Inspire Medical Systems (INSP) 6 Feb 242023 Q4 Earnings call transcript

Good afternoon. My name is Dilem, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Inspire Medical Systems Fourth Quarter and Full Year 2023 Conference Call. [Operator Instructions] I'll now hand the call over to your first speaker to Ezgi Yagci, the Vice President of Investor Relations at Inspire.

You may begin the conference.

thank for and call. in Dilem, you, you participating all today's Thank

released the me and December release Financial available Buchholz, we President Tim XX, Officer. on results Executive today, Joining of Herbert, is Rick XXXX. Chief A are the months and X XX Officer; copy and Earlier our financial ended for press Chief website.

laws. events our and and and limitation, will materially upon risks the financial assumptions. in meaning year operational XXXX differ. financial are federal and securities statements On access These those and within in of without including, uncertainties based that to statements financial this current All make various call, condition, to statements, estimates outlook forward-looking our operations, or changes could material management market cause involve results our business, relating forward-looking results actual the investments full

any you Accordingly, with of on these statements. on the description SEC XX-K, filings Please XXXX, uncertainties. place for our Form file our with which see and including a reliance should February disclaims risks not intention to X, Commission to Inspire plan we Securities projections these the or of undue February and XXXX. speaks and law, Exchange the forward-looking broadcast required or of as live financial This because events any today, new X, contains except statements, whether future or time-sensitive information by of information, revise otherwise. update call obligation conference only as

Tim? my pleasure is it the over Tim that, turn With call to to Herbert.

of update for And Thank the everyone, business fourth thanks, quarter you, XXXX. call for our joining Ezgi.

of and on experience the business, this patient strong and top finish remain that to as ensuring operating with first patient foundation our know very outcomes excited we our is with has to our a We and priority. We our are to therapy the possible and quarter report the committed Inspire best discipline year. focus each income

including the ongoing improvements the therapy, demonstrate that benefit highlight activities today's technology accomplishments During can in that planned on population advancements call, from to many focus Inspire. the XXXX and patients, from our we will broaden access to

also discuss XXXX. full year will We for our outlook

to years announced the Dr. Board of Stockholders. Griffin We would is inspirational retire, like many development our Last after the retirement our individuals and planning an been directors to our very joined of of week, XXXX following to special from having of Annual a the following recently is Dr. the Inspire XX XXXX leader one Meeting back service. the take Jerry Board Griffin, Inspire we who announced throughout commercialization. original in on that recognize has years who X and Board conclusion moment

medical tech med To Curet, our we of our recently maintain industry with Myriam a the Dr. doctor Directors. announced appointed extensive important medical Board experience that Board, business was influence on to and

to our announced the in yesterday, from members Board, as Chair Nelson just has the Secondly, of me we of and great on leader Marilyn following and and husband, XXXX had profound the her Directors. during the team business mentor Glen on others original her impact serve retirement Nelson, organization. Board Marilyn Marilyn Chair. and and our the Dr. a joined Inspire's of Carlson as across Board many time a passing

for role Inspire I of Marilyn's Directors be and Chair ahead. am added growth years to and Board honored forward appointed humbled this to many retirement, look continuing with conjunction to the and Inspire of In of lead

and as of Corporate Ellis Officer an Medtronic. Chief to has extensive Committee. role Board the the appointed career serves of in Board Governance appointed Gary the Lead to XXXX Finally, And of Financial was he Inspire Chair currently as Gary the following the Director. Nominating

them Inspire will for phone remain we always call to away, and just be miss family will Jerry and thank Marilyn, Inspire. a and we they in sincerely While the their will contributions

filled was year The XXXX. of review important with milestones many achievements. and our to Back

excited XXX to compared XX increase that, received warning the quarter, treated events and to In provide been the expanded results. approval with that are and of Index review from XXXX. to fourth the representing hour therapy. Inspire indications to Inspire announce upper year, Body XX Index the quarter We million, limit a Hypopnea the We per of revenue have syndrome let's with XX. With XX% Mass fourth the generated FDA increase we Down of patients from Apnea exiting our XX,XXX to to increase over to $XXX.X pediatric patients to

new growth increased continues existing by centers is the to utilization at Our centers. of be and by activation driven complemented

XX% $X.X million. million, revenue last declined quarter period year. Fourth a $XXX.X International U.S. revenue increase same the over to totaled XX%

As of polyurethane-based on we Regulation Medical supply awaiting we quarter as third our EU earnings European our we during leads quarter, MDR call, Union depleted Device still fourth previewed Europe or are approval. in the

Germany to MDR received more We have silicon-based and enables ship to and This a in contingency those while derogation MDR to Netherlands are and countries working leads as pursue diligently in approval. we Belgium and obtain EU Switzerland. in approval us continue the recently authorization EU

business, to represents we reaffirming XX% year-over-year to XX% revenue million, in guidance our over growth $XXX XXXX we $XXX.X Given revenue of which our strength seeing the million. XXXX are are of $XXX million

income, $X.X We which thrilled to our quarter are million. report totaled first operating with

million quarter fourth per $X.XX prior per to net of to Our year was million in net of fourth share the quarter income compared compared $X.X $X.XX income XXXX. diluted period, for share represented the in $XX.X the

operating leverage to will and we as and continue XXXX year. profitability move plan through the on in beyond progress focus to steady towards We

We provide following guidance will our first earnings. quarter further

strong expect to new to per the quarter by centers, adding ending new U.S., to centers. In increase XX XXXX, the capacity support quarter, of with therapy quarter. X,XXX a total we In we to implanting XX during the Inspire XX continued the demand for activate fourth centers our

XX to add quarter, Regarding fourth we total In quarter. sales the U.S. our team, XX territories per new sales XX XXXX, in expect created territories we bringing sales XXX. the to to

scheduling such, to launch approved success to education ability and therapy our new direct our through XXXX Care expanded on over to continue is testimonials. digital we'll Inspire focusing in initiating this we therapy, drive to in direct-to-consumer-programs Advisor Inspire including excited and we program keys new of inspiresleep.com which website program XXXX. in our XXX of increased features XXXX, were the awareness on a centers, in physician a December, One As our After through Program

and expand We through also Inspire patient an nurturing continue have who campaign continued in program patients to called our visited interest our expressed or therapy. to inspiresleep.com e-mail ACP

access. market to over Switching

we patient positive a market XXXX. Our number access of team Further, our we quarter strong assist our continue to and for demand trends a therapy which vendor the the increased to authorization patient strong with to process, reflect authorization submissions, and Inspire results fourth demand. expect in that onboarded third-party prior growing capacity have increases an prior meet

clinical The payers our into access the necessary engaging with actively payers the process team team approvals the and coverage received market The requesting on indication clinical been year. implementation providing with payer's this involves has information expansion past policies.

progress the policies have expect implementation been further numerous into XXXX. in already We with and successful

procedures. we first continue been expect once with in patients payers study. We replace for The work or when our and to the will to research as long-standing by the effectively designed XXX and Inspire. PREDICTOR capacity assess to an publish to analyzed. perform additional update second make in early of set full experience We and to clinical results completed study Inspire policies their if assessment is unlock flexibility the available, drug-induced the will This should evidenced significantly office provide has are patients can investments sleep of in office-based procedure enrollment improve DISE. ready the assessing which data results physician endoscopy quarter subset are to Once the PREDICTOR patient

need product V is questions V PMA the diligently remains system supplement. lead. On the Inspire sensing into the for sensing accelerometer pressure removes development and neurostimulator The on robust. side, response using Recall, working the our the to incorporates on capability our an pipeline the FDA's team Inspire the

completing and in system are With qualification limited release and production approval testing in level to the normal are commercial a we to market FDA. full launch XXXX, submit time, in targeting XXXX. to expect continue review we We

connected own programmer tablets our and the programming physician future our way system, we the need launch SleepSync the in paving part XXXX, as provided to U.S. Inspire their for will physicians screens allow will computers for the Looking access ahead of eliminate This the called new to programming remote from programmer. programmer. physician patient

digital We SleepSync continue our to the on patient experience platform adoption work long-term and the to contact initial longitudinal management. through of streamline enhancements increase from

In education the outcomes therapy. summary, we and patient of remain focused to Inspire adoption physician on continue

Rick by I'd existing centers place for over strategy are our turn have our at adding excited capacity to to value. call to the of new remain that, utilization while prospects With and increase about financials. centers. to in stakeholder the appropriate future like we confident We opening that his long-term continue reviews drive will We

the existing everyone. million, fourth an generated and from XX% fourth include fourth Total year Thank driver direct-to-consumer period. addition was continuing growth the in number quarter growth million territory The U.S. good million, increase and in $XXX.X a the you, U.S. the the of for XXXX. $XXX.X Tim, primary centers, from utilization quarter quarter higher Other higher XX% afternoon, implanting $XXX.X of $XXX.X the in revenue our centers. million prior of of in was marketing a was at drivers the managers. revenue the increase new

decrease was outside is a U.S. Revenue XX% the $X.X which million, year-over-year.

to of the EU leads to approval As in during impeded silicon-based Tim noted, ability fourth the due this ship quarter. delay MDR was our the that Europe

$XX,XXX in U.S. year The the fourth average quarter period. to price the $XX,XXX compared prior selling in was

U.S. in ASP of the We current remain ASP the the to during outside fourth $XX,XXX expect compared the U.S. quarter level. the steady quarter $XX,XXX at to XXXX. The was

the compared margin improved Total the XX.X% corporate were in continued manufacturing in by compared of as was fourth increased and quarter The in XXXX. expenses million organization, was increase was the for fourth volumes. to direct-to-consumer million, programs, due planned yields period. the higher XX.X% marketing fourth year-over-year year development of driven efforts costs. to Gross general $XXX.X sales XX% operating an and increase to of our This quarter product increase quarter prior the $XXX.X expansion

million driven $X.XX period. fourth compared in the quarter our prior for higher income million. ago. income by compared dividend $X.X cash interest investment $X.XX per increased income quarter year for to number and income average million of in prior million totaled fourth quarter weighted Interest in of rates and a period, was net year outstanding The share higher Net million $X.X to was the XX.X This compared $XX.X diluted representing year shares compared of fourth in was fourth the on to the quarter share balances $X.X the the XXXX. diluted per to

shares expect the We quarter outstanding first XX.X approximately weighted to million. be average

procedure increasing XXXX $XX on centers Our and implanting and position The strategy strong year-end. at total centers. volumes million opening allows training executing existing cash increased $XXX remain at by cash our and new million growth were position of focused cash to in investments us while

Looking XXXX. ahead, to cash expect positive year we generate full for the flow

$XXX.X For totaled growth. full million year XX% XX% outside over was XX% XXXX, or the the a million $XXX.X revenue million. $XXX.X revenue U.S. year-over-year or U.S. growth totaled a while revenue million, $XX.X year-over-year increase

Moving XXXX on to guidance.

seeing continue compared revenue trends our range in of business, million XX% in are an be the XXXX of With we $XXX we year the representing full to million, expect to year to to full revenue. strong to increase XX% $XXX

full gross of margin XX%. the XX% to be expect We range year to in

we territories establish in XX XX U.S. U.S. XXXX. noted, XX and to to Tim As XX sales new centers expect activate quarter new per to

the in have the high business third from reminder, exceptionally XXXX a in was strong on quarter the the first given fourth recovery we seasonality based health deductible quarter. the plans, prevalence historically As Furthermore, our of quarter. seen of

As to levels. of seasonality compared pronounced in first XXXX quarter such, more expect historic we the

continue for XXXX. operating of half improved the leverage will our second expect profitable into to XXXX be We and

We provide first earnings during will details additional call. quarter our

confidence open outlook now strong you questions. In our prepared performance up line Dilem, conclusion, remarks us XXXX. with momentum our are in With for the provide heading into and concluded. business that, our may

Piper [Operator first question I our Adam Instructions] of Maeder And from show line the Sandler. comes from

What's start for and I and can leverage a see XXXX, on just quarter. to me to the go great okay. million of through into the then How maybe Maybe puts assumed the guidance $XXX year growth? finish detail around Just label sales some there? and expansion, you I walk a or thinking the million, Tim Rick, hope $XXX nice to to follow-up. X on more guidance in launch? about are Gen the hear in little you those and a And congrats the you bit us can takes have the utilization same-store just

focus that growth to think, number in going primary centers and one, expect XXXX centers or same-store to first certainly centers. Adam, complement what centers, quarter. we our we at number a provided the are we're the I we continue we with procedures we're of building trend on to But open going think new ENT I on utilization increased at guide sales seeing of is get We as driver again, that into expect the the to existing increasing and done to on new XXXX. and opening the that continue to capacity existing

And any in Tim, figures? around the the or those comment, Gen expansion impact X label

Sure. be launch because in of I we'll full big have a planning a we're and play don't think that a limited in will Gen our doing launch plan XXXX, for XXXX. X

now. with about that think high in on. is the primarily with will Syndrome further So strong pediatric XXXX, and do we'll have start the Down indication time to some I to talk getting the right AHI population expansions awareness show

have endoscopy use driven to obstruction who a and have treat that by That's high of is where BMI BMI patients and lateral obstructions. we having sleep action, high we're trouble. those with today the wall patients tongue-based Remember, mechanism really

where targeting. In fact, that's we're

of may Some GLP-X. a patients from those benefit

the That's I have as can income. this feel I that quarter, any bit I phrase that just was 'XX, but color. constructs I a think think operating leverage course about good you in little us like to models, over I more it leverage in potential is Rick, steady for us know framework year. XXXX you variability And focus there's sounds detail. we I about heard a I and this year. to seasonal the to the And hoping But positive or profitability of some move heard like flesh commentary could give out and the ask the towards earlier, the

we first in seasonality, And in expect that. have We have for quarter. of that do adoption. And that see does saw second to seasonality touch can expect we the we We we did which But and to the Adam. we as we on fourth Yes, later, model. grow Thanks, improve, stated we Sure. leverage our to the in leverage remain focus profitable operating top the why driving that we on strengthening therapy plan XXXX. of growth demonstrate line we I that's be do the guess. But definitely half expect our quarter. that

And I next show from of from Travis Bank our the line Steed comes of question Securities. America

I follow-up revenue had for on 'XX. on Travis. [ the This for Congrats is on Caroline ] quarter. the a guidance

baked you for expect you If could the battery through coming year. start into guidance just that what's talk that to this replacements about

limited So here, the I'll an you follow And also question. us up the where to the on heard the for first of wanted 'XX I FDA? launch at with then question the I a V see you're give and full could and submission to reiteration in Inspire on 'XX if release market then update second in

is replacements Thank you. Battery XXXX. be limited going still to in

some of commercial will through. We see start to coming the patients early

was years, at XXXX XX years, patients in commercialization to of life, the But us trial year who through add 'XX seeing and puts XXXX. STAR are battery still We participated today. still first coming the XX.X

to until really a for through couple very significant this So start but but more get volumes, to a impact won't in we that promising. still larger coming it's have year, years we'll coming see

the As far just XXXX, final do commercial the year working the team in doing and that be the full in to later later ready the provide and is for FDA, submission, great opportunity to information approval limited and launch going XXXX. we're to as do V launch be a job. to Inspire documentation a in able provide hard team is targeting testing to through to We're the to

JPMorgan. the Robbie show from Marcus I our question next of from line And comes

Robbie. This for is Lilia actually on

that is be in the thinking mind challenges? year levels some about of of On supply? for to time in line growing return this can business, keeping a international and how normal And light revenue there we be we the you supply should that should of when

XXXX. in good very Very our Germany had you question. in Thank approval, with primarily derogation getting We much. challenges

comes does us approval that shipped to advance some While to of changes that require EU product in being identify MDR. labeling the do through, derogation

it's we to back we a both we but very EU state, quarters in today going them and And to hopefully, we year movement, steady back are Europe. get to MDR. Germany, are those to but couple for derogation But So making take shipping the in be that with get up. countries full progress a probably coming that's product in of able silicon of leads also to identified getting the rest done promising can provide the

Michael comes Jefferies. line question the Sarcone from of from next our And

wanted you start. somewhat possible, you're year and this just then thinking Just to elaborate And cadence? seasonality quarterly on quarter? is Maybe activity so trending how the give us maybe about on through if update, first far sales how can an

Absolutely. steady. of be able the at think we to with comfortable very the the JPMorgan fourth cadence little Rick our guide to quarter. conference. specifically continues strength organization we're guidance let touch the why quarters, I'll Well, in the set But with I comfortable that forward. or about -- the exiting here felt the of the reconfirm going preannounced we're seasonality quarter, as the we guide of initially bit progress a first That's be

the Thanks Right. for question.

high commercial remarks, have the So with mentioned plans quarter. deductible in the I do the as in a prepared stronger fourth we mix

that So into quarter, a see but recovery the did we first seasonality quarter the also, we from little generally fourth in the see quarter. third

might XX% and growth, at expect And teens midpoint. seen mid- there, typical between from to guidance our it you've it and we more where seasonality then to had $XXX some that's we to seasonality the grow, QX, a into and the so have seasonality plus our strong return XX% pronounced sequentially. the we stronger So from and and QX, mentioned the very have range fourth we high is given quarter, could million

just the in income really, on clarification that guess, I then and on hitting And profitability Again, operating basis? it. just, half of -- profitability. follow-up XXXX, is a the second one Got bolt profitability net

Yes.

As then is for that yes, will be year. of we sit the the case, half second that here today, the

And UBS. I of from show next from our question Danielle Antalffy the line comes

a and Congrats to forward XXXX. strong XXXX end to on looking

question the I one X Tim, guess, wanted I I So -- to have questions.

And Just some you've centers, patients first that's investments bottleneck, on there. sleep going know made sleep I getting through to centers.

just SURMOUNT-OSA sleep curious And those have how Just love Or a bottleneck? at do some out? the ahead is to investments I -- coverage of And to what about starting ease? that thoughts panning been centers would still Inspire apnea represent funnel 'XX see of coming get patients? that we on sleep impact they point, maybe 'XX, for do any in mid-year-ish, how think the should more and for assuming obstructive then

you. you from much, Danielle. Thank very hear to Good

As educating taking with a sleep go, more and patients even to sleep far that physicians spending as higher. of involved the the lot We're specifically even be management. and time centers it's a step involving longitudinal with

the to going we've that be or provide different going opportunities sure we areas testing require the next centers. diagnosed. and trying And we going be them parties while continue to today to the specifically sleep we studies focus XXXX lab to with can assess the do to ENT, at sleep those challenge on and sleep we're That's performed in a home that of polysomnography. to the be to a So sleeping. building and properly -- able to going forward will capacity building help for focus forward not capacity with But enough different testing to around show know talk had A make be able remains the sleep beyond. work of to and payers a because get be challenge to the sleep lot patients that's of a sleep physicians home value be into

years on within the payers a And require sleep moving study of we most do Inspire. current with prior know, to X

the in be and little for yes, reduction earlier As going far bit data XX% as a SURMOUNT-OSA a that's to a trial, challenge of drug. successful hopefully, We will know in the We like show the year. that would come hope out AHI. it's to can

have of Inspire average of As study indication those the with collapse qualify BMI long Inspire for a of XX, in that the reduction loss need there majority the high and they when the patients the with AHI, a study lateral a demographics see won't the average XX% that. as because XX patients is associated having really the But weight move an we that compliance support to today demographics, anyways and we to on of wall BMI. of at and really look approved the into to

but to we data, after as So kind we flow believe not look be of impact patient XXXX. tend this any and forward forward have it's our year to move to on we will positive seeing that do going

And from the I show from our Richard Newitter next Securities. question Truist of comes line

and quarter the the on profitability well. as Congrats

maybe questions for me. X So

this coming, outlook if doctors I I'm you alike. if all? the device, and any hopefully, with just the first, year. The guide it's potentially the Inspire and is if just they contemplating what, expecting know V launch, that. or Should approval impact a patients there have that contemplated you've delaying people coming, be anything, it wanting we is for curious next-generation guess how preliminary at in an later

We challenge believe therapy. are be a will a motivated are with that they moderate receive receive and replacement. patients severe untreated We who Remember, quality delay. motivated patients device with about the life, therapy. we're to have are sleep of Those significant to apnea know don't there to talking

plans system, the system very as later the in so you're the dealing And And when a outcomes. provides well. high year very IV deductible also, strong is insurance Inspire with talking strong we're

a built from when haven't from with going believe on silicon and remote extent, lead. prior launches device polyurethane the the will we the this we Inspire lesser therapy, patient model. any the therapy went new to and delay the and, II consistent patients is into to with that device So Inspire in to We IV continue with

into We any we sure our that. track So patients expect make appropriately, guidance. we We the but to see of educate we are that. built and not that don't delay aware have

unlock where number trial. you exist kick more, like areas, those bottlenecks intended one be looking that throughput the of of removing V DISE with time And capacity [ frame. there and onward XXXX you of more to curious can do kind Great. also one their feels you you the to level of issues time us have maybe the a lot is? Is We're confidence PREDICTOR hopefully some so capacity that I'm them. necessarily think Tim, into will or we initiatives really do could to initial It how that a about talk in what utilization threshold Or about Inspire have potentially just into give some of the problem? a that won't us run before XXXX possible ] impact your -- though just think won't guidance? And frame. a become there where within the context of that

Sure.

think the ENT the today. And and we experience last about is it's real the to to And capacity talk #X very surgeons the thing and years, additional ENT having it it's over the just keep I and confidence. strong method simple, increase as a a having ENT several increase in is let's progressed utilization gained step-wise team.

management their the do performs who longitudinal ENTs manage diagnose all with implant also sleep know is to to longitudinally. the centers can the procedure, a gain progressing the be but the the the to a to the physician can takes physicians So It manage they that centers able proficient. procedure, are time do have that are the strong they less help to centers quickest a with team of but sleep patients, to it's strong those more of procedure, at who procedures. utilization cases become available more confidence do ENT essential that able in more Therefore, partnership roles thereby the patients keeping ENT and team have

getting operating necessarily don't time. have challenges We room

to getting time flow. bring challenges patients We operating procedures. enough ENTs. our do to know the to be direct-to-consumer ENT challenges we the in the have And patient with have don't We room certainly

take the we outcomes. we're ability programs of can website utilization, best the them the get including centers really and make to So a experienced. best have more and the opportunity that centers the have the have focus patient to refine outcomes utilization care with go on highest going our sure patients that to because bit, to little positive know They're and

going simple call help mentioned things development mention we that it's the the the patients about are in our in not technology slightly get to and XXXX, help So SleepSync what system with drive to patient the to us our appointments. throughput

we're to couple grow go OR going and continue of Inspire multiple be here work items with there's a down DISE reduced basic of on we XXXX to XXXX to And we there removal with mentioned, in utilization. is time. to PREDICTOR as then of lot a avenues success. But key later V to in So perform will need continue

I our David of show the Rescott line next comes from And question Baird. from

put you off the the diving you in strong here. of year. of start that international. to around growth where I levels. accretive given of this and commentary guide Congrats in comments the kind derogation know to made the on a of couple take to little the just XXXX with if It's in the growth year I wanted finish company to by around you a bit international mentioned you into -- clarifying just quarters normalized the be then growth returning total get growth are some wondering some levels. these to But back would I'm or markets to

That's Absolutely. a question. good

is start there. allowed strong we that after because And to we're product earlier shipping now start think Netherlands the relabeling 'XX they strong fourth derogation are able product in quarter effort. Belgium really the the I in had us know that coming shipping to Germany back and

in going full country. some able believe We growth to that France to with is new be excited. realize to announce that countrywide coding the We're along 'XX reimbursement in

some can polyurethane the We we're and those have France. up implants the doing excited countries. So to do now continue about U.K. that into Australia help launch in coming in deliver we leads

as And Japan. going to continue countries be get we're Singapore and well. then to to those online So we're hard in to going work in able back

So we do that? year and on see more positive comments growth in the Rick, any

the rates lumpy, David, U.S. a markets. of overall international comment will, on roughly given our XXXX, an the revenue. we expect growth basis, to revenue right in a outside quarterly worldwide of been still X% be little we go forward, if overall have further as dynamics the basis, on I'd our around just But you

helpful. maybe That's investments on of point commentary think where half in from and are you of profit level. And think jumping sustained there you that getting standpoint a piece. a half about of you second of beyond? the around of XXXX any profit next the XXXX go penetration the I this is the into and then as profit DTC just off being then When reason Okay. appreciate XXXX sustained more I the several second some over kind know years, this shouldn't targeted, to level kind be

Yes. about in we the in the basis, guidance fourth quarter provide but excited demonstrated on confidence the leverage our we I revenue annual that XXXX. we for number an have mean and we're

to pronounced our leverage. XXXX, And our giving more we'll on with We're We not as demonstrated have that. going leverage you've profitable but seasonality but in any leverage to annual some we're basis, half comment lose seen. to return we're second build long-term of QX, that the but guidance, for then of we'll that be continuing was an

Group. comes question next from Petrone show line the I And Mizuho of Anthony from our

out strong Rick, and end earlier -- on a year start just Maybe congrats way. it Tim utilization, the solid different strong put to JPMorgan. you guidance and that to tackling at the one

exiting just north implants math of that shows X quarter per you center per Our December. got to here

patient a bit have year? rest that flow Or a little for lumpy number X UnitedHealthcare. will then I'll now how right on the comes in? And just wondering jump quick to the just one remain of is So off follow-up depending

Sure. Thanks for question. the

just procedures per month. that's just -- per over So X, center to clarify that, that X

Yes. correct. That's

that. about Sorry

over just we add more more we up we've to it that centers, quarter. continued had in a under X on centers, and needle year ago basis. Yes, gets as continue move do X the Again, to on just the but we're utilization, to year-over-year a X,XXX to fourth just difficult

needle If there's that. XXXX does at it you to it's that's for and quarter, beyond. room our one on goal -- improve difficult each more but look of utilization, a that lot to move think that's We -- the of

our came XX% XX% our growth, growth at of new from basis, annual growth came of an existing our On look from you centers. centers if and

that's of business, signifies kind consistent that a with XXXX. healthy So and

to So continue implanting we utilization. can centers, maintain move that that, if new add

quartile, If north you per doing well X at top of our look month. they're procedures

buckets all those if you want will. so to we And move up,

real a for focus that's So us.

follow-up basically the it the on year, FDA United. huge with if slow it the thresholds They're turn they net-net, AHI and mandibular down put X. a in them bit. to Positive And Jan BMI maybe earlier positive. a announcement was But in you but will, there, like style line looks in on

UnitedHealthcare from expect there from we do hearing flow and what there? patient payers that anything maybe is you're other out So

to for severity preparing educate Thank anatomy We right with prepared their going to careful our you appliance. had very deal They devices qualify are information Yes. much. don't appliances the include mandibular really or notes there And policies very or be We're they to actually it's have to UnitedHealthcare. to they past. oral patient's the the sites in to prior regards when in the that and some if regional centers their able the in qualifications. think affect oral documentation, authorization the physicians

a bit have practice this of on we dealing So UnitedHealthcare little with subject.

are authorization of from forward. just are patients necessary the prior put we we the move kind we we that make that provided sure the submissions into such get when the All the approvals, information centers authorized so can prior

a make significant from with to see patients a pediatric kind payers in other UnitedHealthcare. don't that and to any we the population let's point, high XXX of that's to for highlight So BMI warning your sure win syndrome. expansion that AHI and the we to it Down is But unique the a XX, the

and in in don't there, work really back being it that. to see continue push we continue them on it's we'll on But with disruptive the UnitedHealthcare, we So to year.

And I Brett question line show comes our next from the Fishbin from KeyBanc. of

Tim and off. start wanted to Rick, just

past the their to nerve had stim a device competitor announced in hypoglossal Over a later launch objective we month, competitive XXXX.

future this hoping you the So just do bit think outside to time? protect guys And have market. for competition normal of I about you're of you on anything might in that potential about you does in the event happen that was share if U.S. actually to just practices, the thinking update a market then an how from

U.S. already indications not international that Inspire technology. We the and the people created what to attractive. that system. coming you call. SleepSync we've treat market longitudinally And to our the here medical company of the the Inspire But We continuing on through everybody. markets there as we we that obstructive about while market we know with and And mentioned Not mention technology groups little is very watch apnea. both our in We're one VII going different sleep largest We resting and ability are VI we've are other these available course, we're give this of have it's up, in health developing, past, currently to digital and quite stages And the industry. patients know on about be manage bit in to are a of one approaches. in pursuing to who mentioned several V others talked have and development. able grow early

out all we're challenges aware today. may know we So there putting some evidence. on some well and out know with the We out clinical some We don't the yes, our rest be competition technology data, there. of very of the

approved the that evidence superior we is on today fact, product clinical evidence the to with In STAR our were trial. the of

So and we'll care grow to to adoption take the do continue Inspire. patients our to continue everything of of

And All then right. Great. my just follow-up. for

plan potentially I a talked the know XXXX on territory. part the You call France is of little And reimbursement about bit that in securing today.

you the little a if opportunity provide and that market reimbursement you on curious view Just bit accelerate detail more could how into region? commercialization how potentially

Brett. much, very you Thank right. All

year, physicians coding And last been to next countrywide the developing system. announced I It the in France. they for the that been reimbursement yet was in progressing reimbursement, step, is criteria think through it the France, implement to formally yet. has and approved which announced that not went has

to that some we We launch. to positive in for hope the have in is with a a very near that the be France in we XXXX. And country team that do We yet We expect do hired. manager preparing have have report progress happen future. that able to

able pretty growth other believe ramp France. And we're at to to our ramping been significant So France be going we a is to have look very demonstrate apnea in as what in with for Inspire to in that the for Germany, going in and area the we've sleep a key And opportunity excited significant again, then about technology. Japan.

with launch So very to made team to announcement working excited and be we're to keep about to and going able get the there. the for authorities our France,

our Kratky Mike Leerink next of line show comes from Partners. from the I question And

by failed the specifically appliance a today therapy? portion Inspire what therapy, oral and I requirement getting changes have then on new policy recent the already patients appliance Regarding oral a follow-up. therapy United, of tried sense of you do not And have of have

of majority them. the think I

of well most use patients, CPAP think been apnea. not I successful or them documented all severe that introduced but attempted patients, obstructive well haven't oral with if to for most sleep have appliances been

In most mild, or fact, it beneficial snoring maybe is moderate. slightly with

anyways apnea. not I that desire -- anatomy, oral our on start majority don't their of probably or based obstructive for and their have severity So think it a of the I because wouldn't the been patients have of sleep to to introduced appliance qualify

going a necessary Or of get able dentist it. as oral therapy to part that patients get process? without custom just to then a Got most appliance fitted? And the Are quick is to Understood. the follow-up.

And going that jaw of create oral to have to volume make cases movement. dentist that's enough will the can your forward apnea, going the moderate need to it's obstructive be you the to able you uncomfortable That's may as as limited imagine when sufficient to address to of the have sure it you apnea. experience more -- to lower that be base if to able able pretty effectively you much a pretty Therefore, appliance, to movement of severe cases. part to jaw the forward because forward behind to to be severe -- In tongue is some to you're the sleep sleep with be properly move get get an lower millimeters. fitted XX

from our And Larry of next I Biegelsen comes question show the from Wells Fargo. line

Larry. calling Lei in It's for

please. First, clarification just on QX, a

the You the $X catch-up later. delays U.S. that, million was? about Maybe Germany bit the of mentioned was you little able in million, perhaps quantify came of Derogation now. a related procedures. QX how QX, because of $XX that also in some in much you of headwind outside strength there catch-up number. the in talked to kind to And Are

number? And had impact QX. that some a quantify in So obviously, I Are have that to you follow-up. able

Sure.

first the some will quantified haven't quarter, in There's quarter or but haven't fourth in of into we not some QX, did in the of done First, we get and mentioned strength before procedures quantified the QX. We've and scheduled second procedures some carry completed it. XXXX.

in take would first come had quarter. see fourth Regarding quarter. headwind outside -- -- will a $X to that before we quarter? that. few in that the That's be we could mentioned clear Will saw, Probably that a about the will That U.S., million quarters the what the fourth we we through we in roughly, see not.

in be won't there we'll quarter. or the So that. bolus first second through work But a

we the get that. on some and did recently, derogation. labeling As Tim most mentioned, for Germany to through logistics We had work

now that but see amount. in And January, there. we won't late a shipping so we in through that come But are really again, started bolus

you in file your so XXXX. talk to are to getting about super I QX, follow-up level perhaps still the talking my That's 'XX, about that QX? think And still in how we Can clarify, V. And question helpful. Okay. later it think in Is QX? about 'XX. you planning Are Inspire confidence in relates early heard approved comment you early I 'XX?

Yes. Thanks, Lei.

to the submission we submission putting the specific in as working final is technology include both going software XXXX, we we in the development well. in and we patient that submission system-level program in the full the approval as on think do have the We're want not it's when have not team submissions. will is out on changes, launch physician limited I Inspire confidence XXXX the work the a FDA a data or to neurostimulator, but or with software V of our changes, that only the but and program do want

our So the that targets we're pretty previously. -- with consistent laid we out

Okay.

is reset? the timing QX clock versus sorry, the QX additional the color approval, on no QX how So whether versus -- on

to drive process we're and FDA Yes, has to continue review. review work the the to going to their with time FDA

more we'll color careful any be into yes, that. So about putting

And Jon line I the from of Stifel. comes from next show question our Block

utilization utilization And revs in opportunity 'XX get year-over-year. down XQ first for XQ you've and me. X% mid- broader Maybe Rick year-over-year to of throes of some the would year-over-year Tim. pediatric those since labels, got be Q-over-Q, the down X% now Solid and quarter, teens X need to high got U.S. 'XX COVID, be I just that down to for Rick, arguably you've the facilities. to

could I 'XX into see ongoing 'XX. even XQ think flop you said some XQ you

put explain level digits, just would that decline in sort the a of sort can of we again, down of single back to low of utilization, falloff see teens. to you sequential mid- So why down to high your

to back thanks Yes. -- you question, look mean for have the I Jon.

we U.S. introduced of to the the first have in benefit quarter had look the remember, growth back that XXX the point year. a silicone from delayed in XXXX, You year basis in last when we orders our last leads

talked of about play. to of different increase that And utilization. areas a to excited on. going the some So focus are and strive we we're going we're with we But to lot at there's that XXXX guidance the that forth set for we

our achieve So is -- plan that. to that's

reasons could it seems Okay. I where And believe I the to before, then That's laid XX% And you beneficial heard to gears, business. Tim, SURMOUNT-OSA, a be shift be reduction, out just you helpful. correctly for think the AHI I for why. like think you

a Just Is to not United's push beneficial? you reduction? there, rough goes XX. Your to Is In is XX. like AHI XX%? down is not it from it XX words, XX, cutoff what's XX% numbers? other XX%

a there back, say the this not expander of of step away the a day? TAM you sort reduction end are AHI be and where Just might of step take at levels to any

GLP mechanism upon lose In we that hypoglossal patients to nerve is AHI. the the about stimulate weight, wall What to action. And we Jon, very the get AHI, the don't difficult reducing the care about of base of tongue able forward, have level act know in reduction believe patient wall. for lateral end, mechanism we to but of relaxation the collapse. our moves we And we that's that be want that the that is the lateral we the what of care

weight, not of AHI thereby lose wall patient to is relaxation reduction and obviously neck a contributing factor have BMI collapse, patients. that a AHI collapse, can they So circumference because lower a get is lateral lose with majority tongue-based can percent higher of the as a the and the presenting a which higher

If you're have a low BMI, it's very reduction. difficult to AHI significant a

go collapse Inspire you to So lose wall GLP-Xs, tongue-based collapse you're can the thereby relieve helping as the on variable lateral and reduction presenting low focused going from a see in Again, I them. think BMI the patients weight, a reduce high we're AHI, to their BMI. more for which circumference as neck treat

And Co. I show our last & Kalia Oppenheimer Suraj from question comes the of line from

all you can hear me Gentlemen, right?

Yes, Suraj.

a on quarter. nice congrats Tim,

new that question same-store about Rick. store further, If terms you So per Tim 'XX there mentioned right or let's split? some I Should quarter you Or say, maybe Rick, split it could the in about XX% to of million, Is million, was $XXX a other it? implants I a million the take, sales? math per applying of exiting, comes think site. between refine XX-XX it round little first for site. $XX guess, same -- from FY just is think is pop. give year-over-year way XX-XX numbers, you're to $X that

from about is more centers XX% revenue question. What of not the the new came and remaining of from growth for our growth, composition the percentage centers. thanks the XX% but Suraj, the of from of our Yes, our I'm talking existing

HGNS number more the a are average a of pedantic or of you shown number intolerance or the by is in, documentation, he's usage of either failure authorization. enough. failed Suraj just let's days When CPAP comes the potential documented intolerant of say for CPAP. level, that getting what And file Tim, on Fair of Okay. average patient, days

Suraj, think last the that's over that place, all Thanks, Suraj. number. that I

Inspire -- therapy I'm they and to come if have insurance X kind most nights, come And are to utilization. CPAP. are -- receive CPAP X they're Inspire of X Therefore, they X part, the for that, night tolerant X tolerant difficult in, to are they're patients hours sorry, to to to in the it to nights approval not not numbers, get compliance For because few the compliant if using who it's is of what very a CPAP.

been tried majority they've of not not patients, had CPAP, it. introduced the to So they are to CPAP. they're our Maybe CPAP. it, tolerant with but They've they've benefit some using

move to from for not CPAP to are a physicians the forward that really are to and with those it's so And able benefit therapy. unable barrier document patients big

So thank very you Suraj. much,

to make for to everybody I the everybody. last to today. joining one Just want note thank call want

patients work remains our success. their always, and the dedicated as the growing United focused well patient efforts I in of As in all Asia. health and the as unmatched to grateful wish on achieve to of team to Inspire we employees consistent motivation as care States, hard element team's thank most to continued I'm commitment important to Europe successful employees The in for and teams and is outcomes. our our their continued remain for the business enthusiasm, expanding further

on forward you call, updates interest months further and you the of look with of all Inspire ahead. to your support we and providing continued in For the appreciate

conference This call. concludes today's

disconnect. may now You