XAIR - Earnings call transcript Q1 2023

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Operator

Good afternoon. And welcome, everyone, to the Beyond Air financial results conference call for the first fiscal quarter ended June 30, 2022. At this time, participants are in a listen only mode. A question-and-answer session will follow the formal presentation. Please note that today's event is being recorded. would from turn LifeSci I to call time, Davis Corey Advisors. this like the to over At Please go ahead.

Corey Davis

we release Thank on be you, fiscal A us. of close, copy joining page thank year the you a operator. Good and website. press our afternoon, Investor Today everyone. XXXX operational of after Relations financial quarter this the found first announcing And highlights for issued of press results. market can release

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

and company's from could differ company's Beyond XX-Q results to results factors Form indicated. uncertainties without those filings actual the including, and recent Air to that XX-K to most forward-looking Commission to that statements. events with or forward-looking may Form cautions cause and those that review materially materially differ these encourage limitation, described Exchange from statements in specific We identifies cause the everyone are Securities the which the risks subject actual

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

update obligation or the events to any no of circumstances undertakes revise date to Air call. statements after Beyond or this reflect

Officer ahead. now Steve call that, and Douglas to Officer; Lisi. the Lisi, of and Financial Executive Officer; Fatkin, are over Steve, Duncan Chief Steve call today's Chief With turn Commercial go I Beyond Air. on Chairman me Joining will Larson, Chief

Steve Lisi

an Chief across of like I'd joining us. our Thanks, commercializing Corey. continue will embody I'll as address then LungFit commercial of overview results receive approval. it launch. has by Officer, several system believe platform update up United our to will in developing begin followed provide Beyond our Financial and This treatment the FDA today's or On the call the PPHN of world. by the surgeries Duncan portfolio, quarter afternoon over mission the Air Beyond who in the to the including and Chief they on will revolutionize Cancer to by our thank an we financial initial States turning team Commercial Fatkin, for organization open questions. hypertension be this providing Larson, which LungFit an potential the around to PH the update includes PH, device This for our We therapeutic the is to before and of to persistent LungFit to our call, Doug Good everyone newborn indications. pulmonary Officer, cardiac

hard been and commercial sales working expected PH. the marketing of very Our implementing phase have weeks At six has been for launch LungFit as from point, positive. everything the since this initial hospitals the feedback and is approval, teams the of

receiving of a also year, year-end. given Europe We partner internationally expectation current Mark CE launching next through anticipate in our before

strategy information will global on more provide as unfold. We matters our these

Turning six now just weeks year ago. I will development since we our reported be to our brief pipeline. fiscal

Physicians at will be in We data at-home the to or that study let are XXXX you very know our College October. LungFit CHEST American pleased we NTM from presenting Chest incremental of

home self-administered on primary guidance what concentration endpoint approved, related that diseases. for presented and has NO, that GO oxide XXXX If Beyond interim study we the we requires FDA a home most population the studies. high in Air reported for potential NTM changer treatment of the to and X,XXX discontinuations showed with believe both door respiratory for the following inhaled data inhalations well of XX-week treating LungFit to due overall PRO [indiscernible] at the lung and tolerated expand enormous severe compliance. reminder, favor be in trended GO, ultimately for is the strongly recent market data this in which pilot that this game treatment study no patients. could initiate for a to total infections exacerbations nitric GO a was As LungFit To open evaluate patient will currently are we to planning landscape in LungFit a COPD high

the XXX under our pneumonia NO two at viral Moving parts infection million bronchitis on and LungFit adults of age. PRO to children community years acquired per uses program, lung viral to in which treat system and

are data fall. this viral study at from to a We our show conference pneumonia community-acquired pleased more medical

Our months on for XXXX. over in a few of with will design, indication next fourth be starting this next discussion a FDA quarter a such the study calendar intention the milestone trial the the of US with

us XXX at study, in profile. NO an an As million X,XXX studies excess pneumonia of with XXX we with NTM adult a along administrations reminder, bronchiolitis over million parts to now parts three per safety several other excellent have completed to studies, give patients studies, to per XXX two

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efficacy solid evaluate tolerated As the is setting. this tumors a oxide into in nitric injection reminder, ultra-high refractory concentration dose, and study of maximum to designed safety

year. working towards later mice also presenting combination Beyond this data in is Cancer

confident be we solid variety combination tumors. a also While in NO that be treat may remain tumors where effective where examining are a as of to used we're there may monotherapy, NO

with Commercial weeks the of six Beyond Now is speak first US call to I that it the about the PH. commercial Duncan? Fatkin, Chief LungFit approved launch of of hand the FDA Duncan Air, pleasure great over Officer to

Duncan Fatkin

FDA And on approval enormous potential received team PH. to weeks truly as whole investors. six we the Steve. in Beyond to With been for goal our focus good June, past LungFit time exciting afternoon the late fulfill Thanks, our a have for Air the

go-to-market measured of represents PH LungFit with which nitric our executing select been a hospitals inhaled level X During to includes have X NICUs that against experienced and a group level The phase approach. oxide. staff busy commercial strategy, this release time, a of or multi-phase we initial have

actively is conducting excited the and by LungFit feedback The to the the The been positive. from system simple overwhelmingly staff which a of to of team hospitals typically been so PH these genuinely and comment evaluate is the have oxide. has generate we speed staff which on hospitals, the to the to far system eliminate Our system. LungFit nitric have will excited can already opportunity at steady how the by of visited demonstrations dose use are PH hospital cylinders

by you been X,XXX was interest waiting NeoHeart Los exhibited respiratory approved. for our country. care at This to delegates waiting almost team and with last to we've the we get had As one hospital Angeles, of hospitals engage the director reinforced the where in opportunity where mentioned, across week attended Conference

of ahead, is sure first with contracts and wave hospitals our focus everything As sign that runs smoothly. the to look we make

first will that industry. three the and support LungFlex six XX/X the up staff Over as components we become Air our initial standard that hospital to to oxide to believe make product engagement, will the nine logistics, Beyond closely an of with this nitric program. hospital performance, are has There and the together collectively gold ensure to refer the team of work what program partnership service we customer which our months optimized

for LungFlex all-inclusive budget transparent, we This First, business model certainty. implies, of and as allow have an hospitals number their providing flexible accessories oxide system that necessary systems, includes will the to designed its to LungFit of be backup and for contracts. the contract PH with period systems, name the their nitric

that will clinical experience registered training, Secondly, will initial therapists we've recruited onsite respiratory team team are available not specialist the demand. a our only and of clinical on members support, expertise have also All specialist specific industry. and nitric very clinical oxide experienced in be provide they

technical, Finally, all the XX/X support and support. and to service to provide will clinical commercial access line LungFlex customers

routine handle and do will of require abundance billing inquiries initial our hospitals using devices emergency Our to upfront. team to deliveries rapid an We program. orders from these expect replacement not everything

the month LungFit a Air PH and of test team. However, they per will a for have hours provide sufficient to volume Beyond rigorous

Of just end of system start granted for before be LungFit commercialization course, the to CE of We Mark the FDA XXXX. our the anticipate approval is the journey. PH

will to fiscal provide broader lead expect Chief XXXX. submit quarter In over an support to sales us for commercial cardiac in Larson, turn an results our an the of supplemental half start label. first calendar of planning expanding to We'll of ended financial these and I phase PMA two now overview expanded success. the call the Then, to year acceleration launch. of addition, our team the our anticipate Officer, FDA efforts our the to XX, Financial for be in commercial are we we XXXX, to Douglas our our June to would much

Douglas Larson

to Duncan. investors. Thanks, afternoon And our good

GAAP launch investments Israel, in of is million increased XX, fiscal administrative loss the Other compared the On expenses year the This $X.X $X.X expense the $X.X the and the quarter XX, Cancer financial XXXX ended quarter general as first June for necessary which the to fiscal to a Beyond ended $X.X with of million to $X.X to XXXX. US. basis, GAAP quarter XX, up June fiscal and June in mostly the both US XXXX, XXXX, ended as with the On million, a XXXX. were the for income fiscal for Our on for follows. million LungFit PH support million for scaling $X.X ended XXXX as quarter basis, XXXX. XX, ended XX, quarter and of the for the for and ended June and June to June million attributable fiscal development compared a comparable XXXX continuous and was June loss commercial expenses fiscal quarter results fiscal XX, research staffing of quarter are XX, the well

quarter per GAAP Beyond was For the million the $XX.X of $XX.X of of ended net XX, Net XX, which during cash the XXXX, fiscal XX, XXXX. share to operating of for million $X.X or the XXXX. a Air, of Beyond a were or those $X.XX Cancer, Inc. shareholders loss $X.XX activities, had loss quarter ended attributable share used in company million $X.X ended June with million, the June quarter compared June fiscal per including

range of cash $XX.X We million. be quarterly within still As the equivalents $X $XX million reported to XXXX, of million. XXXX a cash fiscal our expect company for cash to burn of and June average XX,

As such, commercial LungFit including of sufficient through current initial next operations cash the launch in believe months, equivalents US. we to well cash beyond fund PH XX the the our are phase and

We expect our fiscal to start showing third revenue quarter. in

Doug. even In cost the Operator, goods of let's addition, gross sold. expenses, to for Thanks, we report next two which hand I'll supply low Q&A. start classified with some quarters to And to margins we as back as go chain negative incur or be expect the to will call Steve. that,

Operator

[Operator Truist. Instructions]. from comes with Fraser question Today's Greg first

Greg Fraser

was system you attributes talk the hoping Curious about you've a more the of been I could resonate that most. the what getting bit from hospitals. feedback the

one. Is come You mentioned been out there anything unexpected? speed up that you else anything as discussion in the has would that has and point

Duncan Fatkin

with oxide. it quickly Certainly, produces impressed people how are nitric very

I be to at understand expectation system of and quite just think to all also cylinders there's and training associated the to but the the It's obvious the the and elimination that, their of going be that bulk easy the reaction simplicity. isn't is would with transition process straightforward. the onerous logistics very

questions the process that the it's are reaching of of a such and they last long can happened straightforward whole kind about with that agreement. actually the demonstrations system how I because typically think into too what's some is all to And the hospital use. they don't then integrate So,

of as component of great feedback we're So about. to we're the the obviously we that that the simplicity well something intrigued and is speed getting the generate oxide feedback really expected system is from the system's air, predictability about. and And to ability getting they're nitric excited then, other room the they're about kind at the

Greg Fraser

are Can you care LungFlex comment program if differences the on notable versus any program? there total in [indiscernible]

Duncan Fatkin

very be with are much approaching just terms case. the there very I'll we that response, not similarities. and general aiming our the you had from it, a that repeat certainly, how But perspective, think sure Well, we're in in flexible we're much I'm of business heard, an interruption, model. I of transparent to way but

be protocols that on So, model, oxide their system and beyond got be might nitric certainly to ability they the significant aiming offer. have to because depending the use be because it might the limit using currently potentially flexible use they in of a that our or to And cost we're system either the in of place the difference may flexibility very what terms transparent. hospital, business

going we're we've be experience, to systems, team which our strong as that And of expect nitric recruited, of have oxide locations. locations different. of the amount some clinical to stocking won't a least of offer be to That terms have able In incredible the we network at of particularly backup.

say it's because the transparency see over business going we're time, we most some the we've of difference that initially. So model I'd benefits obvious to partner. the that's built logistical have hoping not capabilities other and that to into that flexibility I'm into also unique go they'll then, And our some going be

Greg Fraser

cost attached more, Logistics, One are cylinders? having to not focused comes Is Is the savings that would tied discussion something may. etc. to also and having that transport to an deal on? to savings important if up hospitals the are for cost hospitals? But in there that potential with to advantage, that is that be the I something clearly, are not

Duncan Fatkin

hospital set from It hospital. clearly they're how depends It varies on to up.

assume the hospital. same it's every wouldn't for So to I want that

a logistics it generally, elimination which cost have the to ease easier that is system, welfare. And workflow there's savings, significantly reactions patient the the direct as the clinicians can allow However, of use, using into couple of our more use can but make and predictability also, also system, on the a the built just there's system. when to to they're focus the of

is type matter use they're matter and setting associated used, dose us how that no is matter filter providing, what this is. being is the what time the the no they the the for have, or no that of dose So hours providing system that flow they're XX treatment them, ventilator with

So additional we to know overrun predictability of effectively happening. and potentially, them much allows for of with use that cylinders, plan exist is avoid of and cylinders, or kind that ease general more sure charges which use just

hospital. I depends we've rather compete as course, intend from don't that, And of So on to price aggressively stated before, on value. to we said, hospital

Operator

comes Capital. The Henry with Scott from next ROTH question

Scott Henry

Just a couple questions.

went the additional selling is million $X.X The G&A as go think million, imagine of the representative forward going First, into is, $X.X go. it. is Should we about some good But number? forward? you what a I that? be question talked about that expenses how there'll we

Steve Lisi

And of probably phase the right, next items move next as bit little that I XX goes will of half get Q as minutes year, think it's up fairly we But the representative. our there's to we in second launch. first calendar in into start begin you're you'll probably there as the well. in the that see in that a XX, of noncash it

Scott Henry

cardiac product, is Another the your question, of the label, how impacts the can addition label other a how it positioned the you talk in market? particularly about to cardiac players

Steve Lisi

cardiac Right now, off for oxide nitric usage is the label.

hurting where use that So they nitric. it profitability to and it's need on the getting hospitals not certainly reimbursed, those surgeries are use that

with give allows physicians obviously it's So, those comes getting that to label target reimbursement where it on along used and being and us hospitals the the them label.

else I'm don't not now, But market, has I others for no the know. one to and may that's it's helpful not it. I us very piece So think be on for Right that saying think of everyone very actually. equation pursuing for in the be a I important going us. label.

think I the think for use can of think if be gladly will very hospitals us time, But I for to it, that's eventually, one get they be label, over accept if on get on it. of helpful. first to label. sure. get reimbursement gets But I one that it's the that Should nice would nitric everyone

Scott Henry

latest percentage the is what usage? market Steve, estimate what's the of cardiac of

Steve Lisi

usage. the half I more than think market, it's well cardiac

acute would you have that say as a for. babies, conditions there do and than cardiac combined, more sure. respiratory being for other have syndrome that all those I COVID-XX used you newborn of distress But it's is babies, certainly well So PPHN component

Scott Henry

right how don't A of a initial the final of talked phase? question. centers phase I targeting, a you've the have And the number many but specific about range are think of know initial in you scope or launch, if given this, you we about we're hospitals, which how should whether now,

Duncan Fatkin

change want other, to period. on tandem, may logistics been want to make But sure because couple on that's and they a It work focus for we've are connected consistent this. use to six whether think working We're that in service I everything's to about nine-month first depending pretty of hospitals aiming and hospitals dozen in we etc. optimize that time each the as to been that planned. a

Operator

The from Matt Thalmann. comes next with question Kaplan Ladenburg

Matt Kaplan

I Scott's guess to just a quick follow-up question.

we you you're for multiple XX XX kind it hope is those in how to systems? as there hospitals? If many of hospitals, of hospital devices system Should do one chances targeting per think or place

Steve Lisi

our depends to units during digits where are XX, into that and anywhere six You're XX beginning there of XX just I they hospital. just teens, have in be And the think mid-single the plenty That's going probably to we're use looking hospitals months. plus the launch that hospital first looking. the on we're units one of single to committing here. nine don't the to from

one don't be think hospitals on hours that year, to where to they're going of so we We've volume they're targeting get and or certain using get can systems. we're how going a have I used that before, per machines said our hospitals two feedback performing. we're can So,

Matt Kaplan

revenue to business the about of and perhaps how back devices, we device your then component business in model. generating, should just component, And generating model filter the think component revenue as terms the for going the

Steve Lisi

charge now, market The is of per the of works hour nitric. way hospitals usage essentially, the

not of pricing. connections our in per cylinder, pay and competitors, the hour nitric. delivery package So forth, included of and so system, for the all they're they for really components what They're these other all for itemized

done, for. are things and quo things contractually, to charged So we're how they going try keep to status with what

just essentially, filters or the of is flow no in else kind for of we'll track situation on to able just the is the XX And or the no at being and concentration is, our like way So that used of look the argument's matter everything competitors you last our an in charging type hours. sake. do, last can the what hourly hours XX basis, us be matter throw NO what vent

So our easy it's used track very for time hospital to the has system for. us the that

Matt Kaplan

Last question.

of the devices hospitals terms first little can that supply to you talk kind of in stage bit any that constraints you of about see your of terms and a the inventory hospitals, able of the being initial In to and devices, XX launch?

Steve Lisi

don't I initial stage. about concerned think we're the

looking what the I months time. there. be supply. will in out supply else demand good that face world plus think we And that we're same the to And everybody electronics nine in and we're faces with at moment challenges the

X we're Phase different we're when everybody So, no X, else to Phase get out we're there. good, from we covered.

time more build and we have gather components We have systems. to more

Steve Lisi

Just jump queue. questions two and in back I'll quick the

pipeline, we On LungFit going CHEST to the have numbers you're said in to updated and should at of patients and that expect see October. data you you're there? on in have the to What of going type terms of there [indiscernible] GO data

Steve Lisi

going going XX don't actually to And know. He have Matt, know, won't what be. patients. my to data I'm we'll I statistician when says see you'll because see the to You're are done, tell me.

I him. bother So it. don't that's

Matt Kaplan

Last question.

to study? are? this In Is of terms Can worldwide study you in terms screening Phase program, quarter. give your June, patients in open you're where this centers oncology a going X sense for your of the the a you involve us first said

Steve Lisi

Israel.

Matt Kaplan

Israel?

Steve Lisi

no first-in-human. a In multi-countries. Israel. It's X Israel. just way it's Phase It's

Matt Kaplan

in IND the have the US an in to opened near do or…? you term And expect

Steve Lisi

the we're Depends absolutely. those mean in get by of at one some Yes, But you to term? on yes, what near point. US going

Operator

comes question next & from Jen Laidlaw with Company. The Yale

Yale Jen

you enough assessment? the How metrics commercialization one. make or mature hospitals by the is of into the other to assess X dozen X to quick entering time, simply any just one that Just do Phase Phase

Steve Lisi

obstacles initially, I initial those months, X with allow need depends And hopeful really and we be certainly nine going there's think, made. enough us try see we the allow that the It's we're for bit anything evaluate making time aim are prepared able sure view on to milestone. that accelerate, we earlier. don't so we've to taken be be a well, fully way. that anything that It that goes. into that no and really our how and and little just things adjustments Phase to comes though, kinds going, time, work to to the we point, will or to that we'll that get six deal of specific more any If at

Operator

question Next Oppenheimer. from comes Suraj with Kalia

Suraj Kalia

all the additional non-exclusive, Steve, you the minimums, Duncan, should based, one for about, of typical give X registry high of just parameters how XX we to volume data, you either that contract, are envision a based you, could? construct talking some the that level PPHN, exclusive, for kind of us NICUs

Steve Lisi

the by fairly contracts out the competitors. way there, standard our It's are made

same pretty based the So know an with We going estimate them. years we're year. stick many XX so on there. will used out of with we're we're work what per to be the rate hours nitric, and hospitals. be the going using to hourly it's past thing to an same that's And do of system them consistent with they're going doing for and how with And

not using would existing of probably what to the it's at barrier confuse something So much time. be That us. really variability another and current them that would them be is

it to trying So as as we're possible. simple make

to change makes to going sense you. we're that that something not or if adjust, it's So

Suraj Kalia

time, just you Steve, injected for gleaning help What we give out can from the solid a some but Cancer the us been long, how is are it for how Cancer, oxide so diffusion? additional in would could more one put Beyond what going of theorized work? to at the think to us PK end has start nitric practice delivery so profile, thing the understand of the mechanisms, better terms that questions guys should from or Beyond looking the tumors, into color should residence we data in of about you other terms

Steve Lisi

don't won't This enter is and PK be profile There local we administration. the bloodstream. any a

doing, Cancer simple minutes fairly our a you So system dosed data, the that's because at five duration we're It's one out website Beyond of intratumorly. surface part for put see this a of exposed we've and point near on we've And skin let's tumors. tumors, your that say, can question.

a it. a with simple catheter just we'll it's able to be So, deliver needle, so

going more inside I'm going exactly either the And reserve of So, Phase proprietary how detail current for In certain system using that a X information is that a do to because proprietary have body, not than we give there deliver do. any amount about to we or skin and and targeting we're just skin system, to Phase study Xb in, probably but tumors. studies. we're surface the current we're the we're that near

So look what be description for we if you see Cancer in the you'll what people believe – to website, show action what the need of we of Beyond body. a mechanism look in and to happens the

in some So to give other and immune tumor B which see for first in of T be biomarkers idea of armed we'll what cells able is first cells safety, but and human is, this hopefully, this an that the be the looking system we'll many saw we'll obviously, activity study foremost, type, looking being in body. will against be for what mice. in And in areas we the us

So, the opened – it's the we've we in we see Hopefully, obviously, get in. humans, should for. activity we'll like that something that some study. data look seen mice When just everyone in

combination what a the of have in like. people a before present the have at end And six we working let meantime, hopefully we in able should of data on in and know now. that opportunity. some that get the to be year we'll hope we we're we'll looked to show conference bunch the So next in months some the them medical data if animals. studies Hopefully, we more can And patients

to little other more works as combination with it and is that So that how bit a information might give mechanism us what therapies. in

Operator

further we no conference Lisi At for back queue. question-and-answer are remarks. to concludes any over closing this questioners Steve showing to I our in the like session. the turn time, now this And would

Steve Lisi

want joining you talk time. thank Just today. to next everybody to for we'll And

Operator

The may conference is for presentation. concluded. disconnect. you today's And now attending now Thank you

Beyond Air (XAIR) 12 Aug 222023 Q1 Earnings call transcript