Insmed (INSM) 22 Feb 192018 Q4 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Insmed's conference call to discuss the company's fourth quarter and full year financial results. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time.

As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Blaine Davis, Head of Investor Relations.

begin. may You

morning, to Good results welcome today's to XXXX. Thanks, our everyone, fourth call discuss financial quarter conference Keith. and and for full-year

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

the Will prepared Executive your the to Joining Tombesi, Chief that, members open today's With management and Roger our Once of are Commercial Chief to call the turn and we'll executive questions. let President Adsett, Will. Officer. including call me we call Officer; Financial me Insmed's Officer; complete Insmed team, remarks, over Chief on take Paolo Lewis,

ARIKAYCE treatments suffering for to this the previously condition. of patients who Thank a for for specifically to was approval ARIKAYCE. a and debilitating disease lung therapy or and Insmed, approval hope approved you, patients pivotal that offers with alternative culminating their had thank Good is everyone, joining Blaine. options. MAC limited of from no launch indicated disease year morning, finally you us. XXXX the in refractory the no treatment of ARIKAYCE, had Prior effects

understand. breadth the key in are with it prescribers we to the early of remains But we launch, are first and our the including strong variables in there still launch momentum We months some patients total therapy. of very initiating US few need seen have pleased and

much in momentum. XXXX and to beyond have sustain work We more to do the

market to ARIKAYCE million However, in we are full-year for enough to confident XXXX $XX provide understanding of $XX million. revenue the guidance our current of

is biofilm. to aminoglycoside care. now an PULMOVANCE. brand a standard penetration shown draw effective lung ARIKAYCE is amikacin, of uptake and liposomal in into regimen specialized a of antibiotic, as of increased This the has a macrophage as current useful. We identify potent I the to that your encapsulated the early ability combination capability technology over areas want as significant to our by millennia, we attention this exploring other have view further we may of where XX% and a lung XX,XXX For last research formed our one older biofilm, estimates, defense preserved our by spend product population, complicated an The on the and we're to who increased story, treating. the MAC rate associated commercial off-label a Based declining may multiple associated that let is is just and disease on chronic not affects is we function. disease an often XXXX moment with new lung a rare patients typically our lung with do MAC those lung to antibiotic me mortality infection disease pulmonary or irreversible comorbidities. XX,XXX disease to progressive damage many you as in believe and to the sentence. been my mechanism be as further through the technology penetrate bacteria respond and US be

our Roger a like now XXXX ask and will update the the to key for approved approved then in patients results in I we patients priorities this our the will moment in last and technologies seen financials. I on only therapy are with have ARIKAYCE, MAC FDA spend the for disease its would safety very cover specifically ARIKAYCE these detail. discussing by now is Paolo efficacy launch of disease. specifically lung treat a to first and commercial approval and We provide then year. treatment have culminating an to excited our

successful The achieved efforts results early by first of and a continued most $X.X the ARIKAYCE. launch important US fourth of priority is demonstrated US strong in to on success focused as remain We our in the execute to laser sales million quarter. our

mentioned believe launch I results, as and very However, lies ahead. more beginning. this earlier, it is in with the just pleased the much remains but work these we We're early

the And further expect to our the to understanding year as the progresses, more product and refine of the have information ongoing. efforts of Our market share. performance we remain to

optimistic. just the a cautiously Roger For now, will moment. very encouraged our early detailed by commercial and more of results cover remain aspects we are in launch

our which Our setting is complete full lifecycle the frontline of will lung is be patients a a by disease. confirmatory trial design to approval next of study, clinical in conducted of plan. part protocol the This important with of the priority FDA as as management MAC the an and well for requirement ARIKAYCE,

and hard in of work this expect have we teams half development at process complete first Our been the XXXX. to

with roughly ARIKAYCE of the ARIKAYCE virulent in in an in evaluating XX% data caused We additional patients, unprecedented of investigator-initiated culture an XXXX Meeting M from presented patients NTM May study Thoracic and in at Abscessus pathogen. these the to explore conversion American Interim were are also Society by result. showed Abscessus, with clinical M disease patients lung efficacy trials ARIKAYCE a particularly

prophylactically comprise for a which in the ARIKAYCE exploring indication the high We believe these with refer NTM recurrent maintenance therapy, eradicate lifecycle would are of seek XX% management seen a bacteria Currently, infection, this patients to with treat as use rate the would who what franchise. NTM. We more about setting chronic ARIKAYCE to three are in within we maintenance opportunities Collectively, reinfected of prevent patients represent disease. to also treating meaningful advance years. a of

substantial satisfy authorities, the with represent serve opportunities regulatory expansion in clinical the trial patients believe we outcomes to years. medical many Assuming these needs unmet coming label

Japan Europe support for regulatory disease to regions in represent first in These help from expansion our worldwide. an important the suffering global patients XXXX. efforts half filings of in priority is potential ARIKAYCE third opportunity MAC to Our and mid-XXXX to continue lung in

take compounds global reach. the our and into ARIKAYCE pipeline growing also for efforts in our planning lifecycle account Our

our trial Our completing indication. to diseases. this bronchiectasis. patients fourth potentially action have pipeline, intended in INSXXXX very bring to efforts patients market and fibrosis Phase to enrollment rare currently of with exciting a with includes six-month for priority of help II non-CF mechanism part a bronchiectasis This INSXXXX non-cystic program our to to specific approved patients by pipeline. This mid-XXXX serious novel for utilizes is additional who therapy no therapies of Study, advance our continue the global which is with our is in WILLOW

II results the And expect expect to Phase in development XXXX. registrational study would positive, the We we early to INSXXXX if from results trial. are advance

also rare that advancing in INSXXXX potential that II exciting that formulation for will extra that including the if seen model offer arterial We're neutrophil-driven this dimension we inhaled drug's will small benefit in will patients we PAH, disease year, could potential profile of this program polyangiitis, suffering studies untreated. believe addition, an of product differentiated or in its some autoimmune advancing potential explore GPA, with Phase add a animal development granulomatosis localized be treprostinil pulmonary an patients. work hypertension, two recent to PAH is from treating a for impact In also in INSXXXX fatal our or

explore highlight nanoparticles have these imbue unique liposomes and as some this serious mentioned biofilm unique ongoing to I'd several research As the earlier, programs, of teams development ways diseases. as may the our beyond applicable of the of research platform effort, of concerted that and to our treat capabilities technologies penetration continuing that discussed include to frequently I we diseases. properties programs. is These programs to of a like well research be leverage areas Through skills potentially which variety our a two in molecules. of serious to team expertise

on focused first fibrosis and early-stage is as infections, such MRSA an patients. cystic The gram-positive lung research program

this refractory developing heart such or biofilm mainstay antibiotic showing those that to replacement infections, subsequent A on second settings fix the we a require For novel program superior that diseases. testing valve can surgeries. serious as for are is treatment and potency surgeries to many in vancomycin, found like significantly focused targeting that is postsurgical treatment in of joint of antibiotic an in is program, vitro gram-positive are

are to we say more very rare, encouraged address are conditions very to their to XXXX While to this Insmed great them expect year and start. we serious a both potential later have by we about year. exciting early, facing are off be programs for patients another to and promises

who the turn to now additional insights me call Roger Roger? our commercial provide can activities. into over Let some

Good fourth saw everyone. early like Thanks, encouraged recap today quarter. US to to ARIKAYCE take moment we a the trends I'd the by during launch morning, remain what Will. and We

have reflective on both is Phase disease launch treatment our in MAC Let or limited our patients me XX,XXX US label the study. in of patients of language you remind III to FDA-approved that estimated This options. who pivotal XX,XXX population our and is the lung in focus no the the

France. more to program the had XXX therapy end the physicians in use than is for first We of $X.X we are launch, prescribed we patients XXXX, US is $XXX,XXX of the of million, fourth ARIKAYCE early million XXXX, our the XXX in $X.X that, authorization of pleased quarter and of very the In as temporary quarter net have was attributable that, which our and of January, reported approximately attributable initiated announced in launch sales to which US.

and We ARIKAYCE the start to distribution quarter physicians first-in-class between our guidance additional clearly for as at there pulmonologists. earlier. steady in a prescribing date, launch these any metrics supports doctors also continue to encouraging for rate, million early you view revenue Will treat. that the very have with intent therapy. and to on roughly disease that feel We to first of an particularly XXXX updating mentioned so look new Notably, a which, things, seen among May. forward million we patients We and equal we've patients launch, infectious $XX product our of other are call $XX To results

results to team as deliver ARIKAYCE. strong sales continues Our launch they very

X,XXX physician X to targets, down broken We X. key have tier tier approximately and

X physicians engaging year-end, from perspective calling detailed these scripts team has year-end, XX% about XX% targets tier about on approximately Our of with X coming and two-thirds market tier and access well were to where uptake non-target to some the targets of our including targets. Market by as formulary actively of with multiple with select physician. I of been VA, Medicaid had VA, Medicare now and progressed and important Medicaid federal as early as to in well for place TRICARE. has now DoD for access as plans well, editions programs plans, turn Also, ARIKAYCE as tier X we've as generated of physicians, federal including X commercial had and and, want remainder tier our wins. programs, access commercial and to access and and

efforts their with Our are they negotiating payers focused meetings key as on hold currently of committees.

hard reimbursement. Our key continued hard in work at remain account efficient of at directors support

positive date, working to that there trends for patients, Although will reimbursement seen are the process is and product the lung attestation the generally through we've continue, MAC guarantee we physician to being is refractory continues. reimbursed disease appropriate ensure that no

expect XX% process, provide remove payer the quarter, of we select smooth Approximately during to plans patients year. ensure formulary a to contracts appropriate for plan eligible executed a are XX% during blocks modest Medicare. the first to and incentive Additionally, authorization and have medically an to offering our make decision discounts for prior

in hole So, in watching affects initiate therapy. intentions the of the year, closely also commercial Medicare to calendar as new a how deductibles donor of we reset enter impact plans and and this patients' are the the we

to not in While XXXX result will we in provide when contracts the gross quarter. update these compared on nets an the of increase the execute, our we guidance, donor the call providing May. fourth in net impact trends gross during to our hole, in We'll an are to plus

better we trending We encouraged XX our XX assumption of than to original metrics, the days. also which by remain time-to-fill are currently

many will key about As factor aftermath, launches A reviews success in is to we be update think this committee support disease on to their to progress rare patient for launch, able an forms. and the P&C metric. how we provide

of and the and supporting having team throughout MAC thus patients. I ARIKAYCE positive the in-house continue strategy team momentum have with launch they is believe enough patients the say we We physicians are extensive with on are US regions, an well, lung resources field-based is our and about disease. while we regulatory launch execute even our launch, exceptional to excited our on serve We maintain patients are Support to refractory focus our experience, have and would and hand like impact both to can't approvals. we I throughout energized our opportunity and stage all year. the so. strong more I the that I'll program Europe that reiterate With to lung about efforts of also ARIKAYCE US like the in and disease early over momentum. continuing. patient necessary for our you to Japan, network that, today that this must other the launch very XXXX We're the potential and at following global progressing right the And Paolo. expansion personnel to MAC and among do sharing about look ARIKAYCE progress and to the forward call the with with approval

we revenue million, the half morning, results sales total million few our of Authorization morning, spend and of just Thanks, minutes reported our sales. The program full-year the guidance comprising first financial $X.X or for cover net of for everyone. of US Use, XXXX ARIKAYCE I Temporary will we'll million XXXX. authorization of from France. a of $XXX,XXX and Good Roger. of ex-US This net other then $X.X reviewing and ATU, sales revenue ex-US $X.X fourth-quarter the net financial reflects in

$X.XX development As of the share net quarter reported we statement, the goods or of income fourth $X.XX XXXX, you fourth of per per like that certain million expense. the that for will cost with sold is comments quarter manufacturing a some of $XX.X approval $XX.X of reporting the I'd net a quarter was on or the Cost for with margin, and a our XXXX. loss loss we're add share for for fourth compared see million note gross additional company to help this as $X.X research to Please time of million. Since material and prior spent first modeling ARIKAYCE, may XXXX.

gross to continue impacted through reasons. margin margin initiation in Only We duration The negatively used patients. in XXXX by of nebulizer vials the ARIKAYCE expect for for inhale the of launch unit upfront therapy. gross gross that hits particularly margin improvement with will the the of of to first associated quarter new cost portion therapy see ARIKAYCE the the upon was the for the the of cost following control of

the of ops fully addition, of tech production overhead to the associated an sales grow, have In of overhead essentially as expect the gross the see we tech allocated expenses cost, the we improvement costs with Since ops ARIKAYCE. allocation is the fixed in margin.

$XX.X development expenses for quarter Moving the quarter in of on, $XX.X million research to the XXXX. fourth and million compared were

with $XXX.X For was manufacturing an were increase R&D the full the million year The an higher and SG&A expenses expenses of external XXXX, increase for fourth for XXXX. versus $XX.X quarter expenses headcount. associated production-related project quarter to of XXXX. due due to $XXX.X compensation the million and in million Fourth million $XX ARIKAYCE, compared in primarily versus Patheon full-year expenses increasing activities related the were

compensation due launch million year For cash versus the were to to increase and full expenses $XXX.X increase We mainly ended expenses The of higher due is to an in increase SG&A $XXX XXXX, in related $XX.X and XXXX. related year in and equivalent. the headcount ARIKAYCE. the cash with full for million the year million expenses

Let the me a XXXX. our half for guidance spend XXXX. The activities first is reviewing in key investing financial in moment the company following of

continued the and ARIKAYCE. launch commercialization of First, of support US the

required frontline with pipeline for approval trials development be for of clinical the management of confirmatory the post-marketing program. will WILLOW our as support our by well FDA, as ARIKAYCE, the ARIKAYCE, the Study, as II study INSXXXX, advancements as in which as a conducted other along lifecycle setting Second, Phase program well of full to

to the increased of Europe buildout third-party for facility. additional this in facility Third, ARIKAYCE our production of region. global precommercial manufacturing Japan fourth, corporate and support regulatory capacity the an And activities at in long-term and expansion new headquarter

be result the of in cash-based half of a to range $XXX expects activities, $XXX million XXXX. these Insmed for million As operating to the of first expenses

cost stock-based exclude intangibles. press As sold, and a expenses of our reminder, compensation products expense, amortization operating release earnings in we define cash-based depreciation and of

the $XX $XX facility of the capital of range support the the in headquarters half the to addition, company expects of million be large-scale first to operation in In XXXX. new expenditures for million in manufacturing

cash expenditure this are seen In investment on to US world. growth continued remain of stage-gated the way, and, as continued expanded All an and here launch. revenue predicated be our expenses both our of ultimately, should success support and the around significantly

As already to back will turn mentioned XXXX revenue, million ARIKAYCE by million. that, With to Will. is Will, of guidance in $XX I terms full-year for it $XX

Thanks, Paolo.

by opportunities remarks XXXX have prepared never our out close a The looked exciting Insmed. that promises me us very for better. to year reiterating before Let be

rare believe generating We while will with shareholders. we patients for serious support have multiple that priorities diseases, value and significant strategic

our of ARIKAYCE continue execute well to believe in the treatment positioned we global in be of disease. leader efforts we the launch the lung the we NTM are As successful to US,

While on label, in efforts investments the our patients, focused laying groundwork the US are for line initially our in world. the and commercial both are around expansion refractory MAC with our

necessary support new capital production to this the opportunity people to in support expenditures need our will next that we bring to fruition the are Our capacity decade. and designed for US vision the to house the headquarters

we companies and are idiopathic XXXX. in Importantly, days the the protections believe disease, NTM of markets broke much world, lung pulmonary property extending changing key of the in ground significantly to the way pulmonary intellectual landscape have we We in fibrosis. that early other arterial around in also hypertension

with patients treat diseases. efforts franchise coming of a the years. company become is and Insmed mission will to reach. on serious diseases, our a will grow of biopharmaceutical additional lives focus NTM, global transform within Collectively, ARIKAYCE into we topic these potential in a rare expect This the to bring believe we to enable rare investing the serious we're Beyond forward to and therapies which investor increasing

the dedication. their and like Insmed work team I'd hard always, to thank for As

exceptional We whose success. in thank clinical recent have finally, and our to program. clearly we I for serve continued their the And, our are demonstrated an team involvement want patients by talents physicians

We I'd are achieve like to here patients please? lives to question and very their day, that, work can open to With important of we this the to make a and, families difference first we the Operator, take in hard every the call questions. goal.

comes the Auster Suisse. [Operator with you. And from question thank first Credit Instructions]. Yes, Martin

specifically, longer-term? COGS next, Hi. around taking first years on curious for see I'm for evolve question in terms you the three what that more year you in get current I Thank see say, of This and Maybe turning you into guess, can rate, Marty. more second what to one, expectations my could my that you. And Thanks half of little rate back the run the into for Mark includes one this my just how SG&A and is, the rate and to outline is a questions. details and spend, how SG&A XXXX?

ask I'll that take Paolo to question.

morning. Good for Thanks questions. Hi. the

first this the our alleviate due started patients, to a have quarter from will to incidence decrease moved course, overheads due the incidence the we So, XX%. when the new help inventory high start patients patients and of beginning have have of to Both, hit of practically course, the for for all volumes was patients, XXXX, ratio fact the And, to of was compared in new ops to launch to we the we to were overhead. of our the therapy because, and will of nebulizer. new production. we of of on clearly so tech inhaler, allocate at all the expense cost the course, first impacted goods the But of second, will

goods cost term. not expect long the a are decrease guidance ratio of can the for So, moment, are At the you during specific XXXX, XXXX, of But, we expecting, in sold. we giving a goods percentage. lower of cost the progressive on

of course, SG&A, of have support lot launch. for we the terms In a of commercial

US. in the are of the still first the We phase launch in

Arikares our launch So, saw critical but on in we – very in patients. of investment the the both to lot will we a investments is needed that still see the patient help support our promotional also support to all activities, increasing terms

in increase global in to will expansion. And we have We're the support the the are these also so, SG&A. key starting areas which also

related presence to there support are increase additional the also Europe to So, and Japan. some investment in

thank Perfect, you.

Thank you. comes from Harrison And question Morgan next Stanley. the Matthew with

XXXX you're our congratulations steady date. you Ishmael is for Matthew. on starting know Thank at you. of This on and a also, guidance? the Hi. And rate. this potential taking assuming persistence kind the I mentioned you detail Thank for question progress new how and influencing new Can key to on quickly, patients you give are other factors existing and more revenue for are what you patients?

thing have that the a had provision guidance one the that the some how revenue a I'll because in just thought year. later progressing. people surprise I of confidence So, say, do come going to originally I we may of say we in But as were launch the is to is have lot to

range so, is putting And million to today, we we've revenue that guidance comfortable feel $XX said a the out which of the consequently, in million. $XX

We other any call. additional haven't on provided this detail

As stage, may detail, the some add would put to launch, the that this weeds. at and we we second the out cut just we think, But guidance so I go launch, quarter into the revenue into there. thought of get you the weeks additional chase we six forward, into can

know. add anything going. helps do think that? to are So, to you Roger, where understand hopefully, want we else that I you things don't

No.

characterization think, that the think the really is – pleased I with. very I'm seeing, what I of launch we're and

And it's I reminder, we And clinical the a by comment our a although discontinue. contemplated XX% will happens patients a of first that think it's that of within had trial, the guidance see that, about guidance. rate, the that XX positive see we to from most in little momentum days. just and as too that's probably I discontinuation characterized Around I earlier. the early continues, think out on given

hopefully I the Arikares manage regimen. expect out – the what educating and with that sure Arikares stick to and physicians making about from to to something therapy, – with our and working that's we're to how the team patients reaching through that and that we're mentioned, them So, therapy of on importance as working the

thank Okay, you.

from next with the Stifel. Adam Walsh comes And you. question Thank

on guys. asked. on first, that math. question the questions congrats taking some my follow-up I and my doing guidance Thanks guess progress. been Hi, question a I've the for is, was just

If would that's you for most price weight and the get of low to December the on on $XX the stayed the patients you had the XXX year, of entire end at of patients current drug And the list at those XX million. guidance. that

the dropouts the So, – least, end other extent conservative, versus and seeing which factors or could be like on market or or implication may either the something after your in a takeaway, that. of pricing these my new then, in have helpful. is there is there slower either that guidance other at could be there suggests pace negotiations else XXXX the they're fourth or Any follow-up things, the one patient built other adds in contract the And be impacting to conservatism of would Thanks. I be color some guidance. just in quarter

behind much what on the into too appreciate guidance beyond wouldn't be I scenes. may read going I the Sure. the question.

launch We expressed of the progressing. and way the it's confidence have a in lot

think I that has variable. been widely not

very So, in year. think have It's to we early a it. the I of in confidence lot continue

project or So, will it's could to difficult where unfold. it go how this

by certainly learn think so the there, some that of going to there revenue though, At the put begin be we into to guidance learned this share this about think as where confidence us caused can we go. that. more, is details. we stage, nothing new could other I But out have will to people the

negative not at beginning or you, adds of prescribing would if indicated. of anything January. Adam, have future. provided we And to to we know, that. patient some just read add want new we'll what the metrics physicians caution to of that those you anything number to Roger, I example, in the don't return I into For

I agree would Yeah, that. with

the I think guidance within factors look is in still we're and trying – going are contemplated what are that rate The number. adherence, get to And net all revenue those run that there to the discontinuation, of gross things that the honestly and to as heads monitor guidance. our around the like. full-year to is contemplated

we and how say So, would launch our on the metrics that's to I that expresses we'll the forward as and confidence progressing, you more number forward. updating look the in go

As we more. learn

Yeah.

where about know? you're do kind second helpful. Thank about and give appreciate and that and of design clinical helpful confirmatory on just the put certainly And protocol expand kind some I on is you Well, that there. question are us nice study. outcome actual that that's thinking Yeah, it's FDA's And if the maybe in for in then, study certainly process in you guidance. approaching thinking my of you out you dollar confirmatory on the could based measure, some what are details terms how for of the about that what the requirement you you. That's

Yeah.

been So, underway. that process has

doing. with I been bunch coming up hard think at been we've at approaches. of a our team has work a different Maybe just comment what on

about out outside which get Phase this were hope, on drug addressable of address, trial would we that trial patient impacts really market the set are we for how the III the to post-approval might some – inform fivefold. indication of and Again, if have cross-examined the understand heck vendors a will data our setting, – using design We requirement. the the population to what increase frontline the including

characterize big in up a interested seeing provide expansion clearly, pretty tried symptomatic we I terms with come that benefit to design They, are So, have a lifecycle of it's to the very think able we as management. and be measure that. in would FDA some productive. will dialog with

designs about have. that I the good think feel we we very

we in to them their one. dialog feel And that we're more satisfy something will assure that than have with land we good on We about needs. that and

two those patients and look for mind, like FDA in we of achieved we culture seen conversion, six-minute indication our things the in is culture you've converters. that have achieved walk it was is only at that result over because, prospectively not and at need about talk good that study, capture applied who've look the that com, measures the the that ad of in my in at past to limitation reflect That's us was those patients time. to designed patients III prospectively Some to and have for for are who benefit the study conversion PRO, a And questions answering as only Phase outcome. just way those those that designed to

So, the is then patients securing go and path as of first our impact. intent the converters examining to down

helpful. That's Thanks.

Thank Flanders comes Sachs. with from you. question the next Dana And Goldman

that Hi. guess, patients on you this something here, will present culture-convert side or they six whether the more you do what kind I payers? questions. case one to your to first so I the not My physician to Is months? be after are Thank not on And able if of need or one follow-up. on assumptions, stay then, point drug the more have for at drive

I'll ask current practice there into just that therapy. on never keep The make a in to clinic leave. Roger the they as comment the is is, sort NTM the out Sure. of to comment treatment mantra patients the but is come that refractory patient, a observation I'll once minute, patients

who access Roger, read We'll the as I point. And months about out. conversion. XXX in So, do to study convert. think continue from culture on We represents a of extremely comment you giving I that and examine the know, them continue path market if advance drug those know drug want remain real that the XXX important these I that's for to the a don't to data think an patients potential six patients question. to after side

Yeah.

we to, guidelines. ATS the prior point pointed to, is that that by position something authorization I can And and looks with about them as like. payers success the where our have and do appropriate talk to them I what to think this was engage process that's we think informed medically on

six on guidelines. months helpful. converted, therapy provide start fact therapy six and patients patient very put and that months additional that's of according a to Will you as for can with something that to. have another if therapy you see not if culture we continue then And, the they that you we mentioned, convert to So, is certainly, And the point

something payers that's that we so, the And educate on. continue to

physicians think are I the there.

PAs they that that of do. payers are see working I think and to to these the is a practice. absolutely that patients, best And on think therapy, if they clinical benefit continuing patients medical they patients, their ensure seeing benefit these willing and with that reflect something guidelines a for now, it's particularly

just data be what also kind of plans durability full are there anytime but that Thanks. the I looking no need approval, we out it kind soon. should I data. for we from Kind provide of And my realize, INS-XXX. thanks. of think if the curious Okay, quick longer, the full for just follow-up. was to full And

Yeah, you bet.

looking a peer-reviewed we're out in that put So, setting. to

group. there. luck, any been included sort get at made So, is able the Submissions up ATS. have of But our to present with to be ATS to and it we'll it hope that's

thank And Ritu next Okay, the you. question with from Baral comes Cowen.

Good the morning, Thanks for questions. taking everyone.

guys. the detailing Some additional for questions you on launch

first on metric you detailed, of have detailed been the guys – that you have have do seeing tier of at tier point? when all, Second, of do expect of Xs. a on been Xs written? When you per to doctor tier patterns mentioned Xs writing prescription XX% You all you to And XX% the this most are by? of average tier prescriptions number do details Xs expect and

to ask address Roger this. I'll

Ritu. Thanks, Yeah,

that shared numbers as were the of So, year-end. we the

that effort. fourth the So, reflects quarter

provided haven't we on the first So, quarter effort. an update

as that team We our I to make we'll that sales expect a XXX%. expand don't ever calls. continues if will know get to continue to

Some doctors as you are doctors, no-see know.

task. reach be physicians. we'll time, But think that's we vast the to an that, elusive maybe over able And these certainly of majority so,

we're to think digital who able not getting And calling in, We it's efforts. see are is through and rep. that's encouraging, – on outreach we're our we're actually very getting them physicians send asking and actually I from to our

entirely I the from extensive the supplementing any metrics likely the where the with, I is, a period. We're depending breadth that And scale just may had and on the of would on digital a a program. that where say we couple have down the that more that tier handful X, who earlier on to X, of we're don't lot are have far and they patients on that there shows tier a of are. in knocking are they we're on now sharing So, just what non-target offices. very would patients on as had And feet now seen number relying tier right depending tier would say shared say per of we X we multiple I it's people in trial is ground, X have X roughly and tier patients equal doors not prescriber. physicians. right as

to give So, it's to gives work XX,XXX thumb of distributed hard XX,XXX an you of rule to average but physicians number, that with. across X,XXX a sort

of fair Is tier X these assumption? as a to you that hit Xs as many Got it. possible expect fair that say and tier by mid-year? And to it is

Yeah.

– have I therapeutic specialists physicians think that's fairly and doing fair to daily We've with calls patients. sized these who NTM there physicians. they're working their these out basis, XX know, reach a you there out on a assumption. And a as sizable put

get think it's throughout that see progress the to I to those fair we'll reached. we to continue haven't yet majority year of So, the

echo XX% And impressive I'll The fantastic add, pretty and want accomplishment. doing a months just job. in Ritu. Roger's is And a just three to I XX% comments, they're

item have Got application. left XXXX for gating do, a that for the Japanese application What's it. and I Japan? follow-up to given on European And the especially especially timeline then,

Well, US and this form. once needs so an as that, middle translated is will application it's the you it written, by their into have we even version, of filed European the the to whether know, Japan, or be European the application, you be year. indicated, put

it and, PMDA accomplish review done, we're sure will in that to So, make we that will talking we once prior on we their will that be be now for be sufficient filing is And resources and hopefully, is the that to task. We'll it approval. to to the have file. also aligned what place

confirming that, with going for know is data you generated When to are PMDA? you right to second, as as no are this far you filings? be meet there clinical the And Japanese the

That's right.

the as the of measure a go As it's that would meeting to gave a we different, always not have they be of think believe fully it's I'm is them in with you no first the one that previously time submission, appreciate. you now, any talk place, before to indication half actually right prudent next us but final sure year. I but taking to the when reason

So, any in don't bumps the anticipate I road.

question, you some for known time, I it. guy. Having last conservative Got a you're Will. guess, reasonably And,

reasonably a conservative got You've team.

surprised quite metrics you're upside. I think XXXX? most Certainly, us number identify Maybe you're this trends can a well-above-current-consensus to by lot this What are the that you the the morning important on seeing? gave. of and that you guidance that those in number you confidence give that were such maybe seeing for Roger separately, you

therapeutic that at I is good as appreciate And question, the starts team really I is way I've progressing. No, think about, Ritu. feel the that what launch had a And accomplished, with gives company level, what when give of confidence of can that with them, me that. the heart I they deal that the me perspective at lean including this team. I And the the commercial said, the interactions Yeah. specialist me on be that's comfort. can I It great think gives exceptional. their I on

fact physicians, beginning different combination come I first This the exciting I desperate I months, therapy I and will, XXX to January, think as And if viewed a I the they think on period. really in is drug breadth – think of selling this is the you from that good This of at itself. excess really testament after data, as think initiating drugs need. a is, have drug is raw data. metrics the when the look is a profiles three And scene. that patients at As said we XXX a of

so, think for favorable sets us that up And tailwinds. I

us lot out there. have the to is presented And year, that it a I saw a intend We this well. as think XXX, look when of And I at see I'll ATS are in comments, first Roger like, at will world people be it of treatments, potentially PAH there of much that the well. beginning of I XXX as is to this. leave help fact the data getting – is hopefully be to just The up ATS to There's dawning at come I the think presence a think of As number going drivers IPF of corner. around was the around big started. the it comment. my and many said as I attention one as NTM to

the commercial Will. executing And Thanks, there; building just in my would I critical. need. an is comments, things Yeah. there say I that I Will's physicians across as team write. unmet The I say that, would And two patients are the are willing is think, on the are just comment, said to board.

are team really the adds, absolutely sure the they've to working terrific ARIKAYCE and the making patients gets a sales continue relationships having patient identify got need we that to genuine and is offices very who see product. our patients hard So, for executing, with the to these passion

far Our beating directors, as out key are metrics fill, I I account think, to as indicated, set the time we those as metrics. we

having an we on, seen our we've any plans, and account hard And guarantee, launch. to as stories continues. working are And we the directors getting absolutely experience, the care. are the important for, these element, on about continue. educating There's well these We're I product for And think great work Arikares we seeing make we're authorization. paid then, them processes so one, the get our the patients reimbursement I with the on prior as key in coordinators think to they're expect successful as one expect that the field but success all people that those no that the and sure patient that doing the trainers that that's and early know, having patients Arikares success you impact directly, that time on with smooth working that

has and confidence execute execution be we'll on that I that been – So, I today. guidance just from I that me the provided to deliver what think confidence able far feel we've a that continuing, and what so to assembled the the team of gives see and we've just tremendous personally continue the that's that

are Duration seeing speak won't we But year. thought, some I I with still confidence this only can closing real there what frankly, add that and of the think don't we to thing late until, know variables a the I as And be far, on Ritu, XXXX. are therapy would so think like going know. what in that's world. we is We

Thanks the questions. for taking it. Got all

Sure.

comes from you. Schimmer Thank And Josh Evercore question ISI. next the with

question. for the Thanks taking Hi.

Japan, granted or Just orphan getting either the price for not you wondering strategy your status that implications Thanks. do what commercial in see of as in drug point territory?

take you do to that? Roger, want

Josh. you. Thank Yeah. Hi,

concerned I'm status orphan about not overly getting not Japan. So, in the

they we've for I good a Japan an there where implications usual, what think free the does commercialized outside ARIKAYCE. And And in us Europe. launch for relatively at a thing have, Japan, for feel goods pricing Japan, to launch price important is first take with we'll look scheme the strategy then with markets we adjustment. look the pricing minor. that of to think the most that Europe. to model it's at looked The is product priced the markets make in of UK is And Germany. and look our we in to plus primarily and to in then, a they cost as those and

is us Japan will launch. we So, pricing our think support and in the that situation for healthy

are is our just in and I ultimately disease as product threshold at their being reason first NTM And but would because, all, also that orphan add of looking spectrum. that across the particular orphan status is used they lower, of the lack for

that this spectrum the appetite don't the refractory So, NTM I the that said, the status, across for over and we've To impact, markets. a there it orphan while as to utilized has think, KOLs are this the we looking line use therapy, minor and person, speaks once data. I in hopefully, get think, seeing Roger country front really to generated the the is

Got much. it. Thanks very

question next CyberLink (sic) Schwartz [Leerink]. [Operator the comes you. Instructions]. Thank Joseph from And with

Leerink. Schwartz SVB Joseph from Hi,

you very world. a physicians are had patient to their therapy which management saw And compare respond how like? So, what what in responder how monitoring rigorous trials, the the real criteria in clinical to defining does patients looks

to Roger, do Yeah. want you that? take

Thanks, Yeah. Joe.

I more part, patient. some the less most centers think of of these mark see weeks But do going those from and the therapy. for in some of now, centers, would and although that outside if to mark, to say the the to early that, I you're on tell. say say improvement of that they continue six-month So, a into do test outside it's make physicians, and encouragement feel are at the they starting community assessments. for conversion, payers to And I to the would for focused sputums maybe early we're to better, therapy on, again, that are are to excellence, tolerate and at they culture XX-month inclined kinds physicians will see little take again, patient I launch can still the those the

Right.

confirmatory Okay. there? how of much information foresee guide and And then, the considerations design what some is the for are study and power you that to your available options for you

Yeah.

because So, benefit kind seeing patient. survives. I'll too metric many Their mentioned interest and giving in in functions – to some think their specifics. and is or usual hold we're negotiation FDA, the feels, with I the on off of discussion on I earlier focus

needs captured it be three measuring. those you're of in One to whatever is

are done more, gone patient or I we we've to So, of a some a we've bit function. And And perhaps obvious that looking on just the mentioned dwell outside, some at this go. cutting-edge feel in as The tools, six-minute of how using quickly, it regard, potential have, those the places through may think, walk serve as I a little data data lot I'll manifestations PRO learning AI. really machine exhaustively. or

were those And design where to the looking elements patients. survive think what database, the it of the where in We is this what complements design going is have and cross examined will key they feel, that. convert function we interesting, the in examine planning do. out or informing It I on study originally on for will the two is that how we We're terms then after lie. heck I of of that study and that's and converted to mentioned focusing patients

it that's kind And once with guiding it's So, detail, of share completed our in community. we'll design. the the all principle

helpful. that's Thank you. Great,

any back comments. to I the closing over And question-and-answer floor management for this session. you. concludes would Thank to now our like turn

concluded. Have attending now The Operator joining presentation. Thanks, day. is a you. great conference for today's Thank everyone, us today. Thank for you

your disconnect all may You lines.