Earnings call transcript Q1 2023

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Operator

Good day, and thank you for standing by. Welcome to the Helius Medical Technologies, Inc. Quarter One 2023 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speakers’ presentation, there will be a question-and-answer session [Operator Instructions] Please be advised that today’s conference is being recorded.

to Bilski conference of like speaker to now Michelle today, In-Site would hand over the your I Communications. The line is now yours.

Michelle Bilski

time, Welcome Helius Chief and is are Dane that all Gerald. conference listen-only Executive Helius. With Communications, Officer; you, to Jeff call Helius participants today’s Helius been Investors At Mathiesen, Chief and a quarter for note Financial section first www.heliusmedical.com. Thank placed webcast obtained recorded, call on mode. being XXXX Investor call this Relations Please for Bilski Medical’s the can Medical Michelle This this Andreeff, Officer. is me in of to Technologies. through at of have access website In-Site the be earnings President and the

could I management. everyone on to Risk and Factors actual remind that reports the involve begin, our recent most forward-looking we that that today contain and results of to XX-K of in like from Report to and inherent responses based XX-Q. Annual differ those forward-looking would expectations These remarks including on are current quarterly may statements identified section questions your uncertainties statements risks cause Form indicated, the our those on Before Form materially

law. except undertake this future updated during by be as otherwise, of new obligation call which filings to with are a are forward-looking result time of from the no may statements factors made revise in our as Such XX, events SEC, All required publicly website. available to time our information, We XXXX. statements as other update on or May or our

over Executive and of I would Officer call to Andreeff, Dane President like Chief now turn to Helius. the

Dane Andreeff

for Therapy practice. to in quarter a year, Welcome, conference the to one steady as sclerosis, seen the number the Michelle. States and as gait increase used due balance and in PoNS introduced number has United you, PoNS XXXX earnings PoNS Helius call. that physicians therapists of treat and of first we’ve in their available impairment commercially multiple in who’ve who’ve time, been day-to-day Americans PoNS registered well everyone Thank Medical’s to into

for continues therapy accessible new potential neuroplasticity, Therapy we’ve the only week. is with devices to each readily of the stem cash basis cost $XX,XXX for PoNS are list which on for neuro substantially portable a $XX,XXX $X,XXX one-time our pay a from which MS. the consistently a and mouthpiece. currently price cash The comprised and a of with makes those discounted the rollout price generate of U.S. inquiries changer of PoNS plus game affected by seen PoNS controller, is $XX,XXX,

to As call, sales and last difficult be to quarter’s mentioned quarterly predict subject can fluctuations. in are

below due therapeutic cannibalization as first PoNS refining program, known to our expectations revenue as as short-term of Our otherwise our quarter by came we of impact differences as some sites to a well e-commerce. at timing steps transition certain processes these in the combination experience and

XXXX traction throughout revenue the cash and sales excited With are year. the about for a pay the project XXXX, our the PoNS unchanged. remains the as to potential we year PoNS outlook in remain on in to gaining are to continue that basis said, remainder U.S. We expected of exceed even of the U.S.

devices. technology with accelerated pleased which proposed CMS’ program, of reimbursement revenue payer are believe innovative is progress medical emerging we achieve the and coverage We pathway or for with the broad third-party new TCET transitional the to our seeing full potential and needed coverage we’re is

are Medicare to PoNS and device bipartisan breakthrough U.S. be bill and in was the four stroke MS [ph], reintroduced and a designation closely covered years. in breakthrough we the breakthrough companies both to OMB for monitoring by designations a with this legislation. Congress March, which has allow designation In would

offer to treatment. pleased the are PTAP, an price. we coverage, January, of be In pursue barrier PoNS that to extension Therapy we cost our Access purchase through can on-label qualifying list Patient discount a at have XX% so Therapy PTAP to to doesn’t or Program of whereby actively XXXX patients announce the we While June

possible want to We many benefit patients PoNS we to impediment just overcome. cost as is from and are qualifying patients as one trying Therapy help

to those allows task. home, treatment the ponstherapy.com, seek walking simply PoNS evaluations to conduct people an online to challenges, directly who For prescriptions house delivered health daunting be living arrange launched to devices with bring closer qualified for doorsteps. PoNS their can a with suffering recently and providers, which to leaving be the we MS To literally wish medical fulfill PoNS

The first PoNS adoption. we’ve the devices to process already the Users appreciate and quicker streamline live, and ability went site were the achieve strong after delivered in shorten January and relief. shortly seen

to cash online will U.S. PoNS continue patients process experience tweak this the We method for pay patients Therapy the access predominant believe for and be PoNS Therapy the and in to

trained with with been patients therapists available. which an therapeutic no patients longer an trained and part pace, program introducing wait conjunction portal we’ve training the supervised Since PoNS year, quickly devices last for to means therapists a to train in physical important quicker must exercise a be be physical process. therapist of need online able is to months used matching at

stroke, mild present injury for the across efficacy to safety MS of world patients. America, Meeting its launch. effects the North many key Because PoNS able Neurology as set American moderate since of Last indications month another broader of time broader were evidence of Boston, and brain Therapy patients the regarding to exhibited about part traumatic the commercial of Educating at the community we reaching as Therapy PoNS first and in new for TBI Annual Academy real of we the PoNS is with benefits possible.

X% Canada in had Therapy a them falling a only at the shift of result shows therapy were approximately of that falling, XX% end Routine, longer at of For no in to patients risk provides instance, patients. from a meaningful among of risk since XX% PoNS significant particular stroke XX-week gait, X% data period, the a significance, of physical of and rehabilitation, improvement their statistically in stroke the treatment

their a experienced U.S. individuals of mitigate PoNS can one XX% ability on medical stroke. traumatic the this life light CDC, authorizing have gait the to for for of altering Furthermore, since is breakthrough neurological injury. balance. is various is spent five falls in non-fatal the in related out sheds impact a MS This with brain Therapy falls the PoNS billion imbalance. conditions $XX has improvement on really to to designation But evidence on especially each and significant significant year of injury causes serious according costs

XXXX and occurring I a to gait was the recently of commercially gait as and disability. Canadian potential for with stroke, TBI to was but now Not Canadians highlights for MS impairment only than Canadians broader that, stroke. turn have a of and With I’ll since living our been year, impairment major estimated therapeutic moment is currently XX,XXX authorized balance XXX,XXX strokes each activities. post-stroke stroke An and win ago, due new this more with set PoNS available of a PoNS. source huge suffering mentioned for the are authorizations

underlying gathered neurotechnology a with innovation. and can balance real gait that makes of in March, health medical Connex, partnership increasingly the conditions. meaningful Health significant our specialized clinically data evident it extended The and/or In we improvement Tech PoNS leading in provide regardless Therapy technology world we’ve company

multiple Vancouver sell, distribute and grants subject to minimums. purchase, excited important PoNS right and market With metropolitan our the partnership the an to near-term. agreement market, rehabilitation been Helius HTC’s neuro HTC the HTC, indications network be of market new as the area could deepen the U.S. Vancouver in clinics. partner presence and in Our throughout exclusive in this as through for of place we’re Canadian edge certain the leading has to large

quarter results the discuss in detail. our call Jeff first me let financial to Now turn to over

Jeff Mathiesen

be Thanks, of to is you today. Dane. with It a pleasure all

first HTC. compared in sales sales the Our included for sales PoNS $XXX,XXX a partially in States. product recognized quarter United lower distribution revenue primarily in agreement quarter with decrease by $XXX,XXX to sales, of approximately $XX,XXX our attributable of revenue was product with Canada XXXX of the product under for connection prior XXXX, $XXX,XXX, offset the net to first devices the the prior of Canada year of

for cost relatively to the remaining first of for Operating decreased For quarter lower activities. quarter as fixed $X.X to million due the costs. of overhead quarter expenses XXXX development transitioned revenue XXXX, million $XXX,XXX expenses period, first year was to of prior of the we due by XXXX, U.S. in compared the to primarily $X.X first flat $XXX,XXX compared commercialization to product

to prior compared loss Our quarter in the year was of $X.X million XXXX first million the $X.X for period.

and diluted million of period reported first $X.XX share loss the share of net common last the a quarter of for million or basic a diluted $X.X loss loss We and compared net $X.X of basic of for year. loss per a $X.XX to a per XXXX same common or

first compared the the $X.X cash on extending of Our to for burn of reducing beyond our reflecting first quarter quarter XXXX. runway focus XXXX, our XXXX operations and was cash $X.X burn cash for from million million

As and of billion we XX, March $XX.X debt. XXXX, of no had cash

portion The our prior commercial fluctuations our PoNS. to refinements for may prior the patients first we exceed Company year as filling quarter company to to second U.S. quarterly expects quarter, to of currently make coverage levels, revenues we experience U.S. of XXXX some year outlook. insurance additional prior prescriptions. in their but now expects revenue continue delays currently to factoring of XXXX pursuing to potential rollout above quarter Turning XXXX and be levels

open With let’s call for now that, Gerald, the questions.

Operator

you. session. a ROTH Instructions] Jonathan question [Operator Aschoff Our MKM. will time, first question-and-answer this Thank of At from conduct we comes

Your line is open. now

Jonathan Aschoff

the strategy TCET taking I Good what’s the you. guess for CMS’ guys. question’s And of reimbursement afternoon, into U.S. pathway? my Thank Dane, consideration first new importance

Dane Andreeff

Yes.

thank question. Jonathan, are there and pathways, your two and for you hello, So

your First old the benefit coding pathway economic of and receiving is of fashioned the code.

quickest to TCET. clear reintroduction allow two first the of It four breakthrough transpiring be for for going it and our course, put receive to the us are but one bill to us designation MS reimbursement for and mouthpiece, We the back for under would is Medicare. controller for with the be and the right the into and reimbursed, fastest becoming what’s codes, that would way now one of years

Jonathan Aschoff

reimbursement in Okay. strategy Canada stroke? Also, what’s TBI for and your

Dane Andreeff

Yes.

with And we area. not are engaged only so the private provincial, TBI multiple right now nationwide insurers in but

the seeing data we that some in with payer the trials We’re TBI. dramatic – are effects doing very very been because have are of is excited good. And very, given we some insurers

in for them in up get TBI we’ll is, my in can for waiting reimbursement those the we not insurance we work only claims set a just start disability because that XXX,XXX, we’re claims those. and how average on of of stroke. to to eventually be can closing are seeing their also successful to treating should trials now report finish able We’re more to but and But if Right lot TBI belief TBI claims and back gait, companies. a balance long-term out XXX,XXX lot these also in those people so

Jonathan Aschoff

for if relevance, stroke does FDA U.S. to in stroke Canada What any mean the your Okay. approval? pathway authorization

Dane Andreeff

data that South outstanding first in We’ll Carolina foremost, reduction Canada, versus stroke we Well, be – in data, a launching application here itself. pilot to and and some rehab of the mentioned our which one therapies fall soon I had MUSC, to by the we XX% of our help just trial. hopefully three University

sub-acute, that indication we due only the at designation, have chronic it’s gait the in breakthrough well. mentioned as stroke, balance but and our a we’re to I and looking and second not also

in XX% indication of with in of because them time right stroke, million a have the tough stroke, patients XX% and the a of where walking about balance gait. X patients very So roughly XXX,XXX in but their which go is rehab stroke into million chronic MS, stroke chronic is

for down to exciting So go yes. time us path, that it’s an so,

Jonathan Aschoff

there five PoNS are still or for sites Lastly, there more? step are

Dane Andreeff

There is PoNS five steps, five steps.

are look of the them and very at enrolling, they’ve to with experience these them and we writing and safety Therapy. see. which due we but looking their to getting And also is opinion look PoNS currently key leaders experienced what patients forward data, forward hope are MS on to All great to nice efficacy

Jonathan Aschoff

maybe expenses that those to SG&A and Does cash the make your lastly, would flat lastly, R&D quarter-over-quarter, flat the say sense work, to down. even you it is your way are quarterly you? if Actually way

Jeff Mathiesen

Yes. is This Jeff.

yes, does. So it

costs First updating kind quarter getting and bit of that doing the a the annual audit have of little filings and on things meeting typically because the for be go the SG&A stronger ready tends some our that. into to and registration like side we

be well we’ll of So, managing be as stronger. And next comp. to a equity tends a again forward, that as make bit component to little expense we cash is non-cash And typically have sure go getting our closely really into the then we cash obviously year.

out. pulled gets always that So

Jonathan Aschoff

very was That guys. helpful. you, Thank

Dane Andreeff

You bet. Thank you.

Jeff Mathiesen

you. Thank

Operator

Thank you. [Operator Anthony Group. Instructions] Our next question of Vendetti Maxim comes from

line Your is open. now

Nick Sherwood

Nick or any Vendetti. Hi, Anthony from seen for sales HTC Have this agreement? results the you is Sherwood speaking

Dane Andreeff

Yes.

one-time this a – component It don’t more of type It typically we it renewed by kind the had again, thing, had on agreement. out that devices and the of Last we report of year. So customer. delivery big that have remaining of we part agreement. we revenue last of to came quarter, we from a original commented did do it that the with was year, been sales that

so And were included that devices put initially in agreement since those deferred revenue in place. original was

of be would into report we’re customer reporting by revenue to the forward But we a so not and out deferred each And revenue what necessarily on came go basis. on going quarter.

Nick Sherwood

number the trained detail. physical do online training total quarter have that you for And you’ve program? the the therapists for through trained in you you many number the of or Thank how therapists physical first Yes.

Dane Andreeff

released that Canada quarter physical that’s in they’re offering for training but we software new well. therapists We since say and every and new in up could new increasing clinics haven’t only started I online is have and to been All the therapists the those U.S., we PoNS not numbers. as register

Nick Sherwood

all time your Thank Perfect. answering them. and for Okay. you are my Those questions.

Dane Andreeff

Thank you, Nick.

Jeff Mathiesen

Nick. you, Thank

Operator

from Thank question Instructions] you. comes Cohen [Operator Ladenburg Our from Jeffrey next line the of Thalmann.

open. is now line Your

Unidentified Analyst

We and start you. feedback the I for with If just detail like appreciate some the on Hey, could Jeff. saw This was of sure guess us I’m to great. more meeting? positive, give the what taking presentations it the the questions. you Destiny of thank received. key but neurology our is be at I guess physicians feedback from actually that idea from an the is you you you that all in was I’d would

Dane Andreeff

Yes. Yes.

which thanks, full than and at we a much so and First conference last attended, foremost, had was Jeff, and booth but AAN the Destiny, you first better we foremost, there. sound

biggest about there, was CMO was guys. we response sales didn’t about heard team our we Our affairs, medical know there. guys, you was never The you

Matt devices we is and action brain. ourselves our from booth, regarding together of our [ph], of at neuroplastic put medical the we had team, a effects to this how was rest our at, the of how our is and that Look potential amazing. non-implantable up TV wonderful video from we promote separate there your mechanism

the was thing. first So that, that

that immediately. was bit then of a second thing the there And was little misinformation corrected we

weeks is would just you thought neurologists Some XX a true. in PT have that clinic, to and not do all

your weeks the physical take first and done your The two with at are therapist, device exercise and physical your then you your Therapy, complete last XX regime. home PoNS weeks

Unidentified Analyst

very Wow, interesting.

awareness, So some broader myths. it and of call want I busting really That’s then interesting. to kind

et pivot What How maybe are you then strategy. updates to And any cetera? e-commerce I’ll can that? are your Okay. just progressing give us, with you over

Dane Andreeff

Sure.

credit learning was quarter, our for the and experience it end coming full again few the near So believe year-end was quarter the looked first first at at the especially I our partner. a quarter inquiries over the and that it in We Destiny, first of and the and we card. we even and to quarter. the they way launched knew we’re lot is, we us May, doing are funnel meaning helping the where of through the and their actually top the to explaining into out starting people, more a to use at for site, the April for the inquiries check the and patients, them how bottom get improving

multiple There’s steps.

if already getting simpler neurologist. have a They you through funnel. to prescription. much now prescription, believe a If there’s your you a We you’ve our that do have how gone get confused were to way

questionnaire, within out XX and usually XX, telehealth gets gait, MS with Patient for PTAP, ask then if it’s you approved again you patient hours. could standard an appointment. your you are for viable Program. up be Therapy If way, prescription, don’t set fill be And Access your potentially That a a have the a

because important also hopefully longer-term it’s basis for and a only also And MS and the very patients of the be a for payers. neurologist, on patient, for us data registry but our we collecting we And to data is volunteer and registered community MS three-year the not are our offer a the registry. part our

Unidentified Analyst

Okay. Got it. you I it. that. appreciate for all Thank

it does go and Thanks jump for that us. queue. think I’ll again. ahead I in back

Dane Andreeff

Destiny. Thanks, Great.

Operator

At now Andreeff, to CEO for Dane this I closing to Thank time, you. back remarks. it like turn would

Dane Andreeff

we Thank Medical for Right. as the to bring you, to Thanks, Gerald. everyone Technologies it. continue Helius PoNS following Therapy who need millions

the We’re pleased the our progress Thank look so in We’ve forward you. future far. past come in sharing year to and quarters.

Operator

today’s conference. conclude your Thank participation in does the you program. This for

You may now disconnect.

Helius Medical (HSDT) 11 May 232023 Q1 Earnings call transcript