- Earnings call transcript Q2 2023

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Operator

Good afternoon. And welcome, everyone, to the Beyond Air Second Quarter 2023 earnings call. All participants will be in a listen-only mode. [Operator Instructions]. Please note that this event is being recorded today.

turn over to Ed like now the to conference Barger. I'd ahead, sir. go Please

Edward Barger

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

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

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

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

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

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

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

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

Steve Steve, that, I turn With go ahead. over now call Lisi. will the to

Steve Lisi

team. experience, some last Relations have teams very eight head the Barger the to to relations take someone Organon. we're joining Ed I'd Wall and and Air to Ed moment time afternoon at fortunate with a to everyone to Ed. Street Beyond new and welcome includes on Ed's Teva of is years our good investor which in us. And Thanks, Investor the like

including be our of will on an an Douglas an turning Beyond Chief by for our overview Officer, Turning for PH today's launch. the On call, Larson. begin financial we to I'll our across to questions. then, our update call update Chief will it review over for the This of portfolio, providing Commercial Cancer, Fatkin, LungFit quarter the business. Duncan commercial up results followed by And Financial open Officer, Larsen. the by Douglas our before

strategy by start pipeline, pulmonary me which we nitric targeting Let the that a LungFit of platform generators, of to across our testament is our continue our team execute oxide successfully stating quality and to therapeutic diseases. our

approval for Leading late LungFit the June. in program FDA received PH way our is that commercial

reminder, hypertension product, to it As the our is around commercial the of a this first and of persistent treatment potential the and PPHN, pulmonary cardiac surgeries or believe has world. newborn, we revolutionize the

initial launch. months, Perhaps most is the The remains past hospitals sales hard have phase feedback over the I'm from been and few with working important pleased progress that very of their implementing the very commercial positive. teams marketing thus far. the

our the have we we launch timeline to Phase year XXXX. in with and team is able commercial anticipate of to track second ahead, on calendar look in we X the As of the quarter being progress place,

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

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

and X,XXX lung rate following discontinuations to inhalations oxide announcements the treatment data home Turning physical present period. disease recent nitric treatment an at compliance reported treatment and Respiratory with high GO maintained follow-up a conferences. of month. function high efficacy at-home non-tuberculous Meeting XX-week that show was refractory, pipeline, were patients a at related overall session total and function oral of with from has during favorable data the several now or our development and data severe, the NTM treatment last safety, mycobacteria tolerated rapid to LungFit delivered These at CHEST tolerability inhaled self-administered during which study scientific concentration excited Annual well above no XX%. We're

of results majority and of NO endpoints with after reduction NO bacterial reduction life in of one of life the showed or the in load seen strong four load improvements Key quality and began, domains quality treatment months cessation bacterial after therapy. efficacy statistical of month

questionnaire according most important FDAs NTM to for patient endpoint. quality is It study, secondary of to required note outcome endpoint pivotal as a a with primary an bacterial guidance life the recent is or the reported load that

this in by real approved. In NTM, at-home for the system further and of as showing generator NO ground enormous a study NO addition GO is ability to supporting population the new used setting. the based if by our an consistently intermittent to successfully treating high treatment LungFit dose this there believe NTM for We home the breaks well world other be conditions of market patient development in opportunity respiratory as safely of

LungFit severe patients. for and we to to discussions pending with is lung the XXXX initiate course, PRO This, in due pilot the evaluate of exacerbations in GO, planning GO landscape expand LungFit currently infections LungFit treating To will a both FDA. late study are that COPD

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

pilot presented poster Week including Disease we positive incremental VCAP, in of inhaled Infectious month, data concentration from presentation the in COVID-XX, NO XXXX. completed Last study high at a LungFit PRO

events efficacy that the supportive treatment. LungFit show standard parameters serious multiple improved treatment with to data compared NO well with overall, was PRO on tolerated adverse treatment-related These no and

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

respiratory suffering As a conducted studies, of hospitalized of infections. viral million this under in already NO we've from concentrations per reminder, XXX total more four with a program, parts or subjects

with a studies efficacy. these have consistently profile of results All strong safety on shown positive

this with as we believe delivery especially to pneumonia, to important we therapy be as NO data, LungFit possible. any soon powerful of Considering a PRO remain can concentration market bringing high against And tool type dedicated COVID-XX. these

our include to over completed everyone XXXX to with two I the now parts excellent million an study, along other safety administrations per adult an per to profile. highlights give patients NO bronchiolitis like NTM pipeline, pneumonia And studies, studies remind that in at of several studies, with we have three would to XXX XXX parts to XXX excess million us for

In that efficacy therapy, of the the or the solid ultra-high evaluate in tumors UNO clinical our safety announced Moving Beyond affiliate, in trial Phase tolerated with dose, nitric to our concentration for and patients the setting. to August, private X late Cancer. treated patient was oxide we refractory first cutaneous maximum

seen an We of immune evidence are response XX,XXX low per nitric million dose that to the already at excited announce oxide. parts of we've

data in While announcing the XXXX. of first the still early, study We this half is initial from anticipate extremely encouraging.

immune survival high Beyond the combination vivo data Based tumor therapy strong of in present prolonged Cancer alone. possibility mice resistance. show believe UNO CTXX is assists Thursday, tumor-bearing NO we anti-PD-X regression compared with that that achieved will rates preclinical with this SITC and there in higher overcoming the in system conference the anti-PD-X study, on concentration anti-PD-X at which a will this

I a on and combination review of important such dataset believe potential clinical a therapy implications. everyone inhibitors, result, the checkpoint encourage with NO high could we breakthrough as full concentration As to the be Thursday. immune anti-PD-X,

point milestone. the last notice very make is an to from our Cancer One on a we recently Patent Office of that important for Beyond received allowance patent, US first

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

Duncan Fatkin

been productive as few The we initial for the to our commercial Thanks, launch off phase have of good of Steve. kicked extremely team Beyond months And PH. afternoon LungFit our the investors. past Air

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

team over that to respiratory demonstrations from the these which conducted report overwhelmingly at be to continues dozens feedback already the pleased very PH LungFit has XXX the I'm staff positive. therapists, hospitals, well our trained system to of of and

the far are cylinders. so eliminate motivated visited we anticipated, to highly hospitals As

the that COVID. the on time feedback increased is training most we since eliminate demands is system which steps common setup or the care, important run patient as addition, focus get have session to their and more In a when onset use, in pre-use teams is easy and we potential to simple demonstrate to dramatically on allow respiratory of especially the the offering

everything that release goal to the limited highly sure with Our controlled is initial runs smoothly. and make

hospital with six first optimized product is customer our our performance. that the staff Air ensure and months, closely to has Beyond logistics, nine to working service team Over

provide We for expect will to sufficient have a and these a month hospitals initial rigorous Air per of team. Beyond test LungFit the volume PH hours

also LungFit We're respiratory this success period. conferences ourselves to and raise and of local during PH awareness national attending up for set

throughout experience in for encourage respiratory perfect the key hands-on for to week through hospitals all some opportunity with opportunity. is premier we're Orleans decision fact, therapists, We have New from you attend if US from which Friday this the In tomorrow system. LungFit the for AARC, PH you makers our conference us the give of to

broaden to our ensure of that from effort sales in learnings of the the use significantly we our are XXXX. will We phase to the spring ready launch first

launch the phase, for start generated our the as specialists demonstrations our controlled on very commercial During we sales exciting both second completed the US. and field clinical time and our commercialization during in expanding journey is the our capitalizing will team, a leads throughout This period. be team we

expanded mentioned the FDA track XXXX. cardiac before our earlier, we on for an submit supplemental PMA as Steve to to of label remain end Also,

we around of will the for Mark be anticipate addition, CE XXXX. granted LungFit the PH In end

very to our our look which I'm have mobilized since approval I these first very LungFit the the months sharing been of our granted to we more The speed at early progress we PH have and few with positive in response forward in system. team. encouraged access field XXXX.

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

Douglas Larson

Thanks, Duncan. And good afternoon to investors. our

results which XX, are as XXXX, our September fiscal XXXX, ended quarter financial year follows. the on Our for second of

compared quarter with in On and the exclusively Cancer GAAP million September expenses development a due September Project $X.X almost for $X.X ended increase Beyond This fiscal UNO. is were million for XX, to ended XX, research and XXXX. quarter XXXX fiscal investments basis,

US. planned necessary well as administrative September launch Beyond expenses the as GAAP and US the XXXX. This a Israel, up to LungFit the attributable to for million increased $X PH is XX, fiscal in compared investments fiscal and $X.X scaling general September the Cancer quarter ended commercial quarter On mostly continued and ended support for to basis, staffing the XXXX million the both in to of XX,

fiscal of expense with income Other quarter million XXXX and for ended of for the a was the $X.X XX, million September XX, loss XXXX. September fiscal compared a quarter $X.X loss ended

in related quarter. If lawsuit a prior recorded $X.X you recall, year, we to in million a contingent second liability our the

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

our Circassia including $XX.X cash September to the includes a Net XX, in agreement. or during accordance which quarter by Beyond company, XXXX, million the burn, $X.X million with was payment cash Cancer, settlement ended used

During year, half burn fiscal $XX.X the the million. first been total cash has of

we you we like Since first in quarter. $XX.X would This out looking million point that are marketable future now cash started is will to the for I just cash company, step ways in have securities of a shift see to to our optimize a direction. commercial this that from inflows.

fiscal cash restricted million expect XX, fiscal start burn and we quarter. equivalents, still range to our to reported revenue and of our million. for in will We of million, cash average As the company of $XX.X September and be cash $XX $X XXXX orderly recording cash fourth forecast that securities, XXXX, that a marketable within

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

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

Steve Lisi

Thanks, to Q&A. Doug. go let's the Operator,

Operator

question [Operator from our Oppenheimer. Instructions]. come And first will with Kalia Suraj here

Suraj Kalia

the on Congrats progress.

would is your some could through? You're be of something you under us commercial Maybe great. seeing QX, fiscal effort obviously can help put the some guideposts you get maybe Duncan, sites these plan, plan How targeting or Steve in certain quantify will how of for into flowing So, that initial NICUs, quantify if this just many converted and in are for terms process evaluation? around revenues. original

Steve Lisi

Steve It's here.

expected very and lead feedback lead to you prepared the go. pretty a as The we And And process as is in remarks. this of contracts. stated going commercial we're it that in evaluations is hospitals months, the good, yeah, know. Duncan going that demonstrations everything's time takes So in as through much several to

So time. numbers quantifying we're on parameters of not this going hospitals to going we put think anything any that at to happen is or

leave we'll to discuss future those more So detail. that in for calls

Suraj Kalia

international LungFit Steve, you the partner. relatively all discussion advanced partnership presume stages I with for potential are of PH, in some

Steve Lisi

comes. stage upon I'm CE definitely to really be And talking we're we're partners. not which Well, it at, but certainly talking going to to we're when to people. hinged again, going discuss Mark, that's the

control. timely comes So, a in those of hopefully, manner, are things again, our but it out

Suraj Kalia

thoughts just to would Mallinckrodt with see perspective or all the your part, as are, factor XXX(k), the form to perspective at by And looks EVOLVE, you get I'd X the maybe indications is to Duncan EVOLVE. changing, submit pound my on iNOmax can to get automated in, love today. the love I'd jump from should and cylinder, love your the market be year, as get the on Steve, setup, your mobility Finally, given even they least it next side,

Duncan Fatkin

Duncan. is This

So, focus obviously, Mallinckrodt direction are the next obviously, plans I LungFit can't design. about reveal on But, generation specific I in. that we're going their PH. of aware for details will

opportunities of for by X other there's is won't because many Phase focus which the to Our so launch be our us. implement system strategy affected any

the and cylinders. air to will What those of is room continue features have that significantly desire than fact three-in-one say we of rid to more the use reinforced which even I get has nitric design There's unique whatever probably of reinforce definitely we the would generate our that I cylinders, to a expected. oxide, size been

actually I think that accelerate. continue and momentum will

as any certainly products and make market. new see see impact enter the the our from and significant don't we short to that assessment So, We'll term. in medium when

Operator

question next Matt with Our here Ladenburg come will Kaplan from Thalmann.

Matthew Kaplan

Congrats on the progress.

on launch. mentioned system? I some train Can expect over at zero trained therapists far. to of the of And respiratory his XXX wanted Duncan sense to in therapists you a hospital guess operate that respiratory remarks. terms your typical in you comments give maybe that each number to Just made of in so you prepared you the us would the

Duncan Fatkin

approach hospital because to I an evaluation. each think that it depends has what constitutes a different

small group, and So, be a there'll some some very focused will will on have team, very a particular widen that.

of don't number So, to the as want but hospitals, a share Steve number specific mentioned, we hospitals. clearly about of it's information

they depends And to get treat patients so, that data number on that of the trial the of want to they the to need the and progress. length

trained. increase as So, whole we routinely those get more more the hospital the of because presumably, it and will to numbers will need be And experienced, varies.

Matthew Kaplan

others The respiratory the feedback from so therapist, been the like far? in the guess, what respiratory therapist, beyond hospitals, has that and I

innovation dealing far, excitement. respiratory This cylinders, test so easy it's deal of what's appropriate. a simple there's and an to very their with great train service to And very we've There's set to There's customer therapists, is to step they of they're they clearly adjustment no the use them. and it change because as surprises have so to to But common, protocol find the think and most used our used is that for I rest up. beyond quick so a the that. logistics time very good. big

Matthew Kaplan

meeting terms you data, and some presented had GO for the you color of recent to Just at CHEST the data reception little the the the Maybe, patients? LungFit can the us you Steve, that to NTM a bit. give feedback shifting pipeline in that

Steve Lisi

weeks for. in the So, very enough? CHEST data were you of positive, want the At a was a Is begs after people period treat time? my data meeting, they treated continue all maintenance was there question reception are opinion. XX people patients positive, were we longer All good. presented. therapy it chatting the with There several to the the certainly, the out of number of large do were how see long for and, Can Obviously, excited. you there

with So, path that next half we'll be of year for in NTM. first the discussing FDA is what forward

it And everything's And, you know, what a primary is as to showed want now, endpoint would quality what these think, impact data pointing of well right as is to load. I wants as directions. they in as on right results, questionnaire, which a outcome, which positive nice patient we stands, bacterial strong as the a reduction. see certainly FDA reported life showed a on be in we see

time prepared point remarks, significant. my was it there in mentioned where a I As was

is what So, this to see. wanted we

XX-patient and and study, we good So trends. small results a positive study, saw it's very

So be excited officially. database, the data, there again, for patient, closed And helping that that and a study last of bit know, very cumulating just it, We're of you then, take analyzing we'll in a up. key will this be in as We opinion moving But interested the course, the about forward. August, us. course, are process everything, locking is leaders little last of then, closing That FDA. the preparing follow time. would

go I take bit that is it a but possible. faster, process could this little not So it's of will time. really a wish

We're So in little XXXX. up terms in bit get preparation and the lull we excitement a should going study have of a in for of around US. to the running it. that But next

Matthew Kaplan

study Last what pivotal of US, a thoughts viral PRO, that or in study there? the LungFit be terms planned in your acquired pneumonia question community could your are

Steve Lisi

study. the be. FDA have design see in size and what overall the of to we'll could the it of Yeah, agrees of terms think to the I study

And our have share information, we make we'll own it. determinations. we'll that when So obviously

a empowered we whether believe enough and be. everyone to I pivotal, be it such study, to it's but as will large as and You else

Operator

Instructions]. [Operator

question here with Our Greg come will next Fraser Truist. from

Greg Fraser

wanted surgery of I what potential about about the talk the you hurdles ask application. confidence your success in to the Curious regulatory if cardiac and kind and path could are?

Steve Lisi

I'll give it a Greg. shot,

path go need care to the of for and patients is to standard surgery when these they this them explain nitric the that So, FDA is to cardiac oxide.

you know, procedure. in hospitals the you'll that not As surgical their be need to during challenge challenge or they go it test, need a lab there's of if who patients world And in cath world. done for with nitric. is know the in the States, know the along just This the It's across in about the where but don't countries. approved. US, I the major or let's is except everywhere say of in around obviously, United smaller US, some approved available, outside it's maybe NO most the countries countries, may

FDA we'll for So see requires this have what approval. to

do tell – going that the you because And shortly. be hurdles couldn't FDA honestly We exact about the good put that's discuss to package when together. are with I revealed feel we really, I what this we

don't really exactly hurdles So we what those know that I have until discussion, are.

a actual having discussion submitting we're the application. to So FDA with prior

the will between So, our that obviously, quick actual of we submit very discussion hope supplement. the turnaround, conversation, place, a post take PMA for we would year. and now And that end and

kind of part we missed where the it. that's stand. I sorry, that's, So question? Was if I'm there another to

Greg Fraser

do say, do covered systems? and if But you to hospitals you some time label cylinder you LungFit like a use work, expansion or, let's with can't it. secure that, it no, No, label additional off they the PH some requires expect to takes related

Steve Lisi

everyone that whether syndrome, competing the promote the used than hospitals. for. used that to something we to I distress for have out LungFit is also just to used acute speak oxide there but can't products obviously. that for certainly obvious COVID It's respiratory for been or nitric it's surgeries, recently. not use have most for off-label I longer today It's that which capacity. It's look we there. they'll the cardiac we Obviously, Well, not in related speak can't in is

that is process vein source However, a the that's used reason could systems being another that cylinder in our or ours NO cartridge the at others create are same filled why be ambient NO, there's can't perhaps system in of NO in. with no competitor major has being used air, bedside. the chemical the Again, difference a other

to as the the our is delivered Again, the that's same from from NO patient NO the it is generator. cylinders

in go the up care up So I would there out present manner. again, for it and the same It's us happens of But, unit. the us. and for the intensive does, to not hospitals be that respiratory to use physicians, train it's all see think in that's therapists to that the us system, to systems not our is you it to the what just going beyond would And neonatal what really decide.

Greg Fraser

Cancer. immune the patient an on to just referring thought dose. dosed to you'd you at Beyond wanted I mentioned X response first was study? in I the about the ask that low seeing Were Phase

Steve Lisi

it it low was I didn't patients just the in say how many I was. dose. said

usually by So what these each patients a minimum trials, they're designs, of three three you level. so three dosing do at

at a on was I'm million, one, higher patients. the three seen I an to just haven't we So, concentration. on seen at or that parts at have it based patient this two I concentration what patients that have didn't only the yet. XX,XXX say immune per all. It treated the been I'm seen fact or have response. we date, commenting we've low whether at that was not certainly saying didn't say or if

Operator

like remaining any remarks. questions, Steve to I'd session. our closing turn no conclude question-and-answer over this With conference to Lisi will back for the

Steve Lisi

meeting for us demonstrating Great. we'll respiratory few AARC joining to and conference nitric year. of today. therapists New PH Friday, in Thanks, be Thursday Thank you of where And see the this at you. a the oxide I largest LungFit and down everyone, at tomorrow, the hope Orleans for

Operator

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

You disconnect may lines. now your

Beyond Air (XAIR) 8 Nov 222023 Q2 Earnings call transcript