Earnings call transcript Q1 2023

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Operator

Ladies and gentlemen, thank you for standing by. And welcome to the NeuroOne Medical Technologies Corporation First Quarter Fiscal Year 2023 Financial Results Conference Call. Today's call will be conducted by the company's Chief Executive Officer, Dave Rosa; and Chief Financial Officer, Ron McClurg.

Before I turn the call over to Mr. Rosa, I'd like to remind you that this conference call will include forward-looking statements within the meaning of U.S. or respect which operations, beliefs are as today's with trends, results, and Laws of performance, date. and based call Securities to financial future events, assumptions Federal specified other on management's

statements NeuroOne's which cause those corporate factors, expressed update involve and materially by implied to may and as risks, press actual unknown Forward-looking results required uncertainties, may such forward-looking other or risks differ results from SEC law, known and regarding statements. uncertainties to filings differ. cause could statements. and no Except release undertakes specific actual by such we obligation for that update See information to

that With turn to over Dave call Rosa, said, of Dave? I'll CEO NeuroOne. the

Dave Rosa

your and everyone for today. operator, thanks attendance Thanks,

significant XXX(k) the received than first During commercial is when we about to for milestones end clearance Evo XX history XXXX Biomet our electrode fiscal calendar the sEEG with of in of days we targeting our that first synergies electrode. company's for FDA robotic the quarter, We're still Evo achieved launch. Zimmer's the platform, exist sEEG one between which the the ROSA Zimmer less use. most quarter using limited particularly a begin excited of

limited shipped launch. continue first market also Evo a during product full to for future manufacture order the company meet Biomet initial product fiscal to Zimmer The to release and sEEG the quarter additional orders

completed a the feasibility Rochester, progress tremendous at made in animal with our as OneRF successful also Minnesota. we electrode with We Van Clinic ablation Dr. therapeutic study Mayo Gompel Jamie system

to the of by brain electrodes. development ablating capable of confirm met recording that activity both XXXX. I'm report tissue calendar system and of our we the results the system goal using end is same completing that the year of The the also pleased brain

to performing our We validation steps testing. complete specifications is and excited that the final are system to our design are

target second remain quarter XXX(k) to application the in submit calendar the of FDA also early XXXX. a on We to

in and electrodes used developing for efforts discuss I'll that chronic be stimulation recording. our Now could

back chronic Our focus treating remains on failed back due to surgeries. multiple pain

to Our to that offer percutaneous an deployed stimulation energy lower electrode requirements. goal percutaneously manner and offering systems, comparable increased in conformability while a area, paddle existing placed improved be is can a

and already positive that key tested prototypes have leaders. developed delivery received have opinion feedback percutaneous system from We

The markets. opportunities potential discussions also expand company engaged with partners strategic are in to offerings and other exploring our to

is these discussions, there I pleased yet While technology. interest of our definitive regarding the see to in am nothing level

the for to well We the are as also potential continuing to or the patient. ability drugs the as explore agent's record offer our technology deliver impact genes to to

conduct to We the assess expect physician preclinical to feedback are feasibility studies based on device's date. to but potential, enthusiastic

Society. the also Epilepsy with and the of Surgeons, the company Evo meetings. American active Congress performance Neurological electrode following The presentations sEEG Neuroscience, was highlighting poster Society at of

booth the Our products were Zimmer the also Biomet and CNS displayed AES at meetings. at

We will an data in effort present to continue exposure. target to key our our society to increase meetings

during increased I interviewed well. to being the had of pleasure quarter show the relating And as Mornings Maria with also exposure, the on

the celebrate the was to Evo closing technology. to sEEG for stock company the addition, ring clearance FDA market In bell invited milestone NASDAQ the

attention. Ron? review in-depth financial for now of quarter over to our for first I Thanks time and to a Ron your the would results. McClurg more turn fiscal call like

Ron McClurg

Thank you, Dave.

revenue of of first fiscal 'XX. of in the of quarter quarter Product had of $XX,XXX fiscal revenue the the collaboration product was in $XXX,XXX We quarter in compared to of revenue fiscal of 'XX. $X,XXX million fiscal to $X.XX compared quarter collaboration in XXXX first 'XX first revenue first

XX/XX/XXXX. is derived recognition Collaboration licensing the development as and exclusivity agreement Zimmer of that revenue eligible of revenue represents is from portion the a for payment

quarter was year. of in same prior period R&D $X.X with the compared in million were fiscal expenses 'XX at $X.X first first operating million the Total the the quarter expense $X.X in in $X.X compared fiscal of compared year of XXXX $X.XX the in $X.XX was period million million XXXX. million prior million expense with the SG&A with quarter first the fiscal same period. in

the in of quarter of a first $X.XX 'XX loss to of At a net per fiscal $X.X loss or or net of $X.X $X.XX the 'XX. million compared share a first million fiscal for share quarter

fiscal investments As had of cash XX/XX/XXXX. The of and short had our company XX/XX/XXXX, the to most company $X.X as as XX/XX/XXXX, outstanding of debt $XX.X no term million compared of million end. recent year

to my pass Q&A. open remarks. to for concludes up That call now back it the operator I'll the

Operator

Instructions] question Nowak question. of with comes your Please Craig with Capital line first Our Alex from proceed [Operator Hallum the Group.

Alex Nowak

FDA are know waiting And we Okay, the sEEG receive Evo drill great. ROSA on commercializing after go everyone. afternoon, various going bits that to accessories electrode. to all be for was to Zimmer for approval Good done I some and robot.

just with So those XXX(k)? stand Zimmer where does

Dave Rosa

Yes.

Regarding they Alex and was receive required there that device was one bit Zimmer, did and clearance XXX(k) that the only a on that. drill XXX(k)

Alex Nowak

Okay.

there getting the roadblocks there reps the the barriers I watch doing So to everything to at end guess it or what is this next the sites pretty with trained or that barrier - field, in Or other getting out into any the getting or for of calendar that much less product go? year? anything there is the commercialization hand, the to Is initial ready is else trained, is up. more

Dave Rosa

the of Well, they're still accessories. procuring some

that to, mentioned, be all to weeks. of on you have the the but that this they the training, been terms time, anything sites like all in have or they in they training, things accessories identified, product but site in And next that shouldn't target the needs need that, six that the there be. at done of not terms in So other at really all holdups least plan the yes, regulatory that work house I'm aware field going yet, sites

Alex Nowak

is with they're debt robots. which so, go launch committed Okay, to understood. then Zimmer And ROSA to you've got the the and is ready the great. approved,

You're ROSA a stick months it cases, see next like, being do of think So lot rollout pilot the a hockey of to how we we do Is ROSA in you more think going this? think this a launch? cases about, launch? to a XX to we to used about should a be, majority or know, modeling worldwide of about just ROSA that to how within users, of bit going expect selected it be sort maybe

Dave Rosa

Yes.

a not S. worldwide The going be to only it's U. So is device be in launch. going to commercialized

So but OUS it rollout. clearance, we be don't have a controlled will

issues obviously are there the why that fine have. making do everything We're you So technology, we to - there's limited the that do with We any be on expect the experience to going which that to is months. that launch. is a I three first don't think six sure going based really be

goal very quarter. But for to least a And methodical at after would I first in controlled that, the it'll launch used be in all mean technology robotic be procedures the to expect then the procedures. in the the is second all I

Alex Nowak

or slowly in initial that the feedback, and into you've all that Is first intend their at to your together, initial yourself Zimmer point, the then be ramps? with that discussions KOL to they it their use initial with situation one-off electrodes of like replace had a kind electrode? KOL to And with do these sites using going

Dave Rosa

of the definitely of feel requested this definitely Zimmer feedback when mean, the but discussions the so where attend haven't was doctors that it. they it, we've on been really these sessions using feel Yes, features held able plan about and electrode in There the how meetings. select has the to discussion about in the itself - it, tactile it using have was participated on just no the I was I of was been, cases.

ever be would And had ever reason of of that no There any the electrode. to electrode, other any over use up heard I discussions in that came our in least of. participated none at or

electrodes are to of being used the be for sEEG So is that today. replacement this intended all a

Alex Nowak

Okay, using more questions is you've that's capital. the two some to know some just the strategic you any was the for regards update? the use plan you talked second electrode? great. generator I any there for in question past. And partnerships needs around with the capital, first product there about then just Is then that on And one pulse that update just potential

similar to through a think about capital about come could non-dilutive that? how it whether have we And Zimmer you also be partnership? think and to Just there something should be, where

Dave Rosa

part Yes, first. the capital so answer I'll

mean there's been say course but we're ablation XXXX, of to in the need yes, We'll going interest about. some I regarding capital, technology. the just at talked strategic point, during technology So that that I

obviously, discussions there's generating So, here other those the the not, of goal is option. that's non-dilutive to be first. are first happening ways capital going if And to capital. always And explore now

I forgot system non-dilutive We can focused as in well. the your raise always question have our And first really now that ATM We do capital, have. in right a interest are ablation of but the because sorry, But we I'm capital on efforts was. an what place.

Alex Nowak

okay. That's

for update chronic pulse around the any Just generator use?

Dave Rosa

same the we that options still had have. No we before, mean, I

So are the can there's on to intending to But so negotiations to the with in connectors communicate anything the electrode that really further designing use. have like nothing nothing is the now on working with start or we that electrode we're we What new system that. addition that.

Alex Nowak

Appreciate you. Okay, update. Thank the understood.

Dave Rosa

Thank you, Alex.

Operator

proceed Our Global your next Partners. question. Ben of line Alliance Please question comes with Haynor from with the

Ben Haynor

for taking the guys. afternoon, Thanks Good questions.

year? is quarter this Just end by you launching check when was end calendar one the wanted launching to it of calendar say - Zimmer this thing, are did the they of

Dave Rosa

It be will quarter. not be this would calendar year. It calendar

Ben Haynor

that right, making just heard I thought I okay sure. Okay.

Dave Rosa

Don't scare me.

Ben Haynor

Okay.

it, I misheard And that can the end? kind and product apologize. you've the implications on manufacturing any you that of got your sEEG maybe then, So I for that forecast electrode - characterize on has

Dave Rosa

has Yes, of that I We're so comments, manufacturing year. right rest XX for I forecast Zimmer said have months. us the mean, units we over my in given the now actually the next as

is what going capability what So manufacturing from is where I'm you're sure it or something in the impact not you're wondering if different? - like a you're is that essence

Ben Haynor

- of that to you've - I characterize maybe that outlook to I trying know has least Zimmer is product then mean, the just activities has mentioned way yes at that at or side? get increasingly points favorable given undertake manufacturing you don't on the aggressive, their right that what know, that have or kind is, or change you to historically, Well, changed I negatively? positively And been - what But it. at does getting the any forecast in historically

Dave Rosa

forecast that. to you demand that the think just to always be with able I you Well, but supply your or have, have beyond not chain being meet, concerned

So that we're supply doing. a can make time been what with we've chain sure lot that to exceed they spending our of

few has So technology ago. in I their a attitude, always we time Zimmer and about this the contract Zimmer years been excited signed of the think terms from

the I to excited as is get mean remain in robot. synergistic with they all their as discussions, them I going least at this are. just with really technology And the that's have we

really I would there's no say So, change.

waiting been of us I been think of this the in excitement hopefully show. over year next there's be the months, couple the pent-up able last for we'll all that and start to

Ben Haynor

Are meeting special mentioned plan then couple with you've that been here. you got anything the of show And around or you you share? coming AANS there to U.S. sEEG planned launch activities or electrode any that a can privy Zimmer months that at the you've up

Dave Rosa

don't are show of know that I for plans outside what Yes, the exhibiting.

think we out have go don't to especially to doing many controlled when too careful I a be you're on time. bring you and at also one try sites that launch

when supply of to before make So but need and we that that we just everything's yet. make sure methodical a said aware sure need I'm to we going way it's we product to, launch, be that as I the walk nothing we controlled a full where performing launch, it have earlier, very there's the run

Ben Haynor

What's Okay, months a be of couple R&D to animal beyond of kind then the there? the going here and submit it going project, no the in OneRF problem. - sounds on to it. couple like a additional testing And V&V you're

Dave Rosa

it's really documentation I and that not it's Yes, mean, trivial. beyond

mean, to and completed, say, that be of not trying But behind some we've additional through the studies. testing of these behind minimize development done, us I once gone and heavy we've us amount So lifting. the trivial. design it's because just has we the got to feasibility let's not I'm the

and technology QX. will where to mean, early feel in at be that, good we submit sometime really we're I the we about able

months, unforeseen encouraged the anything barring doing that's few DB and the last there's mean, been are testing. so with that we've I could come system Now really up. testing always performance. in this I with of But something far, mean,

Ben Haynor

with trials is the And revenue you record, and and you great. how on Okay, generate I drug drug know device use delivery could but some that quickly you plan for associated stimulate research device? actually can mentioned a only there applications. revenue that near-term that preclinical could that something study, be for such then

Dave Rosa

scratch from over not develop you're like it's Well, to this. starting

Now an if what to is you to that design to trying But to own drug the the obviously to really with have this shelf we were now the to would going we're off to drug pump, leverage do that develop able pump. time. your do the be system add

the have consideration revenue, expected an that to are some you extremely in term it define to you depends we only deliver term. be process. in not this because dispersion take even drug there on things can near near drug that is we've mean we backflow into efficacious PMA an I terms So I on. development with done long how to of mean and sure that initial But make testing a have way

the that can. timeframe, no, have this we don't for a really your think have would X benefit. it if ready we'll not that, here we feedback I is but So but expedite to next that is clinical the generate question I is months, as the be as Ben to like research in goal revenue place think could that also have quickly only do it studies, And in

place, be intending to to that actually inform the this see with impact a a the surgeon to And a not it depending reaction thing drug remove device is tissue. you So deliver to tissue may do theoretically good may brain remove. lumen could that upon the neurosurgeon to the through this particular and the the that drug, in

XXX(k). with some definitely investigating what with not a do can clinically proceed to can therapeutic well. or there's as And this we're benefit we So whether this

Ben Haynor

Okay.

then on agreement? So And be partnership me, near stay kind lastly in term on there. anything regarding potential of cord, electrode, we the still lookout for the there should for for spinal maybe a tuned the

Dave Rosa

any testing you'll because we're report I mean that, on I we're there's in about discussions that is to I think strategic this really can't things time doing reports additional but some just how see as and and I move to particular it. continues like can But about do time. going assuming going take at it some Yes. that as a preclinical really That there far talk possibility, that's nothing forward.

can't So that. anymore about really talk

Ben Haynor

Okay, progress. the on congrats Thanks got and questions taking the guys it. for

Dave Rosa

Thanks, Ben.

Operator

turn the of now the have turn remarks. question-and-answer Dave to end And reached we for I'll - Rosa call the closing session. And over

Dave Rosa

progress. today. Please I the stay just want again to thank tuned for joining future everyone for call

Thanks year the I this that it's an going we've to evening. technology a think have be we again really year think to exciting with developing. and good new been respect

Operator

time. And disconnect you this concludes for Thank today's conference. And you may participation. your lines at this your

NeuroOne Medical Technologies (NMTC) 14 Feb 232023 Q1 Earnings call transcript