XAIR - Earnings call transcript Q3 2021

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Operator

Greetings, and welcome to Beyond Air Incorporated Third Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Maria Yonkoski, Head of IR.

Maria Yonkoski

operator. you, Thank and Air’s everyone, for us joining Good call. thank Beyond conference on afternoon, you Today, we of the results after close, for the release the financial announcing third quarter fiscal XXXX. issued year a press of of website. page copy Investor our which on found A the be Relations can

under be expectations, for Before begin, provisions plans XXXX. Reform Safe which forward-looking statements will and purposes Litigation like and of various Harbor everyone that to prospects, Private we comments remind remarks the Act the would we I Securities making the about future constitute of

to that and results Beyond forward-looking those Air cautions these materially differ that statements indicated. actual are cause subject risks could from uncertainties to

Beyond cause from those Securities which events Form Air filings materially XX-K, company’s Commission, actual to to specific differ the in the with the factors that company’s results and identify encourages or may the including statements. forward-looking you review described Exchange without limitation,

being audio of website, will only conference and be February date call this as conference of call for this Furthermore, is www.beyondair.net. that contains live time-sensitive the available is Additionally, X, broadcast, the information our accurate recorded the on of rebroadcast XXXX. content

Officer. now available quarter the turn the to to to fiscal undertakes to Commercial Duncan events for of will any XXXX; Beck, I Chief third who our Executive of Chief Chief Lisi, circumstances provide updates; update Beyond Officer, our no over will that, business call would Q&A. reflect by date am Financial review during results revise financial Douglas this our our after Executive Steve be our statements the Chief joined I and Chairman Steve? Air or Fatkin, call. Officer, today the year With obligation like Lisi, or Steve Officer, will who and who

Steve Lisi

I to to compelling taking we it We which all time investment opportunity our XXXX everyone. subside in we today believe during than current healthy the hope XXXX. progress you’re safe Thanks, listen is all the year. now appreciate more pandemic, hope afternoon, you and even which given staying our and good will Maria, and this was story, an

the will milestones, what for call course, recent of Air for will our ahead results, conclude year trying progress strong very to we enthusiasm team our attributable review financial believe review minutes Of and for Beyond of are their spend of and is the be I our investors. intense to the accomplish we this our a with expected the prepared few to patients a achievements our provide I up recap to a Beyond questions. what and of Air. open Doug remarks for transformative then and will capabilities

newborn we to past know, this a is PPHN. the pending FDA persistent November pre-market PMA our pulmonary LungFit or of hypertension all submitted you of for XXX-day currently for The PH to subject approval a treatment period. the As application review

with respiratory our a to four note commercial therapists. commence will approval. we’ve Just you Please six that commenting curious PH of was weeks actively FDA we say anyone very me which team, application. working than are take other FDA to launch employed launch we States, happy including with our I our meantime, about on interactions let expect LungFit interactions already this on in for United to the are the approximately not be with time, this In two-thirds we about case, at preparing this. be will after in of FDA, that provide several

costs. launch, We continue requires which guide upfront for to low controlled phased

will number with and to post work of reach six phase, the spend perfect proven staff plan approval release to market. this limited release successful the in our be will hospitals, of experience to to has a we We nine limited commercial Once first our out have during team we rest with our and service closely customer will support the phase, will where functions. expand NO a select months we

there the reminder, the a most alone. reports, therapy. XX% are XX sales in United are roughly of majority $XXX which use cardiovascular in and related X of It all of represents note We the is setting use indications, in is the estimate likely U.S. hospitals market, are X than over NICUs to only model. last the important Level NO XXX that U.S., As According NO of care States the of label Level in NO sales published represent hospital the months over greater which to which million units that neonatal on outside or the of approximately classic the intensive using XX%

past novel the advantages We are in to with that first planning offers be CE this market the agreement a the calendar end Mark. in cylinder-based LungFit our technology compared the of U.S. line place be the outside have expected anticipated XX with PH to PH to expect by Considering we year, of receipt disruptive NO years, the to many of LungFit for the dominated the force. legacy systems partner

to a is and air NO truly system, Our integrated revolutionize ambient a industry delivers to it with from goal generates the ventilator this device that circuit.

Air market. simple, that filter smart to products currently to requirements are will clear, chemical NOX substances. without on approximately rely dioxide that a smart hospitals PH X.X deliver are To XX business systems and use. weigh toxicity dispose NOX model. storage offers ounces that and prevents our patients and by staff systems a to the our of while continuous safe, alternative protecting for limited filters easy our nitrogen are place. on or space not NO pound necessary not for XX convenient cylinders This in LungFit be hours We or Instead, lasts the of Beyond requirements special toxic

procedures economics the for NOX to designed vastly safety operational eliminates system Overall, easy to be hospital. Our are use our improved is purging interface providers. user and and for

would that in any chain for for through associated expenses not with like manufacturing up calibration associated for preparation a Our fixed are do Ireland system have systems our with logistics or to have I more than emphasize costs have we LungFit need and subsidiary is you on NO track our are set launch. supply we competitors, to cylinders. at contract inventory gas year launch, the everything our ago, our In work we significantly secured all global lower that NO air. because supply confident our We will and than manufacturers, available filters. our sufficient and with have

calibration NOX reminder, are these to purpose and calibrating the oxide, manufactured a sensors nitric As NO of dioxide. for solely nitrogen and specific gases

and and LungFit worked our delivery all preparation NO in NOX. the appropriate has Vice equipped Injection and the over lead in experience & is product. and LungFit choosing and for years of NOX levels of President the oxygen, the Biomet, safety and are NO Our oxygen, Nephew He XX sensors Diabetes for hospital-based Asia Leading confidence Duncan vote to years the for prior monitoring systems XX has for Becton proper years last Zimmer with our Franchise has commercial at of launch of Beyond in Officer; PH U.S. Europe, devices efforts Prior for of & us than yet was another Commercial of Smith two Duncan is the Duncan Air, Fatkin, the with joining to medical Johnson Johnson. more now. Worldwide Dickinson our in experience who Chief been commercial

portion be the during today and our Q&A available is to Duncan earlier, with mentioned Maria us answer questions the call will call. of on As

to six expect addition pilot also potential our months. the a we from, on In FDA ongoing we have report interim studies PMA, next data decision two that within to all

with includes subsequent more online November month study, COVID-XX. pneumonia Let’s site which our viral initiation. with acute SARS-CoV-X study ongoing in last have come had We we patients acute Israel. post and start infected each viral including in with first our pilot Enrollment activating sites is the began pneumonia,

time, viral to of confirmed this be enrolled warp COVID expect receive increase cases, as the infections vaccine continues in population to patients see the we As Israel’s are expected COVID-XX other speed. at at to an but majority

ratio enrolling inhalations with patients XX standard As parts adult seven receive with no you with safety randomized NO ICU treatment recall, emphasis million minutes, XXX may in XX among open-label one-to-one a safety, a addition are an to assessed. supportive and intermittently day admission To-date, per is up study trial approximately well Patients for clinical of patients SARS-CoV-X. to given on standard randomized infected or for our fever, per treatment times the Endpoints issues. saturation, being oxygen, are to four performing to others related supportive alone. is days, LungFit in device multicenter PRO

full the the interim top We for XXXX over summer. expected with expect data line to in set release results spring the

Moving on pilot NTM to or mycobacteria study. our non-tuberculous ongoing

simple mycobacterium to in enroll Australia and our We are to recently lung avium treatment This Patients remaining in sent specifically to patients weeks. XX XX are single XX-week XXX screening we million I XXXX. LungFit professionals the days, up designed aims As began continuing with plus a or several or be home then for and the believe lot December by in confident NO bring home NO complete NTM patients you cystic are parts Yes. from enroll. and said system XX-week fibrosis included. are dosed home our sent the over period. lung to GO refractory use in both non-medical and arm become this be ongoing complex battle. into hospital MAC, multi-centered bronchiectasis patients infections. suffering key eventually Unfortunately, or abscessus weapon per trial mycobacterium NTM of the program to may chronic severe to is titrated the a We ability non-CF in strains for patients patient NO and first our to we a there will that will treatment these infection, remember, for

hypothesis LungFit bank high are have per we per oxide home antigens has due up during administered parts the a necessary chronic four bacterial thus immunity. course, this for back evaluating is when with safety, bronchiectasis, to day, we report to tumor that demonstrated development, this physical interim to platform data relatively local program patients, XX,XXX helping around XXXX This our we major different and exposing even the triggering tumor such October. to weeks, and expect is data, our from on host LungFit early new system. deaths administrations, parts million for which concentrations, six The function, cell cause oxide study concentrations administrations as solid with top-line is a for two remaining being the per nitric months immune and the achieve will is which XXX,XXX weeks. turn tumor successful, like tumor, most cystic directly high million use Going at-home Though conditions, is XX to of and us two three recognize it exposure our subsequent system well later. immunology gaseous will day to guidance, others. be severe immune about fibrosis, and in received as conference metastases to recent nitric COPD. regrowth, moves of which not per changer patients with may then indication Consistent cancer first at that for that the middle and tumor the program, tumor extremely as study of type anti-tumor game to the would a the GO preclinical load the than will design, underserved create life, to subsection of a among attack presented creating various distal a solid believe greater infections underlying the lung of times XX-minute memory setting, primary ultra trial the quality exciting If conferences, this data vaccination. immunotherapy at AACR product will such as with same those the and now trial past I

tumor XXXX solid respiratory this evident most year as viruses bronchiolitis demands but of to inflammation cause and our out focus the is other overwhelming remains a and is The it to be cause the rhinovirus, but is calendar LungFit the by remains pandemic. the program. costs. study bronchiolitis as inhuman in of to years the Our than goal that I the old, of is program at due ongoing the parainfluenza fiscal the stage, through tract promise initiate globally. for our program, of is less program respiratory our this year. lower can point for end XX% two influenza, this first like of and also Bronchiolitis virus this spend children company, would for expenditure XXXX common syncytial our as respiratory such the leading younger coronaviruses infant well or RSV, than hospitalizations hold on commitment. is

early ranged disappeared. them the experts likely data our to resources from has XXXX-XXXX So, the as bronchiolitis is has to for According and United capital in SARS-CoV-X just than begin the justify program the thus essentially would had team and surmise was from infants the bronchiolitis season season of as parents the upcoming trigger bodies this peak late been to exposing bronchitis XX study States. the limited prior unable standstill RSV so regulatory in brings historically to to as SARS-CoV-X and we Beyond seen could not February that as XX% influence in well, bronchiolitis. months. onset that nine to In mid is environment mid-September under mutations December season to months a SARS-CoV-X how unsure far far appeared they are CDC, One of with in its COVID. showed bronchiolitis same is social not the This information accompanying remain reduction why U.S. more RSV season. situation waning a XXXX, could that to have a have to or age mid-November season. has Air

Air committed hospitals, Beyond remains for families. their the to patients, bronchitis reducing and burden

three parts million per completed and demonstrating our to-date, studies at efficacy and have ready. study data strong We XXX safety pivotal pilot

make financial potential bronchiolitis the and to be investment calendars. respect other However, Doug? enrollment funds believe and only their for this that COVID-XX now, now to Doug on with resolved. related will best and to decision more The the we difficulties getting call resources visibility social over the that, is surrounding We to full we back program must programs. R&D review. I to uncertainty reallocate when will have to waning turn with normal infants our

Douglas Beck

Steve. Thank you,

ended of Here’s to December XXXX. our as XX, licensing ended review share for $X.XX loss $X.XX of net XXXX, $XXX,XXX December to to quarter December XX, million of million, to compared XXXX. a equivalents for as brief for to XX, XXXX months the and expenses compared the development the company the of months which would for revenue. $XX.X deferred quarter fiscal million $XX.X revenue the for $X.X million. share, the administrative XX, quarter a all XXXX, million. million December $X.X expenses the general cash financials the XXXX of loss common the December research compared balance three ended cash, as ended third from December shareholders of XXXX. XXXX, XX, was ended $X.X was XXXX, company million, quarter for XX, ended ended three $X.X for for and three million three had ended of is to for XXXX. XXXX, December XX, ended XX, December per compared months were our net cash January like which $X.X months had cash XXXX or or and per December $X.X provide quarter restricted the XX, a attributed I XX, XX, the on December which $XXX,XXX of were

we access in-the-money the which this equity February this as now increase for to warrants expiring mentioned hand Steve. to sufficient We We January. operations that is in wealthy lines, XX, believe XX back as I’ll have in well cash cash it to next previously provided months. fund on had

Steve Lisi

Thanks, Doug.

Now, to operator? moving questions.

Operator

[Operator with Instructions] question. & Oppenheimer is proceed Kalia your from Our question Company. Suraj with first Please

Suraj Kalia

Steve, everyone. you Good afternoon, right? all hear me can

Steve Lisi

Suraj, I can. Yes,

Suraj Kalia

perfect. Okay,

the been nearing like progress. long looks least finish I all with foremost, a the COVID, on but haul indication. on PPHN So Steve, are at and first congrats know a line it’s we

going the congrats. you know you a interactions. FDA to I are And comment, about made talk Steve, not So specifically

question. So that first throws out my

key internally filters XX one, on us you basis when our me many has your PPHN, how that team per believe let a or the in case move guys XX case to on the launch you remind per first second Steve, So, in analyzed the NICUs hospitals, targets. are

Steve Lisi

sorry. filters I’m mean do per you what case?

Suraj Kalia

is case each to patient a in basis? me many fails per the not daily of so will on changed they or one is required that be average be us require here. will filters, my me, – So, memory on it Remind Forgive days usage. it

Steve Lisi

problem. No

hours. They XX hours. filters last the are So, XX

in it you’re that time. So, at changing point

So, three, a filters per you see average patient, four is average therapy, And will shorter it’s per lengths the longer two days that, than than which right, use. that require different good day. can around to but could figure you but patients of somewhere that’s

Suraj Kalia

Got it.

minus reported, Okay. And going same. the what pricing or it’s be thought plus is process similar is the say, therapies that are to to cylinder to publicly based be let’s days four the for, going

Steve Lisi

Yes. I Duncan here, mean, have I our chief officer. Fatkin commercial

answer to love him So, let him and these Suraj, I’d introduce of to some questions. everyone

question I’ll for let commercials, don’t address if that’s him if mind, So, you, okay. this if you it’s

Suraj Kalia

Duncan. Hey, Sure.

Duncan Fatkin

Hi, the question. answer me Suraj. letting for Thanks

from we is in decline for going are that’s view, expecting and a to little the we a to bit. pricing with So, the past be pricing that point going that are competitive of there the cylinders. gas guided We’ve price the out

will so we or and what to but the be And competitive, that. the to pretty price, of yes, is we hoping additional having to, have currently over used value flexibility somewhat demonstrate cylinders the maintain that if and period have need consistent four-day close we not we can we’re be more with to three

Suraj Kalia

it. Got

Were Steve, any trial? enough. the missed I NTM NTM in LungFit fair patients GO the trial, recruited Okay, maybe, it.

Steve Lisi

Yes.

Suraj Kalia

have I number must then. missed Sorry, the

Steve Lisi

yes, give didn’t many – the there we you was How I enrollment. patients begun number. have just that basically, we’re saying our

Suraj Kalia

Got it.

of Steve, and that on given been happening what’s with obviously enough vaccines with seeing get More are we specifically, vaccines? processes, in think all announced towards just demonstrated end thought matrix? evolving inhaled love be I some to COVID XXXX was you are with I’d believe INO updated are to differential even moving with and Mallinckrodt thoughts, everything I a be fits at. with farmer COVID there of of variants – variants has the over where we Steve, trial, COVID, on do as INO prospect to that guess Okay. your this the in could seeing oxide, we nitric the it

Steve Lisi

we but haven’t we out of a was against oxide oxide know anybody was tested of against what can we Suraj, in nitric came don’t a the tested it’s very is year these in else, XXXX, a against that have Sweden back SARS-CoV-X, that of variants, of that study, corporate SARS-CoV-X, so out or at presentation, and variants. with SARS-CoV-X. They’re I Look, page then nitric do data copy our say that actually of effective happened new. published and these clearly who’s I been and late picture what had front to same group put have that publication – a publication in and against least similar results which last

we So, would coronaviruses can own seems we viruses coronavirus, vitro, but spectrum human I make and oxide success did your here. nitric specifically, on say there. in and a you against OCXX be had conclusions the broad there, to the work

So, mutations for look and coronaviruses, short, very strains. nitric information it oxide you to promising. against against test these would and we previous SARS it from can’t you say about have new other in seem so these the actually but

Suraj Kalia

just And COPD? take have speaking GO everyone. in Got a offline. taking to Steve, and LungFit my ever generally questions, it. Do Thanks maybe, for envision you we can this role

Steve Lisi

Suraj. Thanks,

I’ll no, part do and yes So first. no the

treat COPD the lung will causing oxide to moderate-to-severe treating COPD most – be patients, to severe especially se, infections but wouldn’t be exacerbations. those that are experiencing going are COPD not progressing that per underlying We’re nitric COPD

due COPD COPD, those your showing life or if So, cost expectancy. and they underlying are there those can with and to again, reduce that data exacerbations will are very these healthy severe mild you severe are there with be more exacerbation than this out a hospitalized susceptible hospitalizations, to patients

are We patients go these can we of and where believe and the can think that and who exacerbations, towards we could COPD. perhaps we and that – prevent really for rate self-administering hospitalized rates. types improve that’s with target in these the we is that are NTM, they’re treating in home, oxide hopefully, patients. And in nitric these treat this patients, can home I we’re at home treating their LungFit study so That’s high can COPD happening. them oxide they their in beneficial. these risk in nitric mortality home, these mortality in home for So from be ever their patients, be chronically reduce GO their for who those patients the And where treating the step first exacerbations having

Suraj Kalia

you. Thank

Operator

Henry Our please Capital. Scott with your proceed is next from ROTH with question. question

Scott Henry

I of kind good comes anything the thirds that a a think and you afternoon, promotional that about budget launch guess think we is when How to well? it in first, launch? that as sampling team Thank couple any just trade mentioned the launch, think have I you should to is and questions. place. also of partially expenses, in about already the do you of the of the or sort current be, line Should in you’ll shows when with that two

Steve Lisi

question. now it Thanks, to over promote. Scott. minimal expenses obviously, little the pass take marketing I’ll promotional a are bit very I’ll of I and since expenses we mean, Duncan. can’t

our there let will a do but obviously, bulk the once that that this. the we I’ll of covering are budget, but are in upon product, things So, Duncan we be few expand launch current

we’re can As – imagine, sure. a for is you advertising, doing any DTC not that’s this not

Duncan? So

Duncan Fatkin

yes. thanks Scott. for the question,

prior to and respond significant to launch. accounted inbound have budgeted continue activity, to but some obviously for we we launch, So, for calls.

we We’re the that attended pre-COVID. building on conferences

actually a think the release, a of starting, they that effective to of continue will is not as it’s that the are be the be to and system phase only trial going Steve prohibitive matter for limited and hospitals. those phase have really to relatively and us. specific of certainly the number trial we with cost doing weeks cost actual get problem. not we attend launch and when that’s a that We we a said, and virtually into

very it difficult have covered. anticipate of that we at to certainly So, all. all don’t We be

Scott Henry

these How think by would calendar for – till see Okay, Should color. start some of based area. oncology get indications that relatively trying you a we I should the Steve, Just that then should end marker sense you said, when we great. marker the believe XXXX. data trials? long shorter how readouts there? to I to we see year get And be for Thank in of first-in-man – about

Steve Lisi

Scott, I not – very data biomarkers predict to be is on think that this to show able long-term be a safety there’ll that, will first-in-human forth. tough so be this you’re I we’ll going to Yes, study. when there targeting the be from we’ll path at will point would it’s really be but It and – and be right

relatively it So be short oncology for studies. should

there hard we it’s to fair data. me for by probably would So commit almost to we I be accomplish let’s I get It’s years before by that really could down But think started a so now, couple timing. got out things can see can how specific end end if to of we XXXX, a to XXXX. from goes. that the nail something of showing again, of two that have quarter the it’s But say

Scott Henry

cash to the about real-time you. with And regards how Okay, believe there [indiscernible] the question, is an just sheet outstanding line? then that warrant if million? was to think should given. balance final hear a mostly we difference that exercises? is Thank I great. trying like Just figure $XX.X think I correctly, And Was

Steve Lisi

Thanks, Scott.

our ATM Doug was was of it million remarks. use as was the of line well said of a as yes, in mix prepared $XX.X warrant the And and equity credit. what exercises So, it

was three those So of combination things. a it

Scott Henry

questions. Okay, thank perfect. for clarification, the Thanks for taking the and you

Steve Lisi

Scott. Thanks,

Operator

with proceed question. your Kaplan Matt Ladenburg. with is with question Please next Our

Matt Kaplan

Thanks. Good afternoon, guys.

Steve Lisi

How Matt. are Hey, you?

Matt Kaplan

thanks. Doing well,

planned that respect of the a you launch to for want couple LungFit questions you with to ask have PH. Just

Can as launch. product later – phased you describe – of a and what are year? the launch will this what of you kind the mentioned kind how phase the the how look You first like phases

Steve Lisi

to Duncan. Matt, I’m that you. going pass over to Thank

Matt Kaplan

you. Thank

Duncan Fatkin

Matt. Hey,

Matt Kaplan

Hi, Duncan.

Duncan Fatkin

certainly question. take it as we steady the call to a it approach practice for regard I best release. limited us a for Thanks where

on made experience to prudent a our with have gone gone that us device lot to learn that nine model supply that phase made chain that rate We just this goal don’t first service we the constraints a and the of XX expect around decision. we faster it’s hospitals. hospitals. I’ve anything be way the And certainly we launch We appropriate something chain, confidence. that do. to of to that broaden to of the supply a sure phase, XX plenty going phase month start expand to well, thing tells the as the to probably how any to something the think that the able purpose much haven’t like six we things that we that anticipated. depend medical is And whatever will me to that it to right have and is that make the particularly larger had play has then be at obviously pace go well And to to XX some of much on optimize will and is it months we and can, when after we haven’t And is across group then phase, to period, after get can X accelerate. U.S. accelerate a first out we to So

supply that time. that we’ll allows hoping at quickly We’re go fast and as move just as able chain be to

Matt Kaplan

sense. makes It

Okay, call about each – of to razor going what you charge are great. terms in of those? is are – monetize for the terms device blades, then in That’s it it helpful. And the itself? you thinking you and how And how very the then, of razor let’s

Duncan Fatkin

the we’re you. Sure. idea. Yes, Thank pretty through specifics a have I but still working model, that think we good of that

nitric there maintain reveal sure for think will be of we is advantage, oxide, competitive that hasn’t been intend is incentive want people exactly because to details I flexible. an we usage want You to but that to there. can to to don’t their we the that say make that increase which imagine something I We intend

to that’s In to been model of it with restrict easy going we’re a to to because us existence. fact, the us. them just put protocols I make kind do in for business think usage in business to – trend of easy there’s And do for

Matt Kaplan

right. you. for All And then I guess, right. Steve, Thanks. All

help you data it I readouts present guess, data significant understand the – spring? in Can the the a viral in You expect PRO up near-term. announce acute I should pneumonia from or be us in interim have you for, looking LungFit to coming some, initial what we guess relative that

Steve Lisi

Yes, as that study, and important in it’s most of time for is it’s past for the PRO number been patients used telling I think, the make it’s obviously safe to years you in sure simple here. use safety. to a couple reliable being LungFit system, of a first important we’ve this

not you’ve people been seeing, doing obviously. of get addition, quickly there they resolve In F-Scan resolving how hospital, a Those with all the the we points of as at for kinds because you they will are And quickly for this the And same and acute whatever patients we’ve well, typical, things – how looking patients COVID them, how out for studies, mentioned And been most to symptoms, pneumonia COVID viral have again, patients time. going progressing of COVID-XX would things. ICU. what patients I recorded. will are be for look

there. So pretty it’s consistent

So right now. standard from you’re I companies it’s other what pretty of think seeing

Matt Kaplan

the study, the you we of then how should many And enroll the spring? XX plan that to patients out in expect in

Steve Lisi

Yes, we’ll see.

to the in it, data where that date of point a cut put it this and is terms going we’ll out. compile this and the have we’re then release have will is We to

number from have at at whatever point release. And press specific issue any to say just the It’s of put in kind for and date. timing that’s of looking point, not have some that se. pick we we’ll more one We’re per it. out We a a

the it’s by what really get pretty at going. made to be continues date COVID this we into we So, seems much unless the time of that go will just no, point to quickly. the decision be, very in that but But over way Israel – vaccinating May, haven’t season’s time in

that. too I last to think much it’s So don’t going longer than

So that’s something why have number in basis, of would clearly we’ll we feel the spring an I out know the but exact that who patients don’t on interim be.

Matt Kaplan

Sure.

Steve Lisi

That’s initial some draw to Enough for conclusions. sure.

Matt Kaplan

have would point? similarly expecting efficacy year. data point? interim have you you’re be of guess program I I that then guess we for LungFit What And looking at kind conversion and culture Will the Great. there? this for what And data at data, we NTM mid GO that should

Steve Lisi

know point, early. XX-week at on Yes, too is there’s will XX-week it I cultural going don’t conversion that This treatment, be think observation. be a to anything

conversion would So weeks. XX the stuff culture after be

I’m life then cultural it home, have function. out, with dataset that, know machine would our we final point we’ll data function, talk going compile tolerability system can have at safety conversion, well and data. we they’re the see patients, that’s quality the see to holding home and in don’t of put doses of not we about when And themselves to and aren’t without they’re up most safely safety using these system and important, with here. quickly. on the and can be won’t thing physical and interesting have sure looks how but but on we they’re think patients physical mean, Matt, that is at any and it’s complaining we that many their patients problems data time, we’ll from with and feedback it, the So if But in that I I be data and get honest and good it happy that that as I home it important anything tolerability the taking as we their the you,

Matt Kaplan

added and detail. Steve, for thanks Thanks, the Great.

Steve Lisi

you. Thank right. All

Operator

Instructions] [Operator Please with Yale question Laidlaw with your next question. with & Our Co. Jen proceed is

Yale Jen

LungFit congrats getting Good line PH. afternoon, to Steve, finish and for finally for the

Steve Lisi

Yale. Thanks,

but we’re yet, you. We’re not thank finished close, but

Yale Jen

And the you in, guys you already should because of yards, would The a Do see at of generic that or what XX the value been first eroded? It’s guess? further competition at question reason? you the – reduce, you anticipate, giving that point machine one sort be in is coming so market do how being XX to do that being already market guys this the see market? cylinder I the total

Steve Lisi

because of run has been well set rate. much terms was Praxair And So, it won’t the And plus market, take lower been the pushing first $XXX time in thing we’ve there to plus, they were to that XXXX kind we I’ll think say, knowing that run before of just said, Yale, in the we closer that settle was than million And well-known, It entry. is that pushing think by market million price $XXX Praxair’s go it’ll was coming. $XXX this in always at rate. sales million that started telegraph, million share, it now Praxair $XXX is were we’ve a since saying that around coming.

when the as well. let in. we So, he I I’ll Duncan think would We last what occurring it’s about as projected be actually market I think thinks were come couple talk over the And anticipated we and this will size, we anticipated then happen of years.

Duncan Fatkin

Steve. thanks, Yes.

around that’ll lot restrict We protocols put we’ll use hospitals removing more use, of market and hold and well that earlier is grow those to patients business all change we’re as the any in Steve’s use ease try as model treated protocols time relative that obstacles again. said to so, our I comments, oxide. know, hoping efficiency, the the view to of logistics, cetera, think et goal the use the And reduction cetera, increase in with that nitric to our that with to nitric et a oxide. have of our of think that them encourages system and start them as for I optimistic do the are I

be So that would the cancer.

certainly prevent goal. that But from from enough and not advantages world our We think hospital, story depend got down. obviously, to it’ll that further will expecting enough strong We’re happening. quarterly to to that’s but competitive market it’s a we that hospital a we’ve certainly,

Yale Jen

portion you marketing which more great. on the the XX,XXX just for to that’s the guys market? Okay, presumably one of at oxide, use, feet question, it’s Maybe, side, that, least know you on nitric of very thinking promote but the also helpful. entering top at large That’s is any cardiovascular point a there inch cannot guys that –from I was off-label. strategy, least

Duncan Fatkin

we usage for that I know that exists. Yes. Thanks already question. mean, pattern the

can’t we looking do to certainly use And indication include the we and expand that well. as enter that. we use, course, to hospitals but we’ll to tend of promote a definitely as market, own NICU off-label with cardiovascular be So our can the we promote

requests. to just to of make them have who can to inquiries respond going that sure to use to the and it’s respond easy we’re So, people specialists our our we’ll customers off-label clinical and any and system, for we’re going

So, of formerly reimbursement. can and some getting hope expanding we use part be certainly that we the

Yale Jen

a last ask you but and to have not guys I a the and know, of Steve, moment. going here, between something other Maybe, instance, at you that’s general I’m progress manufacturer this aspects>? still the the question interaction for in terms FDA, Okay. or in agency question about say, the already inspected,

Steve Lisi

now. will one this I Yale. Thanks, Yes. answer

bit So, a process early them facilities. the the inspections of FDA not to do that. in done It’s formal has for little yet

So, last you XXX-day days XX will see XX the that will the days, occur clock in up. about is before

we’re So, not quite there yet.

forward happen sure get it to will when So, we we’re looking there, and it. I’m

Yale Jen

anticipate you the Okay. to Maybe, that year-end. tackle question ongoing, approval you supply of question this need left train is CE agency additional I by, terms one is the that over European in already the there, more process just guess, to information there already whether potentially the Mark, or that station?

Steve Lisi

the a with of to differences Mark already trains generating of working done different before. more And process them. so, through there’s obviously, of in the of than you need by for I to this and process and the data data per extremely left the matter with EU. we’re CE the And like have said, the Europe left the FDA. se of beginning It’s – the There EU, All be you aware there. great similar. year, we subtle Yes. terms no be a them. we get the that’s is station expect dealt some we at to is end with are which team work just mean

Yale Jen

just go. I really one appreciate have to great. that more Okay, you

Steve Lisi

Thanks, Yale.

Operator

Truist. with with Our is question. Gregg your question Please with proceed next Gilbert

Gregg Gilbert

know roll are with potential confidence the whether inspection your but second about incumbents? can confidence Duncan, customers about when, doing and your to how you can’t when or record you model overall? you what maybe, up popular still those business in in terms consumption and part they talk and talk how Thanks. you. Thank And then is inspected, theme, to work speak historical the the Steve, degree on can to get locked speak the track is customers? can your maybe, among the in for all-you-can-eat I becoming and they partners? more with they’re of exception tend of And how your that, contracts off? you that

Steve Lisi

Thanks, Greg. buffet will all-you-can-eat tonight, be sure. I for that’s hitting

many just this because we way, lose on in our to in contractor for they’re They’re ago. globally. that the They for guys, manufacture that and contract fact these these and the not the separate So, are contractors. years the partners at product our the the They with went over LungFit or guys FDA. a this the really – concern with top certainly penny their products it’s – They with manufacturing do that that manufacturers, products very record shape the have going their sleep And to every a filter our industry of manufacturers, and we’re of vacation system, there’s we go kind it’s spent top Really, tier of of for of we’re point, both any game. were with the part. at worth filters and get much They LungFit our obviously or using don’t see with we clean the are I two – many form. that them. they’re

your that hope So, that side. answers I Duncan? question And on

Gregg Gilbert

Yes. Thanks.

Duncan Fatkin

Yes.

years. of respiratory strategies the Air them. contracts. question, to we’ve first typically hospitals very same try lengthen therapy tight-knit of the time, the and very are lens. talked the Gregg, comment of community, definitely incumbent is of and part community, the At lot they one So, aware between those the which the particularly, contract one of are a Definitely, of and three the and is Beyond

those changes. resisting So, they’re

are lot of from view. point ourselves it’s a hospitals mixed for to also technology, allow So, differentiate There we certainly a clauses new that of bag. to think and regard these that contracts in I would break

XXX that are and So, NICUs about the to, there think coming don’t U.S. I off hospitals that you a think in I that can going when with there are speak NICU contract, plenty to be consider should as [ph]. be I see that we that

before So, that to I’ll answers I question, if the on to see pause second go your half. Gregg,

Gregg Gilbert

Thanks. does. it Yes,

Steve’s Now, buffet. on to

Duncan Fatkin

Yes.

one. about that, haven’t that trademarked I’ll we think all-you-can-eat, the but So,

to the the was contracts. lock unlimited sort and provide trade-off would to last type sort definitely and term the down years so try of trend longer that again, was incentives few So of be contracts

of contract, in So, less than the only the they’re they’re some and unlimited, for period the that really reality is not cases, unlimited that.

much the goal Our also And sure change strong of a of view going about restrictive better any point in model cost from use a nitric make isn’t but business very and to structure is way oxide. use we’re our than people competitors, try to more position handle in our certainly we’re way. think that the our can that of the people

are really is it of contract to timeframe. they speak reasonable a So, kind sure that matter with us making in to more available The doesn’t us.

Gregg Gilbert

Good guys. review. with luck the Thanks,

Duncan Fatkin

Thank you, Gregg.

Steve Lisi

Gregg. Thanks,

Operator

have reached the end to I of Ladies would for and remarks. the session, management and gentlemen, closing call to we like the back question-and-answer turn

Steve Lisi

we’ll Thanks, really everyone appreciate see buffet. and joining for you us I the the interest at today.

Operator

concludes today’s conference. This

You lines your this participation. may disconnect Thank at for your time. you

Beyond Air (XAIR) 10 Feb 212021 Q3 Earnings call transcript