Insmed (INSM) 4 Nov 172017 Q3 Earnings call transcript

Good day ladies and gentlemen, and welcome to the Insmed Third Quarter 2017 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 follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I'd now like to introduce your host for today’s conference, Mr. Investor of Head Davis, Relations. Blaine begin. Sir, you may

thanks Thank joining for and you, Good morning, Jimmy. so us much everyone today.

third results. We will business our our an update XXXX begin by providing and you then with on quarter financial discuss

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

the Joining Officer. call today's Insmed; our Tombesi, our and Will Roger that, Financial President With Chief let over Paolo Lewis, Adsett, me on and turn to Officer; Will. call Chief Commercial CEO of are me

you, the data Thank are the you very wake clinical everyone, update the for announced you we made to pleased morning, thank on us. of and This beginning progress quarter joining of in we we’ve strong this the Good at September. results excellent Blaine. morning,

unequivocal the collected our or The early endpoint on met line ability adding we culture bacteria in undertaken of our first to global referred help Amikacin or that regimen patients Phase of trial, were expectations. NTM treatment-resistant patients to conversion to a improved globally conversion top examined X by showed from In from receiving or NTM product Insmed the patients a the a with of the global study the multi-drug exceeding quick potential As in largest margin, The conversion. what with disease. ALIS reminder, opportunity a by an rare patient treatment study lung These the in lung that to failed NTM date will adult success culture with as pulmonary from drug clinical patients and of achieving is MAC to results bring of data evidence for the called Suspension primary XX% a drug the of to Inhalation we which form the culture disease this all sputum prevalent study samples impact with CONVERT our September, rare our a infection eliminate the significantly our announced was nontuberculous for study positive provide disease. market had Liposome X who minimum based guideline caused months. trial, the lung of therapy drug CONVERT mycobacteria and

comorbidities. years, diseases mortality. results XX%. as been patients us to disease be that progressive inadequate destructive our The further step For complicated the X-year increased infection and that can best as lung for an mortality these more that closer fulfilling it's than one mission and serious transform associated lives the lung XX damage battling rates NTM with rare irreversible of and to mission. bring a is is affects Current regimens caused in NTM multiple antibiotic information older by MAC treating that population the by disease. of high us is available NTM informs are rate Typically,

ALIS. Following life building Number four, key planning Number three, five market XXX for CONVERT, our promising filing. pre-commercial of studies. from chain cycle access XXX beyond analyzing ongoing two, number Number infrastructure. completing attention from areas the very five, and expanding and management; Number additional line the to data and U.S. NDA supply top our turned out the we’ve results one, for focus

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expect Anti-Infective Products of review. to Subpart the for approval H under FDA's file with We priority and division request

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the goal unfamiliar for utilize disease. many is physicians NTM is an them whom help to Our to educate

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Our goal time the is launch. of to robust access at ensure

on We to update move will you in as our area we progress forward. this continue important

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to strategy. launch learnings these our using are We focus

study, dialogue our now payers. with In advance addition, we of with the the can results

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who track to will continue XX receive therapy then months. These continue monitored year. all for INS-XXX converted to an background for as their We patients be off will additional from therapy patients patients

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standard INS-XXX. our initial for as longer in will had also over extension is to As actively not those open-label and by whether months. who This if study drug as periods therapy plus monitoring the patients patients study convert future. to patients the are a more data exposure X guideline are studies, These explore therapy XX open-label data continue ALIS an are evaluate of where will care share responsive reminder, our only did further suggests. of background month of to option the had enroll patients our who X-month receive plan the addition of the we to and progress in so This based CONVERT patients to

ALIS Turning [technical to focus, area our Life fourth of difficulty].

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stated As NTM Insmed the our we Investor significant a at prevalence opportunity potentially for based lung Japan disease. we on believe represents of meeting,

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comments XXXX. and provide fourth will for the XXXX on quarter I some Now

mentioned As advancing XXXX. out pre-commercial filing earlier, in very our and to NDA are on infrastructure potential support corporate focused we building the we launch our and product

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inventories Althea. X.X is our put when on are life that to and that approval. secure we comfort In addition, commercial It be us through now good we long for Therapure building worth manufacturing will shelf manufacturing years we noting hopeful relatively which great are gives a be use will product, secure we currently commercial our partners, able to

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We for our to will more on call February the XXXX guidance Will? I'll specific in that, provide With now XXXX. quarter fourth turn back Will. earnings of call

Thank you, Paolo.

top in XXXX, ALIS catapulting are launch of can an event for planning data moment the you XXXX. a line our forward release early ourselves in see, of filled As potential strong September we we including and from perceive

be to milestones way. we proactive as progress meaningful communicating will the continue in along We our reach

I always, investors for support and special want really dedication confidence. patients' their at for difference hard a something our the to to lives to As your team Insmed make in building and thank will work that and

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

Of course.

The comes Joseph first Partners. from from Leerink Schwartz question

Your now is open. line

on could from is you’re was for to morning. little an finding facilitating ability designations that and you NDA talk close expedient special much to manner? the being granted your agency all been you in if Congrats it about quality you’ve I a how progress. how are ALIS file wondering that able the the of all file the Good bit to

we Sure. question, Joe. Thanks for first. about I when timing, tell the think the will principle quality guiding obviously, you is

remain consistent So on internal we’ve and with time an that. we track line,

months data [indiscernible] I X draw any to that of to filing. haven't had your to We path. X line from continue to derailing events attention along top

any going today. it down not narrow are to We further

months. looking first. quality review From X I in quickly all to review, result a which that possible that this moment, secure goal are priority secure aware is our think of are cycle we with to should as we as about filing

encouraging NTM -- FDA core additional I the Did with in to -- able the dialogue you communication on you constant populations. noted Okay. were them the as opportunity have well? with on know you you been

be me clear. let Well,

that may been have an think I misunderstanding.

We our haven't haven't interaction been in contact characterized additional certainly populations. with FDA or around

focus for dialogue and the NDA is the secure designations we’ve, most potential product. following, our approval to of expedient making path these our with around of with centered of and happen FDA All filing the all and that the consistent

really think push KOL. that about has other the from for the we these As areas, come

ERS to describe results, not moment -- what patients, beyond patients ATS and those I'd we on approached I’m We used. terms And of this and should the these the potential But but congratulations as think different experiences there. me need here many life this said to there revelatory understanding of regulatory leaders where cycle the over where U.S. our areas what drug understand think was and severe a a be compelling and But more. agencies' me, requirements a after ERS, secure many and of as perhaps as something U.S., been we excited the XXX,XXX estimated only a to about populations. remember come -- are at year this are Japan, to the perspective key significant, So quite diagnosed who that, think we’ve have the fully go XX,XXX in are which management for opinion a I ability opportunities, that’s in kind go about few at refractory similar in in with that to of number XX,XXX we NTM treated

is refractory iceberg. tip severe of the the population So really the

number that, understand -- this potential KOL's for of the characterize dialogue behind severe an place that FDA is a be I so logical for then way patients refractory. see the opportunity drug and refractory one the right pathway severe what the I is that get the the go is And and enter label the to goal simply as very acceptable they expansion and would treatment pursuing. that’s of perspective, that one beyond from to that to should can reiterate worth approved find

on Okay. call. was actually I That the was to Thanks clarification. for get when able just that

my I misunderstanding. you appreciate clarifying So

rough interim that that of sense do wondering you you’ve Now when an might in was point? a mentioned planning look blinded you’re know if I Study. Willow considering to I you you’re get or the to just

and are on running enrollment Willow excited putting Call time gotten we that’s say for that well. That on running guidance. of are sites We I me development out kind shy would not screen bitten, the that really is, what and think twice and clinical are one trial I commenting and very we’ve lines. ready once But up patients. particular and up that goal program running was to number that

the So visibility calendar take give course into certainly updates I think you will we when next more that soon and year, And we might of as that insights. as we trial provide will that. as can some over the look, we share advances

taking for all Thanks great. my questions. Okay,

You bet.

question next our Walsh Stifel. from comes And Adam from you. Thank

now is Your line open.

Hey, taking good morning, questions. guys. my Thanks for

You bet.

arm, lot, FDA the Have in clients looked the measures? on what just My on distance around is culture you hit surrounding earlier, who the a didn’t those. -- and that and you the but was relative had hit, first George's And culture them benefit patients there patients conversion to endpoint your like, was didn’t get to that clinical six-minute outcome convert. -- measures compare the about question you you any around, culture St. conversions the presented I improvement did importance the when think with in from you didn’t this walk on it in have pre-specified demonstrating secondary demonstrating placebo you. I’m in walk? patients importance pre-specified the In Thank I of clinical around outcome view discussions updated six-minute sorry, a that endpoint of going you six-minute walk an test, data their achieved either that either,

the some of a we state. a information, X a, time important. study great controlled, people that is we’ve was this come of of Yes, that the learned with about, think disease my which best NTM a to in have of run We with anyone knowledge, to quick people. And ever double-blind, results, the evolution learned how understand placebo-controlled Phase And talked that great it's we confuses a begins question customary the endpoints deal. is really Phase But I study in been has perhaps first sometimes tour that our including as as robust byproduct forward breakthrough very referred designations and some therapy design agreement we'd at FDA approval conversion this further with appropriate trial the his endpoint our to a our on that culture QIDP, the be the was conversion. of Phase of those in reexamine look for the around culture study, dialogue, X study. that question, brought full based as Joe designation, And appropriate would that CONVERT primary durable X. of But clinical and

take So conversion. from that what culture that you the that is focus should on FDA message is clear away is from

that brought Now beyond as they forward for which clinical, did things remember this conversion did converted will is data focused focused totality you refer it, patients Phase are clinicians the less But the are always here is focused look see we showed the outcome Phase we the exciting think on walk of X, culture p-value I walk and clinical six-minute some who that into the most that are further, to and at and in regulators X, on X.XXXX. data. was payers that outcome and those on than

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-- that. they on drug for they were another So able between of low cocktail our And p-value to regardless I meaningful. center to is that relationship that, perhaps or is if converted beyond those very think a should on be something conversion, culture walking whether people looking are show who further

this you about in where on at very And are, and jumped That’s that, what expansion how date you’re maybe the or you’ve been you’re you’re to what but approaching conference I maybe this planning partnering Japan I’ve I options market Can given point your for there? it. of late, helpful. the on talk morning, done size Japan, calls missed juggling considering the

Yes.

touching sort So that opportunity excited we’ve opportunity. when to dedicated in we the the to to tell the started the you data, Day that and of way goes post the senior on we are Japan. question a I'd very go Japan. that Analyst about approach team best back of answering This is

clinical drug number our have talked of the to had people the a not consultants, We study. there obviously in because we interest Phase had partnering People time. partner there back this clinical outside was this we Japan X but not We are at been our going as before a Phase to many ground study, to that saw in Japan. over stranger only over in and early X therapy, to there, results have no in back them we regards I choose on even times, personally results. promising to the

at we consider opportunity now, have are Looking to we an will where alternatives.

more go ground. is first I get think on to presence about the foremost best way to and local that the

So we want to open an office over there.

in We are the process of doing that.

we there, keep the parallel talk and for from about Roger which how let will that pretty for and decision And Europe. just to to to think on updated will there ground. go, then moment about of maybe done, while on commercial a make direction opportunity over similar still you be did we could in We a are understanding, think position going This what will to us. that. definitive the on we I people few do have will of process because what be we work some put more we more we this me pause But ask early a there's understanding

Thanks, Yes. Will.

you So quite opportunity is the in as sizable. Japan mentioned,

include physicals X-ray. chest Japan. process We is that screening in a there typically annual fairly know So a rigorous

at once in, And physicians And those treat then are physicians a the tuned diagnose, greater see probably a diagnosing identifying in then patients so the at and NTM, in U.S. rate actually higher also rate. they than we

in previously patients to Japan, -- compares XX,XXX we out, MAC XX,XXX U.S. patients XX,XXX MAC to XX,XXX as approximately about to refractory and currently XX,XXX the laid refractory that we So in think

Symphony the opportunity patients So than a undiagnosed data. the currently based for one currently mentioned machine a there's the that every so U.S., we’ve NTM on that as learning think, sizable we’ve applied opportunity, the two in we think larger to we before U.S.,

favorable all model. an interesting lay that way pricing plus we cost best of to identify Japan will on the our to Japan. it's out be we the of So as We goods the possible opportunity. that work But also think plans in confirming enter into are

filing? And questions then, When so guess, just I here, is take the after to but you I sorry that file me, -- would just guess, I’m more. in U.S. Japan? one Remind many

Yes.

the So of preparation and the completed. authorities begin That submission to priority, about equivalent that. translation them. that’s Japanese moment plan is of the Japan. with feel with there will we think as NDA will regulatory to process had is, good meetings fulsome get involve as the the U.S. I be. The already We’ve needs ensure some the meeting NDA done, we first But of a it in that that,

So be sense of that into was we’ve Phase we Phase data, going the part results work patients the to study. as coming you what required. the will PK already Japanese X a had our done in some I on remind X of

a has going done. of So for that all us Japan. of of of the our puts profile game in to been company It way ahead already work terms

some attention get and terms turn of done In then NDA Japan. we to specific timing for the let's time will lines,

appreciate I Hey, taking it. questions. thanks for my

bet. You

from Baral from Thank comes you. And Ritu Cowen. our next question

Your now open. is line

go over major the see that out XXXX a Good Thanks and in I’ve current you publication durability first few the taking durability patients follow-up. for will or that the got morning, we be included data? in NDA. what’s at question. making might we the from see first of data can ATS mentioned Will, guys. You plan? the And that Could the it when far some

Yes.

question. the appreciate I So

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complete think it's a it is want the to I putting hesitation it we in more about -- picture. we the think earlier be out

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combo opportunities, Got help as without it. frame extension getting maintenance inclinations ALIS? as I therapy drug -- of And off-label KOL but they patient triple you with one what far KOLs they of those they’re could a the into now the right currently mean, do what obviously, months I converts, if What about negative. XX terms still of us XX culture standard strategy, with any like do are care? it how ask months, current the with maybe ALIS that? could out and do into they where patients When go in potential could or manage fit

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the our decades. characterization, been rotating antibiotics or the not telling for on that cocktail a of FDA, at them patients three before standing up is and themselves this four heard they’ve this PFDD, You

therapy they So in guidelines but because monitor they reinfected. are physicians additional get call cocktail treated, of conversion that, quite of patients terms on keep is XX will that not then and you them is to do motivated how for -- long quite ensure tell until often continue patient treatment our really the patients for culture But the months to their the by and patient. after an varies it

think is because doing the NTM in would of us a Front-line in post so So have times kind interesting the have. benefit our therapy to be of the returning? their the same another of to be rest in they this also say, think potential opportunity way. when studies drug, that responsive about And took want that examine X infection socialized conversion opportunity, I that week might potential is context, the belief the of it from keeping is life, about we they that what possibility think and one they of their if our for would I drug clinical benefit with of

study efficacious those and positive, in of we a treated disease is makes perhaps it shown treatment the is treatment-resistant, high have feel physicians we we'd be sickest eradicate that potential a patients less sick Here of and therapy, positive feel And demanding very I the the of there's to our long-term very front-line ability there's statistically that and in for here of which significant most terms evidence demonstrate sputum. to profiles results the effects. in very that CONVERT the we’ve read-through likelihood think patient or the good our why really

Going after as as reinfected the doctors putting as any as seen do therapy if what back on you patients a far hadn't patterns back severe to second, or triple we as conversion, have they even for putting reconverted? far refractory

Yes.

know, the they population, do it, so a events said, as on onerous. as as that their -- into leaders characterized, But I the XX% this treatment. in in not it adverse some high the as we they are to think It's years. that least be is X have significant that’s clinic, guideline rate mean, Patients KOLs available once mentioned some I and at called opinion are it. quite never patients have come the as leave. therapy can you there triple before, Remember will talked reinfection of key I experienced some discontinue for best cocktail inside

them in on I the they when conversion, see it, culture they them then care, culture of retreat that think So they are negative, treat of and achieve standard current when they they transient. [indiscernible], patients the is and number feel whether significant it is or these patients until keep a it's chronic in they words, other acute add treatment, very they with get which reinfected, they

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further remarks. And any I’m you. would to like questions. Thank to the I closing Will Lewis back for no showing turn call

on today. progress XXXX. early us joining for updating all good you our you a Thank look forward in We Have to day.

and you and program have Everyone for today day. a disconnect. this your conclude great gentlemen, may does all Ladies