XAIR - Earnings call transcript Q4 2022

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Operator

Good afternoon and welcome to the Beyond Air Fiscal Year 2022 Financial Results and LungFit PH Approval Conference Call. [Operator Instructions] And now I would like to turn the call over to Corey Davis from LifeSci Advisors. Please go ahead, sir.

You may begin.

Corey Davis

Thank you, operator. thank joining and everyone afternoon, you us. for Good and issued release and and announcing after fourth press market approval financial press we close, quarter fiscal company’s PH Today, results. FDA operational a for announcing the end year XXXX release highlights a LungFit page Copies these Relations can Air’s website. on the be of Beyond found releases Investor press of

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

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

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

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

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

Steve Lisi

today. good and afternoon joining Corey to us Thanks, everyone

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Duncan Fatkin

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Steve Lisi

Thanks, Duncan.

emphasize want our and practice. slide Air the Beyond oxide for revolution, regular states. this discuss a I is the to this what medical team Congratulations basis will Air achievement. just that we NO pipeline, use amazing nitric it that and start of those know improve Everyone this Beyond at significantly to the on Before

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of to I job Larson, by now over turn Another review our a great call Financial Beyond the will the our team. Doug financials. Chief Officer of Air provide to

Douglas Larson

Steve. Thanks,

of on income for the entirely XXXX. to the to March expenses in fiscal were million XXXX, $X.X year related Revenue XXXX, XX, for the ended ended was $X.X XX, follows: year $XX.X million results fiscal March fiscal licensing which million XX, year XX, of year fiscal ended was as March million zero for as fiscal the expenses compared all loss the the operating revenue. launch the commercial to Research which fiscal year and XX, fiscal for Other for March Our U.S. XX, XX, March XXXX. fiscal due $XX.X prepare fiscal fiscal million, to XXXX, the March XXXX, and contingent from million XXXX. XXXX, year, company the required was liability March a and ended are the increased Other XXXX, mainly for for ended settlement ended XX, for the ended expense XXXX, were year the year ended for for $XX.X March May a to XX, to ended year of financial General XXXX, million from the for compared to the investments compared Circassia structural for the XX, March million March $XX.X year development $X.X ended expenses $XX.X administrative

an $X.X lawsuit you quarter XXXX, recall, a loss million. liability If for the recorded the related in company to contingent of for fiscal third estimated

XXXX, For which $XX.X loss per was year fiscal or year XX, compared March Beyond of million a ended a Inc. $X.XX the fiscal or million a XXXX. of net ended to $X.XX million had loss March share Air, the $XX.X company of for net $XX.X the the to share XX, shareholders of attributable

next of commercial As U.S. and operations Steve. XX back We well the phase call sufficient this that, $XX.X of And the hand launch fund the including is had cash company cash the March XXXX, beyond LungFit cash PH to the of in believe equivalents initial with XX, to through I’ll million. months,

Steve Lisi

Doug. Operator, ready we are for Thanks, Q&A. now

Operator

[Operator Instructions] Ladenburg line of question with Kaplan comes from Our first Matt the Thalmann.

your You may question. proceed with

Matt Kaplan

Hi, Terrific Steve, congratulations today. news the on approval.

Steve Lisi

Thanks, Matt.

Matt Kaplan

wanted phase respect to launch. you into get give each a bit can maybe that the you’re I X-phase more as of of those out us in little detail phases And market to with kind guess I you the potentially addressing the size launch?

Steve Lisi

Okay.

at third And have So per we’re train can users, in they high more with of look terms hospitals That’s we looking of look number have necessarily we for themselves, – of so them that this their year the above obviously, experience more say, phase a that are the to from hospitals it hours And lot market. a in certain we team, let’s first not the phase it as learn them. you will easy. be at the revenues. entire so

go to out market. can the broader better as we we be So

would to fairly hospitals. phase what So we that high-volume consider is first going be

just speak. to that of X, Duncan are to in X be with that depend going of X off contracts X. ending to Phase a closer so respect you to closer Phase a be upon contracts you or are are X. in coming say, Remember, Phase can next that It’s some Phase every to hospital long. to. is locked are let’s they hospital last long in expand how to these have multiples worth for, let on could going if like contract how hospitals up X And Phase I’ll this more and for will there hospitals the So years quarter

Duncan Fatkin

fully on the first phase have our think targeting Steve of in Sure. is hospitals And really that we the prepared Thanks we’re said, about to expand that actual as the use of we’re we we’re we’re soon focused And working planned. We question, everything the confident the the of process. logistical so XX% I that Matt. is for that experience the as we then need our get as as the said that hospitals. clinical test remarks going experience Yes, device.

don’t be really that number by any don’t all hospitals the constraint off we to we we going of limited coming we’re are see time, and going targeting. the to mentioned, contracts because as we’re be think So

that question. hope answers I your So

Matt Kaplan

as No, all detail. proof I new kind that’s for this approved. at great. technology And looking of Thanks concept you guess this the get that can of

bit, the LungFit help steps understand of you Steve, a can little maybe GO. for thinking Just us about pipeline, next the kind

you pilot the NTM and study You’ve steps What got see net ongoing. do as NTM in development the there?

Steve Lisi

Yes. Thanks, Matt.

study. to have wrap up the We

all going last so the of straightforward and have the to probably will in It go as and a they Our will half happen with will in to is And them a to a put sit time follow-up instead steps be will to pre-sub And FDA. will we FDA. pretty time Since with schedule meeting we the that to device, next are a down are. This data pre-submission forth. us. takes in-house hopefully, together, we be meeting the data a meeting, use and medical then next get those some we And with will It and last of discuss meeting, pre-IND. in clear. you what at be then we year. first know, submit steps have to we’re And going patient analyzed August point.

clear feel some FDA for there If the But in to in start. into XXXX, with we guidance. be XXXX that’s very will the comfortable go should know, need can sooner, a I study be we think it study when we is the study see. next U.S. next and never might guiding up that be think that we before beginning to things begin I You But we’re

Matt Kaplan

able that device? of would potentially approval be to And you file a for the Okay. study pivotal will be that type

Steve Lisi

Yes, make pivotal. need FDA We is our that’s try first, but speak our it to to intention. to the with a intention

Matt Kaplan

we then what underway? bit detail Cancer, you in question a X can should little great. And us Beyond give study for more the last there and Okay, of Phase get terms you that just look as

Steve Lisi

Well, we’re business. for over

in press release. that our You saw

screening announcing for open we’re very we and of shortly. patients would dosed the anticipate patient So first

So we’re looking first for study. in-human safety. This the is

in in a intend gather. top looking of immune And biomarkers, course. that at we safety see gravy for biomarkers small looking in the we we a if can of safety Matt, if data would positive the on we’re So any number direction, system patients. to that of these be kind just And we movement be – of on will

is – So, study, again, from really And perspective. we that, the of a it safety that for will biomarker be be would if X we can would special. Phase this something point looking main and see efficacy

Matt Kaplan

on again Thanks news. Great my questions. the approval. taking Congrats for

Steve Lisi

Thanks.

Operator

comes of Oppenheimer. next Our with question Kalia from Suraj the line

your may You question. proceed with

Suraj Kalia

afternoon Good Can hear you Steve. alright? me

Steve Lisi

Suraj. Thanks Yes. Yes.

Suraj Kalia

your to congratulations long Hey, Perfect. team overview on the and you approval.

side. Steve, So, three my from questions

multipart question. The first a one is

you more phases? for maybe out initial like three looking been you have just time. could multipart of the to How launch the a how look year, that? your remainder of some cases of the we sites of referencing terms this to the in earlier, Give Sorry, the going? guideposts rolled but gist For us over also should the X launch hopefully, you you are a the PH what do of for terms beyond utilization in are NICUs are in bogeys that case? XX How conversations you out got PPHN, question, if about the some does be how expect all And that you referenced had broader think XXX all it. specifically,

Steve Lisi

will let just the I will and the Duncan rest. about go I through talk bogeys

terms, are we for So, honed this best everyone make are that It’s are in to that manner. again, the in generator. looking a sure us, our need very the methods we brand-new But a to is training device, a sure and bogeys broad training team. and experienced make have we we perfect and

to going look are we So, for methods. ways training to optimize our

to we want think job be of it this. cavalier done prior a hell we optimizing launch, have to I don’t about but on a

we is Second, is metrics doing everybody that from everything important chain use our is we go that look our dozen to well that at smoothly. and when make want ready that XXX, have supply to to running XPL we for XPL, very it’s and to that chain, supply our are make is this, we but a There sure hospitals that. ready sure for

team, as In it our operations back team, ready is for well. addition, team our our office

check our that kind have move that the for to to So, any this, looking are do want to give that concerns this. about we ability box about level. next We Suraj. these don’t things to the are any to of have the don’t concerns I we impression

Everybody prudent I in any make on is the out the a think prudent ironed go six are to our to got nine bugs sure have the measured of thing. thinks months way we it’s launch there months have that kind any. first to if team to

Duncan Fatkin

Jeff – confident the the with year. it’s to. as and for Suraj, physically a a color. incredible important. These product with up are teams interest we hospitals leadership over for last to really the that, talk that up of virtual planning conferences add go are that been room are months to on of the speaking significant in of a experience we that they us and we have and have they to us at we demonstration of visit people can rest contacting now as, directly. be well routinely enthusiasm beyond together we the set experience several this And we the will lining that we obviously, just and even they a their And of think have I Yes, Rebecca amount brought team little that dealing bit mentioned lot very focused and have of because

market, seeing utilization, help and far forward alternative will on through incredible clinical as are this group in the another hopefully, system contracting their professionals, we as terms cylinders they of into on the get experienced of the eliminating And So, to soon. them then evaluation can. very of they particularly side, looking will

clinically everything So, that’s going working deal and both initially then and the then us once because mentioned. we just that by expand point. release utilization want see and Steve to will everything controlled is are increase start we utilization we that valve be will with the we to at logistically, rapidly in to confident And

Suraj Kalia

expand the I in indications. are how mark you more around on non-cylinder-based Steve, and queue. about Got my I you maybe hop real-time PMA timeline? will your ask about NO, Duncan, on-demand status it. CE and have missed I moat comments both now back now just And NO will the in hand, questions, you that the first Steve, if thinking could

Just how again for technology. kind thank and around are your intellectual and you Gentlemen, taking of moat you regulatory thinking walk questions. us through congrats about my the

Steve Lisi

you. Thank

event. I mark, second think clear. we CE were a pretty It’s half

focused is there to there. say our on more We FDA So, were much not approval. – resources

keep the the So, approval. are resources we to had with on track to. pretty the But hoped happy that we didn’t originally have think CE FDA I we process mark

So, small CE it’s on a the mark. on timing sacrifice

we it, moat, As you very around as portfolio are generator. our call our for always our confident in patent

the U.S. Suraj, a XX times some something that growing XX in months. in And as happened even PMA with you year more the about few PMA things happens is times, We approval, last with have confident know, are a that approval

frequent a to who to not entry it a certainly barrier it’s is So, to down occurrence, try come this and others route.

to a So, as follow PMA we just others us did. have with will

is in I our with given with respect will to generator are for concentration area. much going barrier we the around obviously approval We But important high to is more that to will get that for very I portfolio. others have to anybody per anyone we is sure come generator, have patent I So, confident parts it’s going think be opinion. XX difficult that patents entry That’s million years. believe again, am a others to our in unfolds let’s generator. now be with to the the the our anybody to it don’t anyone most our especially harder the do over be PPHN, able to see don’t different it think XXX-plus but a next know else come one, With coming. as our respect of happens who at to what portfolio. we

of so the only We have heard town. far, but are we in lots game rumors,

So, in the is medical very advantage first-mover important device.

it. will very very, what see and happy we to there barriers quite are we are and up, We So, we are confident. with think have But unfolds. wait

Suraj Kalia

you. Thank

Operator

Our next line comes of with Securities. the Truist question from Greg Fraser

You may your proceed question. with

Greg Fraser

on label into for question. current afternoon And remind area? that you pathway Good approval. how Can the the you much Congrats the of what’s the cardiac taking us to is surgery? both. Thank the expand market Hi. oxide nitric

Steve Lisi

Yes.

about it’s cardiac. XX-XX So, estimate. being the rough That’s a split, XX%

data on no is there that, So Greg. of again, kind best real It’s guess. just

be them official get on is a and making goal. FDA this then So, submission we end to going make of the talking label indication cardiac pathway to supplement to We believe will calendar for to That’s submission. an or that just able that to the year. about and pathway PMA that our prior

Greg Fraser

move into Phase the Got of launch, by team? when the you much it. commercial the how plan And do then X to expand you

Steve Lisi

Well, I will let handle that question. Duncan

Duncan Fatkin

is, well-established business Greg. firstly, experienced nitric question, the Yes. in good news pretty The use a is nitric about of Thanks hospitals. for the very there oxide some oxide

commercial it a doesn’t large need organization. So, actually

But to we peak, team. be in be than half of fully expect at we the expect staff. to more phase, second established that around don’t least even So, at XX

the the there So, level we because areas. actually peak and access we between because hospitals on usage, of will can depending are somewhere don’t business continuing we be oxide the have a how nitric off that limited number current launch think on that either the of And the XX they XX time. oxide nitric both in of XXs, of in model on or in backed technology, those to significant use the going like that zone have depending – help then they somewhere at of I would to sort the will we is and expect, grow

seeing forward. So, going that’s what we are

Greg Fraser

That’s it. very Got helpful.

to mark folks? with engaging before potential For the Europe, for have preliminary you you wait have discussions CE or had with do partners,

Steve Lisi

No.

We have people. spoken to

to sure. anybody. forward That’s I say I moving – haven’t definitive we think mark on it’s appropriate talked before have push for to it’s to But we CE terms. wouldn’t

Greg Fraser

taking the congrats for again. Thanks it. and Got questions

Steve Lisi

Greg. Thanks

Operator

comes of with next the question Jen from Company. Laidlaw Yale line Our &

proceed may with question. your You

Yale Jen

were and bit if get something questions we or specific the taking for little Maybe the anything the approval, was Thanks to months hurdle approval. major about? during again afternoon. of see my look backward you Good last congrats can talk that just what before sort few on you the

Steve Lisi

was, resolved really can happy. issue working think that think I keep us thing was that I that very what and FDA, it’s happy the it the we between with was I to are clearly reveal us. Yes, we the FDA best But and just don’t do. And are

Yale Jen

two Maybe questions more Okay. That’s helpful. Great. here.

about The – erosion to first that reverse? some one slide, start is that or the change guys presumably on about the or $XXX million this maybe price due XXX thought you of before million even have is estimate hand, market versus general erosion. in to Is show the you What’s it stop current the price was going terms $XXX forward?

Steve Lisi

Yes.

don’t stable. know price, I I we X%, back much more more. a as here going might sit I don’t the nitric do increase full come was up number I that wouldn’t I that bit, think probably you in for oxide an that would XX% fairly rise XXXX I usage that. predict say pandemic. may down, a But price. it’s in today, price if this forward. the decline little see a see just there in on million year, $XXX Recall little the softening think during

the in those that years, a was there to a quite think pandemic that think volume bit. I X XXXX, So, while I XXXX and price offset due the decline

conditions. peak us don’t so to a the you volume – a of COVID to or going that at volumes we we you the team, don’t patients wouldn’t going a seems We hospitalized XXX% be be think But of in pandemic the oxide place these company, are also saw we are as think there maintained. lose the think to I that as for nitric who are during for pandemic. saw COVID-like that So,

it So, exactly know we will settle. where don’t

not we up years said are to new In corporate the should decline a usage anticipated had ago. few we million that had a You due well we as in greater price market. as see did be than past, than $XXX million. our as we But calling as this presentation again, $XXX that that increased greater COVID much the I will think the evening this one

So, we up stay to going going it think to I know it’s but million million be in $XXX if it’s range. don’t should million, $XXX $XXX-plus be plus a at the market.

Yale Jen

That’s Okay. study additional appreciate that to material of for – any it. of that of the very next one be Would two is like And the year? NICU? one or prepare need in just the in type there you simply Was kind got – a for getting line approval cardiac just terms what quick expansion. ones, you

Steve Lisi

not getting the it’s haven’t for the the are we as as what FDA. submit exactly hope going NICU. I to approval we said to hard But,

So, that I am to hold information yes. going back,

don’t we anybody let exact plans mind, to If what you our want know are. don’t

Yale Jen

the Maybe a housekeeping one. is last Okay. one

side In terms operating is there in quite big of in of of a jump this a R&D, in quarter, number terms lines SG&A.

As was we you next there are of next modeling or for could the directional year, any year guidance provide? fiscal sort

Steve Lisi

don’t half diseases are flattish probably going the SG&A would we best I seasonal, maybe R&D, product, really launching so we our is back mean there think starting and give probably are I Look, to as won’t can take. or I flattish we the to anticipate of be until up. there. be see ‘XX. increase Whereas an go increases studies

spend, on fiscal to there much ‘XX, some our because of things in again, rest the we ends the only which spend of there be But in seasonality obviously, ‘XX NTM the are the conditions be really a going up will There preparation year, of the this that to fiscal get side going, March bump of will finish timeframe. in not study. in is treat. R&D to attempting the So,

a ‘XX towards start with when the see half in back You it That’s commencing. ramp should to bump our of up studies will R&D spend. fiscal

that So, I helps. hope

Yale Jen

I And long-weighted on And outcome. that Absolutely. details. the appreciate all the again, again, congrats

Steve Lisi

it. Thanks, Yale. Appreciate

Operator

we back end this today’s session. comments. of Ladies question-and-answer call I over and to would have closing like the for turn Lisi gentlemen, Mr. reached to Steve

Steve Lisi

investors. Thank today. you. joining day Again, Thanks Beyond for great for and Air everyone our us a

be to you. will Thank you soon. We speaking

Operator

conference. today’s concludes This

time. enjoy and your participation the you your Thank this your may at You day. rest lines for of disconnect

Beyond Air (XAIR) 29 Jun 222022 Q4 Earnings call transcript