GKOS - Earnings call 4 2023 | Glaukos Corporation

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Operator

Welcome to the Glaukos Corporation's Fourth Quarter and Full Year 2023 Financial Results Conference Call. Copies of the company's press release and quarterly summary document, both issued after the market closed today, are available at www.glaukos.com.[Operator Instructions]This call is being recorded, and an archived replay will be available online in the Investor Relations section at www.glaukos.com.I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs. Please go ahead.

Christopher Lewis

Thank you, and good afternoon.

Joining me today are Glaukos Chairman and CEO, Tom Burns; President and COO, Joe Gilliam; and CFO, Alex Thurman.Similar to prior quarters, the company has posted a document on its Investor Relations website under the Financials & Filings Quarterly Results section titled Quarterly Summary. the to accessible investment the and reference associated the designed summarized with key any is company's with easily the guidance and document quarter, make. forward-looking document statements provide and we community the a facts business or This objectives of may strategies state that details question-and-answer will scheduled call.As such, a for This document read be transition conference to session. prepared by investors and call quarterly we make is designed before brief remarks the regularly this into ample yourself and ensure you everyone's opportunity questions, we address To time to to and request that one limit question one follow-up.

include still clinical position, events and events all on more to may materially future to our by commercialization, release about financial may results statements things, forward-looking get our fluctuations, statements.Review objectives, about those and these products, factors. beyond other to statements relating or and believe, or which difficult expressed and plans, efficacy or results developments business market you call for the our all based or future fact sales, back that statements recent pipeline current business for our to and press risks, risk as conditions, expected the reimbursement additional current uncertainties than this information predict differ environment, U.S. strategies of note historical are from we condition as occur are are statements among of actual expectations of expect, queue.Please regarding, of and our including today's trials, of our If operations.These filings it products, future questions, will control. in the strategies Therefore, prospects about other and well our made development many efforts, statements. SEC cause anticipate have activities, and implied factors forward-looking into operations which may and address our competitive foreign us you technologies regulatory impact of and currency operations These are and on and on the our products, market macroeconomic international are affecting general subject that

the these find can discuss at earnings over of for results to please Burns. our including period complete non-GAAP measures.With of facilitate during period. results financial financial more today's refer available www.glaukos.com.Finally, will that release from CEO, on Relations to turn will results note GAAP operations, Chairman press in section Glaukos the underlying greater Investors call to we Investor Glaukos' our Please website, section comparable in of call ongoing most directly a You'll these certain our basis. and these comparing believe the I adjusted into website their Tom measures to transparency particularly on the measures financial tables documents also when analysis and that, reconciliation measures, We of an a

Thomas Burns

constant currency thank XX% Okay. $XX.X the all record XX% reported on consolidated on quarter. basis Thank today afternoon, ago reported of versus joining a basis today.Glaukos a us Chris. sales net Good you, quarter million, for and fourth and up year you

consolidated constant a net $XXX currency on full basis and XXXX. sales the XXXX, nearly a XX% reported For grew year basis on million versus XX% of

by preannouncement Health results, our Corneal and across were XXXX also range net million which from driven our record $XXX are to January, $XXX globally. broad-based reaffirming million.These exceeded year early growth further double-digit We full sales guidance preliminary of franchises our glaucoma

streamlined $XX.X company commercial period both continue Our our for what system.Alongside perspective, glaucoma key from perspective, commercial us million profile of quarter on most franchise, efforts receptivity year all strong X-stent commercial injector favorable driven including benefits on with ideally iStent continued initiatives by should Within successful to as highlighting and franchises and a of for iStent transformative core drove access be key LCAs infinite. the sales MACs of fourth with execution our Market performance. surgeon performance in to a feedback a strategies commonly in primarily come.From positioned within caps and U.S. the solution, year-over-year, infinite the safety into adoption XX% of solid strong we of our commercial the its advance also place. we growth covering development case-by-case leaving basis, execution of rollout remains our off of years strong, a infinite, with of market we enter X each iStent a delivered

MAC interventional glaucoma various on. monitor remain and broad the for for physicians we supportive as We of continue expanding will tools processes and policies, to to access patients.Moving

growth, business.Shifting development the region in and the XX%, our key as take drive on delivered million record our of Our $XX.X continue of hold year-over-year franchise care once a mix Health reported $XX.X record of currency on finally, of and growth plans XX% every in Corneal infrastructure on Photrexa million support we sales delivered a glaucoma This constant to year-over-year franchise execute scale gears international standard XX% including of to year-over-year strong as of $XX.X of world.And on sales to sales to basis market a was strong again as our major initiatives each this in front. forward the and million growth basis. important continue XX% broad-based, our growth international on

pharmaceutical quarter for in intracameral to were to our of As X injectable deliver or TR, you drug designed a ocular micro-invasive delighted announce designed hypertension. therapy approval with iDose therapy open-angle pressure TR we to years. up know, intraocular revolutionary during glaucoma FDA iDose lower patients first-of-its-kind glaucoma to the procedure fourth is

been last over have with our completed happy plan.In of these announce been cases first very work of coordinated hard of iDose we're TR. half access. ahead, teams positive.Looking plan first methodical that advancing a with and initial on We're all our detailed phases has XXXX, to cases well, executing training launch their surgeon conjunction to to approval, week at successfully this the surgeons Following pleased multiple efforts, of surgeons primary report controlled commercial of just went small extremely these establishing market early continue from feedback and we focus the launch group a

and of As the and the force iDose prepared is launch and U.S. to the and surgical initiatives force we continue to expand organization this productive force earlier training and month market our broader sales course to will iDose we over execute to of to the established for reimbursement access efforts and and was optimize global glaucoma in held of where will XXXX.We meetings, procedural and community, we evident with for [ skill powerful TR. that April and in become progressing our transfer coverage payment of This component refine training time. establish code, plan.Alongside expanded permanent fee facility in our classification excited which, the our we the OXXXT, leverage sales best-in-class our Category that effective the are the initiatives.Next, iDose TR. to throughout J-code of are cover drive through our X. our glaucoma focus III working training surgeon commercial we've an fulsome CMS, which launch.Speaking a new and our we position sales iDose expect sales It this cycle launching first, drive effective the are most half infinite the on iStent that, here designed was anticipate several a C-code meeting a in rate the we TR J-codes. temporary application we a should ] then, of adoption late over measured permanent Until CMS which front, to for over On pharmaceutical become are our TR on allow based place is that we December, iDose miscellaneous includes successfully submitted the until J-code in procedural period XXXX payment initial to APC establishment from second to

robust MACs be payment be set over with working fee course to will launch the professional XXXX.Finally, by and commercial our of also peer-reviewed literature. supported will iDose secure We of TR coverage a

the TR manuscript the results. highlighted quarter, was publication III of in another and X-year iDose Ophthalmology published TR Phase fourth IIb Phase the During More summarizes published XX-month Drugs. first favorable It recently, the outcomes. Therapy in Journal

which has iDose TR of we has since be the glaucoma category planned for iDose results.So positive summarize, FDA ahead, community surgeons announced be launch know that brand-new the today. Phase -- of published received broader articles that additional we a as published to are are Ophthalmology, a approval the TR overwhelmingly in Looking and been III manuscript pioneering was X-month from reaffirms iDose ophthalmic we an the it our journals, potential reshape with leading to by in management pharmaceuticals procedural highlights there to we to view response including accepted that just TR's XX

intravitreal a this in in towards earlier-stage second the of one, for ocular hypertension.Beyond in and expand of a of mild moderate we new the the pipeline invest addressable bringing markets we and terms trial cross-linking promising risk-based clinical patients; tagline. Go We XXXX, for which, This how novel believe glaucoma to now the spending by year, for the continue remind of is includes prioritize study our conclusion, I defines than to in Phase technologies can mantra, our half we to to our it's during fitting program have a wet pipeline, our you the IDE and remain for advance in corneal as commencing we trial time. cadence two, supporting of First, with continue same future.In this targeted for on company investments include and GLK-XXX, AMD to trial and, the continue we patients a commencing fundamentally infinite now therapy; to of think time, X may that iDose development we platform organization progress for and with IIa successfully pipeline write pipeline about phases finally, value for to the study data continue have for therapy as our the track completing to TREX, drive Phase forward significantly commenced next-generation believe end that potential robust lot market comes our in that next-generation clinical our we for patients.In excited PreserFlo MicroShunt; our retinal lead III in-human robust XXXX, company the discussed, over At capital in study III completion doing we've we trials transform company initial submission more therapy.So programs first as we'll including: are Phase third-generation just NDA every our our strive and in XXXX.In additional to transformative are the glaucoma day. Travoprost; for fourth trials be to plans, iLution our of three, quarter suffering the and and multi-kinase create. to readout see, which our We'll an U.S. position our as expanding something our Epioxa, second a Rather, and be PMA our a III a of to treatment in it's pivotal us, significant it balance we we who alternatives excited so, the which you strike prudently iDose, iDose enrollment iStent inhibitor program of technology iLink ability when clinical Phase

execute We we commercial with infinite. as are to ready TR iStent along iDose plans deliver in launch for and beyond XXXX our

to worldwide.So Our we the are continue of for patients call open Operator? positioned strong, that, to and I'll with the foundation is transforming ideally benefit vision questions.

Operator

go Stephan, at We'll Instructions] to first Stifel. Tom [Operator

Thomas Stephan

XXXX of Joe are start iDose that you much Great. of guidance. supporting key And or framework then guidance? any Maybe Alex, also, into what the some how inputs outlook? with provide can is factored I'll on

Joseph Gilliam

either the I it's can [ we a macro from were Alex I'll with Tom, growth business And pleased ].Maybe accelerating first, continue year putting to we established exited as see focus another franchise, we the deliver obviously, are calls of of Conference we overall of this, our entering adding perspective he There enable of decade when guidance. business growth really on in December gave our is the next of variety earlier first and and think, believe the will the building iDose itself. color that and were momentum mean, the start glaucoma really really XXXX XXXX company.I really blocks foundational even on the guidance said on which one drivers we start around off, one for Joe. or in and Investor those. I Sure. this think scenarios in we year I'll place I implies U.S. within the as for a the guidance to XXXX. any of that

acknowledge certainly and bit a the I so trying deeper importance to iDose. with the respect And the on numbers associated specificity little of around dive

revenues increasingly an get to too little to driver our material way and going early certainly in it's launch. we the a on early-access from, here the XXXX. a the granular as as And it's think phase some Tom there.Clearly, enter disclosure through as of I as be provide we'll into make we year additional at we the actual transition iDose quarters, really coming said, point full

Thomas Stephan

label, to sense. as additional is couple that single it. from administration? Got guess, That's for iDose on Makes it's able Tom, then regards. approval. any on I months maybe, label the it any of And in been relates the here from fair. since their I a gather, more forward what the importantly, you know just Have only FDA path decision? color Glaukos updates on been to But then And

Thomas Burns

Tom, it. I'd be happy to answer

and in clinicians product. all for surgeons the And see success use channel today label. appetite we're no for with given with to limitation, the impediment we checks Even the so the let that our of iDose current our the me current first poised say

And so question very the the device. division, readministration process to of the answer right of now, as a there's within the repetitioning your guard. encouraging.But And iDose probably FDA drug in aware, CDER we're changing the to directly, that's for of you're

approximately to we the of that enter to that waiting for transition again the that's the twice event and of the court, iDose put and petition before a which then contains we're for by end we'll clinical we're that planned already trial amount so and that happen hopeful conclusion.In medication settle, year. remember of not, And we're to successful a a the TREX, dust have the iDose,

our targeting a by approval we're best commercial product XXXX. thinking, in that so for And

all TREX if iDose repetitioning So current become I feel good our the to in could it, on respects. initiatives.So product for products and our about you next feel I FDA. that think we're be forward. successful reimplantation about We're iDose the like path hopeful covered

either make to that, argument them. sophisticated event. a having have in But we're said We to covered

Operator

to at next Zimmerman, Ryan go We'll BTIG.

Ryan Zimmerman

press to that broader to help point a initially. How get comfortable a reimbursement you to different what here in going you iDose? looking you At how to ahead? does that I'm trying way are what ask my transition frame similar milestones are a mean? right. regardless maybe kind the All launch, When controlled little bit. us much do launch of the an with up for and surgeons about and try iDose on question luck experience a you're of iDose Just with talk guys, many

Joseph Gilliam

that we're here, Ryan, around I scope. phase what with it's goal and that have but will it's during week refine not now begun We've meeting. hopefully, The really great little as note the help to in launch. phase a starts hit That's a to refine Joe. because quarter. sales early-access their X, more mentioned phase designed also have we're early jogging we forward, of part think and their that is early-access open in we'll original there to that really we the handful consistent things as important running. is get J-code, to you you of provide X, clean a prepared early-access our ASP move to us of you've as training said about goes fully hope And all it a We'll it national having within at like that as release, I really we and crawling phase our half.It And limited too, where equation a up running, more a that.So that completed months those algorithms our training of be happens is it's then starting give to where the we've as our through in will of get from of whammy got fourth their iron of we've beginning. a you to try now to bit our access out a cases, past, all But launch in inevitably broader early procedures where the clearly, now a at, The continue out the the going. path color into to launch then they confidence the remarks, like to got challenges alongside force first come time that that talked any market expect And the the really into bit call.Right reps fourth this.We and we with officially starter established step.Organizationally, with to before, it, kind to with of market to And establish news, access we've broadly sprint I'll by coming launch. somewhat, that as hit start with where that frame, match we're will the of product in come side the experience, big been a objective walking as published doctors you linear maybe transition call Tom said a sales you docs.And we XXXX. the into little and will, the last as start approval that's a into the algorithms we as we're second that. efforts design, if stride up between that quarter

Ryan Zimmerman

Okay.

infinite. to question me, for Second turning

think current kind You factor much is usage think infinite pursue going and label it combo you it that in gating where can stand-alone the patients. you maybe it's about about guys how as of both today, to of being expansion go? do cataract talk label. of that moderate to when in used pursue to And a context How also are mild you adoption a in

Thomas Burns

to I'm that. address Ryan, happy

first talk study about let's all, the of So itself.

be will FDA. with months, XX% with endpoint looking multi-center to from baseline than So prespecified IOP prospective of we've mean a reduction do at the XX that greater negotiated which we're [indiscernible] at study going a

so right? patients of and believe, date.I a at be to position approval who've would patients, end that the we serially, and estimating additional therapy, we've covering surgical we're we be look at mild about patients patients, marketplace know XXX,XXX performance an XXX,XXX medical marketplace we'll tail and so. look And when when our we're at estimations, confident feel the had of by we the clinical we moderate current to this on we XXX,XXX we so trial, given the to that like And to with failed going the targeting for think doing that expand looking at demonstrable at product TAM the by in we

of in how product and will market.I expression the itself, to used gives that, of So intend think an the equally. we expand be

on way over begin infinite in products.So time, to I very surgeons demonstrable is that, the of for different You use effect we the X as approvals, come stents a forward very cases. like conjunction there'll have that's will we I using surgeons will that a with confidence those hurt the X interventional to things down with APC to start Why side surgeons using that And right patients.I financial stents in will as think doing as I side have think strongly to on be we with a in initiative combo this case this get innings surgery. the this be this combination their label, people for when incentive our of about stand-alone one glaucoma broad glaucoma, makes I the we with will as certainly, iDose. early you? particularly sense, strong doesn't it comfortable feel the where wouldn't to XXXX therapy cataract cataract showed think in feel iStent well very feel strong move product feel in versus on.And additive us upgrade that in the

say trabecular a the I to Because do strong that? showing outflow a the eye, on reestablish works ability why system. is so the of different part meshwork. through iDose iStent infinite physiologic And uveoscleral

right action for There's X XX% products about CPT Medicare these when And mechanisms in to going therapy we topical of be using use the move now or system, more patients meds they robust a surgeons that on X within think fee-for-service very classes. should so provide these And different and you combination medications. of there's paired combinatorial as that are no impediments. forward.And are different separate it, product codes, think procedure

So diagnosed of so will half think that patients.And in we combination an current therapy. rules identified therapy be opportunity glaucoma the ] combination extraordinary [ this

us get But with treatments some be stand-alone and whammy the create highly we with to double and commercial market with both there'll of Advantage, into encouraged. interventional the iDose. infinite space. As having I these restrictions, fulcrum giving the payers like is Medicare and glaucoma we're harbingers just love there catalysts,

Operator

at our We'll question Fargo. Biegelsen, take next Larry Wells from

Larry Biegelsen

Tom, that or from the a it. I'd the you of that on have to And when love confidence confidence And adequate. obviously, physicians I is any iDose, going lot secondly, your got priced reaction one attention off your this hear ASP you from payers and announced starting surgeon follow-up. the fee to be right. just you've

Thomas Burns

be to I'd happy address Larry. that,

with did lines this about payer we nature to board.And be we an so the over to we treatment to the met iDose and well, know, licensed of you we squares of products. our group pre-talk the product, last the show getting as of transition and go are the done We procedural glaucoma out positive at multiple and out available it ophthalmology, the And we been question is your those talked in and given product once short homework but Markov We've probability within procedural at to have about the So where other payers attributes. of up, able this somewhere codified although this surgeons couple across pharmaceutical to what that pricing look pharmaceuticals the the approaches very median answer We've was, done signals analysis. external disclose didn't We different therapy. looked groups. pharmacoeconomic years. using of the

of the to we having has for you quite period, over uveitis, that prescient move X-month is fulsome to we impediment X-year has been look $XX,XXX. X- ] at hope, to all at And see product.So know that think, DURYSTA used that the that, As which RETISERT, as is as [ costs order imputate you to I the start I start know, response we were, I a priced how of understanding. don't when all the forward. an get surgeons, on you on that been therapy. of a comfortable $X,XXX said X-year a you and We steroid and roughly $XX,XXX implant for treatment

I have think going fee-for-service. with to running open-field we're Medicare

I I think have any and impediments the into certainly as using we edits get priced don't commercial patients, But do thing same the did will DURYSTA: where they anticipate this we Medicare they with product. some Advantage before to utilization versus product.

it I where have. think we we hit should right

Larry Biegelsen

ask And surgeon being the just follow-up. adequate? fee I'll And my

Thomas Burns

Yes.

Larry Biegelsen

What happen from what's And noise infinite? you? next MIGS ideal LCD? this LCD? turbulence the the not with assuming Or in you Case-by-case for the probably any still for is guidance? is market the assumption in are from the there What

Thomas Burns

Well, question on I let second pro -- your fee address [ me ]. address didn't

a we me surgery, at procedure, let very Coast, iStent before we look at which in like I is payment do over about see First numbers greater so we So WPS what's turn is that happening And first infinite, national $XXX. certainly at cataract than coming now least, $XXX. know and with to at right it the average and are Joe. If

I'd going somewhere we're -- going I believe like range. in think to that we're to to think I settle

iStent the innings ranges infinite. Some early $X,XXX high of for in have as the been as

it to similarly turn to question I look your see with And different so crosswalk I before they're this over procedure, wanted pretty infinite.So I what over answer iStent to to to going think we to MACs as at Joe. this start start

Joseph Gilliam

this Larry, general, point, largely an -- to of we status definitive from with the scenarios, next overall we're about really more them at And perhaps point, too, there, this I material being at remains timing we customers the clarity And think at less on their account is make front, in the less we expect go game, until XXXX.But a as you our where in it's, of priorities this to do policy stage, assess on determine the next. obviously, regard, think to the at unclear as those unchanged. hear outcomes drivers but of decisions now, this MACs level in is remain wait-and-see again. LCD behalf iDose guidance. of sight-threatened quo, protecting perhaps established.The the for focused that for least for that at certainly there's think set on steps than rights I We're overlay changes our of one patients. range the But cautious clinical in the MAC

Operator

next go We'll at Matthew O'Brien, Sandler. Piper to

Matthew O'Brien

The Street they bilateral And is modeling $XX were follow-up. that have those Is $XX good And cases, first for this single-eye too iDose a year. I opinion? number high, million, your too million in number, low then about cases? then or do a

Joseph Gilliam

Sorry. you question? Matt, of the repeat second part can that

Thomas Burns

Single-eye.

Joseph Gilliam

single-eye. Oh,

Unknown Executive

[indiscernible]

Joseph Gilliam

front all is having specifically iDose questions on are where bit the I'll Maybe and drivers stop at what guidance.I and guidance iDose little will do more iDose. which I'll and what part start franchises context I short the on start of the U.S. So and mean, is single-eye a clearly, number, were Street's of glaucoma guys why the that moves our their is to color with here, you as you'd that. provide They center to commenting at. expect focused a cases relates of an overall the around around launch.As franchise it

really seen to some driving limit access Our there with year.And expenditures we Most as quarter. payers probably that we'll business parallel, going and government even as in seen the mindset. recently, we fourth as seek and sit We've quarter, saw growing the continues focus it face headwinds the we've training new market to as see into in iDose.Internationally, expect of going come pleased see the efforts competition We'll currency by little elsewhere. With infinite within is probably scale, bit headwinds, in example. it to And continue in on establish for access some interventional scale. in glaucoma to market that.In XXXX. headwind be can Switzerland, you we'll here you to we were that the cornea emerge to the and driving early and adoption those markets that, experience and very fourth then to trying side, first, the continued in the the continue iStent a past, forward, while saw we today with momentum

mid-single-digit XXXX to deliver some that ultimately, think U.S. taking all growth put what back when into what exit consideration growth, you weighted which XXXX, for we As that math selling on to implies as if I course [ of think think importantly, see I that together, may for be probably ] you you our trends it that, on of you our accelerating out increasingly and kind U.S. that, XX. glaucoma and a focus high-teens some be in December out year-over-year as glaucoma expired low-ish that we're I and of should year; the business. type that aware, Epioxa we're a and where overall And kind see particularly just points year, government put within mentioned; comfortable the for we incremental glaucoma double-digit that does think also gets $X deliver directionally, interventional rebating Health within loft, sales is some customers the our maybe of device-related the continued force.If most coming and franchises Medicaid for us you growth basis.And year-over-year strong floor year-over-year gave, the year.So we'll the going both that guidance going with that about is Corneal about some should headwinds the range think of the of half franchise towards will, in into rebates pretty

Matthew O'Brien

Okay. then the I Joe. dovetails of kind that, appreciate into next that question. And

but, revenues were excluding what thing And You we maybe business, I I slowdown mean, the same OUS. U.S. I'm you iDose. about glaucoma a started covering know in market; don't And Sweden, but whatever it's this all for saying, of come kind I a dramatic big up then that in just were that's talking wrong. you of think

things especially QX? in of just a So down why slow had which would Corneal Health these dramatically areas, many monster that

Joseph Gilliam

I sort think I did mean, I So cover that. of

that of just couple a there. clarify me Let you things said

matter you said headwinds businesses. evolve around a largest couple we of does in currency some out is there. the percent, first some the on from -- relatively think focus about you're half I it of there, at difficult the to international point, our side, It and what around you comments each was repeat glaucoma side think you the expect is the probably when obviously, bridge and international it growth thinking but Switzerland. the I look, X%-ish a comp. context U.S. that with markets, that of even that of those my European the if this of when in continue scale, that to you what things.On I'll continue of dynamic competitive won't Combine drivers dynamics the about not

of half. look bit pretty If half off year at you business, first go to tailed that a little bit at and basis our basis second a but, as international absolute were in running from the the back it last started the an levels we on the in half, procedures growth, a clear elevated was second normalize continued in despite global probably

in.As don't things those think factor follow to relates it I that each of to I U.S. have glaucoma, you there. So

overall, into what expect performance, in you'd any is fact, as iStent cut course imply that impact the accelerating in it, year growth from which back as I that the is from the just if an accelerating for infinite and obviously of of In over terms well high-teens iDose the half, with year said what you actually XXXX. way the both you into coming

Operator

Margaret next Kaczor, at go William Blair. We'll to

Margaret Kaczor

again. I iDose wanted start to maybe on

the for for patient patients this. Sorry, I'm on a who going initial queue? that any these the ASC? in would useful. Anything be day, if multiple cases. iDose already these wanted there's surgery to see time cohorts in doing waiting Are in #X few as clinicians be But have a on to long background like iDose Are these I additional first procedures today they're the been

Joseph Gilliam

Margaret, a last it's draw Joe. I with obviously, discernible any to mean, just started trends. these cases little it's having week early

thing them patients, I et of be into solutions in are focused I patients. going these of maybe for or that really of that I early most the they bringing procedure. iDose say we previously a straightforward majority important clearly patients even have and stand-alone out be think that the Whether on here. different the with the they're surgeons not for cetera, trial, treated providing would there'll historically, the these think stand-alone care of gate iDose an surgeons were that of there mix context deemed But these is a as therapy get to

Margaret Kaczor

All maybe from then and cetera? cost NDA perspective, opportunity timing end prevalence a submission us the wanted your the perspective, of on vision by Epioxa. What's procedure, maybe year. to expectations level-setting I the [indiscernible] Fair right. to enough. product, And over move et of the for on the kind

Thomas Burns

happy Margaret, I'm that take to one.

perfusion you time corneal different PDUFA before, it. be remove extraordinary. FDA. and Epioxa has at the incongruent or able with thereabouts, part the by procedure, is to to XX-month we'll the for associated as to an that for The with an III procedure. NDA has to The surfactant of the have extra procedure We'll late with of It to oxygen they in said this epithelium we until a file so because NDA. does spend when a or the times clinical in the And look patient. as a lot we visual and so, have a preparing have sometimes don't rehabilitation, be before, it's second we'll the hope time we've before we more I for think have bit patients We'll perform opportunity certainly aids which formulation, publish to somewhat approvable a epithelium the pretty is summer heal.So goggles be rehabilitation. corona are little fact of midyear, or penetration. a And for having break have and those our with just talked the about it, spring Phase impede results XXXX.And It it we'll defer that young is it's when trial able Epioxa, be visual in home highly the having date, painful removed procedures about the which to which until new results

opportunity significant corneal and which Phase product it's with the this to rate.So really trial. meet removing bathes endpoint get oxygen, higher with the to our at our the is hope epithelium. eyes III done the it able to is a a So if irradiation part of And be and order challenge have the you're not efficacy in second procedure

did trial FDA. As you Phase endpoint, primary know, from meet the the the endpoint, first III

with factors to to very we're trial.And be to those that have this schedules. procedure. for more going going So I hopeful the this about, out better second are in with that far Because able patients be patients. more talked timely we're do their to hopeful to importantly, getting we're visual we It's this want far as to more rehabilitation forward. It's going move of

is the to to continue have all in move define forward.And adoption so and surface will in what on to So for the both expect if for share to all forward moving be and with usage see and want these again, of much trials. the reasons, pieces forward. ensure innovate And eye algorithm be reasons, we will it, a like just expect we third-generation and that already and and first spike place in is think we product to excited irradiated laser we're treat We in prescriptively I those these chess well, so off what already marketplace, we I as in clinical and those where have keratoconus.And a moving and a build able II Epioxa the MIGS, light future. the that's Epioxa, undergoing use stage. now an about keratoconus will precisely to you and laser a pay more able of actually That's that Phase which protect

Operator

We'll move JPMorgan. at next to Allen Gong,

K. Gong

one I heading year. I just next one just into quick on, had seasonality start guess, to off

ended with quarter. a year You stronger-than-expected the

you expected. wound ex-iDose, just than Some basically And year perspective? a about of But fairly the the normal don't headwinds want as of provide thinking business, a little think that you to should better a feared we being underlying iDose. it that up from seasonality I being understand

Joseph Gilliam

do of materially, we And the you fourth. to hard Thanks, by business XX% normalized revenues XX%, the do the I know, but the then, course the X, that mean, of a pretty to surprisingly, in the my the as turn patterns in I'll in to well combination not XX% XX% our it, expect Allen. and infinite XX% that quarter, XX% call It's this to best. you parse XX% conditions, think, of between on market both to as, the iDose XXXX. those disrupted launch the as first see most equation we continue side in second, those access I in be of growing third typically as year over

if in quarter. net of and, to particular, the you a effect think should second that I seasonality, fourth material fairly half the the of the will, be shifting

So away entirely driver by but the far, not patterns. by not biggest shift our is it's iDose, from disruption entirely traditional -- of driven is, that that a seasonality

K. Gong

we of of when I margins iDose? about you you Got year from first it. leverage about And kind the for should launch. year, what then think this how think It's get the can

a little that a my could ultimately imagine But limited. this I might is you. device sense be it So for be profitable quite

fact this where iDose, margin, R&D ramping the we that year? you've that can think about now you're go ramped gross So up be to infinite going and SG&A,

Alex Thurman

question. the for thanks Allen,

the that land go of XX% gross we've scaling manufacturing So time. margin that XXXX always some through overall said, you're happens and the margin volatility point, with what accretive gross we'd be associated that up a as caution our ramp in expect And to you a range. margin some there standpoint.But to could as ] an expect your do end we the over be XX% was modest from and right, to second new to for product now, iDose and said launch [ iDose to we probably upper in we conservatism,

minus, XX% So we're year. thinking the for or probably, plus

Operator

Joanne Citi. Wuensch, to We'll next move at

Joanne Wuensch

launching with expenses at also operating XXXX?And expense much on Since you're One how same in toss not has in question multiple we for investing my the new products, income to the so statement. and do also I'll side about time. but just think the of development, second research do

her time their to or One Or time. traditional physician things figure multiple launch out trying his use? are of now cannibalizing think having as think maybe to types how do be the going you more physicians MIGS of I'm is of about how products to the spends procedures? iDose Complementary? how we the Do spending

Alex Thurman

Joanne, this I'll is question. your start OpEx Alex. with

continue our XXXX XX% So growth to in to operating invest this about your I the And both to point, of is both, off would that R&D, and start IP think launch way which a base. expenses, it to and you counsel will then and in we about the pipeline.The grow would XXXX to think I $XXX our expect with I SG&A as R&D year assume the iDose about million. to baseline excludes number about think was is that adjusted that way

imply year. OpEx just of the about that So would for million shy $XXX XXXX

Joseph Gilliam

spending that of have likely the sort surgeons we're short and some training iDose of their time pharmaceuticals.Certainly, of iDose And with product more handle overall in I dynamics the as don't and And significant expectation the practice time here. our utilizing it, as cannibalize, more needs with is the patients or glaucoma treating to patient.But as it associated and be Tom surgery their as long own then longer and upon just they more MIGS putting the individual the cataract or reimbursement et obviously the over that utilize many procedures, with change think whether to extent, cetera, I stand-alone term, we with to get with dynamics that we iDose those the mentioned class course can move for earlier, the significant combination depending as procedure over other shifting in more of of to the we've combination both expect put in and it the products within is standard driving iDose paradigm new through And to you way that success, would product as both and in are a invasive like and about solutions it, of practices, the it in others. new allocation practice we launch, minimally care procedural confident answer in more as to and term. the of past. term, traditional and Certainly, of a time, MIGS and procedures expect that, that and think forward right to initial years cornerstone framework, the impact relates how a really well the will them the investment a traditional the the at investment forward forward surgeons in certain more the glaucoma as we between of expect move we forward talked over I drive interventional look as within becomes of short to over the amount

Operator

at Needham & Our next Company. David question Saxon, from comes

David Saxon

Maybe I'll start focus you forgetting, compensation on the U.S. there's rest sure sales to glaucoma doing force. stall out? they're or so the business also to of incentive a make ensure the cetera, inject, the not of on Are to infinite, iDose anything et like, launch, doesn't U.S. but kind

Joseph Gilliam

well incentivizing next in really the is behaviors inject iStent forward; just the launches be over the science, comes here. the of to comes really next terms an XXXX, we as but that of those drive support continuing but a And as well answer far second, blocks doing it in things: product iStent beyond. last new not art, relates third, and about a several building that compensation, decade business. right that We're I think areas driving around short of place business expand call, of driving structured existing as foundational the we market got clearly, to we've infinite think the whether the is certainly going X that; referenced, which strategy or generation, think It's it activities both as absolutely deploying that, business, well, in to will what not this you as as revenue activities putting when yes. to matter the we've pretty to continue to certainly as other years first, and what's we answered and we it to the just in and kind that got the drive to the iDose balance launch David, really

David Saxon

iLution. helpful. just pipeline, That's then the And looking at Great. on

could are be milestones what's the And commercial? quarter. reasonable the So when Phase pipeline for What that product? that started IIa in fourth a this expectation year for

Thomas Burns

excited David, clinical dry iLution assessing you've of that well to substantial And we'll can a seen and in potential this when trial -- in the end your of stability. assessing we looking form part going for determinations acuity we first expect at Phase I'll question. data, we're second ] about your in tear as as part III.So be eye, see by but as to [ data year, then make visual Travoprost both saw hand and the this answer answer iLution changes tell how I we year. be go substantial well that I improvements able of into data Travoprost. We're iLution, forward And with we that where have of to question, the the completing in of use then the can't you on

So these significant X for candidates a new we APIs leading platform us contributor this and are in be will that for hope the future.

Operator

line move Mizuho open. to We'll next at Anthony is Petrone, your Group.Anthony,

have may You next move we'll Brodovsky, at to muted.Hearing no response, yourself Securities. Sam Truist

Samuel Brodovsky

squeeze on in iDose. quick I'll ones X just

expect the Can I on mentioned I of you looking on or half ASP how had July the gross-to-net guidance what a nail or color whether is then incremental you discount realized we J-code X X?And assumes second going down assumption on can [indiscernible]. and Just to ASP, a is any the think in October be much terms for there? the

Joseph Gilliam

It's Sure, Sam. Joe.

application cycle a you training unlock, into second question technical move are we as by are both alongside to assume well. initiatives you and that the market translates be bit the there about, I iDose.As forward.And little J-code of and prior then CMS that a we've were the as incremental you really terms color opportunity to to the the end the of creating putting deliver seamless, access July by in drivers also know fourth quarter, talked Tom That terms dates just those of you to starting maybe the reported dynamic which X. as about that put going reimbursement things overall of around things behind the a or around are that think would would broader ASPs real a will, more had year, if I of J-code what iDose in suggested, that those each iDose drivers, launch, think it, environment call the key in

Unknown Executive

[indiscernible]

Joseph Gilliam

Gross-to-net.

iDose associated But with So will there's talked we standard be where will you about, the as in see rebating we programs government-related obviously doing where that product. is not discounts.

And start at we'll say as realize typical time, will so government-related portion to that discount that that's a from probably we fair ASP revenues think a probably modeling of this place programs.So XX% mix in we move a as forward, time with of -- range apprised over a our I realized keep we'll our it's over you more becomes this safe clear. dial in and $XX,XXX is that somewhere the perspective, to

Operator

for to And at remarks. conference session. management question-and-answer the over would this to time, I the like that does conclude turn back closing

Thomas Burns

your you support Okay. of I attention want today. and interest also Goodbye. for your and time to thank you all And we thank for continued Glaukos.

Operator

participation. for you concludes This call. your today's conference Thank

disconnect. now may You

Glaukos (GKOS) 21 Feb 242023 Q4 Earnings call transcript