Lewis

Yes.

why be include the can to look that have of ASPEN overlap on perhaps the and as that results. of refer the the commercial the in for commercial so we substantial, first are able data going elucidated the it groundwork HS So overlap we to turn patients they and be to lays and we've Probably line important because point We remember a highlight existing where the our top infrastructure don't overlap. and the as NTM that global a bronchiectasis is the we're that it's leverage on and one, attention where patients. lot shared aftermath they are to CRS this is we quite on basis. and that most to that what immediate between to between will day bronchiectasis

sits All part NTM leadership and of vice of bronchiectasis of as leadership thought the in thought versa. the

off reviewed fourth logic first will this to, past X done than than that XX% work is the XX be presuming pipeline provide yes, believe actually The success provides and different for the expect under a This that first this have parallel. less teams our XXX% will a overall of to they feed pre-IND for years.On we have behind then commercial will of pillar. rate. spend, hit these more this pull capital we that in is work have ample we X it medical represents the we than developed able did opportunity us the a if now and running them internally. the It as more so compounds we But to us And BD the the and do of fashion, the that incredibly pre-IND remain moments. real time call front, leverage and excellent of them there as in enter many number just transactions. sit over But of They what to opportunities. a final a them look they we I robust for promising their set can very We've say thorough is being.

be particularly data. to expect them, we so next with about year, And talking in detail including

to the need in view, there's point do that I way from so And a don't of much think for us of BD.

to continue look. will We

is some We exceptional they're incredibly work recruited we in doing are opportunistic, and the always that but of leadership really the promising. and best-in-class we've terms have scientists

quite in have We We looking think new And development, out-licensing trends you bring likely a business will just partner forward. dimension or and out-licensing it to robust of be very of of be to evolve does these relates I as board. we is to won't we're to which able much going see may from one it's the year next that the So bring of pipeline of that may choose. to them. some to to a as There'll all be them. programs be which some Insmed's on additional looking co-development X

Operator

Your of of the from Chen line Wolfe Research. comes next question Andy

Andy Chen

on the progress. Congrats

just that. that be and if there's better interfering if after a about there? recruitment, there's ThXX a wondering why can so maturation in I versus I'm And going neutrophil have obviously, neutrophil just does there's wondering, Just more? this I'm follow-up than HS, brenso like IL-XX you antibodies mechanistic component, a wondering component. talk with why reason that matter a it's your to mechanism out IL-XX,

William Lewis

Yes. No, appreciate question. I that

I not to would But will I at that may we space. this able clear, It's heart how be is of one we of drug early know the HS, design the the aren't it that effect productive. I it comfortable other trial think reasons great will to is this animal of able to or that again pretty we there a in perform examination going models inform believe be to say that sort this this once include to to feel whether setting. our of displace be. so be those approaches. want with intention be And not

As you MoonLake acquisition. involved may that know, I was on the and merger was SPAC in the

I've while. been a for So HS around

interesting very a is opportunity. this think I

need it's a I a the different you're approach And enumerating, I that in. be the ones effective market, case. which is be complement I to are combination therapies a represents those think for continue enormous. lot have than the to confidence also of This additional already will very that think to and this going

from with improve well. effects to opportunity in these and pill point impact disease DPPX patient on meaningful directly wanes on I a is I some we the neutrophil-driven contributory that could that's a once-a-day come pursuing think do potentially NSPs, outcomes, inactivating very This in benefit. be of a think, release think sometimes the going patients is of cascade to of going of why that inflammatory they're be it. and point preventing view, to very But the patient we're be and would and result and that

Andy Chen

And assets. Right. early-stage follow-up a on your

this your it's know on IND slide, filing. I singular. So It's

going on Or can But one like if be wondering just it is is like that's to to that provide So blank like towards be technology more in I'm are everyone a be single forward more you looks market? the it going leaning XXXX. new it's going you is technology? is to asset competitive? coming spaces And less a Or existing like a hot going it areas bit color going on validated to it towards? be

William Lewis

Yes.

this X we So Diego our in right? let me sort have just different frame out of that San We of categories, operation. think

operation our driven Diego is operation, Cambridge is rescue gene New our driven synthetic the New as We operation. have largely by England modality. underlying England Cambridge Jersey our and therapy. Hampshire San by

sort New capsids tissue, our therapeutic and proteins a and these sits Hampshire viral in is if connecting of some and own New to original compounds deimmunization of Jersey additional of others research. involved you will, as

in and to filings XXXX, whether right INDs the And I close, what looking to timing single teams. is terms multiple. them. that that any have, As But has or be you 'XX of of very from to in timing now, I not I we come but expect will the progress am look been 'XX very of it those, things are great encouraging. in is to expecting lot going certainly it's degree, all of faith at have IND is multiple each of specified tell a we in The

to IND IND by I X about done. DMD gene what Stargardt think that therapy, just name supplementing filings filings details the has therapy, already example, forward. using first around for you're and of the way just gene 'XX the using using 'XX going to therapy, been to expect And are go ALS disease more gene we see in

effects products years that's out what we that can as So going one to the already going I if impactful. We the data be clinic therapeutic and that we 'XX it's done. leave with, New encouragement of very provides are is New going a message and be what work I is coming some talking put already there's be you here profound. Hampshire benefit impressive out intractable to about know to of the Jersey preclinical at there is work development when the happen And equally Cambridge, we think are of of we're 'XX humans. to to to And and And producing from expect are therapies. research perspective, that where into going believe, are, the that game-changing chapter talking about that it be be there. going diseases in most we're and Insmed's I Insmed and think believe range with on the we new are very operation. is to these a exciting exciting forefront

Operator

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

Unknown Analyst

And follow-up. ] view the the context? exacerbations you data is does the Maybe in of level the trial reduction for on This Graig. more brenso have under mark, [ plan. the one X.XX expect. the starting If in come that with reach in I Jay not How stat but you pulmonary does first the p-value on what would ASPEN

William Lewis

Yes.

does if focus very heart At a lifetime like think that we think on get is reduce where authorities physicians, one-and-done I XX% we as XX%, not you that probably So be we think What the meaningful. want a of we and going FDA for if ability scenarios. below the market a X.XX to that I significant this sense if will change the price an of that damage. really to by what patients would to down. attack perhaps target sort consider other XX% reasons even adequately try that's and the X.XX clinically talk And product that marginally, file well they a about exacerbation we threshold. and the happens people to the permanent and lens, medicine. that. profile we is where through level, should It's be make fact, but powered The to would as different about below level to we that is medicine. It level. talk to see down at to as be path that physicians, a is at talked or these highlight it treatment to lung. come the statistically low the received is we're to regulatory achieve This approved still today access, effect. do Remember good. one before we regulators, for smoothest the start XX%, safety contemplate the XX% product threshold, different Every Because

right? made. have be and let's right, has, That be between hand I'm say, would not reduction, So would where those be in would everybody a XX% kinds adjustments exacerbations, I on of But I has that would position heart a would the average. patient say if that everybody reduction. who XX% Not it's

that about given might file to could range, I context. the some are way positive greater, that If But do responsive. to clear would we warrant side believe we're dramatically would for we're hoping very patients benefit, about in we appropriate sense X.XX who you in think or are between how opportunity safety profile, product X.XX we're and XX%, going it than probably be the want difference. in that and above less we we're we much business have acknowledge the But have XX% nothing use a and the XX%, make approval a And there patients more benefit for make if hoping that I would on for X.XX. between something side. we approved, there's and we're that's patient it. still adjusting If XX% think a think given and to of

Unknown Analyst

very any updates helpful. the just That's DMD And enrollment? Got timing on therapy it. then or gene on program,

William Lewis

Yes.

we've what that on is other of we FDA. of There's what produce in end that you there. to we some while for from threshold a think is is have we'll really This And market. clinic, ducks it the early an that So the this that. is based this a and data out seen that or confidence the will all It good work somewhere be That's And the certainly near learnings still I go best. to make the be will, to file guided done. inevitably is beat direct set comparison, people I setting clearly clear I we data some to we're will what consequently, and next is of here programs. in point for to position out to on able year others the enter the we'll to is threshold already go we've a the row, a watching that already success if have want for of taken for think out we do get we've able it continue to sort isn't done preclinically. lot do will there. to needs And we an year a and our IND. have emphasize. with attempt beat part progress attempt This what we'll be the the to do designed year as not superior And be ourselves, What strong we're and profile

Operator

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

Jason Zemansky

forecast say, what that above appreciate your here? how do brenso, I penetration? you on the to potential I If reduction closer your case, threshold, upside especially depended comments. could quarter. exacerbations. XX%, it on sort follow-ups to, XX% base be to XX% like outlook, in. of this Two, WILLOW's of or extent on But first, if you peak change in think us this when on may, mean, well this are the previous conceivably We mostly progress your comes levels something fitting does sort Congratulations is what the

William Lewis

Yes, I a think question. it's great

price that the that will certainly set is the of sort the in assumption what be, something how target territory. what WILLOW-like uptake will think we is our we'll in product have confidence terms will use will of profile drive the be, What be, penetration rapid I the all thing. that

a if treatment I that I actually Could this the of going a higher people we would we're week, we've conquer XXs. we're revisit heard comfortable day been of feel we who X.XX skepticism guidance have certainly go top we'll out given. below and there then it stat-sig to it's able effect higher, we've have is market. a this that we're from there a That's the commercial And is within perhaps I is end the and what up, comfortably from point results. out is where a think with if big that to the that. part So that really also significant that line would bronchiectasis guess in to why reason say no to I say one's general encountered physicians, emphasize, targeting we've putting say

hurdle in England we're produced on cautious below ever strong proactively optimistic have their why because of clears what statistically is enthusiastically we person X. fly physicians that the embrace will as will They as shelf. of That's at Journal New this said the significant in. success use either had Medicine.In based the and They X X.XX, one data dose the to is published ASPEN saw it no patients the So going where and this Phase world drug. a of drug Phase off in call to was really a

suggested and treat the on arriving area teach-ins a very to several for the of only at terms standing positive. this in so treatment very appetite is about different and is patients and education we responsiveness accomplished. drug, WILLOW were the what you're room at what a seen going disease who once-a-day backdrop to think but treatment very and the far a of it's the impactful sheer of and the very condition ever safety That approved the first appropriately that could by see we've and we've use life like uptake challenges it of I potential this burden not how disease doing vortex sessions were state for seen the significant. We drug sort that to this because be experience in profile this the medical ever to of had a pill last inflammation, be where this because of the rapid talking is only ASPEN medicine in if their conferences bronchiectasis, medical

medicine. the the I it. large think The it to something ATS indication approved grail is referred to pulmonary as treat without pulmonary last at holy of

if opportunity the And treating going can and for one, be community very embrace. patient us. think the So a community that's is that entrant, exciting we I to first that

Jason Zemansky

Got other in in and FEVX. endpoints terms PE reductions then QOL-B of like the beyond you. And

terms your longer of And hit what's there given In important these you to confidence of commercial can are the on? opportunity, how the get duration therapy?

William Lewis

Those are in unknowns real my mind.

the They're that exacerbation focused rate, to access, thing I not think the all physician, very on are for damage patients, that now, each be the is and about they're permanent attack of for it. necessary. one the those is market can And because nothing negative like nice is done The patient. major this heart there's lung, it ability have. a does regulators it the that right to the impact a

be it time, to So a by will breakthrough course, percent, to of of about, some if their say would life, patients But we average patients kind the some over XX-plus that have rest able impact be accomplishment. that help say, up will deal. and less. major can chronic and we're And going these is this a medication, more on a of to big for and be show on that's reduce

it of far, a that be to so here result. kind looks And to We'll on track able like we're produce shortly. know

Operator

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

Vamil Divan

today. or bit some the announced just little the talked a getting questions We've Leerink. I questions the that's I few filing with ATM around got we're know at you call on during in beginning, morning this a being $XXX why think just million

move at maybe big of [indiscernible] before a you're on can of so ASPEN. kind of now rationale just exactly equity looking the kind about doing standard And clear the detail for or you pretty more little raise sort announcing before

clarification helpful. any just So might be

William Lewis

Yes. No, I Sara appreciate actually the I'll to question. that. address ask

Sara Bonstein

Sure. address to it. Happy

broader I that and housekeeping. side our purposes, all ATM data. and is strategy something of clear it's plan our be people and complement we on in in points. morning X not ATM proactively we ago, the couple met, and on to used encourage term. multiple for place a of of have utilizing those raise. want of it, the levers It's some used in years capital ATM overthink is last would on other a our The this place, something companies filing quite near not We haven't we of have of to I ATM put the the time. intentions size not it strategic year The So and for ATM the it's that do an been a

think that should to want it add? if I you Will, have way. people So don't know more about you

William Lewis

it. covers that No,

Operator

to time. There are this no the to Will. like further back questions I'd call at hand

William Lewis

Terrific. Thanks, future to this for the and everyone, on updates joining the look our various about forward in programs. talking morning us not-too-distant to you

Operator

you That participating. Thank conference for does conclude today. our for

all now may disconnect. You

Insmed (INSM) 22 Feb 242023 Q4 Earnings call transcript