HSDT - Earnings call transcript Q2 2024 | Helius Medical Technologies, Inc.

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Operator

Good day, and thank you for standing by. Welcome to the Helius Medical Technologies Second Quarter 2024 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Michelle Bilski, Investor Relations for Helius Medical. Please go ahead.

Michelle Gable Bilski

operator. you, Thank Second Medical the Earnings Call Conference Welcome Quarter Helius Technologies. for to XXXX Michelle Communications, This Helius. of Bilski is Insight Investor for Relations With and are and call Officer. me Helius on President Medical's Dane Chief Mathiesen, Jeff Andreeff, Officer; Chief Financial Executive today's note the Instructions] call this www.heliusmedical.com. Helius to website Please and through the is be webcast at can obtained recorded Investors access that [Operator being the section of

publicly our as result or call over forward-looking new Andreeff. from or obligation filings report pricing to involve remind contain everyone our your Before our on annual recent statements report Form indicated, XX, time this a would available results that those reimbursement remarks statements we including like events statements actual inherent begin, update on required otherwise, information, the to may those which and to I website. quarterly regarding and on of statements forward-looking identified future by as turn Form based most the questions our cause recent are no XX-K Risk with risks to our of uncertainties call could of today in expectations All except on management. of undertake in law. I most differ forward-looking made section time would that responses from are to XX-Q. Such XXXX. as potential August current factors during SEC, like statements, our may be are updated that revise to We now to other materially the These including the Mr. and Factors

Dane Andreeff

XXXX Second Conference us today Thanks, Michelle, and Call. you, thank on Earnings Helius Medical's joining Quarter everyone,

innovative Therapy many been against makes recently have MS priority technology fight to suffering our but a We've [Technical seen get efforts has deficit, greater toward the generated balance and from our access. a firsthand difference common say our significant XXXX, patients MS. meaningful to Difficulty] devastating how as during and proud PoNS second as I'm of to possible. people momentum quarter and symptom gait And During

Jeff Mathiesen

dial another I'll you don't keep going and in why shot. and back give

partnered Lovell certified service, owned the treated our make accessible SBA April, PoNS to disabled VA Government with Services patients MS other Therapy in to business and at Specifically, we agencies. small federal through veterans and

VA network The the of largest system U.S. centers to in States XX,XXX of in the home is MS. excellence. a and integrated sclerosis United estimates VA care multiple live health The between with and XX,XXX veterans that the

mouthpiece only and May, Services General a lead the for therapy and potential in at Lovell's Advantage and for device. Then at the pricing PONs of Administration insurance for in of major DAPA milestones Also CMS and preliminary released written of carrier CMS and payment quarter, higher and a significant contracts was And preferred benefits is schedule VA supply know service in these well third-party $X,XXX.XX for $XX,XXX.XX for XX, inclusion important reimbursement this believe treatment. Shortly PoNS respectively. its treatment. We $XX,XXX for at for PoNS provider inclusion which we more $X,XXX.XX the on in as As approved for approved and PoNS development payers. Last reimbursement subsequent both May, PoNS the to Department in These reimbursement there third-party was $XX,XXX.XX mouthpiece, this assigned thereafter, is we're received all be HCPCS we covering levels strong in changer from was CMS codes PoNS we as controller portable were to pursue may and market readily meeting understood for for accomplishments respectively. and a both. but CMS at Medicare reimbursement a and for to public Helius, This the federal determinations May neuroplasticity, device the that May, and establishing help the of as and game a in access innovative PoNS first the and a the the July, we veterans communications. argument presented controller, with this accessible were the PoNS and device mouthpiece, their and rates members Defense contract PoNS that gratified the for were PoNS families, access mouthpiece. pleased happy pricing in

as appropriate supply lump to a to was item we reimbursed payment argued First, categorize sum structure. mouthpiece on be a that it the

involves As a tongue. a reminder, application the mouth patient's a XX-week and to life piece has

XX-month a appropriate. believe not we therefore, structure rental is cap So

invoices Additionally, the we used of reimbursement method. pricing previously pricing filling gap using levels discussed I pricing recent at contract be market setting the for and provided to the support to

articulated argued how pricing is neuromuscular also therapy is therefore, stimulation controller map such PoNS for Instead, we reimbursement and peripheral not not devices. to should be it We weeks. a expected to appropriate coming established the finalized, payment on XXXX. based final will rates to using in publish the October reimbursement rates be filling effective is gap market the Once pricing. CMS X, the methodology

as basis date, have secure established neurological actively claims VA June, we will in relationships reimbursement. Beginning and on throughout third-party attempts MS payers with building Florida began focused sites in the service we ground covering sales We having believe out VA sites other the plus they VA that the across the the and rep also Puerto U.S. a in to be U.S. with the boots on to XX patients are several critical We organization to out states, Texas assisting submit representatives individual building To have sales disorders facilities sales on a representatives one-off including Rico. established

has for to second Dane and rejoined. see pause if a I'll

Dane Andreeff

have, you. Jeff, thank I

Let continue. me

and progress and has quarter Brooks by neuro the open-label trial of the fully to of investigator-initiated Rehabilitation Carolina secure site using June, to on centers survivors enrollment which South registrational during walking U.S. on placebo-controlled Therapy removing and the also registration open-label chronic the The study been While is we Health open-label Shepherd participation Center program, enrolled. In of study have made groundbreaking as program, and access Neurology PoNS Institute pursuit includes delivered and in participation and rehabilitation a of the such our University and top This X much are to barriers was England. disability. Medical stroke authorization the Center designed in nerve balance stroke company-sponsored which of the neuromodulation the the study REHABOLOGYM, Brooks New where effects of establish balance stroke of survivors. enrolling. MGH our Rehabilitation Professions affected focus started of cranial noninvasive million gait addition with meaningful over at reimbursement, also and has an towards

establish the U.S. of on We impact therapeutic falling also will PoNS' in risk patients.

of In study in anticipate FDA to the based by when X addition patients to neuro all the expected sites we We're begun MUSC midyear third-party falling XXXX excited and to Board fabric XX new centers by about the May. bolster on to enrolling started of patients Canada, treat payers. which in the additional XX stroke approval we where the at already Review subjects effect to evidence extend the was on-label use to effective data will patients stroke. stroke determination is open-label part program X submit treatment further stand major of gait PoNS submission therapy for end PoNS We study, reimbursement reimbursement evidence stroke registrational to enrolling end will authorization in stroke begun authorized of enrolling Canadian of for participants risk support balanced in with in we've of the top for the significantly already TBI we approval where MS package the and into also national results in reimbursement quarter, of study an insurer with for and XXXX. The our XX with A study, of enable expand To and by across October has FDA June, sites across Canada, on real-world and the the Canada from at regulatory year. approximately Medicare deficit expect X, the be goal has of the submission PoNS the the us third rehabilitation. The research excellence the XX received participants price on of third-party established with a has rehabilitation Institutional in further secured that enrolling enrollments. of program Canadian strengthen at

in field growing, PoNS-trained the FDA stroke and remains is therapists number for of track. our submission The on

extended in more second into the And to people we we Given runway benefit we the milestones. I'll quarter goal helping to PoNS. see detail. Jeff financing XXXX our in results over announced now May, key of more turn to all removing place, discuss our achieving main our we a call of toward financial from cover $X.X that and barriers million ahead the with put path clear

Jeff Mathiesen

sales pay for first the compared to of pleasure the up June our $XX,XXX the Dane. XX% today. in be Thanks, of XXXX XXXX. with was as of both temporary a of you and in of of Patient the cash Access the increased a second revenue of U.S. quarter $XXX,XXX, pricing was Program on the for XXXX, result Again, result of XX, to quarter Therapy it's quarter in termination a Total decrease to XXXX May and second XXXX Revenue as the a termination quarter Canada. compared $XXX,XXX of

second compared was year for XXXX compared cost period, compared in attributable $X.X $XXX,XXX prior second general the relatively Selling, the $XXX,XXX For lower second revenue sales and XXXX. quarter quarter million period flat $X.X the primarily prior expenses to the same quarter to of to million to were of of the in year. XXXX, compared the the to remaining administrative for when reported of

by of the compared million were XXXX expenses of $X.X was of activities quarter period. prior for fall Research Total reported expenses quarter for a $X.XX when increase $X.X and $X.X loss second compared was a risk loss XXXX of XXXX million, loss XXXX. Operating loss quarter common driven the million million second the quarter for for million of of in of second for quarter a diluted million $X.X to $X.X the share. compared in the XXXX second or stroke quarter to second of second for to and basic net per in year flat development of trial programs. primarily We of $X.X $X.X the clinical and million the XXXX an

period basic in or average net a million due also number of outstanding. $X.XX loss diluted $X.X prior year per We had common and a higher to shares a of share the of weighted loss

ended from at months the June burn million cash and for operations $X.X Our flat X June XX, XXXX was XXXX. XX,

of XX, no cash in we XXXX, and million debt. June had $X.X As

we final $X.X the stock above announcing warrants X-year are callable includes gross within of extend during for May, that received by of runway price and closed of determination at consecutive controller trades public on company the million, for cash additional financing for In an proceeds net by CMS proceeds our which X million also This will PoNS into share mouthpiece that $X.X per offering million period. XXXX. the reimbursement if days XX and days or $X.X $XX

determination exercised, the We X operations final summer the expect and year. effective additional will into fund warrants proceeds announced of If of the well will in our October year. next second these be this half late from

due for a Turning muted of the on the price patients cash is been markets. that to basis To and outlook. primarily now a not our been have that the our addressable feasible majority in has pay fact date, they sales have vast PoNS to point

we of call Medicare our this our X cash us pathway with effective beginning the the providing this positioned and year, let's VA to flow. With are expected be now significantly the recent boost later revenues that, into questions. year, a Daniel, for reimbursement open positive to However, October believe inroads we to

Operator

Anthony [Operator Group. Instructions] Vendetti Our with comes from first question Maxim

Anthony Vendetti

on And price final what how determination follow-up of a impact the do then have be have And that do is you that sales? from you would will a I once So patients? on like stroke. think received CMS, pipeline -- initial

Dane Andreeff

Anthony, Dane. it's question. Yes. for Thanks your

patients claims we keeping been one-off right CMS have of a waiting insurance, which reimbursement. cannot because list long and now, Medicare Medicare their prescribers, their Medicare with We for file is of course,

list strong of we demand regarding do Medicare. So built-up very a have

Anthony Vendetti

the then And for with in you enrollment wondering Great. the trial? target 'XX? on half stroke are completing it are Okay. and of FDA still submitting patient for then just to where you first And the

Dane Andreeff

wonderful if is We XXXX. period. gives top well that, half of track. first with be Anthony, are a XXX-day designation, on pathway we'll as on FDA breakthrough remember, which second Enrollment of our track in submitting using forward as truly us you on notice

Anthony Vendetti

helpful. that's And with are TBI? No, Great. last potential guess question. I then Okay. or studies expansion you one for Where

Dane Andreeff

that Right now, we're investigating into still TBI. expansion

of long-term to Pacific that work, last their X balance of for XX Blue patients study PoNS and to work. back after the Blue work X for and go their had gait of that claims and white aware, stated X out PoNS came we back balance $X.X had disability back to X in Pacific the where late issues the which of Cross weeks paper of using are own you gait their out As claimants long-term the disability approximately to X do year, therapy million. X Cross no longer therapy saved with went

significant So analysis weighted PoNS traumatic cost-benefit brain for a is patients. towards therapy that injury heavily using

Operator

now questions [Operator for to I'm like further at would Instructions] to turn back showing Dane time. it no Andreeff closing this I remarks.

Dane Andreeff

Medical difficulties. thank Technologies. Daniel. for the Great. But following Helius My apologies again technical for you, Thank just you

and as look and year heard excited this updated authorization for As we we today, reimbursement in keeping the in pursue stroke. at we're where about to forward you you've coverage stand truly point

very thank much. So you

Operator

for This Thank concludes today's conference you participating. call.

now disconnect. may You

Helius Medical (HSDT) 12 Aug 242024 Q2 Earnings call transcript