Beyond Air (XAIR) 9 Feb 232023 Q3 Earnings call transcript

Good afternoon. And welcome everyone to the Beyond Air Financial Results Call for the Third Fiscal Quarter ended December 31, 2022. At this time, participants are in a listen-only mode. A question-and-answer session will follow the formal presentation.

And now, I would like to turn the conference over to Edward Barger, Head of Investor Relations at Beyond Air. ahead. go Please

operational Good on us. Operator. press and you and release year thank announcing copy section. results. Thank this Events website of after afternoon, under market joining press XXXX fiscal of Today, third be a and close, for financial the A found you, can quarter everyone, highlights our we release News issued the

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

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

www.beyondair.net. Additionally, this is and website, recorded be for conference audio our on being available rebroadcast will call

that Furthermore, February of conference contains the is the XXXX. call content of accurate the time-sensitive of as X, information only broadcast, this date live

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

and Duncan today’s Chief Joining Chief Officer; Steve Financial Officer; Chairman Executive Larson, me on Chief and Officer. call Lisi, are Commercial Fatkin, Douglas

turn over Steve? Steve call to the And I will with that, Lisi.

usual, This by Financial our results questions. will of be open call afternoon portfolio, for joining for by an financial as providing across overview we the update and Officer, I will the good Today, followed everyone will to and quarter then Larson, Chief Ed, be Thanks, including up Doug our Beyond Cancer. our an us.

on the I Officer, pipeline Duncan? launch. Fatkin, LungFit our update of financials, Chief Commercial PH turn would Duncan to for over to our commercial an discussing like Before it

Steve, our afternoon investors. and good Thanks, to

with quarter, During PH. phase we the of our last have progress launch LungFit to commercial make the initial tremendous continued of

a group X As initial approach. select that staff go-to-market measured phase PH of have a is commercial multiphase nitric a Level release reminder, experienced hospitals The of X to NICUs oxide. Level represents our inhaled or LungFit with and a strategy

that device. at I different PH a am and to clinical hospitals strategy has our very service, customer line the our LungFit on pleased with team evaluations report variety completed of of of gain course, of the in feedback logistics, performance to our

our awareness moved a has in their our phase expectations with have of experience The of contracting and of into number feedback we line technology. as been the a and with result hospitals

in in team continued regions, our demonstrated given triple of LungFit at target period threat the of state over far. in restrictions and XXX at our PH person and has achievement RSV hospitals national during winter addition, the the so conferences and as flu tremendous a hospitals In system result COVID, a

to the revisit of of some flexible some and models believe, system is and simple impressed PH use. administrators very easy respiratory motivated to we restrictions placed presented, on oxide transparent and anticipated, the positively in cases, they neonatologists the to eliminate highly nitric As are the are reacting with business to Hospital and are due how and challenges. will cylinders and LungFit use logistical cost therapists

in first since the seven we been as our support have months test operations and of as in Based planning accelerated to the feedback spring. on infrastructure, sales LungFlex our XXxX our well move logistics launch, the received to clinical We phase are able into through service. an promotion

launch. optimize of refine the and clinical sure focus our of this make training experience the our business use first we will our to geographical from phase model, that to launch next We phase

key previously have specialists during of commercial and phase, hospitals I building a team, and and will sales network leaders. second mentioned, reference clinical expanding be both we opinion the field our As

coalition very new forward of and a progress supporting are a look excited nitric Beyond. this hospitals, We U.S. delivering about the of of technology across made quarter accelerating last awareness the amazing new and the building to over way oxide and

call that, Steve will back review. With I turn for pipeline the the to Steve?

Thanks, with have delays. PH, where Duncan. start regulatory I will we LungFit faced

going Our must quest until we anticipated of XXXX. for CE first but well, fiscal the half approval our Mark postpone year our is

the our first We before similar to and of these our expect faced so submitted this we in beyond confident thus, of goals. do the remain not supplement expansion, issues of In of PMA for the U.S., half yet but have control, have achieving year. end label we delays cardiac calendar both

that we VCAP agree the have our pneumonia safety efficacy per in given to this study, FDA parts an year program, oxide parts of conducted start other respect began studies we with XXXX. our our FDA to we in be continue three studies, adult with patients. and excess believe intend in studies. fourth work which study for million upon allow over the to XXX NO to and the study, closely the XXX summer discussion X,XXX NTM nitric XXX two With should resulted at We protocol quarter studies, calendar These bronchiolitis in of this to to several profile over per along million administrations

mentioned Clean Squeaky we mention times in many to past. the safety have that the data in animals Not

is reported proposed Israeli study. As a we reminder, extremely from this in viral what to pneumonia similar our design study

test treat virus, to who hospitalized virus SARS-CoV-X. any all pneumonia expect any positive We including for and with of variants patients

parts one per in no long-term the infants pneumonia we million Plus, filed We years five have saw NO and the study. from NO adult studies long-term, more seen than acute no some out XXX per and SAEs related million bronchiolitis effects treatment. three XXX to parts to

to high studies dioxide nitrogen with no data manage Our associated our ability concerns treatment. methemoglobinemia long-term of continuing and exposure reflect concentration and

confident are on to build will we We that results. able be these

study present more medical XX than our was Moving multiple in weeks. per million times day patients no by parts delivered home per to for professional XXX at which with NO,

these can as were see by website. XXXX the they Chest presented Meeting at Annual data visiting our You

were no reported. Just no dioxide nitrogen a reminder, methemoglobinemia issues and

a data fast moving support not until of pivotal for possible. forward we study this year to half with patients and these with that working move meet line. forward see the NTM do second as we believe fiscal the our shorten We time, XXXX. FDA or At beginning as to this will look study We time

COPD in be pilot with winter. underlying this conducted not Our study patients coming will

no. in of FDA immediate We priorities in the work are to to with start LungFit begin will of we the varied will and look calendar PH quarter addressing continue XXXX. our VCAP fourth to and applications

over releasing last strong. since months raised money human ongoing the XX Phase that clinical Xa current calendar Moving later is has very the our data been this we on Progress with topline be year. to Beyond will belief The Cancer. study

publication first with another is expected Our later out year. this

conferences Our preclinical when to shown therapy we in several team at of have added year we animals doubling is a quite medical already anti-PD-X anti-PD-X our this alone. to active and therapy data compared with expected survival UNO

also renowned our with Choy additions of the has of as world Gavin Dr. Stanford expanded Beyond Dirbas Pegram, at been team recent Dr. both Cancer to COO Mark and oncologists SAB. hiring The Fred and the

stay for patent for our this Please later detail first tuned year. and technology the for these beyondcanter.com accomplishments addition, on visit more issued. all of In was

XX, for Officer, now provide to Chief Doug? the our will over to ended results December quarter the an I Doug financial overview fiscal XXXX. call turn Larson, Financial of our

afternoon, good and Steve, Thanks, everyone.

December for the follows. XXXX, in fiscal XX, work which $X.X third XXXX. were areas. the Our XX, XX, fiscal expenses XXXX, as by This as research year ended in financial mainly the results investments December the group ended a done GAAP quarter compensation across up ended XXXX, quarter Beyond for operations basis, of increase increased for on million, are with development our as quarter well in was targeted $X from compared On December and being therapeutic scaling costs fiscal driven Cancer, from preclinical million

continued U.S. quarter $X and million XX, XXXX, systems expenses in December General the -- structural compared Beyond million, launch with was necessary of investments fiscal of increase for planned the fiscal $X.X the the XXXX. LungFit commercial support quarter million XX, December and increased to remaining people $X with the $X.X to in ended in for due administrative to the attributed attributable the investments ended million PH to Cancer,

favorable expense XX, in gains XXXX. December foreign December compared was $X.X XXXX, XX, $X.X main a million income quarter movements. a as two fiscal we the and investments with gain, well in ended ended for were the The from fiscal exchange this the quarter marketable securities, as our million Other improvement drivers loss for year-over-year made

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

December by million Through XXXX. used burn this of first including was Cancer, fiscal million. for quarter company, the cash $XX ended has Net XX, Beyond cash year, $X.X net been the nine the months

December of quarterly XXXX to a We average quarter. As fiscal cash that cash $X within $XX.X and of million. forecast range XXXX, cash and $XX million for of marketable the securities restricted company per million cash equivalents, XX, to our reported still burn be

with And back hand the will that, to Steve. I call

as Operator, at is as to Q&A. with let’s everyone Air. I execution the Hope go Doug. pleased Beyond progress and Thanks, am

ahead. Ladenburg [Operator Matt Instructions] Kaplan Our with first question go comes from Thalmann. Please

taking the question. Hi. Good afternoon for and thanks

initial launch there launches follow the guess, would Just Phase competitive on or down is potentially early in guess, marketplace marketplace that X. terms the to which help potentially launch PH the going learned which is LungFit new penetration? anything unexpected, or slow wanted up in it could of you the expedite I about, I to how hospital,

I before the to will move one But very over I to Duncan thing question. will man is slowly. answer And Matt. say Thanks, this hospitals this that the turn

little the things lots terms Duncan will new through further. getting just I space, think get work eye hospital to on difficult just done. bit bird’s of my this that’s of to COVID a new hospital view, let comment in teams into get made I But from but things the more things in

question, Thanks the Yeah. No. for Mat.

there’s are to it’s the We really going. plan. with way pleased Essentially, change the no

first are that’s our previous conversations, our nine hospitals and as all months months have six to a We to dozen executing doing. been up we per

period. We feedback that excellent during have had really

absolutely have have as And could have the as of as And well we logistics, we focusing on expect. been before, from things gone clinical view, a point said service. we the

pleased getting. very are that we feedback with We been have the

different we trained are in process. of a now We have and contracting respiratory the number therapists hundreds of in hospitals

remarks, access various we I hospitals are I expansion. with my familiar and through now the as considering that all are of got process the these that contract go phase with threat early impressed we in moving we with that in the the forward and ones And now am mentioned very have the triple we with broader

they and some stages different different are processes of there haven’t some different, them have is hospital become have those onerous, and more each And of changed.

from depends it So hospital-to-hospital.

So nothing and that with that us are we progress. surprised we has have learned the pleased

we are And about then, X think Phase this into Great. moving accelerated the the as how spring? you sales should in specifically,

Yeah.

be that think X. Phase I said six we nine the months that that sort of to months first would

to coming that. are we of the So end

for know that process. of luck partly and they So from a view, contractual they start hospitals in the in their in reasons is draw on of to as the I depends next mix and end Steve fiscal said, that for point are all when exactly we the terms hit, of of contracting partly sure up, can’t the are ramp with to year the where we just we on going when it up commented

unfortunately, So, in more have that. can’t extent, more control scale, a confidence get as that will we we obviously to significant we

Great.

Thanks Okay. again.

next go Fraser Greg with Securities. ahead. Please question from comes Our Truist

folks. questions. for the afternoon, Thanks Good taking

eval with been have there have that contract why? done an hospitals reasons discussions, the any forward and not decided move So common to

I at, they looking So, they In the we have it think for dual they and comes done contracting. initial takes a mean, to all that. some an phase down source. example, I In bit are in longer. some -- cases, evaluation little the where cases, If do can are a

of is contracting. part around So reason the that’s

down. group we a to work with do acquired cases, scale hospital have of in be group, a the might have, that it that and done of And things a some group by in might hospital of and the be terms might with the that slows part was other

So working most are and the of process. typically the it’s hospitals. still selective those most the we But been contracting That’s around have with we timing of common.

what’s moves something system us. on that. our question just you seen that’s I -- is getting that are are follow-up with think there at way Greg, to process that of guess people slowly. This The is on. And the base And terms wrong actually going I is off signing of, consistently in up with

to You years, that the have I we have get conference just is nine-month a in process the can call look end back six-month at and all two and to transcripts have this the industry a ball in including said and no-no. at July the usually months August, that launching past is moving of completed and we X knows summer December, this the had

So those obviously. are rough months,

to So get going the process get this is we training knew to take the and going. so was the and education This just ball and fill time some and a time pills not with is a it with long rolling that to forth, hospitals. takes channel

here and about and launch system our the our XX concerns played with or around be These Of that hospitals we any competitors have. the little our are are Are tweaking like just of in probably So for us the system system will and a of seen course. years, we things haven’t that next concerns that seen there? there our it. tweaks normal anything beginning have

INOmax was of their when if you system. and new are looks go look mean, I like and approved versions at what they looked first still coming DSIR, like what with and out it the now look it then

do for room time. improvement. from hospitals at this seen to stops have our nothing with with are always there’s in moment That has our using we that system we system. where So But nothing

where In it moment would to in at we right I fact, faster. this we time. thought pretty we go are much Would like be

time. going that going everybody to get Of months like for the faster, take we that reality the the is be. it’s to go and to months what wants six place would to months ball full It’s to take nine nine course, estimated seems in rolling us is to but we

your wasn’t, please So question. I think that’s if what But you up. it with follow are at getting

Thank No. Yeah. I helpful was That’s That’s what asking. very you. a answer.

NO similar discounts, any already the believe is hospitals supply are color what to discussions, there the to be for would some paying. your to contracting Are that a or I receptive price objective On helpful? hospitals at looking

it Yeah. you same. hospital, kind have varies the one you Look, once one is seen hospital seen again, have of

various at looked we have and as business We learned. models have evolved

adjusted it to clinical and the the are hospitals different very depends have We on setting. for circumstances, what much looking

depends the is the formula the going we removing. cases, a eliminating in expectation. current in the on some be that It some of and much the cylinders hassle cases, In In be very expect are winning that benefits that might actually with logistical at to we premium. of line we just hospital value

again, in a we am needs. not you responsive are general because so But and So, but going be blanket we had area, answer, I difficulty to haven’t is certainly flexible varied. to giving -- to very it that we any their haven’t continue

comment fraction very it. process then the bit Mark CE and helpful. more the expectation? a prior can Got your you timing contributed later just That’s And versus to what about

plus that MDR, the resulted capacity in of They changed Europe, a few that things bodies the remaining lot were I a things, companies was pulled in new number the could years lot the already up new products the bodies of and being subject these market. ago, on it, have they with EU were and of in these significant products the decline off in notified to A market. call the a these notified been by guess, of used rules

you they wasn’t time things line So it are based in. these They We just happen. lot to to communicated time our a communicated guidance were with notified overworked, We a had get of body. overwhelmed line We there done. that capacity. and us. on couldn’t

we are see we Mark, them. good work CE have doing we job. just got We And be them all And expected. things are and just than It won’t time things any and to the through send longer hit could We with time them. lines went hit them. why still process I but these working didn’t these reason with could through we they a with don’t them happen. thought thought They lines. taking are getting together,

U.S. and regulatory with in stuff be to delays seems the There Europe.

think lines. in their what change are and others from recovering happened happened than some I from agencies Europe are time the anyway in regulatory But lucky in getting COVID regulations. what during the companies

been and That’s issue to line. concern us issue. But really are not the is of working of through it’s to meet trying The in we insufficient approval. it time the get terms nothing just for

it but we is a all That’s of it’s couple months. can So just will get it what do. unfortunate, in and is it we

Got it.

will I Okay. will hop queue. then in ask one I more and the back

On the cardiac filing.

I that be hurdle in unexpected meeting think was that you a the potentially to Did up anything come FDA. had much. approval? to Thanks a with so meeting

Yeah.

back was Our it expansion meeting so label conflicts. FDA, cardiac on scheduling pushed was the by

the which why has meeting submitted haven’t supplement. occurred, we yet is that So PMA not

I So I am comment. can’t sorry. really

Okay.

Okay. Thank you.

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

thanks Good all on congrats afternoon progress. the for taking and the and questions

LungFit bit how of PH, terms sales to us that going mentioned have In force. the of might Could I a size phase, and pace expand how in that follow-up. you the be? you are second give you And be might that then little a color

Yeah.

which we to dictated So, next expand coming expected yeah, be the pace contracts. what thanks. in team six months going at see XX the commercial to The is we terms months in by of

is And relatively we really people we focusing focus hurdle are reps clinical up the to will in gotten rolling that team hospital very get the building to more educate, since guys we new build team our need. sales the as train for soon on who you be beginning once and it to first. hospitals. that actual the up Those these then on up we our employees is Duncan the have number are So, be going and clinical that’s starting the going

next in, in team will fingers So months. will snap the We be our they come just bring months ongoing. So waves. everybody right? this will for of ongoing the XX don’t and be to expansion XX The probably

of X mostly the next hope answers XX in launch. Phase XX probably that months the of and building months team. us that few I Like didn’t, it our please the that’s me get I said, know. to last let if So going months question,

That’s in VCAP. PRO on one talk about? that meetings the Any can appreciate you very LungFit question I more that. of FDA Maybe the for helpful. the color meetings

the talk mean us between what we like FDA. said I to don’t and we Yeah. about

Our again… them. with But private communications are

Right.

say certainly study … in what up are calendar quarter I getting that, started this we this is enthusiastic the fourth will of about year.

That’s it. for forward looking are we to sure. So

one just both that will Okay. Great. well quite Thanks. any bit take MTN in talking pushed we guidance, And maybe earlier the out strategic you LungFit recent reason the has a as in which as noticed your PRO, trials, that, was the more, including there move? your slide deck, is that compared COPD to been

COPD again really exacerbations even So That’s don’t And it in seasonal we study is strategic. set have just out. result these it study, exacerbations though a for hospitalization. looking pushed lines properly, is, up in seeing as not time time that need it patients are been because and -- because to FDA see we you those

a that’s in the -- the summer a be more than there months much winter in months. going to be will lot So volume

do given FDA. we on this the of to based been done upcoming no lines in So outside to it can us that want have by and way the don’t a time get we winter season there’s winter

we So that’s are of just reality the today. where

NTM, yeah, we XXXX to respect for we calendar. I were shooting think, With said, late

half guidance just of I year. our back think fiscal made we to our

but possible. as not it this semantics, really to a try will is quickly we of done as kind delay, it’s So get

to some to of maybe in are would don’t being little that want there’s out FDA has overloaded like we because with a I well. of a there things we push and bit conservative give kind a little bit we ourselves case a -- cushion little as think

little yeah, just This a to device to things of our as protocol by that the a that’s run bit, device. the get being it’s not well them, this pull system built. a smoothly, will study, goes. about discussion as -- can We but also about a discussion that just maybe back approved but see with of for the it’s final home obviously study, is pneumonia, the more not whereas in need we how But have we is FDA,

and all Okay. Great. congrats on Appreciate again, progress. Very helpful. it, the

Thanks, Yale.

comes Suraj next Please go Our Oppenheimer with from question & Kalia Company. ahead.

Good afternoon, everyone.

two and one for So Steve. questions. Duncan, for you one

out start Duncan. with Let you, me

if in contracting quantifying all little through consistent of now are you evaluations Duncan, PH. may specifically, that -- when wondering sites phase. have the or was terms next does would the push be you already a a and So, not bit been launch evaluation I it the from [ph]. stage? the What could in Alancarta gone I of -- phase that have to And the you site in finished push of evaluation, has perspective have an to what contracted done with they see typical into NICU terms may

Suraj. Hey,

to going comment other on numbers, not are Duncan We comment but those on can question. the

Yeah.

again, of varies In point view, they in from fact, what the evaluation do they test. on some have the an hospital-to-hospital, they bench and assurance protocol cases, from So it place. process a quality depending in call

connecting So the -- actually a without to them that through protocol to a go requires it patient.

cases, in go need a between in the three they nature experience, period will that week contract and protocol in lined or months, usually to again, matter months four six and a various stakeholders a have through where on somewhere nine of begin clinical go of the ahead they XX contracting something And with hospitals weeks their a based is process up and through. they evaluation typical their before a due. that access in do it’s committee process some months, to some that But value

their have there’s that I our currently size straightforward unfortunately, protocol. They just But use I from so pretty system system instead the it’s system all our have again. question. answered your So, is perspective, using as and to because fast one hope no a fits are per our of process, simple.

getting I in somewhat on Steve, to with for I know stage numbers. Fiscal XXXX, commentary it you, specifics diverse million. revs. looking numbers million are $XX almost you picking in giving Duncan. at are if the But is at this things this fourth and the Maybe way, delayed, of question one quarter Steve. the am enough, about correctly, process Fair guys of if it’s could Fiscal terms I taking just up it some $X position longer.

the needle Gentlemen, you us in thank seeing my and on you numbers guide the taking you based are questions. maybe terms here launch are can help in terms of the how consensus what what for of there? would So you phase out thread

let’s And those Suraj. be Thanks, consensus. other clear, and from are numbers the that’s you analysts

We that’s no so interpretation at not be guidance we giving going this have given just whatsoever, point. and your guidance are to

been think how and when I have obviously are play will gather very about ends things -- we doing clear and that more which information I happen going probably out announce before to see XXst. that March wait and year, more get our that we fiscal and

discussing So time. can forward to that of would guidance kind what more be us giving you look we in detail at

too little to things. still it’s think a those early bit discuss I

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

joining speaking everyone appreciate you Very upcoming us shortly conferences. much Look industry very couple in Thanks. to of for much. very interest. Thank to forward today. the Thanks a

for concluded. The today’s presentation. Thank has now conference attending you

disconnect. You may now