GKOS - Earnings call 3 2023 | Glaukos Corporation

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Hello. Welcome to the Glaukos Corporation Third Quarter 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.

Christopher Lewis

Thank you, and good afternoon.

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

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

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

Thomas Burns

our strong and ago approximately of the key thank joining $XX versus Glaukos quarter Chris. continued million, consolidated XX% you Thanks, globally. and afternoon for reported performance net These execution third Okay. franchises today. Good year quarter sales us reflect results third up Today, all quarter. across

franchise, growth of seasonality execution front, our more offset year-over-year a From August, of $XXX continued million and our quarters, week, latest $XXX establishing are strong of previously. $XX.X July On in formal pronounced outlook, forward net we MAC we sales each Infinite strategies results performance.Within that key on September. drove iStent million coverage experienced as glaucoma to raising million perspective, last in versus by payment. guidance $XXX commercial ahead XXXX with Consistent of continue million we and just strength our solid these X% within advancing prior date of WPS, and range core to to of our coverage with X infinite a effective franchises $XXX with of for Given XX, XXXX, December million sales we the U.S. the updated our LCD FDA iStent request. provides that X MACs in MIGS future consistent reconsideration a approval published and headwinds delivered

We of X as iStent restricts remaining X articles. decision with local steps surgeons taken through we're to a iStent all LCDs outcome proposed fighting that it severely MACs to infinite. with relates aspects disappointed that this clinical infinite discretion the ahead, threating are have final for But pleased preliminary and coverage assess the LCD sight including disease.Looking other coverage, X

monitor they to access are the remain policies and tools as ultimately supportive as the MAC broad continue for processes in finalized and and expanding advance to patients. glaucoma physicians various future we We interventional for of

intervention that on encouraged and XXXXX move of a $XX.X newly assignment was international some transient XXXX While glaucoma of effective ahead stand-alone XXXX APC-XXXX. ordering while cataract on forward plus code once reported broad-based region scale treatment our pioneering on, to glaucoma January our patterns to a care basis procedures the continue release delivered for stand-alone and, therapies changes, on broad-based await we to in we as plans to to the our to for advance basis. accelerating XX% drive proposed, of and on as iStent driving to again combined constant execute international we time. CMS' to late positive market strong and we our our X, APC-XXXX. infrastructure believe in our CPT final and bypass Glaukos, in restructured for the The world.While rule, a do as we in disruptions MIGS of major currency XXXXT to as execution, one market may turn, finalized standard rules, If was near-term cover by Infinite XXXX.Moving of growth becoming proposed strong million on the XXXX care in trabecular franchise year-over-year at the these new focused growth founding APC also is disease proposed of every And efforts XX% procedures of support we in used a lifted are a customers each part over create our and earlier XXXXX missions which sales glaucoma remain was paradigm of procedures

believe year-over-year care, Interventional Consortium We this in at numerous organically closely standard advanced leaders in our markets continue novel we development lead promising to invest the platform through that have to Salt over gears the transform addressable we in work our corneal events the September to ESCRS City Lake XX%, including the Vienna annual Annual display broader initiatives thought implemented continue including time. Glaucoma throughout Francisco U.S. and surgeons globally take to seasonality San with drive upcoming offset the our successfully of and and and million meeting record again held year our in our and more the prudently revolution quarter.Shifting AAO Similar franchise in expand robust glaucoma once of weekend.And throughout strength in key in ability the as franchise, this by on Photrexa These growth, growth delivered to full significantly our year-over-year with sales Meeting health August; October. fundamentally $XX sales headwinds being of strategic business to hold at efforts experienced iDose. company the on front, will remainder a pipeline U.S. on the this finally, record of of pronounced technologies past of $XX.X million support business. Health be continue of Starting to important in XX% Corneal

the in work continue We as their FDA to with review be encouraged process. NDA ongoing closely we

the no of new quarter, already preapproval X observations. facility, completed During or state-of-the-art inspection with successfully our pharmaceutical the hybrid manufacturing notably third we required PAI,

X commercial peer-reviewed preparation that robust are a Based the and next like be including over going year development published PDUFA agency's increasingly type first of in decision support confident that are launch our the review into on to teams for advancing productive others mid-cycle that least quality of we this, have to agency publication this to planning to pleased Alongside December planned Shifting the iDose remained XX, in been unblemished could for manuscripts August, drove by review XXXX.Our expected targeted of of year, outcome with already plan through this includes date this Epioxa, and not therapy. literature the remainder company submitted and X set for corneal a early gears be and this meeting held recognize at teams cross-linking For efforts operations, robust result. submission. next-generation our journals the XXXX. pharmaceutical to with rigorous our and I more time, the leading our would

position commenced submission NDA to pivotal development Phase to to as Infinite right remain continue create. study the risk-based see, iDose now have the in expect a mild in the III to spending we XXXX. our our of our and balance iStent that have programs cadence follow-up lot the begin for and strike advance and when strive targeted we At of as by investments value for with patient We significant a excited by year-end, believe second on potential PMA pivotal for a we may study of the we respectively.So the iLution Epioxa, recently future. first-in-human the programs Phase continue as capital The and track population moderate Travoprost same we our study along prioritize you be retinal clinical discussed, end about pipeline in it we of and can for to and our to the IIA to one time, glaucoma comes

earlier-stage truly in sequentially, prioritize our as SG&A at of resources evidence to operating again advance can care conclusion, of X% the I novel and suffering pleased our the some of with sight-threatening reflecting early execution continue successfully transform am commercial in our anticipated We the made we R&D of a patients the continue we've to next programs our are standard as expenses diseases. advance to business eye to improve ahead in that and in see by adjustments pioneering year.So pleased third performance chronic the this Glaukos launch our we grew as and quarter meaningfully outcomes non-GAAP iDose from pipeline modest mission platforms vision continued for

the years well strong. positioned call Operator? open as what And we enter be our with period should that, to for is foundation transformational are the questions. into we a I'll company in ahead.So Our

Operator

first Stefan. question [Operator Our Tom comes the line from Instructions] of

Thomas Stephan

maybe of sort any about year changes of the market And ramp from that probably next the then will tailwind qualitatively, be how assume net year? MACs to next align the any aiming a LCDs. guys way you off strategic capitalize Maybe X I want company about the first talk on remaining is can with just WPS, to if the start Glaukos perspective we thinking we uncertainty just in with the or potential from LCDs? should for

Joseph Gilliam

Joe. a Tom, thanks It's macro this I the on some prepared of think, standpoint, Tom in really, for the one. questions. reiterate From start I'll remarks. said what would off I

foremost, at WPS a in X similar from in is, from First that at what we've seen see iStent infinite. to MACs that we the expect first LCD coverage seem to least importantly, would be and the other for place most likely least and

in really that really we efforts the it of as around us, from that, access requested or and for trying step proper this removing obviously, was and that, Infinite there. iStent context drafted clinical patients activity our totality hands. starts other iStent For WPS And the we're that intended. that on established sure that takes towards to LCD clinicians' that And the the thankfully, disappointed a front, coverage final that were make as decision-making getting infinite.Beyond hopefully, the LCDs the to

us, time, And sure that to to we so us, -- have part going try something to hands in decision-making about we of that quantitatively it. for those in on that's call of capabilities think work can make how their our asked play behalf who some for be in making our getting we for surgeons patients.As are you back the on you the think about the it

ahead effective will, off turn volatility, to to short-term inventory most we're LCDs some I shelves especially dates so of probably their prioritize they burning of think procedures a the any And say if in variety non-stent may XXXX, a continue in you change other ahead is are we we're of what as but XXXX ordering and reasons, the expect some in we that I'll this impact. final headwinds, policy this.And the accounts December, year, remainder importantly, evaluating as as of for do on into going these finalized. have like based

to as have -- may mean and with would I'd what comment it may before our takes as the contain specificity beyond. or I really XXXX think caution for it the say investors through puts of product just probably more totality I can portfolio. And LCD. WPS a go lot we It to interim I'd and relates does not we the of on that any in

Thomas Stephan

short-term quick you follow-up. one what's maybe you follow-up. can I quick see kind talk informing about maybe then more When volatility, Or to And I get that view? that? of are starting guess, the And one

Joseph Gilliam

Yes, seeing in of I This it wouldn't say thing. that more an anticipation way. that we're is

have expect. either are those -- treatment you not sit their seen past And like their on where we've adjust into go reimbursement themselves in the customers policy hold algorithms that. what Most I that dates they going think to inventory around anytime past are and adjusted. or the the change shelves. stock a is you'd things what this effective have to Obviously, have in keen

inventory we ordering of just-in-time that They'll algorithms anticipate kind and a then whatever they'll that And that process. perspective. certainly as use New they would Year the starts date, to go so they've to more they'll they of treatment adjust changed as get to from up. have And closer unfold a

Thomas Stephan

ramp. call work for XXXX? how reasonable early question of trainings. kind doc just Joe through But physicians mix MIGS models. There pivoting we methodical annual or think can you looked doctors. be about in less early full when maybe the what's trainings trained And of ask us a I wanted this on reimbursement? sense you as XXX And to establishing at established. first what, kind XXX, any to And training think to couple you X,XXX-plus the about give year. trained then deliberately XB. on have, in that's of iDose, refine Tom, ramp doctor much periods cadence iStent per Will of our now it I'll I sort were years, of you back the that as well We were But

approach it think is Doctor of reasonable So Trainings to per couple iDose, years? for for first could year X,XXX the

Joseph Gilliam

Tom. problem, No

X, for You ahead snuck honor and X it. go in but we'll

taken. So, doctors' good. a the it's same From we're take always we've all to going standpoint, approach

just of training to case the as outcomes be the always I the going iDose. to it And of it that way. wouldn't We've for so the driving say even were doctors XXXX, done methodical superlative I'd beginning. in we're on entirety say relates that

be for know a of we'll go those work these Now nailed let's early year, the down that obviously, even and we in that the the there. sales more half days, the force before call well surgeons expand from case in of it, that situations, we early-stage will in start to training make handful first our we've algorithm out training sure that to

other it of item think is to pace point gating to as that the training I the key I relates reimbursement itself. would

be side fee and willing you to ready, be from you start fee regular So more payment will trained. code facility a iDose, a associated transition with J to able practices establish as more and to the permanent code, as professional recurring surgeons on their and even miscellaneous more the and and

this. role those so also in a things play And

statistics accurate. and they're You referenced historical

our of docs on technologies training generation, think a move bit the the between at will think based XXX a was that angle be angle on little teaching first iStent a somewhere which we forward, lift we them were surgery.As year and lot I less. I XXX peak,

to that than hit get rate would more stage more that as it's we of rate get iDose. to we have that deployment. expectations that with can on at XXX, we doctors train So run historical a hard steady the that run specific XXX really But

Operator

Zimmerman from line the comes question from of BTIG. next Our Ryan

Ryan Zimmerman

and the going one rules follow-up. and a ask I'm to here stick to just

the Tom. FDA labeling to about you're I on what think, terms iDose. look of know in one, having kind Tom, you're process, But ask read don't say with you're the where number the iDose. comfortable and like label could the you of going what conversations can I So what saying. for I'm of in for early at

Thomas Burns

earlier, I briefing had most based you preliminary. on these our these from Yes, review think be Ryan. you -- as respond. would I'm we happy stated be highly mid-cycle the would And midyear. of that to deep And

to is we label. I yet So tell have a you receive draft what will

finalized. So the said tell land I at clinical you we view know can and label for do PDUFA of we're in will the as previously, and until never the that's we will prism same data you remain the December whether that we're using the strength as while process data, I point. is that where as will this you FDA confident our the far towards What confident really is that we robustness as But date of assure tracking XX. sure

Ryan Zimmerman

December. Okay. of Fair. have XXnd till wait the We'll to

LCDs saw business the week. launch how less we question and I'm impact for concerned the think derisking your WPS me, year. this just about iDose with next how the other finalized what in interested more likely Second you from with with surgical

change it to mean, when iDose. imagine kind I the year, and your need some off mid-quarter, first iDose some would for is will 'XX calculus from that be that does on year? I of how to this the messaging we really takes inflection second So LCDs. of that have come the what you half benefit were But you of spoke achieve because there next the half pressure

has how the past maybe cadence texture? your that shifted for iDose in thinking And so on the week,

Joseph Gilliam

Ryan. Yes,

the if context that would I of think as it of to leap far don't know I I the make a in iDose. relates LCDs

the go key in down really side the training comfortable facility you previously. of these in that. bit recurring the establish which and back in iDose a pace we're and doctors on going the to pace said can to alongside of more to process I drivers reimbursement, of It's come and XXXX we little the think I particularly what which predictable

phase. the C J or miscellaneous code So want get you through to

of going on you're determining that recurring initial and professional get and You want fees to side. stages get to the facility regular through the paid

of the the back incremental I spending. those But with in to XXXX. certainly later the of think are the versus benefit into all, first more into there'll the year from I walk think going ultimately until be that that things and be run demand the lot procedures a half across year shift our probably associated that that into shifting of It jog whether portfolio, possible won't is iDose half. the the from

Operator

of comes question next Wells Larry Fargo. the from line Biegelsen Our from

Charles Ellson

I up the follow This Larry. is Congrats just the wanted on quarter. LCD for to Charles nice on again. on

So takes there's you about before. appreciate puts talked and I

I to up make positive understand so you maybe that. so on follow wanted of And sure the negatives that

mean, So the that? I are The the up those procedures. therapy. Infinite goniotomy the stacking you But canaloplasty, there? MIGS a maybe maybe some first those to of stents a confirm on stents positive read side, on it then, of takes multiple for the procedures sounds puts its those. competitive eliminate I iStent negative Can side, the pick we only that second-line and like and some talking covered And as like Are follow-up. about have you're seems of language

Joseph Gilliam

Charles. Yes,

policy and always have it. That's like in you literal will I the mean, adjudicate the time of policy inherent the line. out some think, this course to over ambiguity exactly this. know from a I that foremost, comes a the years. first like these hard MACs any several And reading how the that's policy first always changes there's of matter I will next think

into folks that to factor consideration. take one that's think I So have

or shifts the from that the canaloplasty options these surgeons correct. associated clinical the it to pickup and action. might that placed going the disease multifactorial it adjustments complement and are the proposing anticipate restricts of That of decision-making When of have is WPS certainly an of fight and assess what's the restrictions tools goniotomy some it as it obviously, to you the on of the think to considered procedures, puts one standpoint. of procedures. a LCD the any an we they're does of that relates And restrict and side. using here takes as we're the goniotomy against that comes canaloplasty, time have referenced, to to combining The something that some that is finalizing be being combining share take it's You and that on to mechanism have our to overall offset with relates

Charles Ellson

follow-up to quick as LCD then, iDose. just more relates And it a on

XX-month they're So better iDose asking for a they published broad looks mentioned But it for mean, wasn't more data more like I that -- label. specifically data just -- LCD. like want

lastly, us data data? qualifications III do when have seems it? not mean, be And like eliminating XX-month for data we You an physician able the like would I would publish tell Phase meet a -- Phase with need that you for IIB mean iDose? get good just plus would be to would think iStent will to And Glaukos the do enough stacking, and or covered iDose it

Joseph Gilliam

Tom one comment well. as and may start, this I'll want to on

I and within it by to know. WPS. released not is covered LCD stage a the It's as the And as it's think relates that this you at was pharmaceutical, LCD. not foremost, by first iDose, this purview of

think entirely consideration different that's a have there. conversation I and So that to take we so into

behind line will the a I I'm that commercial say to you, evidence we'll more at what the it as of have will would -- sort think, fortunate I that broader that evidence we I guess that product of we're if iDose ever launch. than we approval ever sure has get the had drew expect, is launched As not to time

as of within prior evidence sheer the it. totality You've of heard have, that of expect Tom within the the we peer-reviewed long-term it evidence, publications referenced as to that that's calls, well on contained patients the number number

do You'll in of recall studies. to support same ultimately, our our expect time II study. of out Phase over Phase And multiyear shown of the III that we've already out evidence we'll iDose

pretty good including any any that up come the MACs. there. feel So against the I payer, think may We evidence from overall request stacks

Thomas Burns

data, care meds standard of standpoint, the which, XX. we've those of Timolol, impressions XX% you controlled now versus X a And it, years. was those I the just same the would patients add, carried as showed hopefully, from or we know, fewer that Phase And when are topical all with now, out current years Yes. after think X some about data, IIB on

And -- in so discussions admirably in And is the to will It's the it future bare that serve any data prompt and robust. will receive payers any believe to we profound. payment. be with able us

Operator

of from from Our comes line the Sandler. O'Brien next Matthew question Piper

Phillip Dantoin

Phil is for This on Matt.

more August on step down pronounced that And Or Is led guidance, is effect? And baked a starters, about in specifically, that of it trends into sequential LCDs competitive of to it seasonality? that in function down seasonality how as For ahead glaucoma these final to revenue? in that that inventory pause rule? what what's relates was trending QX? a front taking working is CMS' it really more of it

Joseph Gilliam

Yes.

in think well, aberration the -- bit an normal we've little we new the in of was of a it seasonality. third perhaps of I versus what in what first, last But context August in couple seen of years. quarter, was the context the saw a

frankly, December U.S. in of through I in softening our we've short-term what commented headwinds back pattern procedures, some question, XXXX guidance, them. translates and Clearly, on October. really and potential XXXX glaucoma When into fee effective think but remarks, both was consideration continued year. that terms some it a was It it a seen the of And seasonality in into increased the try you fashion. was as facility more similar potential expect strength franchise. final similar because as XXXX in of across in what demand. final mentioned the XXXX. has think rule Tom in that, volatility That's quite of than we our about just within XXXX. we offset also all pretty our those the variety in we both as saw of by in dates, to were and And ordering and to we corneal you your I both take with U.S. franchises prepared a associated, health into payments glaucoma in XXXX variables the enter of LCD CMS July September, how exit strength

on the the We little -- of the payment. the more be folks end in of to more off where do hold be expect first disruption there fulsome a year bit quarter at them as procedures pay they'll could

there that's could U.S. also our some And We going based of end variety we That potential be also a the to disruptions health trending in a a iDose early operationally customer quarter to headwinds bit year as impact Several team in putting bit be service of FX in expect corneal launch areas quarter moves experience this sequential that create that business been we're priorities our little in glaucoma quarter. the upon those in place make ordering disruption well. some the anticipation and of we're of our of headwind like business. may a potential side could XXXX. things corneal incremental as where relation payer at in this can going operational in little fourth of the international on

Phillip Dantoin

further line Therapeutics for one about the That's helpful. that iDose. Stuart with and that time on ST-XXX drug candidate? you speak give that agreement And focus Can you just to then doesn't maybe

Thomas Burns

Yes, be I'll happy that. address to

what assaulted Stuart Stuart substantially in is glaucoma. a back the given And saw kind we a associated the hope very actually liked preparation. to you the fact But very neuroprotection bolus know, in It's of being compound. novel that in that grail. of by nascent in of aid you the we as and is glaucoma, the contemplate ganglion Can analysis. many pressure preserve it's has repeatedly eye, the cells which the holy has some of injection the could in we preclinical So what a that data with

again, early, a glaucoma It's Pharmaceuticals, formidable break proprietary. validates -- whole that novel that in a to making the exciting, it Stuart terribly into first. go like fact it's early. again, further advances ground terribly it treatment. say, to effort this we hopeful trial. clinical is area And We're here we're this compound, an of new a like I So But very and is both.

Operator

Joanne Our the next question Wuensch. line comes of from

Joanne Wuensch

about launch the in everything the start expenses dovetail little I'd then how but on including time your versus about talk bit an update not think what not think did could operating next. product as a be. sort Congrats which like you that on thinking something the iDose, And quarter. that exciting, to then about you do year maybe you've and less expenses. hear I of got a you this we XXXX, just preparing pipeline, year launching of is, your

Alex Thurman

operating start Alex. is I'll this the question. Joanne, expense with

And pleased just all, come of sequentially. the up modestly the to we as million, quarter of so, operating for X% only first in I were $XX did, which mean, was expenses they see shy

we've talked balance and to initial So trying anticipation again, prioritized we've pipeline our as past, to capital been towards with and sheet in of our we focused making happy as about basically adjustments in allocation. the were that. we that allocate And very our resources on iDose

about quarter asked fourth the You OpEx.

basically, what you for of sequential quarter. in from I seen saw charges. R&D to XX% the put to quarter or somewhere what a the would to the would around expect to a call total us which little guided what should typically so, want from point modest is it in line in the increase actually do this we past, fourth is in which quarter, we've this if excluding And standpoint, you seasonality -- guide a we with year, at was increase year, had a over last fourth little XX% quarter to, for the higher the IP than all third rise up again, tends we a what That

Joseph Gilliam

the we not relates side -- as expense then of part more planning. launch it product have those. other we're some the we there's into And think, means each getting those lot points think that your if going of mode overall Thankfully, going lot what quite towards on. expense year, planning we've perspective into in finer now question, Joanne, of how priorities. with against the sure second or balance a next do opportunity an been We're But from for which to, was of yes, the that time. I'm a We with I that

fulsome we're going iDose behind infinite hopefully pretty to side, invest enter is so iStent And commercial what be more XXXX continue a putting we the on our think bit covered we as we rich in quite to pipeline reimbursement -- a of then ultimately, opportunities. and full while with into

Joanne Wuensch

reasonable a given increase the starting bit, is point? Or a XX% push to higher else? XXXX, just it in So much is than everything annually that

Alex Thurman

to comment XXXX the what on operating we expense Joanne, would that, I our like. about profile look call and the when in think guidance quarter's talk next get we we'll and

Operator

Our call from Needham. David from Saxon line comes the next of

David Saxon

one a I'll on quick Maybe iDose. with start

and obviously August. mid-cycle guys review the completed you in inspection So

You mentioned label. draft a

do aside when you're from you is when expect out And And to XX. other before receive that? community? to that, going then do, you So share with that to investment call the milestones December something any

Thomas Burns

to that. I'm answer David, happy

that contest begins estimate there process to next near and So that is be label to draft provision receive extent their that then term, of gives days. or that upon we the let's routinely, the it response disagree for data in shape think from the they're ordinarily and call should what expect is would reviewing. FDA company the And based And they the labeling the with the best the the process to it, to several FDA's the that they label position.

occur the that will something date will won't that clearance. which be final, we period you will respect that hope, be done a prior that clearance. to probably prior can to think I we targeted favorable of the negotiation, the and PDUFA be PDUFA And privately. date as there'll And FDA So share

David Saxon

what's no timing concerns milestones document In posted, I'll that guess half I second this starting your just got approval of in so FDA And looks on you next the address my after had then in like question Does raised study And throw then a the to PreserFlo previously? that. other you year. of potential first estimate the here. product. it And the

Thomas Burns

best of -- as I relooking a novel believe, saying at we experience approach how the happy I safety might be I that in area. a evaluate and put to address given wouldn't mean, taken it we've as substantial I'll in the can. I I the efficacy device more, Well, our PreserFlo

commercialize our We're we'll year, with had So we discussions. as certainly wouldn't IDE half. up a within informed conclusion, we'll such those skill FDA. conclusion. be in successful too opening bite we've next potentially the that will are encouraged first to to the we things able apple. successful reach confident bring that year. be kind clinical et a product could And beginning a when with we'll of the part many first of study to I This very rate be comment think second a will and study in to the and conclusion an enrollment, early the you it art, we And into I on to enter of able hope that adoption next I cetera. of of that start finalizing tell that the in But to feel half study I

Operator

the Alan from comes of next from Our JPMorgan. Gong question line

K. Gong

mid-cycle to meeting. I your can't had the details iDose guess relative I timing. of interactions just one quick you share wondering, frame. past sound time confident the And of really kind the the of I review you December a But kind on meetings pushed side on I like was with worse just you not FDA, that us mid-cycle feel kind out or some do because and of better the are the delayed asking your we've to table. reasons roughly visible on line. seen getting in this of approvals I'm with past FDA understand

you curious anything gives of provide just and if you can what there's So confidence? that kind that

Thomas Burns

Yes. confident I I best we're going between that any the as reasonable that up as date I to review might now towards conclusion, for and of I'm And mid-cycle be FDA December feel for final guess I'd come give move given From pretty aware to to of everything tracking able assurance and XX. the we're that towards. that be potential can. searching review of the impediments happy

K. Gong

the been too iDose, question. the there's we another clearly think how kind reimbursement of much then quite talk about now. with Hopefully, there's to the and the and some think that want going just we years. last just of market But LCDs XXXX about going bumpiness be But changes. And growth few forward? XXXX, over takes we should stable about I puts MIGS don't understand when x few growth the market to a

Joseph Gilliam

not shifts on to all LCD our puts front the these is making I'm associated right with because the the we're MACs. XXXX be period, takes perhaps Alan, going way and through obviously sure Yes, measurement that various from the

as talking cataract. certainly fashion the in aside we've standard the increasingly in some parts that think I care healthy we're of moving from in to MIGS an continues combination of underlying that that settled becomes about market a grow there maybe

iStent be coming drive and approach the larger accelerate our a from interventional technologies, macro much standpoint, in that we in would the that Infinite to glaucoma stand-alone patient including expectation as by much, iDose Our patients. a population into years, starts again, that's served

think are net of things XXXX effect of context where the be So the may period where in procedures being settle a what I out done which. some

we've be once environment that comment macro a on think some work we'll to market. additional overall, that front. larger But a to said, done we're we after got going As from we're going favorable a headed I because much more standpoint,

Operator

And our Stephen line Lichtman from the of next Oppenheimer. question comes from

Unknown Analyst

might new the general? since Or lose for LCD trade-off market positive on to hopefully, net also just guys possible know see about else question just can I And guys balance? the your think Ron you since in a you maybe do for short much I probably was competitors will LCDs, has wanted is LCD. it the more another on everything This Steve. And this about everyone do MIGS a how is. this shrink for as you as asked ask business? think one, and a

Joseph Gilliam

as puts it XXXX. to think relevant with population. after short larger And what and over those one heart various as that growth. will term. shake going, But the said. in earlier restrict they have just I the share were term, of you obviously, Again, don't the I Yes, we question think at dynamics long of some a over or I term, is market is the to be the much the constrain much in the market here itself short as that's LCD patient answering relative back Ron, all the I similar what mean, we're how or out trade-off the will of is LCDs takes

a this think because out be it's neutral at But as that's LCD at part was that's we're a to of that, and that our quantify particularly technologies WPS. very positive this ultimately, to I evidence for stage amount should behind slightly far of upon the this single validated a LCD. confident least in that come of based thus difficult them

Unknown Analyst

iDose nobody the asked But follow-up I it plan? think promote not is just will guys one targeting or you and something trying of this as that on part is you about is -- it an office-based obviously, to yet. or that procedure market Okay. And can't be

Thomas Burns

Ron, to I'm address happy that.

and will advantages be just I moving understand. philosophically, environment. used. there And But site beginning, the agnostic it's so to product as we some we've is said to we're an from service where into is, think the where And of in-office do

work kind to the of relative proposal with MACs over on and to then able XXXX board course And will so the of is supposition there what the get create societies, into with reimburse MACs what scale be should level. at be non-facility that workup XXXX payment a our to a to and work of be

to will ASC, this our over then we move will have And assure in-office into continually give on that that programs be of ability ability product is to you within that And which so continue for study. I process. the dominant into well can And in-office time as work the be the surgeons committed the something will be use aid some the the development we facility. to time. to It want that doing an ongoing to we we'll alternative expect

Operator

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

Anthony Petrone

congrats momentum. And going good ones, on on in mild X expansion study iStent iDose. on that one here a your you comments on. on On just moderate good you Maybe infinite, have quick infinite, label prepared quarter quarter a the mentioned iStent a and one to

in data I out has had should just pivotal that primary X-month is the about think years. label, So the we company, XX-month terms When duration then, be we of And believe, endpoint, on study it we thinking month be And completed implant, data had see X so about right? you will of that a secondary to that? endpoint a study? iDose. what quickly on how large When

scenarios thinking we be of So iDose? just how for should of range the on implant about duration

Thomas Burns

our to whole product question, supplement the answer treatment and this philosophy we've Anthony, study yes, part glaucoma clinical first interventional intervention the To and Okay. the really of and to this And was infinite. move program. begun into earlier the with and iStent our the calculus

some And protocol will some will consist the glaucoma. both of open-angle mild so and under patients pseudophakic of fall that phakic that moderate descriptor

treatment supplemental, earliest for prior label allow This of question, a and therapy. repeat infinite have of a failed And the iStent both glaucoma. who us the will think positions on phases treatment could you iDose surgical be for and that ability we to device.Second open use alternative the again? infinite we nice that to medical now will patients the So iStent up to in combinatorial

Anthony Petrone

implant duration on label be of would and It for iDose.

You study have your at primary X-month endpoint. a

implant XX-month I has years. referenced a the endpoint. on But company X believe had to the secondary out data You

wide a duration high-level could be? range the just what on for any thinking of of the implant There's iDose there's there. scenarios So

Thomas Burns

Yes.

that I that remember, well was to that some to pivotal we've we for be about payers II robust to on X-year reasonable FDA endothelial years. we conduct the that loss prior patients study security. will an a a forward. pulled out I me device. primary Remember, patients What IIB Let Phase done where to address high have that degree cell years. assure Phase Timolol. with that set coverage approval X-month iDose of done And at X provide it moving data XX approval endpoint they iDose that longer too. of with that device. topical for pretty out the so seen the the all no That the think data that data that we'll the be carried that be show will to term. were a endpoint this X And basis for works and be the to FDA have we argument versus exchange data, exchanged, the we'll to re-consented and again, be non-inferiority exchange safety all indeed data. the with can there from cold is you can longer how how happy we'll term product And pristine the patients came you've the our And from we for There was will product pivotal up to approach payers assured does talk was show this that, that efficacy reasonable When a have basis of substantive iDose data, way determination least we I for think of confidence the the think agree assured

Operator

Sellers question next George of the Stephens. line from comes our from And

George Sellers

for Maybe thinking quick the back you where your share just you XXXX, me. do changes? could in just one one, reimbursement that market MIGS shifted XXXX, have to sense and the procedures us, a of for remind And of share how But end U.S. went? some

Joseph Gilliam

George, our basis. its on Joe. XXXX pretty about a in I results year-over-year U.S. franchise, at consistently look mean, if back every on glaucoma you down XX% quarter, our we were

think I least the share occurred. a period, gives at shift in that you sense good of that pretty time that

Beyond went. procedures of went that, of some goniotomy I share canaloplasty either that But I say upon surgical lion's don't depending have that would terms where combination in of the the data or preference. to that front me of procedures in

Operator

are the turn back there company. over I'll this questions. to further At it no time,

Thomas Burns

Okay.

So support And continued I of time for and today. all you for and interest to you we your want your again always thank of attention Glaukos. thank

So with goodbye. that,

Operator

does Have pleasant day. That a call. today's conclude

Glaukos (GKOS) 1 Nov 232023 Q3 Earnings call transcript