HSDT - Earnings call transcript Q3 2021 | Helius Medical Technologies, Inc.

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Operator

00:06 Thank you all for standing by. And welcome to the Helius Medical Technologies Q3 twenty twenty one Earnings Conference Call and Webcast. Please note that all lines will be in listen-only mode until the question-and-answer session of today's conference. Please also note that today's call is being recorded. 00:24 I'll now turn the call over to your host [indiscernible]. begin. now may you Ma'am,

Unidentified Company Representative

would to future call to mode. With are Andreeff, XX:XX note otherwise as participants a our Officer is obtained Thank obligation today like to one as as the this This QX current statements All that quarterly These twenty report Officer. XX-Q. statements materially events this the time Helius Please Form call uncertainties like SEC, November be forward-looking President to Officer the for of to [indiscernible] Chief everyone Dane inherent differ statements At our other no results webcast with call, Before our on Investors Andreeff, XX:XX of are to Helius been our revise Jeff information, Dane Jesse. expectations conference to Executive turn call Factors over those Mathiesen, filings XX:XX those by based the to one. of are Dane? placed Welcome management. recent law. from the indicated, cause access Medical’s in the this except recorded of and XX:XX which would Helius. including most Relations Such call that earnings Investor Technologies. annual made Chief Insight Helius. actual XX:XX remarks that the being on for factors a and President of or undertake today's on that new identified or and result of begin, are and contain section Form I have required Executive www.heliusmedical.com. could XX-K twenty twenty listen-only can in update and now to website. involve during Communications, forward-looking risks you, of website the report all me updated tenth, twenty from on questions Risk publicly and on may and forward-looking I Helius remind is your Financial time, our We we Medical responses be at statements may time section to and Chief available

Dane Andreeff

Judy gait third high XX:XX ago, twenty toward Goods Therapeutic Americans million sclerosis. device head twenty call. authorization twenty a of multiple and everyone the two Helius our we as United to the is MS, as A received deficit medical need Thanks, twenty with indication welcome Administration TGA mild-to-moderate there to XX:XX It's earnings quarter conference one time PoNS of few symptoms the approved due exciting therapy the or only commercial Medical’s for PoNS sale one approximately we an a PoNS launch unmet company for of With the and for medical from IIa device. the market the is suffering for days Class this States. in QX Australian

this as is a authorization We is program to and possible therapeutic and balance adjunct short confirmed improve use exercise an the professionals the by healthcare have since to gait, term broadest scope. for

in our unit introduce Therapeutic advance patients go PoNS to XX:XX gait. Helius toward centers to be and assess commercialization U.S. their TEP improve the twelve multiple therapy Australia the first pathway We'll the are Earlier or The clinicians week, now leveraging that helping need announced pursuing portable who way this launch. planned to able of this toward will with is the a our – it assess we adherence to Australia help Health therapy to Commercialization sclerosis to with launch to of We ten in of therapy NYU we with patients Langone patients the designed balancing will of TEP commercialization. Experience simulator excellence. breaking objective and thrilled of study as begin to adherence in ground the Program long in PoNS fund neuromodulation

PoNS. We new also the let XX:XX provide those indications. to expect For these potential sites has across offer first the imbalance this improve some dynamic Helius, therapy variety to to be who we to be may centers me innovative among background deficits commercial on believe of gait that a

gait pulses that no your simply five function, and now non-pharmaceutical PoNS with weeks independence patient champagne of The safe water symptoms In To help had have symptoms due twenty the XX:XX with million significant Stimulator. deficit quality stands both life impacting Gait balanced First, nerve compared the implant mechanism The system to PoNS through minute of when physical that brain. like meaning neuro with combined nerve involved nervous gait stimulation first mild-to-moderate modification there's strengthen Neuromodulation the per neuromodulation the therapy via neuro disabling and effective. stimulate therapy of twenty shown to by for interventions and targeted disease is the only tongue. with the to of advantage trauma. stimulation mouthpiece works via or combining and electrodes carbonate or with sits MS XX:XX This has for time. the tongue sending people with is conditions, The deficit is it's PoNS signals Portable reduce feels connections It trigeminal therapy alone, the to to the Another is and delivers improvement session. translingual fourteen it of induce stimulation action rehabilitation. on physical XX:XX the walking or to designed stimuli. of associated is neuromodulation trigeminal limitations. neurological therapy procedure bubbles. MS, is neuro tongue believed PoNS physical or device subjects It PoNS. patented surface, until

more deficits was moment, including this second the I granted see why a pre-launch color PoNS August, You complications, times XX:XX seven in significant ground a is seven a detail. the from suffer FDA cover XX:XX more gait to Let's provide estimated piece number This take breakthrough stroke. breaking time first about of of for could that's another this we're imbalance exciting in our of news. resulting a treatment minute for I'll In with a strategy, as share excited and MS. TEP afflicted Helius milestone highlights but from about to these an want million therapy. American designation dynamic stroke

bring As the for treatment quarter I plan twenty deficits mentioned, during we twenty of PoNS to to first related therapy MS two. gait market

call. Langone therapy XX:XX third, to Program campaigns is label, patients initial which treated; patients U.S. of MS early greatest the for in beginning to [indiscernible]. information adopters NYU, nation's academic neurorehabilitation patients the likely media. and or at fourteen technology important by TEP MS of one centers with who and efforts centers with efforts which the fifty comprise PoNS at improvement. twelve which commercial raising start percent focus having adherence may premier XX:XX of potential to key program can our first, PoNS the outcome and than An three as with of Dr. I a second, prescribe Our centers Through through and engaging awareness other personnel PoNS is therapy and week on neurologists launching therapy; patients. combines medical where XX:XX neurorehab we ten to and themselves the on observational program, the audiences: more to partner interventional, neurologists targeted device commercialization identified research states of be of relationship NYU Health, we establish TEP, primary open physical plan at our focus excellence will and social will which centers will be this Therapeutic the that TEP, therapy between study, our ten In will functional conducted an TEP addition Experience the be mentioned physicians,

enable opinion the commercial MS leaders in to TEP build launch, informing In to knowledge of the of key PoNS will addition the their therapy. management

pre-commercial patients and to XX:XX treat onboarding with currently our distribution including and inventory, expect in strategic our an KOLs patient finalizing other sixty potential model, creating fifty partners. identifying clinics activities building engaging treating We access programs MS neurorehab study. patients, to Our

based America's U.S. We'll and resources expand During conferences the also including clinicians ponstreatment.com quarter, the Committee [indiscernible], several presenting XX:XX website, patients. be we is introduced our online for at treatment to which U.S. PoNS is twenty the which the of sclerosis and And finally, CMSC, centers February treatment April. sclerosis Academy then for Neurology in and multiple multiple in of twenty research in consortium and American the March. two

of pathway. XX:XX coverage. period devices coverage into effect or first, mentioned continue was We customers to will in FDA pay Medicare on our government expedited would for medical in due to while coverage the launch breakthrough building A innovative obtain potential pursuing under we that CMS technology coverage both obtaining monitor rule, the this, the which that Medicare go December, repeal the commercial September proposal common strategy out published reimbursement thirty and and the through United of with for to proposed we reimbursement and commercial and part also provide pathway to M-set States actively will to quarter, and Medicare cash in payers. we U.S. had the therapy the day government proposal nationwide we XX:XX Last remain was fifteen, hope while our designated a On programs. the PoNS focused M-set

We commercial Turning on Canada. engaging brief used with devices line payers now in XX:XX the a are for PoNS neurorehabilitation to our pricing in also pricing commercial space. with comparable establish in to update activities

deficits symptoms launch chronic of authorized Canada, are restrictions An pleased a informed due providing to commercial recovery. U.S. valuable spike therapy. see in increased Following a deficit gait XX:XX due greatly the Canada market we MS of to of is PoNS activities injury. Canada to PoNS making its period brain traumatic important insight toward about due cases, and in in COVID own In right, for progress treatment balanced the Commercial to our

have six Canada. of We throughout thirty clinics now the established country

patients that, indication. results. obtaining two we quarter Americans the MS about U.S. now during XX:XX first If bigger breakthrough we trial to approved, in me markets, aim even the With we commercialization of let seven therapy of from to financial the gait the With excited suffer a twenty PoNS an of stroke, twenty physical third in call Jeff turn stroke experienced the of for launch and percent our for pivotal is commercially of are patients. and second estimated the clearance are opportunity twenty impairment. who second over discuss granted, planned twenty designation as targeting quarter with see Of the the PoNS, effects eighty XX:XX million for four. Canadian As stroke half

Jeff Mathiesen

or in was It one to revenue overhead today. both thirty twenty our third thousand third thirty point Dane. XX:XX been For profit and twenty with third by the of including and Thanks, in management however, in Canada Operating the twenty twenty primarily zero year. Operating options sequentially in during point quarter Product nine five expenses as twenty the to extension the for supply the condition dollars provide prior impacted increased period chain. one reported balance year-over-year thousand dollars neuro compared increased thousand dollars Canada nine the dollars PoNS related million decreased basic third one million employees the loss from was four this you is COVID of and dollars well two point dollars non-cash this sheet, loss point hundred be involved Expenses thousand to therapy per three period dollars on of or and of net two twenty twenty former twenty gross was quarter. the percent million to activities. compared per one, five quarter last of have and financing reduced hundred Revenue these dollars point to by quarter as seven periods and Chief year three XX:XX included of loss one-time pricing. and our twenty sales third quarter the pleasure of net one-time point one twenty twenty third of a by hundred Total diluted, for of in five the second the dollars four dollars common million in of loss or point the quarter including in four three a quarter million four of a exercise by quarter point wages significant to salaries recent one the versus of hundred temporarily million and share one, to to diluted of last severance for that clinics COVID-XXpandemic, XX:XX the of point thousand for share thousand our twenty Turning by the one seventeen four current therapy of were nine dollars to driven XX:XX dollars expenses year. the and during to related prior We the in XX:XX of driven year, six current one XX:XX seventy acceleration loss costs, dollars. thousand the costs of quarter discussion same business Operating to one our seven remain a for year. basic hundred than disruption one sales related of the period. year twenty outstanding. zero third investing of Operating nine million charges expenses to compared dollars authorized three officer, quarter other

two As four of of -- first was of million added thirty, operations twenty nine the quarter. three had from three Current burn nine Our twenty. point third twenty cash dollars million nine point nine December twenty. twenty the twenty point twenty three during compared point twenty XX:XX six to months year point of cash to dollars during one point of approximately nine we million seven first cash nine million burn of compared million thirty dollars dollars one, for the September as one, months dollars

balance had nine debt needed, the greatly XX:XX underwritten no credit of equity therein, scheduled over dollars to allotment had which conditions customary are period. runway. our closing to in one point add call, intend which if Following fourteen We is morning, in million this subject spring six subject registered twenty four million point pro fourteen four and dollars. in close public Shortly conditions. announced received a of could thirty, the exercise twenty dollars million capital either the notice under Lincoln extend as pricing will source cash option million which Capital, the this offering, cash to the outstanding of our Friday Park point line a to before available full, company we underwriters XX:XX also gross another the one to We This five equity then proceeds. closing, terms ensuring dollars of with obligations point September forma

the activities, a we pre-commercialization our to while including operations, to connection support with expect increase Turning quarter assess able not recent our our our XX:XX to are we until in ahead, anticipating U.S. quarter in maintain our outlook, Canada, we evaluating continue to different the approach restrictions be commercialization strengthen efforts. revenues balance are fourth levels. sequentially Looking expenses spending, disciplined currently will and we better our actions QX COVID while to significantly impact of to third to from sheet

now As In for we to XX:XX questions. sales operator, from pre-commercialization terms the anticipate let's to U.S. twenty incremental twenty of of during one that, U.S. the during the we open expect Commercialization. one. operating twenty our quarter XX:XX twenty therefore investment of related expenses, not fourth activities twenty we twenty to mentioned, do prepare for begin reflect as With the commercialization call the and two quarter expect U.S. in our PoNS revenue Dane any in first

Operator

XX:XX session. will the our of [Operator begin Participants, Noble question-and-answer is Capital. we Speakers, Instructions] from question Joe first now Gomes

open. Your line is now

Joe Gomes

XX:XX Good Dane evening, Jeff? and

Dane Andreeff

Good XX:XX evening, Joe.

Joe Gomes

out wanted maybe a So to more XX:XX Dane color. little start here, try

in the You the going twelve, talked to be begin the starting up got enrollment experience about you're late you quarter. therapeutic that to Do to Langone. going at just ten one you've here, fourth

still said through twenty XQ time and to first looking why really launch. of some until if still two think study at people. two in kind walk start occur I will a just the twenty you wonder launch fifty quarter? I not is the can to the commercial process of going you And But the think commercial quarter you sixty if you're first us

Dane Andreeff

Yes. XX:XX

not program So, again, share is really expand Dr. PoNS share, at to NYU. there only It's the these TEP mind on expand educate to [indiscernible] to but experts like them therapy. mind experience with the MS there

of the in we'd that like patients we sites, would in the always these excellence. what team centers these our So we've is stated And preparing quarter. first do start is and launch to

are to with experts that bring is to really it MS how an show therapy great the sites the not And of first really this them patients. our these MS centers is confident in for but for only in excellence their we progress them offering commercialization year. So to new and in we're PoNS these study will adoption the program, along that quarter, full

it So, a targeted we're with. very launch is out starting that

Joe Gomes

in the Medicare XX:XX rule your Okay. mouth coverage going And put call, it words it's to the happen. the sounds I under don’t M-set really is not to looking like want that on

talking other coverage insurance you you insurance So for who with how are far for product? ways to of advanced coverage, getting the

Dane Andreeff

going to moment. the at XX:XX I'm one to Jeff over that hand

Jeff Mathiesen

XX:XX Yes, hi.

the So as Is companies saying That's targeting far ahead. total. that, for it? insurance you're Go right? as to question pay

Joe Gomes

getting what going not XX:XX under like looks M-set it I I'm just happen to to going was is say, from coverage here reading.

the out you? insurance trying figure do to And some need the are to them just coverage? how are are to give What along you companies you guys so proved you process, for do you are to, where far talking order who in of in to

Jeff Mathiesen

XX:XX Yeah.

you. Thank Okay.

and So the cash it there. of looking we get to by we'll that it the we'll carriers basis. basis be carriers kind with with a on pay program initially to experience going case going and will looking be from and third-party both third-party TEP And expand payers case are target basically, be those cash for on pay, regional out patients reimbursement from that then

time. over through data get to plays out it's can take to year, just And the going it’s to that a the that go build we process bring out we reimbursement. payers to as those so And some time

also to and giving expecting for reimburse up Medicare payers And signed next so national then to some then and to into get patients. the year, regionals by and of CMS by we're looking the year have end

Joe Gomes

that. Australian launch Okay. you terms paid in same XX:XX of later getting there? Thanks maybe could give first model, commercial the little us and of for it again, us, the color market, on there first can for And a timing cash a if insurance pay size you what's more kind cash

Dane Andreeff

XX:XX Yes.

Joe, It's you it's receive. there's indication So, received early. deficit, could label It's no just gait authorization. for attached. balancing We the broadest

will neuro basically could caregiver, the therapist. this. physical use the It neurologists, you the So, up be

in million Canada. thirty there's people million roughly So thirty million live about that thirty dollars and people five live in Australia

two have with not brain this we gait So It's gait think in with patients for Parkinson's palsy, MS cerebral only label, the balancing and and you traumatic deficit. or both MS But about brain Canada, deficit indications if strokes, potentially it's injury. also traumatic for like. injury disease

So, a much label market actually the because from that of larger received than did the we TGA. Canada it's

Joe Gomes

a And I through walk just about thought you of Okay. never then raise, a we if to process could of the discount price chart your XX:XX at kind looking it announcement the got seems traded of and dollars company and stock chart priced fourteen, today's they eight, which may, where week, on one stocks wondering if were and the me just significant at more as the fairly I was was and to slide as low back started middle last some be at eight was trading.

to through could was price walk wondering if of why that was So process I your chosen. kind us as you thought

Dane Andreeff

Jeff. ahead Go Yes. XX:XX

You start. could

Jeff Mathiesen

XX:XX Right.

as the into price probably investors aware So is that well you're it. chosen coming dictated was the by

steady, been over nicely little but very last liquidity. pretty fairly year have traded it's said, you As we the

fundamental named so to offering. ones, we to have investors, wanted straight institutional bring stack as institutional a investors, And in we look

us that the looking go that And a we to future, you're out from out we that is set need to price this, basically doing financing sure of the what the to to cash the consider commercialization. and a there. so making like opportunity from here have when at huge we it's giving through allows end needed investors price And cash a this we there and see standpoint, a and runway we day a our went at of

Dane Andreeff

that, first three a our warrant last after Yes. a warrant attached. was only just had stock the to full half continue this either And clean XX:XX deals deal just or

deal whole a in brought institutional as we new healthcare -- feel of well. investors we into group this Second,

was So the stronger. we much investor group believe

the this fourteen invested much at rounds, I the September also a open higher in again, up last price Third, in as like personally I range. the two stock market financing in round bought in

a keep year trial in down, believe So, believer as could into into keeping provide next big you I'm I will Joe, milestones stock. pivotal head hitting launch value for in our our stroke our the their see, investors our optimal and

Joe Gomes

Thanks XX:XX for appreciated. that insight. Much

Jeff Mathiesen

go really one may there no I no first is if back didn't other out, just like there we that I obviously, out thing Joe, in we go question, device And mention as there's your to XX:XX ours. and

that some fixed And generic around so process a if something in that's April fourth that code looking activities initially, get we we are expected, we'll until and we'll at that's approved up thereafter well as been here set we'll fixed goes and setup but we've the first code have be have shortly getting code, as all something in got And quarter. using beyond that.

Joe Gomes

XX:XX Thank you.

Operator

closing remarks. you Thank Andreeff to now for XX:XX Dane back turn it I'll over participants.

Dane Andreeff

looking strengthened to XX:XX you, positioned stroke furthering therapeutic launch Helius, Internally, the for to our and well forward Thank therapy breakthrough and our is our validation accomplishment and multiple our leadership are U.S. as from the administration. PoNS have we the significant authorization innovative TGA and for we team market and Australian second PoNS was goods our through our from a execute Commercial everyone. With team you, the operator are Receiving our patients. technology, FDA the and stakeholders of thank XX:XX of studies designation plans.

has Parkinson's platform large indications, the a cerebral population disease, injury. and technology brain traumatic stroke, palsy, help across a Our MS, potential including variety of to

Helius the become for for deficit Again, U.S. of in for our interest We potential neuromodulation bringing and while you today value in gait to our continue thank time care XX:XX Canada and to the the in unlock shareholders. to your of full Technologies. standard your and believe Medical ability

Operator

joining. XX:XX That concludes for today's all you conference Thank call.

disconnect. now may You

Helius Medical (HSDT) 11 Nov 212021 Q3 Earnings call transcript