Beyond Air (XAIR) 13 Nov 232024 Q2 Earnings call transcript

Good afternoon, and welcome, everyone, to the Beyond Air Financial Results Call for the Fiscal Quarter ended September 30, 2023. [Operator Instructions] And now I'd like to turn the call over to Edward Barger, Head of Investor Relations at Beyond Air. Please go ahead.

Thank you, operator. Good afternoon, everyone, and thank you for joining us. Today, after market close, we issued a press release announcing the fiscal second quarter 2024 operational highlights and financial results. press the be News this website, on of under www.beyondair.net and copy release found can our A Events section.

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

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

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

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

Lisi, on Lisi. Steve? Larson, Commercial Chairman today are call Fatkin, Steve to with the over Financial Chief the me that, Duncan call Officer. And Officer; Executive Officer; Joining Chief and Douglas Steve Chief and I'll turn

by highlighting press guidance good and quarterly today. I'll revenue to today's everyone the Ed, afternoon call announced us Thanks, in earlier joining we release. our today start

time for providing $XX XX, is For this the impetus in anticipate million year revenues. XXXX, $XX we at The threefold. to March ending fiscal guidance million

to hospitals of length confidence and in support of supply by chain users done First is with work the our system. for provide our PH teams the commercial great and

the the in contract October; which our to announced software, Vizient third, September. approval was and granted we an FDA of update in Second,

as production up new entire will end machines of fleet with the significantly be well anticipated demand. systems by to January of Our of meet ramping updated

Looking of to partnership milestone we In the We year. which Pacific announced early for Healthcare Mark payment commercialization PH occur outside a LungFit the to Japan. CE U.S. expected once Asia a received, of is triggering forward excluding is September, next in look with Getz region,

very company We the reputation pleased have of the endorsement are to Getz. with a of

Another recent PMA is LungFit label to expansion for cardiac our under achievement milestone surgery. the PH the program of submission include the

half and on positive we regulatory and clinical a commended putting is to look beginning a Our team our be strong impact to XXXX. for of forward fiscal the back revenues together in submission,

an programs. in other ] At the Beyond [ the administration last [ Phase have presented X- ] patients, oxide. tolerated. X of million our XX,XXX to average nitric first-in-human all treatment The each line conference study, failed per of on In X-minute week of from X treatment whom regimens, received intratumoral cancer safe SITC to trial. Moving prior top Ia was parts this San well data Diego, and

cells macrophages up-regulation and such very while was is effect and animal immune regulation key T these cells, have MX central seen similar memory of as to suppressor over effect we the mononuclear in cells clearly T were that XX-day on T cytotoxic immunostimulatory would dendritic regulatory emphasize of with an period observation Additionally, biomarkers, I to biomarkers myeloid-derived what like shown. studies. cells, the evident cells, down

done EORTC data survival regression a have significant UNO of efficacy positive XX at Therapeutics, multiple with respect monotherapy models. pooled cancer checkpoint presented last X demonstrating XX,XXX years with as studies alone. UNO with combination plus multiple XXX,XXX tumor the shown treated anti-PD-X tumor over or molecular and survival multiple Conference targets published benefit and was anti-PD-X million administration studies minutes. single nitric versus consistently well mice oxide a Cancer to for on Also presented inhibitors or Beyond with a This X as International statistically in animal during in Our analysis per in with and the preclinical of the quarter,

was of in Ia Additionally, the program data cancer's Regression XXXX. to excited article in sharing progress an Rates from forward manuscript Journal look the the We're Oxide Mice. data study Sales Tumor second Nitric in UNO Anti-PD-X Intratumoral titled the our High-Concentration and Improves completed Tumor-Bearing Phase and in CTXX published Beyond about Treatment and Survival and Administration of very

you II expected regulatory team Phase cancer XXXX study will XXXX. before Ib be as I about that and for also in as a on website or authorities the tumors. Viral therapy study begin initiating solid is this Cancer is to Our underway. those from FDA suffering potential Phase get visit encourage educated transformational other well pneumonia to program Beyond of a the approaching to community-acquired all better year-end RECAP

seasonal nitric Keep this days. X already As for reminder, parts we oxide a million pneumonia studies demonstrated study treat fall to pneumonia, to activity, the randomized, hospitalized winter months. pilot in and consistently have XXX up double-blind, a viral per viral Due treating will patients running completed of have this X safety following through patterns efficacy. intermittently and is which with both seasonal placebo-controlled mind, study

of hospitalizations worldwide. announce over and Viral more States in to medical unmet XXX,XXX data result, XXXX. XX is line and top a significant year United the by pneumonia middle As calendar we a than with need expect the million

of conclude program XX on In the autism Let in a effect track is data our newest University in my produce to injection single extended-release formulation. of human partnership by to showing Recall for new that least therapeutic that a announced an days the Jerusalem, we on at September, which after me touching XXXX. data. is of this with remarks treat have to publication data opening continues Hebe preclinical exciting

the we the associated show phenotypes additional forward and a autism, data Just like university. daily to of data reversal the injection, with look behavioral from

for commercial a Duncan look the closer Now I Officer, PH LungFit Fatkin, over will Duncan? to turn Commercial our the call at Chief launch.

investors. our good Thanks, afternoon Steve, and to

revenue of PH. LungFit Since LungFit fiscal have Steve for for XXXX. we given PH we last using guidance doubled As we in hospitals spoke have the August, than more mentioned, number

with I metric to customers, NOX the our QX, customers. with shipped quarter would to share In you shipment fiscal approximately Another filters of we XXX our like first is filters.

today, that clips the September and During in customers. we're XX, shipped ended that quarter October number which reporting filters we X,XXX our to XXX over alone,

expect acceleration on software approval gained We limitations recent the of minor and updates software approval FDA. Based by for to that sought the for address LungFit continue FDA usage. feedback, this PH we given upgrade hospital some device on our

I in to of recent in confidence separation a We make the that further between and the LungFit statement with our can of that the Care Respiratory expect marketplace. updates American week value PH experience given increase place our these competitors took ago. Academy

more revolutionary volume. billion customer achievement reporting accelerating our and we annual improvement represents technology growth for in This stage our largest of in company. at confidence been innovative validates group us have purchasing recognition U.S., gives time. the that provider-driven the that approval is the health than from technology for the contract positive $XXX This award care event largest purchasing in this nation's in some representing our market a the performance organization from experience Another Vizient, seal feedback

like emphasize clinical PH care, worker has to the may the care opportunity expand would contract excited our to qualities safety, enhance innovative technology network. I Vizient safety members operations. an reach unique that Vizient that LungFit We patient are by signifies very to through health customer and the this that business

As field PH on the broaden opportunities over reach. year based we our growing mentioned interest the out LungFit we're building and previously, a as developed team the past in

the system of our surgery. anticipated as a build, months, majority revenues contract, of PH expansion updated continue XX for the next afforded team capitalize the the the the sales opportunities Over label to expect we approval United on LungFit increasing by Continental States our and cardiac across the Vision to

Now I'll to over turn Doug. it

Thanks, Duncan, afternoon, good everyone. and

the million primarily for as $XX.X with fiscal stock-based compared our $X fiscal an increase for million Our The Revenue with the long-term XXXX. million The associated fiscal fiscal fiscal fees $X.X essentially, a $X.X the XXXX. are the compensation remeasurement and ended and quarter was debt with to of was million were XX, only million September expenses million derivatives the saw the loss the financial XX, costs and to quarter the million in million associated moving by development a income compared quarter September September XXXX. true-ups due offset non-product increase gain a follows: to quarter salaries with for fiscal results for related were SG&A stock-based warrants $X.X fiscal with the additional gain fiscal million $X.X the and zero for and was $X.X development expense of ended for offsets interest lot compared partially ended compensation, September professional mainly showed XXXX. quarter and parts, our for from $X.X pipeline. September we as XX, ended expense quarter XXXX, XX, litigations. Other with due income There's ended quarter the Research but compared the was interest quarter for salaries. $X.XX expenses XX, roughly fiscal quarter for

XXXX, payments, recorded loss to compared $X.XX $XX.X quarter $XX.X $X.XX was fiscal million, $XX.X quarter million which September in XXXX, $X.X XX, XX, million, net XXXX. Net per fiscal the For million in or quarter of ended been share Inc. net the onetime ended cash with the September the ended Air, accrued. of attributable Beyond company and which had shareholders XX, a disclosed previously a of the of $XX share loss for was used million a including or September

one-timers, which burn of was from million $XX guidance quarter line Aside in million, cash $XX.X our with in these per the approximately is quarter.

had of hand with XX, September to XXXX, marketable of As that, and cash Steve. securities back restricted call cash, the million. And I'll equivalents the cash, $XX.X company

Doug. Thanks,

may you We will have. any take now questions

[Operator Truist Instructions] Securities. Jacoby Jeremy of question have we first is The from

and delay what's the approval? this Mark give then you And how takes causing CE you just puts the guidance got us Can your range? on to in

likely is our by not not this is just So We're CE think come that. after control. saying coming delay Again, not will the not Mark more of in in in end We it's December. control. it's it our approval

was I driving it with respect the So mean what's to straightforward. pretty guidance,

as compliant to software for nitric this devices main some our some important our that You tweaks well from out oxide upgrade. for we've to is there systems are different performance. other hospitals to for quite for, of go gives that be system, got This system, visibility have been time. system into FDA this the optimize lots with which the a to upgrade Obviously, waiting us ventilators, be as ability we on so being obviously waiting

is have on that deliver us critically for important encouraging our and with Vizient we which feedback of. we're GPO now potentially to ability existing the market. visibility is to from into this respect get as a very the again, in that customers part We And customers hospitals are service new on side, our

So confident I question. in your that highly feel answers range. hope We that

question is next The BTIG. have we Thibault of from Marie

that want seeing October us number, mistake which the of reordering can impressive, as to Maybe don't is bit you things and then you'd anything quarter, approach. appropriate they for filters contracts? the that more the are the a then to make I that Are prorating stocking the understand pricing of very What's of ramp. stable about great along Are -- in cite filters, how staying when shipped. with expected? to wide big gave on folks Are is to the dynamic, what terms you if sort ramp entire they're detail shipped, of range? that's try but over sort think And typically a a little these needed? bolus I there are Thanks about

Marie. Thanks,

we our deliver of There's be stocking, look will doubt, expected. the every a I past range of change. going it's that plus, all what the pricing it has chunky. on In kind it's want but on in not and price the so filter think opinion, expected. not monthly stabilized basis, if much within that's but the to month. over you to no we've within that expected as the range can It's the market X is for the pretty everyone, it obviously, ranges, year hospitals Yes, some

there's obviously interim will every quarter, look there. Some and

out, sooner, us call on So and if a basis. quarterly they're thing they running the they'll do monthly, same

these know So get to on things depending with mean, I how on I hospitals. guide we the to how contracts with will you coming respect October more move don't number, obviously,

there in you we in trend, obviously, really put customers to that is that out this a there show of So usage and that number upward have. just

sure. for That's Yes. helpful

guess I fiscal have then And the Okay. glad to my guidance. follow-up, 'XX

for us drivers are list, so list How on like Vizient time these that, of help could like earlier to of Some sort approval. the of there look one think start at new to think They XXXX, could drivers fiscal when start or the like those help to ahead of the times folks that start GPO vendors about maybe they software points thing. about kind adoption to of their hit? seem of

for take things Thanks these And Yes. time. that.

came GPO takes hospital a X X with of contract Vizient So middle It to to months October. roughly. average on

So have specs things process ramping it will pretty that up months, few for III the that much you systems well that's just overnight, see which medical will to improvements the the be happen. doesn't the take Class with our time in come in heard plus happening a frame our happen software is completed you upgrade as remarks we'll that need the a system This It's existing why January. up or now, and the of to device. all new prepared market systems, but as we'll

that about the I March So you're going Feb, looking when time yes, think frame if events. happening impact from you're the mean, see to it Jan, at way, things these you towards major

we from Sandler. question Bednar of next have Piper is Joseph The

This is John I for question. the Jason. Yes. appreciate

So of just cycles decision terms a curious current processes on or how quick right contracting just differently hospitals environment? in be the in partnerships now technology. of might in conversations or And with else embracing forming are any follow-up. general? Are seeing note Anything going the new hospitals then how you to lengthening slower behaving your

pandemic, are I the still slower in think and is or slower are for don't what the in in Things going little them. than I we're things bounce Okay. fast supply of the that any bit mean as hospitals in post post the a don't mode. I pandemic, world the mean, back normal chain world. hospitals

to were back what aren't they things prior. So

-- why hospital. months it's the So out X looking X done that's you're to with things to get

going year not I or probably that's going really forward. and it's the don't change in past think So changed so, to

I'm another your was to part there So question, sorry.

Yes.

in or So of terms technology. of in your might how forming terms hospitals new partnerships behaving embracing be differently just

Yes.

think new -- hospitals technology. support we we prove had look, things Again, them. technology a This for to part the is these I time. embracing that the to it's is, take to normal can life-saving ourselves

can't And in overload not or that to had we've year and a be crisis be or last so another could able more an critical hospital situation and that obviously, forth. they to over them why may a in those and kits guidance the or need, proven we we've you more X need machine They support this sure where that's or of plus, the So they support major have them provide of at time periods. part given our filters point.

curve them with one So the the other work -- optimization from of us, compatible confidence of based being across a the offerings all on is and across is of system in our obviously, number is all the companies. adoption ventilators event things, to one,

things, critical are and X then, obviously the these course, So GPO contract. of

took time move need, mean that we that, that's is we these complete, we forward. things feel timing to and I and and -- we're now this what can get just on. So the through

So show to be milestones be we're X of taking with here as hit after optimization that, we to this that was we comfort the again, first were period respect to where we share, We've period certainly learn you the happy significant the our comfortable was really to I getting of share, we'll and taking share. taking ever something system out we'll the that our that think that are the think hospitals. and in X guys months time conveyed market was to And us. us and get hospitals don't with

than faster things any we I was curve think in could going are. where it Maybe favor, So adoption be few the where a we saw. it's a different are been but just to have with don't that's little what just today. we our falling

Steve. a that, state? potential interactions off of customers in Are gaining your comments you any about as competitive with Appreciate across line then seeing just great And struggles pickup of there the share. or interest result piggybacking

made our is week, from people decision our we doubt put weren't very mean, competitors, that there have Absolutely, sure clear And guidance this wouldn't had coming our with certainly clear interest system, call in best anybody out it's were struggles there. There's many and respiratory that our increased I'm there, the to out. mean too that it's overall. in -- there we conference if system, XXX%. that was I in out no we and increased with doing Nashville are but big this this that we I business way. there on or some there's it's system have put interest there. last careful us, guidance

we Matt Thalmann. Ladenburg of question next Kaplan from The have is

get granularity the to should new see perhaps inflection we to of with wanted -- that GPO should in the respect When to to and the some translate a in you're should increase guess, the that of software momentum, little contract bit to Just is in seeing have filters. respect And impact October start when revenues? I more revenues? with to an does terms terms start to have the starting have something see in on we're of

Matt. of this took like months place Thanks, to I in events, X mean I feel it's -- September X to the which about October. and impact these is said,

it process. up because X- going expect takes. a but just Feb, to is I over there tell to us, could will wish a month, it quarter, Things but quarter looking the in to magnitudes X-month be September we and I time progress I were be just the quickly. So think don't significant the going picking time this do the in you're December it is reported, up. wouldn't that massive this contracts that move when Jan, March December I frame I in be opinion, to you're really volume you, sooner. see wish picking bang-up is our

would Feb that in we numbers we're put time us frame, say comfort going us that for going we're do to the give up would and putting you what So March do. that Jan, confidence to

you helpful. contracts? that and Okay. do chunky the as No, GPOs should think of additional and think you kind additional would that's of Or kind in And we ramp? be about revenue increases get how

going Yes, coming contracts predict chunky, when it's certain I I Matt. up. mean be to can't

to up. X I be control. hospital be combined. X obviously when could they're small. that are and our month is contracts respect X issues The are X timing on So could hospitals that's something those with Xx just these next beyond mean And that's new

-- not taken as would account, get We'll basis. forward. for X give either Hopefully, we'll in go as I'll or this have you I out clarity why difficult. model, difficult and into report as a why to better we smooth how guidance it way when. fiscal or may chunky and it to hope be that's our quarterly that's be 'XX give on monthly better But very very we like So predict it's able June XX, XXXX, and now, but putting next be right February we're might it's clarity when to because it more we've that we're details the to doing quarters. March and on

on What you study? complete helpful. [ when And that ] CAP then just X do started. That's hope to your you that pipeline. show With question the the study you

already X in No, in X the we've done X infants and the adults in during pneumonia, pandemic. studies

there. you're you much see what pretty saw So to going

you'll pilot I published see the you efficacy well well, primary on as be studies. endpoint will endpoints be the endpoints the And They've tolerability. our as have in have conferences as at them course, see other to efficacy safety, we been of of to saw going same website. journals. mean, medical our will then safety, there study, You're which

thing. So see to you're going same the

time nitric this see if in fifth have to done these than be it. faster improving general. going oxide Again, will don't they patients we've You're the

I So I if be X. X, probably going would go anybody for X shocked think mean, you to you're X go for

a results, take to our previous know coming. want what's you if So you'll at look

follow-up a that. just So on

study or to pivotal, take this you to to a generate is of you clearance that can show? to goal the hope data FDA is what get to So

study. registration States. registration final study study Yes. would go in correct. This a United be a before we The be the into That's next the study will

at the to further I closing to comments. over no are back There questions like would Lisi, this time. turn floor Steve for

here, Matt our everybody, We outlook. guidance program. pneumonia Thanks, very excited question, for on as out last our And we're have mentioned on positive joining Internally Yes. that put the there. we're about today. wouldn't very

seasonal note Just a It X last that. is on condition.

studies So move quickly. do these

with and to I again, talk will So that, thanks you say soon.

This conference. Thank concludes you joining for us. today's

now disconnect may You your lines.