NMTC - Earnings call 4 2023 | NeuroOne Medical Technologies Corporation

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the NeuroOne Medical Technologies Corporation Fiscal Fourth Quarter and Full 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 the federal -- U.S. federal securities laws with respect to future operations financial results, events, trends and performance, which are based on management's beliefs and assumptions as of today's call or other specified dates.

Forward-looking statements may involve known and unknown risks, uncertainties and other factors which may cause actual results to differ materially from those expressed or implied by such statements. press and SEC actual uncertainties differ. update regarding for results corporate risks specific that NeuroOne's release filings and information to See could cause as call over obligation Dave Rosa, undertake statements. With Except NeuroOne. said, to law, of such that the update forward-looking no turn I'll CEO by required to we Dave?

David Rosa

cough I nuisance, just advance, heads get and just apologize in up a operator. finish over everyone that Thanks, the cough a start, And for I it start have Ron to if before I'll to a becomes I'm trying call. I

thanks first and joining So evening. foremost, for us this

system XXX(k) licensing both our to today, FDA of development procedures. responded I they obtained clearance launch accomplishment generators. and X we decision the will the utilizing commercialization. We half that submission for release in a System, this and first company's product available, make relating radio the regarding has responded to in hardware a During is mentioned like regulatory last tissue to of quarter the with in components XXXX, the fourth application submitted an the which our we for commercial believe is we technology are our to for ablation The currently, future. June. fiscal first procedures for the are past reach past that a and what and expect for the company objectives We Monday, discuss this our and organizations these FDA significant FDA, that to with in interest that the activity lesions discussions strides through announced quarter of to had the most last in clearances. I anticipate for remain commercial their confident FDA-cleared we a continued for near indication RF and the functional frequency strategic nervous same we product questions to Once OneRF history, were nervous progress, creation waiting month. our provided would significant electrical clearance first device. I We system, XXX(k) responses the and is the the Ablation FDA that FDA neurosurgical tissue, recording in in of for to

open the We commercializing also directly it company. remain option we the to for if best believe device presents the

updates other the In be applications and may there of system, to exploring future. for in pain. system advantage further the take addition, able treat company the this We additional the is with market regarding opportunities to are believe provide we'll we

we open like fiscal now continue the We regarding commercialization this excited sEEG our but to company's business of Evo in months. seeing accomplishment are remains to continued electrode opportunity. I'd the recent We our to us device compete with sales major launch ablation only strategically product Zimmer product to well fourth on offering for provide positions and addition our quarter, and the system Feedback our not extremely increasing an to believe for update sEEG the with are plan. Zimmer of strategic Biomet. In regarding partner, that ability new to electrode positive expanded performance, consistently line centers. execute the the also demonstrate our the usage

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to drug delivery Moving on program. our

therapy's electrode offer sEEG I the potential might impact. as discussed ability to to the deliver technology as You genes to well drugs the the recall or for brain that record

Patent both the granted product States studies and develop a patent the use and for During clinical requirements, research, in by the were future United past and prototypes Trademark defined quarter, Office. we for

a with discussions company as discussions in well. currently in biotech with partners and their scheduled studies their are have potential our in interest upcoming other regarding contract device clinical using We

prospects the and therapy its neurosurgical may calendar to their also XXXX. with technology procedures. add an value revenue existing development, clinically excited If with but delivery are has the potential are in in of or how technology biopharma, this the We able drug it gene later our biotech assist industry contract negotiations, current to agreement the in year we reach

placed back with a efforts are approach similar paddle electrodes treat development placement paddle members cadaver able X-millimeter stimulation to Advisory to chronic our percutaneous place Board they Regarding electrodes cord our or cortical pain, a concept model. to utilizing very electrode were spinal a in successfully program a Physician of film but our X-millimeter and

notable In of year management And market histological fiscal full revenue for Ron? technology. Thank fourth paddle pain implanted time. more concerns. results, the other our your completed metrics. Spinal review turn a opportunity over and and potential company now to electrode the of a you addition, any without stimulation to XXXX financing a cord remain quarter XX-day I'd in-depth competitive given priority it Ron analysis gains, highlighting past we fiscal for advantages financial for and like our key a financial of and

Ronald McClurg

of of the for during revenue $X.XX compared the of year was Product revenue revenue represents you, in of revenue and exclusivity of agreement billion last $X.X in full year portion $X.XXX a compared to million payments full XXXX. The $XX,XXX the periods. below the 'XX the to of full were fiscal and million that the of fee company year XXXX million was had the fourth year in quarter for Dave. fiscal in milestone year, XXXX from $XXX,XXX Zimmer and Collaboration quarter and full and Thank development fiscal no for revenue respective quarter quarter derived the collaboration $XXX,XXX about a 'XX the the XXXX. fourth $X.XXX fiscal for slightly fiscal eligible revenue for fourth just recognition fiscal the and fourth fiscal product collaboration

million fiscal fiscal quarter compared fiscal the same compared prior year in in year. of of fiscal quarter XXXX with prior full fiscal SG&A expenses expenses fourth the the in XXXX compared expenses $X.X year. the prior to million fiscal $X.X SG&A million was the in compared million the for for expenses the million $X.X in of the operating prior year year. the million quarter 'XX $X.X fourth million 'XX period with fiscal year in were to were prior period. Total million in year. in were in the year compared XXXX $X.X fiscal $X.X million XXXX expenses operating $X total of $XX.X $X.X of for the $X.X of of compared with R&D fourth XXXX. Our the same were full the $XX.X R&D million expenses with full were fiscal million of million period $X.X

$X.X period. Our prior net quarter of a the million fiscal $X.X compared loss fourth to year XXXX net loss was for in the million of

full compared which consummated $XX.X gross XXXX, $X fiscal year net offering $XX 'XX for was an underwritten fiscal of XX a in in of million the net company $X.X loss the its loss the this million net For proceeds. in proceeds from million to common of for company public million of received year, XXXX. On July stock

company price sold stock under $X.X at of of common received the million. addition, the from net average company which In $X.XX an proceeds program per share the ATM

XXXX of XXXX. million million XX, XXXX. With of at back The that, as had September as million compared cash to cash, had the XX, capital debt compared investments XXXX. Dave. $X.X working or of end September of million outstanding of $X.X September working as $XX.X XXXX, $X.X XX, September equivalents company As XXXX, our of and to no will September XX, capital the of XX, fiscal company We short-term it I turn of had to year,

David Rosa

for at the think I Operator, can time, Ron. open this up Thanks, we questions. call

Operator

Ben first Partners. question from is with Haynor Alliance Global Our Instructions] [Operator

Benjamin Haynor

Congrats on the FDA clearance.

me, curious kind a commercialization, I guys regarding of for do it's go whether a just scoped off be that loan? choose sort if have what or you sales on might First force out out just activities how partner, to you was of and the needed through you

David Rosa

Thanks look that. reasonable when number distributor at terms really X accounts and a that in of the if about what's probably XX see handle, the that centers X. bulk you're take for centers Good pushing the terms we could is from of on hear doing at question, look many when It's they upper I'll procedures. these Ben. now you you. Sure. rep of What the a to you or end. how of sales And in are it,

like U.S. it's being the this many are procedure, situation old where about of procedures So hospitals a it's XXX, isn't of the roughly XXX. licensed of XX-XX the and of in thousands done the rule. about do XX% It's have XX% are to at that kind only centers. technologies the you

working we those They because the really centers. of with a already that what is adding going are are direct focus would to we low-hanging on kind a to start call the Ben, be a we've with think there could already already the distributors this had expressed in obviously and that and are And product no-brainer. of well, product already have handful that using product So centers do, the distributors would ablation we those interest to as and on the fruit. distribute converted believers procedure combination of top XX people effectively we're and us

Benjamin Haynor

you've reasonable. FDA just That dozen And folks, from received number following the curious now any I huge clearance. clinicians then such, a -- be feedback of half a people, on it won't to that that Okay. imagine in makes sense. fairly but and sounds And you

David Rosa

get is, to when have. a system, nice Yes, a is we the problem can feedback which

when we the bring our -- be for will is like what's the there's that will the device in plan And what's with enthusiasm and been So things for they're fact since physicians in been from to a ablations. really we've And interested last FDA, using cases rollout the up the submitted partners very supporting been field. device that. And the Zimmer building that available? the happening

board, the I and -- literally, they the were physicians on it's from were wondering to put already we mean, cleared, the gotten going system. when who out day advisory Monday, had announcement, that to get from I our e-mails able now neurosurgeons be So

because for in product exciting field. to get for and excited obviously it's interest see build, has I'm pretty and to into the works the this me of out the the been a while kind So this momentum

it's very I think to do going well.

Benjamin Haynor

helpful. That's Okay.

better March? color that Any Is first when so what them it than half? can have February? it And been Is April? get you May? on telling system? they

David Rosa

throw to problem physicians, that people there's a then when anybody, whenever a -- out Yes, the doesn't expectation. And the becomes date of to you that really disappointed. whenever make is lot you well, a happen,

what schedule parts are these perspective that parts to lead the generators XX-month is that physicians XX- from for told parts about March, are had we've those time. waiting to but in in come So we're a for due a

completely we're all some get on and So ago, has been in. know, And reliability but the the vendor parts dependent during as to COVID, quite just we not challenging. we ordered these a while those after of vendors,

say is become parts they available, Now making to going this be been the has in in news company in year, X those X they continue the the can first the we half can of has commercialization. those that's deliver, if feel our we're on months, consistent doing vendor product that. But lines when will but by to pretty for us confident for first until months, expedite when boxes hand, available the time good we're those units

will We not delay.

is they certainly that parts XXX%. burned commitments in from hopeful them been when before say, we are get vendors when all I'm but in, coming we've on and So

ourselves, this we're So product of the could a February, we we're that the the waiting the it's actually but full manufacturing have just January, few them that assemblies, parts, devices in launch we on. in that confidence generator electrodes,

Benjamin Haynor

the folks might or to to is trials of at that then in that lastly mean, me, That's their earlier for the And think to talk be delivery. kind clinical about that to what's What the contact right trials with trials? scheduled Okay. with sort of that stage I drug firm some would accurate? these I you're sort And on stage at? fair you're talking way then understandable now, point, just of and enough. presume the what

David Rosa

Yes.

So for a incorporate without device II a to my I, mind, has Phase it protocol. that be very difficult Phase done a would company it's -- then their kind in. that to be, change significant would That our of in

start something being companies haven't dunk, their FDA, because to been your companies early being are with And would to other to bit QX. developed, protocols now. Or we're FDA. but that for new expected a be with of very that the areas of then want started been brings to one So And epilepsy, the talking late is if the personally risk this to one. goes the And company it introduced? So the so it our given consistent is these evaluate looking The are with I are talking today. we're has those it yet. question studies ALS, to technology. this but that happen they speaking in product? another any technology a that is, is had really It's to companies done they're which unlikely Lou about, was QX, that, would me you Parkinson's little that's the that slam it be our I've is we're procedures change very, Phase kind protocol all was where added wrong, studies other Gehrig's where that that disease. then surprising this would

they want a bit need be versus cortical the the use to still type or to more of the may how would sEEG that it and about we procedure. that strip So learn for electrodes one, device, our little

Operator

further There I'd at over management any questions to hand floor are like no time. closing this back to for the comments.

David Rosa

on on we operator. System, And electrode believe our FDA has that We May Thanks, fiscal our set FDA We Biomet, the with handful actually XXXX. everyone distribution in remind we clearance just fiscal to OneRF just company close clearance product of well. FDA just the with really these, we extraordinary Zimmer towards launched of subsequently actually wanted commercially during made that progress goals Yes. a that clearance, I XXXX. for to line that received our obviously, for submitted partner. sEEG received for as Ablation

XXXX to and In existing company addition, without me, and progress regarding our our partnership contributions beyond has investors a even pain. I in continue system for all from sales, we the make our launched to new follow partnerships. In potentially institutional with coming you drug Thank continue warrants, progress. we electrode raise add have our revenue capital, and more drug a you, with did program also to the believe importantly, closing, implantable hope treat potential to ablation delivery or sEEG including delivery intended I back evening. and good exciting

Operator

conference. today's concludes This

your your You time. at you may this participation. disconnect Thank for lines

NeuroOne Medical Technologies (NMTC) 14 Dec 232023 Q4 Earnings call transcript