INSM - Earnings call transcript Q1 2019

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Operator

Good day Ladies and gentlemen, and welcome to Insmed Conference Call to discuss the Company's First Quarter's Financial Results. [Operator Instructions].

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

You may begin.

Blaine Davis

you. Thank and financial conference results everyone our to to quarter first for welcome morning, call today's discuss Good XXXX.

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

call me Roger will Once including Chairman our we Lewis, open Insmed team over on that, of Chief prepared question. let for call we Joining the Officer, With Management Executive to Tombesi, today's turn Insmed Commercial me your Executive remarks Officer. Will our Paolo Chief the Financial Chief Will. are and complete members call Officer, Adsett, and

William Lewis

us. morning, thank everyone you, Thank Good Blaine. you for and joining

MAC have the positive of of into and patients launch see feedback We quarters are very from excited about disease Two received refractory ARIKAYCE. physicians. to with trends progress lung treating encouraging full the U.S. launch continue both and we

potential and ARIKAYCE. While to confidence long more much gain term the importantly in work the for more near term continue remains we

payer rate discontinuations time continue spend for lung potential off patients Roger believe are just as an are few in will more a refractory patients new great and of starting launch the the We ARIKAYCE well MAC with a to to community. support expansion as some launch disease. prescribers. the of growth to on for see continue breath to we of steady strong specifics from we of are U.S. more therapy, see on of and a to see we the start the optimistic help We minutes. initiating consistent Overall,

a performance to million we million over quarters full early of raising launch, year two XX previous of are our guidance XX guidance from to our to result As the revenue XX our of strong first million. XXX million

let for XXXX. Now our priorities update an me provide strategic on

Our Our remains first execution the important ARIKAYCE. and priority launch U.S. of of most

resources will market of We growth the phase sustained as franchise. we continue early in and that ARIKAYCE focus we areas believe our ship out execution the to refine understanding plan the launch long of move our continue for term to we for to allow

ARIKAYCE on U.S. of and MAC full lung ARIKAYCE disease. for is us launch current post-marketing approval been be confirmatory setting have patients conducted in which indication, will the Beyond a frontline of working the we the it's required diligently of study, and with

expect also second abscessus. of pathogen and year to initiate disease abscessus We virulent Mycobacterium a most this is particularly and later NTM lung by Mycobacterium NTM in the cause a caused common lung disease. study

abscessus from ARIKAYCE, meeting be data by in Updated showed XX% roughly presented data interim and in later ATS Thoracic the from supported investigator month. ARIKAYCE initiated conversion at the recall XXXX an will six may Society study patients. promising patients that American Insmed You Mycobacterium of this month culture year with these presented result at by last were a trial

Mycobacterium setting and meet coming and the a to expect with abscessus to post-marketing the discuss weeks in We the frontline study. the both further study FDA

see for used are we of a meeting patients come. and a we the clinical population a serve active Insmed completing of aspects approval to moving was study our of authorities By with opportunity set and post recently post ARIKAYCE. community unmet NTM. positive, frontline to Importantly, together substantial closer a and the years FDA defined productive the management that in our beyond pardon patient medical of from ARIKAYCE just and clinical to our of leaders clinical would of regulatory advancing for from me, to programs, participant lifecycle could marketing our we discuss an for industry study marketing study see was our very treating lifecycle and advancing brought and felt endpoints representing NTM the study dramatic the studies completing be discussion addressable If needs management number programs. that expansion

share regulatory Neil Neil line drive approvals as appointed Manager outside Europe, am and we that worldwide Japan support ARIKAYCE in the and served We are to opportunity an year, preparations potential effective forward appropriate patients of from us X lung to on very we of of of the the anticipate Europe with June joins These welcoming To East focused as middle Head to from to add on MAC expansion filings In where to in track this General have to half our by represent to first our regions important launch recently Europe. to I disease we We in regulatory remain XXXX. most plan Africa, that for filing suffering serve to U.S. continue Neil. Hughes Shire look Endocrinology. global our Middle pleased file growth. forward end, top he

with ARIKAYCE, the Phase steady bronchiectasis. At I'm we target make Study, stage, of enrollment to pleased patients progress of announce in month this trial reached with patients. X Willow our six non-cystic have continue our XXX to fibrosis INS-XXXX we global Beyond

Granulomatosis XXXX. mechanism our This that, non-cystic potential to a has available the are GPA. We're present advancing positive, specific INS-XXXX patients will into indication. of therapy preclinical for with we of ARIKAYCE formulation the of INS-XXXX utilizes INS-XXXX of have We parallel, this is a to part for like pipeline results some continue interesting our unmet address currently advance XXXX. to are fibrosis need. INS-XXXX the If we for or we a expect approved advancing trials development have the significant In expect in registrational non-CF novel Phase potentially who polyangiitis at data to trials of be to Phase treprostinil treat very exciting would program bronchiectasis, no inhaled also ATS data program and for X X action potential early treatment an with into bronchiectasis. to

We have holds for a to XXXX and the the us. of had what very year strong are star rest excited for

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

Roger Adsett

morning, Thanks, everyone. Will. Good

we're the thus ARIKAYCE launch far. As excited Will mentioned earlier, U.S. very about of

of of Let me take a details the our today. moment you through some performance walk to

disease U.S. up discuss of our XX,XXX time treatment in-line in X our the believe pivotal population patient now who that We we at studied leading about XX,XXX options, the Phase like our First, with no or the had in MAC approved to FDA XX,XXX I'd addressable estimated with to we to addressable and an between patients on population patients. those update language addressable trial. label, XX,XXX launch, patient our is the our the limited be in and lung patients, population to and

this of overall are them. now we for made works adjustment may on means currently even opportunity lung a patients population. reach the disease the suffering This who MAC have We absence have in the paradigm more to treatment growing that based

which we and in attributable U.S. XXXX, our $XX.X programs $XXX,XXX first very reported million our the sales the of million to quarter is pleased launch to at $XX in quarter the We that net was attributable of compassionate which are France is launch, use and second of Germany.

the performance we're let in the to of me take a metrics you to using measure walk Now revenue. moment U.S. launch through some beyond

patients As initiated strong for of In are XXXX, patient and had fourth XXX XXX we seeing approximately treatment of than patients least with with ARIKAYCE a new over XXX demand had reminder, at physicians one that prescription. XXXX new the the starts more quarter. written in first quarter we quarter the reported

prescribers We aXXXX trends also the clearly treat. launch. have reflect believe strong approximately an there metrics the that to these ARIKAYCE the prescribing to with fact are We physicians since patients continue intent see and unique

as launch, these continue encouraging. are While to in we early still our review we results very

are in some metrics how reimbursed me now product additional we and being understanding the is believe to-date. helpful on spend used Let that time

stabilizing better that dropout mentioned Will the are we saw in rate we discontinuation, we a As slightly XX% seeing rate a the patient study. of earlier, than is clinical believe with

factors and our ARIKAYCE of monitoring through and is We that metric closely of effects with their believe believe side initiating help possible therapy. which appropriate Arikares patients intended program this expectations continuation influence set therapy experience important support that We for treatment X this are robust will gaining more physicians help support patients journey. to are

we adherence carefully to also treatment addition the are patient monitoring regimen. discontinuation to In rates, monitoring

then XX% within of seen with the in we While and limited, patients adherence for therapy as from to mind seeing between take the other with XX% adherence to of consistent therapy and is expectations are rate, antibiotics. early our inhaled short data effects rates to it's benchmark with and Keep patients the appropriate. adherence in with a manage persist line and allow break somewhat resume label reduce This necessarily potentially our ARIKAYCE. will but medically side

covering of see reimbursement, to now acceptance an that and the plans. XXX seeing dominant process. coverage comes March, reimbursement patients, in commercial population in provide rates the patients, from over lives million Medical from community. date, while continues lives approval approximately support to access currently patient XX% the are approximately Turning be to plans to we for have of path Medicare ARIKAYCE to XX% strong we payor from approximately Through ARIKAYCE plans policy comes reimbursement reimbursement through for of continue over To U.S. XX% commercial place. Medicare, and covering XX%

appropriate comes that pay. lung remain trends other reimbursement the or patients, fact encouraged being is generally ARIKAYCE for from physician by and Medicaid, patients. through MAC TRICARE cash positive attestation means, reimbursed remaining the For disease reimbursement including We refractory the

ensure We process to that continues. are working that

I that momentum As resources the team, believe necessary have to strategy, the exceptional I XXXX. maintain said and throughout have before, an right we launch

of global regulatory both advance we anticipate Europe filing file Turning our by and continue first in we strategy on expansion, of In in XXXX. to year Europe to middle to Japan. remain track Japan half we our the and the continue this in to

the encouraged these extremely infrastructure are potential of are for fully ARIKAYCE the and prepared by be regions commercial in investing in to We potential launches.

to that, very stage, to our over sharing you progress are excited forward Paolo. with hand the and year. the And early launch this ARIKAYCE with look the throughout We call at all about I'll of

Paolo Tombesi

net ex-U.S. of sales utilization the and France morning, U.S. Good Roger. everyone. we net cover will guidance. $XX.X from minutes million, our of morning, of our of first then and reviewing Compassionate Germany. both financial million $XXX,XXX ex-U.S. $XX ARIKAYCE in few quarter ARIKAYCE. comprising of total a Use just reported results revenue This programs The reflect spend and sales we'll financial Thanks, I net sales

or million $X.XX statement, will we share $XX.X a XXXX, you our of for reported see quarter $X.XX compared of for on with a per quarter loss or $XX.X first XXXX. As million first per loss of net net share income the the of

This approximately beginning Our of gross to as hole expected. increase the quarter of the fourth net largely million. reset quarter attributable the were calendar Cost the XX% for gap sold to slight for of from coverage at was $X.X goods is a and year. the the result quarter the donut was a as first

activities were XX%. gross inventory of expected, XXXX. million As to to during FDA quarter of for XXXX first margin expenses data and everyone million the the field was for expenses development salesforce, that and the continue an in primarily and in equivalents. the XXXX. expenses higher XXXX ARIKAYCE. cash expanded $XXX quarter $XX.X in produced million of related million due XXXX were to important in increase from and $XX.X $XX.X of in quarter It including increase is of awareness, of to activity for The reinsurance will We approval including the SG&A closed million first first hiring the improved commercial with patient gross our compared our support to headcount margin the Research first benefit ARIKAYCE, remind $XX.X quarter to prior operations. the cash the quarter quarter versus

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

and to regions; additional of confirmatory along with management these of which WILLOW program the trials study ARIKAYCE, U.S. setting front-line second, other global commercialization activities as for First, as programs; be life-cycle approval INSXXXX, and Phase post-marketing and X the well for the will by pipeline and the an facility Japan ARIKAYCE; a as required in support increased for our advancements facility. and ARIKAYCE FDA the our fourth, development the headquarters pre-commercial clinical corporate launch third-party the third, production expansion continued to of regulatory a new manufacturing of of Study, long-term our support build-out of Europe and conducted support ARIKAYCE, full capacity of in in

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

As stock-based compensation earnings press define operating we of expenses in revenue, total of and a cost release product reminder, amortization expenses excluding intangibles. and cash-based expense, our as cost depreciation

addition, new million and of the expects capital headquarters significantly support the are revenue manufacturing In first the our $XX facility investment million for support world. to be our expenditure U.S. the and predicated the the of cash here launch. In expenditures and the way, remains an to expenditures in for around of The continued XXXX. Patheon this both stage-gated should range potentially seen on success growth, as expanded at company of in $XX to be half majority large-scale

now in With to I the will for back million to full in range $XX As already Will, of by guidance, of XXXX year million. to $XXX revenue be turn revenue mentioned Will. we expect terms ARIKAYCE it that,

William Lewis

Paolo. Thanks,

me prepared MAC Let our progress patients that out refractory in from remarks disease. has far made lung close year been for so have very helping us a we tremendous XXXX and exciting reiterating suffering by

well our strategic shareholders. value while executing significant are priorities against also generating We for

with to altering way urgency health of our on therapies that to company empowers populations experiencing building patient people well leading are a to pharmaceutical and a big our deliver, problems. We life achieving of compassion, great sense small profound vision bio

and our significant our our of value future the management exciting to believe we continuing the pipeline, our global With of we potentially potential ahead. franchise, execute plans, lifecycle an have expansion successfully ARIKAYCE efforts

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

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

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

Operator

[Operator Instructions].

ahead. question Credit Please from first Suisse. with Auster Martin comes The go

Martin Auster

have Hey, I on the a quarter. the side. for the Thanks on on guys, taking reimbursement congrats question. couple guess I

very of comparable any kind to Germany, if seeing you you'd if price that patients meaningful how of think curious is and the And over of I you're kind seeing data clinical on any looks international start so of improved kind translate business, data currently changes, of any price average I then was an that realizing that France getting Thanks. ATU of pocket price you've how you're sense uncovered. might or there updates far. kind any if Curious, and if in as sense have in changes in kind commercial found the of the any encouraging realizing. of have like. or situations formulary what ARIKAYCE reimbursement net out kind you a of And adopted for you're costs

William Lewis

as ex-U.S. So to predictor? you want take of question Roger, a price reimbursement the do

Roger Adsett

reset. to question. donut for Yes, very date Thank you primarily this attestation first appropriate gross the mentioned, pleased quarter, for had we to We also as continue see, Yeah, an made asked to happy so progress Medicare the patients. with on whole physicians as you. being associated impact that payor and see take to the with are mentioned basically the we've in net, did the Paolo we're

make secure had we the patients slightly the contracting have reception previously to impacted entered the and strategically of for access that appropriate as physicians would that any been into PAs GTS have the that So quarter. the We've first our in contract We sure and the pleased necessary To and the date and processing very yet plans. access arrangements. we not prioritization. with smooth mentioned

contracts haven't on a So any specifically impact had we date. price an to tied to

as ATU a than price primarily our As below but a an ambition ATU net far viewed to to will is give the as on closer is that I EU ATU price floor, would more generally price, be update than that that. it. certainly say be price and the secure to would ceiling Europe no there

William Lewis

I think just we're in XX,XXX still ATU of the Euros north getting setting.

Roger Adsett

Thank you. correct. That's

Operator

with go question Please is ahead. from Adam The next Walsh Stifel.

Adam Walsh

questions. Good ones I've quick got morning. Thanks here. for taking X my

in The half? then about some side guidance. you Are INSXXXX, what on the payor thinking Roger, themes payor, today And turned second cash-based reauthorizations, quickly, Will, the Thank for XXXX how for first the to know the the now and you outlay just first of there Paolo, what really of are you which can talk about on trial guidance of seeing reiterated read one the seeing speak GPA second the action kind terms have with to also, anything Roger. the for launch you about X-month you. can you are half commonalities or that in the it can you for of respect should What any thirdly the we mechanism might you from? can For I OpEx and of And of say timing that? fit design. the half? over.

Roger Adsett

for or will that as lengths time just of different payors and different is I months giving that perspective, clinical would reauthorizations sputum least education say are the you off I It's the that and the for Adam, for a generally, that see talk to time, will guidelines, either timepoints around fact appropriate XX those to physicians the therefore some, where And apparent payor physician the Roger. question us. X you're has is therapy will paying time plans we're of But general for there patient, question. tests, prescriptions the and sputum to this another through. patient say attestation occur. thanks period reauthorization. from our are for that giving see we in for therapy. months around at therefore to writing broadly, benefit according are authorizations to coming putting therapy a I'll efforts their And from the when From continue for a to some the it's starting start that will then patient. Hi, indicated reauthorization right, that about theme more around converted be different

So about really are how so patients we're these pleased payors I that thinking for would far the process reauthorization with say

Paolo Tombesi

is This the Paolo on guidance.

first for the to and guidance U.S. the you strategic morning million manufacturing expansion the Adam, to being company the this million. priorities reiterated launch, mentioned, As global tests. key have We we $XXX for the confirmed half field the $XXX pipeline

giving not we are that We case the any that we is rigorous predicated success stage-gated guidance the launch. mentioned half. What to for of the U.S. second approach see in very

William Lewis

I growth change which that's in look, spend proportion you the that way, the think, we're see so the capital we're rigor it were revisit why If would capital. obviously deploying now, line. in revenue deploying aggressiveness is. just success right on the to or we we're And the see some we phase where to the with

just question of type GPA kind a action. a of of and with GPA on touch Both mechanism which moment is a vessels. the this. then of GPA vasculitis is type on that's is polyangiitis. granulomatosis GPA, a is I'll GPA to take Your inflammation type of on blood of, a

the involve neutrophils. cells the GPA, in inflammation So of

two three of in decreases proteinase action. So of of the in sort expression mechanisms the it fairly neutrophils. One is specific to XXXX GPA that has

ANCAs. expected be the to of result, a the activation by it's cytoplasmic antibodies neutrophils anti-neutrophilic as less or So

that better anti-inflammatory is could the think the to be specific agents. that and makes experts them other is less aspect intriguing most so than And XXXX

that serum decreases inflammation XXXX makes neutrophil the mechanism production copeptin bronchiectasis. action damage driven potential endogenous proteases, levels. that active thing non-CF it of when same neutrophils the second G X The other X, and to [ph] they them like is in interesting of all the cause excess to can proteinase neutrophil elastase that in which neutrophils are recruited tissue including contribute of In of

that of way, I it. excited So reasons this impactful companies out by one ending driven inhibitors have inflammation neutrophil the there. we're in are potentially so know it's in other there DPPX and

also is remind that, the of and advanced, it most is Ours reversible. I'll just you

that we next beginning got of super that XXX excited and topline So out results we've be patients should are recruited year.

those I'll that GPA, to going Phase just in For add year. X trials off are kick this

Operator

Please is The Ritu with next Cowen. from ahead. Baral go question

Ritu Baral

for thanks guys, A morning, me. question. the taking Good for couple

the you be The auth? attestation the the first else What most prior step if one far any thinking can as requirements guys of the frequent? main edit, talk other we as should prior is even plans in about attestation is, authorization as to any

Roger Adsett

Hi, Ritu, yes.

So thank you.

as making And education efforts we So been been fruitful. the primarily it I is payors about, think we've with attestation. particularly has talked

are they focused appropriate much on patient. the very So

MAC scan a are from prior disease. typically refractory therapy considered got and a for these least X make that to the physician exposed antibiotic So that at so what the want this CT that being of a patient, of culture And is combination therapy ARIKAYCE, months they they've that they're hear sure of been is appropriate to diagnosis definitive includes to or NTM patients. patients a to

say focused that's label. where would they're with that I primarily consistent very on that So is the it's

Ritu Baral

month X So prospective X therapy of treatment a retrospective the attestation with other guidance-based with currently? treatments. months Nobody is it's requiring basically

Roger Adsett

To to seen at have ARIKAYCE. lookback. they XX within I been to a I But have knowledge for X there plan a to believe proactive seen have limit six you've got with remember, may on before has least to plans I've months and said last time a not There my another that now put that happy knowledge, that of eligible I'm reinitiate are months some trying the months for therapy. my you're be a but

Ritu Baral

versus setting, expansion that one that's have thing? community I Then mentioned sort characterize follow-up. last base. of versus of come have of is Got pulmonology that in mix, QX? How prescribers onboard Centers it, helpful. prescriber the new Then the the Can Excellence ID you you

Roger Adsett

Sure.

experience. our Slightly but been more. only So with it's think more infectious fourth I than disease pulmonologists remarkably actually slightly specialists, consistent quarter

a Most of also not pulmonologists IDs, they coming community the Tier are That from excellence. patients. the the basis, most per on would predominantly as centers beyond pulmonologists IDs. the but excellence most the just productive imagine, X infectious prescribing out the X of the you Those with are prescribing reflects because broad our the disease and broad-based of prescribing and physician of coming is specialists, those So physicians. those seeing pulmonologists specialists. have physicians centers are, is But the and we

William Lewis

want the that my launch, level at just Because what you a means for I ability time. enthusiasm term indicate it's add to the for about writing any early, is this to company. so this studies have with what to medium to And that broad, engage a the if And success strong look the and yields long physicians community those excited of X in of super get fact. really to over very X prescriptions many physicians, sign, that this

Ritu Baral

to of call penetration how repeated many your Is of or tracking line? even penetration, And Are targets calls calls and it from have the salesforce X,XXX left? had in salesforce? -- from how you prescribers do fair that rate much the I in the all the sort what's they guess have the say further

Roger Adsett

all that from say actually prescribers have specialists. our of would the I So call not therapeutic a received

our as So so talked X X,XXX got tiers physicians. right, about about we covering we've previously,

account X,XXX Tier there's about and remaining sort of patients. healthcare So over X, in in for Tier the professionals Then X. potential NTM XX,XXX a XX% of X,XXX they

will interest physicians a as without there seeing specialist. for the we're therapy certainly some and cover So all can not is so physicians for approved the to prescribe those of and first some you this imagine of therapeutic sized disease,

reach the speaker things specialist investing programs. is that beyond just One we've in been therapeutic of the

very And so the ARIKAYCE. experts how we we these to treat are have message important in of with who patients carrying think

educate to about NTM that's disease. We have important comprehensive how and something this particularly network we ARIKAYCE that is And where on use to experts and how manage to pretty a program think speaker think MAC peers can the effective.

We updated the metrics on haven't reach. the

It's campaigns. our expect to the very to just over around reach efforts prescribing call ARIKAYCE single a on of continue therapeutic time. and I as beyond put call, is said, high grow percentage the we the all we physicians But the making impact including that, a a digital physician. our specialists to that and that our education We

William Lewis

just and therapeutic is we lot to there by here. job done efforts, an I But here at is And because forms. excellence both the question to the that and my of have the no and group in it add of enthusiasm a digital they focus excellent our that marketing their want company, another masked specialists

of the later that's things we wind year can sales a additional campaign happening be to is past this will release which in one that branded Because think that. think now going where to the going be I launch. our we're we point have we're

that tested we'll super our excited we're about very campaign. It's well that in hopefully So and in see reflected numbers future. the

Ritu Baral

the design? panels? it. guess period the conversations having what's finalization these question, trial you but the and delay? time? FDA I guys roundtables of the Are you and Got everything, for are market guys time Is confirmatory on Last waiting why this before still breakthrough designation-like very real

Roger Adsett

had that consistent are right with is timeline track. we agreed FDA, This the with so we to on

FDA panel, and the trial was further look just in of considered only comments endpoints sort for that mentioned my it NTM a and new touch that thing is I is asked convened to what a the elements bit panel, that a on think trials it I'll little specifically. design I here, interesting should but be at when briefly, doing

to to the And we that we were they a members directly Dr. in which brought in through asked we them. present the the panel in to was also brought patients directly ask to this They to us Sullivan role. important in experts, did across what's daylong they where participate invited Gene on and So brought of country, from panel physicians had panel they other then our them team.

different endpoints. it that within things day comparator positive and extremely what avenues trial shortening could measure we potential number trial, contribute elements and we I to think primary was that entire how raised a at look length, of the for like the that

to we come aftermath our as overall the think up. talking trial be design just weeks. here happened which feeling coming and about end the going going a about that I And comments, strong away mentioned I ago couple the to we're in in of from weeks So in that we're the FDA where final of a positive to very with

So are, very where on in right should have on good distant not the based too future track, feel information and about discussions those go. where

Operator

The next go Please Canaccord. question with Dewey from is Steadman ahead.

Dewey Steadman

guess the bronchiectasis, of WILLOW for COPD they is thanks the study and excluded a taking guys, have in patients I should, trial entirely? Hi, component the been how with there or question.

William Lewis

have I'm is I the to of get about can't know and particularly on have gate But I that out this I to You what, that bronchiectasis about or we to not. COPD that. where you apologize non-CF that. back with whether what recall focused XX% we're overlaps I NTM. that say it know included going would in

have XX% of about patients NTM. So non-CF bronch

So logic specialists when you it's but for could this trial mean not us, directly represent terms it strategic value potential expansion and it treat, only in their could and does in of about a therapeutic think the significant of point. wheelhouse patients of what our the we of call

Dewey Steadman

in expansion? specific broader getting the led or Great. ID estimate were I is guess you're detailing it patient you're of awareness your patient Or just more NTM factors population knowledge as that Was to population it expansion what the community? that docs?

William Lewis

X% his using beyond perspective some you can we machine to that about I'll of know comment databases that terms we've the there in learning on that a that U.S. suggests. that NTM XXX,XXX know claims is ask work But just remind I I'll from comment growing maybe XX% and NIH excellent that, NTM you and diagnosed the Roger it what it from on estimates then Roger, to are Patients about done in year

Roger Adsett

Sure.

there's literature from but primary to takes expanding. bit, growth, XX% year down little oversimplifying seeing, we population a confident I'm driver driving. that the So and very NTM that. funnel. ultimately as work the there's that through it the But we're that to then has our believe some, Dewey, the We some refractory prevalence probably And it I puts feel that right, we XX,XXX X% population XX,XXX on is the think comes per to that been

there an increasing for I think is that certainly NTM. awareness

therapy that there's certainly now available, willing think are to I more a diagnose. physicians

identified get and approximately we system with patients done patients, with in learning that's have are some high through there. medical a work something to way so very already some that to their had the the Will that NTM database As likely confidence working diagnosis. mentioned, do try machine level Symphony accurate an to there two we system, these the And is

about incumbent we'll that diagnosis. think of to help physicians us patient branded I And off patients this raise that having year campaign educate on getting to well a help end, be later accurate kicking as them and to educate it's that NTM and the disease awareness. that possibility

at through consistent diagnosis look the and what As we there that codes, ICD literature. an definitive the expected we we increase is the as look at from with see Symphony database we the

very prevalence we about increasing feel number. So good that

William Lewis

he said currently. when X patients two there clear, patients, are And diagnosed be to just he means every for two

additional XXX,XXX an would way we So to that that be undiagnosed going potential patients believe their make through system. are the

treatment who refractory physician find for become benefit portends disease the really the us for as way get drug. our to hold their appropriate things frontline patients to the in interesting the future that of So potentially and into take continues awareness

Dewey Steadman

Thanks. near-term My give, could out be bit for the event a I the thing on Is your that we a and question, maybe you that potential control, it's ATS updated. IDFA guess but should be to for? opine of guidance that last

William Lewis

You bet.

here exciting. comment XXXX why to just generally me let we on be So think from gets pretty

there, some of of Thoracic a in pretty May this to at later see rollout so positive we things Texas. is which one you have a anticipate number splash have Society and the we'll year a that data in and we'll That's ATS. of we'll American hope big We lot have

The we approved that date, we but the to close decade. And is guidelines. for therapy are out the And guidelines are support we a be anticipate included hopeful an additional in be impeded be that We since as we mentioned, the our updated forward. time you there, will it think in the them. as we ability point could that only go will of to success first second, to have hasn't certainly

do our that potential of both launching get patients is the value And of We're treatment, we'll importance and we additional see that CHEST. to and ID this mentioned, year which to the excited raise treatment. branded will disease finally, awareness conferences the is, third about highlight campaign shortly. will Week and that's what here later be can The

the of are forward. drive end that a the we going we've of potentially through here us to year, lot So think got positive catalysts

we about super So excited are it.

the One of mentioned. is update which guideline you that

Operator

Joseph is go The Please question from next Leerink. ahead. SVB Schwartz with

Joseph Schwartz

very thanks much. guys, Hi,

the what evolved wondering, was consensus I all So to community FDA would broad of most the seem have study think shared terms like population a about earlier, on with since does control, to of thoughts follow And some on a most look for recently. design interactions likely result? confirmatory a in were comments and strokes addressable drug, heading study are treatment any in that of your and and you the the clinical to also needs do how Where the may how as you size likely have confirmatory to then thinking be endpoints? you perform the

William Lewis

wish We've I I I mentioned, and FDA. specific as question give that had, appreciate discussion answers a more with stage. you could at the good I this very

perspective, trial objectives, looking patients. way and very potential and desire from think our design a at in is of least for very I with are our positive I our matched are benefit think aligning FDA the matched for and what that their closely

where so additional any designs They about until there am I offer down. and So excited are finalized hesitant not this are at I'm going. locked detail all trial point yet that's to

refractory think saw say until in But will will now it's in we in is a close an I as perspective, these What really you for certainly culture And trial and we that and current in there M. addressable data population abscessus. M. because equivalent the probably to the in abscessus as M. where coming look the As you a to investigator-initiated good too I targeting our are potential population MAC drug population not to that from population. continue study that right interim U.S. trial dialogues is far That is the put the number for of and our in things future. at abscessus drug need. last minute. the clear last ATS design portends from evolve larger discussing exciting be is XX% potential these in is that the the our using rate severalfold than the addressable in a frontline, know, conversion And weeks, year, patients we know and to frontline both

So if approval hopeful that. moment these represent would really authorities about just with when we're significant path to agreement say able there's very this come and a and I expansions to we're if at regulatory to

Joseph Schwartz

update, adoption usage how guideline is will practicing in ARIKAYCE view? expect to what guidance lead guidance line what community you this Can extent think to will help different to patterns? extent you regarding the impact the treatment your Then appreciate And Great. do NTM to already new us in the what with new say? it of you

William Lewis

I it first guidelines As as out has our inclusion and not the impeded there are the it we've recognize before, of we that. because therapy approved in ever said the hasn't uptake -- lack seen people

And are and going I the this expect even be so be refractory of at all. included, that think insight to what our alter the have guidelines, paradigms guidelines that that be for considering. of would treatment the they would approval first I label obviously we're in course what expectation they no we drug in My line with wouldn't into whether aspect patients. would bring would that all, of line, our

awareness of NTM to I patients. reissuance the treat disease what guidelines and the think that their energy around more really is state appropriate these way bring in

campaigns up picking going continue. momentum our are on time. significant to That's been going awareness for that long a have through disease We

talk heard there this. out about the speaker have panels You've Roger talking about that been

if in I fail drug. the use and potential think standard it awareness potentially our current patients how all therapy. terms helps that get of that, the positive effective that Being or of they is raises of an of care,

think strong could look of rest we I a XXXX. as possibly about in as we're the be position well as So toward

Joseph Schwartz

Great. just is WILLOW expect inform what it, I at on like that little Then data a current the I that point there? the how study, beyond you And if this how you're would the one sneak see will but design would contemplating trial? to you it that would could ways in know away,

William Lewis

that study is the it's QLOV track rate pulmonary exacerbations. We're elastase So this a XX a arms, timeframe everybody, versus just topline to endpoint mg at and for FEV-X looking is of over out frame by the the is X measure how WILLOW feel, instrument. looking time neutrophil we're safety going and X-month of results. the to evaluation. conclusion is finally At we'll One We're exacerbations, mg a which in X is study follow-up for XX the placebo primary one-month have of followed levels The to second at sputum. secondary endpoints. and then patients

of agreed primary pulmonary all think studies. of of for collection the to able the the of will endpoint here approval design the FDA data exacerbations, I one to them. is that that that We So appropriate The key inform is upon drug. anticipate be has careful primary a be to of there full the Phase X endpoint, be time would two the

to highlight, should we anticipate see inform specifically a If go in a very able not, discussed should XXXX I diseases. to, the thing. Phase impact has earlier, be X mechanism we're in So how able trial if the forward with of inhibitor we're measuring right we clear to patients, inflammatory couple a DPPX the a And here, impact I to action this of trial. XXX as potential just is and to want

We up that right Phase of at excited are looking going that X running in but as are non-CF and to as and success And and are that a most first Phase X bronch very that trials is those be our promising, GPA. well. we high think is alongside probability

data beginning will but in program will whether absolutely future, to So the this first the part we and hit more go the come Phase X. year of next forward in on into inform

Operator

any the like back remarks. over any closing turn have I for to conference questions. additional don't would Will Lewis to We

William Lewis

to us all got moment by in date excited be I I whole made we've to mentioned we the trends saying I just we've think progress to And how a the ago, that close XXXX. for reasons want are forward. move positive we a number of as going about supportive are of

to you talking forward to the joining next quarter. on we you look for all So thank and

Operator

Thank for presentation. today's has now attending you Conference call concluded.

now may You disconnect.

Insmed (INSM) 7 May 192019 Q1 Earnings call transcript