INSM - Earnings call transcript Q2 2020

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Operator

Good morning, and welcome to the Insmed Second Quarter Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Stacey Jurchison. ahead. go Please

Stacey Jurchison

Good to Debbie. and welcome today’s to a Thank our morning, second call discuss update. results quarter conference business you, and XXXX provide financial

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

that GAAP earnings For to release a issued please the earlier we measure reconciliation today. refer to of our results,

promotional call Additionally, not this today’s prescribing on sufficient information intended is purposes for and decisions. for not

Joining Officer; Chief today’s Will Chief Dr. Operating Flammer, management and and executive Lewis, Officer. Financial Chair of team, Executive members me Officer; the call Bonstein, Roger Adsett, including Chief Martina Officer; Chief on Medical Sara Insmed are

remarks. of over call Will me turn call Will? now up Let the for those will the Lewis Upon for open to we prepared completion remarks, your questions.

William Lewis

the healthy. there remain of to and quarter. for several We midst with ARIKAYCE hope us. I’m safe pleased thank behalf you in joining accomplishments. Stacey. families were strong you, report you everyone, your continue morning, franchise, second challenges, noteworthy Thank to and Good of Starting unprecedented and a the On Insmed

with updated recommendation the in use. strong included a for were international treatment we guidelines First,

Commission on for for territory Europe from us the XXXX a CHMP. right a by end to enable before the Use, Second, European add end schedule. approval anticipate European opinion or we by September. of the will Medicinal the of positive This Products Committee We, therefore, as Human received commercial

to to in increase a for able presence become world. care setting of were standard front-line try COVID-XX we we and despite base the evaluating confirmatory to our the potential around made preparations return the of Fourth, revenue of new Third, to the quarter-over-quarter ARIKAYCE to stable treatment growth. which the study, established from final

For DPPX brensocatib, our novel of we potential understanding potential. significant advancing unique our inhibitor, made molecule’s first-in-class strides this

WILLOW franchise, this and unique disease explore in unique is ARIKAYCE As neutrophil Insmed to range if the same to of promising action. potential bronchiectasis. a both time, the will believe Initially, synergies continue for of additional mechanism on a existing from the in position market we bring by suffering has diseases. need our indications a and first-in-kind this longstanding for it the Driven we data potential immunomodulator, our approval. be unmet focus with compound patients secures to of At strength wide this

Lastly, we to palmitil, pipeline, treprostinil given in the are seen to excited advance results our the date. candidate early next

during September We all and in will programs on Research of Day Development detail a XX. explore virtual these

So information. please stay more tuned for

their our team challenging momentum. for towards we want environment. commend look to are Insmed I XXXX, entire we second-half to continue this As we in efforts the ability to believe excel for of the well-positioned their and

now of. that through before, world, than Sara this financial I patients With the to we proud over results. to the team delivered Sara? is for whole around have is context, turn ever the run that more quarter, our and know me call This something quarter’s let

Sara Bonstein

good Will, morning, everyone. Thanks, and

expenses, strategic our leaves this managing significant our for second our bring my progress as As well-positioned approach Will believe fully Chief a where priorities. Officer, programs. success. across quarter, supporting on keen we made had while continued mentioned, Financial key we to a us I’ve operating In capacity strong tried I focus

and capitalized, our X advancement of proceeds quarter our press advancement development. Phase and well are issued appropriately brensocatib our capital into key expansion, our strategic Earlier treprostinil release. clinical in currently we a very results an commercialization second Global financial to detailed the label in priorities. today, we With ARIKAYCE resources recent bronchiectasis, aligned advance financing, of are palmitil

of looking Let for We net total the of revenue despite me the compared highlight you second first over $XX.X increased throughout the just And impact second a those ARIKAYCE of Notably, COVID-XX strong ongoing sequential to sales growth for quarter for second revenue net XX% year-over-year, few the the total reported million. results now. when the as showed quarter, quarter. quarter quarter.

gross-to-net XX%. for quarter the approximately were Our second

be our approximately guidance XX%. gross-to-net result, of to we mid-teens. was gross quarter our $XX this million Cost revenues for the was full-year for the the the reiterate in margin Given previous and product of

to expenses. Turning

For research expenses development and were SG&A the XXXX, $XX.X of million second expenses million. $XX.X were quarter and

upon expenses brensocatib initiation for program compared quarter in the second Our second as confirmatory second on In of study of was X XXXX. the $XX.X the discipline the Phase quarter XXXX, highlighting and GAAP of of second operating in earnings operating compared for our continued adjusted our million increase of defined setting. to cash were $XX.X our and $XX.X expense, expenses ARIKAYCE focus quarter our in front-line release, note preservation. quarter million efforts for treatment million, million that, we the and expect to XXXX, our to $XX.X do Please

which with further core let our quarter that, $XXX.X ended for our the proceeds priorities. strategic cash an ability to Martina update includes call execute we recent our the Martina? strengthening a million, on turn me of With our strong on from to over position financing, pipeline. Finally,

Martina Flammer

good and morning, Thank you, Sara, everyone.

the for Insmed, programs. Officer company on As Chief three primary focusing I’m Medical

X, brensocatib, DPPX. with novel or inhibitor a peptidase oral reversible dipeptidyl of start me Let

the and promise brensocatib for with to the study endpoint A in followed the final placebo. previously, a as of pipeline the immunomodulator American study met patients as session, were holds investigator for we Society of its Recall the its website positive believe date quarter, an bronchiectasis provides of that XX first-in-class, our over compound, to results recording As treatment our and performance of future versus both to virtual WILLOW significantly XX-milligram inflammation, a represents X potential was Thoracic non-cystic neutrophilic this uncontrolled available primary to for time Chalmers, characterized product. importantly, disease-modifying primary its an period overview is brensocatib of build by investor prolonged Phase the for with study. event multitude pulmonary James a our potential. excellent on and fibrosis of exacerbation and indicated an this with XX-week Professor patients a treatment Earlier doses we first call WILLOW opportunity significant us brensocatib pleased the by of from around part share diseases

We of One the both presented key to serine protease hazard new activation. both the concentration XX-milligram active WILLOW saw neutrophil response this Professor across in a of point exacerbation estimate with NE had patients of aspect mechanism and level results of of recent to baseline data primary patients the levels that various for elastase, neutrophil also had achieved subgroup. from clear supports sputum a Chalmers ATS quantifiable brensocatib the data action view endpoint post-baseline from quantification, who a subgroups consistency pulmonary compelling. subgroups, as At limit NE, post-baseline. favored reduce the session, with ratios the larger nearly versus and the in of secondary of every data We showing the pooled variety sputum the across test the XX the in that in very were reduction endpoint. doses compared study consistency analysis placebo. finding who dose Frequency levels the lower incidence NE a or both of reduction of treated brensocatib quite the pulmonary for in striking patients is This sputum brensocatib of doses, the of brensocatib, of below for of of of a sputum exacerbation NE a

gives by exacerbation that to keep infection, serine opportunity introduce an of that impact reduce have systemic broader of for us potential mind by neutrophil branding Importantly, bronchiectasis, the X well of highlighting targeted demonstrate serious in exacerbations the reducing detailed risk the results for serine reducing the these with affecting that the a pulmonary plays bronchiectasis, brensocatib Breakthrough fight without significant in the strength antibiotic as by the neutrophil into advance we damaging FDA accompanies Designation. unique neutrophil WILLOW therapy the Therapy for acknowledged believe confidence And lower current more We game-changer pleased inflammation It’s protease, or in patients, as brensocatib has these that that risk the the the suppress of this and the The to were was that development proteases these resistance therapy. nature driving of to we to disease results care XX% of of effect true populations approved if doesn’t successful. carry in and Phase no elastase of potential potentially as one bronchiectasis. the of strength selective, effects more therapies ability standard that data, brensocatib the diseases likelihood exacerbation. neutrophil a we important having

Phase our program of brensocatib XXXX. initiate patients before bronchiectasis to with the of X expect We in end

patients Additionally, in an the ongoing brensocatib in hospitalized investigator-initiated COVID-XX with UK. remains of study

clear we useful infected drug of period be increasingly treatment a for are that will and time, our COVID-XX with becomes be hopeful it for be extended needed, an will As options patients will us therapy.

potential that as applications novel believe immunomodulator. broader Beyond bronchiectasis, we a brensocatib has neutrophil

believe of we as polyangiitis diseases bowel brensocatib represents of a common entirely fibrosis, an arthritis, COPD well include is rare diseases, neutrophil deficiency, broad like component process. disease, range more These action, alpha-X a diseases Given the with asthma. way activity granulomatosis and cystic address rheumatoid antitrypsin that of mechanism lupus, a as like and to inflammatory disease high where of new range the

work preclinical areas. We that completed therapeutic have positive generated already potential in has several some results

us are we of focus or existing on compound care attention evaluation no insufficient. pursue what diseases for because and rare standard that high is with which other either need, underway. of is our potentially this will for relatively there therapies because diseases principle that is is An there unmet are we Our important well will

inhaled pipeline treatment formulation our of pulmonary that the arterial a on, for potential are dry treprostinil PAH. we palmitil, Moving also powder, hypertension, prodrug includes advancing or treprostinil

other X treat results early we You products. to about excited initiate expect important to a summary, feature study next yet study forward for year a to September, look on candidate. opportunities bronchiectasis this are with of as drug. the at sharing for continued make and over drugs additional move palmitil, animal data candidate Day suggested treprostinil multiple important X R&D the treprostinil steps including the demonstrate Phase Xa model We and in for in has and may pipeline drug-to-drug to year. confirmatory in including of ARIKAYCE, data treprostinil program insights in differentiating of relevant around later palmitil for have and that recall potential into more of will another more details the we the Phase of promising remain next various in impact model track updates approved palmitil advancing study progress a drug this to design on We disease-modifying brensocatib In PAH for These the provide potential indications PAH. very well this study comparison as our this would a potential animal Phase a our of our

me to discuss the operational call Roger over turn updates. some to now Let Roger? key

Roger Adsett

pleased the Good Performance well perspective, as was had build-out the a our to company’s success the commercial growing ability second through the advance marked operational ARIKAYCE quarter the by team’s infrastructure. programs across from Martina. global organization. in an as morning, of we to I’m solid report franchise, everyone. a Thanks, that

Turning both Sara our we for virtual ARIKAYCE million continued from $XX.X of patients second to setting. mentioned, had engaging in as health quarter, specifically the performance quarter, care and this providers which success results revenue this

only still seeing other as COVID-XX states short, while the significant levels. landscape reaching infection seen which In We we are their rates variability, peak unpredictable. now some are have remains decline, expected, regional states

and so unusual these to our second-half these in quarter, be lines we’ll going and of ability the to Northeast south the second we we clear we should continue those year. times, we forward. to see Despite in innovate confident in the proud growth the franchise, adapt during adapt I west recovery challenging the to strength remain potential continue believe However, for which long-term effectively and ARIKAYCE the time saw in efforts the of of company’s have the we similar circumstances. to the

of thanks for the month-over-month, two quarter, the the year. catalysts adds ARIKAYCE We back-half saw benefit the second Within in again team to our patient from support new potential provided patients growth in starting we the Arikares up and seamless to part physicians. other may tick remote also believe

societies, First, Clinical lung and the guidelines guidelines Society new The the America. clinical ARIKAYCE the issued Infectious major medical we European was were pleased by Infectious to disease. report and NTM four included Society, Microbiology are collectively treatment practice that of European of in Diseases for Respiratory international the Society Diseases ATS,

months of more guidelines Specifically, of improve significant recommend guidelines care with that disease guidance diagnosis and strongly NTM regimen is culture outcomes. treatment of XX the lung a treatment the standard six can guidelines management patient the decade, should recognized the play providing new treatment continued convert globally of critical with latest after failed marking with the role negative underscores be clinical in patients guidelines after a newly least at issued disease. recommend lung for MAC the in disease a who evidence-based to also guidelines treatment treatment. the the first months ARIKAYCE conversion. inclusion have culture management lung of The in the of for to The refractory prevention, these The This are standard milestone addition MAC and the lung treatment ARIKAYCE to to for sputum in ARIKAYCE patients goal than to update disease. the of NTM the

experts further working patients, view specialists. approach important optimal pulmonologists community forward efforts. reinforce expand ARIKAYCE MAC educational appropriate We infectious NTM We amongst refractory patients, with the opportunity to of look and this an including expect to and that as on will disease these duration new use recommended for guidelines the the of especially treatment therapy for

We making progress are also internationally. exciting

our has antibacterial in the adults treatment As in CHMP mentioned, have combination anticipated will ARIKAYCE we that the opinion a for pleased EC in decision options underway. limited with positive lung adopted opinion drug were complete do MAC well to with who to CHMP of Will infection Europe as the of cystic recommending of announce treatment regimen Efforts the a a not are infrastructure final review fibrosis. part September. The build-out

activities approves managers in place the have UK, of We ARIKAYCE positive from Italy country progressing anticipation XX-person in Germany, September, we field Accordingly, followed end field launch and the EU anticipate in If France, including the we have the being by ARIKAYCE able in evenly EC to between are team roles. strategy. educational year, of Pre-launch a in launch in thereafter EC, place, shortly pricing in development Benelux. Germany in materials Germany, markets, key by of medical the a UK. and the a opinion split and commercial

launch. head add in medical launch. one medical head more XXXX XXXX of commercial We have the team expect seven more UK, to to our and commercial in one three and three-person roles to field the growing support field currently XXXX two-field in a In to in support we growing

European In Japan. and regulators, addition to regulators success in progress our with about we’re excited recent also commercialization our plans with our

Regulatory Welfare, Health, MAC in sufficiently lung recently Authorities. recall, Application may Labor medical interactions quarter, are prior you which second In the first of notification, to for for caused Drug administration NTM ARIKAYCE. underway, for As who ARIKAYCE and Japan Ministry the well for with Japanese we The by device patients ARIKAYCE to the the regulatory disease the submitted of we not filed designated approved forward MHLW, the the we with productive process Japanese or and Lamira, treatment. by did is a treatment a to quarter, respond New for continued of looking MHLW is device in

appropriate seeing sales a Once care Japanese educating build intend allow deploy lung the disclosed, safe MAC patients. lung an force promoting standard As treat field, disease is with the MAC regimen, use physicians with to Japanese dedicated compliance and top in including we manufacturer, sales to to of to to and to the return are our macrolide we patients. treating physicians generic of force, relationships team with law, establish and disease previously collaboration a plan to we in Insmed who on

Our to scientific and having and including anticipation also we key roles the are deploy medical disease which filled we pre-launch activities outreach field will XX anticipate and have key Other support Insmed opinion five of distribution consist in in selection underway, Japan planning in the fourth field in been in launch to efforts, leaders are partners. awareness of specialists, Japan liaisons. to quarter of therapeutic force our operational

U.S. We The the turn let to composite outcome, order study and Europe as in our or Finally, approval anticipate address and for this will front-line front-line demonstrate for patients by confirmatory MAC a me with clinical in endpoint also patient label study be ARIKAYCE in benefit diagnosed endpoint in required efforts the conversion the to study primary using NTM disease. around primary PRO, lung expansion regions. the for Japan planned FDA. will culture this requirements of for those U.S. reported durable the that

study We we and to remain validation expect the these trials PRO of XXXX. that confirmatory parallel the will on and end initiate before the track advance in

and the efforts brand to the Insmed excited I’m ARIKAYCE long-term pursue and the very a U.S., of potential are continue NTM continued the ARIKAYCE inventory franchise strength ahead disruptions for of supply perspective, the of Europe want the chain commitment to and the to the no have diligent I testament to and team. what Japan about a in their maintain community. team observed advance to we From satisfactory date. lies supply thank Our to

of anticipated for hand we through prepare end meet XXXX. ARIKAYCE global potential demand for the on sufficient we launches, forthcoming API international have As the to

overlap particularly NTM commercial of between trial synergies impressive it’s supply and global emphasize for an perspective, From among programs, bronchiectasis. our to that program. Phase brensocatib, we addition, clinical we ample a to the X important strategic have In see potential our pipeline meet the requirements

to programs treprostinil for to and advancing progress let to sharing advancing committed Will. about call our with these back promising you. look excited that, We turn PAH. palmitil, a also And with forward are remain me the candidate We

William Lewis

Thanks, Roger.

by we continued proud Let faced. of We has the advance them. managed of ever care clinical execution quarter well the reiterating the ever as me the close extremely remain during by for are serving programs of patients, one providers this remarks to challenging out our prepared who Insmed all grow healthcare committed revenue mission We team. most our as company that environment the as our as to and

mission this pursuing are strength. We a of position from

adapt And stay ability course to us circumstances. the the We with have we that, a please? challenging to balance questions. we to build impressive will like call the successfully sheet strong have promising open team that enable to towards these an to With demonstrated as future. we first a our take can question, finally, Operator, I’d

Operator

Yes.

the begin Our Auster question Credit now question-and-answer Please [Operator will ahead. first We session. from Instructions] Suisse. go Marty comes with

Martin Auster

Hey, thanks guys, congrats for I just and my a on quarter. I execution for questions. the guess, of the question, couple one had taking of Roger.

dry that the administrative whether curious change on second profile you’d kind inhaler? and the palmitil. question I’m or advantage, us with of pricing Europe, you expecting – kind if band just for how kind of and And treprostinil previously around powder from Thanks. if thinking but you’re doses you’re nebulized higher then you a bit little that developed, might your how different on to maybe dry thoughts you can across you’re beyond to curious a the pricing curious if formulation, in able to your about kind XXXX I’m about thinking about also As wide of tolerability the the the Martina global I of it’s you’re Roger going powder a Will, with achieve I’m launch there? update think to? be think of regions usability – And amenable improve

William Lewis

questions? Roger, take you why don’t pricing the

Roger Adsett

Will. Thanks, sure. Yes,

So thanks the question, for Marty.

in provide a U.S., recall, as for towards the price band Europe ARIKAYCE scale, the high when quite may rare a we had of quite what and that So priced we Japan. large we sets the think nature to scope fairly narrow pricing is think value on in the and the given about disease. we actually And you that that as it us we I chose price that And up to lower-end.

my not, as an price. how idea this disclosing we’re But point, that that. comments thinking We’re you sort that give I of at about think to

And pricing price will Just prices over as followed the Germany pricing to the UK first and will reiterate, and a in the XX negotiations price adjustment the UK, the markets in in Germany by the markets, used Europe. months that coming just a basis to be in XX – with for foreign prices be list reminder those free – Japan.

for take eligible final in foreign a Japan, price and the a Japan. on look product So the at they final to the model we believe cost then we’ll prices look take adjustment pricing in going where agreeing a be that before into at make cost-plus

William Lewis

maybe you question XXXX. can Martina, on the take

Martina Flammer

Yes, Marty.

yes, rate – the So the would also tachyphylaxis, area called side from NTI blood we that therapies, is of in better we in do current effect. effects the frequency a troublesome also which and and expect with also profile, have is elevated pressure consistency which more what safety especially less are heart with

Martin Auster

of achieve current Martina, do the to the then, therapies? possible to even exceed kind think in Or target expecting? are into the area curve that? it’s you comparable X comparable a to Is you Phase

Martina Flammer

that will nine in high over is dosing. study. Well, now, and and we to is pressure dosing greater do also to that time, burden physicians. current think I what we’ll But pulmonary right you we’re in know, frequent mean, plan to which for less up have of we have arterial therapies, patients for is consistency times see I the as disease

to dosing. once-a-day forward potentially looking be will we so And

Martin Auster

Okay, your thanks. I appreciate answers.

Operator

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

Lyla Youssef

your the Lyla they you with been Hi. Thank the have physicians a And to they’d taking on thank that that quarter, think delayed interact the impressive and This new for backlog patients revenue indicated Do the conversations backlog to prescriptions quarter testing, Congrats but able person? COVID? like of in still and that on NTM is reflects you. haven’t of question. for the at have you start with have for Ritu.

William Lewis

two Actually, points. address those Yes. I’ll Thanks for much question. ask Roger to the very

Roger Adsett

the Will. for sure. question. Thanks, Yes, you Thank

patient prepared were reflects did mentioned we the we that, that occur. do think that as that starts I within month-over-month beginning And to see, that remarks, is new see return normalcy up to we quarter. did was some second in ticking what So that

having challenge. that, refresh very we’ve all makes see we’ve we first around what index COVID proactively in hard predict. those discuss continue NTM and so our we spiked as in in we are that, a visits. But to as and as seen treatment back their talked the and course, states had as about research, previously said others, quarter But as suspicion mentioned to was physicians cases has patients market think it we and Now to putting their of call abated different to of the it’s office know, – I off patients into been do options, NTM raised. intend And

the who actually to on of this intent suspicion already prescribe So increasing. are to increased this and we and attention patients see index therapy also

certainly also So growth their – see abates say increased offices we do we through go we about believe to that that follow catalysts. on they and they into on those could from that will physicians’ could adds some of ARIKAYCE. patient those a that intentions we say if once COVID I perspective, see back patients talked what certainly allows

of ARIKAYCE, I about talking, use care We’re of guideline helps appropriate IDs of add. that reinforcing therapy. patients, around think community particularly the standard excited that, with really the and and pulmonologists us also the those refractory the And community duration really in

months. XX another plus conversion culture to treat So

is about going think, really of opportunities excited ARIKAYCE and We intact those up. growth the firmly believe lining I forward. things, the So are all opportunity

Martin Auster

Gotcha. That’s Thank helpful. you. very

Operator

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

Joseph Schwartz

pandemic wondering before, in when been how was to on distribution Congrats hotspots could of much. very that been believe, I if a adds Thanks very the versus strong How adds the quarter. have trending colder geographic it patient new you I distributed. bit spots? patient talk a new relative evenly about has said was trending during period you little fairly

William Lewis

don’t all if – think the aware date, can Thanks I insight. from the know any Joe. significant you variability Roger, maybe given the out question, of we don’t for And country. to detailed can well we’re qualitative provide that news comments. watching the we’ve think I But but I anymore across

Roger Adsett

access. don’t had that numbers – imagine, But in we then Yes. that for I we pulled that and seen Northeast, still little think any to sort Joe. the been we’re had for importantly, initially in these of more to example, that rebound, what might the abate And as start their that were to patients you, them have have taking treat duties quantitative have saw specific a states do get hospital away. I pulmonologists open starting you COVID and was In bit. been

we’re their become doctors these NTM to as that to hospital I think, so return on better see treating as, now, So in patients that certain and starting doesn’t them focus heavy at regions, practice, the including be to then burden seem allows the patients.

of ability start your – the turn the from away that for of hope and hospital spikes So question. their But I follows their spikes it’s attention in NTM, treat physicians NTM that really trends to very states, kind the as to and the practices, think, the that outbreaks. own variable. as you kinds in I might back answers imagine, patients those

William Lewis

I respond. started thing country across and is pulmonologists March/April, in completely disease when sort of situation. this indeed among add a the in is, were happening Everybody dialogue around world. to we infectious and There’s only that with experimenting would was and between of that look, the a Joe, how unknown lot to the

these much spikes respond. And new so think arrive, there how better I is of understanding to as a

also surges to COVID-XX of are for and understood is patients much appreciated. to spring the COVID-XX from importance suffering more response the And the ability think, outside who so consequently, back so doing of is I from conditions

variability impact on different that important wouldn’t a it’s circumstance. But of over So regional I the skate basis. a

watching be and to that those for now, very like going in areas are Florida. Arizona, hardest We’re hit the rebound Texas carefully

Joseph Schwartz

country-by-country and about the much do the color. your in Europe and reasons could process Okay. have size of then relative launch the launch helpful U.S.? are I to there ask many the patients a that look views on places reimbursement there obvious will for addressable? the you That’s had And strong market, to perhaps be really example, any how from Germany get the by And wanted the estimates UK, presented you’ve different here beyond a for In Thanks. latest U.S. that like differences

William Lewis

Yes.

I think we about off are approval year, And Japan. specifically, in and end very to those are next to ask excited assuming about at program two this the understand the kicking total going Roger now. into Europe, that I’ll interrelated. talk international be we year what of On we’re

Roger Adsett

Thanks, Yes. Will.

about the MAC medical – population, So think we you within But as the need we’ll Joe, to see. the the literature X,XXX the elderly think market if about I there’s seems patients. I think that, and lung will on patients probably approximately do reflects refractory underlying think the population we these side that rates, in the previously low if the the disease seems Europe, for that Europe, we But of will think I maturity to that’s smoking probably drive discussed, it overall that you probably you identification the of underdiagnosed. work which example, – and tell that

Europe largely break puts a center rare I on launches experience. think, diseases also Europe that here. slower always my we’ll these for the that think, excellence uses And somewhat I than of uptake. of in look, model The U.S., see

on, now. think U.S. we jump excellence that robust Europe robustly we go and that and so long-term as pulmonologists underestimated where mostly think early saw just ARIKAYCE the uptake in in community physicians opportunity really is model. right that that opportunity and exist through of the we on perhaps I IDs the doesn’t I But initial center saw

the this would it’s U.S. going But probably opportunity. a certainly long-term, I robust the not So near-term. uptake to look the think probably – like we is say, in

Joseph Schwartz

Japan? maybe Thanks. on there? I that you things ARIKAYCE a launch a there to success sufficient think that’s to size the quick since do color sense. a you’re How make that do successful makes you you then And you’re field the alluded And That force for about the that, prepare to appreciate Japan, to doing and now. in get one deploying

William Lewis

Yes. that Again, over one I’ll to Roger. turn

Roger Adsett

Yes. Will. Thanks,

we’ve is doing. again, as our team, been building been So out, the work this Japanese have that

KOLs and then then centers these being and of evaluating So looking working again, patients the where the are the at Japanese treated. excellence with –

patients. Japan, So quite larger, as data of Japan domestic in than the is the diagnosed know, NTM certainly, there data, patients, it’s It’s in looking are patients you And prevalence for at more the high. U.S. in the

as patients where out some currently to there��s pretty good are. information So these there

team, Japanese Orihara, Yuji capable the mapped under of leadership out resource the has so needs. And the

certainly support think that we’re So MSLs will XX launch we sales sufficient – to population, to for there. this a looking be successful and sales deploy the five refractory reps the team

Joseph Schwartz

again. Thanks,

Operator

Matthew next Please Our Harrison ahead. Morgan comes of from go Stanley. question

Matthew Harrison

from talk patients. you demand guess, you to Thanks taking side? – But were treat little a know Good of focused are for what having physician just the question. COVID Can me. Great. I pulmonologists for patient morning. seeing talk bit on I a about the the people you’re side. little lot bit I two a can know

after And so I’m the that. the wondering second-half And how that the and then just of follow-up over impact the into year? of a Europe has course have on I shifted going quarter

William Lewis

Sure.

market good comment of that And to feedback. the in mean, the doctor on we are can close side, trends I research on constant the commercial stay some U.S. to news you maybe Roger, the launch. doing So is,

Roger Adsett

Yes. Sure.

of the again, that quarter. about So of for we repeated the index we And index as the research NTM. talked that first and have thinking pulmonologists about had before, in suspicion mentioned amongst suspicion we

two-thirds professionals pulmonary of index the And so healthcare in including anticipated infections, had an we July, of suspicion post-COVID-XX. in increase NTM, about for almost

their course the reach ebbs some bring approximately healthcare previously did infections. offices. trying increased COVID-XX new missed that see disease subsides. So XX is to patients. predict of is have that’s normalcy, physicians in bring the their and from these of get we proactively this and last – And results for of able to this patients NTM of the And But in sense certainly, this physicians that difficulty, actually them to will particularly those as market going as we to appointments April. to we them two-thirds be diagnosing expect patients research shared and and The professionals, back into time will that’s out be course, we these research the who helpful the some return about of with. flows still the we market And

to hospital see – regional again, this the to away being that of us practice. of – the We index for proactive patients pulmonologists from own and do see pulmonologists on put together able that to once sort now that into do attention is bring outreach variability. So if bodes have these their of we and suspicion a COVID-XX. taking well care more We office, their think are turn duties and the you towards patients we better and handle

are going So treat able will the they – with to with this that continue. will and likely to physicians outreach do beyond think continue, that’s who much who – continue hopefully, trend – And say, currently being would hopefully, maintaining we attuned, these be research, COVID-XX. connection that the to for health the and how treat I better to therapy disease, and more positive do and on need respiratory a burden obviously we that’s and lessen the treated understand we as are to see is patients to NTM, that, part of in as patients pulmonologists

Matthew Harrison

That’s And to discussions Europe, a then ask other guess, wanted We the can the Thanks. and know set of launch take Germany, countries. I some outside that rapidly. price Okay. obviously, all pretty while reimbursement of a I what on where can you in is, helpful.

UK other analog at be terms Italy look to I guess, pace given products? so has in sense let’s say, can France or what the similar could in more specifically, Thanks. And you maybe I then trying to about any us And or what that is, products reimbursement, launch the of give any ask amount was for you of of think you countries?

William Lewis

we of so the us. think I free is for fall will pricing that, And is UK, outside good Yes. that also question. appreciate NICE I market that the a in news

price So by the both any through already to and getting and this comments Roger, want a not, ATU well to around and disease approval. that will Germany in government experience the an fully and in the was securing were UK reimbursed for will have, France be we obviously, of terms program patients extensive prior free And attractive pricing markets. in There, reimbursement we US$XXX,XXX excess of That’s an in where used for severity sense, of and out of pace? is just we in you of be of roll the product Europe, it need the recognition any the price indication its indication about to year. the efficacy. add but an XXX

Roger Adsett

this It’s course, the a Yes. of and, Europe. with question is great always trick

the second-half there out including year. mentioned, kinds launch some where probably be process There to the UK. as over of procedures a Austria, the improve follow a has meaningful the longest Other we of markets. reimbursed a sort price roll year So of rest I take UK, you months. been delayed the that those UK to are that past Germany probably XXXX to the in The throughout end pace by think, have by NICE, the of we’ll probably work as get the the But markets, by reimbursement. a Italy, We’ll in of expect to probably launch. – will NICE reimbursement by is that France could few to who’ve we those with mean that and credit potentially to Will be But, the NHS through the couple over uptake working markets, markets, don’t the in able suggested, we proactively team, for Belgium, which over will years. of a throughout the is and to to be expect

Matthew Harrison

much. very Thanks Great.

William Lewis

there are questions? Operator, any other

Operator

on Take the Sachs. podium. Goldman with Suvannavejh Graig

So please go ahead.

Unidentified Analyst

what on get on taking about Thanks. get to for is study PRO for you FDA If Jack blessing? align left the with a you Hi, on front-line little the that tool and their we kind of everyone. talk that bit to and Graig. the [ph] and there, could to quarter, plan Congrats use questions. is for the thanks This underway

William Lewis

the I appreciate question. Yes.

we are the them. to about say, excited with a we the collaborative where I front-line study our very very that track of remain We’ve study excited dialogue very think, much end about on the FDA. with where are in I we year. And start very are this on we had relationship would by

X be We of great our that program Phase detail brensocatib will great study deal at alongside our XX, that are Research September deal design about a detail where reveal and on XXXX. of will with of we for the Day on a

to providing but would more going detail I and any We’re that be today. characterize locked loaded. as But all, not just

September explore going you excited so those be super on we’re And XX. details the to studies with of to

Unidentified Analyst

Thank Okay. you.

Operator

conference closing turn for concludes back our over to to question-and-answer This session. Will I like Lewis the would any remarks.

William Lewis

joining us Stay safe for Thank healthy. and you today. all much very

Insmed (INSM) 8 Aug 202020 Q2 Earnings call transcript