NMTC - Earnings call transcript Q4 2021 | NeuroOne Medical Technologies Corporation

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Operator

Good morning ladies and gentlemen and welcome to the NeuroOne Medical Technologies Corporation Fourth Quarter 2021 Earnings Call. At this time, all participants have been placed on a listen-only mode and we will open the floor for your questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, James Carbonara. Sir, the floor is yours.

James Carbonara

Thank you, operator and once again, welcome to the NeuroOne Medical Technologies Corporation fourth quarter and full year fiscal 2021 earnings conference call. conducted its company’s Mcclurg. Chief be Dave Executive will and Rosa; Financial call by Chief the Officer, Today’s Officer, Ron

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

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

Dave Rosa

welcome and operator everyone. Thanks

Evo our to diagnostic During our well great quarter, commercializing fourth progress we make our Electrode sEEG as efforts line. continue technologies towards for strides development in the our fiscal product, product therapeutic as both second

through a lines cortical Zimmer XXX(k) quarter's Biomet diagnostic distributor. As reminder our marketing call, EVO product last as FDA clearance electrode are for from we have the and currently, exclusive

quarter's FDA the product September with time, the platform, Zimmer less relies than and received, product be than agreement. XX it surgery for end, additional our high include for been ROSA similar in extended for we by diagnostic brain we place decided strip invasive Biomet XXXX our also Applications less This company clearance opportunity for for we of submit line their manufacturing the hours will and when last calendar less and Our areas from fill product XX that submitted and activity, procedures recording XX quarter I'm to procedures and activity, indications invasive for brain the as We more conduct November due the than from that sEEG use sEEG targeting XXX(k) use pleased at portfolio FDA epilepsy monitoring their clearance to has begun. represent the the the and cortical surgical of electrodes in product brain grid, pending as film XX during smallest problematic clearance to EVO implantation that call and were than diagnostic identifying less At during to year mapping sEEG cortical our are electrodes it represents for EVO commercialization I tumors. of stimulation, clearance. on mentioned electrode definition thin technology. intraoperative received testing electrodes recording a brain for to line. by initial today, end day stimulation, the to our expected application than FDA begin of as robotic performed is If and orders first electrodes confirm to development to has of monitoring bulk have orders. of used distribution has begun placement. this included already FDA hope days. to This for is Zimmer's XXXX. for less days.

performance from the Biomet Zimmer As payments milestones. a to additional has on reminder, the company receive certain based opportunity meeting

by previously of year the fourth animal of targeting system, the we reported Moving in end potential feasibility to complete completion ablation the were therapeutic we project calendar to with studies the had XXXX. our quarter electrode

one using and in Combining outcomes. seizures. brain to improve the two and due therapeutic or same to to these a activity device to patients time, is save separate tumors both the brain system required As patient intended that is brain visits are contribute Currently, that designed the hospital seizures being and to oblate to diagnostic treat reminder, both have contribute surgeries functions record epilepsy electrode. tissue money, and potentially

radio a the to RF generator I'm to agreement that to our leader a customers. and system RBC We also of our the offer and intent reported generator. report market previously our therapeutic both pleased both partnership Innovations, recognized to complete electrode we frequency to Medical a manufacturing and signed develop with therapies development manufacture in electromechanical

We University study of Gross, feasibility Georgia. with assistance Dr. completed the Emory a neurosurgeon an in also animal Robert successfully Atlanta, at

to other used apply for is potential also would failed back for mental would or disease, a and on electrodes conditions back be progress indications surgeries, that the that continue permanently -- such implanted electrodes. testing as Parkinson's of pain epilepsy, requiring due both and/or chronic make This health We for stimulation. our recording OCD/depression, to

initial initiated report the on next company The results Our over spinal cord to the market, and represents in currently the durability target quarter. stimulation long-term U.S. to which focus in quarter billion the third $X fiscal expects market alone. is testing

the development higher electrodes might well be applications for on intelligence. work continued of also We definition artificial useful as current that as

and the those and devices have we Mayo testing results. We for look Carnegie updates forward receive University sent as to Mellon Clinic to providing additional

for In of company for fiscal quarters, presented and American post-market the company the at of third Neurological generate focus and has Conferences. area Epilepsy Congress clinical data Society support been the the to to Another Neuroscience, our the Society and Surgeons, effort the pre the technologies. fourth

full equity call quarter our like with In addition, I results. a also gross now fiscal more end. of financing year in-depth would we to fiscal Ron the of $XX.XX financial after turn year proceeds for successfully review to over fourth Ron? million completed and an our

Ron Mcclurg

$X.X million in $XX.X million in portion prior and expense year fiscal expenses revenue XXXX. loss the SG&A year. $X.X the fiscal the $XX,XXX million year Total for fiscal for the year. of prior for compared and was in in of year collaboration XXXX. a with of in to $X.X expense in year XXXX year $XXX,XXX the in fiscal SG&A Dave. XXXX. $XX,XXX $X,XXX full million in of $X.X all were full of a Net revenue fiscal was Collaboration in loss all $X.X year compared XXXX. the with of million XXXX you, no is product $X.X prior fourth the revenue fiscal compared million for the was the period. million compared quarter expense XXXX $X.X Thank prior $XX.X quarter compared Product and fourth period. to fiscal revenue million Collaboration for development fiscal $X.X revenue XXXX the of million quarter of compared XXXX initial the XXXX was year fourth fourth represented the fourth $X.X full fiscal fee fiscal of the fiscal million was from for were revenue prior million XXXX for fiscal quarter same that million million period to $X.X R&D Net of upfront with loss all with compared compared the to development in quarter quarter for $X.X net the recognition September operating of in expenses the of million R&D XXth, XXXX prior $X.X the XXXX. of period period. fiscal and quarter of the operating the eligible to agreement fourth was million was as same payment the was Total fiscal for Zimmer XXXX full $X.X net compared million, the periods fiscal of XXXX $X.X loss fourth million with the compared in year. was $X.X in in expenses derived in

XXXX. approximately an September compared proceeds As XXth, public $X $X.X subsequent end. The from of Dave. offering of outstanding stock The to $X.XX pass of back cash at company at XXXX the a share, common That XXth, XXth, registered now my include resulting $XX.XX September received million had underwritten remarks. million company per no year XXXX, price Dave? million it of to gross does to September shares XXth, September its proceeds XXXX. of at had X,XXX,XXX balance at I'll concludes cash not in of debt

Dave Rosa

adding and areas, by fiscal including the progress international in distribution completion will XXX(k)K NeuroOne's your a RBC Center milestone it institutional leading platform. Biomet. of Gross for Robert plan electrodes our in University. a for introduce from orders A clearance company questions. use senior executive up the investment Ron the commercialization, in commercial of of Medtronic. prominent allow for I looking design EEG $XX.XX company's greater meaningful the Completion national million, investors. advances XX-hour less and line to sorry the Medical that the develop thank in which completion to addition firms and the at ablation you of financial capital Biomet broader of $XX.X fiscal to initial freeze the electrode a Emory offering Hijaz want Partnership for intent our The accomplishments. required we'll Vice of by than interest attention appointment study, product, President Receipt and of product in and million for successful electrode investment EVO for electrode closing, some proceeds year XXth, will first Ron. second and cortical of Dr. year, testing In power highlight Thanks even the And with Zimmer in experienced now, our across Technology great California. generate the NASDAQ development, technology past development to community. help to made of position to applications. after -- up-listing of operator, family, variety of public A the want feasibility institutional of with electrode The I XXXX deal. and Innovations us wide launch Successful gross feasibility and of electrode as electrode our under source. as ablation as company neurological EVO execute a sEEG occurred manufacture formerly located any to December product us CFO open facilitated appointment variety raising sEEG Initiation Marketing, Establishment payment Zimmer Development of use; testing for our XXXX gross continue for end. financing for to proceeds Haris of of chronic from raises, time Mcclurg of of a electrodes at

Operator

Ladies question Alex Knopick and Certainly. from from now first is Instructions] gentlemen, questions. is Capital. open coming floor Your [Operator for Craig-Hallum the

Your line is live.

Alex Knopick

just anything was good walk test. results, much go? morning the you biocompatibility Great. resubmission solid out through pretty test the around everything to if did was the Electrode everyone. to green stood Can Good you rerunning Depth The light, of

Dave Rosa

was So, and everything criteria. of acceptance a one for the range detailed analysis the tests. it very, very of within just Alex, was that's

was And was there that just for report over analysis the pages. are a extraction an about the that found test, analyze is period. where solution electrode in while XXX of they test the any One placed substances XX-day just

potential -- me with to biocompatibility you him, was I said, day only any of our said And said, any all of are I that it So, I'm clean that said, see there who's biocompatibility a companies the working risk? had I'm he former FDA he you're a working asked Thanksgiving, areas actually -- expert, of I number the with, and that weaknesses data. the companies reviewer company after or now

and so he's guy, I -- feedback promise happy was really and from individual, pessimistic a deliver generally So that over under him. get to

Alex Knopick

makes around is expecting No, remember XXX(k), FDA? commentary that's around conversations if a clock. any correctly, since back with Maybe very special any the had think update I FDA review the or now hear. But with to that? -- with resubmitting approval you just sense. yes, the FDA I FDA know I XX-day -- be had the the submitting Have you've XXX(k) backlogged, conversations the XXXX good your the should QX so so on just here,

Dave Rosa

Sure.

notified everything submission that So, the gotten us any and with that us the that additional they looking don't require complete for. information FDA has really to were they from us back was

desire to So, And think a the back of they tell before I But us little a information did and that's Christmas. the expressed amount by surprised good they we us submitted. were news. get to

XX day honestly, -- an an Just one to options maybe have a few taking make a option less as for address actually argument different we use. the simply shouldn't as us to to And submission given how actually why actually really test, FDA or very and meet them And that they do was testing. of to those additional than we it. of risk step had to back, tests the the which to biocompatibility confident would with going a it, in that felt And high were couple were -- we that very the demonstrate very robust into was product requirements. recommended that conducted

back is Christmas. to So, get that things told they've to where And would like the again, now stand already they us before us started review.

up environment but to backed had was still it's in they've else no we'll of feedback today, that, see. that our from get our complete. there was hear the already that, And They good but for The wait there are hoping were be they submission. the given January, Christmas. probably, year, the my we'll So, things just at prioritizing we our given looking likely nothing hopefully, communication FDA, additional before it's end feeling given is that they before the started and the according review And and them. news this requests. more it'll with are I'm is

Alex Knopick

patterns That's Zimmer great. here Depth the ordering centers neuro with stocking going what Zimmer's you orders, out one. how the Electrode about on reached a just are expand anything launch approved, plan, full forward? to the just good from upon just already That's has hear. Maybe is the about commercial initial that gross been to. thinking given once launch And initial has response

Dave Rosa

that's Yes, question. fair a so

I that been going their launch. ahead encouraged by the forecast without into has that of Zimmer definitely been fact think we've increasing details

mentioned I as that with we've our the with agreement allow be think providing before accessories will to them, robot. that they electrode used part our are of also,

those product, the accessories we and process the will from have clearance once So, ship to begin. FDA ready, are

ensuring So, FDA really that accessories. their have it's ready and waiting with inventory enough and they're on they

they enthusiasm, game, wasn't got So, which it in especially in we compared of with product, and of we really there's up had there lot deal clearance cortical very enthusiasm, done quickly the just to planning, time about great to I'm as to lot was the Tremendous a then a assuming terms as were possible. of the of so are late and the launch, that as well amount of ramp now. they spending time And and preparation they have a invested as this have dollars personnel launch --

these into that being a in run company, all before said, making as launches, Now, walk that I've sure we always run. we

into the matter every there's of a to So, that get a situation then launch center, we where And occurred. you find that just unexpected never want and product practice. to something that's

there's expected able launch really to So, but quickly provide up to product. ramp initially, a additional to as would Zimmer this as be limited we're like

increasing been patterns, the remains as far this so as because That'll a or it's So, irregular, quantity, ordering year. to little continue seen. throughout keep be year they next

Alex Knopick

Yes.

items the FDA more then two questions you the And are and through ablation key get of actions to what Okay. to just then and just just watch walk necessary approval there? electrode, the

Dave Rosa

Yes, to we're with having a planning so on meeting pre-submission them get further clarification.

XXX(k). think On a agreement that before our it to want is that sure make we've the status, discussed FDA ablation I we're approaching technologies plan. are with other XXX(k) we the There have in that but as clearance,

back be think anticipating development February, FDA. the strategy hear I at getting in that it's to not Really what our timeframe. But the probably to plan, really in there'll the required. from we're be But confirm that's with stage, So, but then February-March we they FDA, the to system, our clinical done still assuming with the we're waiting any want going testing this agree that to the done. it's data and

to standard perform as simply So, the XX-day be the give this ablation diagnostic ability would to to us with what expect to adding device. ability our it this -- add current XXX(k) an for the -- but our that be submission we're we or purposes, indication indication treating procedures a would

in to we really wait we feel that a until but are in argument from it we strategy will and So, strong better be our direction. clarification confident further have get FDA, that marching

Alex Knopick

there? then how game get a to work longer just bit not this stem? the can use that spinal for a stem the chronic question, cord or But deep plan question and whether just a last around plan and little or And understood. electrode, ready term Yes, you one's this here. Just brain game

Dave Rosa

Yes, so, five at we have years. that's electrodes that to do will the demonstrate least the first have we last thing durability is the to required feel

fact these at film lot circuit. look you that's issues between technologies metal layers through ours, So, and stimulating always there's happens revolved of and point the And the there's with over the pushing with film a fluid getting ability involved it's some in imagine electrodes. in current at the whether are to stimulate to the when the is spine, what brain just area. the and the thinner, less in imagine in so these degrades around that XX/X, less it's Or electrodes or historically, like shorting potential thin metal through obviously the time the lose the eventually that

probably last? in which all reach So, in step the the we'll timeframe, five-year of the time will we is February limit anticipate one terms be I a is really have with samples information the it that will technology releasing when And testing.

a one. as step critical more from do for And cord to here. is electrode's have that market the there? really tweaks generator So, technology, then clearance where spinal me, And possible ready, getting stimulation. for assuming to aspect that's And some your to which two go make so we step had And we the FDA previous you okay, from question quickly opportunity is an pulse license or required anticipate as license would FDA. avoid we and some to, -- it data will is time the but device the system, that really go we'll do, have obviously testing able all that still able development to do that it, or we will have clinical development We'll huge. to to and demonstrating make but still testing the be what to that's just say required minimize avoid have be to changes, to the

gain can and a huge access by pulse really generating cord savings. that's highest It's amount that And cleared for already savings the been FDA us cost it's revenue, stimulation. time spinal we're to any why already among prioritizing a we generator of is that's significant given So, indication. a

Alex Knopick

you. appreciate Really update. Thank great. the That's

Dave Rosa

you. Thank

Operator

Thank you.

Ben coming question from Alliance Global Haynor from is Partners. Your next

line Your live. is

Ben Haynor

good me Hey Can you gentlemen. okay? morning, hear

Dave Rosa

Sound great, Ben.

Ben Haynor

all the feedback mentioned upon just that potential based forecasts, market Is for on the deal. on and how you they've Good in, color the out it to was market Congrats thanks they've the presume reception all Zimmer the that's increasing progress consistently product? that feeling the I that those. and for kind the wondering safe here. and there been got of,

Dave Rosa

earlier -- time as on obviously, clearly look of had get lot month. We've this to to actually the what is in to And disclose, accepted they've speak, electrode. Zimmer's American there response as level Epilepsy they provided Meeting specifically, feedback so they in and Yes, but so neurosurgeons. I by product have with physicians Society desired, them discussions enthusiasm a this recently the community the short spent diligence definitely samples, confidence and doing the the that be will perform and to all talking is, can't and the

So, at the product and positive very still -- we're but there, some get is to which have launch, hence, least a why get encouraging. been that very out has response early the doing limited initially, we -- use,

Ben Haynor

just Okay, a manufacturing -- can have your mean Zimmer's great. kind on ability when given That's on you will do forecasts, you helpful. only their -- on And I your side, increasing sense your ready? obviously, end, guys the on then does accessories stand? how things, the end of ramp-up side be of to those of and then control

Dave Rosa

everything's volume. vendors you you building one; you in going back confidence, can't are product, especially, But volumes, higher new to sure process, fine and and want increasing orders. our a high it's like manufacturing start any out the that can to to of that other our make day go product so gain we Well, launch, going

obviously really we're -- asked much more we've produce. to And So, them inventory, vendors pushing product. of start being they time, anticipating them fact we as our to to the produce when in commercialization, some that front launched least in QX, have as some asked way commercially than building out to we ever expect it's we've really really at commercial-ready ever the all are

meet and it manufacture then the Zimmer's see, starting now, Right the have catch they up is their confidence to we able quantities have product. we'll going can we and up. slower they're are. how expressed The to really annual feel vendors requirements on requirements -- course over So, to that what to XXXX can the depend of out quickly our ramping

is we our so we for an So, game that's now for COVID seems impact. years, the down. like slow just their potential and front really good. two now, companies having got had it. no to fact plan and the so but It's -- on suppliers got far, definitely is that's But are impact it interesting increasing that the process of out orders in the

is things really surprised impact see any So, but to that's I'm wildcard we'll that just took years kind have of two don't probably change. to impact. COVID of biggest potential the if see, the it

Ben Haynor

their in I And clinical there? is developing publications. there And a or planning you're of on helpful. publications data -- we the recent you're you kind you have color the that then kind have do lookout strategy of of on should anything just get of for the presentation The know then to be terms electrode front, that the kind ablation data out clinical for

Dave Rosa

things more on some still with there's electrodes. think cortical I diagnostic the even side we can Yes, do

traumatic whereby brain to there's film very done an can the physicians and electrode no neurosurgeons -- electrode there's be procedures incision do electrode. put it in, able insert they make already, thin that would would but injury this they So, tiny or where to love are

just data we want neurosurgeons data. those as utilizing develop post-market is have we leaders key data, to but post-market So, I with put really that a we Board the can the animal having finish electrodes is current thought help the will line demonstrating the our the to Ablation together the if that Advisory establishment to The ability and purpose. strip use for some of study added, intent closer human conversations see get small ultimately, really clearly -- us

using data. centers us generate really So, be to help clinical supporting those we'll

Ben Haynor

the gentlemen. Okay, for had questions. Thanks great. Well, that's all taking I

Dave Rosa

Any guys. other right All questions?

Operator

today's are queue. you everyone for no in call. the further questions joining you. There Thank Thank

You may your now disconnect lines.

Dave Rosa

Thanks very much.

NeuroOne Medical Technologies (NMTC) 15 Dec 212021 Q4 Earnings call transcript