NMTC - Earnings call transcript Q1 2025 | NeuroOne Medical Technologies Corporation

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, ladies and gentlemen. Welcome to the First Quarter of Fiscal Year 2025 Financial Results Conference Call for NeuroOne Medical Technologies Corporation. Today's call will be conducted by the company's Chief Executive Officer, Dave Rosa, and Ron McClurg, the company's Chief Financial Officer. Chris Volker, the company's Chief Operating Officer, will also be in attendance.

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

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

I will ahead, go Dave call NeuroOne. over the sir. of CEO turn to Rosa, With Mr. Please that,

David Rosa

operator. Thanks,

the technology recording, neurological we a invasive of and is dedicated those we NeuroOne, solutions have For are transforming and for solutions who ablation to stimulation you company EEG epilepsy, for where that new high-definition Initially with be diagnosis treatment medical frame minimally may patients. to disorders. of

disruptive and FDA-cleared that for system, procedures from suffering the the for OneRF first product and performing therapy electrode therapeutic and it both in hospitalizations same only SEEG applications and is patients given treating seizures ablation due reduce improving uses to willing diagnostic number is patented well epilepsy. Our extremely We hope of to this patients to designed expand the outcomes. number opt of the to while

our almost $X margins, achieved sales product plan report very key the quarter XX% objectives. accomplished and in and which XX.X% that through development fiscal of in I the of to as double of XXXX revenue to today, am of During of our as have milestones growth gross fiscal when represents margins we and our revenue to quarter. product first several in gross we quarter product the have first quarter well million product have million of fiscal execute XXX% This financial continued $X.X record and proud regarding compared commercialization, record first first were XXXX.

The of the Zimmer result with Biomet. is strong financial deepening performance a partnership

criteria our XXXX, XXXX announced Zimmer began the and in a the expansion partnership, we reporting of States the Biomet $X.X payment reminder, expanded quarter system consideration exclusive partnership record the the NeuroOne milestone for and In October license to a in million the if for Biomet certain upfront with are United $X to in of and performance with U.S. geographies. relationship potential additional Combined, also an our revenue achieved. OneRF for As we NeuroOne. distribution payment rights earn certain outside ablation million, an of include are first received total Zimmer

transfer boost includes extensive and distribution Zimmer with partnership is revenue profitability to drive improved expected NeuroOne improved network Biomet scale. to expanded The and and prices given their

and Regarding the largest system, completed the Biomet the device United launch of global Zimmer stocking during to first medical companies initial States one is quarter. of Biomet the majority year. centers epilepsy the procedures the and in approximately of in is epilepsy presence market. strong each are Level X the epilepsy a used United has in There Zimmer ablation orders we the the in performed XXX system robotic the OneRF Zimmer's States

to growth mass provides adoption. For and the positions a time for NeuroOne, believe faster significant we us relationship line

procedures but the OneRF that of X to are ablation performed are patients the to pleased in all We report date, seizure-free.

the severe patient seizures seizure occurrence that has after and experienced less was reduction However, significant performed. procedure ablation a OneRF in one

enabling the over the in life. ablation We been significant quality procedure, OneRF X months enjoy are report one to happy of now especially patients to the patient that improvement for has following of seizure-free

hospitalizations ablation with that and purposes. hospitalization Instead that changer. These months X they is undergo are X undergo a technology apart, now to electrode with allows this typically of neurosurgeon OneRF both system having that multiple can the exciting game diagnostic ablation procedures a the confirm to use results for same few patients the

our remains off-label single RF and noted, and and OneRF the first a procedures using unique, applications, both for favoring system brain for FDA-cleared only FDA-cleared increasingly implant ablation Hospitals advantage. As creating therapeutic solutions system a first-mover a diagnostic competitive ablation over are alternatives.

patients are an more use concerns. more lastly, technology. inclined liability to And of are Second, approved reducing system, approved trusting physicians

will trigeminal on using condition new CMS designed by face. to ablation neuralgia. in system. first performed ICD-XX procedures and sudden the pain X, inpatient recurrent new severe, States. are face debilitating October ablation is XXXX data in system a Trigeminal facial to by pain known ablation and OneRF application the year reimbursement support in in body, the procedure. OneRF that the important became each of located United to system side with patients which the to PCS code is to treat Also XXXX, will patients for nerve ablation to of trigeminal This FDA effective each over characterized with the submit on nerve also diagnosed of report as XXX(k) with neuralgia hospitals year areas X calendar pain procedure for trigeminal our to chronic XXX,XXX by the claims The pain the accurate treat the facial the hospitals is remain RF our of for nerve hospitals, half serve collection granted a other processing we track allow and Leveraging

partnerships cord nor continuing XXXX delivery to we With regard ablation our programs, technology in RF would to make thin progress exploring revenue which revenue to other currently leveraging NeuroOne's and our are further nerve drug strategic of from platform has potential electrode to multifunction both film technologies, benefit capabilities contribute and technology, plan the can spinal potential immensely in the that develop commercialize that our product stimulation XXXX development offer. guidance. to trigeminal NeuroOne's revenue year factored calendar not our system our is

comment over it I Before updates. would like to few financial a also turn to I on Ron,

are fiscal guidance. off And our to are great start a this with in XXXX with reiterating we the year financial confidence first results We quarter. our

range revenue XXX% be of margins and XX% to the XXX% $XX an between to to million, representing in product of to XX% million gross compared and product expect XXXX. be in We and over XX% between XXXX increase $X

this excludes guidance our upfront Importantly, license from received payments Zimmer.

expanded strengthen improved Additionally, million the sheet in Zimmer we able Biomet prices a have driving Zimmer payment been along from the our partnership $X product margins. to from quarter improved gross balance first with with transfer the license

patience share to Finally, grateful standards all for this and I pleased listing to are our shareholders during announce time. that am have also NASDAQ's with their regained price compliance we of

turn McClurg Ron first a provide to of like now call Ron? the review quarter would results. to over I financial to fiscal our

Ronald McClurg

quarter gross $X.X quarter XXXX, to the 'XX. of of revenue in with company License quarter our of Thanks, Dave. Product revenue revenue Biomet. to million of 'XX product the also revenue revenue the was or compared $X.X first Product compared to exclusive XX.X% of in increased from fiscal the in fiscal license in of of profit fiscal million XX.X% XXXX of quarter an Zimmer gross the in in the license fiscal of was XXX% in of revenue quarter million profit XXXX. had increase XXXX. XXXX fiscal quarter or to $X.X million significantly expanded first the revenue no first first of $X of product The compared first agreement first fiscal distribution the first quarter fiscal million $X derived of

$X.X 'XX quarter in first to the $X.X compared fiscal in fiscal of first Total $X.X the expense the to XXXX of fiscal first to expense decreased million, operating in $X.X R&D million fiscal to to of XX% expenses of million the million XXXX. quarter first million fiscal first the in in of of million same period compared quarter fiscal also quarter $X.X XXXX were decreased XXXX. a quarter $X.X decrease compared in XXXX. of SG&A the

the the loss net the income quarter reported For $X.XX $X.XX or share net of fiscal per of XXXX. of a XXXX, million or loss compared million $X.X of $X.X a first per fiscal share of to in first quarter company

cash capital equivalents $X.X XX, compared As XX, million $X.X debt had of XXXX. as XXXX. cash XXXX. of September company and The company as had XX, XXXX, December million to of September of of compared XX, December $X.X of no XX, of XXXX, The as company $X.X capital to working outstanding of working December had million million the as

$X million of $X the agreement. XXXX, of Zimmer Following license standby secured payment the million Biomet November receipt facility in company terminated from credit the

stocking December, fiscal initial second product year recently For the given product in expands. we decline year fiscal revenue Zimmer that ramp in of launch the through the the will the order completed full then financial and end XXXX quarter to fiscal XXXX of sequentially guidance, the as we've expect

of year product expects and XXX% gross margin revenue expect million XXXX compared XXXX. XX% guidance fiscal As increase million million $X.X in year to margin between year representing product fiscal the in the company reiterating revenue to Dave $XX is when between year range XX% fiscal The product XXXX fiscal range full between $X XX% of mentioned, for gross company XXX% and of to fiscal and compared and product an to in also XXXX. XXXX

can we questions. for up think I open time, this at Operator,

Operator

Instructions] [Operator

Unknown Analyst

epilepsy? quarter. positive stick why success what submitted. were the great maybe measuring like to ask your so Dave, And I'd on Congratulations results date? just clinical off, a that been few to questions for first have is a for

David Rosa

Sure.

to preferred actually frequency So therapy, that ablation been resistant therapy method. it's patients pharmacologic use to laser technology, ablation been epilepsy are whether for the that preferred or radio have ablation a those patients it's for it's

the So as success. the the I'm both is as that procedure part the not having But same we're of we're I that do surprised the therapeutic. having, to device success diagnostic we're reason well think using

that's patient few within diagnostic determine come fact this back later, sending device the doing and hospitalization. that the X typically, is really able And when all home, precisely tissue a we're they the a to not the process given week, in seizures. replacing So the we're the months triggering

that certainly having. I success we're think it to the contributes

it's The is measuring X year, time either epilepsy reduction is you'll in see post the -- seizure-free dramatically improved stick improved seizures. literature for clinical that -- or typically, what the in surgery, X-year line patients,

the So is the now, bit discussion, a right months. patient treated we that's mentioned beyond longest the as in been X

with will next that. many those a are great patients of the how course the to XX see it off start we're seizure-free of remain interesting dramatically but improved, months, So be to or over

Unknown Analyst

strong you second reported really to guidance Great. levels year XX%. of is Do a expected for of And long QX. And XX% the almost are and between gross margin sustainable range these in XX% term? is X think your the product you margin

David Rosa

But margins of the agreement, finalizing XX% that higher. the were the -- commercializing technology really we gross very the to higher we're why are because of I'm if Biomet, a QX to actually that, The margins provided in be with was that's prior and to XX% XX% range extension margin margins and confident to NeuroOne saw guidance, was within very those confident directly that reason and we remember, the sustainable. our you XX%. expect in Zimmer

Unknown Analyst

the the how long application follow-up, what pain? for do And to before is, final NeuroOne does have FDA And for submitting facial the a XXX(k) as that? question is expected review

David Rosa

of tough is expect that is we've how clearance. and get the it's the always determine timing together in here in calendar half we've remaining news And like for track I in to expected we submission. of submission. the required of mission, testing, FDA It's on take it clearance. good the was question time of long sterilization in what There is But FDA have But process things last perform really said to we the time XXXX, already putting to actually say and actually submit for included through that, here about good received kicked from FDA we X a off system the the still application that that to the to is that brain, guess review first that's going I submitted with which testing we that certainly we're packaging, OneRF to be would the months the our ablation took the that. the to the some news terms

especially submit this range of that expect we but a would So somewhere ablation mid-year, in for that stay But before. with I would on not we've success, be the probably experienced system guarantee, brain. our assuming it's use by we great and what track in we've it had

Unknown Analyst

great Excellent. quarter. a Congrats on

Operator

question-and-answer back I for end call the We have would like session. the the to closing now And turn to remarks. Dave of reached

David Rosa

and well delivered momentum We Thank XXXX and you, transformational a With this partnership record Zimmer NeuroOne. In summary, strong operator. market. for fiscal was our are executed with adoption positioned our strategic full we execution, implemented in and advantage, the clinical year revenue, commercial quarter for first-mover continued Biomet growing growth. on building significant

for margin product product as XXXX, revenue happy the and guidance during gross mentioned fiscal We session. both year for the full our are to reiterate

year potential and next the with everyone make look would The community throughout connecting continuing our on to development thank ablation XXXX in and we leveraging the RF to investor represents our again nerve system technology. to are I longer-term calendar like platform trigeminal programs, forward next late attending commercialize progress call, for product driver, quarter. we growth our to the

Operator

We This does conclude participation. thank today's for conference. you your

may You at and time, lines disconnect have day. wonderful this your a

NeuroOne Medical Technologies (NMTC) 12 Feb 252025 Q1 Earnings call transcript