INSM - Earnings call transcript Q3 2018

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Operator

Good day, ladies and gentlemen, and welcome to the Insmed Third Quarter 2018 Financial Results Call. 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. [Operator Instructions] As a reminder, this call is being recorded. I would now like to turn the call over to Blaine Davis.

begin. may You

Blaine Davis

Michelle. conference you financial everyone welcome and Great, to Good discuss today's call XXXX our to thank morning third results. quarter

call risks based statements. differ start, through you Please judgment SEC, the SEC's Such refer the results as we our me to that and will that the our today's results include from or the may may available discussed could today filings involve for the www.sec.gov actual Before which at statements represent forward-looking uncertainties forward-looking our are on let statements website information of current and expectations. that remind the in website with affect our risk to from Company. concerning cause factors

call and promotional intended today's is prescribing decisions. In not not for addition, purposes information for sufficient the on

Chief members Chief on Will including Officer; Insmed's Management me call Joining Officer; today's Financial the and Officer. Paolo Insmed Executive Chief Team, of Adsett, President Commercial Executive Tombesi, and Lewis, are Roger

For Paolo today's and give let the progression to activities a commercial With and call, quarter the of our financials. on call update provide an third turn update us Will. that, Will briefly the review will will me Roger will over corporate

William Lewis

The no MAC us. treatment morning, have alternative granted thank a everyone, who company. you, in quarter Thank Good accelerated or Blaine. end as you At for approval disease ARIKAYCE for of achieved most FDA treatment and history adult significant the the limited of joining the the for we third the lung patients options. milestone in

treat have mission approval pivotal and taken concept have them and patients last dedication their physicians the want in this thank and the finally I new followed on dedicated therapy ARIKAYCE, to from the this with Insmed thank over rare who unmet MAC for needs serious to approval commitment to journey we we of need. patients of and team six been important the successfully transition first us know, also inhaled congratulate you lung diseases. of of and As the have I who the tireless of have part approval progress as for a specifically This us. addressing those disease. patients ourselves ever treatment point marks to to our want with years to our approved

on to first For is successful regulatory of seen package this organization mobilize to in a the thrilled that the with U.S. the three advancing In built I've we that we very efforts I'm developing been approval. commercial the and ready focused execution year led team to keenly solid were quarters date. a mode approval. FDA report with to and this we've discussions launch parallel, upon the pleased

As in early launch. I'm sure can we very our a are point at you still appreciate,

community ramp our reception are of in the provide Roger believe more provide date, translate launch data progresses. scripts around strategy this and will worth full with a a encouraged or That but revenue quarter's the sharing from once it activities. the are we to on to update We early executing data. as at to it time those and growth said, an commercial will treating to revenue. meaningful received look we've have forward is We we details scripts too

frontline of collaborating setting. the Let study explore will confirmatory the me approval full spend a in support ARIKAYCE a design next front. of moment on the benefits a of the with talking To the approval FDA post about steps are on the therapy regulatory clinical we that

The We're in with we in and of the basis. is lung committed ARIKAYCE also we more in addressing MAC a timetable with to previously, global you As on of study a clinical next detailed to disease. year. patients providing finalized that study clinical a needs the of forward placebo-controlled double-blind, look this we've and XXXX first randomized, be half describe the shared proposed trial scheduled assess patients protocol be to to benefit

initial the and Our our priority on is in U.S. launch where efforts focused a successful are squarely

our lung Japan. This including Japanese there pursue with ]MAC is successful to and it XX,XXX Notably for Japan relatively treating compared approval plan NTM front a [Author Europe where exclusivity are occurrence at estimated half for we seven infections given This ARIKAYCE part in were the new to this is in Oct disease that, high issued Office. is pulmonary infections. from a patent on market the the for to issuance the by eighth patent JPO and in in Following in an through XXXX meaningful in U.S. years extending the Insmed the refractory patients of to to by of XX Wed IDX: XX:XX:XX and to relates XXXX XX,XXX XX,XXX Japan XX,XXX ARIKAYCE Patent systems

build world and to continuing lung progress patients our sharing forward our global objective around disease the are with look We we the of MAC with you. team to with serving

provide ARIKAYCE me over Let to XXXX IDX: a Commercial XX launch. Roger at Chief Roger? ] the Officer, with XX:XX:XX brief Adsett,[Author you to Oct around update our Wed call turn the U.S.

Roger Adsett

and morning everyone. good Will, Thanks

these mentioned organization support entire Wed professionals on treatment Oct the Oct XX XXXX comprehensive [Author The includes engaging Wed commercial peer at journey. XX:XX:XX ] educating Wed throughout patient upon providing our approval. enable their shifted XXXX at Will IDX: team and is at executing into IDX: immediately now As XXXX its ARIKAYCE, XX key XX:XX:XX mode XX Oct launch FDA [Author reports to to patients IDX: access, ]payer[Author XX:XX:XX healthcare ]community

XX,XXX in have is launch to activities line In educating we focused study. field to Our XX physicians on focusing are begin previously on no the MAC XX,XXX reflective therapeutic lung the awareness U.S. on population been roughly to who X patients treatment in the ARIKAYCE. eager specialists pivotal with our into label approved who of to Phase patients our disease disease our options. This get back the were have limited

we and infectious physicians targeting pulmonologists between These fairly Oct specialists. of the for XX:XX:XX physicians XX% population. approximately reminder, disease approximately[Author patient Wed XX split at ] account IDX: evenly a diagnosed XXXX are As XXXX

the based of accounting XX%. they physicians in XX% XXXX group on and have physicians for with two tier We for X patients further opportunity XXXX number this tier accounting X of about in the divided tiers MAC into have

of XX, are that targets. over our information have received base promoting in these immediately March awareness a year, our since Because can treating the In our our already upon on disease of the our launch. key approximately group we're October to patients. prescribing team also have our will opportunistic call FDA in to four X. specialists conducting finding therapeutics are early ARIKAYCE In that approval. reached targets prescriber were with level We support trained two this approval on Friday, September field we launch we activities Monday, they as expected believe we on the ready of on be final tier We identified the field therapeutic and of a among label first weeks days of are we the a enthusiasm thirds weekend X launch successful

both infectious Disease medical disease provide and present these we us ARIKAYCE venues In high-profile Together addition, month specialists. to earlier two lung to at the data and disease Infectious allowed two to about and pulmonologists CHEST. Week about MAC important information ARIKAYCE this meetings, had opportunity

enable on November. XX-day launch launching MAC also speaker local of will speaking period These country We following in assets training event on designed for November and others use resources to early educate in of disease review Insmed We to are speaker programs ARIKAYCE. lung held in digital required beginning the marketing across programs the experts to including recently a plan Denver be behalf the promotional ARIKAYCE additional our materials. and and print

market coverage. of our discussions access, account terms team directors advancing and In are payers with key about MSL

support for sides ARIKAYCE directly prior patients the and and formulary We continue processes coverage of the both engaging to clear ensure authorization are facilitate access business. commercial to on Medicare for and payers expect to appropriate from

support support, team approval. patient has been months, several trained Turning fully to for has since running program ARIKAYCE been our

directly the the Over while product. early opportunity to had them physicians so pleased has patients am far. operating very Again, assist is in the to and it's navigating how already the the past few everything with for access with weeks engage team U.S. I in

meaningful a upon support of lay to launch and batches. commercial manufacturers Within and there inventory we we our pharmacy to distributor from partners. strong it a as early packaging appropriate kits the Finally, into as launch. growth approval advance our continue days approval. product shipped levels we to We these prescription relates to manufacture specialty XX-day our believe striving translate contract our swiftly have we finalized to to will manufacturing, of month currently in are that believe we through FDA we foundation Overall that

Financial need. in the right the to call have our hand appropriate over clear Paolo place Paolo? As patients I'll And review. to Will and we bring Tombesi a Officer, with for said, to Chief team the ARIKAYCE in that, strategy financial

Paolo Tombesi

morning in quarter joining expenses million compared million in $XX.X and share Thank next development net manufacturer loss or was expenses a for loss the for activities per Roger, to everyone. net primarily reported good the for financial The will for million morning production headcount. a I reviewing of increase $X.XX results. compared million XXXX. an third $XX.X the XXXX third the higher related few related per quarter due of Research of the external Thanks third This quarter XXXX. to increase $XX.X share to were minutes spend with of us or due $XX.X expenses an you we quarter today. ARIKAYCE and increase and compensation $X.XX in

in million including force the increase to expenses in We and quarter in activities expenses increase $XX.X Third this due related mainly were equivalents. million cash The with pre-commercial our XXXX. versus an quarter hiring to for $XXX.X ended ARIKAYCE. million headcount and G&A higher of $XX.X planning is cash field

spending our operating the Our the ARIKAYCE approval, the investments. deployment of subsequent approach of million expenses press our disciplined for website. cash and our to launch utilized operating our a based these up as expenses is the available release focused included quarter Reconciliation to gated Investor of capital regulatory in remain ramped expenses Relations is operating and the quarter. with associated $XX.X [ph] of GAAP on our were review, on cash-based during We state section release which

to of guidance cash-based million capital second other dollars and will Turning we and investments the XXXX, $XXX half range end for operating cash low or the that now to expect of half expenses toward be cash $XXX XXXX. the second of the for

We in U.S. I With back to expanding effort are market while launch to that, it turn Will. our for the geographically. also invest will continuing

William Lewis

like I'd confident have critical Thanks that and the we community. some ARIKAYCE much-needed Week Disease impact lung Paolo. disease thoughts could lung Chest the opinion close treatment lung refractory are feedback and paradigm Having out Infectious to ARIKAYCE MAC patients for ARIKAYCE We've believe heard on therapy both a in with the the disease. treatment transformative this of the from MAC meetings believed around underscores for be participated disease. we in treatment leaders we have for medical on change important can will MAC with to key anecdotes and that always coming patients the impact potential and these

once question can for open and first made the achievements sincere to we the and a the team we with dedication. with to am that, have strong hard the ARIKAYCE conclude continued Insmed me we've thank of already Let the let's bringing work their you again proud take here And in Operator team questions. patients. line please? to I built

Operator

Our Adam Walsh first Instructions] comes question of from Stifel. [Operator

open. is line Your

Adam Walsh

for I good for think Hey so some, have Thanks Roger. questions taking here. mostly much morning. guys, they are my I

in us first X of IDX: months, there over to culture the the ARIKAYCE in XXXX conversion conversion three one,[Author was definition consecutive in practice any assessed XX:XX:XX can Wed would of The commercial XX is expect in of negative compared we pretty clinical Phase and at differences X could the Phase setting conversion, rates total stringent impact a setting? how culture nine cultures to in trial remind actually the Roger, methodology ] whether you that a the Oct see

William Lewis

Yes, go ahead Roger.

Roger Adsett

see which rigor conversion something Yes within Phase in conducted clinical typically the that sure, X thank with say trial culture that the not practice. that I we you. is would Yes, you

Oct speed IDX: at IDX: Oct will XX [Author ]on vary, I with say not that's physicians would physicians that the ]sputum guidelines months culture Wed in they habits Wed But XX [Author to along months out check conversion but that they universal. check atypical although the that six always a would to six conversion, not that treat XX:XX:XX XX Oct the XXXX IDX: XXXX vary for think tend and ]test XXXX at I around XX:XX:XX [Author confirming and see Wed send for at it's culture conversion XX:XX:XX at point. after and

Of again make the the that months the then for that culture they've is point not to bug and check recommend to point. guidelines back treating that a course XX sure after if then comes if eradicated it further six negative at and further months

Adam Walsh

in could XX treatment? [Author of Oct done at a would ] Oct [Author That's in at for they XX ]payer[Author single looking trial just the at are XX:XX:XX the right. the at and about that at having that with for payers reimbursement done months And how we patients XX:XX:XX criteria the that you XXXX May similar practice they ]interaction have testing Wed say interactions you then might the just Oct the post be better they XX us in are practice? peer X sputum payer and or they terms are think XX:XX:XX IDX: IDX: X XX documentation terms Roger, that, relative the [Author talked let's samples Wed IDX: looking XXXX at to or XXXX the XX:XX:XX clinical of at IDX: looking it that Phase of it about ]be XXXX the Wed Wed the commercial way to sample was characterize way is reimbursement kind of Page at Oct way six

Roger Adsett

the Yes, thank first see of And – all the I to payers of the that great to how continue I they and MAC our think culture and them I it’s on primary to in that would you, yes, culture disease, opportunity lung also interact and as the endpoint, idea say value times conversion think been so that. like think test. so NTM, appropriate guidelines, that on conversion about to a the educate

not, culture opportunity and some One treating time that. continue takes has our actually of grow do on or that’s during the with and to We've actually important flipped able an been and culture or negative is medical the patient ascertain you that things not educate time payers that this or whether not team. to is, to to the the should

the to to and that this I direction from the point. think X, the don’t guidelines is did replicate the give the and is certainly they and us experts the the anybody are understanding that believe and looking experts we time from in the at So I’ve heard rigor that Phase I medical what appropriate design best open

Adam Walsh

that’s you Okay the jump that’s from I’ll back thank in me, helpful, queue.

Operator

Martin open. your comes is question Our from Suisse, next Auster of Credit line

Unidentified Analyst

at Wed guys, on XX ] Oct XXXX Wed XXXX is Oct XX:XX:XX this XX:XX:XX IDX: XX XXXX Hey IDX: at at for XX ]Chago[Author [indiscernible[Author Oct Wed ]] [ph][Author Marty. XX:XX:XX IDX:

ARIKAYCE XX:XX:XX Wed XX just between IDX: ] ID Thank awareness physicians, questions at at Oct about curious physician [Author Oct So, even XX:XX:XX or at IDX: XX:XX:XX Oct in of that XX:XX:XX XXXX seeing XX XX they[Author at Oct pulmonologists dynamic? Wed receptivity ]curious[Author give IDX: at XXXX Wed Oct of and ]and differences ][indiscernible][Author just – XX Wed Wed are you. IDX: XXXX if us[Author IDX: XX XXXX terms XX:XX:XX ] XXXX

William Lewis

the sure I appreciate question.

I from of Roger of over information if departure just any we and scheduled, think the after the I’ll which the experience fortuitously a detail. were as have say the that week very point would approved. see our turn two was have drug we I comes conferences to

CHEST consistent morning at out our So out Monday this Friday Friday. XX:XX:XX to we XXXX just label team we drug for got IDX: Week that ] and late with the frame first XX be which the there Oct to approval,[Author week. Wed happened Disease promoting literally everybody, was that the and speaks into the energy Infectious it of doing right were talent I think deployed, to team and

to feedback trend create So a have that we firsthand don’t know have line. although enough I we

Roger Adsett

that floated think still other receptiveness I me think Will, specialists. anything right, infectious is nothing would any very and gives I early. that to it’s say I that’s there attention Yes than that's up both pulmonologist from my positive disease or pause

take we country tend overall, IDs trend what to encouraged We previously so has be we think reception to about in of and from the the experience I about, we’re some see physicians have others in in seeing far. different think been out. very positive and regions and continuing lead and continue to that play But hearing regions talked pulmonologists the we’re how by the

Unidentified Analyst

Great, thanks for answer. the

Operator

Ritu line Cowen, of Our from comes open. next your question Baral is

Ritu Baral

give XX:XX:XX on thanks XXXX first [[Author my Wed ]in Good is be IDX: XX going your proposition, And IDX: proposed propose be confirmatory Oct you can’t be for do even in Wed exact or you'll morning you at ] considering the think guys, taking and when you endpoints [ph] what question are table of on, the submit I My XX FDA you when followup. trial, box][Author question. the to as are what some the would brief required? that you at XX:XX:XX us to a that wouldn’t have on you endpoint, FDA go XXXX not Oct if talking what are the to just

William Lewis

Yes,[Author and IDX: question Wed Ritu. for Oct so the thanks XX:XX:XX ] XXXX sure, at XX

we on know the of very in confirmatory are FDA there as you and midst discussion trial. characterize the circumstance would overall I design with positive. As the the

Our do very them interactions the we what design. might with have terms in productive of with been

FDA. we’re specified haven’t propose what specifically to We going to

this to XXXX of socialized that,[Author first have be who have will degree you evident would XX:XX:XX people the design Oct trial that to ] that some that that ideas its guiding instance. Wed they’ve I confidence and IDX: one high think observe has will for the I at trial some successful a principle be the XX be in provided the feedback. us where tell and is design We of we

be culture in to a can X the our going that X endpoint It that guiding Phase and that And on what data. mean? by informed way and clinical Phase both are align be conversion so does that will means we endpoints

be So to high beyond higher X walk degree be hit Phase and on bringing six-minute Phase six-minute would that Obviously we what terms and possible will so culture our patient we have the forward data walk. we have impact What like enrollment, look the had, of that trial to needed trial and we we’ll from Phase X will in able if greatest think in be conversion? design could X a we number extrapolate patients so of that have confidence. on we indeed that had

we others that trial, we we drug one that reported is walk weren’t patients know George's improve and over a that and We signs the we the the converting anecdotally As culture both in concernedly St. secondary experience and in patient with ran in questionnaire but it how endpoint X U.S. Phase powered in the show six-minute discerned the the patients, show are to it from was outcomes. did time. Europe, what feel that symptoms the from

full important the the is market or from So is there will we're population north combination in I And we this craft which endpoints a somewhere use highly point, the that and got addressable the data already will to different agreement it get think of really six-fold. of design of market. in. the requirement endpoint expansion with approved and of on the from not approval will FDA is focused only and I patients and that this but we approval increases we’ve propose frontline wealth can am result Post refractory an addressable we confident

as we underway significant a get So we want as one opportunity, can. it's quickly to

Ritu Baral

around - it for you trial you and trial have on might long roughly how clinical long reps, the endpoint? take spend been you balance So a your what confirmatory the offsetting the might budgeted versus what you give concerns like sales investor a take or us one can think for might versus how this cash of it has

William Lewis

regard align details budget I any of at were to we've exactly would the to of trials were had specific management architecture what FDA throughout or This my an the additional We thought try So the I'm were will for in year expanded be about frontline if we lifecycle say mind to this trial or we is FDA. one was to talking label trial were that and getting about in is. proposal going the around running the not work, of provide duration we going is going and with until What align where with trial that's frontline I to our trial year. the an with the come already that we and beginning we of itself to patients. commentary can't completely this it the agreement

point at cost our of aligns we And of this with beginning expectations. so, the from year our began the when a view budgeting

So feel with a original lifecycle disconnect like we're our point planning around frontline I study. therapy at management don't of

already In alignment pretty the fact I our frontline, strong puts with think in us ahead with request if to go plan FDAs anything of a place.

Ritu Baral

follow of XXX spend five the you’re think for going the that how sort of be lower or given my you’re QX going have to considerable at current XXXX? the significant guiding XXX is ramp what Paolo, increase for we at there then to SG&A side Okay, I for the given should end to literally launch of the burn, with just that incremental believe, flip could not about ramps XQ ongoing in forward, SG&A a in SG&A for

Paolo Tombesi

in are not more movement new are February giving giving We that. as precise guidance. for for be direction At movement on any about QX are this we earnings usually calls guidance our any the specific will at we XXXX there with that the not the his

Ritu Baral

sort potential going? fully on a engines significantly SG&A of there's or if between But power increase larger all or to in XXXX

Paolo Tombesi

As the we I as February. feel next we don’t plan I any that guidance and said give for will at give to moment comfortable year, in

William Lewis

approval, the you me well, place is team commentary add just successful in we for loaded seen a which team so in I, that fully and the this months have prior this for let commercial place six have May to launch.

resourcing white on that here of only boards of and the person every this launch that effort. company, phrase once," sits a at have We commercial approached informs we've the the phrase "You how

we're gives the bringing bear. resourcing you to think this year months the I sense some of So six

Ritu Baral

answers. Thanks to I Fair the enough had for guys. try.

William Lewis

the Of extra effort. course, I appreciate and

Operator

question comes Partners. Joseph Schwartz of from Leerink next Our

open. line Your is

Joseph Schwartz

give the that in but progress a us in congrats was you gauge the and point on know you order to to the share the could of early and I look with Good to launch, at and I I we metrics morning launch? what all do that us can of if wondering progress. the this it's sense forward realize expect just

William Lewis

in, Yes, I appreciate There's placed the more question specificity. the think, I that areas think is provide we're we to that some develop trends and looking to I on interested n become we'll the margin but metrics clear it in and better as clear obvious people what allow be think launch I are trial else the to before to becomes we going be a might it's, provide, want that what develops insightful.

that commitment my to express the just at has provide and looking That opportunity where opportunity, my ambition possible the the know that this us notion get the a sense the any shape the the to are be me at of of that it feel so earliest launch. just to information stage going. confident information doesn't specific share once begin forum, need we're transparency in people for Let guided to we of we to trends

think So just to what yet think spell it's be I know. don't will we out because sort I don't productive it of

Joseph Schwartz

receive out And you sounds good. meetings. valuable of you medical that recent some Okay, then mentioned anecdotes

might any wins uptake early the how of base, do many of headwinds if the could and that or think now you've you've so seen patterns these sorts characterize reached be I'm for wondering going you in your just you prescriber us launch forward? for So, physicians of shape the representative whether and

William Lewis

Roger. say things So I'll two turn it over I'll to and

have The with first we're patients so in and today. seeing is we're happy what drug we far

your So to Roger, want perspective? if I you know add don't

Roger Adsett

I think I'm is that the, think very would team I Will, to Yes, pleased thanks with the add executing. that how just I

I started reception what from the [ph] It the work for think and community well I had and we've Griffin as what that Dr. the some broader had I been Dr at Daly ID session CME we're prescribing and well CHEST has good and I very attended hoped as Week had the getting [ph] insights. think very community expected.

and obviously hearing from say when they CME we're also with audience about who during potential very That's doing but feedback terribly what the only ARIKAYCE do is think I ARIKAYCE the our a the patients. different saw feedback we impact appropriate. for that, six those patients that That's obviously think you need been physicians in engaging the with refractory of place ARIKAYCE don't I their talking at make clear set respond months based think centers had expected MAC I think also for first then the and - that's I consistent because these these about familiar prescriber questions effective adding really you're disease, guideline we would were that lung to with broader and reception talked the with can a not patients there consistent excellence not endorsing set and the for for it that and with and that more the how patients about something label therapy converting when has also those physicians. positive.

are with very the remain pleased I far. things So going how feedback and so

Joseph Schwartz

for Great, questions. taking my thanks

Roger Adsett

Sure.

Operator

Our Stanley. Harrison question from Matthew comes of Morgan next

open. Your line is

Matthew Harrison

rate taking the Thanks curious the address label they can for two I think everybody. physicians recently the me, which the Great, one with so you the know guess you in think or Thanks. is the I of coverage, the is And a sort how early question second quickly terms label? should occur views about you we can concern about view from or I you've morning they of population label have I not just how about was with comment they that narrow had after gaining not? guess good that the what on around, and question. can you've then they how discussions got of how view

William Lewis

both interactions the discussions, just then let with on we specifically to prior me the LPAD to Warning Black both speak also I'll and the - in I'm payers. of comment turning But the any research physicians coverage over context had Box our the and that's entirely launch. context comments of so consistent it done and early the generally turn label Roger are both with I to and in payers positive think Sure, that to

Roger Adsett

Yes, thanks Will.

the around think what we've So the actually them, for studied feedback really has and MAC not who and options. limited patients majority the the no been the from are, label Phase this no few responded vast who it's or limited in have was about that from X I can their had as a nonevent or had was population first NTM physicians describe expected they population is so months the disease fewer think they a that at that limited patients have least limited six of with options lung their a in

does not for to about patient as seem may that an ARIKAYCE. where think they impediment So prescribe they be of population their them

think I about [indiscernible] of pair provided of Dr the with release. the decisions, this fact saw the with community, his press came that underscore we from actually was helped I population our designation seriousness think this is disease, coverage with things FDA out in quote their limited it one the the and

I that was community. thing for think payer So a positive with very us the

it on on the engaging educating as We the disease, payers about we've our will, we are product. talked and

working in progress we we are their continue effort patients, to do the exception as update the we'll the in Until willing the and put the that's And see Medicare for over to months access medical that and for business, time the have time reviews. commercial side go. you expect process. and coming that but physicians of to we'll be We paperwork secure to so on until the on P&T in both ARIKAYCE

Operator

question of Sachs. Goldman from Dana next Flanders Our comes

is line open. Your

Unidentified Analyst

Dana. [ph] is guys for Chris the for questions. Darragh Hi Thanks on this taking

in their MAC the MAC wondering be followed be you was patients I non tertiary spread touch mostly magnitude academic may medications CF up who speed for and of briefly if with use on versus who with CF in uptake of may centers the on could patients existing community? top CF First throughout

William Lewis

Sure, so that take I'll one.

are top byproduct who for have arrival of infections and that an attention infection pseudomonas especially trouble. you label most not As NTM topic cystic the patients as patients at their cystic National on already of more gaining Conference, fibrosis in saw more does and the a because patients recent cystic the we is aware include of NTM the of spells fibrosis specifically really fibrosis, as

is for attention MAC treatment course great on and for So to is patients a are so are the and focus cystic drug of topic consider these in patients appropriate at centers discretion of patients fibrosis those at concentrated it have use this are any cystic NTM label lot groups. they of large where these and those of that fibrosis patients to refractory their our of those a on physicians

appropriate specifically So increasing community discussion label aware condition. an that this that stand Conference being those support of that it the their of on treatment we observe year of very ready been physicians and uptake. I the We're just Fibrosis that for of comment that we're the patients it a has at topic to we’re find aware in MAC and going are on the not very trend. topic to Cystic would

Unidentified Analyst

if like, can and look of where would so, you what done? examples setting approval from secondly then helpful. the study a Great, I any that's to the process generated data frontline to post on good can very was there path and and that’s And be wondering is is been for approval based there that point potential to past, present, a the that expansion if confirmatory

William Lewis

I appreciate the So question.

I can think clearly out as going as I let we're we me to go. think lay where

the the study also we accomplish about in of an of for against refractory by XXX%. The to was with this in addressed indicated year, as bring completion gain the raise new would refractory As drug the just bear byproduct population could expand beginning at in one requirement you to was population. the that secure we in to this We additional population. that the managed study is approval, frontline drug not the the the the pursuant And to order full study, that. approval goal frontline to approval we market frontline in important a population, but the because point, of FDA's

patients work not diagnosed NTM, two against about that XX,XXX team we're that who with identify some So undiagnosed we NTM database are to that patients calculated I likely beyond describing out the there those have diagnosed. by of and when you by and the addressable six yet to the is MAC that patients that learning that done was sort very can we ratio the now refractory. population think that been highlight machine insightful for is We think potential but patients multiply one who there commercial Symphony have we XX,XXX was are are this population market about went disease for would right lung think think and just those every

frontline two we while data patients our So have MAC identify that from XX% a securing as additional been that in six-fold the a not with qualify confidence market addressable observed that increase who would patients diagnosed. status, yet there's frontline patient suggests probably I

NTM that's many ever all experience to originally been not say not going we that be this there launch you just as increase, think not that the before going you we might no rare NTM when find in it's really patients, informative that's diagnosed more contemplate know yet and an I thought. really six-fold has did where when than have have uncommon one And of launched diagnosed. is into population those So disease to because patients of

Unidentified Analyst

I here, the last in you could Got before you I it. if That's very on helpful. made sneak flip know ARIKAYCE clinical switch program maintenance And that ad a can the a sense. mentioned if one it trial com

ARIKAYCE's So program did Thanks communications or we the how now that in and strategy potential you and post FDA at all? to approval up viewing program the are change for execution through how that leading through guys. approval setting, the in that are if

William Lewis

the Yes, question. thanks for

therapy as at concept Thoracic therapy both Society some the opinion our at that We update we original of frontline key which and up of designs looked indicated came we that with community an to with in socialized So that you. therapy. provide made strategy half as other the the of it next when what some we year if management designs now what final a frontline with But we're With parallel And therapy indication bring half a on the lifecycle on maintenance of on like. reconciling fine in next in way. American in do in visibility and that frontline that to back leaders we're those some tuned FDA as well. and information this the going we're whether the that study May. we've parallel that, In to we'll or is in expect of that look first as will maintenance it would trial information exploring and year run would some first terms and we've decisions the I will study part we Meeting like might and looks soon as have

Operator

Will for to call the over at There CEO any like time. questions this closing turn to back further remarks. are no Lewis, I'd

William Lewis

the future. Thanks much your joining everyone our an for in launch. early days in to I We forward very the us you appreciate update today. very near look interest of providing

Operator

have and all Ladies program in Everyone for the you gentlemen, today’s participating does and great may day. conclude conference. disconnect. This you thank a

Insmed (INSM) 30 Oct 182018 Q3 Earnings call transcript