Insmed (INSM) 4 May 182018 Q1 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Insmed First Quarter 2018 Financial Results Conference 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 conference is being recorded. I would now like to introduce your host for today's conference, Mr. Investor of Head Davis, Relations. Blaine

You may begin.

Bruce. to discuss you, Good Financial morning. conference today's to welcome our And Results. Thank First XXXX Quarter

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

review will financials. activities, a will call, general then continued the For Paolo discuss our we'll followed then of update, prepared quarter we open for progression today's commercial the corporate followed by start the with our And your well briefly who first by remarks, Roger, questions. call

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

that here. lead Liposome refractory efforts the and goal thank Suspension, and this that Recall the We evaluated milestone alone, month on GBT treatment. therapy, excited primary building optimistic conversion within fighting Blaine. conversion of first drive, this secure regimen of quality. goal standard full adult many six. months year is We remain address impact XXXX nontuberculous GBT have mycobacterium team declining on The converting treat these would launch NTM the for GBT, and the Drug remind us. We approval with launch data with disease team care, first will for or to based characteristics you, process an study moving To by their approval the Food of about treatment you, and important Results to moment key the you X.XXXX. with irreversible to aiming culture p-value the filing drug, with endpoint dive the was we MAC current Inhalation highest of our by of XX% the versus culture patients our off offer that with the estimate progressive function. lung for to addition sustainable a that are inhaled our to a the ambition, NDA time morning, ever Thank We're quarter led infection XX% are Amikacin potential has using everyone. ALIS and XX% on disease a the rare company. complex, and We Good the patients the And less of in lung ALIS biopharmaceutical by achieved U.S. ALIS alone closer in I'll accomplishing will our momentum, treatment circumstances. to than accomplished a and as NTM damage joining file that label this of antibiotic quarter. with a prospects primary show for the GBT to or plus lung this or efforts pulmonary kicked the when of off we're mycobacteria, study. or important disease. end throughout endpoint over which is fail patients take associated MAC. our are us we our timing first potential acknowledge NDA from or the the be for our approved ALIS GBT shortly. that plus margin an the month unequivocally as six ALIS of on of a INS-XXX We avium caused therapy I further of to like into treatment Administration at six to and guideline-based with this with with

culture potential Our the program XXX, the converted clinical additional our from patients shared plus information by have on The was all Patients, of INS-XXX XX the to which studies gather study year. receiving this patients trial positive were earlier robust convert, the designed in treatment. continuing ALIS. solid months you, XXX who GBT. additional study in clinical two culture line data these did in an seen in To option advantages of to ALIS who for we the in long-term remind additional not top corroborated enroll results that are

we interim what GBT the reinforcing XXX at with the consistency, echoed strength the we achieving data XXX culture submission. to similar month confidence the six demonstrating was XXX of data in First, the previously our clinical on alone in we of what conversion conversion conversion patients in This in NDA of our study observed from XX% by month in set rate saw used study. six culture

achieving the XXX culture in six in least patients patients six culture important an These ALIS. conversion aspect of support achieving is benefit in year further conversion, on beyond of treatment we value observe patients ALIS results treatment with of months believe at for the a from in XX% which of the longer-term we XXX. proposition by prior more plus data Second, GBT nonconverters month

guidelines indicate they culture As once remain converts, patient current on the additional an a therapy for reminder, months. that XX

for remain time. on that of research know much also We market guideline-based therapy patients through periods longer many

study time more median the was patients four entering years. XXX for into GBT on than the fact, In

will showed substantially versus also with data interim for full higher ALIS durability at culture study XX% The all a off arm conversion culture the durability the of culture the of of of treatment. is receiving plus months has compared for treated is substantially Durability in off of XXX conversion the alone the FDA's showed importance GBT all alone. months GBT an examination Third, important GBT be to believe approval. the conversion full as patients higher X%. extension durability particular focal We conversion GBT is of patients ALIS of this ALIS regulatory XXX those point culture three of X at plus of approval was aspect treatment

that these these process. While consistent in review data submission, are they are demonstrate were profile and use finally, not antibiotics. of included similar INS-XXX. findings consistent in to studies, acceptable to we these with the other shared we requested INS-XXX serious both our and are during observed FDA, public a we The scene previously in the safety inhaled discuss emergent if NDA those regulatory profile remains across prepared believe with events studies And as adverse treatment safety with

INS-XXX studies remain the to INS-XXX anticipate late and be Let me you remind in study ongoing. completed with topline the sometime that XXXX. INS-XXX We data both available

in about few on San the of Conference, awareness coming clinical further for ATS May event treating treating opportunity health educate community results. NTM May across XX XX disease few taking up a and a minutes Thoracic the spend grow exciting American Diego. Society to and to Awareness continues International community our in the of will us another care through our us an for efforts provide providers me Let weeks, or ATS place

by results the treatment discussed results of on investigators an of XX will study. oral III NTM First, CONVERT the of Phase the be our for presentation we'll MAC. May Tuesday, one study the outlining ALIS These have principal of of

this risk Second, at forward have NTM the of we open challenges lung identification additional NTM has data to test, and walk increasingly presentation detailing a on to and predictive outcomes, data results for will importantly, and reported disease. X-minute at individuals label forum, poster associated results this We health how the disease. look patient which unveil sharing study these with focused to with on you address

in Third, open trial lung of be will abscessus an there an presentation oral ALIS label M. of disease. investigator-initiated

continue development in These will in and important we gather important work disease interact our field to understanding option. continue and the this today. new enhance from ATS, treatment learning’s disease conversations at to our to further all while building awareness insights leaders of us of and the guiding in with thought of potential our share be Finally,

As filing the March with end end month the priority of should I June six anticipate with or division We when at the great by review the early third decision, but May we've to a should the agency. regulatory front of mentioned we NDA expect products. result H end the This quarter. of the on by PDUFA know Subpart made progress the infective PDUFA earlier, date U.S. under of any for ALIS a in

As potential for planning in of currently quarter. at launch discuss we fourth a are the Roger commercial will start moment, the a

committee novel advisory PDUFA the advisory with therapeutic unmet are of of in agency's areas meeting consistent also convening and practice for the in to We an the review committee expecting Gold date need. connection with FDA's preparing prior with products meetings

forward and will We continue look to AdCom prepare the to for an dialogue.

in from spend a I the a Society over around fruitful to geographic opinion the on next very well returned me our on with the expansion. geographic priority progress efforts In Let moment our also just on of advanced few market, the front as team focus over Japan, line have this past the build ongoing our support Japanese connection with our Meeting. is awareness met Respiratory expansion the trip to a months. to This effort disease with of Japan, dozen further part key where leaders we strategy. with

data in NTM is local The in to the to further identified status the of Japan. of We with of patients including currently look progress disease understanding in than ongoing. lung XX,XXX approximately strategy in further Japan on refractory package gain refractory treatment world updates providing of orphan with prevalence are than the U.S. treatment filing NTM A PMDA, MAC higher the receiving perspective We forward more to also throughout Japan NTM process elsewhere in our is year. the and advance the the on XX,XXX drug pursuit

European use given several patients Compassionate Turning Europe. programs in ALIS. a access of to number to have countries

in approval, with our these limited, our are treating Europe. relationships community a to establish and program the U.S. Following a be we intend will program across them named Europe fully drug, patient allow to access the treat to this reimbursed nonetheless to patients ability while successful broadens

Insmed geographic The As help U.S. this review of rare you see, in advance disorders the organization. a to our of INSXXXX, rapidly support regulatory team will U.S. the process number expansion other next is can efforts potential focus. and of out year for we're organization launch later ahead These our programs a our of to expansion. the preparation precommercial approval, build with successful with the working also global area and moving

we've focus a sharing has to amount advance previously, particular programs more NTM CF details the interest continue the to been of of these the we noted treating these and to in INSXXXX year. community bronchiectasis to patients. to look for and non-CF significant due the program's in half As initial expect accelerate in second activities forward these this as Development advance. We activities overlap

update cover me turn by for followed activities here commercial who pause first quarter it and to financials. our over now Roger? on Let our Paolo, an will Roger

Thanks, Will, morning, good everyone. and

in precommercial few the specialist therapeutic Let our Healthcare deployed in were a Awareness disease made me you spend In expanding weeks, already team engaged at of They specialists We've the disease. the progress first targets. of our update minutes with efforts about our March. tier just education. have Professionals field, today. half five X We of an conducting with our therapeutic solid end on providing our the

under a As targeting reminder, physicians. just XXXX we're

the that we conducted We work targeting using experience are the validates Symphony the databases. pleased

welcome have targeted they been While disease. about discussion it's well to the received learn engagements early, physicians and our lung more our NTM with

gather engagements launch. allow believe director team in also their our our the Thus We're also is to the today, payers information with through state that have productive in importance are hard in script product. approved our disease generated supportive we for on and continue and to use work disease enhance process out payers about an healthcare state professionals, access actively product key for gather discussions insights patient therapies. recognize We that and further potential the NTM. insights of patient engaging we'll preparation build been our at support account the our a commercial a which will efforts far of those been to of receives with by further that that view efficient that They've the to services of new currently a and the no with

supply support making it Era our on-boarded of a an who I'm for safety build patient patient ensuring We've in our to and great one launch team, process have we way through coming elements sufficient to And an expected batch we the Thus we this launch. the operational entire have Paolo production Collectively beyond, when year. investments financials gone specialists, partners, of With closer over solid and as work device towards we in this can we're ALIS. will play our the the forward of long about final set on-boarded is a were will smoothly, expect potential commercial build we we have in of of the able team excited will access experience commercial months year later role to to our addition, necessary who the the go quantities we continue as to preparation critical positive as first of of of will And at be. that, Cares way quarter the we inventory In looking commercial and with area to great let secure the through are This time us on turn review us second where support has U.S. to these having drug each a a of are of well XX process, that patient ensuring to the can of critical the with dating, we launch. approval. stock invest and me launch focus bring ALIS a this continue activities the to build early is launch. far and which organization. for so and inventory quarter. to call the excellent three commercial

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

period. quarter to an his The First website. many Investor planning remarks investment compensation our million million. expenses activities related were increase increase Roger quarter quarter $XX.X $XX.X in headcount as compared operating for of to to XXXX. versus expenses our operating which which expenses prior to Cash-based of reconciliation was due million of primarily and pre-commercial ALIS, G&A is in of our in $XX.X the in and is higher higher included first due our highlighted Relations for release, GAAP expenses press year related for cash-based available the expenses A were operating the our section to

end as as and as our and of well inventory As in you a our would potential expenditures infrastructure year. continue expenses one the of in of build on the primarily building capacity XXXX million, our expect, Capital launch facilities. commercial to third at out of we were rise the activities first will manufacturing of related support this efforts quarter product corporate party anticipate of $X.X to ALIS our long-term remain other at the production

of this equivalents. January result, $XX through offering in As reflects proceeds quarter senior operating completed received net of of This the we total ended and XXXX. million convertible the approximately public X.XX% notes cash We and in first of expenditures our were position cash-based quarter the $XXX in million expenses a the successful $XXX.X operating XXXX. million cash with cash

return including million. resulted to of Capital. The at paid an offsets expense convert. prepayment Hercules, of February, early cash debt improved and reminder, capital. interest we our repayment approximately Hercules fee back-end of debt the to was the cost penalty our end This payment total $XX the a As overall the the in on Currently,

Turning guidance. our now to

would and XXXX. million the cash of first be half $XXX This continue reflects other for We and capital expenses that million to cash-based investment the range mainly as spending range and ongoing within study operating to investment activities. expect INSXXXX, ALIS. study, regulatory of follow also for include to The estimates INS-XXX expenses clinical to including the well commercial the as related INS-XXX continued on ongoing support $XXX

As to resources appropriately guided and milestones With our focus that, I this we'll our and we on are responsibly. back year, upcoming continue by utilize turn it financial budget Will. will to

Thanks, Paolo. the strong quarter into we year. of carried momentum XXXX this Clearly, of the first

to with advancing option address potential serious make important continue an progress We medical in a unmet the treatment to need. impressive new

team. at a thank in like everyone hard We positive response want lives also are the difference for many from our I'd and continued their execute dedication. patients been continued of our to close, see I in who excited are ability remain work and for about make confident us, to of the physicians, their to meaningful looking as clinical At we, program. ahead and the milestones physicians' to the to thank excited a patients. involvement We've a in Insmed,

and question, Now can take open first the your questions. take Operator, line the let's we please?

Instructions] Stanley. from Harrison Matthew comes from our question [Operator the And of line Morgan first

line open. is Your

This Asante Matthew. Ishmael you our is for questions. Thank taking for

couple have Japan. We expenses a in on

you. inventory for of in you how we about and should think 'XX steps commercial 'XX? can going to Thank second build should be peak manufacturing quarter if completed talk there? second are about about and half by Also, think commercial much What how you remaining the on expenses filing, First, it how on need spend/activities expenses the Japan? on

from announce think, characterize manager looking went. that What of just the to to We've Respiratory of hands looking to from start, provided before detail on, provide be the a I it breakouts cash is, about so. had that is that for given So guidance come not-too-distant with shortly. that product potential in going general and already the the starting was we there. to very back our an of consumption. importance happen. going to the to say for beyond Paolo. knowledge, I be think more really is being guidelines, direction a And team going that put that owned that awareness to I very before to by and in then want NTM to into to excited over onboard we I that Japan, Having I that It disease come world able announce our to you ball us. candidates be go up hope we're it the just very way tell for the ability even on in going what's JRS, close will are local we've is for part we've by disease more and well community over meeting, I'll opportunity been interesting to clear control is we a turn impressive not just of the number But extremely that at, And future. received that set I Japanese Japan, person high, Society is and am extremely about very the Japan, to having we're

I the during with in NTM refractory the are there U.S. in remarks, As they than are Japan, more patients mentioned MAC

it think have us, a any is Paolo? and resource Do significant other we this don't details to guidance. opportunity very So going on for appropriately. I we're we

No.

Okay.

with spend. Japan detailed specific can't that's in unfortunately, questions your more response think regard to I - I to be So

that least substantially You is or That in having well. very did developmental to important build, mentioned, at are as stage. have inventory we that. about expensed an aspect ask investment we're anticipate we still resourcing because dating, the X-year Roger That's as

be of frame. safety build the be now time coming time the use beyond the of anything over during launch a at course we'll launch anything and the able years to we nice So will that, stock

helpful. So hopefully, that's

That Thank was helpful. you.

our And question Martin line the from Suisse. Credit of comes next Auster from

line is Your open.

Hi. Tiago question. on Thanks is for Marty. taking This for the

have your you awareness. And interactions points far, you had physicians' learning’s some especially about you at if thus of ATS? that could Thanks. for relates interactions So to expect from physicians' the have a key of key the disease little are as perhaps, to bit focus perhaps some it that just what talk

to that Roger. turn Yes, over one I'm actually going to

question. Yes, great. the for Thanks

I about we've think, of the X as engaged a our weeks with field about of they've reminder, therapeutic X half targets. had and out in our specialists Tier

early we've interactions. physicians in taken think, And those X,XXX I We're total. some so about calling encouragement, from on

is So lung right. the NTM that maybe have thing these physicians on, the most calling we're encouraging for patients, me

that's rare that the So that, in a that for with epidemiological strong And interest that we're calling have and one of NTM available patients to seeing data launch successful a the something they disease be able patients very and they with they're what disease the shared support is with the have we're treating. are these treatment. patience physicians their of number you validated efforts in on, we've lung That's from find actively that in sure previously. still things consistent we've that to practice the very make these and

very And opportunity so that's not is the encouraging the we what those guideline-based are validation also size they portion and the responding patients of to think patient reported therapy. of that of well substantial

all those us. very The are So I particularly of educational received. encouraging are well for resources think things

office, the our specialists healthcare the our have to decision they're investment really to about professional the that welcome make So to the educate to physicians, talk come disease therapeutic the awareness into access welcome patients the to materials that where disease they really and particularly they they community the because have they disease before. have about anything the can now didn't had some -- finally about validates provide

have from also, continue patient We're across learn our digital So continue with with and we encouraged digital strong early our from see in we I by therapeutic we the disease from the the to seeing to efforts. engagement think interacting of active will in digital things, channels, professional We're both healthcare awareness side they side performance but and invest very the experience, capabilities. experience the all continue to specialists.

ATS And one. I'll the on just add

regard of I to think -- physicians enthusiasm on lot seeing in a NTM. from we're

I was this Society little at European One ago I there meeting NTM of my went and and an a Respiratory when X.X favorite recent company years the started is, to over anecdotes standing people presentation only were room. there the At NTM. it on last in room hear physicians people, the waiting XX was held, session, oral X,XXX being year's to with about session

Oftentimes into this its disease the think both arriving endpoints, very be state. have found to set harbinger from and is an It where of see bronchiectasis the topic to that impact Aradigm III drug disease Grifols [indiscernible] against circumstance, that a that has meet non-CF failures I IPF, soon you the of we Phase So strong our PAH when III and did have going it's becomes whether the in a not discussion the come. may or on unfortunate results and Phase trials were approved. arena significance their statistical not what's

that is this to be and say to fair lot and enthusiasm about ATS is going the topic, is just So lot I this its with, interacted think a for this potential of approval of on the talking there the it means impact from we've disease. hot it's awful physicians an and product

taking for question. Thanks Great. the

line the of Walsh from question from Stifel. next comes Adam our And

now is Your line open.

a drug treatment the or a just is And given thoughts lower guess, for couple rate population include would commercial could I some in got prior Good patients. ALIS ALIS approval a that drug a a label for Thanks. morning, I And those grant either here. front-line simple in potential guys. given first thanks perhaps or planning a scenarios broader FDA label questions. then naive and drugs a quick that guess, mentioned that clients you narrow device pass How have combo, refractory device of from have patient my theory, here, are manufacturing had taking I've filings, filings there? that than combos what your internally possibility are follow-up standpoint? two for the

CMC that and want is well make doing as very that the but production for much we're always we're a that constantly, simple, just commercial side circumstance of are having we take the and for that on to quick along in pretty adventures we stab. be Sure, get simple. The the that reason having there the journey, I'll as that ready preparation so can full is into habit whatever said regard. running One, may

brought to linked at we the do launch, or I have think, agreed label not important or we're to so discussion H way I in AdCom about because what I Subpart X-year any may we on mention I in what be a recent need a under discussion, our all debate and you whatever is upon, little discussion. on our remind III approval. will you it you think, think get was just you of but endpoint content labeling, that's and much and I and think that's we're what also, where from approvability supply this I a Subpart hit It's as a just Phase to so of definitively the And going secure surpassed. other of not context to speculating to I'll not distinction concept a plenty the be an filing to H if premature finger label, perhaps view difficult you more happen, AdCom AdComs your anticipate to with that's endpoint about. what's primary primary label is really put may because in and be going your time to going

this approval. think Drug of of combos going be device I this more challenging to label, some is discussion not So as regards. we've in a be they heard can

been where recently, an end this that have has is by already the of year. a approved device advantage the here think, and last FDA I that at is we most

a look another at look it with is looking took this just will They of the not in fresh they device approval fresh that from take want to at. fall a So Sunovion. the similar a drug

and whatever I for going you the in bit don't the be. be case. preparation, we think of will suspenders view, cetera. point if that We're outcome to the prepared, know, are that may Roger, to want from talk preparation continue So a little belt and continue investing I commercial to about et

absolutely. Yes,

might we expect, you in and outcomes the label. are as do case contemplating we So both that that broader get

value both much disease we've so to for and with scenarios, can. refracted as given through we consider more place there see of think them that as and disease we're and under engaging product appropriate the to ALIS, strong might the initially they them some and research value therapy specific Nonetheless, to label well, broad think, the the We're you know profile payers. whether pricing prior a and the engaging narrow value need label. as we've will overwhelmingly our as thinking product see convey we of with as on are and state, broader and making that The example the in talk the come about studied. contemplate initially I prescribe also value the ALIS broader need But if would the the value to the population. And to our very in for label, we like the versus that would product unmet highest physicians is think what to the physicians that see we that about state, to I a I label -- also and authorization, what would a unmet and a intent physicians within the high look that I different or for pricing not as got that prepare mean a scenarios for population research, we nearly of done I given a product. refractory population was think a

So we preparing for both scenarios. are

will the the of provides news the and to a have scenarios is from the very strong opportunity confident my in I that perspective patients receptiveness think therapy. the we we ALIS value feel both the that to good physicians given

And other add I'll with the interaction the just regulatory authorities. on thought one

as have all, H designation, by we've the our regulatory Subpart mentioned, Breakthrough got therapy we QIDP fact review, sales. Of we expect designation is we offers. approach AdCom in we supported into enter the course, accelerated the that we FDA orphan approval, wind this with as enthusiasm discussions priority our every AdCom and them that with

Thanks at you for the color. see And ATS.

to it. Look forward

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

Your line open. is

much. very Thanks

the plan know patient previously. I focused supportive launching is payers access So and significance you differ of appear a to according a for Medicare whether of mentioned commercial Does payer a to recognize and cycle mentioned on off plan Medicare this ALIS. that the you've versus importance

jive how does So the far -- how thinking? of early that you does some feedback know Thanks. so with these

Great.

So it's Roger.

say we've and directors from this payers, a number with directors, key plans, with feedback from the board really of I advisers. did we me advisory an just encouraged was several that pharmacy the Let conducted the accounts, with recently medical and large

educating I educate physician the supportive think about the unmet the the around their very NTM, but need their conducting need in NTM. community management, membership state. not that they accounts recognize to and recognize actually, of just this we're also, physicians in They disease the efforts and are currently the

small overall, think, the recognition already is population things. the their system. patients see in of that this fairly in are I scheme we a grand These

expensive. that the they resources are not a where So for shared are data we've therapies available and patients these particularly know effective previously They're patients. of lot consuming these

that still think my that's that, phenomenon, see ALIS we patient is payers So Medicare And conclusion right I off-cycle really that clear in something about exists. and that a population. for place talked the

this deny appropriate patient medical with as patient I Medicare will see launch. be supporting access very very to put system and support the be believe few However, deploying months in a the do difficult payers, strong engaging first of with into they going appeals for be them we're over and that the that that to think option that place process we a to will is

laying think, were it the ads I is, commercial the our some out see we that a of when than I see really a maybe commercial do value. plans, well. something and there's However, really recognize that a as we plans possibility that's Medicare From encouraging initially in more They contemplated think some that some, I do in also that ads perspective, I is a we'll off-cycle think little possibility will plans.

very will consistent I plans may overall, And period I -- think selling be a matter or when, the get the are ALIS, on of as add won't appropriate patient for appropriate identified think will feedback the recognition will we of product, the results, I the not access. population the is validation eventually for if. It's need have patients There just customers. be a of But there difference they through their cover trial of the the those as new to new therapies therapies issues kinds the endpoint of where endpoint. some a commercial would the clinical as the of long say, for time.

Great. Thanks information. the added for

Cowen. from Ritu our question comes line from of the And next [Operator Instructions] Baral

Your line open. is now

Hi, walk FDA tells to guys. there's sort and label, know they amongst well the the label, might at Maybe six applications may preparing discussion the are aminoglycoside other from broad the the of some back look recent the for? data, about how been question. the Thanks on beyond for perceive in you taking AdCom, the what some any are of things I that safety? minute how functional guys community investment

Sure.

closer not to data seen AdCom, responsive and the respect think, is to and this more a we I'll said closer think this directing and there the dialogue. get going I There's difficult reticent about the not that ours caveat not be be we debate So is agency want don't as lot to Having or event, look, a be process. where because be just speculating that more It's as and that we it to that, provoking is their to of being I presented. complex we're submission.

-- then context, first of primary discussion those it's and great intense about deal The for hearing as with particular by released this aminoglycosides the on that related think see profile It's we to and see consistent remind again, that is safety as I encouraged be loss, inhaled your safety I safety intense the is why And remarks, in to a don't more the debate on this not in idea debate during think, everyone that designations. and of an data it's the with done to regulatory on antibiotics. having turned to We anything well point, go always very about are our I we had confidence, drug. having an approval, that front, labeling, distinct characterized to that other continue we this and in our So all we didn't study. endpoint, we topics probably efficacy.

concern aminoglycosides that in of nephrotoxicity of also time that using So of in an here encouraging from profile, is the alone was sustained period was terms for encouraging view. didn't see a safety point not an improvement of consequential aminoglycoside evidence

into enter safety we think with a this pretty solid the I side. feeling So on

is unequivocally achieved. efficacy side, the On the there's endpoint, primary which

I six for well an improvement walk in minute test, endpoints, I got aware to patients is know think of, minute culture walk those the where we've who converted. other which secondary everyone we able show six were

- lot an that and because outcomes culture benefit category, does that then the beyond a that, demonstrated think expecting clearly in treatment. six to see the primary I conversion to conversion our functional cultural a way in to last the in in it important is months study reported fashion time and first X of aspect in endpoints patient the blinded link that's we a weren't

refractory safe very of effective I'm will more folks the these So have, I of we the panel and be that be overall, treatment the think drug I pulmonologists I community. hope use and appropriate of NTM. - going questions we into it characterization there the all will sure understand of folks will be on the that about as treating as for ID received think, be the to in of addresses a from and well them that question? point group, view discussed. fully to is the dataset are kind the But

helpful. Very thinking interactions, consultant about timeline interactions I'm you're wondering regulatory Japan, recent then to trip on in most of Yes. Japan? did you And or regulatory regulatory your the have any what

tell is regulatory will putting Yes, GM are that talking been that more we to firemen consultants, for time. have so we a we're onboard. I our you long on until

the of context from Phase remember, received went to Phase wanted Just a primary patients to statistically design specific We They our we I publicly Japan the their III we may of XX, on through they with into exceeded that. Japanese said got of that significant had III the Japanese trial. we them we PMDA, see endpoint. number and study, think not that actually XX, those place we and in those before for analysis we who wanted and visited the endorsement the trial, of subjects also significantly was the have sub

in the arm, In a response the was rate fact mid-XX% the treatment it I and there therapy arm think ALIS. was guideline-based -- with on zero in

a So where understood From widely status. very of community orphan treatment will pursued. Japanese strong here, we file data for subpopulation is in into NTM and

That quality thematically seen will timing a as file the said approval second, Japan very companies, this can that seems something takes JNDA. time, of be we to entering. that, is but be a the first, to have from for obviously, process diseases. soon think It seen some products an translate NDA with that but We favorable into as we other is disease and having all some probably -- we you've environment embrace rare is what and

of why recent we're that's so it, and this And most the so by given enormity excited trip. encouraged

status quick manufacturing GMP it. other you approval expecting inspected? Where certification recently to the just your Can inspections Last relatively And Got status closer -- date? briefly question. inspection they for go you are the the over of of status sites?

Yes.

such the the trial. any for that So review facilities FDA I out the what in for to clinical is anticipated is sites and heck on engage mean, inspection specific are ready certainly and you companies. same always the involved We process resource that's of a place. to don't what -- with of an have tell if to will that going take part of which we comments it have being to I when But buy potential in eventuality,

So that different I regard in attention. feel our are we for the all where very good about their that of be subject of may facilities

Got for taking it. Thanks question. my

Sure.

line Securities. next Bayko our question And comes from of from Liisa the JMP

open. is line Your

Thank Can Hi, run worse relate the you think main base kind think case, follow a label may you on the we out? scenarios good be how morning. just of of you. you in up terms said some to and through case, I of best about play sort wanted conversation you label. a in discussion to a ask now could case

slightly. some divisions been There there's designed up MAC what Sure. is, this Well, have has recently are at if we data beyond our discussion think FDA. gone that and we refractory don't precedent The and Subpart FDA a That's worse in with following clear way we was about is assuming expanded path the study NTM to we to H, the patients. know best, has the look I approval we under where the there, clearly will population demonstrates feel with refractory and what case. label a mid end other

for thinking they ask label. of I'm and given Soliris gravis, were myasthenia where a Here broader for refractory

be to it don't that talking but just differ the prudent refractory less my infection up. the think bacteria, of responsive bacterial a that, going are bacterial in we're there expectation from it's regimen. is logic because it about in to therapy I they patient So guideline-based Having broader a said non-refractory would treatment could to there's a we a and in patient, end a not that's a where contemplate label, if infection

and some a there the FDA certainly granting to seems So has is in the a that that of broader been label logic divisions to in evidence of spirit be certain recently.

a patients. label it. think our to prepared I NTM as for be it's be just out prudent date clear, MAC something crystal treat and approval we But So AdCom are to of within to PDUFA come refractory

Thank you

Of course.

questions. no like for And I'm at showing back time, turn to this Will to remarks. I'd further any closing call the

quarterly to of for call you and at Look on this morning. forward you giving hopefully updates many seeing joining the everyone us next ATS. Thanks,

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