Insmed (INSM) 5 Aug 222022 Q2 Earnings call transcript

Good morning. My name is Dennis, and I will be your conference operator today. At this time, I would like to welcome everyone to the Insmed Second Quarter 2022 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. now Investor turn Relations. would to conference I Barisser, Eleanor instructions] like the to over [Operator Please ahead. go

Thank you, results Dennis. conference to call Good a morning, and discuss provide second welcome our quarter update. financial business for and to XXXX to today's

Exchange from to me expectations. that decisions. website our to Before current may not today's Please call intended based statements filings involve on results today Commission, our may the with and prescribing represent results which purposes or affect our the promotional risks www.sec.gov for that available you the will we remind website materially the SEC's information that not Securities the uncertainties forward-looking cause in include actual the forward-looking differ start, factors call information sufficient The refer statements for concerning of and and risk today's through let Such is on discussed judgment as from and for are at could company. statements.

on Sara Joining and Management Chair Officer Executive today's Insmed Officer. and Chief Will Executive of team, including the Chief Lewis, me Financial Bonstein, are members call

Let remarks, up now will of prepared completion remarks. the turn those Lewis over the Upon Will me to call questions. for for your open we call

across finished four Eleanor. Good than effectively morning, continue pillars second Thank position you, XXXX of business. everyone. the the a we of execute to stronger Insmed our in quarter ever as before

the evidenced second ARIKAYCE. advancing, global sales by tremendous commercial are operations Our quarter of

improvements and shareholder we expect advancing Building robust that The number deliver patients we on transformative second of launch. therapy this on marked success, to value. a create quarter since are active lives our pipeline significant patients' will highest

in been of to development trials line side, with into and expectations. tract are our our all the strong patients continuing clinical attract to programs clinical our On ability our clinical has

in lung disease, briefly first treatment year our global our on ARIKAYCE, Starting MAC on in for of excited are the demand in marketed increase extremely the product for progress across half we made we three serve. to level, business. our we me have the all first refractory Let markets the product an of touch with pillar, a see the

anticipated As demand, at a in of reiterating XX% least our result of growth XXXX. we revenue are strong this

excited We light headwinds we foreign particularly about this are the significant in experienced. of performance have exchange

in Let me recent quarter most touch successful marked launch. In US, seen ARIKAYCE upon quarter since our the market. progress second the each we've the

an their attribute and During the use quarter, and we we back duration in in-person visits to increase with starts to going favorable higher saw to patient continuation of which demand, patients addition in new rates physicians.

We the underlying in maybe also by in exceptionally driver which we key continuation second rate and believe strong demand. quarter revenue retreatments, In saw to increase future an driven Japan, growth. strong we saw an a performance

about into Japan, overall year the the Now excited one extremely we opportunity launch ARIKAYCE franchise. and remain this the importance of in to market

is sizable, Japan, Europe, and quarters. we are in patients estimated Italy for the XX,XXX to refractory pricing and of XX,XXX with patients Recall in We decisions in population progress an forward that global XX,XXX in in MAC Finally to look updating the the this of to France. you US, on approximately coming approaching market in XX,XXX finalization patients X,XXX Europe. addressable England,

diagnosed international will for also trial is believe ARIKAYCE know FDA newly we you full which ARIKAYCE in NTM support approvals As being of patients. clinical frontline select explored program, a and

data enrolled ARISE remain by and the be of on into screening over plan patients to We of frontline to a ARISE XXX,XXX course a that estimate and much approximately strong We fully door our consists trial. complete open could that XX,XXX to to we and there the would NTM trials. diagnosed two As indication recruitment are will size patients of setting in reiterate represent efforts has we a larger share multi-fold to XXX,XXX the we US Japan. track in in and Pending pace of opportunity XXX,XXX ARISE program all this Japan. the the range end of ENCORE future to before the focus expansion month, ARISE refractory on end NTM enrollment the the market of largest frontline XXXX. and to this the alone. trial a the ENCORE diagnosed increase reminder, guidance year frontline markets The US the from in the the approval, anticipate of The allowing our been the

brensocatib molecule of of using are release activation active which anti-inflammatory to the Our to brensocatib, or proteases small a the of second could We pillar serine reversible range therapies. become inhibitor we addition range treat conditions. a by process, diseases, of novel the NSPs, a a be brensocatib for inflammatory pathway of the neutrophil component involve a to class in clear NSPs. this oral once-a-day key impacting interrupting that potentially way, inhibiting we believe a inflammatory of is see DPPX that neutrophil-mediated In

currently separate disease areas. to brensocatib, pursuing with four additional are indications evaluate We continue and we'll

these first of bronchiectasis. is The

ASPEN Our in of XXXX. is complete track Phase first X trial enrollment on the to quarter

resources as and confidence internal our has have commercial result Our attention time we a our and in to lines readiness. grown turned

the currently for of to this with approved this advancement have indication time indication no an announce second medicines. of an the indication respiratory enormous estimate patients for specific for generated represent one opportunity in therapies. would that, of fibrosis. also in specialized at major population bronch, a approval our launch approximately An market more patients forecast cystic I'm addressable of potential pleased patient million at brensocatib. we process, addressable As a part We

the PK/PD this modulator of study, of Phase and top anticipate arm line enrollment II completed we having have year. CFTR the We later data

moving to CRS thereafter without For rhinosinusitis nasal of or polyps, the step extremely HS. clinical into polyps patients brensocatib or Taking our a newly hidradenitis million without anticipate another middle alone. no for XXXX development announced presents CRS nasal with treat we nasal polyps approved US indications, by without chronic followed suppurativa XX the attractive brensocatib. market are there CRS in this opportunity for back therapies With

patient on represents initial patients significant the will globally. to patients, HUMIRA annual HS US. market moderate target where patients basis, HS, in target with there approximately thousand on on an for XXX,XXX population, we Currently, we injectable Our considerations. the approved which believe we can the biologic severe be severe With plan several one is the product focus hundred most side effect to an

pill, As could therapy be for important an a patients. once-a-day brensocatib

rates attention Phase first, formulation Turning as enrollment we timing are top third data trial before end our which expectations. trial, continuing open share treatment to line we in be palmitil for and powder each thereafter, for having for is dry treprostinil the the have Phase sites IIb trial in PAH to underway PAH. data of expect At could our and PH-ILD next of Once, the TPIP, a pillar currently data. in anticipate specific in in hypertension our currently with X clarity which are to line early we PH-ILD by high on of level, followed as year, pulmonary

we which study patient proves study, Phase extremely on a difficult recruit. did recruit For challenging one Nonetheless, this manage design in treat novel PAH has the successfully a setting to and in this study setting. Xa practical an to update

measures encouraged a a by data during in various from period. cardiac XX-hour While we trend patient and predictive, the single are is improvement not

and concerns extension completed to micrograms. titrated the not XXX safety observe the Importantly, dose XX-week We also successfully TPIP. of patient period was did a any with

our Finally, department. emerging translational work medicine pillar from our fourth research is encompassing important the

together the disease years. areas, range of We capabilities two progress for per manufacturing, are a INDs will as novel one several that and engineering harnessing anticipate which a work in of we year making yield therapy, of protein next platform gene to all

promising and time addressable will a technologies, provide commercial We which in-depth comprehensive research host details an across we additional including at our and markets anticipated data expect on four day lines. to look pillars, time indications,

can we have our well progress to appreciate, XXXX. across very performed four you on strong made significant building As start our pillars, and

four operations, cash supporting underpinning is to a We the across disciplined and effectively execute our to work continue management. approach our pillars

for comments to the over the about turn financial call our Let me quarter. during profile Sara now second further

you of a financial our support second Thank internal will second our issued line, continue with the our Earlier and pillars a detailed Will, we press strength financial to all in ended the position we quarter of quarter in of morning fall everyone. We today, good which believe results, expectations. four release with that business.

Let you me highlight, for now. those results a of few

million Consistent with As reported current cash into support guidance, ongoing this cash we cash and position our morning, quarter ended securities. will and marketable earlier anticipate with the equivalents, this our XXXX. we $XXX.X programs in

focus on quarters in levels consistent of in dedicated cash burn preservation the second and first year. resulted cash this Our

$XX.X compared a when increase the levels of to first of revenue to Total million pleased were second the we half ARIKAYCE of for addition, XX% quarter show burn quarter of for half net showing XXXX. second XXXX, XXXX first was the in consistent the versus In XXXX.

extremely revenue million net in million second the rates of are million headwinds in this $X.X was performance, the Europe and regional the in basis, rest both especially by world. $XX.X in and We exchange related in the to On considering Europe. encouraged Japan a quarter $XX.X Japan US, and

a largest saw US, quarter Specifically, continued growth our overall increase performance year showing the XX% in prior over we second market. in

me market on for important ARIKAYCE. briefly touch Japan, an Let

the franchise to pleased from XX% strong which and future second In foreign highly in our guidance year. be continue effective, quarter, the reflected listed, being despite has do launch did we a We by reiterate strategy, a benefit mentioned. in increase limit very second we on headwinds. we by the Guided of growth onetime this this of previously least ARIKAYCE inventory anticipation at builds the two-week of effective Japan entire Our we quarters. been which are basis optimistic global is revenue quarter exchange sales, about dispensing expect to trajectory commercial not

touch a from now me highlights financial quarter. Let on the few

as for also product of the in of prior XX% basis for XX%, nets revenue, Our to with guidance well the US the consistent aligned quarter is or our XXXX mid-teens second a of which on XXXX prior was of XXXX approximately with periods. consistent with gross percentage were which years. is quarter revenues $XX.X of throughout Cost as second million

infrastructure Turning second expenses. expenses which including ARIKAYCE our geographies. million. SG&A In These levels key start our and commercial $XX.X the the strong quarter of and builds pipeline expenses closing, with continued pleased GAAP for to our the development $XX pillars in second in on trials extremely performance were research the In four XXXX, in three operating million our we to were our XXXX. clinical our are our ongoing of reflect support expense and quarter,

financial commercial for Will to and closing the ongoing our I'll of position strength allows business, research. call to remarks. execution across early-stage clinical back the pipeline now Our us support turn

Sara. the future I Thank Insmed. you, than am about ever excited more of

working and to to strategy Our our serious and bring innovative with tirelessly rare therapies continue priority diseases. is to executing on patients

who as on their for move questions, work I'd we to questions. you Operator, role to to Insmed that, to the a all question patients caregivers thank to a They all like a hard we in play as in critical participate of the well our open I'd our like Before the With extend call success. take moment team the to please? studies. and can entire take first

of Yes. line Fye the [Operator Instructions] And J.P. the first with Morgan. question from is Jessica

there. our quarter. congrats for us. questions the Hey, Nick. from It's questions Thanks Two taking on and

say Is half First, line data top like of that that going half sharing you're of XXXX. follow-up of looks we first to to just the that. top first data was throughout But XXXX. the ARISE And in sharing the previous it line not -- guidance a won't be share get like XXXX? to for that kind in after

Yeah.

of a just PRO. would arcane, And without is is dialogue underlying test study the ARISE to are the try validate into its know primary understand. queue, say responsivity. so the in that the the much bit going too what PRO sensitivity working. the measures we about through of And little could that this is And and need we I So objective you people way that to that called to

one of who and of these year the completed patients expect the the are to answer the responsive in other. get first a versus terms questions can we on sensitive So assess therapies. in hand, and change showing Once those in in half to is various we that then arm PRO is the

And validated data those in the versus you point effective also think view top assuming the been what and and measures will be first PRO that traditionally culture using I will of to would half So suppose the of sort be they've way be of the line is results measures. will the be second in important other then half and will the is, Those one first that arm half about will the simplest year. conversion. include most the the working this of the in sensitivity responsivity think from comparator

range And the you Great. that the Okay. hours cardiac PAH trends on on the then effect small first of favorable six-plus And about? kind just you you because saw that within of of Phase strength lowering or is XX in using the can patient signal? of one, hours because PVR you're in second size sample of that elaborate the one the trends Xa measures are over trial thinking the

Yeah.

the balance to only discuss. of of could study one this And we So challenge have could the -- we the period I Q&A patient. spend

this description this how with That's things very view patient. to why internal have this our of in gone seen sort our So have with represent cautious about be patient. well been on we've is we've we that we what generic

weeks drug don't patient this draw its measures it the taken going think you weeks are setting what other was to continue I to that but difficult thing away from experience. on way conclusions a patients, of was with the idiosyncrasies for part. most drug I on where safety we on micrograms to wishes that related is patient's details the issues what the up that titrated the see leave to drug I the in study the are each beyond wanted that from And or think into the this and without We ICU positive was and XX most with a were back think to suggest important without take has should continue the specific the to XXX hoping successfully once-a-day XX patient. to difficulties I of is area this make for that you aspects there treatment. hold performance saw and The caused this the performance, sort us would

max be titration we All extraordinarily in micrograms. dose of label that consider Tyvaso's And their remind I'll after positive. XX to you that is

that So consistent do we to from XXX that and expect with to extremely programs. for to in what able to well bodes the this be were produce got Phase patient able X X measurements we temporal we Phase

patient. difficult we PAH how it's still their is the they is find there PH-ILD If additional mind in very open, from Xa patients While are to encouraging either now But technically know the focused put come certainly one share been that data the a Xb patients in any study. or right PAH on in X my study investigators place have Phase Phase that.

Great. Thanks again.

go from Your Please of Morgan Jeff the next question line is Hung with ahead. Stanley.

Even keep there should seasonal reiterated growth year? even can are a dynamics that a have Hi. Thanks for rest the my taking slightly quarterly questions. strong the think declines quarter I XQ, then meet we the mind? sales after guidance, And follow-up. And we about which you from how of any if headwinds you should for the XX% in

of leave us the the this that everything thought. The had been part one I've CEO on. to have and is this XX it COVID just I woken years. Every taught everyone humility of but is has didn't This with degree that goes a experience I best hate quarter anymore, delivering. has even for since company company about in caution

not different so what on commercial to our And group. be we about the go of on maybe, that and all think mirrored where the a we see. I a takes Sara couple come and tremendous half operational momentum, areas. way things could world I see of do that around about in within is the to research you I'll are the there the and but clinical When those ask year, And second with performance by in aspects she the the comment are. into of down second of year trial side awareness half I where the happier sense puts

sure. for thanks Jeff. Happy and the Yes, to, question,

Yen change about So, the in this as exchange today time XX% the year change just rate see all in in you the foreign XX% versus headwinds, a Euro. last

as about significant think headwinds, foreign some we exchange. So

these we to basis least revenue And on encouraged and XX% so reiterate global despite excited be really were able headwinds. growth a to our

the sort first that's that to So of I is make. think important point

COVID and as mentioned, has point, peaks the second The valleys. its Will

news just $XX.X we we instance. COVID significant the matched a Despite I see you in all able up think revenue in in Japan million read were in some quarter XXXX. some in for to put -- that if very Japan, Japan, essentially which -- our of

optimistic So organization least where nature really of proud the about encouraged just our and of. of we're by the going we're cautiously revenue XX% a reiteration at momentum guidance on really sort

in Xa? if can of patients to a think year? set on patients you Phase how or Great. more I TPIP data additional still Thanks. you this patient data? I And do you first just share Otherwise, guess, clarify, many to do the expect robust need based that then are present would more deprioritizing And I Thanks. you guess robust enough

on we've that represent get cohort. Xa Yes, if always a half dozen a probably interesting we would built an could patients

one be all in investigations I what a at extremely while. been that gone even happening enroll at say my that's you well-meaning perhaps arena accomplish. opinion more this really for encountered out from is, hospitals going of up it patients What they've actually all had something very And catheterization. would to challenging. is could few the We've ended now put even best knowledge, and here of a to we right been discovered be the key done site we've never giving to six. we been his practice, that could that early we've doing which that felt than got study, hours, on he heart That's guidance from never he in site. are as of who but that aspect it try alone we a think challenging wasn't this needed leader is, quite his know into patient fact. close And the once XX-hour most What to a nothing in is the

patients specific. The this all right heart hours get even or in So is highly very ask surging. of it of a whether to find patient of huge and for not physicians makes to of a the volunteer that it's catheter ICU, selection is cautious. the the someone consequence to is COVID The just difficult treating is XX

is right longitudinal going XX-week this that, the data. out the Xa the think I the of one has that. performance study one given up-titration We on the quite have that and hurdle what of get accept to confidence, what in more patient before there's lose patient the that be the sleep next seen. see than environment study, promise whole quick To the no would us to XX-week was teaches that's we XXX that lot the end probably the quick the program successfully of we And but drug one a the going look patients me said know by the that to go this it. have on drug of tell controlled eyes a that we here? encouraged be do so from study, study you that that But in have was this us from data given and we could micrograms. I PH-ILD us been and we has of everybody, the from exposure, in I'm year, And we in the anything, a And give based guidance over comes idea the of we where bigger should as next to and showed study which on for that pause nothing physician. not If certainly to we treated I'm remind and snapshot to remains, contrary, successful and gives a wanted

the excited that described. catheter for heart about challenges be what patients anticipate to I've is X hurdle it's procedure will recruiting I'm not show that really in Phase the We programs So either clear, do that the right of here. onerous

PAH could so patient And them attention in treated. to any our and get really eligible turns come where

you. right. Thank All

Please, Sachs. Your line Tan next ahead. with Goldman Andrea question is from go of the

for Good the magnitude the build of you in Japan? that for terms you morning. you quantifying my just in taking question. saw of Thanks one mentioned Sara, inventory

Sure. Thanks for the question.

we handful can view but So these internally something and left. And as a had something that weeks. weeks is Japan for see haven't two of quantified that that we you we around traditionally something it forecasted anticipated, you in it,

what you And to exposure it able Medicare if might like look your characterize brenso? if just any then, wondering have be And is you on then, what current for Okay. for ARIKAYCE. might thoughts

Yes.

touching Part I of these would legislation looked the out-of-pocket don't that's the us cap on yet. why if the it's XX%, for a bit, Brenso, as So, certainly very and answer a this we perspective, the that don't proposed would little know at my about it. time from is both you're ARIKAYCE last now, know right positive D on XX% significant I that our former, costs for that of for perspective. to it from being the be on But

a lot. Okay. Thanks

Your Cowen. go next Scott ahead. question [ph] Please, the Yamil is from of line with

a had brenso expectations? versus I Ritu. ongoing for rate on event I'm What study. the is question regarding your Hi. the

So expectations. even up are events a tell would regional The a actual we study, that successful more ensure repeatedly what rate is we able and and is basis. to weekly make an we our we're blended our is would tracking here that, can seeing I enough be we're that elements seeing. recognizing are where study seeing -- very are effect at happy level. on that a that the event with to this a that what specific to we're one haven't the we're you I events medicine have blinded demonstrate that see totally basis what disclosed that the goal What match And we said is we're on

good I about are feel where we good where brenso. ARIKAYCE. we with So are I about with extremely extremely feel

studies a basis, looks very and albeit on the performance, good. of our All blinded

detail regarding study pursuing approvable for on the would patients endpoint some follow-up quick be? the the and one And study? potentially or How CRS you're what many us design endpoint the Thanks. study, more the give the can of you

Yes.

So looking at. we're that's something still

solid of focused is, cetera. to say at what detail around would the a be looking pretty at. think we've behind a We'll the that design and incident I nasal handled et logic thousand got basis I in best I importantly, and the design Commercial and the the go Day. probably Research it, What it's handle sizing the about into that of more just several of not on spectrum patients we're CRS end we're a prevalence. severe population, that's global will going that polyps, reiterate hundred on that year, without

So to that that be with substantial be Nothing reason is successful. condition very the of deal emphasize how that and cascade a very, inflammatory opportunity. believe gives I a next approved the population really half the time be to in DPPX we're that into that every would of which treat confidence mitigated this looking kick-off and And that could can't neutrophil-driven us the could great the reasons inhibition. lot at coming design spending of to why significant make a one first study, that's phenotypes sure we're year. that will of additional on of patients different

Thanks, Will.

next Instructions] go is line [Operator question the of Frommer Credit with from Please, ahead. Suisse. Judah Your

Thanks and Hi, quarter. question taking on the Yes. for the guys. congrats

the the off scripts? Just you're of limit of message and just the that information of coming Japan Thanks. Is a could script you ARIKAYCE, getting? more on where retreatment to scripts? separately, impact come that the color two-week trajectory how you seeing And in dynamics can dispensing the remind with you're what's Is for And you're us was kind it hoping it is as that docs? tracking talking anticipating then from? little

Yes.

are menu ways we to just can of given things haven't that are a of what there. at look we driving trend detail around there the we've With say, ship seen retreatment, overall, I definitive very elements So that I positive. are more a number is would respect And lot specifically, a that. things. say

prescription patients, the and identify the opportunity infection because as with it And patients new amount infection. With period it. that long were able seeing it's to I where we of can that time. that extremely So drug But evidence in to a what getting of these be we're coming the for being are reinfected in to keep restricted treatment were They a is that the Japan, drug and because is It the the get to now role enough successfully script every same believe consistent weeks are in the been a these for and regrettable because way now for patients market to feel is on new enough able obviously back ultimately, long the We've ARIKAYCE least, first that year. two they infection for I'd post-COVID in that but two-week eradicate thinking retreated and well. environment, have for ,what with patients us do And returning a areas encouraging retreatment get think a we calendar ubiquitous for is larger for again, at environment, that in are susceptibility. bodes the of in saw pathogens trends Phase of world way. in we that's the is, new ARIKAYCE long physician respect the comfortable play to X for meaningful trend. infections they're where of change, and about just we say comfortable to that patients represents the really talking

can they get handset every restriction, to to that month three of lift months. get up the a have With anyway. They

recognizing patient see comes So back for you'll prescription to some but you're albeit, handset the they're once the going a fills new that, longer around see inflection probably month not dramatic a -- anyway.

Got it. Thank you.

go SVB ahead. Your Securities. Please next Schwartz Joseph question from of is line with the

questions. I'm our Joe. Joori Hi. dialing in for Yes. for taking Thanks

the is how could, expect Xa Phase we when one First trial? that? TPIP, your to representative data for see And the patient on PAH in

Yes.

holding be on would hope I'm that -- not breath that might my other we my patients, So one. we'll see but

to my said to Xa. I the they'll traditional I I enroll. length weeks -- I PH-ILD are studies, are easier focusing easier each the than PAH on be mentally before, XX as have and to I shifted enroll think in think much X much Phase be that'll which very Phase designs, know Xa and

it's I see individual going patients, from why of data. think to single in you're which idiosyncrasies always draw broad is to conclusions patient a hard

the universal target think takeaway product that And can results up them titrate accomplish, TPIP most is you do. then levels, to you you know moiety previously you have of what higher these been which the a to is, than what if objective profile. able and vasodilatation, important are will I patients in accomplishing can with they treat a

one a more you're as unbelievably And And to right? Xb We these I saw physicians, fairly open at PK/PD and which to is to what of successful we've these a be dosed that's way Tyvaso profile at a too of and enthusiasm that looking other Xa next is convenient the studies promising looking powder indications them. in end think, for as doors that clearly, are with there nothing represents group market by great once-a-day pave they that leaders profile PH-IPF, of right? opportunity, the treat year. wherever And which PH-ILD, intend PH-COPD key incredibly what three opinion dry at You a doing once-a-day is are and out from we we it way, a the the Those to in trials She's patients and getting significant low out see the it treatment administer goes, this go I saw powder trying dry approved in This drug drug patients. this and is, additional. formulation, to X X. to want I because profile. deal what going for certainly an the in is the the There's running producing. in And heard is ability it should and inhalation. an the something think, that's specific risk more Phase the well. Phase prove in therapy, Phase, we of We to successful, will Xa expect patient Tyvaso

ASPEN to trial through in the question expect brensocatib. like, bronchiectasis? is my your this CF on that non-CF does X Phase study X Phase how next Okay. And we in should what patients read to guess PK/PD see year? And from I

PK/PD metabolize to a in to condition, patients see doing that those whether as of the slightly need level PK/PD GI dosed drugs again cystic to get to the whether study, patients fibrosis who profile higher related in at result the patients. So we're track other same we differently be would complications examine will is a their

study, be this not designed the It's pharmacodynamic efficacy particularly in expect that wouldn't effect, doses a think biomarkers, of Certainly, the So XX-day four startling to short we'll I two be is But we looking positives. but about drug full would of time and looking that to major takes we to those at study. if the period weeks PK/PD what get given see changes. an at is. that different profile to be did drug

particularly PK/PD we I say a to go will so and is what see lot but sort that's drug. certainly after us allows expectation. right the say that we we know And to could CF that it, And think, for the not upside don't I secure of the I it. to it's dose program, exciting would CF have patients other If expect, to than about need share to we anything, what into for approval go study,

you very Thank much. Okay.

Stifel. Willey line Your is with Please the go next of Stephen from ahead. question

Yes. taking Thanks couple just on of ones. to follow-up questions a the prior Maybe for

and proportion how the I are terms in study that background see PD, on Phase to of the between do on guess, just a meaningful differential PK patients CFTR the can metabolized? to CF speak So therapy? expect the on you two based X of drugs And you

Yes.

that of many patients we being two are So more obviously, modulators. CFTR in treated with terms the have

fairly the are really is that to important so point. ubiquitous, that Vertex and check is And a patients this wanted those responsive for we drug

treat expect or we CF patients. work to not. trying all what we're to And these the drug, still in which experience CFTR modulators are whether they're on Our exacerbations, patients

expect the that at a by want two find study, So because are we both Those are make all those there would study one applicable are distinction who CF background points to But completing modulators. to major are the to have of I the patients to It's between on that's number and fewer CFTR them don't appropriate dose. are of have to which and not. on smaller be who split harder obviously. see this the we the therapy that a patients not is

kind about net of earlier. maybe me, of, can should as sense guess. growth build know then I Thanks. and And we how helpful. in just Japan the a is inventory be That's that you of that a handful was to weeks But you provide quarter, just can get rough quantification Okay. just that forgive Sara, if provided sequential the I of thinking in for And during ARIKAYCE there speak way gross any to then, characterized representing, you some geography? to that

problem. Yes, no Thanks, Sure. Stephen.

the So gross the XX%. in US net for to was quarter

with Japan, said you. close talked So had so guidance rate foreign reiterated that's you can full previously. little that Japan like probably In handful again is enough have bit headwinds about a the about in probably no our builds, exchange the two estimate for weeks surprises a consistent inventory we a last year of for mid-teens We year weeks-ish specifically there.

trends, it quarter that And encouraging. just broadly if always look been a seasonality the you $XX.X for has quarter. trends, historically despite those QX the has performance encouraged as really I in More really historically if you so think spoke US little Will up of quarter momentum as basis are some at a well million as look that with bit strong at about us. QX franchise in global headwinds again, to our last really, year is think you put lighter to. ARIKAYCE on the a this But history in a by but of best we ever

taking for Thanks questions. Great.

Yes.

Please ahead. from Kim line the Cantor is Jennifer with Fitzgerald. of next go Your question

Hey, two taking thanks questions. for have my here. I

will read your that saw year? the is how change, data always you ARISE the was on just of anything how you terms half in I'm out out. said XXXX. in that the throughout I coming coming First, second that the know color drive top-line of wondering did or

were on underlying thing focused the The saw about arrival we're the That's of when instrument data. teaches the PRO what we ARISE, reference is we always to making data coming out it how first itself. and us from foremost

again, that meaningful for by -- to ability and that the an overall that feeling on so and the a meaningful two are mean mind change responsivity. of important sensitivity even documents of patient's those clinically importantly for the is And in what the for components there essential are the we experience And questionnaire And be. PRO to are measures more FDA. improved change well to correlated the be the to be valid considered based

what it's of Does year. PRO know what about think meant half the And the that's feel to And next I being There good do using. instruments the we'll do? that so in we're we say first would outcome. that two we are

QOL-B a you, and remind then a fatigue -- of to measure one is other fatigue is the the Just instrument.

those can their see of perform the well-being are which we and study so to and if of the feeling one look then at minds. then we both patients arms accomplished measurement of then with in And responsive the the that goal of sensitive will capture they our better. of have primary And can we that in and validation, these course two

the of is is that study primary providing to primary endpoint along PRO forward the looking for data important. we're so US. the ENCORE also conversion endpoint the the Japan The for whereas of study And which culture with

that's year. hopefully helps next going So explain to unfold that how

growth and or fair going US, like I that? given should should way we there keep we lot second specifically is a think of there ARIKAYCE. My the a you about future quarterly is on Japan But that think color anything question to something is is the think inventory you. about mind, Thank that in that XX% you've that guess Yes. and in back quarter-over-quarter growth? build And how to FX impacts

that cautionary say that there. second year, half have are going. I I word But seasonality with mean, we of feel made to good coming some the comments regard the about very where only would where Sara watch to about into trends we see and we're we be my

world our them. the I about where work a COVID that gaining were able out means year in commercial just are the the team were a in-person successful has diagnose XX% and for coming exceptional return performance, in that see last that more activities rate choosing a over and we a office weren't live to US, people think midst world in corrected engage strength. diagnosis the physicians visits, been And mean the post-COVID we steady where COVID this them XX%, which revenue in effort. if to way to year, plays NTM a we to diagnosis patients normal allows share we have has of we down that in happened in call more with just the what to day-to-day due in done in rates think to weren't I to still have last I or maintained our

that As have some we my we could things provide up diagnosis We'll and our to to return to normalcy, again pick where that go. expectation efforts. rate see is tailwinds would see

We saw trends. in retreatment improvement also the

different trends think excited approach is of becomes the third which see the these And we'll lot but watchword. seasonality, a about, as more be So caution there's quarter we I to manifest.

quite out I Japan moment. there call COVID is think the the in at is of thing, extensive presence would I only the over

or But the first year I of beginning So the ask the that said in. would have half results year we'll have stronger, what the I think of the to me going the second if be second to see you is at in would half. do

headwinds very was feels of. the where company think the half real ago, the continue how from the enter I to I I of but proud year describing conservatism with mean year-over-year I As and mean, FX. go have of see but growth we is XX% we're accomplishments Japan off we here. we'll it a that second in XX% year kind those are caution, from

guys Thanks, congrats Great. quarter. Really helpful. on and the

call. now turn the of the This any closing remarks. back portion Q&A today's call Will will concludes for Lewis to I

our joining for all today. call you Thank

conference financial results you thank call. gentlemen, joining second XXXX Insmed's for and quarter Ladies the

disconnect. You may now